At the ESMO Immuno-Oncology Congress 2022, Compugen Inc. shared phase I data for COM-701 in dual and triple combination with Bristol Meyers Squibb Co.’s Opdivo (nivolumab) and with or without BMS-986207. Compugen’s candidate demonstrated preliminary durable antitumor activity and immune activation in patients with platinum resistant ovarian cancer with a favorable safety and toxicity profile.
Top-line primary data from week 48 of Eiger Biopharmaceuticals Inc.'s phase III D-LIVR study of lonafarnib, a prenylation inhibitor for treating chronic hepatitis delta virus, also known as hepatitis D, hit statistical significance vs. a placebo in the composite primary endpoint.
Investigators at Relmada Therapeutics Inc. believe the same problem that plagued an earlier phase III effort called Reliance-3 – an “implausibly” high placebo response at certain sites – also foiled the latest phase III study (conducted at overlapping sites) known as Reliance-1, testing REL-1017 (esmethadone), meant as an adjunctive treatment for major depressive disorder.
Pancreatic cancer is the deadliest of cancers with just one in nine patients surviving five years after diagnosis. The low rate of survival largely results from the late stage at which the cancer is first detected, as 65% patients are not diagnosed until the disease has metastasized. Bluestar Genomics Inc. hopes it has developed an assay that can detect the cancer much sooner, allowing patients and their physicians to get ahead of the malignancy well before it spreads.
Replimune Group Inc. has found consistent treatment efficacy in its pivotal phase II Ignyte melanoma study. The interim data strongly bolstered the stock (NASDAQ:REPL), which ended Dec. 7 with a 22% increase to $23.09. The new results for the combination treatment show what Replimune called clinically meaningful durable activity across the range of anti-PD1 failed cutaneous melanoma presentations, including in patients with moderate to high tumor burden, with 85% of responses ongoing.
Patients suffering in the long-stagnant therapeutic landscape of ulcerative colitis and Crohn’s disease gained encouragement with positive mid-stage results from Prometheus Biosciences Inc., which tested its tumor necrosis factor-like cytokine 1A-targeting PRA-023 against both forms of inflammatory bowel disease. San Diego-based Prometheus closed at $95.80, up $59.74, or 165.7% after the company made known data from the phase II study called Artemis-UC and the Apollo-CD phase IIa experiment. Prometheus intends to advance PRA-023 into phase III testing next year.
Gossamer Bio Inc. shares (NASDAQ:GOSS) fell 74.6% to $2.36 Dec. 6 after the disclosure of phase II results that, while meeting the study's primary endpoint of reducing pulmonary vascular resistance vs. placebo, failed to show the company's pulmonary arterial hypertension (PAH) candidate, seralutinib, holding its own against the performance of Merck & Co. Inc.'s PAH candidate, sotatercept, in separate PAH studies.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
At the recent Clinic Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, Regenlife SAS presented the design for its Light4life study examining the therapeutic efficacy of the RGn600 device. This trial on more than 100 subjects will evaluate the cognitive impacts of new photobiomodulation technology.
Twelve months after a single shot of Valneva SE’s chikungunya vaccine, positive antibody persistence was found, threatening a deadly disease that has long resisted treatment. The new data are derived from a study of 363 healthy adult participants that followed them from month 6 after vaccination to month 12. Nearly all, 99%, kept their neutralizing antibody titers for 12 months beyond the seroresponse threshold of 150, which hit the primary endpoint and the antibody level agreed with regulators as endpoint under the accelerated approval pathway.
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