Biohaven Doses First Patient with its Novel Trop-2 Directed Antibody Drug Conjugate (ADC) BHV-1510 in Advanced or Metastatic Epithelial Tumors
Biohaven has dosed its first patient in a Phase 1/2 study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC) targeting advanced or metastatic epithelial tumors. BHV-1510 has shown promising preclinical results, including superior efficacy and a broader therapeutic margin compared to other Trop-2 ADCs. The study will evaluate the drug as a monotherapy and in combination with Regeneron's anti-PD-1 therapy, Libtayo®. Biohaven's proprietary ADC technology and partnership with Regeneron aim to advance treatment options in oncology, particularly for cancers with significant unmet medical needs.
The multicenter, open-label trial will have a dose-escalation phase followed by a multicohort expansion phase. Preclinical data suggests BHV-1510 could offer a better safety profile, including no lung toxicity, and improved clinical efficacy. The partnership with Regeneron will see Biohaven sponsor and fund the trial, while Regeneron supplies Libtayo. This initiative represents a key step in Biohaven's broader oncology strategy.
- Dosed first patient in Phase 1/2 trial for BHV-1510.
- BHV-1510 has shown superior preclinical efficacy and a broader therapeutic margin.
- Partnership with Regeneron to study BHV-1510 in combination with Libtayo.
- BHV-1510 demonstrated a lack of lung toxicity preclinically.
- Biohaven's proprietary ADC technology could potentially improve efficacy and safety.
- Potential to treat advanced or metastatic epithelial tumors, a major unmet medical need.
- Phase 1/2 trial initiation implies no current clinical data supporting BHV-1510’s efficacy in humans.
- Financial burden on Biohaven as it sponsors and funds the clinical trial.
- The success of BHV-1510 is still highly uncertain and contingent on clinical trial results.
Insights
From a clinical standpoint, the dosing of the first patient with BHV-1510 marks a significant milestone in oncology research. The novel Trop-2 directed antibody drug conjugate (ADC) is designed to target epithelial tumors, which comprise the majority of cancer cases. The unique mechanism of action, combining Trop-2 targeting with a potent Topoisomerase 1 payload, indicates a potential for higher efficacy and lower toxicity compared to existing therapies.
Importantly, the preclinical data suggests a broader therapeutic margin and lack of lung toxicity, a common issue with other Trop-2 ADCs. This could translate to safer and more effective treatment options for patients with advanced or metastatic epithelial tumors, which are currently underserved by existing therapies. The collaboration with Regeneron to study the combination with Libtayo® further underscores the innovative approach and potential for synergistic effects in cancer treatment.
Overall, the initiation of this study is a positive development, offering hope for new, effective treatment modalities in oncology.
This announcement highlights Biohaven's strategic entry into the oncology market with BHV-1510, leveraging advanced ADC technology. The Phase 1/2 trial aims to evaluate the safety and efficacy of BHV-1510, which has shown promising preclinical results in terms of cytotoxicity and immune response. The involvement of Regeneron, providing their PD-1 inhibitor Libtayo®, indicates a strong partnership and confidence in the potential of combination therapies.
For retail investors, it's important to understand the significance of ADCs in cancer treatment. ADCs are a class of therapeutics that combine the targeting capabilities of antibodies with potent cytotoxic drugs, allowing for selective targeting of cancer cells while sparing normal tissues. The innovative MATE™ platform technology used by Biohaven could potentially offer a competitive edge in this space, promising more efficient drug conjugation.
Given the unmet medical need in advanced epithelial tumors and the potential of BHV-1510 to address this, the clinical progress of this ADC will be closely watched by the market. However, as with any early-phase clinical trial, the outcomes remain uncertain and investors should be prepared for potential variability in results.
Biohaven's latest endeavor into the oncology space with BHV-1510 is noteworthy from a financial perspective. The initiation of the Phase 1/2 clinical trial suggests progress in their R&D pipeline, potentially paving the way for future revenue streams. The partnership with Regeneron, a well-established player in immuno-oncology, to explore combination therapies also signals a strategic move to enhance the therapeutic potential of BHV-1510.
However, investors should remain cautious. The clinical trial phase is fraught with risks and the eventual success of BHV-1510 will depend on demonstrating superior safety and efficacy in human subjects. The preclinical data is promising, but it’s vital to observe how these results translate into clinical outcomes.
Moreover, the competitive landscape in ADCs is intensifying, with several companies developing similar therapies. Biohaven’s unique technology and partnership strategy will be critical in differentiating BHV-1510 from its competitors. Long-term investors should keep an eye on the trial's progression, any potential regulatory hurdles and subsequent market adoption if the drug advances successfully through clinical trials.
-BHV-1510 is a novel trophoblast cell surface antigen-2 (Trop-2) directed antibody drug conjugate (ADC) that has demonstrated a highly differentiated preclinical monotherapy efficacy profile, the potential for broader therapeutic margin than other Trop-2 ADCs currently in development, and synergistic affects when combined with anti-PD1 therapy
-Biohaven also entered into a clinical supply agreement with Regeneron to study the combination of BHV-1510 with Regeneron's anti-PD-1 Libtayo® (cemiplimab-rwlc) in the Phase 1/2 clinical trial
-Malignancies of epithelial tissue account for the vast majority of all cancers and the advanced or metastatic forms of these carcinomas represent an urgent unmet medical need
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 https://www.clinicaltrials.gov/ (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. (
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.
About Biohaven
Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit www.biohaven.com.
Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable
MATE™ is a trademark of Biohaven Therapeutics Ltd.
Libtayo® is a registered trademark of Regeneron Pharmaceuticals, Inc.
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