AnaptysBio and GlaxoSmithKline Amend Strategic Immuno-Oncology Collaboration

• Dostarlimab royalties to AnaptysBio increase from 4-8% to 8-25% of global net sales, with first US approval in endometrial cancer anticipated in Q4 2020
• Additional 1% royalty to AnaptysBio on GSK’s global net sales of Zejula (niraparib) starting January 2021
• GSK to pay one-time cash payment of $60MM to AnaptysBio within 30 days
• GSK obtains freedom to develop and commercialize Zejula in combination with third party molecules
• $75MM in dostarlimab FDA BLA and EMA MAA regulatory filing and approval cash milestones anticipated by AnaptysBio in upcoming 18 months

SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that AnaptysBio and GlaxoSmithKline (GSK) have amended their immuno-oncology collaboration agreement. The amended agreement provides AnaptysBio with increased royalties on dostarlimab sales under the collaboration, a royalty on GSK’s Zejula and a one-time cash payment. GSK receives freedom to conduct combination development and commercialization of Zejula with third party molecules.

“We are pleased to continue our strategic immuno-oncology collaboration with GSK and look forward to the anticipated first FDA approval of dostarlimab,” said Hamza Suria, chief executive officer of AnaptysBio. “The three clinical-stage antibodies under this collaboration were generated by AnaptysBio using our somatic hypermutation technology platform. While our internal focus is the advancement of AnaptysBio’s wholly-owned first-in-class anti-inflammatory antibody pipeline, we are pleased to partner with GSK in advancing novel immuno-oncology therapies for patients suffering with cancer.”

Originally signed with Tesaro in March 2014, the GSK collaboration is focused on advancing checkpoint receptor antagonist antibodies against PD-1, TIM-3 and LAG-3 in oncology. Dostarlimab is an anti-PD-1 antagonist antibody currently under development by GSK for multiple oncological disorders, including endometrial cancer, non-small cell lung cancer, ovarian cancer, colorectal cancer and mismatch repair deficient solid tumors. Cobolimab, an anti-TIM-3 antagonist antibody, and GSK4069889A, an anti-LAG-3 antagonist antibody, are also under development under this collaboration for various solid tumors. Dostarlimab is being combined with certain antibodies and small molecule agents, including cobolimab, GSK4069889A and Zejula. First US FDA approval of dostarlimab is anticipated in Q4 2020 for the treatment of endometrial cancer, while MAA review is also underway for the same indication. A second BLA filing for dostarlimab, for the treatment of mismatch repair deficient cancers on a pan-tumor basis, is anticipated in the first half of 2021. Zejula is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, which has received US approval for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy regardless of biomarker status, and is under development for additional cancer indications.