Benzinga | Nov 9, 2021 04:06PM EST

GeoVax, City of Hope Announce Agreement To Accelerate Development And Commercialization For City Of Hope's COVID-19 Vaccine

GeoVax Labs Inc. (NASDAQ:GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, today announced that it has entered into an exclusive license agreement with City of Hope, a world-renowned cancer research and treatment organization. The agreement grants GeoVax exclusive rights to further develop and commercialize a multi-antigenic SARS-CoV-2 investigational vaccine, developed at City of Hope for immunocompromised patients, which is currently being studied in an ongoing Phase 2 clinical trial and shows a strong potential to be used in the general population as a primary and/or general booster vaccine against COVID-19 worldwide.

The license provides exclusive worldwide rights to key patents, as well as certain rights to expertise and clinical materials, related to COH04S1, a synthetic, attenuated modified vaccinia Ankara (sMVA) vector expressing spike and nucleocapsid antigens of the SARS-CoV-2 virus. Financial terms of the transaction were not immediately disclosed.

The rapid development of this COVID-19 vaccine investigational vaccine -- COH04S1 -- represents City of Hope's commitment to identify, invest and accelerate development of therapies that can significantly impact patients. COH04S1 is the only COVID-19 vaccine that includes both SARS-CoV-2 spike and nucleocapsid proteins to advance to a Phase 2 trial in cancer patients. Such vaccines also tend to produce an immune response quickly -- in less than 14 days -- with only mild side effects.

In a placebo-controlled Phase 1 clinical trial of healthy adults, COH04S1 was shown to be safe and immunogenic.

A Phase 2 clinical trial to evaluate the safety and immunogenicity of the COH04S1 investigational vaccine, compared to the Pfizer mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy is currently underway. The trial is also the first to compare an investigational multi-antigenic COVID-19 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccine from Pfizer/BioNTech in people who are immunocompromised. Such patients have often shown a weak antibody response after receiving currently available COVID-19 vaccines.

The ongoing Phase 2 trial is designed to evaluate COH04S1 in immunocompromised patients. An additional Phase 1/2 trial to evaluate COH04S1 as a universal booster to current FDA-approved vaccines is anticipated to open soon for enrollment in healthy volunteers.

"This agreement meaningfully accelerates the development of COH04S1 with the goal of better protecting immunocompromised patients from COVID-19 with a vaccine specifically designed to meet their needs," said Don J. Diamond, Ph.D., professor in City of Hope's Department of Hematology and Hematopoietic Cell Transplantation and the vaccine's lead developer. "City of Hope is excited to license this vaccine to GeoVax to progress to large-scale clinical trials and other milestones, including emergency authorization and worldwide distribution."

David Dodd, GeoVax President and CEO, said, "This license agreement represents a significant and exciting milestone for GeoVax and our shareholders, as it adds an additional Phase 2 clinical program in a primary focus area for our company, complementing our expertise in MVA technology. We look forward to a strong working relationship with Dr. Diamond and his colleagues at City of Hope, as we accelerate the clinical advancement of this promising vaccine for patients and look for opportunities for further collaboration in other areas of vaccine and immunotherapy needs.

"It is important to note that the addition of COH04S1 to our product pipeline is synergistic with, and complementary to, our ongoing development of GEO-CM02," Dodd continued. "Both vaccine candidates are potential second-generation COVID-19 vaccines, with COH04S1 representing a near-term opportunity for a niche-market indication for use in immunocompromised patients and possible expansion to a broader market indication as a universal booster vaccine. GEO-CM02, in contrast, is being developed as a single-dose pan coronavirus vaccine. With today's announcement, in conjunction with our September announcement of our licensing of Gedeptin(r), we have advanced our two core product development areas related to SARS-CoV-2 vaccines and immuno-oncology into clinical-stage testing. We look forward to providing further updates soon."