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Bristol Myers Squibb and SystImmune plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.
Bristol Myers Squibb and SystImmune, a clinical-stage biopharmaceutical company, have entered into an exclusive license and collaboration agreement potentially worth up to $8.4 billion to jointly develop and commercialize SystImmune’s BL-B01D1, an epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3) bispecific antibody-drug conjugate (ADC), in the United States.
Under the agreement, SystImmune will receive an $800 million upfront payment from Bristol Myers Squibb. The company can also receive up to $500 million in contingent near-term payments. SystImmune is further eligible to receive additional payments of up to $7.1 billion upon achieving certain development, regulatory, and sales performance milestones.
Also under the agreement, SystImmune will retain exclusive development and commercialization rights to BL-B01D1, through its affiliates, in mainland China. Bristol Myers Squibb will receive a royalty on net sales in that market. Outside the US and mainland China, SystImmune will receive a tiered royalty on net sales.
SystImmune (through its affiliates) will have sole responsibility for the 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, meanwhile, will assume sole responsibility for development and commercialization in the rest of the world.
BL-B01D1 is currently in a global multi-center Phase I study in metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical studies demonstrated promising anti-tumor activity in patients with a range of solid tumors, including NSCLC and breast cancer, who had progressed after standard of care treatments, according to a Dec. 11, 2023 company press release.
“Recent BL-B01D1 trials have shown broad potential across different solid tumors as well as a manageable safety profile,” said Yi Zhu, CEO, SystImmune, in the 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.”
“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, executive vice-president, chief medical officer, Drug Development, Bristol Myers Squibb, in the 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.”
Source: Bristol Myers Squibb