Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
SK Bioscience Co. Ltd. signed a simple agreement for a future equity (SAFE) deal totaling $2 million with Hingham, Mass.-based Sunflower Therapeutics PBC on July 25 to secure both Sunflower’s equity and its yeast-based protein manufacturing technology. The conditional agreement will grant SK Bioscience future equity rights in Sunflower without the need for immediate valuation, allowing for minimal investment.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, gained U.S. FDA approval of Epysqli (eculizumab-aagh) as the second biosimilar product to Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) to treat two rare diseases. The regulatory clearance July 22 grants use of Epysqli to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – two rare hematologic- and kidney-related disorders known to affect about 50,000 and 5,000 patients in the U.S., respectively.
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
The industry is looking, with renewed hope, to the “promise” of messenger RNA (mRNA) therapeutics for a wide range of diseases beyond COVID-19, and not only in vaccine form but also for gene and cell therapies.
Two weeks after reporting positive top-line results in first-line head and neck cancer with its lead candidate, eftilagimod alfa, in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab), Immutep Ltd. presented updated data indicating the treatment could offer a non-chemotherapy option for patients with negative PD-L1 expression. Data from cohort B of the Tacti-003 (Keynote-PNC-34) phase IIb trial, which included 31 evaluable patients with PD-L1 expression of less than 1, as measured by Combined Proportion Score, showed a 35.5% objective response rate per RECIST 1.1 assessment.
Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act.
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