Anaptysbio Inc. has signed an exclusive license agreement for Centessa Pharmaceuticals plc’s blood dendritic cell antigen 2 (BDCA-2) modulator antibody portfolio, including lead asset CBS-004 (to be renamed ANB-101) and related family of backup antibodies, for the treatment of autoimmune and inflammatory diseases.
In what TD Cowen analyst Joseph Thome called an “upside surprise,” Anaptysbio Inc. reported positive top-line data from its phase III Gemini-1 study of imsidolimab, a monoclonal antibody designed to inhibit the interleukin-36 receptor, in patients with generalized pustular psoriasis (GPP), positioning the firm for a potentially productive out-licensing deal.
About two months ahead of the planned PDUFA date, the U.S. FDA has granted expanded approval of PD-1 antibody Jemperli (dostarlimab) from partners Anaptysbio Inc. and GSK plc for use in combination with standard-of-care chemotherapy. GSK said the drug would be the only frontline immuno-oncology treatment for endometrial cancer available in combination with carboplatin and paclitaxel. The supporting supplemental BLA for the expanded indication previously received priority review.
CD122 signaling plays a key role in the function of CD4, CD8 T cells and natural killer (NK) cells, as well as in the development and survival of tissue-resident memory T cells (TRMs).
Eli Lilly and Co.’s phase II data with LY-3462817 (peresolimab), a monoclonal antibody (MAb) that functions as a PD-1 agonist for rheumatoid arthritis (RA), juiced hopes for the approach being tried by a handful of firms.
Another PD-1 antibody is about to hit the U.S. market, following the FDA’s accelerated approval of dostarlimab (TSR-042) from partners Anaptysbio Inc. and Glaxosmithkline plc. But dostarlimab, branded Jemperli, will be only one of two PD-1 drugs indicated for endometrial cancer, going up against Merck & Co. Inc.’s Keytruda (pembrolizumab).
Anaptysbio Inc. is calling it quits for developing imsidolimab in treating moderate to severe palmoplantar pustulosis (PPP) after its phase II Poplar trial failed to hit its primary endpoint. However, the company said it would continue imsidolimab development for five other indications, including a phase III trial in treating generalized pustular psoriasis (GPP) that’s set to begin in mid-2021.
DUBLIN – Glaxosmithkline plc and Anaptysbio Inc. were able to get over some of the disappointment arising from a delayed FDA decision on their PD-1 inhibitor, dostarlimab, earlier this month, as the EMA came through Feb. 26 with a positive recommendation for the drug in endometrial cancers that are deficient in DNA mismatch repair or that are categorized as having high microsatellite instability.
San Diego-based Anaptysbio Inc.’s phase II blowup with anti-IL-33 monoclonal antibody etokimab in chronic rhinosinusitis with nasal polyps (CRwNP), disclosed Aug. 10, followed the compound’s mid-stage atopic dermatitis (AD) fizzle in November of last year, and raised questions not only about the lead candidate but also about the target.
In the wake of each dosing arms' failure to hit the primary endpoint in Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis (AD), the stock dropped steeply and the company postponed initiating its phase IIb etokimab trial in eosinophilic asthma until it analyzes the phase IIb result.