Bristol Myers Squibb, SystImmune Announce Deal to Codevelop, Commercialize Bispecific Antibody-Drug Conjugate

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Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.¹

Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.¹

“Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said BMS Executive Vice President and Chief Medical Officer, Drug Development Samit Hirawat, MD, in a press release. “SystImmune’s BL-B01D1 adds yet another ADC to our diverse pipeline and helps strengthen our approach of matching the most appropriate therapeutic modality to areas of unmet medical need across solid tumor oncology. We look forward to working with SystImmune to advance BL-B01D1 in hopes of offering a differentiated treatment option for patients in need.”¹

BL-B01D1 is a bispecific topoisomerase inhibitor-based ADC that consists of an epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3) bispecific antibody bounded to a novel TOP-I inhibitor payload via a cleavable linker. The novel therapy is currently being evaluated in the global, multi-center Phase I BL-B01D1-LUNG101 trial among patients with metastatic or unresectable non-small cell lung cancer (NSCLC).²

Clinical trial data have shown promising anti-tumor activity in patients across a variety of solid tumor types that progressed following standard of care treatments, including NSCLC and breast cancer. Data from a first-in-human Phase I trial (NCT05194982) in multiple solid tumor types released earlier this year found that the novel drug has shown the most promise treating EGFR-mutant NSCLC.²

The trial included 114 patients with NSCLC previously administered a median of three prior lines of treatment to receive at least one dose of BL-B01D1. The drug produced a 63.2% overall response rate with an acceptable safety profile.²

“BL-B01D1 demonstrated encouraging efficacy in heavily pretreated metastatic/locally advanced NSCLC, especially in [patients with EGFR mutated NSCLC],” the study investigators wrote.²

As part of the deal, SystImmune will be solely responsible for the development, commercialization, and manufacturing of the drug in Mainland China as well as for manufacturing specific drug supplies for use outside of the country. BMS gains sole rights to develop and commercialize the drug throughout the rest of the world.

“Recent BL-B01D1 trials have shown broad potential across different solid tumors as well as a manageable safety profile,” said SystImmune Chief Executive Officer Dr. Yi Zhu, in a press release. “We have long admired Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology, and this strategic collaboration is an exciting step forward in delivering potential antitumor medicines to patients worldwide. We look forward to a productive partnership.”¹

References

1. SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1. Bristol Myers Squibb. News release. December 12, 2023. Accessed December 12, 2023. https://news.bms.com/news/corporate-financial/2023/SystImmune-and-Bristol-Myers-Squibb-Announce-a-Global-Strategic-Collaboration-Agreement-for-the-Development-and-Commercialization-of-BL-B01D1/default.aspx

2. Zhang L. et al. 1316MO BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate, in patients with non-small cell lung cancer: Updated results from first-in-human phase I study. Annals of Oncology. Volume 34, Supplement 2, S758, October 2023. DOI: https://doi.org/10.1016/j.annonc.2023.09.2350. Accessed December 12, 2023. https://www.annalsofoncology.org/article/S0923-7534(23)03187-3/fulltext