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Phyton Biotech Partners with PellePharm to Develop Renewable Supply of Cyclopamine for Investigational Topical Cancer Therapy

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Phyton Biotech and PellePharm today announced an exclusive partnership to develop a plant cell culture-based process to enable the future renewable production of the raw material for PellePharms 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 Gorlin Syndrome patients in a Phase 3 trial.

The foundation for this joint initiative is Phyton Biotechs proprietary Plant Cell Fermentation (PCF) technology, a unique platform that enables renewable, reliable and scalable supply of plant-derived compounds like cyclopamine, the key building block in the synthesis of patidegib. Under its agreement with PellePharm, Phyton Biotech will begin development of the new process immediately.

We are incredibly excited to partner with PellePharm as pioneers in precision medicine to advance 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 markedly improving patient care.

Currently, cyclopamine is sourced from the perennial herb Veratrum californicum (corn lily), a member of the Liliaceae plant family found in remote mountainous parts of western North America.

PellePharms partnership with Phyton Biotech underscores our commitment to bring a new therapeutic option to patients with Gorlin Syndrome and other skin cancers, said Sanuj Ravindran, president and chief executive officer 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 the demand for cyclopamine will grow, spurring the need for a supplemental and more scalable source.

Gorlin Syndrome, also known as Basal Cell Carcinoma Nevus Syndrome, is a rare, genetic disease 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 as many as 30 or more surgeries per year, which can be repetitive, scarring and disfiguring.

The partnership with PellePharm follows Phyton Biotechs successful demonstration of its ability to express cyclopamine directly from Veratrum californicum plant cell cultures via PCF. Further development and full scale-up into commercial-size bioreactors of up to 75 m³ in volume, operated in Phyton Biotechs facility in Germany, is anticipated to follow the current program.

In addition to this project with PellePharm, Phyton Biotech is working on expanding its patent for the renewable production of alkaloids by Liliaceae cell culture to Europe as it is already granted in the United States and other jurisdictions.

Phyton Biotechs award-winning green chemistry model focuses on plant cell culture development and offers superior quality, reliability, environmental and cost advantages over other methods of production of complex small molecules, plant-based actives and recombinant proteins.

About Phyton Biotech Phyton Biotech, a wholly-owned subsidiary of DFB Pharmaceuticals, is the 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 contract development solutions for clients around the world. The company is now the worlds 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, genetic dermatological diseases, including Gorlin Syndrome and High Frequency Basal Cell Carcinoma (BCC), at their source. PellePharms mission is to improve the quality of life for those suffering from 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 first-in-class topical formulation of a proprietary hedgehog inhibitor.

About Patidegib Patidegib topical gel has shown early promise in a Phase 2 clinical study for the mitigation of BCC tumors in Gorlin Syndrome by blocking the disease at its source within 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 ongoing, at-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 U.S. Food and Drug Administration (FDA).

For Phyton Biotech:
Alex Russell, Principal, Russell Communications
(604)
562-9262 I alex@russellstrategy.com

For PellePharm:
Lauren Barbiero, W2O Group
(646) 564-2156 I lbarbiero@w2ogroup.com

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