Biotech Team Awarded $7.8 M Army Contract

A four-organization biotech group led by San Antonio-based nonprofit BioBridge Global (BBG) has been awarded a $7.8 million contract from the Medical Technology Enterprise Consortium (MTEC). The funds will enable the development of large-scale manufacturing capabilities for clinical-grade stem cells for research and therapeutic use.

BBG led a group including the U.S. Army Institute of Surgical Research (USAISR) Coagulation and Blood Research, San Antonio biotech firm StemBioSys and Maryland-based RoosterBio Inc. in submitting the proposal for funding.

MTEC is a nonprofit corporation created by the U.S. Army's Medical Research and Materiel Command to collaborate with companies, universities, foundations and other entities to develop medical technology solutions through flexible and innovative business practices.

While human bone marrow-derived mesenchymal stem cells (hMSCs) are the most widely used type of stem cell in both research and clinical settings, researchers in the growing field of regenerative medicine have difficulty acquiring hMSCs in significant volumes while maintaining the processes that ensure quality. This limits the conversion of laboratory findings into new cell therapy and regenerative medicine products. Regenerative medicine is a novel therapeutic approach in which damaged tissues and organ systems are not just repaired but completely regenerated through the application of stem cell therapies.

The consortium will address this issue by developing economical platforms for large-scale manufacturing of stem cells, while maintaining their critical quality attributes, thus supporting the development of cost-effective products and related services for use in regenerative medicine.

The capability expected to result from the contract-funded work will enable large-scale manufacturing of clinical grade stem cells for therapeutic use. Such treatments could revolutionize medical care for soldiers injured in combat and would also serve the broader military community including dependents and retirees. The treatments also would have widespread use in civilian settings.

The contract specifically will fund scale-up of xeno-free biomanufacturing processes for stem cells, which is preferable to using bovine-derived materials for therapeutics.

The contract application included letters of support from a number of universities, commercial centers and other potential end users, including the Mayo Clinic, confirming commercial and clinical demand for the capability expected to result from the biotech group's work. Possible early applications identified include development of therapies to achieve tissue regeneration in non-healing wounds, bone fracture, devastating soft tissue injury and treatment of ischemic heart disease, as well as enabling technology development in fields such as 3D bioprinting.

"BioBridge Global and our collaborators were in a unique position to pursue this contract because each of us brings critical capabilities required to develop a process for large-scale manufacturing of clinical-grade stem cells," said Becky Cap, chief operating officer of GenCure, a BBG subsidiary focused on the area of regenerative medicine, including cellular therapy products and services and product development. "Developing the process to scale up manufacturing will enable other research and development efforts that will result in truly translational, tangible therapeutic benefits for patients."

Under the parameters of the collaboration:

• RoosterBio will expand its existing novel hMSC product platforms in several phases.
• BBG subsidiary GenCure will work with RoosterBio and StemBioSys to develop a novel, xeno-free nutrient source for hMSCs in culture, testing a range of source materials available at BBG and integrating technology developed by StemBioSys.
• USAISR Coagulation and Blood Research will assist in development and evaluation of media components and develop assays to test the hMSCs for safety and potency.
• The technologies developed under the contract are expected to result in the capability to produce clinic-ready stem cells.
• The grant will fund three years of research, process development and manufacturing.

Jon A. Rowley, CEO of RoosterBio, said, "RoosterBio is excited to bring our stem cell biomanufacturing technology platforms together with an amazing team of collaborators to push forward scalable regenerative medicines for both military and civilian use. This MTEC contract allows the opportunity for a true acceleration of the manufacturing sciences aspects of regenerative medicine."

"StemBioSys is pleased to participate in this important collaborative contract," said Bob Hutchens, president and CEO. "We believe the output from this work has the potential to accelerate the transition of effective stem cell therapy from research to therapeutic applications."

Hutchens added that results from the contract may also allow StemBioSys to validate the clinical importance of one of the technologies it has been developing in the regenerative medicine space.

"We're honored to have been awarded this contract; ultimately, patients around the world could benefit from the work we do," GenCure's Cap said. "The confidence MTEC has in our proposal reinforces the importance of exploring the ability of regenerative medicine therapies to improve health outcomes."