Cue Biopharma Inc.’s Kenneth Pienta, acting chief medical officer, called “very strong” the latest phase Ib data with IL-2-based candidate CUE-101 in HPV-positive, recurrent head and neck squamous cell carcinoma (HNSCC), and “by midyear, we're going to have enough data to go forward to talk to the FDA to develop a strategy with them” for a registrational study, likely in third-line patients. Meanwhile, Wall Street sifted through the latest findings from Cambridge, Mass.-based Cue, which closed (NASDAQ:CUE) at $7.99, down $2.61, or 24%. The stock had been posting a gradual run-up for several days.
Shares of TG Therapeutics Inc. fell 40% Jan. 27 after the firm disclosed in a U.S. SEC filing that the FDA had put a partial clinical hold on certain studies testing Ukoniq (umbralisib) and ublituximab, or the combination, for chronic lymphocytic leukemia and non-Hodgkin lymphoma.
Nearly two years after Gilead Sciences Inc. spent $4.9 billion to buy Forty Seven Inc. and its lead candidate, magrolimab, the FDA clamped a partial clinical hold on five of Gilead’s clinical trials combining the therapy with azacitidine. The cause, according to Gilead’s management, is “an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.” The company said it has not identified a clear trend in the adverse reactions or new safety signals.
Touting a series of firsts and a premium price tag to match, Immunocore Holdings plc is poised to launch the uveal melanoma drug tebentafusp in the U.S. following FDA approval for the medicine. The regulatory nod makes the drug, branded Kimmtrak, the first T-cell receptor-based therapy to reach the market, the first approval for a drug targeting gp100, and the first drug approved in 40 years for the cancer, which is the most common eye cancer in adults, though still rare.
LONDON – Cytovation AS has raised $20 million in a series A, enabling it to expand the monotherapy arm of a phase I/II trial of its tumor membrane immunotherapy, Cypep-1, and to test it in three combination arms with the checkpoint inhibitor Keytruda (pembrolizumab).
Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%.
With data due the first half of this year from the phase III trial testing Opdivo (nivolumab, Bristol Myers Squibb Co.) plus Nektar Therapeutics Inc.’s bempegaldesleukin (bempeg) in metastatic melanoma, the possibilities for engineered cytokines such as the latter remain alluring in many quarters.
In late February 2021, Oncopeptides AB scored a big win on the FDA’s accelerated approval for the first cancer peptide-drug conjugate, Pepaxto (melphalan flufenamide), in multiple myeloma. Less than eight months later, it was shutting down commercial operations and heading back to the drawing board after safety issues emerging in the confirmatory Ocean study prompted the Stockholm-based firm to pull Pepaxto from the market, just ahead of what was likely to be a negative FDA advisory panel vote.
When, late last year, Daiichi Sankyo Co. Ltd. won breakthrough status from the FDA for HER3-targeting lung cancer prospect patritumab deruxtecan, Wall Street began taking stock of other candidates in the space. “The winning strategy to therapeutically target HER3 remains to be seen,” noted a recent paper in Clinical Cancer Research, “but HER3 is a promising drug target, and the era of drugging the ‘undruggables’ has already started.”
New and updated preclinical and clinical data presented by biopharma firms at the ASCO Gastrointestinal Cancers Symposium, including: Abivax, Astrazeneca, Cardiff, Chimerix, Exelixis, Immunitybio, ITM, Leap, Merck, Seagen.
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