Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Acadia, Advaccine, Albireo, Alzheon, Beyondspring, Galapagos, Gilead, Mirum, Point, Precision, Valbiotis, Valneva, Vincerx, Virios, Zynerba.
A first-of-its-kind blood test that can detect whether cancer is absent, imminent, or present in different stages is on its way to the market. This is a claim made by brothers Ashish Tripathi and Anish Tripathi, who lead Singapore-based molecular diagnostic company Tzar Labs Pte. Ltd. and Mumbai-based Epigeneres Biotechnology Pvt. Ltd., respectively.
The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant?olaparib?after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.”
Novartis AG’s CAR T therapy, Kymriah (tisagenlecleucel), is heading for a third indication after the Basel, Switzerland-based pharma announced supportive results from a pivotal phase II trial, lining it up to compete with Gilead Sciences Inc.’s rival, Yescarta.
DUBLIN – Ronopterin (VAS-203) failed to meet the primary endpoint of a phase III trial in traumatic brain injury (TBI), but developer Vasopharm GmbH is nevertheless convinced that it has an active drug on its hands. It has also received backing from the study’s data monitoring committee, which has provided, Vasopharm said, a “positive benefit-risk assessment” on the basis of the efficacy signals detected and the drug’s known safety profile.
Novartis AG is closing in on a label expansion for its blockbuster inflammatory disease drug, Cosentyx (secukinumab), after announcing supportive phase III results in children with two subtypes of juvenile idiopathic arthritis (JIA).
Protalix Biotherapeutics Inc. saw shares dip after releasing initial top-line data from an interim analysis of the phase III Balance clinical trial of pegunigalsidase alfa (PRX-102) to treat Fabry disease. The 24-month, randomized, double-blind, active control study is evaluating the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme). Two of the study’s 78 patients dropped out because of treatment emergent adverse events and one left because of a related adverse event.
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy. The data built on positive data released in August from another phase III study showing sugemalimab (CS-1001) prolonged PFS when used as a first-line treatment for stage IV squamous and nonsquamous NSCLC plus standard-of-care chemotherapy, hitting the study’s primary endpoint.
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