SAN ANTONIO – 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.”

About BioBridge Global

BioBridge Global (BBG) is a San Antonio, Texas-based nonprofit organization that offers diverse services through its subsidiaries – the South Texas Blood & Tissue Center, QualTex Laboratories, GenCure and the Blood & Tissue Center Foundation. BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is rooted in the South Texas Blood & Tissue Center, which has a proud history of serving the South Texas region and beyond for more than 40 years. BBG is committed to supporting groundbreaking research, addressing unmet clinical needs and enabling the development and commercialization of novel biotechnology products. www.biobridgeglobal.org

Contact: Mary Uhlig, Corporate Communications director: 210-296-9026, mary.uhlig@biobridgeglobal.org

About GenCure

GenCure, a Texas nonprofit organization, focuses on regenerative medicine and uses the power of human cells and tissues to inspire hope, enhance lives and enable clinical advancements. Using processed tissue and cell-based therapies, GenCure works to connect health care requirements with innovative solutions that best serve the needs of the global patient community.  www.gencure.org

Contact: Mary Uhlig, Corporate Communications director: 210-296-9026, mary.uhlig@biobridgeglobal.org

About StemBioSys

StemBioSys Inc., a privately held San Antonio-based biomedical company, which manufactures and develops innovative, advanced stem cell technologies to meet the promise of regenerative medicine in a surging global market. Its patented and proprietary technology platforms – licensed from the University of Texas System – overcome key obstacles to creating clinically useful stem cell therapies.

Contact: Bob Hutchens, bob.hutchens@stembiosys.com

About RoosterBio Inc.

RoosterBio is a privately held biofabrication technology and products company focused on accelerating the development of a sustainable regenerative medicine industry, one customer at a time. RoosterBio has simplified and standardized how stem cells are purchased, expanded, and used in development, leading to appreciable time and cost savings for customers. RoosterBio’s innovative products are ushering in a new era of productivity and standardization into the field, where researchers spend newly found time and money performing more high-value experiments, accelerating the road to discovery in regenerative medicine. RoosterBio serves customers worldwide. For more information, please visit www.roosterbio.com, or follow on Twitter (@RoosterBio), or read the blog “Democratizing Cell Technologies” (www.roosterbio.blogspot.com).

Contact: Margot Connor, president and chief business officer: 240.839.0144, margot@roosterbio.com

About the U.S. Army Institute of Surgical Research (USAISR)

The USAISR is one of six research laboratories within the U.S. Army Medical Research and Materiel Command of the U.S. Army Medical Command. The institute is the Army’s lead research laboratory for improving the care of combat casualties. The Coagulation and Blood Research program mission is to
develop novel blood and cellular therapy products to optimize combat casualty care.