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Cancer immunotherapy developer Xilio Therapeutics Inc. has raised $95 million in series C financing to support its efforts to move a duo of tumor-selective candidates into the clinic. IND applications for both its interleukin-2 agonist, XTX-202, and anti-cytotoxic T-lymphocyte-associated protein 4 antibody, XTX-101, are planned for this year.
Jaguar Gene Therapy LLC, a startup reuniting former Avexis Inc. executives to develop a portfolio of potential treatments for severe genetic diseases, announced its public debut Feb. 25 with more than $40 million in series A financing from co-creator Deerfield Management.
As expected, the FDA granted an approval for Amondys 45 (casimersen), a new Duchenne muscular dystrophy (DMD) therapy developed by Sarepta Therapeutics Inc.
Gene therapy developer Beam Therapeutics Inc. has acquired drug delivery specialist Guide Therapeutics Inc. in a deal valued at up to $440 million, adding yet another piece of the integrated platform CEO John Evans told BioWorld the company is striving to build. Guide's lipid nanoparticle (LNP) screening technology could help medicines developed by Beam and its partners reach new targets beyond the liver, an increasingly important endeavor for gene therapy developers like Beam, seeking to maximize the breadth of their growing portfolios. Terms of the deal included $120 million up front, plus up to $320 million in stock-based technology and product success milestone payments. Shares in Beam (NASDAQ:BEAM) fell 12.6% to $96.48 on Feb. 23.
Hopes that a second clinical win for Otonomy Inc.'s phase III Meniere's disease candidate, Otividex, might set the stage for a third-quarter registration of the drug in the U.S. have been dashed, sending company shares (NASDAQ:OTIC) down 44.3% to $3 on Feb. 22. For the intent-to-treat (ITT) population, the trial missed its primary endpoint, the count of definitive vertigo days in month three for the sustained-exposure dexamethasone therapy vs. placebo. The trial also failed to achieve statistical significance for a per-protocol analysis. It was déjà vu for the company, which suffered a harsh reaction to an earlier setback for the program from which its stock has yet to recover, years later.
News of Vaccinex Inc. signing two multitarget deals with undisclosed "prominent pharmaceutical companies" sent company shares (NASDAQ:VCNX) up 70% to $4.88 on Feb. 19, even as financial terms of the deal went undisclosed. The collaborations will focus on using the company's ActivMAb antibody discovery and novel viral display platform to develop candidates against complex antigens such as G protein-coupled receptors and ion channels, the company said.
Just months after a modest IPO, shares of Immunome Inc. (NASDAQ:IMNM) climbed 75.6% on Feb. 18, closing at $39.01. Driving the momentum was an announcement that pseudovirus testing indicates that its antibody cocktail, IMM-BCP-001, appears capable of neutralizing several SARS-CoV-2 variants, an emerging challenge to currently available vaccines and pandemic management efforts.
Shares of Bluebird Bio Inc. (NASDAQ:BLUE) fell 37.8% to $28.44 on Feb. 16 as the company temporarily suspended two trials of its experimental gene therapy for sickle cell disease, Lentiglobin (BB-1111), while investigating one unexpected case of acute myeloid leukemia (AML) and another of myelodysplastic syndrome among participants in a phase I/II study of the candidate, called HGB-206. A second patient experienced MDS in 2018.
Sagimet Biosciences Inc., a company developing an oral fatty acid synthase (FASN) inhibitor for the potential treatment of nonalcoholic steatohepatitis, has raised $80 million in a crossover financing led by an undisclosed public equity health care investment fund.
Nearly five months after its tau-directed antibody, semorinemab, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease, AC Immune SA is back with positive data on a different approach with its anti-phospho-tau vaccine candidate, ACI-35.030.
