FORT WORTH, Texas–(BUSINESS WIRE)–January 31, 2019–Phyton Biotech and PellePharm today announced an exclusive partnership to develop a process based on plant cell culture to enable future renewable production of the material premiere of PellePharm’s patidegib, an investigational topical therapy for Gorlin syndrome 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 BCCs in patients with Gorlin syndrome in a phase 3 trial.
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The basis of this joint initiative is Phyton Biotech’s proprietary Plant Cell Fermentation (PCF®) technology, a unique platform that enables a renewable, reliable and scalable supply of plant-derived compounds like cyclopamine, the key building block for the synthesis of patientgib. As part of its agreement with PellePharm, Phyton Biotech will immediately begin development of the new process.
“We are extremely 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 PCF® technology,” said Colin Marr, President of Phyton Biotech. “This 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 Liliaceae plant family found in remote mountainous regions of western North America.
“PellePharm’s partnership with Phyton Biotech underscores our commitment to bringing a new therapeutic option to patients with Gorlin Syndrome and other skin cancers,” said Sanuj Ravindran, President and CEO of PellePharm. “As we begin our pivotal Phase 3 clinical trial of patidegib topical gel and prepare for commercial-scale production of patidegib if approved, we anticipate that demand for cyclopamine will increase, which will drive the need for an additional and more scalable source.
Gorlin syndrome, also known as basal cell carcinoma nevus syndrome, is a rare genetic disorder that results in the chronic formation of multiple basal cell carcinomas, often on the face. With no FDA-approved medications 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 via PCF®. Further development and full scale-up in commercial-size bioreactors with a volume of up to 75 m³, operated at Phyton Biotech’s facilities in Germany, is expected to follow the current schedule.
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 benefits and cost compared to other methods of producing complex small molecules, 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 technology (PCF®), offering complete services for the development and commercialization of molecules, extracts and recombinant products based on plants, serving the pharmaceutical, Chinese traditional medicine, cosmetics, agriculture and food ingredient industries. By using PCF®, Phyton Biotech offers a balanced time, risk and cost pathway to commercially viable production processes, overcoming the limitations often encountered with traditional plant extraction and chemical synthesis.
As a biotechnology leader 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 PCF®, with the ability to meet more than a third of 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 genetic dermatological 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 BCC by providing an easy-to-use topical gel that eliminates the need for regular, painful and disfiguring surgeries. Patidegib topical gel is a premier topical formulation of a proprietary hedgehog inhibitor.
About Patidegib
Patidegib topical gel has shown great promise in a Phase 2 clinical study for attenuating 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 adverse systemic side effects. The gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for the ongoing home management of Gorlin syndrome and high frequency BCC. PellePharm has received both Orphan Drug Designation and Breakthrough Therapy Designation for patidegib topical gel in Gorlin syndrome from the United States Food and Drug Administration (FDA).
See the source version on businesswire.com:https://www.businesswire.com/news/home/20190131005847/en/
CONTACT: For Phyton Biotech:
Alex Russell, Director, Russell Communications
(604) 562-9262 [email protected] PellePharm:
Lauren Barbiero, W2O Group
(646) 564-2156 [email protected]
KEYWORD: UNITED STATES EUROPE NORTH AMERICA GERMANY TEXAS
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY
SOURCE: Phyton Biotech
Copyright Business Wire 2019.
PUBLISHED: 01/31/2019 2:29 PM / DISK: 01/31/2019 2:29 PM
http://www.businesswire.com/news/home/20190131005847/en
