Onco-Innovations Advances Manufacturing Process for Cancer Drug Candidate ONC010
Onco-Innovations Limited has initiated process development and scale-up for ONC010's active ingredient, a key step toward regulatory studies and clinical trials.
Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H, WKN: A3EKSZ) has announced the start of process development and intermediate scale-up activities for A83B4C63, the active pharmaceutical ingredient in its proprietary drug candidate ONC010. This milestone advances the company's chemistry, manufacturing and controls (CMC) strategy as it moves toward IND-enabling studies and planning for first-in-human clinical evaluation.
The company reported that the program will focus on optimizing synthetic processes, improving yield and reproducibility, and scaling production of key intermediates required for downstream manufacturing and formulation. The effort will be conducted in collaboration with Dalton Pharma Services, aiming to establish a robust, scalable manufacturing process capable of supporting continued preclinical development, regulatory readiness, and future clinical supply requirements.
This development is significant because it moves ONC010 closer to clinical trials, potentially offering a new treatment option for solid tumors. Onco-Innovations has secured an exclusive worldwide license to patented technology targeting solid tumors, and advancing the manufacturing process is critical for meeting regulatory standards and ensuring a reliable drug supply for future studies.
For more details on the announcement, visit the full press release at https://nnw.fm/kfFWv. Additional information about the company is available at https://oncoinnovations.com/.