From GlobeNewswire:

OBI Pharma, a clinical stage oncology company, has received FDA approval for a new investigational drug, OBI-992, to treat advanced solid tumors including lung and gastric cancers. The drug’s IND application has been approved and it is set to undergo a phase I/II study. OBI-992 targets TROP2 and is a first-in-class novel antibody-drug conjugate with potent potential. The company plans to begin administering the drug to its first patient in early 2024. OBI-992 utilizes a unique hydrophilic, enzyme-cleavable linker that shows remarkable antitumor efficacy and improved pharmacokinetic properties in animal models.

Furthermore, OBI Pharma has exclusive rights to distribute OBI-992 outside of China. The company aims to bring promising therapeutics to cancer patients. The clinical trials are aimed at assessing OBI-992’s safety, pharmacokinetics, and preliminary effectiveness. Dr. Wayne Saville, OBI Pharma’s Chief Medical Officer, feels optimistic that the clinical trial will be a significant step forward. Unlike other TROP2-AWKs, OBI-992 has demonstrated excellent preclinical efficacy, favorable safety, and high stability.

OBI-992 has excelled in numerous in vivo studies, making it an ideal target for cancer therapy due to its strong expression in a variety of solid tumors, such as lung, breast, ovarian, and stomach cancers. The company’s first-in-class immunotherapy portfolio, aims at Globo H, and includes two active Globo H immunotherapy vaccines: Adagloxad Simolenin (formerly OBI-822) and OBI-833. The company has developed its unique AWK pipelines, which also includes OBI-902, OBI-904, and OBI-905 targeting TROP2, Nectin4, and HER2. Additionally, the company’s pipeline includes OBI-3424 which is a low molecular weight prodrug that selectively releases a strong DNA-alkylating antitumor agent in the presence of the enzyme Aldoketo-Reduktase 1C3 (AKR1C3).

OBI Pharma was founded in 2002 and is a Taiwan based oncology company committed to developing innovative cancer therapeutics for patients with high unmet medical needs. They also have future-oriented statements contained in this press release that are not historical facts. Such forward-looking statements include statements about future clinical trials, results and the timing of such trials and results. OBI Pharma has previously disclosed these risk factors and discussed them in reports and presentations to the Taiwan Securities and Futures Authority.



Read more: OBI Pharma gibt Freigabe des IND-Antrags für