Safi Biotherapeutics 获美国国防部 470 万美元追加资助，推进工程化红细胞进入首次临床试验

Award funds the final IND-enabling work needed prior to initiating Safi's first clinical trial

, /PRNewswire/ -- Safi Biotherapeutics, a company that manufactures stem-cell derived human red blood cells (mRBCs) as a dual-use product for civilian and military transfusion needs, today announced a $4.7 million non-dilutive award extension from the Department of War, Defense Health Program, Combat Casualty Care portfolio, through the Medical Technology Enterprise Consortium (MTEC). The award extension funds core activities needed to carry the mRBCs through to a planned Investigational New Drug (IND) submission for acute blood loss in 2027.

In the United States, hospitals transfuse more than 10 million units of red blood cells each year. While this demand has remained steady, sufficient blood supply is not always available. In this year alone, the American Red Cross declared a national blood supply crisis, a severe shortage, and an emergency shortage. An on-demand universal mRBC product could help solve these shortages; however, producing it at clinical scale has historically been the main barrier. Over the past year, Safi has demonstrated a path forward: its manufacturing process economically produces more than a full transfusable unit in a single 10-liter bioreactor. The new funding enables Safi to enter the clinic, its next major milestone, while continuing to support the development of a readily transfusable, cryopreserved mRBC formulation.

"A blood supply that depends on donors will always be fragile, whether on the battlefield, in a hospital setting, or in the aftermath of a mass casualty event," said Doug McConnell, Chief Executive Officer and Co-Founder of Safi Biotherapeutics. "Patients with chronic conditions, people undergoing medical procedures, and trauma victims all depend on a supply that is vulnerable to fluctuations. We believe the future of blood is manufactured, and we've shown it can be produced at large scale. This award funding supports the critical work needed to file our IND and initiate our first clinical trial in 2027."

The funding is provided by the U.S. government through MTEC, under Other Transaction Number W81XWH-15-9-0001, Military Prototype Advancement Initiative (MPAI). With this $4.7 million DoW award, Safi has now received over $27 million in non-dilutive government funding to date.

About Safi Biotherapeutics

Safi Biotherapeutics Inc. biomanufactures stem-cell-derived, human RBCs (mRBCs) to provide a highly characterized cell therapy product at a scale and cost required to meet civilian and military transfusion needs. Safi's manufacturing blueprint for mRBC production is the most advanced in the industry, and the company's readily addressable markets include acute transfusion settings, such as civilian and military hospitals during critical times of need, and chronic transfusion indications, such as sickle-cell disease. Safi's product pipeline includes refrigerated, cryopreserved and freeze-dried mRBC formulations. Safi leadership, comprised of industry and cell therapy veterans from DARPA, Vertex Pharmaceuticals, Mass General Brigham, and Loughborough University in the United Kingdom, launched the company in 2020 as part of the U.S. Department of War On-Demand Blood program. For more information on Safi, visit: https://safi.bio/ or follow us on LinkedIn.

About MTEC

The Medical Technology Enterprise Consortium is a 501(c)(3) biomedical technology consortium that is internationally-dispersed, collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel.

Disclaimer: The views, opinions, and/or findings are those of the author and should not be construed as an official Department of War, Defense Health Program position, policy, or decision unless so designated by other documentation.

Safi Contact:

Doug McConnell
[email protected]

Media Inquiries:
David Rosen, Argot Partners
[email protected]
212-600-1902

SOURCE Safi Biotherapeutics