European Commission Approves JEMPERLI (dostarlimab), the First Anti-PD-1 Therapy Approved for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer in Europe

• 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 Regulatory Approval in Europe
• $10MM Milestone Payment Earned by AnaptysBio Upon EC Approval; Additional $35MM and $165MM Milestones Due Upon Dostarlimab Regulatory and Commercial Milestones, Respectively
• AnaptysBio Due to Receive 8% to 25% Royalty on Global Net Sales of Dostarlimab

SAN DIEGO, April 23, 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 European Commission has granted conditional marketing authorization for JEMPERLI (dostarlimab) 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. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe.

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 regulatory approval.

“We are delighted that JEMPERLI is the first AnaptysBio-generated antibody to be approved in Europe and look forward to meaningful potential future milestone and royalty revenue from our collaboration with GSK,” said Hamza Suria, president and chief executive officer of AnaptysBio. “These revenues will continue to support AnaptysBio’s primary value-creation strategy, which is focused on advancing wholly-owned first-in-class therapeutic antibodies through multiple upcoming clinical catalysts in 2021 and 2022.”

JEMPERLI is indicated as a monotherapy for treatment of adult patients with recurrent or advanced dMMR/MSI-H endometrial cancer, who have progressed on, or are being dosed following, prior treatment with a platinum-containing regimen, and is the first indication approved by the European Commission for JEMPERLI. AnaptysBio has earned a $10.0 million milestone payment as a result of this approval. Earlier this month, AnaptysBio earned a $20.0 million milestone payment as a result of approval by the U.S. Food and Drug Administration for JEMPERLI in endometrial cancer. In 2020, AnaptysBio received milestone payments of $10.0 million and $5.0 million for the FDA’s and EMA’s acceptances of the BLA and Marketing Authorisation Application (MAA) filings for JEMPERLI, respectively.