TX-PHYTON-BIOTECH

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 to be used for rare dermatologic conditions. This is the first step in efforts to enable the renewable production of cyclopamine.

Through Phyton’s proprietary Plant Cell Fermentation (PCF®) technology, researchers successfully developed high-yielding plant cell lines of V. californicum and established protocols for cryopreservation, allowing for stable long-term storage of cell lines in liquid nitrogen. In addition, Phyton Biotech demonstrated its ability to express cyclopamine directly from V. californicum plant cell cultures via PCF® 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 anticipated in the next project phase.

“Currently, 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 culture-based approach is highly desirable,” said Gerd Kochendoerfer, Ph.D., senior vice president and head of operations of PellePharm. “We appreciate the technical progress the Phyton team has achieved, and are hopeful that we will be able to scale up and leverage their innovative services as alternate supplier of this raw material for potential commercialization of patidegib topical gel.”

PellePharm is currently investigating the safety and efficacy of patidegib topical gel in a Phase 3 study for the reduction of basal cell carcinoma burden 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 further expanded with a patent grant by the European Patent Office (EPO).

Colin Marr, president of Phyton Biotech comments on this progress:

We are excited to have met a significant milestone in this project where we have established proof of concept for the development of cyclopamine through the use of our PCF technology, and that it may be used in PellePharm’s medical treatment of patients with Gorlin Syndrome. We look forward to continuing our work with PellePharm, an important customer of Phyton, and wish them great success in the development of this revolutionary medical treatment.

About Phyton Biotech

Phyton Biotech, a wholly-owned subsidiary of DFB Pharmaceuticals, is a global leader in Plant Cell Fermentation (PCF®) Technology, offering comprehensive services for the development and commercialization of plant-based molecules, extracts and recombinant products, serving the pharmaceutical, Chinese Traditional Medicine, cosmetic, agricultural and food ingredient industries. Using PCF®, Phyton Biotech offers a time, risk and cost-balanced path to commercially viable production processes, overcoming limitations often experienced with traditional plant extraction and chemical synthesis.

As a biotechnology leader with certified GMP facilities in Germany and Canada, Phyton Biotech has a successful track record of developing and implementing innovative solutions for clients around the world. The company is now the world’s largest producer of paclitaxel and docetaxel via PCF®, with the capacity to meet more than one-third of the global demand for these critical active pharmaceutical ingredients. For more information, please visit phytonbiotech.com.

About PellePharm

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 those suffering from 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.

About Patidegib

Patidegib topical gel, an investigational treatment, is designed to reduce the basal cell carcinoma (BCC) tumor burden in people living with Gorlin syndrome and high frequency BCC (HF-BCC) by blocking the disease at its source within the hedgehog signaling pathway. Patidegib topical gel has shown early promise in a Phase 2 clinical study for the mitigation of BCC tumors in Gorlin syndrome. The topical formulation of patidegib was developed with a goal of providing the clinical activity previously demonstrated by oral Patidegib in Phase 1 trials and a favorable tolerability profile without the adverse systemic side effects observed 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 ongoing, at-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 EMA’s Committee for Orphan Medicinal Products in the EU.

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