Windward Bio AG was established with plans to both license a drug and establish wet labs to create an internal pipeline of drug candidates. SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital and Pivotal Bioventure Partners funded the Basel, Switzerland-based company’s $200 million series A financing round.
Climb Bio Inc. has entered into an exclusive license agreement with Beijing Mabworks Biotech Co. Ltd. for rights to develop and commercialize MIL-116 (now CLYM-116), an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy, in the territory outside of Greater China.
Despite positive preliminary data from its early stage study of treating hives, Jasper Therapeutics Inc. saw its stock drop dramatically on Jan. 8. Results were from the ongoing phase Ib/IIa study of the monoclonal antibody and lead candidate briquilimab in treating chronic spontaneous urticaria, often referred to as hives. The results showed clinical responses across several of the dosing cohorts. The treatment also displayed a favorable safety profile.
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
Rounding out a year of insider trading charges involving biopharma companies, the U.S. SEC reported Dec. 30 that it had filed a complaint against two top Humanigen Inc. executives, Cameron Durrant, CEO, and Dale Chappell, chief science officer,
for trades based on insider knowledge of FDA actions.
Intriguing scientific data continue to roll out in the head and neck cancer space, where the need for therapies has spurred a number of drug firms to try new approaches, which BioWorld examines in part two of a series that began in the Dec. 30 issue.
Radiopharm Theranostics Ltd. has been granted Belberry Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human phase I therapeutic study of 177Lu-labeled RAD-202 (177Lu-RAD-202) for the treatment of HER2-expressing solid tumors, including breast and gastric cancers.
Clinical data reported by a handful of biopharmas on Dec. 19 sent stocks soaring or plunging, as company leaders laid out next-step plans. Investors showed enthusiasm for Omeros Corp.’s narsoplimab to treat hematopoietic stem cell-transplant-associated thrombotic microangiopathy (TA-TMA), and Roche AG’s Parkinson’s prospect prasinezumab, which is partnered with Prothena Corp. plc.
Tigatx Inc. has been awarded up to $33.5 million in funding by the Advanced Research Projects Agency for Health and a 2-year $2 million Direct to Phase II Small Business Innovation Research grant from the National Cancer Institute.
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