PlantForm signs agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab cancer drug

GUELPH, ON, and RIO DE JANEIRO, Brazil, April 6, 2021 - PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz (Health Ministry of Brazil) today announced a collaborative research and development agreement to develop a biosimilar pembrolizumab for the Brazilian market.

The original antibody drug, pembrolizumab, is widely used in immunotherapy to treat a variety of cancers including melanoma, lung cancer, head and neck cancer, and stomach cancer.

"This agreement advances PlantForm's collaborations in Brazil to make affordable, effective cancer drugs available to millions of Brazilians," said Dr. Don Stewart, PlantForm's President and CEO. "It also advances PlantForm's global strategy for biosimilar drug development and manufacturing to increase affordability and access to a wide range of life-saving medications."

"Since 2015 when ANVISA approved the first biosimilar in Brazil it paved the way for more people to have access to advanced health treatments," said Germana Regazzi, PlantPraxis Director. "We want to make a difference in this market by transferring an innovative technology that will bring a low-cost biosimilar pembrolizumab to Brazil."

"Bio-Manguinhos, a pioneer institution in the development and production of vaccines, biopharmaceuticals and diagnostics and a protagonist in the production of biosimilars in Brazil, is now investing in plant-based technology. We strongly believe it can be an important option to bring high quality/low cost biopharmaceuticals and vaccines to the Brazilian Universal Health System (SUS). PlantForm holds one of the most promising technologies in the field, representing an ideal partner to pursue this goal," commented Sotiris Missailidis, Deputy Director of Technological Development of Bio-Manguinhos/Fiocruz.

The original drug (Keytruda^® by Merck) is a global market leader in oncology treatment and is on track to be the world's best-selling drug by 2025 with annual projected sales of US $22.5 billion. It will lose exclusivity protection in the U.S., EU and Brazil in 2028.

PlantPraxis is a joint venture between PlantForm do Brasil (a wholly owned subsidiary of PlantForm Corporation) and Axis Biotec Brazil to develop and commercialize certain biosimilar and/or biobetter versions of key biologic drugs using the vivoXPRESS^® manufacturing platform for biopharmaceuticals. Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and biopharmaceuticals to meet public health needs.

With this partnership, the three-year research and development initiative will culminate in protocols for Phase 1 and Phase 3 clinical trials. Following successful completion of clinical trials and market entry in Brazil through Bio-Manguinhos/Fiocruz, PlantForm and PlantPraxis will take biosimilar pembrolizumab to world markets.

PlantForm Corporation is a biopharmaceutical company focused on the rapid development and production of biosimilar and specialty antibodies and proteins using the company’s proprietary vivoXPRESS® platform. The plant-based vivoXPRESS® system makes it easier, faster and less expensive to produce biologics for approved and novel indications. PlantForm has an expanding portfolio of patents in seven families to protect both the core platform technology and products in development.

About Bio-Manguinhos/Fiocruz (www.bio.fiocruz.br)

As part of the Brazilian Ministry of Health, for 44 years the Institute of Technology on Immunobiologicals of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz) has expanded access to health care for the population through the research, development and supply of products that prevent, diagnose and treat diseases. To establish itself as the largest public laboratory in Latin America, Bio-Manguinhos wrote parts of the History of Public Health in Brazil. It has played a decisive role in the eradication of poliomyelitis in the country and in the Americas; was instrumental in the control of measles and yellow fever, becoming one of the main producers of this vaccine in the world, having already exported to more than 70 countries.

Partnerships with public and private institutions through technology transfer agreements, Partnerships for Productive Development (PDPs) and autochthonous development projects contribute to the expansion of its portfolio, which has more than 40 products among vaccines, in vitro diagnostics (IVDs) and biopharmaceuticals. Each year, millions of units are provided to the Brazilian Ministry of Health programs.