Reviewing the Market Trends in the Antibody-Drug Conjugate Development: A Focus on Roche, Sanofi, BMS, Seagen, and BioNTech

In the rapidly evolving landscape of cancer treatment, antibody-drug conjugates (ADCs) have emerged as a beacon of hope, offering targeted therapy options for various cancer types. This article delves into the latest developments and collaborations in the ADC arena, highlighting significant strides made by leading pharmaceutical companies, providing a comprehensive overview of the current state and future prospects of ADCs in oncology.

Roche and MediLink Therapeutics Forge $1 Billion Collaboration for ADC Cancer Treatment YL211

On Jan 02, 2024, the collaboration between Roche and MediLink Therapeutics involves the development, manufacturing, and commercialization of MediLink’s ADC candidate, YL211. Roche will pay MediLink upfront and near-term milestone payments totaling $50 million, with the biotech potentially eligible for nearly $1 billion in potential milestone payments for development, registration, commercialization, and royalties on future net sales. MediLink will work with Roche’s China Innovation Center to push the candidate into Phase I clinical trials, while Roche will be solely responsible for developing and commercializing the treatment globally.

The YL211 ADC targets c-MET, a receptor tyrosine kinase closely associated with tumor formation, aggressive growth, and metastasis. According to MediLink, the candidate has shown promising efficacy and safety in preclinical tumor models and other experiments. This collaboration is part of a broader trend in the biotech world, with prominent players securing ADC deals to develop next-generation cancer treatments.

Sanofi’s ADC Development Faces Challenges as Tusamitamab Ravtansine Fails in Advanced Lung Cancer Study

On December 21, 2023, in contrast, Sanofi faced a setback in its ADC development as its experimental treatment, tusamitamab ravtansine, fell short in a late-stage study in advanced lung cancer. Despite the drug not meeting its main study goals, Sanofi expressed a commitment to continue exploring the potential of ADCs that involve a component of tusamitamab ravtansine and its target, a tumor protein called CEACAM5, which is overexpressed in a variety of epithelial tumors, including gastric, lung, and colorectal cancers. This setback highlights the challenges and risks associated with pharmaceutical research and development, particularly in the highly competitive area of ADC development.

Bristol Myers Squibb Expands Cancer Drug Portfolio with $800 Million Deal for SystImmune’s ADC Candidate BL-B01D1

On Dec 11, 2023, Bristol Myers Squibb (BMS) made a significant move to fill the ADC-shaped hole in its pipeline by striking an $800 million deal with SystImmune for a phase 2 solid tumor candidate. The candidate, BL-B01D1, is designed to block EGFR and HER3 signals to cancer cells and deliver a cytotoxic payload without causing intolerable toxicity in healthy tissues. This deal demonstrates BMS’s strategic commitment to diversifying its pipeline with promising ADC candidates and expanding its presence in the competitive cancer drug market.

Seagen Announces Positive Phase 3 Results for TUKYSA® in Combination Therapy for Advanced HER2-Positive Breast Cancer

On Aug 16, 2023, Seagen, Inc. (acquired by Pfizer) announced positive results from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA^® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla^®) for the treatment of unresectable locally advanced or metastatic HER2-positive breast cancer. The combination showed a statistically significant improvement in progression-free survival (PFS) in patients who received the combination compared to those who received placebo plus ado-trastuzumab emtansine. This underscores the potential of ADCs in improving outcomes for patients with certain types of cancer and validates the growing interest in developing combination therapies for cancer treatment.

BioNTech and Duality Biologics Gain FDA Breakthrough Therapy Designation for HER2-Targeting ADC in Advanced Endometrial Cancer

On December 21, 2023, BioNTech and Duality Biologics (Suzhou) Co. Ltd. received Breakthrough Therapy designation from the U.S. Food and Drug Administration for BNT323/DB-1303, a next-generation ADC candidate targeting HER2 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. This designation reflects the potential of ADCs to address significant unmet medical needs in cancer treatment and signifies a positive step forward in the development of novel ADC therapies.

Summary

In conclusion, the ADC market is witnessing significant advancements, with major pharmaceutical and biotech companies entering into strategic collaborations, making substantial investments, and achieving positive clinical outcomes in the development of next-generation ADCs. These developments underscore the potential of ADCs to revolutionize cancer treatment and provide hope for improved outcomes for patients with a wide range of cancer types. The increasing interest and investment in ADC research and development demonstrate a clear commitment to delivering innovative and effective therapies in the fight against cancer.

Author

Oscar Wu