Just ahead of the Aug. 13 PDUFA date, Citius Pharmaceuticals Inc. won the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox-cxdl), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T cells and regulatory T cells. It’s also the first green light given by the FDA for r/r CTCL since 2018.
A year after Alkermes plc announced it would divide its oncology and neuroscience efforts into two separate businesses, the Dublin-based company spun out Mural Oncology plc with $275 million in funding and the lead solid tumor candidate nemvaleukin alfa. Shares of Mural (NASDAQ:MURA) will begin trading Nov. 16. “We’re very excited,” Mural’s CEO Caroline Loew told BioWorld. “We’ve got two major clinical datapoints in the next 18 months.”
Researchers from Neoleukin Therapeutics Inc. have described NEO-TRA1, a novel CD25-targeted de novo non-α agonist of the IL-2 receptor (IL-2R) designed to selectively expand Tregs.
Deka Biosciences Inc. has submitted an IND application to the FDA for its lead oncology asset, DK2-10 (EGFR). DK2-10 (EGFR) is the first of many experimental therapeutics developed as part of Deka’s platform of molecules, with each Diakine in Deka's platform consisting of two complementary cytokines coupled together via attachment to a single chain variable fragment, enabling the cytokines to accumulate more specifically in targeted tissues.
Gentibio Inc. has announced preclinical data relating to the company's platform technology, demonstrating technical progress to engineer regulatory T cells (Tregs) for the prevention and treatment of autoimmune diseases.
DUBLIN – Anaveon AG raised CHF110 million (US$119.5 million) in a series B round to accelerate development of its interleukin-2 (IL-2) agonist ANV-419, which is currently undergoing a phase I/II trial. “We are putting our compound into multiple clinical trials and multiple indications in parallel,” CEO and co-founder Andreas Katopodis told BioWorld.
Less than six months after closing a $55 million series A round, Asher Biotherapeutics Inc. has added another $108 million in a series B round to accelerate development of its early stage pipeline of targeted cytokine-based immunotherapies for cancer, autoimmune disease and infection.
Bright Peak Therapeutics Inc. closed a $107 million series B round to progress a pipeline of engineered cytokines, which are produced using a chemical synthesis method instead of classical recombinant protein production approaches.
Asher Biotherapeutics Inc. raised $55 million in a series A financing round to take forward a series of engineered cytokines designed to selectively activate T cells or other immune effector cells, in order to eliminate both the toxicities and the loss of efficacy that can result from indiscriminate activation.
Merck & Co. Inc. is paying $1.85 billion, or $60 per share, to acquire Pandion Therapeutics Inc. on the back of early stage data in human volunteers for its lead program, PT-101, an engineered interleukin-2 mutein fused to an Fc backbone, which is designed to stimulate targeted expansion of regulatory T cells for use in autoimmune disease indications.
