Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.
Some favorable and some not-so-great results from separate midstage trials testing the anti-dickkopf homolog 1 antibody sirexatamab in combo regimens for two types of gastrointestinal tumors vexed Leap Therapeutics Inc. (NASDAQ:LPTX), shares of which ended Jan. 28 at 66 cents, down $1.60, or 71%.
“The [colorectal cancer field is moving, and thankfully it’s moving quickly,” said Marwan Fakih, gastrointestinal specialist at City of Hope, speaking about initial phase II data from Xilio Therapeutics Inc.’s ongoing trial with vilastobart (XTX-101) when paired with PD-L1-blocking antibody Tecentriq (atezolizumab, Roche AG) in metastatic microsatellite stable disease.
Among the companies to provide updates at the J.P. Morgan Healthcare Conference in San Francisco was Vigil Neuroscience Inc., which has intrigued Wall Street more since the deal signed in December by Muna Therapeutics ApS, of Copenhagen, Denmark, with London-based GSK plc.
Roche AG’s disclosure in December that prasinezumab, partnered with Prothena plc, fell short of its primary phase IIb endpoint put the spotlight on microtubule binding region (MTBR)-targeting therapies in neurological disorders.
Mountainfield Venture Partners and Chengdu, China-based Keymed Biosciences Co. Ltd have partnered to form San Diego-based Timberlyne Therapeutics, which will progress Keymed’s CD-38 monoclonal antibody globally excluding China.
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.
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.
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.
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