Vaccinex Reports First Quarter 2020 Financial Results and Provides Corporate Update

Approaching key topline data in non-small cell lung cancer and Huntington’s disease

Advancing plans to expand pepinemab development to include Alzheimer’s disease

ROCHESTER, N.Y., May 14, 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 first quarter ended March 31, 2020 and provided a corporate update.

First Quarter and Recent Accomplishments:

• Presented updated interim data from the CLASSICAL-Lung Phase 1b/2 study of the company’s lead product candidate, pepinemab, in combination with avelumab (BAVENCIO) in non-small cell lung cancer (NSCLC) at the American Association for Cancer Research Virtual Annual Meeting.
• Delivered three oral presentations highlighting Semaphorin 4D (SEMA4D) as an emerging and important cancer target at the American Society of Clinical Oncology (ASCO)-Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium. Pepinemab is a monoclonal antibody that targets SEMA4D.
• Delivered a virtual presentation at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD Focus Meeting 2020 highlighting the potential of the company’s lead candidate, the anti-Semaphorin 4D (SEMA4D) antibody pepinemab to regulate glial cell activation and neurodegeneration in Alzheimer’s and Huntington’s diseases.
• Announced financing agreements for an open market sale agreement with Jefferies LLC, including a related prospectus supplement for “at the market” sales of up to $11.5 million, and for an equity purchase agreement of up to $5 million with Keystone Capital Partners, LLC. Execution of these agreements depends on share price and market conditions.
• 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 - CLASSICAL-Lung Clinical Trial. The company’s ongoing CLASSICAL-Lung study is evaluating pepinemab in combination with avelumab for the treatment of advanced (stage IIIB/IV) NSCLC. Of the 62 subjects enrolled in this phase 2 trial, four remain on study with continuing objective response or stable disease. Vaccinex has been invited to present near topline data at the virtual ASCO conference in late May 2020.
• Huntington’s Disease – SIGNAL Clinical Trial. The company’s ongoing, potentially pivotal, SIGNAL clinical trial is evaluating pepinemab for the treatment of Huntington’s disease. As of March 31, 2020, 37 of the 265 study subjects enrolled in cohort B have not yet completed the planned 18 months of treatment. The majority (32/37) have completed 16 of the 18 monthly visits specified in the trial protocol. The company is working with clinical investigators and sites to safely complete remaining visits and assessments and to use statistical projections as necessary for what we estimate may be up to 10% of the remaining subjects who are unable to compete the final one or two visits due to the COVID-19 pandemic.
• Alzheimer’s Disease. As announced in November 2019, the pepinemab development program has been expanded to include Alzheimer’s disease based on findings from cohort A of the SIGNAL trial. The company had previously anticipated initiating a trial of pepinemab in Alzheimer’s disease in mid-2020, but the initial enrollment date is now delayed. The extent of the delay is subject to evaluating further developments and risks related to the COVID-19 pandemic.
• 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.
  • 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 first quarter and subsequent period, we took significant steps that we believe strengthen our balance sheet as we look to conclusion of important trials of our lead clinical candidate pepinemab in both Huntington’s disease and non-small cell lung cancer,” said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. “And while the COVID-19 pandemic has created unprecedented disruptions and uncertainty affecting clinical development timelines around the world, we continue to engage with our trial sites and, given the advanced stage of both trials, we do not currently anticipate that these trials will be materially impacted by the pandemic.