Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
After the phase IIa failure at lowering intraocular pressure to a statistically significant degree with SBI-100, Skye Bioscience Inc. is dropping work with the ophthalmic emulsion, meant to treat primary open-angle glaucoma or ocular hypertension. Resources are turning to the firm’s metabolic program, which includes nimacimab, targeting the cannabinoid 1 receptor, due to start a phase II trial in obesity during the third quarter of this year.
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago.
In an indication with few treatment options for patients who are running out of time, Replimune Group Inc. revealed positive top-line results of its lead candidate, RP-1 (vusolimogene oderparepvec), in anti-PD-1-failed melanoma. Data from the phase I/II Ignyte study of RP-1 plus Opdivo (nivolumab, Bristol Myers Squibb Co.) showed the treatment hit the primary endpoint with a 12-month overall response rate of 33.6% and a median duration of response of more than 35 months.
Amgen Inc. is looking to position inebilizumab as the first therapeutic specifically for treating immunoglobulin G4-related disease (IgG4-RD), a rare, immune-mediated condition that can affect multiple organs, after yielding what Leerink Partners analyst David Risinger called “exceptional” phase III results.
An expert in hepatitis delta virus said Vir Biotechnology Inc.’s phase II findings with the monoclonal antibody tobevibart and the small interfering ribonucleic acid elebsiran in chronic disease could lead to a “change [in] the entire care cascade and paradigm.” Shares of Vir (NASDAQ:VIR) ended June 5 at $12.66, up $2.08, or 19.7%, on the clinical news.
Annexon Inc.’s stock (NASDAQ:ANNX) climbed 31% June 4 following news that a single infusion of C1q protein complex inhibitor ANX-005 at the 30-mg/kg dose delivered a statistically significant 2.4-fold improvement in Guillain-Barré syndrome patients. Shares closed at $5.99, up $1.41.
Bridgebio Pharma Inc.’s data from the phase II study with infigratinib in achondroplasia “swings the pendulum of debate sharply in favor” of the firm, competing with Biomarin Pharmaceutical Inc. in the space, Leerink analyst Mani Foroohar said in a report.
Miami-headquartered Summit Therapeutics Inc. expanded rights to Akeso Inc.’s non-small-cell lung cancer (NSCLC) drug, ivonescimab (SMT-112; AK-112), June 3 while raising $200 million to advance the therapy.
While there was much talk about the vast potential of artificial intelligence (AI) during one of the world’s largest research cancer conferences, antibody-drug conjugates (ADCs) continued to grab the lion’s share of attention as Corbus Pharmaceuticals Holdings Inc. and Takeda Pharmaceutical Co. Ltd. released new and positive data.
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