FORT WORTH, Texas – (COMMERCIAL THREAD) – Phyton Biotech today announced that it has established high-yielding plant cell lines of Veratum californicum, the source of cyclopamine, a key raw material for PellePharm’s patedigib topical gel, an investigational treatment for use in rare skin conditions. This is the first step in efforts to enable the renewable production of cyclopamine.
Using Phyton’s proprietary plant cell fermentation (PCFÂ®) technology, researchers have successfully developed high-yielding plant cell lines of V. californicum and established protocols for cryopreservation, allowing long-term stable storage of cell lines in liquid nitrogen. In addition, Phyton Biotech has demonstrated the ability to express cyclopamine directly from V. californicum plant cell cultures via PCFÂ® and also showed that cyclopamine can be expressed efficiently in a standard bioreactor environment. Further development and full scale-up to a commercially viable process is planned in the next phase of the project.
â€œCurrently, the raw material for patidegib is derived from a wild plant, Veratum californicum, and while we are committed to harvesting the plant sustainably, a plant-based approach is highly desirable, â€said Gerd Kochendoerfer, Ph.D., senior vice president and chief operating officer of PellePharm. â€œWe appreciate the technical advancements made by the Phyton team and hope that we can expand and leverage their innovative services as an alternative supplier of this raw material for the potential commercialization of patidegib topical gel. ”
PellePharm is currently investigating the safety and efficacy of patidegib topical gel in a Phase 3 study for reducing the burden of basal cell carcinoma in patients with Gorlin syndrome. In addition, the company is engaged in a phase 2 trial studying it in high frequency basal cell carcinoma (HF-BCC).
In addition to these technical milestones, patent coverage has recently been extended with a patent grant by the European Patent Office (EPO).
Colin Marr, President of Phyton Biotech comments on this progress:
We are delighted to have taken an important step in this project where we have established a proof of concept for the development of cyclopamine through the use of our PCF technology, and that it can be used in the medical treatment of PellePharm of patients with Gorlin syndrome. We look forward to continuing our work with PellePharm, a major customer of Phyton, and wish them every success in the development of this revolutionary medical treatment.
About Phyton Biotech
Phyton Biotech, a 100% subsidiary of DFB Pharmaceuticals, is a world leader in plant cell fermentation (PCFÂ®) technology, offering comprehensive services for the development and commercialization of molecules, extracts and recombinant products based on plants, serving the pharmaceutical industry, Chinese Traditional medicine, cosmetic, agricultural and food ingredients industries. By using PCFÂ®, Phyton Biotech offers a balanced path in terms of time, risk and cost towards commercially viable production processes, overcoming limitations often encountered with traditional plant extraction and chemical synthesis.
As a leader in biotechnology with GMP certified facilities in Germany and Canada, Phyton Biotech has a successful track record in developing and implementing innovative solutions for customers around the world. The company is now the world’s largest producer of paclitaxel and docetaxel via PCFÂ®, with the capacity to meet more than a third of the global demand for these essential active pharmaceutical ingredients. For more information, please visit phytonbiotech.com.
Founded by world leaders in hedgehog pathway signaling, PellePharm, a BridgeBio company, is committed to targeting rare forms of basal cell carcinoma, including Gorlin syndrome and high frequency basal cell carcinoma (HF-BCC), at their source. PellePharm’s mission is to improve the quality of life for people with Gorlin syndrome and HF-BCC by providing an easy-to-use topical gel that could potentially reduce the need for regular, painful and disfiguring surgeries. Patidegib Topical Gel is a topical formulation of a proprietary hedgehog inhibitor.
Patidegib topical gel, an investigational treatment, is designed to reduce the tumor burden of basal cell carcinoma (BCC) in people with Gorlin syndrome and high frequency BCC (HF-BCC) by blocking the disease at its source in the hedgehog signaling pathway. Patidegib topical gel has shown great promise in a phase 2 clinical study for the attenuation of BCC tumors in Gorlin syndrome. The topical formulation of patidegib was developed to provide the clinical activity previously demonstrated by oral Patidegib in phase 1 trials and a favorable tolerability profile without the unwanted systemic side effects seen with the oral class of hedgehog inhibitors. The topical gel formulation is stable at room temperature for at least two years, potentially making it an option for the continued home management of Gorlin syndrome and HF-BCC. PellePharm has received both Orphan Drug Designation and Breakthrough Therapy Designation for Patidegib Topical Gel in Gorlin Syndrome from the FDA, as well as Orphan Drug Designation in Gorlin Syndrome from the EMA Committee for orphan drugs in the EU.