Biohaven Administers First Dose of Trop-2 ADC BHV-1510 in Advanced Epithelial Tumors

Biohaven Ltd., a clinical-stage biopharmaceutical company based in New Haven, Connecticut, announced the commencement of dosing the first patient in its Phase 1/2 clinical trial of BHV-1510, a novel antibody drug conjugate (ADC). The trial, which is the first of its kind for Biohaven, targets advanced or metastatic epithelial cell tumors using Trop-2 directed therapy.

BHV-1510 is distinguished by its highly optimized structure, which includes a Trop-2 specific antibody linked to a proprietary Topoisomerase 1 (TopoIx) payload. This new ADC employs a unique conjugation methodology and a stable, irreversible linker chemistry, developed by GeneQuantum Healthcare. Preclinical studies have demonstrated superior efficacy for BHV-1510 both as a standalone treatment and in combination with anti-PD-1 therapy, highlighting its potential for better therapeutic outcomes and safety profiles compared to other Trop-2 ADCs.

The clinical trial is designed as a multicenter, open-label study, beginning with a dose-escalation phase followed by a multicohort expansion phase. This structure allows for the careful assessment of BHV-1510's safety and efficacy across a variety of advanced epithelial cell malignancies. These types of cancers represent a significant portion of all cancer cases, and advanced or metastatic forms are particularly challenging to treat, making this trial crucial for addressing an urgent unmet medical need.

Biohaven's collaboration with Regeneron Pharmaceuticals further strengthens the trial's potential. Under a clinical supply agreement, Biohaven will sponsor and fund the clinical trial, while Regeneron will supply Libtayo® (cemiplimab-rwlc), an anti-PD-1 therapy. This partnership aims to explore the synergistic effects of combining BHV-1510 with Libtayo®, potentially enhancing treatment efficacy across a range of tumors.

Dr. Nushmia Khokhar, Chief Medical Officer of Oncology at Biohaven, expressed pride in advancing this groundbreaking oncology program. The initiation of this monotherapy study represents a significant milestone in providing improved treatment options for cancer patients. Dr. Shiraj Sen, director at NEXT Oncology-Dallas, echoed this sentiment, highlighting the compelling preclinical data of BHV-1510 and its potential to offer a better safety and efficacy profile in treating solid tumors.

BHV-1510's unique formulation, which includes a homogeneous drug-antibody ratio (DAR) of 4, demonstrates superior cellular cytotoxicity and immunogenic cell death. This has been validated through IND-enabling studies, showing a broader therapeutic margin and a lack of lung toxicity, which could translate to improved clinical outcomes.

Dr. Brian Lestini, President of Oncology at Biohaven, emphasized the potential of Biohaven's ADC technology to stand out from existing treatments that use older payloads or maleimide linkers. The progression of BHV-1510 into clinical trials as both a monotherapy and in combination with an anti-PD-1 marks the first significant opportunity to demonstrate the breadth and potential of Biohaven's ADC pipeline. With extensive expertise in oncology clinical development and complex manufacturing, Biohaven aims to establish leadership in the field of oncology.

Biohaven's broader ADC portfolio is designed to offer increased therapeutic margins, prolonged treatment durations, and enhanced efficacy. The company's MATE™ platform technology focuses on novel single-step conjugation chemistry, positioning it as a potential superior alternative to current industry standards.

In summary, Biohaven is advancing its portfolio of innovative therapeutics across various domains, including oncology, immunology, and neuroscience. The company's strategic partnerships and proprietary technologies underscore its commitment to developing life-changing treatments for a range of diseases.