Industry insights, June 2025

COLLABORATIONS AND PARTNERSHIPS

Veraxa Biotech to go public in $1.64B merger to advance conjugate cancer therapies [1]VERAXA Biotech. VERAXA and Voyager Acquisition Corp. announce business combination agreement to create Nasdaq-listed biopharmaceutical company advancing a pipeline of next-generation cancer therapies. Apr 23, 2025.  and launch bispecific ADC program in partnership with OmniAb [2]VERAXA Biotech. VERAXA Biotech enters co-discovery alliance with OmniAb for a novel bispecific antibody drug conjugate program. May 5, 2025. 

Swiss biotech Veraxa Biotech will go public in the US via a $1.64B merger with healthcare-focused special purpose acquisition company (SPAC) Voyager Acquisition, gaining access to capital for its next-generation ADC and bispecific T-cell engager programs. Veraxa’s lead ADC, VX-A901, now in Phase I for leukemia, targets FLT3 with enhanced Fc potency. The company aims to have three conjugate-based candidates in clinical trials by 2029. Its proprietary BiTAC platform enables dual-targeting cytotoxicity with improved safety profiles, addressing dosing limitations of current therapies. The merger includes a $253M cash infusion, with listing expected on NASDAQ as ‘VERX’.

Additionally, Veraxa has partnered with OmniAb to co-develop a novel bispecific ADC (bsADC) targeting solid tumors. The partnership leverages OmniAb’s transgenic antibody discovery technologies with VERAXA’s proprietary conjugation and linker platform to create next-generation therapeutics. VERAXA will lead development of a bsADC candidate by applying its in-house conjugation expertise to high-affinity human antibodies sourced via OmniAb’s in vivo platforms. The resulting conjugate will address two cancer-relevant targets, with VERAXA handling preclinical validation. The bsADC program will be jointly owned, with both companies sharing future revenues from development, licensing, or commercialization. This marks VERAXA’s second major alliance in six months, reinforcing its strategy of growth through innovation-driven collaborations.

Araris strikes ADC partnership with Johnson & Johnson, extending conjugation platform reach [3]Araris Biotech. Araris Biotech AG announces research agreement to develop next-generation ADCs using Araris’ AraLinQ™ technology. Apr 29, 2025. 

Araris Biotech has signed a new ADC collaboration with Johnson & Johnson, marking its third major pharma partnership despite its recent acquisition by Taiho Pharmaceutical. Deal terms of this partnership remain undisclosed. The agreement centers on Araris’ AraLinQ platform, a site-specific, one-step enzymatic conjugation technology that attaches payloads to off-the-shelf antibodies without prior modification. This method yields highly uniform and stable ADCs, aiming to lower production costs and shorten development timelines.

Astellas secures $1.3B deal with Evopoint for CLDN18.2-directed ADC [4]Astellas. Astellas enters exclusive license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2. May 30, 2025. 

Astellas has signed a licensing agreement with Evopoint Biosciences valued at up to $1.34B for global rights (excluding Greater China) to XNW27011, an investigational ADC targeting CLDN18.2. The deal includes a $130M upfront payment, up to $70M in near-term milestones, and further milestone payments plus royalties. The ADC leverages a topoisomerase I inhibitor payload and linker technology and is in Phase I/II clinical trials in China for solid tumors expressing CLDN18.2, including gastric, gastroesophageal, and pancreatic cancers. This acquisition complements Astellas’ existing portfolio, which features Vyloy (zolbetuximab), the first approved CLDN18.2-targeted therapy.

REGULATORY CHANGES AND UPDATES

FDA grants accelerated approval to AbbVie’s EMRELIS for advanced NSCLC with high c-Met overexpression [5]AbbVie. US FDA approves EMRELIS™ (telisotuzumab vedotin-tllv) for adults with previously treated advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. May 14, 2025. 

The US FDA has granted accelerated approval to AbbVie’s EMRELIS (telisotuzumab vedotin-tllv) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients with high c-Met protein overexpression who have previously received systemic therapy. EMRELIS is a c–Met–directed ADC designed to selectively deliver cytotoxic agents to tumor cells overexpressing c-Met, improving precision while limiting off-target effects. It is the first and only approved therapy for this specific biomarker-defined patient population, targeting tumors where ≥50% of cells show strong c-Met staining by FDA-approved immunohistochemistry testing. The approval is based on findings from the Phase II LUMINOSITY study, which enrolled 84 patients and showed an overall response rate (ORR) of 35% and a median duration of response of 7.2 months. Continued approval is conditional upon confirmation of clinical benefit in an ongoing Phase III confirmatory trial (TeliMET NSCLC-01).

Daiichi Sankyo and Merck withdraw BLA for patritumab deruxtecan in previously treated EGFR-mutated NSCLC [6]Merck. Patritumab deruxtecan Biologics License Application for patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer voluntarily withdrawn. May 29, 2025. (website is not accessible to users in UK). 

Daiichi Sankyo and Merck have voluntarily withdrawn their Biologics License Application (BLA) for patritumab deruxtecan, a HER3-DXd ADC, which was intended for accelerated approval in adult patients with previously treated, locally advanced or metastatic EGFR-mutated NSCLC. The drug, known as MSD outside the United States and Canada, is based on the HERTHENA-Lung01 Phase II trial. The decision to withdraw follows discussions with the FDA and the OS results for the confirmatory HERTHENA-Lung02 Phase III trial not meeting statistical significance. The withdrawl is separate from the FDA’s June 2024 complete response, which addressed issues related to a third-party manufacturing facility.

MARKET TRENDS

Merck & Co. begins construction on $1B US hub for ADCs and biologics production [7]Merck. Merck breaks ground on new $1 billion biologics center of excellence in Wilmington, Delaware. Apr 29, 2025. (website is not accessible to users in UK). 

Merck & Co. has broken ground on a $1B biologics facility in Wilmington, Delaware, and is set to become the US manufacturing base for Keytruda and next-generation biologics, including ADCs. The site will support launch and commercial-scale production, with lab operations expected by 2028 and clinical manufacturing by 2030. The center is projected to create over 500 full-time jobs initially, with potential for 1,500 more as operations expand. The move highlights Merck’s push to strengthen US-based manufacturing amid evolving trade policies. CEO Robert Davis emphasized the facility’s role in producing medicines “closer to patients” and its contribution to high-quality job creation. This investment positions Merck to scale ADC and biologics capabilities domestically, reinforcing its long-term manufacturing strategy for complex therapeutic platforms.

CLINICAL TRIALS AND RESEARCH

SystImmune’s ADC first-line triple negative breast cancer trial expanded by Bristol Myers Squibb [8]Bristol Myers Squibb. A study of izalontamab brengitecan versus chemotherapy in participants with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer ineligible for anti-PD(L)1 drugs (IZABRIGHT-Breast01). CA244-0008. Updated Jun 5, 2025. 

Bristol Myers Squibb (BMS) is advancing izalontamab brengitecan (BMS-986507/BL-B01D1), a bispecific ADC targeting EGFR and HER3, into a Phase II/III trial for first-line triple-negative breast cancer (TNBC). The conjugate links the antibody to a topoisomerase I inhibitor. This trial (IZABRIGHT-Breast01) will compare the ADC to standard chemotherapy in patients ineligible for PD-1-based therapy. BMS acquired ex-China rights from SystImmune in 2023 for $800M upfront, with milestone payments tied to clinical progress. This expansion highlights strong interest in ADCs and could trigger significant payouts for SystImmune if first-line trials begin on schedule in 2025 and 2026.

RemeGen’s ADC success in bladder cancer [9]RemeGen. RemeGen’s disitamab vedotin gains approval in China for its third indication making it the first ADC approved for HER2-positive advanced breast cancer with liver metastasis globally. May 9, 2025. 

RemeGen’s HER2-targeted ADC (disitamab vedotin), met primary endpoints for progression-free and overall survival (OS) in a Phase III bladder cancer trial, boosting prospects for Pfizer, which holds rights outside Asia. The 484-patient study in China tested the ADC with anti-PD-1 therapy Tuoyi (toripalimab), against standard chemotherapy, showing significant clinical benefit regardless of HER2 levels or cisplatin eligibility. The results support Pfizer’s parallel global trial, expected to read out in about a year. Disitamab vedotin, marketed as Aidixi in China, is already approved for HER2-expressing bladder, gastric, and most recently, breast cancers. Despite the encouraging data, Pfizer earlier took a $200M impairment charge on the asset due to intensifying competition in the ADC space. Despite this, RemeGen’s positive findings could shift momentum, particularly as combination strategies become a growing focus in ADC oncology pipelines.

Enhertu boosts response rates in early breast cancer, expanding ADC potential [10]AstraZeneca. Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial. May 7, 2025. 

AstraZeneca and Daiichi Sankyo’s HER2-targeting ADC Enhertu (trastuzumab deruxtecan) has achieved a new milestone, outperforming standard chemotherapy in the neoadjuvant setting for high-risk, early-stage HER2-positive breast cancer. In the Phase III DESTINY-Breast11 trial, Enhertu, followed by taxane-based THP therapy, significantly improved pathologic complete response rates versus the current standard regimen with ddAC-THP. Enhertu also showed a trend toward better event-free survival and had a more favorable tolerability profile with no new safety signals. Already approved for advanced HER2-positive, HER2-low, and HER2-ultralow breast cancers, Enhertu continues to expand its reach across disease stages and may now be poised to enter curative-intent settings.

Iksuda Therapeutics doses first patient in Phase I trial of CD19-targeting ADC [11]Iksuda Therapeutics. Iksuda Therapeutics announces first patient successfully dosed in phase 1 trial evaluating IKS03 in advanced B cell non-Hodgkin lymphomas. May 30, 2025. 

Iksuda Therapeutics, based in Newcastle upon Tyne, UK, has successfully dosed the first patient in a Phase I, first-in-human trial evaluating IKS03, a CD19-targeting ADC, in advanced B cell non-Hodgkin lymphoma. IKS03 utilizes a clinically validated tumor-selective payload release format designed to enhance safety and efficacy. The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-cancer activity across escalating doses to establish the recommended dose for expansion. Subsequent disease-specific cohorts will further evaluate efficacy. Patient enrollment is ongoing at sites across Italy, Spain, Australia, the US, and Canada, marking a significant step forward for Iksuda’s novel ADC platform targeting hematologic malignancies.

David Simpson, CEO of Iksuda Therapeutics and Editorial Board Member of Bioconjugation Insights, stated:

“With the first patient successfully completing the safety evaluation period with IKS03, Iksuda demonstrates its continued commitment to drive its differentiated ADCs through clinical proof of concept, further solidifying our position as a clinical-stage ADC-focused company. Although there have been advances in the treatment of non-Hodgkin lymphoma in recent years, there remains a significant unmet patient need, and we hope that IKS03 will be able to build on the potential benefit-risk profile suggested by the data generated in preclinical studies.”

COMPANY START-UPS

Synthetic Design Lab launches with $20M to redefine ADC payload precision [12]Eaton ES. ADC startup sets sights on 10-fold improvement in targeted payload delivery. First World Pharma April 23, 2025. see also Synthetic Design Lab. https://www.syntheticdesignlab.com. 

Synthetic Design Lab has launched with $20M in seed funding to engineer ADCs that deliver cytotoxic payloads with up to 10-fold greater efficiency than current platforms. Its proprietary SYNTHBODY platform is designed to enhance ADC precision, safety, and adaptability through advanced conjugation control. Backed by Playground Global and Godfrey Capital, the biotech aims to enter the clinic in 2026, though pipeline details remain undisclosed. While others pursue broader approaches with dual-payload ADCs to address low antigen expression and resistance, Synthetic Design Lab focuses on pinpoint accuracy. Founder Daniel Chen, former VP of cancer immunotherapy at Genentech, leads the effort.

TOOLS AND TECHNOLOGIES

ProteinQure raises $11M to advance first AI-designed peptide-drug conjugate into the clinic [13]ProteinQure. ProteinQure raises Series A financing to advance first AI-designed peptide therapeutic into clinical trials. May 28, 2025. 

ProteinQure has secured $11M in Series A funding to launch a first-in-human trial of PQ203, a potentially first-in-class peptide-drug conjugate (PDC) targeting the sortilin receptor in resistant tumors, including TNBC. Set to begin enrollment in Q3 2025, the US/Canada-based Phase I trial will test the AI-designed candidate in 70–100 patients. Unlike conventional ADCs, PDCs such as PQ203 may offer improved tumor penetration and safety due to their smaller size and lower immunogenicity. The candidate was designed using ProteinQure’s ProteinStudio platform, which integrates AI models, molecular simulations, and wet lab validation to engineer novel peptides using non-canonical amino acids. With $16M in total funding and a proprietary machine learning model library, ProteinQure is positioning itself as a next-generation player in the targeted therapy landscape.

CONFERENCES, EVENTS, AND PUBLICATIONS

Heidelberg Pharma to share new clinical data on amanitin-based ADC HDP-101 at EHA 2025 [14]Heidelberg Pharma. Heidelberg Pharma to present promising new clinical data on its lead ATAC candidate HDP-101 at EHA 2025. May 14, 2025. 

Heidelberg Pharma will present new clinical results for its lead ADC HDP-101, at the 2025 European Hematology Association (EHA) Congress in Milan this June. The Amanitin-based ADC is being evaluated in a Phase I/IIa trial for relapsed or refractory multiple myeloma. The candidate has shown promising early signals, including an ongoing complete response in a heavily pretreated patient treated continuously for over 19 months. Additional patients have demonstrated meaningful biological activity and clinical benefit. HDP-101 uses Heidelberg’s proprietary antibody-targeted amanitin conjugate (ATAC) platform, which leverages the potent RNA polymerase II inhibitor Amanitin for targeted cytotoxic delivery. The study is currently enrolling cohort 8 at a dose level of 140 µg/kg. The data supports the potential of HDP-101 as a novel ADC approach in multiple myeloma, especially in treatment-resistant populations.

Genmab’s FRα-targeting ADC, Rina-S, shows strong response in endometrial cancer at ASCO 2025 [15]Genmab. Genmab to highlight new data evaluating late-stage oncology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. May 22, 2025. 

Genmab has reported encouraging data for rinatabart sesutecan (Rina-S), a folate receptor alpha-targeting (FRα-targeting) ADC, in heavily pretreated endometrial cancer, reinforcing the rationale behind its $1.8B acquisition of ProfoundBio in 2024. The presentation at American Society of Clinical Oncology (ASCO) 2025 showed Phase I/II data had objective response rates of 50% at 100 mg/m² and 45.5% at 120 mg/m², with durable responses ongoing in ~80% of responders in both cohorts. Two complete responses were observed at the lower dose. Disease control was achieved in all patients in the 100 mg/m² group. The most common treatment-emergent adverse events were neutropenia, anaemia, and gastrointestinal issues. Only 3.1% discontinued due to side effects. These results strengthen Genmab’s strategic decision to advance Rina-S, now a core ADC asset in its oncology pipeline following a broader portfolio reprioritization.

Pfizer unveiled data on novel ADC-immunotherapy combinations at ASCO 2025 [16]Pfizer. Pfizer advances bold vision for future of cancer care at the ASCO 2025 Annual Meeting. Apr 23, 2025. 

At the 2025 ASCO Annual Meeting, Pfizer spotlighted data from its expansive oncology pipeline, presenting data from over 60 abstracts, across major tumor areas, including breast, genitourinary, hematologic, and thoracic cancers, as well as colorectal cancer. Among these, they shared their strategy to explore novel vedotin ADCs in combination with immune-checkpoint inhibitors. This approach is aimed at amplifying anti-tumor immune responses. Notably, for the first time, Pfizer presented early-phase clinical data on two investigational ADCs in combination with pembrolizumab for thoracic cancers: sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC being studied in lung and head and neck cancers, and PDL1V (PF-08046054): a PD-L1-targeted ADC being investigated in head and neck cancers. These Phase I findings highlight Pfizer’s growing interest in rational combinations that leverage tumor-directed payload delivery with immune activation.

Promising CD123-targeted conjugate shows high response in newly diagnosed BPDCN [17]The ASCO Post. Novel antibody-drug conjugate for newly diagnosed BPDCN. May 6, 2025. 

Pivekimab sunirine, a novel ADC, demonstrated high response rates and manageable safety in newly diagnosed patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), according to Phase I/II results from the CADENZA study presented at the 2025 ASCO Annual Meeting. As a CD123-targeting conjugate, pivekimab delivers a cytotoxic payload directly to cancer cells, inducing cell death. Among 33 newly diagnosed patients, the ADC achieved an 85% ORR and 70% complete response rate, with a median OS rate of 16.6 months. Peripheral edema was the most common side effect, but it was reversible and manageable. Compared to existing therapies such as tagraxofusp-erzs, pivekimab sunirine represents a next-generation ADC approach with promising front-line potential. Researchers emphasized its role in advancing treatment for this rare and aggressive disease, with future studies potentially exploring combination regimens. The trial was funded by AbbVie.

Summary

The ADC field has continued to expand with key clinical progress and strategic partnerships highlighting the growing momentum in conjugate-based oncology. Veraxa Biotech announced a $1.64B merger to advance it next-generation ADC and bispecific T cell engager pipeline, alongside a new bsADC collaboration with OmniAb targeting solid tumors. Araris Biotech also extended its AraLinQ conjugation platform through a new partnership with Johnson & Johnson, while Astellas secured a $1.3B global licensing deal for Evopoint’s CLDN18.2-directed ADC.

Regulatory milestones included FDA’s accelerated approval of AbbVie’s c-Met–directed ADC EMRELIS for advanced NSCLC. Meanwhile, Merck began construction on a $1B US-based biologics and ADC facility to scale domestic production. 

On the clinical front, pivekimab sunirine, a CD123-targeting ADC, demonstrated high response rates in newly diagnosed BPDCN, suggesting front-line potential. RemeGen’s HER2-targeted disitamab vedotin met survival endpoints in a Phase III bladder cancer trial, and AstraZeneca/Daiichi Sankyo’s Enhertu improved pathologic response rates in early HER2+ breast cancer, and BMS expanded trials for its bispecific ADC in first-line TNBC.

At the 2025 ASCO and EHA conferences, key data underscored the growing role of ADCs in oncology. Genmab reported robust response rates for its FRα-targeting ADC Rina-S in endometrial cancer, supporting its $1.8B acquisition of ProfoundBio. Heidelberg Pharma presented sustained clinical responses from its amanitin-based ADC HDP-101 in multiple myeloma. Pfizer also revealed early data on novel ADC-immunotherapy combinations, reinforcing the momentum behind rational conjugate-based combinations in solid tumors.

References

1. VERAXA Biotech. VERAXA and Voyager Acquisition Corp. announce business combination agreement to create Nasdaq-listed biopharmaceutical company advancing a pipeline of next-generation cancer therapies. Apr 23, 2025.

2. VERAXA Biotech. VERAXA Biotech enters co-discovery alliance with OmniAb for a novel bispecific antibody drug conjugate program. May 5, 2025. 

3. Araris Biotech. Araris Biotech AG announces research agreement to develop next-generation ADCs using Araris’ AraLinQ™ technology. Apr 29, 2025. 

4. Astellas. Astellas enters exclusive license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2. May 30, 2025.

5. AbbVie. US FDA approves EMRELIS™ (telisotuzumab vedotin-tllv) for adults with previously treated advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. May 14, 2025.

6. Merck. Patritumab deruxtecan Biologics License Application for patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer voluntarily withdrawn. May 29, 2025. (website is not accessible to users in UK). 

7. Merck. Merck breaks ground on new $1 billion biologics center of excellence in Wilmington, Delaware. Apr 29, 2025. (website is not accessible to users in UK).

8. Bristol Myers Squibb. A study of izalontamab brengitecan versus chemotherapy in participants with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer ineligible for anti-PD(L)1 drugs (IZABRIGHT-Breast01). CA244-0008. Updated Jun 5, 2025. 

9. RemeGen. RemeGen’s disitamab vedotin gains approval in China for its third indication making it the first ADC approved for HER2-positive advanced breast cancer with liver metastasis globally. May 9, 2025.

10. AstraZeneca. Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial. May 7, 2025.

11. Iksuda Therapeutics. Iksuda Therapeutics announces first patient successfully dosed in phase 1 trial evaluating IKS03 in advanced B cell non-Hodgkin lymphomas. May 30, 2025.

12. Eaton ES. ADC startup sets sights on 10-fold improvement in targeted payload delivery. First World Pharma April 23, 2025. see also Synthetic Design Lab. https://www.syntheticdesignlab.com.

13. ProteinQure. ProteinQure raises Series A financing to advance first AI-designed peptide therapeutic into clinical trials. May 28, 2025.

14. Heidelberg Pharma. Heidelberg Pharma to present promising new clinical data on its lead ATAC candidate HDP-101 at EHA 2025. May 14, 2025.

15. Genmab. Genmab to highlight new data evaluating late-stage oncology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. May 22, 2025.

16. Pfizer. Pfizer advances bold vision for future of cancer care at the ASCO 2025 Annual Meeting. Apr 23, 2025.

17. The ASCO Post. Novel antibody-drug conjugate for newly diagnosed BPDCN. May 6, 2025.

Affiliation

Esohe Idusogie 
esohe.idusogie@gmail.com

Authorship & Conflict of Interest

Contributions: The named author takes responsibility for the integrity of the work as a whole, and has given his approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The author has no conflicts of interest.

Funding declaration: The author received no financial support for the research, authorship and/or publication of this article. 

Article & Copyright Information

Copyright: Published by Bioconjugation Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2025 Esohe Idusogie. Published by Bioconjugation Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Invited.

Revised manuscript received: Jun 17, 2025.

Publication date: Jun 24, 2025.