The Phase II portion of the trial will evaluate the preliminary efficacy of the drug in signal-finding expansion cohorts. Credit: Halfpoint / Shutterstock.

Biohaven has dosed the first subject in its Phase I/II clinical trial of BHV-1510, a trophoblast cell surface antigen-2 (Trop-2) directed antibody-drug conjugate (ADC) for advanced or metastatic epithelial cell tumours.

It is a first-in-human, multi-centre, open-label trial structured into two segments: a Phase I dose escalation and a multicohort Phase II dose expansion.

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The initial phase will focus on determining the safety and tolerability of BHV-1510, establishing the recommended doses for expansion (RDEs), and identifying the maximum-tolerated dose (MTD), if applicable.

The subsequent phase will evaluate the preliminary efficacy of the drug in signal-finding expansion cohorts.

BHV-1510 features a homogeneous drug-antibody ratio (DAR) of four and employs a Trop-2-directed antibody linked to a Topoisomerase 1 (TopoIx) payload.

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The ADC employs a unique site-specific conjugation method and a highly stable and irreversible linker developed by GeneQuantum Healthcare.

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Preclinical studies have demonstrated that BHV-1510 delivers cellular cytotoxicity, bystander killing, and immunogenic cell death, potentially leading to enhanced monotherapy efficacy and synergistic effects along with anti-PD-1 therapy.

BHV-1510 exhibited a wider therapeutic margin compared to other Trop-2 ADCs in IND-enabling studies, notably without lung toxicity. This suggests a possible improvement in the clinical efficacy and safety profile for patients.

Furthermore, Biohaven signed a clinical supply agreement with Regeneron Pharmaceuticals.

Under this agreement, Biohaven will sponsor and fund the clinical trial, while Regeneron will provide Libtayo, a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor.

Biohaven Oncology chief medical officer Nushmia Khokhar said: “We are extremely proud to advance our first oncology clinical programme with a potentially best-in-class ADC.

“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 tumours.”

Last September, the company concluded the enrolment of 180 patients in a Phase III study evaluating taldefgrobep alfa as adjunctive therapy in patients with spinal muscular atrophy (SMA).