Vaccinex Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update

On-track to report topline data from CLASSICAL-Lung and SIGNAL clinical trials this year

Announces expansion of pepinemab development program into Alzheimer’s disease

Completes private placement of common stock, raising gross proceeds of $7.5 million

ROCHESTER, N.Y., March 09, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and Huntington’s disease, today announced financial results for the fourth quarter ended December 31, 2019 and provided a corporate update.

Fourth Quarter and Recent Accomplishments:

• Expansion of the pepinemab development program to include Alzheimer’s disease based on findings from Cohort A of the company’s ongoing SIGNAL Huntington’s disease study was announced. This research will be funded in part by awards of up to $3,750,000, expected to be received during 2020 from the Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Association “Part the Cloud” Program.
• Company scientists and collaborators made three oral presentations highlighting Semaphorin 4D (SEMA4D) as an emerging and important cancer target at the ASCO-SITC Clinical Immuno-Oncology Symposium. The company’s lead therapeutic candidate, pepinemab (VX15), is a monoclonal antibody that targets SEMA4D.
• Presented updated interim data from a Phase 1b/2 study of pepinemab in combination with avelumab (BAVENCIO) in non-small cell lung cancer at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
• Raised gross proceeds of approximately $7.5 million through a private placement of 1,468,563 shares of the company’s common stock in January 2020.

Pepinemab Clinical Updates:

• Non-Small Cell Lung Cancer (NSCLC). CLASSICAL-Lung clinical trial. Near topline data in the first half of 2020.
• Huntington’s Disease. The company’s SIGNAL trial evaluating pepinemab for the treatment of Huntington’s disease is ongoing, with topline data from Cohort B expected in October.
• In addition, the company’s lead drug candidate, pepinemab is being evaluated in multiple investigator-sponsored trials (ISTs) in additional indications:
  • Melanoma - The UCLA School of Medicine, in collaboration with Bristol-Myers Squibb, is evaluating pepinemab in combination with the checkpoint inhibitors nivolumab and ipilimumab in a small cohort of patients with advanced melanoma whose tumors progressed during or following initial treatment with immunotherapy.
  • Osteosarcoma - The National Cancer Institute’s Children’s Oncology Group is evaluating pepinemab for the treatment of osteosarcoma.
  • Other Cancers - Multiple “window of opportunity” trials are being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.

“During the fourth quarter, we achieved a very significant milestone for our company with the presentation of updated interim data from our ongoing CLASSICAL-Lung Phase 1b/2 study of pepinemab in combination with the anti-PD-L1 checkpoint inhibitor, BAVENCIO (avelumab), in non-small cell lung cancer,” stated Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. “The data showed that 17 of 29 study subjects who had failed prior single agent checkpoint inhibitor therapy appeared to benefit from the combination of pepinemab and avelumab. Notably, two of these subjects were partial responders with tumor reductions of 63% and 52%, and 15 subjects experienced stable disease. We are very pleased with these very compelling interim data and look forward to near topline data by mid-year as we continue to efficiently advance the promising combination of pepinemab and a checkpoint inhibitor through clinical development.