Janux Therapeutics Inc. has announced that it has submitted an IND application to the FDA for JANX-008, an epidermal growth factor receptor (EGFR)-tumor-activated T cell engager (TRACTr) in development for the treatment of EGFR-expressing solid tumors, including non-small-cell lung cancer (NSCLC), colorectal cancer (CRC), renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).
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.
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space.
Two weeks ahead of its Jan. 6, 2023, PDUFA date, the U.S. FDA has approved the bispecific Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. It’s the first bispecific antibody approved for treating any type of non-Hodgkin lymphoma (NHL). FL is the most common slow-growing form of NHL.
Sciclone Pharmaceuticals Holdings Ltd. has obtained marketing approval in China for Danyelza (naxitamab) for patients with relapsed or refractory high-risk neuroblastoma. The drug, in combination with granulocyte macrophage colony-stimulating factor, was approved to treat pediatric patients aged 1 and above, as well as adults, who have relapsed or refractory high-risk neuroblastoma in the bone or bone marrow and have demonstrated a partial or minor response to prior therapy or stable disease.
Two deals for antibody-drug conjugates inked since May between Merck & Co. Inc. and Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. have blossomed eight months later into the year’s biggest agreement, one that could bring Kelun-Biotech up to $9.3 billion in development, regulatory and sales milestones. The exclusive license and collaboration deal has Merck paying an up-front $175 million to Kelun-Biotech plus promising to make an equity investment in the Sichuan, China-based company.
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has developed antibody-drug conjugates (ADCs) consisting of 19F6_Hu35V1 antibody covalently linked to a cytotoxic drug through a linker.
Research at Silexon Biotech Co. Ltd. has led to the identification of mitogen-activated protein kinase kinase kinase kinase 1 (MAP4K1; HPK1; MEKKK1) inhibitors reported to be useful for the treatment of cancer, hepatitis B virus, hepatitis C virus and HIV infections.
Trastuzumab deruxtecan (DS-8201a) is an antibody-drug conjugate used for the treatment of metastatic HER2+ breast cancer that is refractory to anti-HER2 therapy such as T-DM1, however, there is a lack of knowledge on acquired or innate resistance to the drug.
Researchers from Kbluebio Inc. and affiliated organizations recently reported the discovery and preclinical evaluation of a novel prohibitin-2 (PHB2) ligand as a potential candidate for the treatment of multiple myeloma (MM).
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