On May 29, 2024 Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported the first patient has been dosed in a first-in-human Phase 1/2 study of BHV-1510, a highly differentiated Trophoblast Cell Surface Antigen-2 (Trop-2) directed Antibody Drug Conjugate (ADC), and the lead ADC program to advance into clinical trials in Biohaven’s growing oncology pipeline (Press release, Biohaven Pharmaceutical, MAY 29, 2024, View Source [SID1234643816]).
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The Phase 1/2 study of BHV-1510 is a multicenter, open-label study in subjects with select advanced or metastatic epithelial cell tumors. The trial consists of a dose-escalation phase, followed by a multicohort expansion phase. Additional information can be found at View Source (NCT06384807).
"We are extremely proud to advance our first oncology clinical program with a potentially best in class ADC," said Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven. "With the initiation of this monotherapy study, we are one step closer to providing differentiated and superior treatment options to people living with cancer. We are also excited to work with Regeneron and efficiently explore BHV-1510 in combination with its PD-1 inhibitor Libtayo across a range of tumors."
BHV-1510 is a next-generation, fully optimized ADC that consists of a Trop-2 directed antibody conjugated to a proprietary best-in-class Topoisomerase 1 (TopoIx) payload at a homogeneous drug-antibody ratio (DAR) of 4. BHV-1510 incorporates a unique site-specific conjugation methodology and highly stable and irreversible linker chemistry designed by GeneQuantum Healthcare Co. (Suzhou) Ltd. Preclinically BHV-1510 has shown superior cellular cytotoxicity, bystander killing, and immunogenic cell death resulting in improved efficacy as monotherapy, and synergistic efficacy in combination with anti-PD-1 therapy. In IND-enabling studies, BHV-1510 also showed a broader therapeutic margin relative to more advanced Trop-2 ADCs, including a lack of lung toxicity, that may translate to an improved clinical efficacy and safety profile.
Shiraj Sen M.D., Ph.D., Director of NEXT Oncology-Dallas, commented, "Antibody drug conjugates have shown promising efficacy in solid tumors, but their clinical potential is currently limited by their safety margin. BHV-1510 has compelling and differentiated preclinical data, with the potential to translate to better safety and efficacy in several tumors including those with significant unmet need. We are excited to be working with the Biohaven team on this important clinical trial for patients with advanced epithelial tumors."
Biohaven entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) under which Biohaven will sponsor and fund the planned clinical trial and Regeneron will provide Libtayo. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1).
Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven stated, "Biohaven’s ADC technology and portfolio has the potential to differentiate from current ADCs in the market that use older payloads or maleimide linkers. The advancement of our lead ADC program, BHV-1510, into clinic as both monotherapy and in combination with Regeneron’s anti-PD-1 represents an important first opportunity to show the breadth and differentiation of Biohaven’s extensive ADC pipeline. Coupled with our deep in-house expertise in oncology clinical development, ADC chemistry, and complex manufacturing, we believe our diverse and growing ADC portfolio positions Biohaven for future leadership in oncology."
Biohaven is developing a broad portfolio of highly differentiated ADCs with the potential to broaden therapeutic margin, increase time on treatment, and improve efficacy. Biohaven’s proprietary MATE platform technology focuses on novel, single-step conjugation chemistry, with the potential to be superior to the current industry standard maleimide and lipophilic click chemistry.