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.
JEMPERLI (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. A BLA for JEMPERLI was approved by the FDA in April 2021 for the treatment of advanced or recurrent deficient mismatch repair endometrial cancer (dMMREC). This is the first AnaptysBio-generated antibody, of eight currently under clinical development, to obtain FDA approval. In April 2021 the European Medicines Agency (EMA) granted conditional marketing authorization in the European Union for JEMPERLI for use in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen, which approval makes JEMPERLI the first anti-PD-1 therapy available for endometrial cancer in Europe. A second BLA filing for JEMPERLI, for the treatment of mismatch repair deficient cancers on a pan-tumor basis, was accepted by the FDA in Q1 2021, and we anticipate FDA approval of this second FDA BLA of JEMPERLI during the second half of 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 JEMPERLI, 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, including an additional $15 million and $165 million in milestone payments upon achievement of certain JEMPERLI regulatory and commercial milestones, respectively.
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.