Synergys Receives Third NIH SBIR Grant from National Cancer Institute

Fast-Track Grant will support ongoing preclinical development of a Vasculogenic Mimicry-blocking Antibody Fusion therapeutic for Triple Negative Breast Cancer

ALAMO, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) — Synergys Biotherapeutics, a preclinical stage biotherapeutics company developing Vasculogenic Mimicry (VM)-blocking antibody fusion drugs, announced today that it has been awarded a Phase I/Phase II Fast-Track grant from the National Cancer Institute under the auspices of the Small Business Innovation Research (SBIR) program of the National Institutes of Health. The grant will support ongoing preclinical development of the Company’s lead biological drug candidate, SYN-001, as a treatment for Triple Negative Breast Cancer (TNBC). SYN-001 is a novel antibody fusion therapeutic that links an anti-EGFR antibody to a highly anti-angiogenic dimeric mutant endostatin as its fusion partner.

The Fast-Track grant includes a 1-year Phase l funding for efficacy studies of SYN-001 in TNBC patient-derived xenograft (PDX) models which will supplement efficacy results already obtained from TNBC cell line based xenografts that were recently published in the journal CELLS (Cells 2021,10,2904. https://doi.org/10.3390/cells10112904). Contingent on Phase I success, Phase II funds for 2 years will be allowed to carry out further studies essential for filing an IND.

SYN-001 is an exciting new and innovative targeted “immuno-anti-vasculogenesis” therapeutic for prevention of TNBC growth and metastases. In addition to anti-angiogenic activity directed at endothelial cells, SYN-001 is uniquely capable of inhibiting vasculogenic mimicry, i.e. the direct formation of vascular channels by TNBC cells. SYN-001 also inhibits TNBC tumor cell motility, migration and metastasis, and retains ADCC activity. Unlike SYN-001, most currently-marketed anti-angiogenic drugs lack significant VM-inhibitory activity.

Synergys will develop SYN-001 in collaboration with Joseph Rosenblatt, M.D., Professor of Medicine, Microbiology and Immunology, and Sundaram Ramakrishnan, Ph.D., Professor of Surgery, both from the University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL. The laboratory of Dr. Rosenblatt, the academic co-PI of the project, originally designed the SYN-001 fusion protein and demonstrated the ability of SYN-001 to block VM and metastases by TNBC cells.

Regarding the award, Dr. Rosenblatt notes, “We are delighted that NCI has continued its recognition of our collaborative research with Synergys on inhibition of Vasculogenic Mimicry in TNBC by SYN-001. The current Fast-Track award has followed on the heels of two recently completed Phase I SBIR grant, one of which involved the development of SYN-001 for TNBC. We look forward to expanding our highly productive collaboration with Synergys for the preclinical development of SYN-001.”

“We are highly thankful to the NCI grant review committee for recognizing Synergys’ vastly impactful research towards providing a new therapeutic treatment for TNBC,” stated Rathin Das, Ph.D, Founder and Chief Executive Officer of Synergys. “The planned studies for which NCI has awarded us the Fast Track grant will facilitate progress in preclinical development of SYN-001 for submission of an IND as a first-in-class biotherapeutic for human testing involving TNBC patients.”

Dr. Das further said, “We will continue to aggressively pursue securing government grants as non-dilutive funding in addition to external investment and partnerships for developing our pipeline candidates”.

About Synergys Biotherapeutics
Synergys is a preclinical stage biotherapeutics company developing Vasculogenic Mimicry-blocking Antibody Fusion products for treatment of various cancers. The Company’s most advanced product candidate, Anti-EGFR-TAP (SYN-001) is currently in preclinical development for Triple Negative Breast Cancer. Additionally, a second candidate, Anti-HER2-TAP (SYN-002) is being developed for ovarian cancer. Both candidates were derived from the technology termed A-TAP (Antibody-Targeted Anti-vascularization Payload). Synergys utilizes a virtual business model and works with its academic partners and various CROs for the development of its therapeutic candidates.

Contacts
Dr. Rathin C. Das
Chief Executive Officer
Synergys Biotherapeutics, Inc.
Ph: 925-575-0181
email: rathindas@synergysbio.com
https://www.Synergysbio.com