Industry Insights. Expanding the conjugate landscape through dual-payload breakthroughs, regulatory wins, and pipeline progress

Summary

October through November saw the bioconjugation field broaden on multiple fronts. New alliances, such as Samsung Bioepis-Phrontline, Invenra-Xcellon, and SK pharmteco-LOTTE, strengthened end-to-end capabilities, dual-payload innovation, and linker-payload access. On the regulatory side, momentum continued with US FDA approval of Blenrep in combination for relapsed/refactory multiple myeloma, plus Fast Track designations for Heidelberg Pharma’s HDP-101 and Avzeno’s EGFR/HER3 bispecific.

Market activity featured financing with Valink and NEOK, strategic updates with Sutro, ArriVent, and Bicycle Therapeutics, and a headline acquisition as Novartis moved to buy Avidity Bioscience to add antibody-oligonucleotide conjugates.

Clinically, first-in-human studies advanced with Daiichi Sankyo’s STING agnostic DS-3610 and InnoCare’s B7-H3 asset, and early efficacy signals were reported across multiple programs (ATM-116, JK06, CRB-701, ZW191), while Phase III readouts highlighted potential new standards. Non-oncology applications progressed with Lifordi’s immune-cell-targeting glucocorticoid ADC in rheumatoid arthritis.

Tool and technology innovation remained brisk: Syngene added a GMP bioconjugation suite, Debiopharm paired AI-guided payload discovery with a dual-payload linker, and Catalent unveiled SMARTag enhanced conjugates.

Research and development highlights included kidney-targeting ligand-siRNA conjugates from Judo Bio, a resistance-bypassing TOP1i payload from Immunome, and a tumor-specific targeting to truncated core 2 O-glycans from Precision Biologics.

COLLABORATIONS AND PARTNERSHIPS

Samsung Bioepis and Phrontline Biopharma entered global collaboration to develop bispecific, dual-payload ADCs [1]Samsung Bioepis. Samsung Bioepis and Phrontline announce a global strategic partnership to advance best-in-class antibody-drug conjugate therapeutics for solid tumors. Oct 21, 2025. 

Samsung Bioepis and Phrontline Biopharma announced a global collaboration to develop, manufacture, and commercialize two ADC programs, including TJ108, a bispecific, dual- payload ADC targeting EGFR and HER3. This follows Samsung Bioepis’ expansion into ADCs after separating from the Samsung Biologics CDMO unit. The agreement also grants Samsung Bioepis an exclusive license to a topoisomerase I inhibitor (TOP1i) payload used in its ADC pipeline. TJ108 incorporates both TOP1i and tubulin inhibitor payloads via Phrontline’s dual-linker payload platform, enabling simultaneous delivery of two cytotoxins through a branched-linker architecture. Phrontline will receive upfront and milestone payments tied to development and regulatory achievements. The collaboration supports Samsung Bioepis’ expansion into oncology and Phrontline’s goal to advance bispecific, dual-payload ADCs as a new class of precision cancer therapeutics.

Charles River Laboratories and the Francis Crick Institute partnered to accelerate ADC discovery and development [2]Charles River Laboratories. Charles River and the Francis Crick Institute combine expertise in antibody-drug conjugate development. Oct 22, 2025.

Charles River Laboratories and the Francis Crick Institute announced a collaboration to accelerate ADC discovery and development through an integrated, end-to-end approach spanning antibody generation, conjugation, in vitro profiling, and preclinical evaluation. The partnership combines the Crick’s antibody discovery capabilities with Charles River’s Retrogenix™ platform for off-target interaction profiling to enhance safety and therapeutic index early in development. The jointly managed initiative aims to streamline ADC candidate identification and preclinical validation, reducing timelines and improving translational efficiency.

Xcellon Biologics and Invenra formed partnership to develop multispecific ADCs [3]Xcellon Biologics. IntoCell and Xcellon Biologics partner to expand access to next-generation ADC technologies. Oct 31, 2025.

Xcellon Biologics and Invenra announced a strategic collaboration to advance multispecific ADC development by combining Invenra’s B-Body^® bispecific and T-Body™ trispecific antibody platforms with Xcellon’s expertise in bioconjugation, ADC development, and manufacturing. The partnership will generate and evaluate novel multispecific ADC candidates to accelerate progression from discovery through preclinical and clinical stages. Invenra’s platforms streamline antibody discovery with high developability, while Xcellon provides integrated conjugation and production capabilities for complex biologics. The collaboration aims to expand the therapeutic reach of targeted ADCs and establish a streamlined framework for developing next-generation bispecific and trispecific antibody-based therapies.

SK pharmteco and LOTTE BIOLOGICS signed LOI to establish integrated global ADC CDMO platform [4]SK pharmteco. LOTTE BIOLOGICS and SK pharmteco sign strategic partnership to strengthen global ADC CDMO capabilities. Oct 29, 2025.

SK pharmteco and LOTTE BIOLOGICS signed a Letter of Intent (LOI) to collaborate on a strategic initiative to develop a fully integrated global CDMO platform for ADCs. The partnership will combine SK pharmteco’s expertise in linker–payload development and manufacturing with LOTTE BIOLOGICS’ cGMP bioconjugation and drug substance production capabilities at its Syracuse Bio Campus in the US. The companies aim to deliver one-stop ADC solutions spanning development through commercial manufacturing, minimizing process gaps, and accelerating timelines. Joint marketing and client engagement efforts will target global biopharma partners. At the same time, the collaboration supports supply chain resiliency through established manufacturing infrastructures in the US and Europe.

Piramal Pharma Solutions partnered with IntoCell to enhance ADC development and manufacturing capabilities [5]Piramal Pharma Solutions. Piramal Pharma Solutions formalizes partnership with IntoCell, expanding its payload-linker platform and bioconjugate capabilities. Oct 30, 2025.

Piramal Pharma Solutions signed a Memorandum of Understanding with IntoCell to expand collaboration in ADC development, leveraging IntoCell’s proprietary drug-linker technologies and Piramal’s integrated CDMO capabilities. Under the non-exclusive agreement, IntoCell may license its OHPAS™ linker, Duocarmycin-based OHPAS payload, Nexatecan-based OHPAS payload, and iso-Nexatecan-based GGFG payload to Piramal’s clients. Piramal will provide R&D and GMP manufacturing services for ADCs and other bioconjugates. The partnership strengthens Piramal’s ADCelerate™ platform, designed to streamline bioconjugate development from concept to clinic, offering clients faster development timelines, expanded linker–payload options, and enhanced efficiency across the ADC value chain.

Mycenax Biotech licensed RIN Institute’s VLK linker technology to enhance global ADC CDMO services [6]Mycenax Biotech. Mycenax and RIN sign license agreement to advance ADC development using RIN’s proprietary linker technology. Oct 31, 2025.

Mycenax Biotech signed a global license agreement with Japan-based RIN Institute, granting rights to integrate RIN’s proprietary Val-Leu-Lys (VLK) linker technology into its CDMO services. The VLK linker offers high serum stability and dual antitumor mechanisms, enhancing ADC internalization, promoting cytotoxicity within the TME, and enabling the development of more effective and stable ADCs. The partnership expands Mycenax’s technical capabilities and supports the delivery of differentiated ADC solutions for global clients. This agreement follows an LOI signed in April 2025, further solidifying collaboration between the two companies in advancing next-generation ADC therapeutics. the two companies’ collaboration to advance.

REGULATORY CHANGES AND UPDATES

Heidelberg Pharma received US FDA Fast Track Designation for Amanitin-based ADC HDP-101 in multiple myeloma [7]Heidelberg Pharma. Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma. Oct 23, 2025.

Heidelberg Pharma announced that the US FDA has granted Fast Track Designation to HDP-101, the company’s lead Amanitin-based ADC, for the treatment of relapsed or refractory multiple myeloma. The designation was supported by preclinical and clinical data from the ongoing Phase I/IIa trial assessing HDP-101’s safety and antitumor activity in heavily pretreated patients. HDP-101 remains investigational, with clinical evaluation ongoing to establish its safety and efficacy profile.

GSK received US FDA approval for Blenrep combination therapy in relapsed or refractory multiple myeloma [8]GSK. Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. Oct 23, 2025.

GSK announced US FDA approval of Blenrep (belantamab mafodotin-blmf), an ADC targeting BCMA, in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, the risk of death and a 3-fold increase in median progression-free survival to 31.3 months versus 10.4 months with including a proteasome inhibitor and an immunomodulatory agent. The approval is based on Phase III DREAMM-7 results showing a 51% reduction in risk of death and a tripled median progression-free survival of 31.3 months versus 10.4 months for the daratumumab-based comparator. Safety was consistent with known profiles of the individual agents.

US FDA Fast Track designation granted to Avenzo Therapeutics for EGFR/HER3 bispecific ADC AVZO-1418 [9]Avenzo Therapeutics. Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, for the treatment of patients with EGFR-mutated TKI-pretreated NSCLC. Nov 10, 2025.

Avenzo Therapeutics announced that the US FDA granted Fast Track designation to AVZO-1418 (DB-1418), an EGFR/HER3 bispecific ADC (bsADC), for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations after progression on EGFR tyrosine kinase inhibitor therapy. AVZO-1418 is currently being evaluated in a Phase I/II, first-in-human, open-label trial assessing safety, tolerability, and preliminary efficacy as monotherapy and in combination regimens in patients with advanced solid tumors.

MARKET TRENDS

Valink Therapeutics raised $11.8M to advance bispecific ADC pipeline and expand US operations [10]Valink Therapeutics. Valink Therapeutics closes $11.8 million pre-A financing round to advance oncology pipeline. Oct 10, 2025.

Valink Therapeutics closed an $11.8M financing round to support the development of its bsADC pipeline and establish new headquarters in Cambridge, MA, US. The funding, led by redalpine, LongeVC, Oxford Science Enterprises, and existing investors, will advance the company’s V-gate discovery platform and oncology programs. Valink’s bsADC technology integrates dual-targeting mechanisms with optimized payload delivery to enhance therapeutic precision and safety. The company is also exploring complementary modalities beyond ADCs to address broader oncology indications. The investment strengthens Valink’s position in next-generation ADC innovation and supports progress toward upcoming clinical and translational milestones.

Avacta raised £16M to advance peptide drug conjugate and pre|CISION^® oncology pipeline [11]Avacta. Equity fundraise of £16 million. Oct 20, 2025.

Avacta raised approximately £16M through an oversubscribed share placing to institutional and high-net-worth investors, providing additional working capital to progress its pre|CISION oncology programs into the second half of 2026. Proceeds will support ongoing development of faridoxorubicin (AVA6000) in Phase Ib, initiation of the FAP-EXd (AVA6103) Phase I trial pending US FDA IND approval, and advancement of the Dual Payload Technology (AVA6207) peptide drug conjugate platform. The raise also enables amendments to the company’s convertible bond terms, extending repayment timelines. Avacta reported a 91% disease control rate from its faridoxorubicin Phase Ia data presented at the 2025 European Society for Medical Oncology (ESMO) Congress and aims to maintain full ownership of its pre|CISION-based assets while pursuing partnership opportunities.

To learn more about the pre|CISION platform, you can read our interview in Bioconjugation Insights with Avacta’s CSO, Michelle Morrow here.

NEOK Bio launched with $75M Series A financing to advance bispecific ADC pipeline [12]NEOK Bio. NEOK Bio launches from stealth with $75 million Series A to advance next-generation bispecific antibody drug conjugates (ADC) in oncology. Nov 4, 2025.

NEOK Bio emerged from stealth with $75M in Series A funding led by ABL Bio to advance two bsADC programs into clinical development. The financing will support IND filings for NEOK001, targeting ROR1 and B7-H3, and NEOK002, targeting EGFR and MUC1, with both programs expected to enter Phase I trials in mid-2026. NEOK’s proprietary SYNtecan E™ linker–payload technology enables high stability and optimized biophysical properties to improve efficacy and safety over conventional ADCs. The company’s dual-targeting approach aims to address tumor heterogeneity, enhance internalization, and reduce off-target toxicity.

Novartis to acquire Avidity Biosciences, expanding into antibody–oligonucleotide conjugates for neuromuscular disease [13]Novartis. Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience pipeline. Oct 26, 2025.

Novartis announced plans to acquire Avidity Biosciences for ~$12B, gaining access to its proprietary antibody oligonucleotide conjugate (AOC) platform that enables targeted RNA delivery to muscle tissue. The deal, expected to close in the first half of 2026 following the spin-off of Avidity’s precision cardiology assets, will integrate Avidity’s late-stage neuromuscular programs into Novartis’ neuroscience portfolio. AOC programs in development include potential first-in-class therapies for myotonic dystrophy type 1, facioscapulohumeral muscular dystrophy, and Duchenne muscular dystrophy. By combining the tissue specificity of antibodies with the precision of oligonucleotide therapeutics, Avidity’s AOC platform offers a transformative approach to genetic muscle diseases and strengthens Novartis’ leadership in RNA-targeted conjugate therapeutics.

Bicycle Therapeutics provided 2025 Q3 financial results with pipeline updates and regulatory progress [14]Bicycle Therapeutics. Bicycle Therapeutics reports recent business progress and third quarter 2025 financial results. Oct 30, 2025.

Bicycle Therapeutics reported third-quarter 2025 financial results, with cash and cash equivalents of $648.3M as of September 30, 2025, compared with $879.5M at year-end 2024. The decrease primarily reflected R&D expenditures supporting its Bicycle Drug Conjugate programs, including the development of zelenectide pevedotin. R&D expenses rose to $58.4M from $48.3M year over year, while general and administrative costs were stable at $18.9M. Net loss was $59.1M compared with $50.8M in Q3 2024. The company remains well capitalized following receipt of a $38.2M UK R&D tax credit, and continues advancing multiple oncology programs toward regulatory milestones in 2026.

Sutro Biopharma reported Q3 2025 results and advanced next-generation ADC portfolio following strategic restructuring [15]Sutro Biopharma. Sutro Biopharma reports third quarter 2025 financial results and business highlights. Nov 6, 2025.

Sutro Biopharma reported third-quarter 2025 financial results which highlighted a strengthened focus on its next-generation ADC pipeline following a corporate restructuring. Cash, cash equivalents, and marketable securities totaled $167.6M as of September 30, 2025, compared with $388.3M a year earlier. Revenue rose to $9.7M, primarily from its collaboration with Astellas, while total R&D and G&A expenses decreased to $48.6M from $76.4M due to cost-saving measures. The restructuring and expected milestone payments extend Sutro’s cash runway into at least mid-2027. Key pipeline updates included FDA IND clearance for STRO-004, progress on the ITGB6-targeting ADC STRO-006, and advancement of dual-payload ADC programs, including immunostimulatory collaborations with Astellas.

ArriVent BioPharma advanced ADC pipeline with FDA IND clearance for ARR-217 and reported Q3 2025 financial results [16]ArriVent BioPharma. ArriVent BioPharma reports third quarter 2025 financial results. Nov 10, 2025. 

ArriVent BioPharma reported third-quarter 2025 results and key pipeline updates, including FDA IND clearance for ARR-217, a CDH17-targeted ADC being evaluated in an ongoing Phase I study in gastrointestinal cancers. ARR-217, developed in collaboration with Lepu Biopharma, represents a potential best-in-class ADC for solid tumors. The company plans to expand its ADC portfolio across additional solid tumor indications. ArriVent also highlighted late-stage progress for firmonertinib in EGFR-mutant NSCLC. As of September 30, 2025, ArriVent reported $305.4M in cash and investments, providing operational runway into mid-2027, with R&D expenses totaling $121.2M driven by the $40M ARR-217 licensing payment.

Wave Life Sciences reported Q3 2025 results and advanced RNAi and RNA editing therapeutics into clinical development [17]Wave Life Science. Wave Life Sciences reports third quarter 2025 financial results and provides business update. Nov 10, 2025.

Wave Life Sciences reported third-quarter 2025 results emphasizing the advancement of its GalNAc-conjugated RNA medicines platform, which enables targeted delivery to hepatocytes for RNA editing and RNAi therapies. Clinical data for the GalNAc-siRNA WVE-007 showed potent, durable INHBE silencing for obesity, while GalNAc-AIMer WVE-006 achieved physiologic AAT restoration in patients with alpha-1 antitrypsin deficiency. The company also introduced WVE-008, a GalNAc-conjugated RNA editor targeting PNPLA3 I148M for liver disease, and unveiled a bifunctional oligonucleotide construct that simultaneously edits and silences RNA. These advances underscore Wave’s leadership in conjugate-enabled RNA therapeutics, integrating precise chemical design with ligand-directed delivery to achieve durable, tissue-specific gene modulation across metabolic and genetic diseases.

RESEARCH AND DEVELOPMENT HIGHLIGHTS

Judo Bio presented preclinical data on megalin-STRIKER ligand-siRNA conjugates for kidney-targeted gene silencing [18]Judo Bio. Judo Bio presents data demonstrating sustained, kidney-selective gene silencing across species. Oct 20, 2025.

Judo Bio presented preclinical results at the 21st Annual Meeting of the Oligonucleotide Therapeutics Society, demonstrating that its megalin-STRIKER ligand–siRNA conjugates achieved potent, kidney cell-selective gene silencing in rodents and non-human primates. The conjugates target megalin receptors on proximal tubular epithelial cells (PTECs), enabling precise delivery and mRNA knockdown within renal tissue. A single administration resulted in approximately 70% target gene silencing sustained for two months, with dose-dependent effects in rodents and clear translation to primates. The data underscore the modularity of the STRIKER platform and its potential to enable kidney-specific oligonucleotide therapies addressing disease-modifying genes expressed in PTECs.

Immunome presented preclinical data showing HC74 ADC payload overcomes resistance mechanisms [19]Immunome. Immunome presents preclinical data showing proprietary TOP1i ADC payload HC74 overcomes multiple mechanisms of ADC resistance. Oct 23, 2025.

Immunome presented preclinical data demonstrating that its proprietary TOP1i-payload, HC74, can overcome multiple mechanisms of resistance to ADCs, including drug efflux and target heterogeneity. HC74, used in the ROR1-targeting ADC IM-1021, currently in Phase I trials, and other preclinical candidates showed strong cytotoxicity and bystander activity due to its high membrane permeability. ADCs incorporating HC74 achieved efficacy in preclinical models of colorectal cancer resistant to trastuzumab-DXd and irinotecan, as well as in NSCLC with heterogeneous target expression. The findings, presented at the 2025 AACR-NCI-EORTC Conference, support HC74’s potential as a next-generation ADC payload designed to address multidrug resistance and improve therapeutic durability.

Precision Biologics presented preclinical data demonstrating efficacy and safety of tumor-specific ADC [20]Precision Biologics. Precision Biologics to reveal preclinical efficacy of novel tumor-specific ADC against multiple human cancer types at SITC 2025. Nov 5, 2025.

Precision Biologics reported preclinical data for PB-vcMMAE-5, a tumor-specific ADC targeting truncated core 2 O-glycans, at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting. PB-vcMMAE-5 combines the monoclonal antibody PB-223 with a cleavable mc-vc-PABc linker and monomethyl auristatin E (MMAE) payload, with DAR 3.92, showing selective binding to tumor tissues and no reactivity with normal tissues. The ADC demonstrated potent in vitro cytotoxicity across nine human cancer cell lines, including triple-negative breast, prostate, ovarian, and lung cancers. In vivo, PB-vcMMAE-5 produced dose-dependent tumor inhibition in ovarian xenograft models, achieving complete tumor necrosis at 9mg/kg with no observable toxicity or weight loss. These findings support its potential as a targeted therapeutic for core 2 O-glycan–expressing malignancies.

CLINICAL TRIALS AND RESEARCH

Daiichi Sankyo initiated first-in-human trial of DS-3610, a first-in-class STING agonist ADC for solid tumors [21]Daiichi Sankyo. DS3610 enters clinical development in patients with advanced solid tumors as first STING agonist ADC in industry-leading ADC portfolio of Daiichi Sankyo. Nov 10, 2025.

Daiichi Sankyo announced dosing of the first patient in a Phase I first-in-human trial evaluating DS-3610, an investigational STING agonist ADC, in patients with advanced, metastatic, or unresectable solid tumors. DS-3610 combines precise tumor targeting with an immunomodulatory payload that activates innate immune pathways and may overcome resistance to current immunotherapies. The global, multicenter, open-label study will assess safety, tolerability, pharmacokinetics, and preliminary efficacy, including objective response rate and disease control rate. DS-3610 represents the first STING agonist ADC to enter clinical development and a new frontier within Daiichi Sankyo’s ADC portfolio, expanding its exploration of immune-modulating payloads to enhance anti-tumor responses in refractory solid tumors.

Multitude Therapeutics reported early clinical data for CD44v9-directed ADC AMT-116 in advanced solid tumors [22]Multitude Therapeutics. Multitude therapeutics announces promising interim Phase I/II results from the ongoing first-in-human study evaluating its CD44v9-directed antibody-drug-conjugate, AMT-116, in heavily pretreated EGFR wild-type non-small cell lung cancer (NSCLC) and other advanced solid tumors at the 2025 ESMO Annual Meeting. Oct 17, 2025.

Multitude Therapeutics presented initial results from its ongoing Phase I/II dose escalation and expansion study of AMT-116, a CD44v9-targeting ADC, in patients with EGFR wild-type NSCLC and other advanced solid tumors. Across 164 patients treated at 1.5–5.0mg/kg every two weeks, AMT-116 demonstrated a manageable safety profile and promising efficacy. In heavily pretreated EGFR wild-type NSCLC, overall and disease control rates were 40% and 93%, respectively, increasing to 80% and 100% at the 5.0 mg/kg dose. Objective responses were also seen in nasopharyngeal, anal, and salivary gland cancers. The ADC showed reduced mucosal and skin toxicities compared with other TOP1i-based ADCs, supporting continued dose expansion.

Salubris Biotherapeutics reported Phase I/II dose escalation data for 5T4-targeted ADC JK06 in advanced solid tumors [23]Salubris Biotherapeutics. ESMO 2025 poster presentation: a Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer.

Salubris Biotherapeutics presented results from the dose-escalation phase of its ongoing Phase I/II trial evaluating JK06, a 5T4-directed ADC with an MMAE payload, in patients with advanced, relapsed, or refractory solid tumors. Among 29 response-evaluable patients, six achieved confirmed partial responses (21%), including five of 13 with NSCLC (overall response rate (ORR) 38%) and one of seven with breast cancer. JK06 was generally well tolerated, with predominantly low-grade adverse events; isolated Grade 3 events included peripheral neuropathy, keratitis, fatigue, and ALT elevation, and one Grade 5 pneumonitis at higher doses. Pharmacokinetics supported doses up to 4.5mg/kg. Dose expansion is ongoing in NSCLC and breast cancer cohorts.

Corbus Pharmaceuticals presented Phase I/II data for Nectin-4-targeting ADC CRB-701 in advanced solid tumors [24]Corbus Pharmaceuticals. Corbus Pharmaceuticals presents CRB-701 robust clinical responses in HNSCC and cervical cancers at ESMO25. Oct 18, 2025.

Corbus Pharmaceuticals presented data from its ongoing multicenter Phase I/II trial evaluating CRB-701 (SYS6002), a next-generation Nectin-4-targeting ADC, in 167 patients with advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC), cervical cancer, and metastatic urothelial carcinoma. The trial, conducted in the US and Europe, reported no dose-limiting toxicities, with 2.7mg/kg and 3.6mg/kg selected for optimization. CRB-701 showed a favorable safety profile, with Grade 3 treatment-related adverse events in 18% of patients and no Grade 4 or 5 events; peripheral neuropathy was limited to 8.4% (all Grade 1–2). Clinical responses were observed across varying levels of Nectin-4, PD(L)-1, and HPV expression. Corbus plans to meet with the US FDA and initiate registrational studies by mid-2026.

Sichuan Kelun-Biotech reported Phase III results for HER2-directed ADC trastuzumab botidotin versus T-DM1 in metastatic breast cancer [25]Sichuan Kelun-Biotech. Kelun-Biotech presents positive Phase 3 data for trastuzumab botidotin compared to T-DM1 at 2025 ESMO. Oct 19, 2025.

Sichuan Kelun-Biotech presented Phase III data from a randomized study comparing the HER2-targeting ADC trastuzumab botidotin (A166) with trastuzumab emtansine (T-DM1) in 365 patients with unresectable or metastatic HER2-positive breast cancer previously treated with anti-HER2 therapy. Median progression-free survival was 11.1 months with trastuzumab botidotin versus 4.4 months for T-DM1 (p<0.0001), with consistent benefit across subgroups. The ORR was 76.9% versus 53.0%, and a trend toward improved overall survival was observed. Grade ≥3 adverse events occurred in 69.8% of patients with trastuzumab botidotin versus 63.7% with placebo, with ocular events the most frequent with trastuzumab botidotin. No on-treatment deaths occurred amd the data support trastuzumab botidotin as a potential new therapy for pretreated HER2-positive breast cancer.

SystImmune reported positive Phase III results for bispecific ADC iza-bren in metastatic nasopharyngeal carcinoma [26]Systimmune. SystImmune announces iza-bren meets one of the dual primary endpoints in the BL-B01D1-303 trial in recurrent or metastatic NPC patients with results presented as a late-breaking oral presentation at ESMO. Oct 19, 2025.

SystImmune announced positive topline results from the Phase III BL-B01D1-303 trial evaluating iza-bren, a bispecific ADC targeting EGFR and HER3, in recurrent or metastatic nasopharyngeal carcinoma (NPC) following at least two prior lines of therapy, including platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. Iza-bren achieved a BICR-assessed ORR of 54.6% versus 27.0% for chemotherapy (p<0.0001), with median duration of response and progression-free survival of 8.5 and 8.38 months, respectively, compared with 4.8 and 4.34 months. The ADC was well tolerated, with mainly manageable hematologic toxicities and limited cases of interstitial lung disease.

Zymeworks reported preliminary Phase I results for FRα-targeting ADC ZW191 in advanced solid tumors [27]Zymeworks. Zymeworks presents initial clinical data from the Phase 1 trial of ZW191, an antibody-drug conjugate targeting folate receptor-α at AACR-NCI-EORTC Conference. Oct 23, 2025.

Zymeworks presented preliminary data from its ongoing Phase I trial evaluating ZW191, a folate receptor-alpha (FRα)-targeting ADC incorporating the proprietary payload ZD06519, in patients with platinum-resistant ovarian, metastatic endometrial, and NSCLC. Among 27 response-evaluable patients, ZW191 achieved an ORR of 44% across doses and 53% at 6.4–9.6 mg/kg; gynecologic cancer patients achieved an ORR of 50% and 64% at higher doses. Responses occurred even in tumors with low or negative FRα expression. ZW191 was well tolerated, with no treatment-related deaths or discontinuations and low rates of Grade ≥3 events. Dose optimization at 6.4 and 9.6mg/kg will proceed further to evaluate efficacy and safety in advanced solid tumors.

Lifordi Immunotherapeutics initiated Phase I trial and presented nonclinical data showing immune cell–targeted glucocorticoid delivery [28]Lifordi Immunotherapeutics. Lifordi Immunotherapeutics presents nonclinical data on glucocorticoid antibody drug conjugate LFD-200 at ACR 2025 and initiates Phase 1 study in rheumatoid arthritis. Oct 27, 2025.

Lifordi Immunotherapeutics presented nonclinical results and announced initiation of a Phase I SAD/MAD study of LFD-200, an ADC designed to deliver a glucocorticoid payload selectively to immune cells for the treatment of rheumatoid arthritis. Data presented at ACR Convergence 2025 showed that in non-human primates, LFD-200 achieved sustained glucocorticoid exposure in immune tissues for seven days, reduced TNFα and IL-1β levels, and did not affect cortisol, bone formation, or bone mineral density after 13 weekly doses. The ADC’s VISTA-targeted approach achieved anti-inflammatory activity without systemic toxicity. Preliminary clinical data from healthy participants are expected by the end of 2025, supporting translation of immune cell–selective glucocorticoid delivery into first-in-human studies.

InnoCare dosed first patient with novel B7-H3–targeting ADC in solid tumors [29]InnoCare. InnoCare Pharma’s novel ADC drug ICP-B794 has been successfully administered to its first patient. Oct 30, 2025.

InnoCare announced the first patient dosing of ICP-B794, a novel B7-H3–targeting ADC developed using the company’s proprietary platform. ICP-B794 combines a humanized anti-B7-H3 monoclonal antibody with a potent cytotoxic payload via a protease-cleavable linker, enabling precise tumor targeting and minimized off-target toxicity. In preclinical studies, the ADC demonstrated superior antitumor activity and strong efficacy even in large tumor models. The therapy is being investigated in patients with solid tumors, including lung, esophageal, nasopharyngeal, HNSCC, and prostate cancer. As no B7-H3–directed therapy has yet been approved, ICP-B794 represents a first-in-class opportunity.

BioAtla reported improved survival with AXL-targeting ADC in treatment-refractory sarcomas [30]BioAtla. BioAtla’s mecbotamab vedotin (Mec-V), an AXL-targeting ADC, demonstrates a median overall survival (OS) of 21.5 months in subtypes of refractory soft tissue sarcomas. Nov 7, 2025.

BioAtla presented Phase II clinical data for Mecbotamab vedotin (Mec-V), an AXL-targeting ADC, at the 2025 SITC Annual Meeting. In 44 patients with treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma, Mec-V achieved a median overall survival of 21.5 months, 22.9 months in combination with anti–PD-1 therapy, and 18.4 months as monotherapy when compared with the median overall survival of 21.5 months, 22.9 months in combination with anti–PD-1 therapy, and 18.4 months as monotherapy, compared with a historical median survival of approximately 12 months. The 12-month overall survival rate was 73%, with a disease control rate of 52% and two partial responses. Adverse events were manageable, with no treatment-related deaths or ocular or pulmonary toxicities reported. Mec-V uses BioAtla’s Conditionally Active Biologic (CAB) technology to bind AXL selectively in acidic TME, minimizing off-target toxicity while maintaining potent antitumor activity.

PDS Biotech presented new data highlighting immune mechanisms and biomarker correlations for PDS01ADC and PDS0101 [31]PDS Biotech. PDS Biotechnology announces translational data showing strong immunological and clinical activity of PDS0101 and PDS01ADC presented at SITC 2025. Nov 10, 2025.

PDS Biotechnology reported new translational and clinical data at the 2025 SITC Annual Meeting, demonstrating strong immune activation with its investigational HPV16-targeted immunotherapy, PDS0101, and its novel immunocytokine, PDS01ADC. In analyses of 50 patients with advanced HPV16-positive cancers treated with PDS0101, PDS01ADC, and a checkpoint inhibitor, the combination induced broad pro-inflammatory cytokine responses and measurable T cell recruitment associated with improved clinical outcomes. Serum proteomic profiling identified predictive biomarkers correlating with anti-tumor activity, supporting future biomarker-guided patient selection. These findings, developed under PDS Biotech’s CRADA with the National Cancer Institute, validate the immunologic basis of its platforms and reinforce the clinical potential of PDS01ADC in combination immunotherapy for advanced HPV-associated cancers.

TOOLS AND TECHNOLOGIES

Syngene International expanded capabilities with new GMP bioconjugation suite for end-to-end ADC services [32]Syngene International. Syngene International announces plans to add bioconjugation suite for end-to-end antibody-drug conjugates development. Oct 22, 2025.

Syngene International announced the addition of a GMP bioconjugation suite at its commercial biologics’ facility in Bengaluru, enabling fully integrated end-to-end services for ADCs from discovery through GMP manufacturing. The OEB-5-rated suite will enable monoclonal antibody production and bioconjugation at a single site, supported by in-house payload, linker, analytical, and bioanalytical capabilities. Expected to be operational within the financial year, the facility will streamline ADC development timelines and reduce supply chain complexity. Building on over a decade of ADC experience, Syngene will also provide process development, analytical characterization, and scale-up for early- and late-stage programs, enhancing its position as a full-service CDMO partner for ADC development.

Debiopharm partnered with NetTargets to integrate AI-driven drug discovery with dual-payload ADC linker technology [33]Debiopharm. Debiopharm forges AI-powered alliance with NetTargets to pioneer dual-payload ADCs against drug-resistant cancers. Oct 30, 2025.

Debiopharm announced a research collaboration with NetTargets to accelerate the development of next-generation ADCs by combining AI–driven discovery with precision linker engineering. NetTargets’ AI-Powered Discovery Engine integrates multi-omics data and neural network modeling to identify synergistic compound combinations, which will be incorporated into Debiopharm’s proprietary MLINK Duo platform. MLINK Duo enables the attachment of two distinct payloads to a single antibody, supporting coordinated intracellular release and a high DAR (up to DAR 8+8). This integration of AI-guided payload selection with Debiopharm’s modular MultiLINK platform aims to rationally design dual-payload ADCs that overcome tumor resistance while minimizing systemic toxicity, thereby representing a convergence of computational biology and advanced conjugation technology for oncology innovation.

CONFERENCES, EVENTS, AND PUBLICATIONS

Sacituzumab govitecan improved progression-free survival in PD-L1-negative triple-negative breast cancer [34]Dana Farber Institute. ADC improves outcomes for patients with advanced triple-negative breast cancer who are ineligible for immune checkpoint inhibitors. Oct 19, 2025. 

Results from the global Phase III ASCENT-03 trial presented at the 2025 ESMO Congress showed that ADC sacituzumab govitecan significantly improved progression-free survival compared with standard chemotherapy in patients with previously untreated, PD-L1-negative triple-negative breast cancer (TNBC). Conducted across 229 sites with 558 participants, the study reported median progression-free survival of 9.7 months versus 6.9 months for chemotherapy, and a median duration of response of 12.2 months versus 7.2 months, respectively. Overall survival data remain immature. The ADC’s safety profile was consistent with prior studies and manageable with standard supportive care.

Akari Therapeutics presented preclinical data showing immune activation and synergy of spliceosome-targeting PH1 ADC payload [35]Akari Therapeutics. Akari Therapeutics presents promising immuno-oncology data for its novel splicing-targeted ADC payload driving immune activation, both as single agent and in combination with anti-PD1 checkpoint inhibitors. Nov 10, 2025.

Akari Therapeutics presented preclinical data at the 2025 SITC meeting demonstrating that its novel spliceosome-targeting ADC payload, PH1, drives both tumor cytotoxicity and multi-faceted immune activation. In preclinical HER2-positive colon cancer models, a Trastuzumab-PH1 ADC combined with anti-PD1 therapy achieved complete tumor regression in 74% of cases, compared with 42% with Kadcyla^® plus anti-PD1 (p<0.05). PH1 disrupted RNA splicing to increase neoantigen generation, inducing macrophage polarization, neutrophil infiltration, B cell expansion, and γδ T cell activation—effects not seen with traditional microtubule payloads. The data highlight the potential of PH1-based ADCs to synergize with checkpoint inhibitors, expanding immuno-oncology applications beyond cytotoxic mechanisms. Akari’s lead Trop2-PH1 ADC, AKTX-101, is entering IND-enabling studies.

Catalent showcased SMARTag^® Enhanced Conjugates and new MUC1-targeting ADC data at World ADC San Diego [36]Catalent. Catalent’s SMARTag^® ADC pipeline and new enhanced conjugates offering featured at 16th World ADC San Diego. Nov 4, 2025.

Catalent presented innovations from its SMARTag technology platform at the 16th World ADC San Diego conference, including preclinical data for CAT-09-833, a MUC1-targeting ADC for platinum-resistant ovarian cancer, and the debut of SMARTag Enhanced Conjugates. This new ADC class integrates both cytotoxic and non-cytotoxic payloads on a single antibody to amplify efficacy while maintaining safety. Enabled by site-specific aldehyde tag and HIPS chemistry, the platform allows tunable DAR and controlled payload release via a tandem-cleavage linker. These developments expand SMARTag’s modular capabilities for designing dual- and triple-payload ADCs tailored to complex tumor biology.

References

1. Samsung Bioepis. Samsung Bioepis and Phrontline announce a global strategic partnership to advance best-in-class antibody-drug conjugate therapeutics for solid tumors. Oct 21, 2025.

2. Charles River Laboratories. Charles River and the Francis Crick Institute combine expertise in antibody-drug conjugate development. Oct 22, 2025.  

3. Xcellon Biologics. IntoCell and Xcellon Biologics partner to expand access to next-generation ADC technologies. Oct 31, 2025. 

4. SK pharmteco. LOTTE BIOLOGICS and SK pharmteco sign strategic partnership to strengthen global ADC CDMO capabilities. Oct 29, 2025. 

5. Piramal Pharma Solutions. Piramal Pharma Solutions formalizes partnership with IntoCell, expanding its payload-linker platform and bioconjugate capabilities. Oct 30, 2025.  

6. Mycenax Biotech. Mycenax and RIN sign license agreement to advance ADC development using RIN’s proprietary linker technology. Oct 31, 2025. 

7. Heidelberg Pharma. Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma. Oct 23, 2025. 

8. GSK. Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. Oct 23, 2025. 

9. Avenzo Therapeutics. Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, for the treatment of patients with EGFR-mutated TKI-pretreated NSCLC. Nov 10, 2025. 

10. Valink Therapeutics. Valink Therapeutics closes $11.8 million pre-A financing round to advance oncology pipeline. Oct 10, 2025.  

11. Avacta. Equity fundraise of £16 million. Oct 20, 2025. 

12. NEOK Bio. NEOK Bio launches from stealth with $75 million Series A to advance next-generation bispecific antibody drug conjugates (ADC) in oncology. Nov 4, 2025. 

13. Novartis. Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience pipeline. Oct 26, 2025.  

14. Bicycle Therapeutics. Bicycle Therapeutics reports recent business progress and third quarter 2025 financial results. Oct 30, 2025. 

15. Sutro Biopharma. Sutro Biopharma reports third quarter 2025 financial results and business highlights. Nov 6, 2025. 

16. ArriVent BioPharma. ArriVent BioPharma reports third quarter 2025 financial results. Nov 10, 2025.  

17. Wave Life Science. Wave Life Sciences reports third quarter 2025 financial results and provides business update. Nov 10, 2025. 

18. Judo Bio. Judo Bio presents data demonstrating sustained, kidney-selective gene silencing across species. Oct 20, 2025.  

19. Immunome. Immunome presents preclinical data showing proprietary TOP1i ADC payload HC74 overcomes multiple mechanisms of ADC resistance. Oct 23, 2025.  

20. Precision Biologics. Precision Biologics to reveal preclinical efficacy of novel tumor-specific ADC against multiple human cancer types at SITC 2025. Nov 5, 2025.  

21. Daiichi Sankyo. DS3610 enters clinical development in patients with advanced solid tumors as first STING agonist ADC in industry-leading ADC portfolio of Daiichi Sankyo. Nov 10, 2025. 

22. Multitude Therapeutics. Multitude therapeutics announces promising interim Phase I/II results from the ongoing first-in-human study evaluating its CD44v9-directed antibody-drug-conjugate, AMT-116, in heavily pretreated EGFR wild-type non-small cell lung cancer (NSCLC) and other advanced solid tumors at the 2025 ESMO Annual Meeting. Oct 17, 2025. 

23. Salubris Biotherapeutics. ESMO 2025 poster presentation: a Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer.  

24. Corbus Pharmaceuticals. Corbus Pharmaceuticals presents CRB-701 robust clinical responses in HNSCC and cervical cancers at ESMO25. Oct 18, 2025.  

25. Sichuan Kelun-Biotech. Kelun-Biotech presents positive Phase 3 data for trastuzumab botidotin compared to T-DM1 at 2025 ESMO. Oct 19, 2025.  

26. Systimmune. SystImmune announces iza-bren meets one of the dual primary endpoints in the BL-B01D1-303 trial in recurrent or metastatic NPC patients with results presented as a late-breaking oral presentation at ESMO. Oct 19, 2025.  

27. Zymeworks. Zymeworks presents initial clinical data from the Phase 1 trial of ZW191, an antibody-drug conjugate targeting folate receptor-α at AACR-NCI-EORTC Conference. Oct 23, 2025.  

28. Lifordi Immunotherapeutics. Lifordi Immunotherapeutics presents nonclinical data on glucocorticoid antibody drug conjugate LFD-200 at ACR 2025 and initiates Phase 1 study in rheumatoid arthritis. Oct 27, 2025.  

29. InnoCare. InnoCare Pharma’s novel ADC drug ICP-B794 has been successfully administered to its first patient. Oct 30, 2025.  

30. BioAtla. BioAtla’s mecbotamab vedotin (Mec-V), an AXL-targeting ADC, demonstrates a median overall survival (OS) of 21.5 months in subtypes of refractory soft tissue sarcomas. Nov 7, 2025.  

31. PDS Biotech. PDS Biotechnology announces translational data showing strong immunological and clinical activity of PDS0101 and PDS01ADC presented at SITC 2025. Nov 10, 2025.  

32. Syngene International. Syngene International announces plans to add bioconjugation suite for end-to-end antibody-drug conjugates development. Oct 22, 2025. 

33. Debiopharm. Debiopharm forges AI-powered alliance with NetTargets to pioneer dual-payload ADCs against drug-resistant cancers. Oct 30, 2025.  

34. Dana Farber Institute. ADC improves outcomes for patients with advanced triple-negative breast cancer who are ineligible for immune checkpoint inhibitors. Oct 19, 2025.  

35. Akari Therapeutics. Akari Therapeutics presents promising immuno-oncology data for its novel splicing-targeted ADC payload driving immune activation, both as single agent and in combination with anti-PD1 checkpoint inhibitors. Nov 10, 2025.  

36. Catalent. Catalent’s SMARTag^® ADC pipeline and new enhanced conjugates offering featured at 16th World ADC San Diego. Nov 4, 2025.