Novarock Biotherapeutics Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd., has received FDA approval of its IND application for NBL-028, a CLDN6-CD137 bispecific antibody.
Oncusp Therapeutics Inc. has received IND clearance from the FDA to begin clinical trials with CUSP-06, a cadherin-6 (CDH6)-targeting antibody-drug conjugate designed for the treatment of multiple solid tumors. CDH6 is overexpressed in cancers including ovarian, renal, uterine, thyroid, lung, and cholangiocarcinoma. A phase I trial will pave the way for expansion in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Artiva Biotherapeutics Inc. has received FDA clearance of its IND application for Allonk (AB-101), to be used in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis.
Dicot AB has received clearance from the Swedish Medical Products Agency to begin a first-in-human trial with LIB-01, a potency agent to treat erectile dysfunction and premature ejaculation.
Zumutor Biologics Inc. has received FDA clearance of its IND application for ZM-008 to enter a first-in-human phase I study for the treatment of multiple solid cancers. A phase I study is anticipated to begin in the fourth quarter, and will include evaluation of ZM-008 followed by pembrolizumab.
Bloomsbury Genetic Therapies Ltd. announced that the FDA granted orphan drug designation for its investigational liver-targeted gene therapy, BGT-OTCD, for the treatment of ornithine transcarbamylase deficiency (OTCD).
Genprex Inc. announced that the FDA has granted orphan drug designation to the company's lead drug candidate, Reqorsa immunogene therapy (quaratusugene ozeplasmid, GPX-001), for the treatment of small cell lung cancer (SCLC). Reqorsa contains a plasmid that expresses the tumor suppressor gene TUSC2, the expression of which is reduced or not present in SCLC.
Lemonex Inc. announced that the IND application for its mRNA vaccine candidate LEM-mR203 has been approved by the Korean Ministry of Food and Drug Safety (MFDS) on July 21, 2023. The company plans to evaluate LEM-mR203 as potential treatment for COVID-19, with the planned phase I clinical trial being designed to assess its safety and immunogenicity in healthy adults at Seoul National University Hospital, Korea.
Georgiamune Inc. announced that the FDA cleared its IND application for GIM-122, a first-in-class dual-functioning monoclonal antibody designed to target a highly novel mechanism to overcome immunotherapy resistance.
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