Industry Insights: Regulatory advances, clinical momentum, and dealmaking drive a dynamic period across the bioconjugate landscape

4D Path and Daiichi Sankyo announced a collaboration to develop physics-informed predictive biomarkers for ADC clinical development [1]

4D Path announced a collaboration with Daiichi Sankyo to develop predictive biomarkers for an ADC clinical development program using 4D Path's proprietary Q-Plasia OncoReader™ platform. The platform computes physics-informed, quantitative biomarkers associated with cell-cycle deregulation and TME dynamics from standard hematoxylin and eosin-stained tumor biopsy slides, without requiring specialist staining or molecular testing. The collaboration aims to identify patients most likely to benefit from the selected ADC, supporting more precise and cost-effective patient selection in both retrospective and prospective settings. The approach is also expected to generate mechanistic insights into tumor-specific patterns of response and resistance, including the relative contributions of ADC targets, linkers, and payloads to clinical outcomes.

Daiichi Sankyo and Imagene AI announced a collaboration to identify ADC biomarkers and guide patient stratification using multimodal AI [2]

Daiichi Sankyo announced a collaboration with Imagene AI to identify biomarkers predicting patient responses to cancer therapies and support ADC development using real-world data. Under the agreement, Daiichi Sankyo will leverage Imagene's OI Suite multimodal platform, powered by the CanvOI foundation model, to interpret hematoxylin and eosin and immunohistochemistry whole-slide images in the context of molecular profiles and longitudinal clinical outcomes. Imagene will develop response prediction models and apply its Composite Continuous Scoring method to assess target expression from immunohistochemistry, with the goal of enhancing companion diagnostic strategy and patient-therapy matching. The collaboration represents Daiichi Sankyo's third artificial intelligence-focused ADC partnership in 2026, following agreements with Tempus AI and BostonGene.

Roche and C4 Therapeutics announced a collaboration to develop degrader-antibody conjugates against undisclosed oncology targets [3]

Roche and C4 Therapeutics announced a collaboration to develop degrader-antibody conjugates (DACs) against two undisclosed oncology targets, expanding a partnership that dates to 2016. Under the agreement, C4 will design degrader payloads using its TORPEDO platform, combining AI-assisted design, DNA libraries, and proteomics, while Roche will select and engineer the antibody component and perform conjugation. Roche will be responsible for preclinical and clinical advancement and commercialization. The deal includes a $20M upfront payment to C4, with potential discovery, regulatory, and commercial milestones exceeding $1B, plus tiered royalties. Roche also holds an option to add a third target.

Roche and C4 Therapeutics announced a collaboration to develop degrader-antibody conjugates against undisclosed oncology targets; Collaborations, Acquisitions, and Partnerships. Credit: istockphoto.com

Gilead Sciences announced the acquisition of Tubulis for up to $5B, adding an ADC pipeline and proprietary P5 cysteine-selective conjugation platform [4]

Gilead Sciences announced an agreement to acquire Tubulis for $3.15B upfront, with total consideration reaching up to $5B including milestones. The acquisition adds an early-stage ADC pipeline and Tubulis' proprietary P5 conjugation platform, a cysteine-selective chemistry designed to generate ADCs with highly stable linkers and enhanced biophysical properties. The lead asset, TUB-040, is an NaPi2b-targeting topoisomerase 1 (Topo 1) inhibitor ADC in Phase 1b/2 evaluation for platinum-resistant ovarian cancer and non-small cell lung cancer (NSCLC). The acquisition also includes TUB-030, a 5T4-targeting ADC with early clinical data across multiple solid tumor types. Tubulis will operate as a dedicated ADC research unit within Gilead following deal closure.

Akari Therapeutics and WuXi XDC announced a strategic partnership to advance Akari's novel RNA splicing modulating ADC payload [5]

Akari Therapeutics announced a strategic partnership with WuXi XDC to accelerate development of its proprietary PH1 payload, a spliceosome modulator designed to disrupt RNA splicing in cancer cells. PH1 is designed to combine direct cytotoxicity with activation of innate and adaptive immune responses. The partnership will support advancement of AKTX-101, a Trop2-targeting ADC incorporating the PH1 payload, initially targeting metastatic urothelial cancer, toward a Phase 1 clinical trial expected to initiate in late 2026 or early 2027, subject to regulatory clearance. In preclinical studies, AKTX-101 demonstrated superior antitumor regression and complete remissions compared to other ADCs. WuXi XDC will support further validation and advancement of the PH1 payload across Akari's ADC pipeline.

Zai Lab and Amgen announced a clinical trial collaboration to evaluate DLL3-targeting ADC in combination with tarlatamab in SCLC [6]

Zai Lab and Amgen announced a global clinical trial collaboration to evaluate zocilurtatug pelitecan (zoci), a DLL3-targeting ADC, in combination with tarlatamab-dlle (IMDELLTRA®), a DLL3-targeting bispecific T-cell engager, in patients with extensive-stage small cell lung cancer (SCLC). Amgen will sponsor a global Phase 1b study to assess safety and efficacy of the combination, with Zai Lab retaining full ownership of zoci and supplying the study drug. The combination strategy is designed to leverage complementary mechanisms: zoci delivers a cytotoxic payload directly to DLL3-expressing tumor cells, while tarlatamab activates T cells against the same antigen.

NJ Bio and Ajinomoto Bio-Pharma Services announced a collaboration to integrate site-specific conjugation platform into ADC discovery workflows [7]

NJ Bio and Ajinomoto Bio-Pharma Services announced a research collaboration to integrate the AJICAP™ site-specific conjugation platform into NJ Bio's discovery and early development workflows. AJICAP enables precise chemical modification at defined lysine residues without antibody engineering, preserving antibody structure and functionality while supporting improved pharmacokinetics, therapeutic index, and developability across cytotoxic and non-cytotoxic payloads. The platform is compatible with a range of stable, hydrophilic linker systems and standard antibody production processes. Through the collaboration, NJ Bio's clients will gain access to a scalable, reproducible site-specific conjugation approach to support next-generation ADC and targeted therapeutic development from early drug design through preclinical development.

Biocytogen and Taisho Pharmaceutical announced a platform license agreement for fully human heavy chain-only antibody discovery [8]

Biocytogen announced a platform license agreement with Taisho Pharmaceutical that grants access to its proprietary RenNano® fully human heavy-chain-only antibody discovery platform for internal research and development programs. Under the agreement, Taisho will use RenNano mice to generate and screen fully human heavy-chain-only antibodies in vivo to support downstream antibody discovery workflows. The platform is designed to generate fully human VHH antibodies with high diversity, specificity, affinity, and favorable developability, supporting next-generation antibody modalities including bispecific antibodies, ADCs, and in vivo CAR-T therapies.

Biocytogen and Taisho Pharmaceutical announced a platform license agreement for fully human heavy chain-only antibody discovery; Collaborations, Acquisitions, and Partnerships. Credit: istockphoto.com

Tempus AI and Daiichi Sankyo announced a collaboration to accelerate ADC development through AI-driven biomarker discovery and patient stratification [9]

Tempus AI announced a collaboration with Daiichi Sankyo aimed at accelerating ADC development in oncology through AI-driven biomarker discovery and patient stratification. Under the agreement, Daiichi Sankyo will apply Tempus's PRISM2 multimodal foundation model, which integrates pathology imaging with clinical data, to build proof-of-concept models designed to optimize patient selection for novel ADC programs. The models will be deployed across Tempus's oncology database to map treatment responses and support the design of control groups for future clinical trials, combining Daiichi Sankyo's clinical and preclinical ADC data with Tempus's real-world dataset.

Aptamer Group and Radiopharmium announced a collaboration to develop Optimer®-based radioconjugates for targeted radiopharmaceutical applications [10]

Aptamer Group announced a collaboration with Radiopharmium Ltd to develop targeted radiopharmaceuticals using its Optimer® synthetic binder platform. The program will initially target three proprietary therapeutic targets, expanding Aptamer's radiopharmaceutical pipeline to four assets alongside an existing partnered program with a top-3 global pharmaceutical company. Aptamer has previously developed fully integrated radioligand conjugates incorporating proprietary chemistry, linkers, and chelation systems, evaluating stability with Gallium-68 (Ga-68) and Lutetium-177 (Lu-177). Comparative testing demonstrated only 8% degradation of Lu-177 Optimer®-based radioligands at 24 hours in the absence of ascorbic acid, versus 34–83% degradation observed for leading peptide comparators under equivalent conditions. In vivo data from the expanded pipeline are targeted for delivery by the end of 2026.

Voro Therapeutics and Daiichi Sankyo announced a research collaboration to develop masked ADC candidates using PrimeBody™ platform [11]

Voro Therapeutics announced a research collaboration with the Daiichi Sankyo Research Institute San Diego to evaluate the PrimeBody™ platform for generating masked ADC candidates. The platform incorporates proprietary masking domains and protease-cleavable linkers designed to maintain biologics in an inactive state during systemic circulation and in healthy tissues, with selective activation occurring within the TME. Under the agreement, Voro will apply its masking and linker technologies to design and characterize masked ADC candidates against a selected oncology target. The approach aims to improve therapeutic index by enabling tumor-selective payload activation, with the potential to expand the addressable target universe to antigens with broad expression profiles.

GlycoNex received Japanese regulatory approval to initiate a Phase 1 trial of glycan-targeting ADC GNX1021 in advanced gastrointestinal cancers [12]

GlycoNex announced that Japan's Pharmaceuticals and Medical Devices Agency has approved the initiation of a first-in-human Phase 1 clinical trial of GNX1021, a glycan-targeting ADC designed to address tumor heterogeneity in gastrointestinal cancers. The multicenter, multinational study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of GNX1021 and establish a recommended dose range for subsequent development. The trial will initially be conducted in Japan and Taiwan, with patient enrollment in Japan expected to begin in June 2026. GlycoNex plans to submit an IND application in Taiwan in June 2026, with enrollment anticipated in the third quarter of 2026. The milestone marks GlycoNex's transition to a clinical-stage company for its proprietary glycan-targeting ADC platform.

DualityBio submitted a BLA in China for HER2-targeting ADC trastuzumab pamirtecan in second-line metastatic breast cancer [13]

DualityBio announced that China's National Medical Products Administration has accepted for review a BLA for trastuzumab pamirtecan (T-Pam), a third-generation HER2-targeting Topo 1 inhibitor-based ADC developed using DualityBio's proprietary DITAC platform, for second-line treatment of unresectable or metastatic HER2-positive breast cancer. The application is based on positive interim results from the Phase 3 DB-1303-O-3001 trial, in which trastuzumab pamirtecan demonstrated a statistically significant improvement in progression-free survival versus trastuzumab emtansine as assessed by blinded independent central review. Trastuzumab pamirtecan is being co-developed by DualityBio and BioNTech and is also being evaluated in global pivotal trials in HER2-low hormone receptor-positive metastatic breast cancer and second-line endometrial cancer, among other indications.

NextCure's CDH6-targeting ADC received US FDA Fast Track designation for platinum-resistant ovarian cancer [14]

NextCure announced that the US FDA has granted Fast Track designation to SIM0505, an investigational ADC comprising a CDH6-targeting antibody conjugated to a proprietary Topo 1 inhibitor payload, for the treatment of platinum-resistant ovarian cancer. The designation is intended to facilitate more frequent interactions with the FDA to accelerate development. NextCure plans to initiate dose optimization in ovarian cancer patients in the second quarter of 2026. Evaluation is ongoing in an open-label Phase 1 study in advanced solid tumors.

Corbus Pharmaceuticals announced US FDA alignment on registrational study designs for Nectin-4-targeting ADC CRB-701 in HNSCC and cervical cancer [15]

Corbus Pharmaceuticals announced broad alignment with the US FDA on registrational study designs for CRB-701, a Nectin-4-targeting ADC incorporating a site-specific cleavable linker, homogeneous DAR of 2, and MMAE payload, in second-line head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Both agreed registrational designs are single randomized controlled studies comparing CRB-701 to physician's choice chemotherapy, with objective response rate as the primary endpoint for potential accelerated approval and overall survival for full approval. A registrational study in second-line HNSCC is expected to initiate in mid-2026.

Zymeworks' FRα-targeting ADC ZW191 received US FDA Fast Track designation for platinum-resistant ovarian cancer [16]

Zymeworks announced that the US FDA has granted Fast Track designation to ZW191, an ADC targeting folate receptor-α (FRα), for the treatment of advanced or metastatic platinum-resistant ovarian cancer. The designation was granted irrespective of FRα expression level, supporting ZW191's potential applicability across a broad patient population without biomarker selection. ZW191 is engineered to internalize into FRα-expressing cells and release a proprietary Topo 1 inhibitor payload (ZD06519) with bystander activity. ZW191 is currently being evaluated in a Phase 1 study (NCT06555744) assessing safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with advanced solid tumors.

Trastuzumab deruxtecan received conditional approval in China for neoadjuvant treatment of HER2-positive early-stage breast cancer [17]

Daiichi Sankyo and AstraZeneca announced that China's National Medical Products Administration granted conditional approval for trastuzumab deruxtecan (ENHERTU), followed by paclitaxel, trastuzumab, and pertuzumab, for the neoadjuvant treatment of adults with HER2-positive high-risk stage 2 or stage 3 breast cancer. Approval was based on Phase 3 DESTINY-Breast11 trial data, in which trastuzumab deruxtecan followed by paclitaxel, trastuzumab, and pertuzumab achieved a pathological complete response rate of 67.29% versus 56.25% with dose-dense doxorubicin and cyclophosphamide followed by paclitaxel, trastuzumab, and pertuzumab (difference: 11.17%; 95% CI: 3.95–18.28; p=0.003). Full approval is contingent on ongoing adjuvant studies confirming long-term clinical benefit. This represents the first global approval of trastuzumab deruxtecan for neoadjuvant treatment of HER2-positive early-stage breast cancer.

Trastuzumab deruxtecan received conditional approval in China for neoadjuvant treatment of HER2-positive early-stage breast cancer; Regulatory Changes and Updates. Credit: mims.com

Kelun-Biotech received IND approval in China for TAA-PD-L1 bispecific ADC SKB103 in advanced solid tumors [18]

Kelun-Biotech announced that China's National Medical Products Administration Center for Drug Evaluation has approved the IND application for SKB103, a bispecific ADC developed using the company's proprietary OptiDC™ platform, for the treatment of advanced solid tumors. SKB103 is designed to simultaneously deliver cytotoxic payload to tumor cells while modulating the tumor immune microenvironment through combined tumor-associated antigen targeting and PD-L1 blockade within a single molecule. Preclinical studies demonstrated antitumor activity and a favorable safety profile.

CanWell Pharma received US FDA IND clearance for dual-payload HER2-targeting ADC CAN016 in ADC pre-treated solid tumors [19]

CanWell Pharma announced US FDA clearance of an IND application for CAN016, a HER2-targeting dual-payload ADC developed using the company's proprietary StarLinker platform. CAN016 integrates two distinct cytotoxic agents with complementary mechanisms of action within a single antibody construct, designed to counter resistance mechanisms that limit single-payload ADC efficacy. In preclinical studies, CAN016 demonstrated synergistic tumor cell killing and potent antitumor activity across multiple cell line-derived and patient-derived xenograft models, including those resistant to approved HER2-targeted ADC therapies. A Phase 1 study will evaluate safety, tolerability, and pharmacokinetics, determine the recommended dose for further development, and explore preliminary antitumor efficacy in HER2-expressing solid tumors in patients who have progressed following prior ADC therapy.

Trastuzumab deruxtecan's prescribing information updated in Japan to include second-line treatment of HER2-positive gastric cancer [20]

Daiichi Sankyo announced that Japan's Pharmaceuticals and Medical Devices Agency has accepted an update to the trastuzumab deruxtecan (ENHERTU®) prescribing information, expanding its approved use to include second-line treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer. The update is supported by Phase 3 DESTINY-Gastric04 trial data, in which trastuzumab deruxtecan demonstrated a 30% reduction in risk of death versus ramucirumab plus paclitaxel (hazard ratio: 0.70; 95% CI: 0.550–0.896; p=0.0044), with a median overall survival of 14.7 months versus 11.4 months. The safety profile was consistent with prior trials, with interstitial lung disease occurring in 11.6% of patients across multiple clinical trials requiring close monitoring.

GSK's B7-H3-targeting ADC risvutatug rezetecan received orphan drug designation in Japan for small-cell lung cancer [21]

GSK announced that risvutatug rezetecan, a B7-H3-targeting ADC, has received Orphan Drug Designation from Japan's Ministry of Health, Labour and Welfare for the treatment of SCLC. The designation was supported by preliminary clinical data from the Phase 1 ARTEMIS-001 trial demonstrating durable responses in patients with extensive-stage SCLC. This represents the sixth regulatory designation received for risvutatug rezetecan, which is under clinical investigation across multiple solid tumor indications, including lung, prostate, and colorectal cancers.

Trastuzumab deruxtecan received Japan's first tumor-agnostic approval for a HER2-directed ADC across multiple solid tumor types [22]

Daiichi Sankyo announced Japan's Ministry of Health, Labour and Welfare approval of trastuzumab deruxtecan (ENHERTU), for adult patients with HER2-positive advanced or recurrent solid cancers refractory or intolerant to standard treatments. This represents the first tumor-agnostic approval for a HER2-directed medicine and ADC in Japan. Approval was based on four Phase 2 trials, with confirmed objective response rates of 56.5% (HERALD), 61.3% (DESTINY-PanTumor02), 52.9% (DESTINY-Lung01), and 46.9% (DESTINY-CRC02) across a broad range of tumor types, including biliary tract, colorectal, cervical, endometrial, and non-small cell lung cancers. A companion diagnostic for liquid biopsy HER2 amplification testing was approved alongside this indication. Interstitial lung disease, occurring in 11.6% of patients across trials, requires close monitoring.

EMA validated a review application for enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment in muscle-invasive bladder cancer [23]

Astellas Pharma announced that the European Medicines Agency (EMA) has validated for review a Type II Variation Application for enfortumab vedotin, a Nectin-4-targeting ADC, in combination with pembrolizumab as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer eligible for cisplatin-containing chemotherapy. The application is supported by Phase 3 EV-304 (KEYNOTE-B15) trial data, in which the combination reduced the risk of tumor recurrence, progression, or death by 47% and risk of death by 35% versus neoadjuvant gemcitabine and cisplatin. Pathological complete response was achieved in 55.8% of patients in the combination arm versus 32.5% in the chemotherapy arm.

Chugai obtained Japanese regulatory approval for polatuzumab vedotin in combination with mosunetuzumab in relapsed or refractory large B-cell lymphoma [24]

Chugai Pharmaceutical announced approval from Japan's Ministry of Health, Labour and Welfare for the combination of polatuzumab vedotin, a first-in-class CD79b-targeting ADC conjugated to an antimitotic payload, and mosunetuzumab, a CD20/CD3 bispecific monoclonal antibody, for the treatment of relapsed or refractory large B-cell lymphoma. This represents the first global approval for this combination in this indication. Approval was based on the Phase 3 SUNMO study, in which the combination achieved an objective response rate of 69.7% versus 44.1% for rituximab, gemcitabine, and oxaliplatin, with a progression-free survival of 11.5 months versus 3.8 months and a 59% reduction in the risk of disease progression or death. The safety profile was consistent with the known profiles of each agent individually.

Chugai obtained Japanese regulatory approval for polatuzumab vedotin in combination with mosunetuzumab in relapsed or refractory large B-cell lymphoma; Regulatory Changes and Updates. Credit: istockphoto.com

Adcendo raised $75M in Series C financing to advance three ADC candidates through clinical development [25]

Adcendo announced a $75M Series C financing led by Jeito Capital, bringing total funds raised to over $310M. The round will support clinical advancement of three ADC candidates. ADCE-T02, a tissue factor-targeting ADC incorporating a hydrophilic cleavable linker and exatecan payload licensed from Multitude Therapeutics, is in Phase 1 cohort expansion in HNSCC, pancreatic ductal adenocarcinoma, colorectal cancer, and NSCLC. ADCE-D01, a uPARAP-targeting ADC delivering a deruxtecan payload, is in Phase 1/2 dose escalation in soft tissue sarcoma and other mesenchymal cancers. A third candidate, ADCE-B05, targets an undisclosed antigen in squamous cell carcinomas, with a dose escalation study planned imminently. New investors include Vida Ventures, BPI France, and EIFO.

Sidewinder Therapeutics raised $137M in Series B financing to advance its bispecific ADC pipeline in solid tumors [26]

Sidewinder Therapeutics announced a $137M Series B financing co-led by Frazier Life Sciences and Novartis Venture Fund, with participation from OrbiMed, Life Sciences at Goldman Sachs Alternatives, DCVC Bio, Samsara BioCapital, Longwood Fund, Astellas Venture Management, and Alexandria Venture Investments. The funding will support development of the company's bispecific ADC pipeline, which targets receptor co-complexes highly expressed on solid tumors to enhance tumor cell specificity and internalization, with a focus on HNSCC, lung, and gastrointestinal cancers. Sidewinder has partnered with Synaffix, a Lonza subsidiary, to apply its site-specific linker-payload platform across multiple programs. The company's lead program is expected to enter clinical development in 2027.

Stipple Bio emerged from stealth with a $100M Series A to advance epitope-targeted ADC platform toward clinical development [27]

Stipple Bio announced its emergence from stealth alongside an oversubscribed $100M Series A financing, led by RA Capital, a16z Bio+Health, and Nextech Invest. The company is developing ADCs designed to target tumor-specific epitopes, with a focus on epitope selection as the primary driver of tumor selectivity rather than conventional payload or linker innovation. Its lead preclinical candidate, STP-100, is designed to engage tumor-specific epitopes while minimizing binding to normal tissue, with a Phase 1 clinical trial planned for early 2027. The approach is based on the concept of tumor-specific "epitomics," exploiting differences in epitope accessibility between malignant and healthy cells to improve the therapeutic index of ADC therapies.

Oncomatryx raised $67M to advance its Quantum ADC pipeline targeting the tumor microenvironment into clinical trials [28]

Oncomatryx announced a $67M funding round to support the clinical development of its Quantum ADC pipeline targeting the TME. The round was led by existing institutional investors, including a $28M strategic investment from the Spanish Government through CDTI's Innvierte programme, $18M from Kutxa Fundazioa, $12M from the Basque Government and Ekarpen VC, and $2M from BBK, alongside private investors. The funding will support advancement of lead candidate OMTX705 and progress OMTX105 and additional Quantum ADC candidates into clinical trials.

Intensity Therapeutics announced the issuance of a new US patent covering its non-covalent drug-conjugation technology for cancer treatment [29]

Intensity Therapeutics announced the issuance of US Patent No. 12,496,345, in December 2025, supporting its non-covalent drug-conjugation technology platform. The platform is designed to create drug products that kill tumors and enhance immune system recognition of cancers. The new patent adds to Intensity Therapeutics' existing portfolio of registered trademarks and proprietary know-how, reinforcing the novelty of its conjugation approach in both the US and international markets.

Ryvu Therapeutics reported progress on its ADCraft project developing next-generation small-molecule payloads for ADCs in oncology [30]

Ryvu Therapeutics provided an update on its ADCraft project, a grant-funded initiative focused on discovering and evaluating next-generation small-molecule payloads for ADCs in oncology, encompassing both synthetic lethal and immunocytotoxic mechanisms. The project, supported by PLN 9.9M in funding from the Medical Research Agency toward a total net project value of PLN 13.2M, aims to develop methods for identifying and testing novel ADC payload classes alongside a broader portfolio of R&D activities in oncology therapeutic modalities. The ADCraft project forms part of Ryvu's dual-pronged preclinical discovery strategy alongside the ONCO Prime precision oncology platform, with the goal of advancing future oncology therapies addressing high unmet medical needs.

Henlius presented preclinical data for CDH17-targeting ADC HLX403 in gastrointestinal cancers at ADC Asia Congress 2026 [31]

Henlius presented preclinical data for HLX403, a CDH17-targeting ADC developed using its proprietary Hanjugator™ platform, at the ADC Asia Congress 2026. CDH17 is selectively overexpressed in gastric, colorectal, and pancreatic cancers, making it an attractive ADC target. HLX403 demonstrated nanomolar binding affinity and high cadherin-family specificity. The Hanjugator™ hydrophilic linker-payload platform conferred a 19.7-fold stronger bystander killing effect than deruxtecan-based ADCs, with superior efficacy demonstrated across multiple cell line-derived xenograft and patient-derived xenograft models, including drug-resistant and low CDH17-expressing tumors. In non-human primate toxicology studies, the highest non-severely toxic dose was established at 40 mg/kg. A first-in-human clinical trial is expected to commence in the third quarter of 2026.

Cellectar Biosciences enrolled the first patient in a Phase 1b trial of Auger-emitting radioconjugate CLR 125 in triple-negative breast cancer [32]

Cellectar Biosciences announced enrollment of the first patient in a Phase 1b trial of CLR 125, a proprietary phospholipid drug conjugate (PDC) incorporating iodine-125 as an Auger-emitting radioconjugate, for the treatment of relapsed or refractory triple-negative breast cancer (TNBC). CLR 125 shares the molecular structure of iopofosine I 131 but differs in radiobiologic behavior, delivering intracellular Auger electron radiation to achieve direct DNA-level damage in tumor cells. The open-label, dose-escalation study will evaluate three dose levels and dosing regimens across approximately 15 patients per treatment arm, with endpoints including safety, tolerability, tumor response per RECIST criteria, and progression-free survival. Preclinical studies demonstrated selective tumor uptake and significant in vivo activity in triple-negative breast cancer models with no observed end-organ or hematologic toxicity.

Samsung Bioepis initiated a Phase 1 first-in-human trial of Nectin-4-targeting ADC SBE303 in advanced refractory solid tumors [33]

Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SBE303, the company's first novel ADC candidate, targeting Nectin-4, an adhesion protein overexpressed in tumor cells including urothelial, lung, and breast cancers. The open-label, multicenter, first-in-human study is designed to evaluate the safety, tolerability, and efficacy of SBE303 in patients with advanced refractory solid tumors.

Genmab reported Phase 1/2 safety data for FRα-targeting ADC in combination with bevacizumab in recurrent ovarian cancer [34]

Genmab presented safety data from cohort D2 of the Phase 1/2 RAINFOL™-01 study evaluating rinatabart sesutecan (Rina-S®), a FRα-targeting Topo I inhibitor ADC, in combination with bevacizumab in 40 patients with recurrent ovarian cancer. The combination demonstrated a manageable safety profile consistent with the known profiles of each individual agent, with no new or unexpected safety signals. The most common treatment-emergent adverse events were nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No ocular toxicities, peripheral neuropathy, interstitial lung disease, or clinically significant bleeding were reported. Rina-S is currently being evaluated in three Phase 3 trials across platinum-resistant ovarian cancer, recurrent endometrial cancer, and platinum-sensitive ovarian cancer maintenance settings, as well as a Phase 2 study in NSCLC.

GSK reported Phase 1 data for B7-H4-targeting ADC mocertatug rezetecan in ovarian and endometrial cancers and announced five pivotal trials [35]

GSK reported Phase 1b data from the BEHOLD-1 trial evaluating mocertatug rezetecan, a B7-H4-targeting ADC incorporating a topoisomerase inhibitor payload, in platinum-resistant ovarian cancer and recurrent or advanced endometrial cancer. At 5.8 mg/kg, confirmed objective response rate was 62% in platinum-resistant ovarian cancer; at 4.8 mg/kg, confirmed objective response rate was 67% in endometrial cancer. Median duration of response had not been reached at the interim analysis. Grade ≥3 treatment-related adverse events, primarily haematologic, occurred in 64% and 54% of patients respectively, with low discontinuation rates and infrequent interstitial lung disease or pneumonitis. GSK announced plans to initiate five Phase 3 trials, with the first two using a recommended dose of 5.8 mg/kg.

AbbVie reported Phase 2 data for mirvetuximab soravtansine in combination with carboplatin in folate receptor alpha-positive platinum-sensitive ovarian cancer [36]

AbbVie presented late-breaking results from the Phase 2 IMGN853-0420 trial evaluating mirvetuximab soravtansine-gynx, a first-in-class FRα-targeting ADC, plus carboplatin followed by mirvetuximab soravtansine-gynx maintenance in 125 patients with FRα-positive recurrent platinum-sensitive ovarian cancer. Confirmed objective response rate was 62.7% in the FRα ≥50% subgroup and 62.4% in the overall population after induction. Overall population objective response rate increased to 68% with continuation monotherapy. Median duration of response was 11.2 months. In patients with prior PARP inhibitor exposure (49% of the overall population), objective response rate was 63.9%. The safety profile was consistent with prior studies, with low-grade reversible ocular events being the most common treatment-related adverse event.

BioNTech and DualityBio reported positive Phase 2 data for trastuzumab pamirtecan across all HER2 expression levels in advanced endometrial cancer [37]

BioNTech and DualityBio reported primary analysis results from a Phase 2 cohort evaluating trastuzumab pamirtecan, a HER2-targeting Topo 1 inhibitor-based ADC, in 145 patients with HER2-expressing advanced endometrial cancer progressing after first-line therapy. In 73 centrally tested patients with prior checkpoint inhibitor treatment, confirmed objective response rate was 49.3%. Across all 96 centrally tested patients, confirmed objective response rate was 47.9% with a median progression-free survival of 8.1 months. Responses were observed across all HER2 expression levels, including IHC1+ (33.9%) and IHC2+ (40.4%). Grade ≥3 treatment-related adverse events occurred in 46.9% of patients. A global confirmatory Phase 3 trial and a planned US FDA BLA filing are underway for 2026.

ArkBio dosed the first healthy volunteers in a Phase 1 trial of antiviral Fc conjugate AK0406 for influenza infection [38]

Shanghai Ark Biopharmaceutical announced the dosing of the first cohort of healthy volunteers in a Phase 1 clinical trial of AK0406, a novel long-acting antiviral drug-Fc conjugate (ADFC) for influenza infection, following approval by the Human Research Ethics Committee in Australia. AK0406 is designed to combine the direct antiviral activity of a small-molecule payload with Fc-mediated immune clearance and extended half-life through conjugation of a potent antiviral to the antibody Fc domain. Preclinical data demonstrated broad-spectrum activity against both influenza A and B viruses, maintained immune effector function, and prolonged exposure. The Phase 1 study is a randomized, double-blind, placebo-controlled trial assessing safety, tolerability, and pharmacokinetics in healthy adults, with data to inform subsequent dose selection and proof-of-concept trials.

ArkBio dosed the first healthy volunteers in a Phase 1 trial of antiviral Fc conjugate AK0406 for influenza infection; Clinical Trials and Research. Credit: arkbiosciences.com

Adcytherix dosed the first patient in a Phase 1 trial of exatecan-based ADC ADCX-020 in advanced solid tumors [39]

Adcytherix announced the dosing of the first patient in a Phase 1 open-label clinical trial of ADCX-020, an ADC incorporating a stable linker and an exatecan-derived Topo 1 inhibitor payload, in patients with advanced solid tumors. The study includes a dose-escalation phase followed by dose-optimization and selected cohort expansion in patients with relapsed or refractory disease, designed to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. ADCX-020 was developed using the company's proprietary ADCX Engine platform and is designed to address therapeutic index limitations of earlier ADC products.

IDEAYA Biosciences dosed the first patient in a Phase 1 combination study of DLL3-targeting ADC IDE849 and PARG inhibitor IDE161 in solid tumors [40]

IDEAYA Biosciences announced first-patient-in for a Phase 1 combination study evaluating IDE849, a potentially first-in-class DLL3-targeting Topo 1 payload ADC, with IDE161, a potentially first-in-class poly(ADP-ribose) glycohydrolase inhibitor, in DLL3-upregulated solid tumors, including SCLC, neuroendocrine tumors, neuroendocrine carcinomas, and melanoma. The combination is designed to induce accumulation of Topo 1 cleavage complexes through complementary DNA damage repair mechanisms, enhancing antitumor activity and durability. In the ongoing IDE849 Phase 1 monotherapy dose escalation study, multiple partial responses have been observed at 2.4 mg/kg, including 3 of 4 responses in SCLC patients pre-treated with tarlatamab. IDEAYA aims to initiate a registrational study for IDE849 monotherapy by year-end.

PDS Biotechnology reported early Phase 2 data for IL-12 immunocytokine PDS01ADC in combination with docetaxel in metastatic castration-resistant prostate cancer [41]

PDS Biotechnology reported encouraging early results from a National Cancer Institute-led Phase 2 trial evaluating PDS01ADC, an interleukin-12 tumor-targeted immunocytokine, in combination with docetaxel in patients with metastatic castration-resistant prostate cancer, the majority of whom received the combination as a third-line treatment. The combination demonstrated a median progression-free survival of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% PSA decline.

Callio Therapeutics dosed the first patient in a Phase 1 trial of dual-payload HER2-targeting ADC CLIO-8221 in advanced solid tumors [42]

Callio Therapeutics announced that the first patient has been dosed in a Phase 1 clinical trial evaluating CLIO-8221, a first-in-class dual-payload HER2-targeting ADC combining a Topo 1 inhibitor (exatecan) and an ATR inhibitor payload, in patients with advanced HER2-expressing solid tumors. The trial is ongoing in Australia and the US, following US FDA investigational new drug clearance, with planned expansion to China pending National Medical Products Administration review. In preclinical models, CLIO-8221 demonstrated tumor regression in both Topo 1 inhibitor-insensitive and -refractory models and superior efficacy compared with single-payload ADCs. The dual-payload approach is designed to address resistance mechanisms associated with single-payload ADCs, with a next-generation linker platform intended to support a broad therapeutic window.

Alphamab Oncology dosed the first patient in a Phase 3 trial of bispecific TROP2/HER3 ADC JSKN016 in triple-negative breast cancer [43]

Alphamab Oncology announced that the first patient has been dosed in JSKN016-301, a Phase 3 open-label, randomized, controlled, multicenter trial evaluating JSKN016, a bispecific ADC co-targeting TROP2 and HER3. JSKN016 features a homogeneous DAR ratio of 4 achieved through glycan-specific conjugation, delivering a Topo 1 inhibitor payload with the aim of simultaneously blocking tumor signaling pathways and enhancing intracellular payload delivery. The study will evaluate JSKN016 versus treatment of physician's choice in patients with unresectable locally advanced, recurrent, or metastatic TNBC who have failed at least 2 prior lines of systemic therapy, across approximately 60 sites in China. Co-primary endpoints are progression-free survival and overall survival as assessed by a blinded independent review committee.

Alphamab Oncology dosed the first patient in a Phase 3 trial of bispecific TROP2/HER3 ADC JSKN016 in triple-negative breast cancer; Clinical Trials and Research. Credit: alphamabonc.com

Antengene reported Phase 2 clinical data for CLDN18.2-targeting ADC ATG-022 in gastric cancer and announced plans for a pivotal Phase 3 trial [44]

Antengene reported updated data from the Phase 2 CLINCH study of ATG-022, a Claudin 18.2 (CLDN18.2)-targeting ADC, demonstrating potent antitumor activity across all levels of CLDN18.2 expression in gastric cancer and other CLDN18.2-positive solid tumors. Grade 3 or higher treatment-related adverse events were reported in 19.4% of patients, supporting a favorable safety profile. Clinical development is being advanced across first-, second-, and third-line gastric cancer settings, including combinations with checkpoint inhibitors and chemotherapy. A pivotal Phase 3 monotherapy trial in gastric cancer is planned, with enrollment expected to begin in the second half of 2026. Updated clinical data are expected in the second quarter of 2026.

OKYO Pharma reported Phase 2a quality-of-life data for lipid-conjugated peptide agonist urcosimod in neuropathic corneal pain [45]

OKYO Pharma reported exploratory patient-reported outcome data from a Phase 2a randomized, double-masked, placebo-controlled study of urcosimod, a lipid-conjugated chemerin peptide agonist of the ChemR23 receptor, in 12 patients with neuropathic corneal pain. After 12 weeks, patients receiving urcosimod (n=6) demonstrated greater improvements versus placebo (n=6) across measures, including enjoyment of life and relationships (mean change from baseline −4.5 versus 0), mood (−1.5 versus −0.5), and time spent thinking about eye pain (−3.0 versus −1.5). These secondary findings build on previously reported primary efficacy signals showing meaningful pain reductions on the Visual Analogue Scale. OKYO Pharma plans a larger confirmatory Phase 2b/3 trial.

Aro Biotherapeutics reported positive Phase 1b data for CD71-targeting siRNA conjugate ABX1100 in late-onset Pompe disease [46]

Aro Biotherapeutics announced positive topline results from the Phase 1b portion of a clinical study evaluating ABX1100, an investigational conjugate comprising a CD71 receptor-binding Centyrin linked to a short-interfering RNA (siRNA) targeting glycogen synthase 1 (GYS1) messenger RNA (mRNA), as an add-on to enzyme replacement therapy in nine patients with late-onset Pompe disease. ABX1100 achieved approximately 62% GYS1 mRNA knockdown in quadriceps muscle through Week 10, with observed siRNA levels at Week 16 supporting quarterly or less frequent dosing. A mean improvement in forced vital capacity of approximately 2.5% was observed at 5 months in seven evaluable patients. No infusion reactions, serious adverse events, or treatment discontinuations were reported. Full results will be presented at a future scientific conference.

Bicycle Therapeutics reported Duravelo-2 dose selection data and announced a strategic reprioritization toward next-generation conjugates [47]

Bicycle Therapeutics reported initial dose-selection data from the Duravelo-2 trial evaluating zelenectide pevedotin, a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, for metastatic urothelial cancer. The 6 mg dose achieved a physician-assessed overall response rate (ORR) of 65% and a blinded independent central review-confirmed ORR of 58% at the 27-week cutoff, with a differentiated tolerability profile. Following regulatory feedback from the US FDA, European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA), the existing trial design is no longer considered an acceptable approval path. The company plans to convert Duravelo-2 to a randomized Phase 2 trial. Bicycle Therapeutics announced a strategic reprioritization toward nuzefatide pevedotin, a BDC targeting EphA2, and its Bicycle Radioconjugate pipeline, including isotope supply partnerships to support commercial-scale radiopharmaceutical development.

Kyntra Bio reported Phase 1b/2 combination data for CD46-targeting ADC FG-3246 in metastatic castration-resistant prostate cancer [48]

Kyntra Bio presented topline results from an investigator-sponsored Phase 1b/2 study, conducted by the University of California, San Francisco. The study evaluated FG-3246, a fully human ADC comprising an anti-CD46 antibody (YS5) conjugated to the antimitotic payload MMAE in combination with enzalutamide in patients with androgen receptor pathway inhibitor-treated, taxane-naïve metastatic castration-resistant prostate cancer. In biomarker-unselected patients, median radiographic progression-free survival was 7.0 months overall, rising to 10.1 months in patients who had progressed on only one prior androgen receptor pathway inhibitor. The safety and exposure profile was consistent with prior FG-3246 monotherapy data. Higher tumor uptake of companion CD46-targeted PET imaging agent FG-3180 was numerically associated with PSA50 response (nominal p=0.053), supporting its potential utility in patient selection.

Ardena announced the launch of a new GLP bioanalytical laboratory in New Jersey to support ADC and drug conjugate development [49]

Ardena announced that its new GLP-compliant bioanalytical laboratory in Somerset, New Jersey, USA, is now operational. The facility expands Ardena's North American scientific capabilities, offering controlled sample storage, liquid chromatography-tandem mass spectrometry, and immunochemistry platforms for quantitative analysis across preclinical and clinical studies. The laboratory is designed to support complex therapeutic modalities, including ADCs and other drug conjugates, as well as biomarker analysis, complementing Ardena's existing European bioanalytical operations.

Ardena announced the launch of a new GLP bioanalytical laboratory in New Jersey to support ADC and drug conjugate development; Tools and Technologies. Credit: ardena.com

VivoSim Labs announced validation of its NAMkind™ liver and intestine models for predicting ADC toxicity profiles [50]

VivoSim Labs announced at the Society of Toxicology meeting that its NAMkind™ liver and NAMkind intestine models have been validated for predicting the toxicity and side effect profiles of ADCs. Testing of approved ADCs in the liver model demonstrated clear differentiation between hepatotoxic agents such as gemtuzumab ozogamicin and those with low liver toxicity such as enfortumab vedotin, and distinguished differential toxicity between trastuzumab emtansine and trastuzumab deruxtecan with strong comparability to clinical outcomes. The intestine model demonstrated sensitivity to antibody activity, payload impact, and overall ADC effects on epithelium, including permeability endpoints. NAMkind™ liver and small intestine toxicology services are now available in the US, Europe, South Korea, and China.

Whitehawk Therapeutics presented real-world MUC16 expression analyses supporting ADC development in ovarian and endometrial cancers at SGO 2026 [51]

Whitehawk Therapeutics presented three posters at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women's Cancer, featuring real-world analyses of MUC16 expression to support the clinical development of its MUC16-targeting ADC HWK-016. Large-scale RNA analyses demonstrated high and stable MUC16 expression across ovarian cancer histologic subtypes, disease stages, and platinum sensitivity status, as well as across the most aggressive and common subtypes of endometrial cancer, including later-stage disease. The findings reinforce the rationale for MUC16 as a clinically meaningful ADC target across both gynecologic indications.

NextCure and Simcere Zaiming announced an ASCO 2026 abstract for CDH6-targeting ADC SIM0505 in advanced solid tumors [52]

NextCure and Simcere Zaiming Pharmaceutical announced that an abstract for SIM0505, an investigational CDH6-targeting ADC incorporating a proprietary Topo 1 inhibitor payload, has been accepted for presentation at the American Society of Clinical Oncology Annual Meeting 2026. The abstract will feature data from an ongoing open-label Phase 1 study (NCT06792552) evaluating SIM0505 in advanced solid tumors, with an emphasis on platinum-resistant ovarian cancer. SIM0505 is designed for broad antitumor activity, fast systemic clearance, and an improved therapeutic window.

BioNTech announced first clinical data for HER3-targeting ADC BNT326/YL202 in non-small cell lung cancer at ELCC 2026 [53]

BioNTech announced presentations at the European Lung Cancer Congress 2026 featuring data from its lung cancer portfolio. First clinical data from the NSCLC cohort of a Phase 2 trial of BNT326/YL202, a HER3-targeting ADC developed in collaboration with MediLink Therapeutics, demonstrated antitumor activity and a favorable safety profile in patients with advanced or metastatic NSCLC who had progressed after standard-of-care therapy. These findings support an ongoing Phase 1b/2 trial evaluating BNT326/YL202 in combination with PD-L1/VEGF-A bispecific immunomodulator pumitamig. Additional presentations cover pumitamig and gotistobart, a CTLA-4-targeting candidate, across multiple lung cancer subtypes and lines of treatment.

Companies announced presentations at the AACR Annual Meeting 2026 covering advances in ADC and bioconjugate platforms; Conferences, Events, and Publications. Credit: aacr.org

Companies announced presentations at the AACR Annual Meeting 2026 covering advances in ADC and bioconjugate platforms

Several companies announced poster and oral presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026 (17–22 April, San Diego, CA, USA). Companies and their topics include:

• BeyondSpring: Preclinical data on plinabulin, a dendritic cell maturation agent, as a combination partner to enhance the antitumor efficacy of topoisomerase inhibitor-based ADCs with or without immune checkpoint inhibitors [54]
• Akari Therapeutics: Preclinical rationale for a differentiated Trop2-targeting ADC with a novel RNA splice modulating payload in bladder, lung, and breast cancers [55]
• Bicycle Therapeutics: Phase 1/2 clinical combination data and preclinical data for EphA2-targeting Bicycle^® Drug Conjugate nuzefatide pevedotin in head and neck squamous cell carcinoma and pancreatic ductal adenocarcinoma, EphA2 biomarker analyses in muscle-invasive bladder cancer, and first clinical experiences with an EphA2-targeted bicyclic peptide PET imaging agent [56]
• Avacta Therapeutics: Fibroblast activation protein (FAP)-activated peptide–drug conjugate AVA6103 delivering sustained exatecan release in the TME, and novel pre|CISION^® dual-payload conjugate candidates [57]
• Zentalis Pharmaceuticals: Preclinical combinations of WEE1 inhibitor azenosertib with ADCs and chemotherapy in TNBC, and real-world outcomes in Cyclin E1-positive ovarian cancer [58]
• Zai Lab: Clinical data for DLL3-targeting ADC zoci in SCLC and neuroendocrine carcinomas, and preclinical data for LRRC15-targeting ADC ZL-6201 and immunocytokine ZL-1222 [59]
• Adagene: Phase 1b/2 clinical data for masked anti-CTLA-4 SAFEbody® muzastotug in microsatellite stable colorectal cancer and unresectable locally advanced or metastatic hepatocellular carcinoma [60]
• Whitehawk Therapeutics: Preclinical proof-of-concept for next-generation ADCs HWK-016 (MUC16-targeting), HWK-007 (PTK7-targeting), and HWK-206 (biparatopic SEZ6-targeting), all incorporating proprietary carbon-bridge cysteine repairing linker-payload technology [61]
• Orum Therapeutics: Preclinical efficacy, pharmacology, and non-human primate safety data for CD123-targeting degrader antibody conjugate ORM-1153 in acute myeloid leukemia (AML) [62]
• Zymeworks: Updated Phase 1 clinical data for FRα-targeting ADC ZW191, preclinical combination data for ZW191 with standard-of-care agents, and preclinical data for a pan-RAS inhibitor ADC platform spanning PTK7-, Ly6E-, and Claudin 18.2-targeting candidates, plus a novel eIF4A inhibitor payload platform [63]
• Aarvik Therapeutics: Preclinical validation of its MUTTA™ multispecific tetravalent ADC platform and AQUALINK™ hydrophilic linker-payload technology, including data for dual-target MUC16/NaPi2b ADC ARR-002 [64]
• ArriVent BioPharma: Preclinical characterization of ARR-002 (AV-P138-ADC), a dual-target MUC16/NaPi2b tetravalent ADC with site-specific vcMMAE conjugation, in ovarian and endometrial cancers [65]
• Antengene: Preclinical data for bispecific ADC ATG-125 co-targeting B7-H3 and PD-L1 with a Topo 1 inhibitor payload, alongside T-cell engager candidates ATG-106 and ATG-112 [66]
• Ipsen: Preclinical data for first-in-class ITGA2-targeting ADC IPN60300, incorporating an exatecan payload and EZWi-Fit™ linker technology, in pancreatic, gastric, and colorectal cancers [67]
• IDEAYA Biosciences: Preclinical data for bispecific Topo 1 ADC IDE034 co-targeting PTK7 and B7-H3, demonstrating avidity-driven tumor selectivity in solid tumors [68]
• Voro Therapeutics: Preclinical data on tumor-activated biologics platform, featuring protease-cleavable linkers and affinity-tuned masking domains, demonstrated in the context of its lead CD47 blocker program VOR-101 and broader applications in ADCs, T-cell engagers, and cytokines [69]
• HUTCHMED: Preclinical data for HMPL-A580, a first-in-class EGFR-targeting antibody-targeted therapy conjugate incorporating a cleavable PI3K/PIKK inhibitor payload, demonstrating tumor-selective internalization, bystander activity, and dose-dependent antitumor activity in EGFR-expressing solid tumor models [70]
• Genialis: First results from an AI-based algorithm to predict trastuzumab deruxtecan response in breast cancer, incorporating biomodules capturing ADC-relevant biology, including HER2 targeting, internalization, and topoisomerase payload activity [71]
• Kivu Bioscience: Preclinical efficacy and safety data for CEACAM5-targeting ADC KIVU-305 in colorectal cancer, alongside an update on PTK7-targeting ADC KIVU-107, currently in Phase 1 evaluation, designed to address tolerability challenges associated with earlier PTK7-directed programs [72]
• Debiopharm: Preclinical data for the MultiLINK™ dual-payload ADC technology suite (MLINK Duo), demonstrating enhanced therapeutic efficacy and resistance-overcoming potential, alongside a translational poster using multiplexed spatial profiling and 3D cluster analysis to refine HER3 bispecific antibody and ADC therapeutic strategies [73]
• OBI Pharma: Ten posters featuring its GlycOBI^® and GlycOBI DUO^® glycan-based site-specific conjugation platforms, including preclinical data for TROP2-targeting ADC OBI-902, Nectin-4-targeting exatecan ADC OBI-904 demonstrating enfortumab vedotin resistance-overcoming activity, a MET/HER3 dual-target dual-payload ADC, guide-effector bispecific ADCs, hydrophilicity-enhanced linker technology for DACs, and cell-based dual-payload release characterization studies [74]
• Callio Therapeutics: Preclinical data for CLIO-8221, a HER2-targeting dual-payload ADC combining a Topo 1 inhibitor and ATR inhibitor at a DAR 4:4 ratio, demonstrating potent antitumor activity across HER2 expression levels, tumor regression in trastuzumab deruxtecan-sensitive and -insensitive models, and a broad therapeutic window with no toxicological findings at up to 70 mg/kg in non-human primate studies [75]

Lauren Coyle, Commissioning Editor, Bioconjugate Insights, has extensive experience in bioconjugation (i.e., ADCs, conjugate chemistry, diagnostics and imaging, bi/multi-specifics, targeted delivery, and theranostics). Lauren's focus is on advancing the field by facilitating and disseminating high-impact research on bioconjugates, conjugation technologies, and their applications. Lauren works closely with researchers, scientists, and industry professionals to publish cutting-edge studies exploring the latest advances in conjugation chemistry, drug delivery systems, and the development and delivery of targeted therapeutics. In addition to her editorial responsibilities, she maintains a strong network within the biopharma industry, staying up to date with emerging trends and breakthroughs in bioconjugates.

References

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29. Intensity Therapeutics. Intensity Therapeutics strengthens IP portfolio with issuance of new patent in the US. Mar 24, 2026. https://ir.intensitytherapeutics.com/news-events/press-releases/detail/122/intensity-therapeutics-strengthens-ip-portfolio-with

30. Ryvu Therapeutics. Ryvu Therapeutics reports 2025 fiscal year financial results and provides corporate update. Mar 19, 2026. https://ryvu.com/press-release/ryvu-therapeutics-reports-2025-fiscal-year-financial-results-and-provides-corporate-update

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32. Cellectar Biosciences. Cellectar enrolls first patient in CLR 125 Auger-emitting radioconjugate phase 1b clinical trial targeting refractory triple negative breast cancer (TNBC). Apr 14, 2026. https://www.globenewswire.com/news-release/2026/04/14/3273404/29076/en/Cellectar-Enrolls-First-Patient-in-CLR-125-Auger-Emitting-Radioconjugate-Phase-1b-Clinical-Trial-Targeting-Refractory-Triple-Negative-Breast-Cancer-TNBC.html

33. Samsung Bioepis. Samsung Bioepis initiates phase 1 clinical trial for SBE303, nectin-4 targeting antibody-drug conjugate (ADC) candidate. Apr 14, 2026. https://www.businesswire.com/news/home/20260414313544/en/Samsung-Bioepis-Initiates-Phase-1-Clinical-Trial-for-SBE303-Nectin-4-Targeting-Antibody-Drug-Conjugate-ADC-Candidate

34. Genmab. Genmab presents the safety and tolerability of rinatabart sesutecan (Rina-S®) in combination with bevacizumab in advanced ovarian cancer. Apr 13, 2026. https://www.globenewswire.com/news-release/2026/04/13/3272591/0/en/Genmab-Presents-the-Safety-and-Tolerability-of-Rinatabart-Sesutecan-Rina-S-in-Combination-with-Bevacizumab-in-Advanced-Ovarian-Cancer.html

35. GlaxoSmithKline. GSK presents positive data for B7-H4-targeted ADC in gynaecological cancers. Apr 12, 2026. https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-b7-h4-targeted-adc-in-gynaecological-cancers/

36. AbbVie. AbbVie showcases late-breaking phase 2 data for mirvetuximab soravtansine-gynx (ELAHERE®) in platinum-sensitive ovarian cancer (PSOC) at SGO 2026. Apr 12, 2026. https://www.prnewswire.com/news-releases/abbvie-showcases-latebreaking-phase-2-data-for-mirvetuximab-soravtansine-gynx-elahere-in-platinumsensitive-ovarian-cancer-psoc-at-sgo-2026-302739847.html

37. BioNTech. BioNTech and DualityBio's antibody-drug conjugate trastuzumab pamirtecan demonstrated clinically meaningful efficacy in patients with HER2-expressing, recurrent endometrial cancer. Apr 11, 2026. https://www.globenewswire.com/news-release/2026/04/11/3272109/0/en/BioNTech-and-DualityBios-Antibody-Drug-Conjugate-Trastuzumab-Pamirtecan-Demonstrated-Clinically-Meaningful-Efficacy-in-Patients-with-HER2-Expressing-Recurrent-Endometrial-Cancer.html

38. Shanghai Ark Biopharmaceutical. ArkBio completed dosing of first cohort in Australian phase I trial of antiviral drug-Fc conjugate drug AK0406. Apr 9, 2026. https://www.prnewswire.com/news-releases/arkbio-completed-dosing-of-first-cohort-in-australian-phase-i-trial-of-antiviral-drug-fc-conjugate-drug-ak0406-302737671.html

39. Adcytherix. Adcytherix doses first patient in phase 1 trial of ADCX-020 and strengthens leadership to support next phase of growth. Mar 31, 2026. https://www.globenewswire.com/news-release/2026/03/31/3265385/0/en/Adcytherix-Doses-First-Patient-in-Phase-1-Trial-of-ADCX-020-and-Strengthens-Leadership-to-Support-Next-Phase-of-Growth.html

40. IDEAYA Biosciences. IDEAYA Biosciences announces first-patient-in for phase 1 combination study of IDE849, DLL3 TOP1 ADC, and IDE161, PARG inhibitor, in DLL3 upregulated solid tumor indications, including SCLC, NETs, NECs, and melanoma. Mar 30, 2026. https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-first-patient-in-for-phase-1-combination-study-of-ide849-dll3-top1-adc-and-ide161-parg-inhibitor-in-dll3-upregulated-solid-tumor-indications-including-sclc-nets-necs-and-melanoma-302727304.html

41. PDS Biotechnology. PDS Biotech reports full year 2025 financial results and provides update on PDS0101 phase 3 program and PDS01ADC clinical advancement. Mar 30, 2026. https://www.globenewswire.com/news-release/2026/03/30/3264482/37149/en/PDS-Biotech-Reports-Full-Year-2025-Financial-Results-and-Provides-Update-on-PDS0101-Phase-3-Program-and-PDS01ADC-Clinical-Advancement.html

42. Callio Therapeutics. Callio Therapeutics doses first patient in phase I clinical trial of dual-payload ADC CLIO-8221 in advanced HER2-expressing solid tumors. Mar 24, 2026. https://www.globenewswire.com/news-release/2026/03/24/3261154/0/en/Callio-Therapeutics-Doses-First-Patient-in-Phase-I-Clinical-Trial-of-Dual-Payload-ADC-CLIO-8221-in-Advanced-HER2-Expressing-Solid-Tumors.html

43. Alphamab Oncology. Alphamab Oncology announces the first patient dosed in a phase III clinical study for triple-negative breast cancer of TROP2/HER3 bispecific ADC JSKN016. Mar 20, 2026. https://www.prnewswire.com/apac/news-releases/alphamab-oncology-announces-the-first-patient-dosed-in-a-phase-iii-clinical-study-for-triple-negative-breast-cancer-of-trop2her3-bispecific-adc-jskn016-302719422.html

44. Antengene. Antengene announces 2025 full-year results: first TCE out-licensing validates platform value and marks inflection point towards 2026 profitability. Mar 20, 2026. https://www.prnewswire.com/news-releases/antengene-announces-2025-full-year-results-first-tce-out-licensing-validates-platform-value-and-marks-inflection-point-towards-2026-profitability-302719675.html

45. OKYO Pharma. OKYO Pharma reports new phase 2 data demonstrating meaningful improvements in patient-reported quality of life outcomes with urcosimod in neuropathic corneal pain. Mar 18, 2026. https://okyopharma.com/okyo-pharma-reports-new-phase-2-data-demonstrating-meaningful-improvements-in-patient-reported-quality-of-life-outcomes-with-urcosimod-in-neuropathic-corneal-pain/

46. Aro Biotherapeutics. Aro Biotherapeutics reports positive phase 1b topline results for ABX1100, a muscle-targeted GYS1 siRNA, in patients with late-onset Pompe disease (LOPD). Mar 17, 2026. https://www.businesswire.com/news/home/20260316177283/en/

47. Bicycle Therapeutics. Bicycle Therapeutics reports recent business progress and fourth quarter and full year 2025 financial results. Mar 17, 2026. https://www.businesswire.com/news/home/20260317342933/en/

48. Kyntra Bio. Kyntra Bio reports fourth quarter and full year 2025 financial results and provides business update. Mar 16, 2026. https://www.globenewswire.com/news-release/2026/03/16/3256693/0/en/Kyntra-Bio-Reports-Fourth-Quarter-and-Full-Year-2025-Financial-Results-and-Provides-Business-Update.html

49. Ardena. Ardena opens new bioanalytical laboratory in Somerset, New Jersey. Apr 15, 2026. https://www.globenewswire.com/news-release/2026/04/15/3274408/0/en/Ardena-Opens-New-Bioanalytical-Laboratory-in-Somerset-New-Jersey.html

50. VivoSim. VivoSim releases antibody drug conjugate (ADC) data showing power to detect ADC toxicity and guide design of safer ADCs. Mar 24, 2026. https://www.globenewswire.com/news-release/2026/03/24/3261196/37000/en/VivoSim-Releases-Antibody-Drug-Conjugate-ADC-Data-Showing-Power-to-Detect-ADC-Toxicity-and-Guide-Design-of-Safer-ADCs.html

51. Whitehawk Therapeutics. Whitehawk Therapeutics presents real-world analysis confirming MUC16 as a highly expressed, clinically relevant target for gynecologic cancers at SGO 2026. Apr 10, 2026. https://www.prnewswire.com/news-releases/whitehawk-therapeutics-presents-real-world-analysis-confirming-muc16-as-a-highly-expressed-clinically-relevant-target-for-gynecologic-cancers-at-sgo-2026-302738766.html

52. NextCure. NextCure and Simcere's SIM0505 (CDH6 ADC) abstract accepted for ASCO 2026. Mar 31, 2026. https://www.globenewswire.com/news-release/2026/03/31/3266022/0/en/NextCure-and-Simcere-s-SIM0505-CDH6-ADC-Abstract-Accepted-for-ASCO-2026.html

53. BioNTech. BioNTech clinical data at ELCC 2026 highlight potential of differentiated late-stage portfolio in lung cancer. Mar 24, 2026. https://www.globenewswire.com/news-release/2026/03/24/3261033/0/en/BioNTech-Clinical-Data-at-ELCC-2026-Highlight-Potential-of-Differentiated-Late-Stage-Portfolio-in-Lung-Cancer.html

54. BeyondSpring. BeyondSpring announces plinabulin and ADC combination poster presentation at AACR Annual Meeting 2026. Mar 30, 2026. https://www.globenewswire.com/news-release/2026/03/30/3264525/0/en/BeyondSpring-Announces-Plinabulin-and-ADC-Combination-Poster-Presentation-at-AACR-Annual-Meeting-2026.html

55. Akari Therapeutics. Akari Therapeutics announces abstract accepted for poster presentation at the American Association for Cancer Research Annual Meeting 2026. Mar 18, 2026. https://www.globenewswire.com/news-release/2026/03/18/3258129/0/en/Akari-Therapeutics-Announces-Abstract-Accepted-for-Poster-Presentation-at-the-American-Association-for-Cancer-Research-Annual-Meeting-2026.html

56. Bicycle Therapeutics. Bicycle Therapeutics announces oral and poster presentations at the AACR Annual Meeting 2026. Mar 18, 2026. https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-oral-and-poster-presentations

57. Avacta Therapeutics. Avacta announces preclinical and translational presentations of pre|CISION® platform candidates at the 2026 AACR Annual Conference. Mar 17, 2026. https://www.globenewswire.com/news-release/2026/03/17/3256882/0/en/Avacta-Announces-Preclinical-and-Translational-Presentations-of-pre-CISION-Platform-Candidates-at-the-2026-AACR-Annual-Conference.html

58. Zentalis Pharmaceuticals. Zentalis Pharmaceuticals to present two posters at the American Association for Cancer Research (AACR) Annual Meeting 2026. Mar 17, 2026. https://www.globenewswire.com/news-release/2026/03/17/3257674/0/en/Zentalis-Pharmaceuticals-to-Present-Two-Posters-at-the-American-Association-for-Cancer-Research-AACR-Annual-Meeting-2026.html

59. Zai Lab. Zai Lab to present new data on three internally developed oncology candidates at AACR 2026, including zocilurtatug pelitecan, a DLL3-targeting antibody-drug conjugate (ADC). Mar 17, 2026. https://www.businesswire.com/news/home/20260317815099/en/

60. Adagene. Adagene's muzastotug (ADG126) to be highlighted in two presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA. Mar 17, 2026. https://www.globenewswire.com/news-release/2026/03/17/3257692/0/en/Adagene-s-Muzastotug-ADG126-to-be-Highlighted-in-Two-Presentations-at-the-2026-American-Association-for-Cancer-Research-AACR-Annual-Meeting-in-San-Diego-CA.html

61. Whitehawk Therapeutics. Whitehawk Therapeutics to highlight its next-generation ADC portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026. Mar 17, 2026. https://www.prnewswire.com/news-releases/whitehawk-therapeutics-to-highlight-its-next-generation-adc-portfolio-at-the-american-association-for-cancer-research-aacr-annual-meeting-2026-302716323.html

62. Orum Therapeutics. Orum Therapeutics to present new preclinical data on ORM-1153, a CD123-targeting degrader antibody conjugate, at the AACR Annual Meeting 2026. Mar 17, 2026. https://www.businesswire.com/news/home/20260317412366/en/

63. Zymeworks. Zymeworks to present clinical and preclinical data on ADC programs including novel RAS ADC platform at AACR Annual Meeting. Mar 17, 2026. https://www.globenewswire.com/news-release/2026/03/17/3257732/0/en/Zymeworks-to-Present-Clinical-and-Preclinical-Data-on-ADC-Programs-Including-Novel-RAS-ADC-Platform-at-AACR-Annual-Meeting.html

64. Aarvik Therapeutics. Aarvik Therapeutics showcases novel ADC molecules based on MUTTA™ and AQUALINK™ platforms at AACR 2026. Mar 17, 2026. https://www.businesswire.com/news/home/20260317376935/en/

65. ArriVent BioPharma. ArriVent to present two preclinical posters on the EGFR inhibitor firmonertinib and on the novel dual-target MUC16/NaPi2b tetravalent ADC ARR-002 at the 2026 AACR Annual Meeting. Mar 17, 2026. https://www.globenewswire.com/news-release/2026/03/17/3257720/0/en/ArriVent-to-Present-Two-Preclinical-Posters-on-the-EGFR-Inhibitor-Firmonertinib-and-on-the-Novel-dual-target-MUC16-NaPi2b-Tetravalent-ADC-ARR-002-at-the-2026-AACR-Annual-Meeting.html

66. Antengene. Antengene to present on three preclinical programs at AACR 2026, highlighting next-generation ADCs and AnTenGager® TCEs. Mar 17, 2026. https://www.prnewswire.com/news-releases/antengene-to-present-on-three-preclinical-programs-at-aacr-2026-highlighting-next-generation-adcs-and-antengager-tces-302716101.html

67. Ipsen. Ipsen showcases transformative potential of early immuno-oncology pipeline at AACR. Mar 18, 2026. https://www.globenewswire.com/news-release/2026/03/18/3257884/0/en/Ipsen-showcases-transformative-potential-of-early-immuno-oncology-pipeline-at-AACR.html

68. IDEAYA Biosciences. IDEAYA Biosciences announces upcoming presentations at AACR 2026 highlighting multiple clinical stage pipeline programs. Mar 18, 2026. https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-upcoming-presentations-at-aacr-2026-highlighting-multiple-clinical-stage-pipeline-programs-302715276.html

69. Voro Therapeutics. Voro Therapeutics to present new preclinical data on PrimeBody™ platform and VOR-101 at upcoming AACR 2026 and AET Europe conferences. Apr 1, 2026. https://www.businesswire.com/news/home/20260401386197/en/

70. HUTCHMED. HUTCHMED highlights data to be presented at AACR Annual Meeting 2026. Apr 9, 2026. https://www.globenewswire.com/news-release/2026/04/09/3270617/0/en/HUTCHMED-Highlights-Data-to-be-Presented-at-AACR-Annual-Meeting-2026.html

71. Genialis. Genialis Supermodel predicts patient response to HER2-targeted therapy Enhertu. Apr 13, 2026. https://www.businesswire.com/news/home/20260413597137/en/

72. Kivu Bioscience. Kivu Bioscience to present preclinical data on next-generation ADC programs at AACR Annual Meeting 2026. Apr 15, 2026. https://kivubioscience.com/news/kivu-bioscience-to-present-preclinical-data-on-next-generation-adc-programs-at-aacr-annual-meeting-2026/

73. Debiopharm. Debiopharm to unveil new pre-clinical and clinical research advances in DDR inhibition, dual payload ADCs, and AI-driven biomarkers at AACR 2026. Apr 14, 2026. https://www.businesswire.com/news/home/20260413727021/en/

74. OBI Pharma. OBI Pharma announces ten poster presentations at the AACR 2026 Annual Meeting for GlycOBI® glycan-based site-specific antibody-drug conjugates (ADCs): mono and bi-specific (inc. dual payload) and Obrion™ ADC enabling technologies. Apr 15, 2026. https://www.acnnewswire.com/press-release/english/106378/obi-pharma-announces-ten-poster-presentations-at-the-aacr-2026-annual-meeting-for-glycobi(r)-glycan-based-site-specific-antibody-drug-conjugates-(adcs

75. Callio Therapeutics. Callio Therapeutics to present poster on CLIO-8221, a novel dual-payload antibody-drug conjugate, at AACR 2026. Apr 15, 2026. https://www.globenewswire.com/news-release/2026/04/15/3274377/0/en/Callio-Therapeutics-to-Present-Poster-on-CLIO-8221-a-Novel-Dual-Payload-Antibody-Drug-Conjugate-at-AACR-2026.html