AnaptysBio and GlaxoSmithKline Amend Strategic Immuno-Oncology Collaboration
- Dostarlimab royalties to
AnaptysBioincrease 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
AnaptysBioon GSK’s global net sales of Zejula™ (niraparib) starting January 2021
- GSK to pay one-time cash payment of $60MM to
AnaptysBiowithin 30 days
- GSK obtains freedom to develop and commercialize Zejula™ in combination with third party molecules
- $75MM in dostarlimab FDA BLA and
EMA MAAregulatory filing and approval cash milestones anticipated by AnaptysBioin upcoming 18 months
“We are pleased to continue our strategic immuno-oncology collaboration with GSK and look forward to the anticipated first FDA approval of dostarlimab,” said
Originally signed with Tesaro in
Under the terms of the amended agreement, GSK has agreed to increase the royalties due to
AnaptysBio is 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. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-36R antibody imsidolimab, previously referred to as ANB019, for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, palmoplantar pustulosis, or PPP, EGFRi-mediated skin toxicities and ichthyosis; its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated; and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology collaboration with GlaxoSmithKline, including an anti-PD-1 antagonist antibody (dostarlimab, GSK4057190A), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889A) and an anti-LAG-3 antagonist antibody (GSK4074386), and an inflammation collaboration with Bristol-Myers Squibb, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the royalties, milestone payments and cash payments payable to the company, and the timing or outcome of any regulatory submission or approval of dostarlimab. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the
Source: AnaptysBio, Inc.