SystImmune, Bristol Myers Squibb ink licensing agreement to co-develop & co-commercialise BL-B01D1 in US

SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC).

Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world.

BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global multi-center phase 1 study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical studies of BL-B01D1 were presented in 2023 at ASCO, ESMO and the San Antonio Breast Cancer Symposium; these data demonstrate promising anti-tumour activity in patients with a range of solid tumours that had progressed after standard of care treatments, including NSCLC and breast cancer.

“Recent BL-B01D1 trials have shown broad potential across different solid tumours as well as a manageable safety profile,” said Dr. Yi Zhu, chief executive officer at SystImmune. “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.”

“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 Samit Hirawat, MD, executive vice president, chief medical officer, drug development at Bristol Myers Squibb. “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 tumour oncology. We look forward to working with SystImmune to advance BL-B01D1 in hopes of offering a differentiated treatment option for patients in need.”

Bristol Myers Squibb will pay SystImmune $800 million in an upfront payment and up to $500 million in contingent near-term payments. SystImmune is eligible to receive additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones for a total potential consideration of up to $8.4 billion. The companies will share certain global development expenses and profits and losses in the United States. Through its affiliates, SystImmune will retain exclusive development and commercialization rights in Mainland China, where Bristol Myers Squibb will receive a royalty on net sales. Outside the United States and Mainland China, SystImmune will receive a tiered royalty on net sales. The agreement is subject to customary clearance by antitrust regulators.

BL-B01D1 is a potentially first-in-class bispecific ADC developed by SystImmune, targeting both EGFR and HER3, which are highly expressed in most epithelial tumours. BL-B01D1 is comprised of SystImmune's proprietary bispecific antibody and linker-payload which contains a stable, cleavable linker and a topoisomerase inhibitor.

SystImmune is a clinical-stage biopharmaceutical company located in Redmond, Washington. SystImmune specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bispecific, multi-specific antibodies, and ADCs.

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

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