Black Friday is still weeks away, but Exelixis Inc. has gone shopping and inked two deals that together are potentially worth more than $1 billion, bolstering its pipeline with cancer drugs from Cybrexa Inc. and Sairopa B.V. Both deals are eye-catching, not just because of their potential value but also because of the technologies involved. Cybrexa’s drug is a peptide-drug conjugate, a class where only one drug is FDA approved and established, and Sairopa is working on an antibody targeting SIRPα, a potential next-generation immunotherapy. Read More
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones. In addition, it could capture a 40% net profit share for COVID-19 vaccines and up to double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens. Read More
Alkermes plc’s decision to explore separating its commercial-stage neuroscience business from earlier-stage oncology efforts – forming a distinct, publicly traded company to investigate cancer therapies – drove speculation about the launch of the firm’s Lybalvi (olanzapine and samidorphan), approved by the U.S. FDA in the middle of 2021 for schizophrenia and bipolar I disorder. Read More
CV6 Therapeutics Ltd. raised $9.2 million in grant and equity funding to move a first-in-class inhibitor of deoxyuridine 5’-triphosphate nucleotidohydrolase (dUTPase) into a phase Ia trial in cancer. The compound, CV6-168, will from the outset be administered in combination with fluorouracil, a mainstay of chemotherapy for the past 60 years. Read More
Zhuhai Beihai Biotech Co. Ltd. has raised nearly ¥200 million (US$27.5 million) in a series B round slated to support clinical trials for its lead candidates as well as preparations to file an NDA for its core asset, BH-009, an injectable formulation of docetaxel that excludes polysorbate 80 (Tween 80), a surfactant that has been associated with increased risk of adverse events, including hypersensitivity. The company claims that no similar product is currently available worldwide. Read More
New hires and promotions in the biopharma industry, including: Actinium, Ambrx, Anebulo, Aristea, Coeptis, Focal Medical, Lexeo, Novavax, Providence, Reset, Turn. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, Biothera, Cingulate, Denali, Dragonfly, Ensysce, Harmony, Hoth, Merck, Monte Rosa, Orum, Pfizer, Pieris, Promore, Receptor, Remegen, Stealth, Teon, Unity, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apex, Astrazeneca, Aulos, Brim, Karyopharm, Moderna, Rhythm, Shanghai Henlius, Stealth. Read More
