Philadelphia, PA – January 8, 2018: Frontida BioPharm, Inc. and Oncoceutics Inc. announced that the two companies have entered into a product development and commercialization agreement to further develop and scale-up the finished product manufacturing process for ONC201, Oncoceutics’ lead molecule. ONC201 is an antagonist of the G-protein coupled receptor (GPCR) dopamine receptor D2 (DRD2) and is the first molecule designed to target this receptor specifically for oncology. The drug is currently in Phase II clinical trials for select advanced cancers, including multiple trials in high-grade gliomas, where patients treated with the compound have shown complete regressions of tumor lesions.
As a part of this agreement, Frontida will manufacture ONC201 drug product in their GMP certified facilities for clinical trials and future commercial purpose. Frontida has also made an equity investment in Oncoceutics.
“Our partnership with Oncoceutics gives Frontida an important and strategic opportunity to contribute our development and manufacturing expertise toward the commercialization of a promising oncology therapy,” said Ron Connolly, Chief Operations Officer of Frontida. “Oncoceutics’ lead molecule ONC201 has yielded compelling clinical outcomes, and our team is excited to have the opportunity to contribute to its advancement to commercialization.”
“We are pleased to enter into this agreement with Frontida that provides Oncoceutics with the scale of ONC201 drug product manufacturing necessary for future commercialization,” said Martin Stogniew Ph.D., Chief Development Officer of Oncoceutics. “The fact that Frontida has become a manufacturer and investor makes them a partner in Oncoceutics development programs, not simply a service provider.”
About Frontida BioPharm
Frontida BioPharm, Inc. is a leading provider of drug delivery technologies, product development and manufacturing services for both small and large pharmaceutical and consumer health companies. Combining the rich heritage of resources from URL/Mutual Pharmaceuticals in Philadelphia, PA and Aurora, IL with the development expertise from Frontage Laboratories and the region’s best pharma companies, Frontida is helping our partners reach the market faster, ensuring robust product performance and on-time supply of clinical and commercial products. Our 300,000+ ft2 manufacturing facilities supply prescription and OTC products, Highly Potent Active Ingredient (HPAI) products, Fixed-dose Combination Products and DEA schedules II – V products. Our 4 commercial packaging lines, equipped with validated product serialization technology, provide packaging services for both commercial products and clinical trial material supplies. Since its inception, Frontida has supported the Greater Philadelphia region’s efforts to retain highly talented pharmaceutical professionals through its job training programs for skilled workers, providing employment opportunities for more than 250 personnel over the last 18 months. Frontida – Quality Manufacturing, Extraordinary Care.™ Visit frontidabiopharm.com for more information.
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds that selectively target G protein-coupled receptors for oncology. The first lead compound to result from this program is ONC201, an orally active DRD2 small molecule antagonist that is well-tolerated and effective against advanced cancers. The company recently completed a successful Phase I study in solid tumors and has begun additional Phase I/II and Phase II clinical programs in both solid and hematological malignancies. Oncoceutics and collaborative groups have received significant grants over the last two years, from institutions such as the National Cancer Institute, the U.S. Food and Drug Administration, the Pennsylvania Department of Health, and The Musella Foundation. In addition, outside interest in the company’s portfolio has resulted in several R&D alliance agreements and collaborations between Oncoceutics and leading cancer research institutions, including The University of Texas MD Anderson Cancer Center, the NIH/NCI, Harvard and the Fox Chase Cancer Center. The company has established a robust intellectual property position, including several issued patents.