Indicating its continuing strategy to invest in antibody-drug conjugates (ADCs), Astrazeneca plc obtained exclusive global rights to Claudin 18.2 ADC CMG-901 from Keymed Biosciences Inc. and Lepu Biopharma Co. Ltd. in a deal worth up to $1.163 billion. Keymed and Lepu’s joint venture, Kym Biosciences, will receive a $63 million up-front payment and is eligible to receive up to $1.1 billion in additional development and sales-related milestone payments, as well as low double-digits tiered royalties. The deal is expected to close in the first half of 2023.
Ahead of schedule, a hemophilia A drug from Sanofi receives FDA approval
The U.S. FDA has approved the priority BLA for Bioverativ Therapeutics Inc.’s hemophilia A treatment nearly a week before its Feb. 28 PDUFA date, according to FDA documents. Bioverativ is a Sanofi SA company. Altuviiio (efanesoctocog alfa) is a recombinant factor VIII therapy, which the company has managed to partially incorporate into the drug’s brand name. The BLA was based on data from the phase III, open-label, XTEND-1 study, which demonstrated that once-weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, with a statistically significant reduction in annualized bleeding rate based on an intra-patient comparison. The therapy was also well-tolerated, with no inhibitor development for factor VIII detected. In June 2022, the FDA granted the therapy breakthrough therapy designation and a few months later, in August, the FDA accepted the BLA for priority review.
Mei, Infinity to merge in all-stock transaction; three cancer drugs in the works
Shares of Mei Pharma Inc. (NASDAQ:MEIP) were trading at 25 cents, down 4 cents, or 16%, and those of Infinity Pharmaceuticals Inc. (NASDAQ:INFI) were selling for 31 cents, down 24 cents, or almost 44%, on word that the firms are merging in an all-stock deal. The combined firm will have about $100 million in cash – enough to fund operations through mid-2025 – and three oncology candidates in the pipeline, led by phase II-stage eganelisib for head and neck squamous cell carcinoma. The news comes about two months after Mei, of San Diego, quit development of its phosphoinositide 3-kinase delta inhibitor zandelisib outside of Japan, based on guidance from the U.S. FDA. Under the merger terms, Infinity will become a wholly owned subsidiary of Mei and trade on Nasdaq.
US CMS refuses to budge on coverage of Alzheimer’s drugs
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies granted accelerated approval as Alzheimer’s treatments. In a letter yesterday denying a request to reconsider that decision, CMS made it clear to the Alzheimer’s Association that the FDA’s accelerated approval path, which is based on surrogate endpoints, does not provide the evidence of clinical benefit CMS requires to determine whether a treatment is “reasonable and necessary.” However, even full approval is no guarantee that Medicare will broadly cover the drugs. “If the FDA determines a clinical benefit for a drug within this class through its traditional approval program, CMS will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a registry-based study where the drug is tested in real-world settings,” the agency said.
CROI 2023: Path to a broadly effective HIV vaccine is coming into focus
In the larger picture, the fight against HIV has been a triumph of modern medicine. A patient diagnosed with HIV in the 1980s had a remaining life expectancy of 1 to 2 years. In 2023, they can expect to live another half century. But so far, an HIV vaccine has remained elusive. In the newest phase III failure, Janssen Pharmaceutical Cos., of Johnson and Johnson, closed down its Mosaico trial more than a year ahead of schedule, following a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint. And so, the 2023 Conference on Retroviruses and Opportunistic Infections (CROI), like CROI 2022 (Imbokodo), CROI 2020 (Uhambo), and other CROI meetings before, included a session to both present a failed HIV vaccine trial, and the lessons from its results.
Fusion raises $60M to acquire phase II radiopharma asset targeting prostate cancer
Radiopharmaceutical company Fusion Pharmaceuticals Inc. is acquiring a phase II actinium-based alpha-emitter radiopharma program for prostate cancer from Radiomedix Inc. The program, which is IND-cleared for phase II trials, is evaluating an actinium 225Ac-PSMA I&T, a small molecule targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancers. Following the closing, the alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial will be known as FPI-2265. Under the terms of the deal, Fusion will pay $2.25 million up front, up to $10.5 million in clinical and regulatory milestones and royalties, and up to $50 million in sales milestones.
The BioWorld Insider Podcast: Cambrian carves out a new niche as it works to keep people from getting sick
As James Peyer, the CEO of Cambrian Biopharma Inc., watched his grandfather fail every cancer treatment and pass away, he also saw the structure of his future company being born. Waiting until people became sick was the wrong way to treat disease, he found. Instead, Cambrian was created to develop anti-aging therapies, a unique business model that fits the new field of geroscience. To do that, Cambrian became a biotech business, a VC fund and an incubator. Peyer spoke to the BioWorld Insider Podcast about his pipeline and how he goes about fundraising in a little understood field.
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