Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
The phase IIb study results of Supernus Pharmaceuticals Inc.’s SPN-820 in treatment-resistant depression had pulled the company’s stock (NASDAQ:SUPN) down 15.6% on Feb. 19. The randomized, double-blind, placebo-controlled study of adults failed to show a statistically significant improvement on the primary endpoint of change from baseline on the Montgomery-Åsberg Depression rating scale. Shares closed at $33.52 apiece on Feb. 19.
With Gilead Sciences Inc. stepping away from its exclusive option rights to casdatifan in treating cancer, Arcus Biosciences Inc. has decided to move on by pricing a $150 million common stock offering. Arcus said Gilead’s rights to the HIF-2a inhibitor, which just produced positive early phase data, had expired.
The tumor microenvironment plays a crucial role in the resistance of solid tumors to immunotherapy. In particular, fibroblast activation protein (FAP)-expressing cancer-associated fibroblasts have been shown to contribute to immune evasion.
Bind Research has launched as a not-for-profit focused research organization (FRO) with the aim of transforming disordered proteins into viable drug targets. The organization has secured financing from the U.K. Government’s Research Venture Catalyst program, with matched support from industry, philanthropic and charitable donors.
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year.
HCW Biologics Inc. has received clearance of its IND application from the FDA to initiate a first-in-human phase I trial to evaluate HCW-9302 in patients with moderate to severe alopecia areata.
Shares of Tectonic Therapeutic Inc. (NASDAQ:TECX) closed Jan. 30 at $54.84, up $29.12, or 113%, on what Leerink analyst David Risinger called in his report “the most impressive hemodynamic results we have seen” in heart failure with preserved ejection fraction. Watertown, Mass.-based Tectonic unveiled positive interim data from the phase Ib acute hemodynamic trial with lead candidate TX-45, a long-acting, Fc-relaxin fusion protein.
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year.
Researchers have developed an innovative immunotoxin (a fusion protein called GrB-Fc-KS49) designed to target epithelial membrane protein-2 (EMP2), a biomarker overexpressed in more than 75% of breast cancer cases, including triple-negative breast cancer (TNBC).
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