FDA Approves JEMPERLI (dostarlimab-gxly) for dMMR Endometrial Cancer
- PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in Collaboration with GlaxoSmithKline (GSK)
- First AnaptysBio-Generated Antibody, of 8 Currently Under Clinical Development, to Obtain FDA Approval
- $20MM Milestone Payment Earned by AnaptysBio Upon FDA Approval; Additional $45MM and $165MM Milestones Due Upon Dostarlimab Regulatory and Commercial Milestones, Respectively
- AnaptysBio Due to Receive 8% to 25% Royalty on Global Net Sales
SAN DIEGO, April 22, 2021 (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 the U.S. Food and Drug Administration (FDA) approved GSK’s Biologics License Application (BLA) for JEMPERLI (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.
JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date, and JEMPERLI is the first AnaptysBio-generated antibody to obtain FDA approval.
“The approval of JEMPERLI is a transformative milestone for AnaptysBio. This event provides important validation for our proprietary SHM antibody discovery platform and provides significant potential future milestone and royalty revenue to support AnaptysBio’s growth,” said Hamza Suria, president and chief executive officer of AnaptysBio. “While AnaptysBio has partnered certain pipeline assets, our primary value-creation strategy remains focused on advancing wholly-owned, first-in-class therapeutic antibodies from discovery through development, and we look forward to multiple upcoming clinical data readouts from our product pipeline through 2021 and 2022.”
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