#USA #Cancer Treatments #Biohaven #New Haven #antibody drug conjugates

Biohaven Oncology Program Unveils Exciting Developments

On May 28, 2025, Biohaven Ltd., a leading clinical-stage biopharmaceutical company based in New Haven, Connecticut, presented pivotal updates regarding its oncology development programs during its annual RD Day, held in conjunction with the Yale Innovation Summit. Central to this presentation were exciting preliminary data on innovative antibody drug conjugates (ADCs), particularly featuring Trop2 and FGFR3 ADCs combined with a proprietary TopoIx payload. These advanced therapies show significant promise in treating various tumor types, particularly for patients who have not responded to existing standard therapies.

One of the key highlights was the performance of BHV-1510, a unique Trop2-directed ADC. Data from the ongoing Phase 1 study indicated highly encouraging preliminary clinical activity both as a standalone treatment and in conjunction with Regeneron's anti-PD-1 therapy, cemiplimab. Reports from the clinical trials revealed that all six patients treated with the BHV-1510 and cemiplimab combination experienced tumor reductions, including instances of confirmed partial responses. Such findings underscore the potential efficacy of BHV-1510 in combating tumors that have proven resistant to current treatment modalities.

The favorable safety profile of BHV-1510 was another reassuring aspect. In the Phase 1 study, side effects reported so far have included manageable cases of stomatitis, a known toxicity associated with Trop2-targeted therapies. Importantly, researchers noted the absence of severe complications such as interstitial lung disease linked to the payload, and low incidence of gastrointestinal and hematological toxicities. The initial cohorts using the combination therapy have also tolerated the treatment well, with no reported dose-limiting toxicities.

Dr. Nushmia Khokhar, Chief Medical Officer for Oncology at Biohaven, commented on the positive early findings, highlighting the observed potential synergy with anti-PD-1 therapies as particularly encouraging. The preclinical stability, differentiated safety, and signs of enhanced efficacy of the TopoIx payload reinforced the belief that BHV-1510 could advance urgently needed treatment options to patients suffering from tough-to-treat cancer types.

In addition to BHV-1510, Biohaven announced the successful dosing of its first patient with BHV-1530, which targets fibroblast growth factor receptor 3 (FGFR3) and also employs the TopoIx payload. This ADC has a specified potential for treating cancers linked to FGFR3 alterations, such as certain urothelial cancers. As FGFR3 remains a clinically validated target within oncology therapies, the advent of BHV-1530 presents a novel avenue for intervention in a field where options are currently limited.

Dr. Michael Song, a principal investigator and seasoned oncologist involved in the study, expressed excitement regarding the partnership with Biohaven. He emphasized the substantial therapeutic promise associated with the FGFR3 target, forecasting the ADC's ability to extend significant clinical benefits to patients with FGFR3-driven tumors.

This was not the only innovation highlighted on Biohaven’s RD Day. The company outlined its portfolio of next-generation technologies aimed at modernizing ADC development. Partnerships with entities like Merus and GeneQuantum aim to leverage preclinical insights into novel high-value targets, thus continuing to advance Biohaven's ADC platforms.

Brian Lestini, President of Oncology at Biohaven, articulated the excitement surrounding their innovative ADCs, lauding early clinical experiences as evidence of their efficacy and the multi-faceted potential of the TopoIx payload. The initiation of the first human study of BHV-1530 marks a significant step in offering new solutions to specific unmet medical needs in oncology.

Biohaven's commitment to revolutionizing cancer treatment through cutting-edge pharmacological advancements, including ADCs with superior potency and specificity, indicates a promising future for oncology therapies. The developments shared during the 2025 RD Day mark an important milestone in the pharmaceutical landscape, opening avenues for research and new treatment paradigms that could greatly impact oncology care in the coming years.

About Biohaven

Biohaven Ltd. is focused on the discovery and development of life-changing therapies across a spectrum of therapeutic areas such as oncology and neuroscience, leveraging its extensive patented technologies and drug development experience. For more information about Biohaven’s commitment to innovative treatments, visit their website at www.biohaven.com.