More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks.
Biosion Inc. is getting more than $40 million in cash up front from Aclaris Therapeutics Inc. for the rights to develop two antibodies. The regulatory and sales milestones could also bring Biosion another $900 million. The two assets are BSI-045B, a high affinity and high potency anti-TSLP monoclonal antibody, and BSI-502, a bispecific antibody directed against TSLP and IL4R.
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
University of Auckland senior research fellow Jeff Smaill first visited China in 2012 as part of a team of 15 scientists from the Maurice Wilkins Center, one of New Zealand’s centers of excellence, to meet with scientists at the Guangzhou Institute of Medicine and Health to find partners to collaborate on drug development projects. The scientists started collaborating that year, and the first project is already in phase I trials in China. It was a joint discovery and development partnership from the beginning, he said.
Continuing its streak of promising early clinical data, Jasper Therapeutics Inc.’s briquilimab impressed in a preliminary readout from a phase Ib/IIa study in chronic inducible urticaria (CIndU), showing a clinical response of 93%. CIndU, an inflammatory skin condition causing hives that is often induced by physical or environmental stimuli, is commonly treated with antihistamines, though some patients are refractory. Beyond antihistamines, there is no treatment available globally, explained Edwin Tucker, Jasper’s chief medical officer, so briquilimab has the potential to be “a new treatment paradigm for patients,” both in reducing disease burden and in improving quality of life.
Despite a phase IIa failure in 2018 for lupus, Biogen Inc. and UCB Inc. maintained their collaboration and now have new positive data for their anti-CD40L candidate. Top-line phase III data show dapirolizumab pegol, along with the standard of care (SOC), met the primary endpoint in demonstrating an improvement in moderate to severe systemic lupus erythematosus compared to placebo and SOC at 48 weeks.
Novartis AG is enlisting the help of Generate:Biomedicines Inc. and its artificial intelligence platform to generate drugs for multiple undisclosed targets. The number of targets and therapeutic areas also weren’t disclosed. Novartis will pick the targets, although the targets Generate has been working on are off limits. Generate will be responsible for creating the lead candidate, at which point Novartis will take over development.
A drive to overcome the limitations of traditional antibodies led Toronto-based scientists Jean-Philippe Julien and Bebhinn Treanor to work toward discovering a multivalent, multispecific platform to develop therapies that can reach difficult targets. As a result, through the support of VC firm Amplitude Ventures, Radiant Biotherapeutics emerged in 2020 armed with what has become its Multabody platform.
Candid Therapeutics Inc. launched with ex-China control of two bispecific T-cell engager antibodies that it plans to develop for autoimmune diseases. The San Diego-based company will start off with a pocketful of cash, having raised over $370 million for the development of the in-licensed candidates.
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
RSS
