GEMMABio Announces $100 Million Agreement with Brazil's Leading Health Research Institute

News provided by

GEMMA Biotherapeutics and Franklin Biolabs

Oct 08, 2024, 11:00 ET

Unique international partnership marks significant momentum for new gene therapy entity

PHILADELPHIA, Oct. 8, 2024 /PRNewswire/ -- Today, GEMMA Biotherapeutics ("GEMMABio") – a new therapeutics company founded by gene therapy pioneer Dr. Jim Wilson – announced a major agreement with the Oswaldo Cruz Foundation ("Fiocruz"), a public health research institution that is part of the Ministry of Health of Brazil and has extensive experience in biomanufacturing.

GEMMABio partnered with Fiocruz – which is the main supplier of immunobiologics, biopharmaceuticals and diagnostics to the Brazilian Ministry of Health – to sponsor research that will bring gene therapy treatments to the people of Brazil under the Sistema Único de Saúde (SUS), Brazil's publicly funded health care system. Fiocruz will fund up to $100 million, which will be used to conduct clinical research and manufacturing – ultimately securing approval for programs that will allow the country to increase distribution of rare disease treatments and at a more affordable cost.

"By combining our resources and knowledge, this collaboration represents a major advancement in making gene therapies accessible to more patients quickly and at a fraction of the typical cost," said Dr. Wilson, who will serve as President and CEO of GEMMABio. "We are optimistic that this deal will serve as a global example for expanding access to advanced medical therapies as well as pursuing non-traditional ways to capitalize biotech companies."

A key component of the partnership will involve tech transfer, replicating GEMMABio's manufacturing technologies and process so that the companies can collaborate on programs and production in Brazil and for Fiocruz to utilize with other sponsors and programs. The agreement will also fund clinical development activities in Brazil for six core programs, including GM1 gangliosidosis (GM1), Krabbe Disease, Metachromatic leukodystrophy (MLD), and three unnamed programs. In return for their financial support, Fiocruz will be able to license related treatments to supply the Brazilian public health system.

"Brazil has the largest public health system in the world, offering health services and products to more than 200 million people. We are very proud to bring this innovation to the Brazilian system, a technology that was previously restricted to those with higher incomes, will now be accessible to the entire Brazilian population" said Marco Krieger, Vice President of Production and Innovation in Health, Fiocruz.

About GEMMABio
GEMMABio is a therapeutics company focused on speeding the research of and global access to life-changing advanced therapies for those living with rare diseases. The company will provide research and product development functions to bring gene therapy discoveries from the bench to the bedside faster and affordably.

GEMMABio is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the Chairperson of Franklin Biolabs, a Contract Research Organization. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most.

For more information, please visit gemmabiotx.com.

About Fiocruz
The Oswaldo Cruz Foundation (Fiocruz) is the largest biomedical research institution in Latin America, which also produces vaccines, medicines and in vitro diagnostics (IVD) to supply the Unified Health System (SUS, acronym in Portuguese for the Brazilian public health system). Linked to the Brazilian Ministry of Health, the Foundation was created on May 25, 1900 to initially manufacture serums and vaccines against bubonic plague. Since then, the institution has experienced an intense trajectory, which is intertwined with the development of public health in Brazil. Currently, Fiocruz is installed in 10 states, in addition to the Federal District, and has an office in Maputo, capital of Mozambique, Africa. In addition to the institutes based in Rio de Janeiro, the Foundation maintains units in the Northeast, North, Southeast and South regions of Brazil, and offices in Ceará, Mato Grosso do Sul, Piauí and Rondônia. In total, there are 16 technical-scientific units, focused on teaching, research, innovation, assistance, technological development and extension in the field of health. For more information, visit https://portal.fiocruz.br/en.