New MTEC Contract Funds OxyBridge™ Manufacturing Scale-Up

VirTech Bio has been awarded a twelve-month, $1.4 million contract modification through the Medical Technology Enterprise Consortium (MTEC) to advance manufacturing scale-up of OxyBridge™ toward clinical-grade production. Non-dilutive government funding for OxyBridge™ development has now reached $15 million.

The work is being carried out at GBI Biomanufacturing in Plantation, Florida, VirTech Bio’s contract manufacturing partner, with technology transfer managed by Cipher GMP.

“We are pleased to support VirTech Bio as it advances this innovative HBOC program,” said Jesse McCool, PhD, CEO of GBI Biomanufacturing. “Our teams share a commitment to scientific excellence, efficient development, and ultimately bringing new therapies to patients who need them.”

MTEC is a non-profit consortium that awards and manages research contracts on behalf of the US government’s military medical research programs. It has funded most of OxyBridge™ development since 2019.

The new contract funds the step between development-scale production and the clinical-grade batches needed for final IND-enabling studies before a first-in-human clinical trial.

Scale-up to cGMP production has historically defeated other hemoglobin-based oxygen carrier developers. It is being funded because the six preclinical studies with OxyBridge in large and small animal models have had very promising results. Preclinical results do not fully predict outcomes in patients but they are necessary to assess preliminary safety and efficacy, and flag any issues. MTEC has supported most of those studies.

Clinical trials have not begun, but MTEC has supported the work needed to get there.