The U.S. FDA’s Oncologic Drugs Advisory Committee will determine the fate of privately held Secura Bio Inc.’s Copiktra (duvelisib) in a vote later today. The FDA sees a detriment in overall survival (OS) and some other safety issues that were revealed in newly updated data for the cancer treatment. Approved in 2018 for treating adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, Secura told the committee earlier this morning that its data continue to show a statistically significant and clinically meaningful benefit in OS and also in progression free survival. The committee will vote whether it believes the risk/benefit profile is detrimental to patients.

ODAC axes Pepaxto, Oncopeptides’ troubled MM drug

The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) took up the matter of Oncopeptides AB’s long-storied multiple myeloma (MM) drug, Pepaxto (melphalan flufenamide), and briefing documents ahead of the meeting – which provided little cause for optimism – proved predictive of ODAC’s vote. For ODAC balloters, the single, ominously worded question was: “Given the potential detriment in overall survival, failure to demonstrate a progression-free survival [PFS] benefit, and lack of an appropriate dose, is the benefit-risk profile of [Pepaxto] favorable for the currently indicated patient population?” Voting came out yes 2, no 14.

Sino Biopharm acquires NASH drug from Inventiva in $307M deal

Sino Biopharmaceutical Ltd. subsidiary Chia Tai-Tianqing Pharmaceutical Group Co. Ltd. has acquired greater China rights to lanifibranor from Inventiva SA in a deal worth up to $307 million. Included in the deal are rights to develop and commercialize the drug in mainland China, Hong Kong, Macao and Taiwan for the treatment of nonalcoholic steatohepatitis (NASH) and other metabolic diseases. In return, Sino will pay Inventiva $12 million up front. Inventiva is also eligible to receive a $5 million clinical milestone payment, as well as up to $290 million in clinical, regulatory, and commercial milestones.

Alkermes’ Lybalvi launched, schizophrenia war marches on 

As the hunt for new approaches in schizophrenia continue, Alkermes plc’s recent update on sales of its olanzapine-samidorphan combo drug Lybalvi (approved last year, indicated for bipolar I disorder as well) along with positive phase III data from Karuna Therapeutics Inc. testing Karxt (xanomeline plus trospium), shone more light on the troublesome indication. Another player, Cerevel Therapeutics Holdings Inc., is advancing emraclidine in what could be a registrational phase II study.

Newco news: UK’s Stratosvir aims to unlock the potential of oncolytic viruses

Stratosvir Ltd. aims to overcome the drawbacks experienced with oncolytic viruses, using technology based around vaccinia viruses that allow for a systemic injection and with a larger payload capacity. Stratosvir was started up by CEO Chris Ullman and co-founder Antonio Postigo in 2020 with funding from Cancer Research UK and the Deep Science Ventures, tasked with finding new ways of treating solid tumors.

The BioWorld Insider Podcast – Psychedelic evolution: Mindset Pharma looks to change mental health treatment

An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Lanthier discussed challenges facing companies developing psychedelic treatments and how to overcome the one-size-fits-all, trial-and-error approach to mental health treatment that often seems stuck in the past.

Also in the news

Aadi, Almirall, Astrazeneca, Avenue, Cadrenal, Casi, Cassava, Citius, Corcept, DBV, DMB, Eli Lilly, Immutep, Keymed, Kinnate, Krystal, Merck, Nanobiotix, Neurona, Relief, Revolution, RVAC, Spectrum, Spexis, Trevi, Vir, Virios