FORT WORTH, Texas – (COMMERCIAL THREAD) – Phyton Biotech and PellePharm today announced an exclusive partnership to develop a process based on the cultivation of plant cells to enable the future renewable production of the raw material for PellePharm’s patidegib, an experimental topical therapy for the syndrome de Gorlin and high frequency basal cell carcinoma (BCC). PellePharm is currently investigating the safety and efficacy of patidegib topical gel for the reduction of surgically eligible CBCs in patients with Gorlin syndrome in a phase 3 trial.
The basis of this joint initiative is Phyton Biotech’s proprietary plant cell fermentation (PCFÂ®) technology, a unique platform that enables a renewable, reliable and scalable supply of plant-derived compounds such as cyclopamine, the cornerstone of synthesis of patidegib. Under its agreement with PellePharm, Phyton Biotech will immediately begin development of the new process.
â€œWe are incredibly excited to partner with PellePharm as pioneers in precision medicine to take this topical skin cancer treatment to the next level of excellence with our patented PCFÂ® technology,â€ said Colin Marr, President by Phyton Biotech. â€œThis application of our ‘green chemistry’ process is just the latest example of how Phyton Biotech is advancing traditional manufacturing approaches for high-value phytochemicals and dramatically improving patient care.
Currently, cyclopamine comes from the perennial grass Veratrum californicum (corn lily), a member of the lily plant family found in remote mountainous regions of western North America.
â€œPellePharm’s partnership with Phyton Biotech underscores our commitment to bring a new therapeutic option to patients with Gorlin syndrome and other skin cancers,â€ said Sanuj Ravindran, President and CEO of PellePharm. â€œAs we begin our pivotal Phase 3 clinical trial of patidegib topical gel and prepare for commercial scale production of patidegib if approved, we expect the demand for cyclopamine to increase, which will boost the need an additional and more scalable source. ”
Gorlin syndrome, also known as basal cell carcinoma nevus syndrome, is a rare genetic disorder that leads to the chronic formation of multiple basal cell carcinomas, often on the face. With no FDA-approved drugs currently available for Gorlin syndrome, the standard of care is surgery. People with severe Gorlin syndrome may have up to 30 or more surgeries per year, which can be repetitive, scarring, and disfiguring.
The partnership with PellePharm follows Phyton Biotech’s successful demonstration of its ability to express cyclopamine directly from Veratrum californicum plant cell cultures using PCFÂ®. Further development and full scale-up into commercial-size bioreactors with a volume of up to 75 mÂ³, operated at Phyton Biotech’s facilities in Germany, is expected to follow the current program.
In addition to this project with PellePharm, Phyton Biotech is working to extend its patent for the renewable production of alkaloids by cell culture of Liliaceae to Europe as it is already granted in the United States and other jurisdictions.
Phyton Biotech’s award-winning green chemistry model focuses on the development of plant cell cultures and offers superior quality, reliability, environmental and cost advantages over other complex small molecule production methods, plant active ingredients and recombinant proteins.
About Phyton Biotech
Phyton Biotech, a 100% subsidiary of DFB Pharmaceuticals, is the 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, cosmetics, agriculture 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 contract development solutions for clients 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 global leaders in hedgehog pathway signaling, PellePharm, a BridgeBio company, is committed to targeting rare genetic dermatologic diseases, including Gorlin syndrome and high frequency basal cell carcinoma (BCC), at their source . PellePharm’s mission is to improve the quality of life for people with Gorlin Syndrome and High Frequency CBC by providing an easy-to-use topical gel that eliminates the need for regular, painful and disfiguring surgeries. Patidegib Topical Gel is a first-class topical formulation of a proprietary Hedgehog inhibitor.
Patidegib topical gel has shown great promise in a phase 2 clinical study for the attenuation of BCC tumors in Gorlin syndrome by blocking the disease at its source in the hedgehog signaling pathway. The topical formulation of patidegib was developed to provide the efficacy previously demonstrated by oral patidegib in Phase 1 trials without the unwanted systemic side effects. The gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for the continued home management of Gorlin syndrome and high frequency CBC. PellePharm has received both Orphan Drug Designation and Breakthrough Therapy Designation for topical gel patidegib in Gorlin Syndrome from the United States Food and Drug Administration (FDA).