Our immuno-oncology collaboration with GlaxoSmithKline (GSK) is focused upon the development and commercialization of AnaptysBio-generated checkpoint antagonist antibodies to PD-1, TIM-3 and LAG-3. The exclusively licensed products being advanced by GSK under this partnership include dostarlimab, cobolimab and GSK4074386.
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. First US FDA approval of dostarlimab is anticipated in H1 2021 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 was accepted by the FDA in Q1 2021. Cobolimab, an anti-TIM-3 antagonist antibody, has completed a Phase 1 study and is currently in combination Phase 2 trials with dostarlimab for certain solid tumor indications. GSK4069889, an anti-LAG-3 antagonist antibody, is undergoing Phase 1 studies.
Under the terms of our GSK collaboration, AnaptysBio is entitled to receive an 8-25% royalty upon global net sales of dostarlimab, where the 8% tier is applicable to annual global net sales below $1 billion while net sales above $1 billion will be paid 12-25% royalty. Royalties upon global net sales of other products under the collaboration, including cobolimab and GSK4069889, will range from 4-8%. A total of $1.1 billion in development, regulatory and commercial milestones are due to AnaptysBio under this collaboration. AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues.
GSK has also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of ZejulaTM. In addition, GSK has agreed to pay AnaptysBio a one-time cash payment of $60 million in fourth quarter of 2020.
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Bristol-Myers Squibb Partnership
Under our collaboration with Bristol-Myers Squibb (BMS) we developed therapeutic antibodies against multiple targets. We granted BMS the option to obtain worldwide commercial rights to antibodies generated against each of the targets under the agreement, which option was triggered on a target-by-target basis by our delivery of antibodies meeting certain pre-specified parameters pertaining to each target under collaboration. BMS is currently advancing two AnaptysBio-generated anti-inflammatory antibody programs, and has initiated a Phase 1 trial for one of these two antibodies known as CC-90006, a PD-1 agonist antibody, which is indicated for psoriasis.