On December 19, 2017 Onconova Therapeutics, Inc. (Nasdaq:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported the signing of a license and collaboration agreement with HanX Biopharmaceuticals, Inc., a company focused on development of novel oncology products, for the further development, registration and commercialization of ON 123300 in China (Press release, Onconova, DEC 19, 2017, View Source [SID1234522713]). ON 123300 is a first-in-class dual inhibitor of CDK4/6 + ARK5, which is currently in advanced pre-clinical development. This compound has the potential to overcome the limitations of current generation CDK 4/6 inhibitors.
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Under the terms of the agreement, Onconova will receive an upfront payment, regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX will provide all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Companies also intend for these studies to comply with US Food and Drug Administration (FDA) standards. Accordingly, such studies may be used by Onconova for an IND filing with the FDA. Both Companies will oversee the IND enabling studies. Onconova will maintain global rights outside of China.
"This collaboration provides an innovative way forward for our promising pipeline molecule. We are excited to advance ON 123300 towards a US IND as we seek to create a new standard of care with the potential to overcome the limitations of current generation compounds that require a combination treatment for therapeutic use. We believe that ON 123300 also has the potential to act as a single agent, due to the unique targeting of ARK 5, as well as CDK 4 and 6, making it potentially suitable for indications that may not be responsive to the current generation of CDK4/6 inhibitors, such as Palbociclib," commented Ramesh Kumar, President and CEO of Onconova. "CDK inhibitors have emerged as one of the most promising and targeted large market cancer therapies. We remain focused on our later stage rigosertib clinical development programs in MDS with near term milestones, and look forward to a close collaboration with HanX as we leverage their strong expertise in drug development and commercialization."
Faming Zhang, Ph.D., founder and Chief Executive Officer of HanX, commented, "HanX is a specialty pharmaceutical company focused on oncology, with an emerging pipeline of targeted agents including a proprietary PD-1 checkpoint antibody soon entering Phase 1 trials. We are pleased to be working with Onconova, which shares our commitment to developing innovative therapeutics in oncology. We look forward to working together to accelerate the development of ON 123300 for patients suffering from many types of cancer, including breast cancer, in both China and globally. As we launch our internally developed programs, such as a novel PD-1 program and other kinase inhibitors, we are excited by the potential synergies between our pipeline of checkpoint product candidates and CDK inhibitors."
Onconova recently presented promising pre-clinical data on in vitro metabolism and bioavailability for ON 123300 at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition. The data showed improved understanding of the metabolism of ON 123300 and the identification of metabolites, as well as a two to three-fold increase in bioavailability as a result of the Company’s formulation development efforts.