The bispecific antibody drug conjugates (BsADCs) field is gaining momentum as a novel therapeutic approach in cancer treatment. These innovative therapies combine the precision of bispecific antibodies with the cytotoxic power of traditional antibody-drug conjugates (ADCs). While most BsADC programs are in early stages, several candidates are making significant strides toward late-stage development, attracting substantial interest and investment from pharmaceutical and biotechnology companies.
Late-Stage BsADC Development
Two BsADC candidates, Alhamab Oncology's JSKN003 (anti-HER2) and Sichuan Baili Pharmaceutical's BL-B01D1, also known as Zalontamab Brengitecan (EGFR×HER3), have advanced to Phase 3 clinical trials for solid tumors. BL-B01D1 is undergoing Phase 3 studies in China for breast and lung cancer, while JSKN003 is in Phase 3 trials in China for breast cancer. These advancements are closely monitored as potential precedents for the first BsADC approvals.
The Chinese National Medical Products Administration has granted BL-B01D1 breakthrough therapy designation, potentially accelerating its market approval. This designation provides significant benefits from the regulatory body.
Collaborative Efforts and Licensing Agreements
Recent months have seen increased collaborative activity in the BsADC space. Biocytogen and ABL Bio have partnered to discover new BsADC candidates with improved safety and efficacy profiles, leveraging their expertise in antibody engineering and development.
Licensing agreements are also shaping the BsADC landscape. Biocytogen and SOTIO Biotech have an agreement allowing SOTIO to license bispecific antibodies produced by Biocytogen's RenLite® platform for next-generation ADCs. These collaborations pool resources and expertise, potentially accelerating the development of promising treatments.
Combination Therapies and Clinical Trials
Clinical trial collaborations are exploring the potential of BsADCs in combination with other treatment modalities. Xuanzhu Biopharma and Innovent Bio have a clinical trial partnership and supply agreement to evaluate KM-501 (anti-HER2 BsADC) in combination with Sintilimab, an anti-PD-1 monoclonal antibody, for solid tumors. These collaborations may broaden treatment options and expand the patient population benefiting from BsADC therapies.
Regulatory Approvals and Patent Activity
Regulatory agencies are increasingly familiar with BsADCs, leading to more candidates entering clinical trials. Doma Bio announced FDA approval for their BsADC candidates, DM001 and DM005, to begin Phase I studies for solid tumors in July and August 2024. This trend is expected to continue, increasing the number of BsADCs in active clinical development.
Companies are actively seeking patents to protect their technological innovations. The United States Patent and Trademark Office (USPTO) granted Biocytogen a patent for their RenLite® platform, used to generate BsADCs.
Future Outlook
The BsADC market is poised for substantial growth as more candidates progress through clinical development. The outcomes of ongoing and upcoming late-stage trials will significantly influence the regulatory landscape and investor confidence in this drug class. Specialization and diversification are expected as the field evolves, with companies focusing on platform technologies or specific indications and targeting combinations. This diversity will contribute to a thriving ecosystem of players advancing BsADC therapeutics.
