MEI Pharma Inc. has discontinued the global development of its phosphoinositide 3-kinase (PI3K) delta inhibitor, zandelisib, outside Japan. “In light of FDA’s guidance, we no longer believe clinical development can be completed within a time period that would support further investment, or with sufficient certainty of the regulatory requirements to justify continued global development efforts,” said Daniel Gold, MEI’s president and CEO.
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.
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.
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.
Anavex Life Sciences Corp. posted positive top-line data from its phase IIb/III study of ANAVEX 2-73-AD-004 (blarcamesine) in treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD. The oral small-molecule activator of the sigma-1 receptor (SIGMAR1) met the study’s primary endpoints and key secondary endpoint with statistically significant results.
Theratechnologies Inc. paused enrollment of a phase I trial testing TH-1902, its lead peptide-drug conjugate for sortilin-expressing cancers, after finding efficacy "not convincing enough" nor outweighing adverse events in some participants, an undisclosed number of which experienced neuropathy and eye toxicity, the company said.
RSS
