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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
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 Foundationand 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 millionthrough 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 Groupis evaluating pepinemab for the treatment of osteosarcoma.
- Other Cancers - Multiple “window of opportunity” trials are being conducted by the
Winship Cancer Institute of Emory Universityto evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.
- 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
“At the same time, our SIGNAL clinical trial of pepinemab in Huntington’s disease, our most advanced study, is ongoing and we look forward to topline data from Cohort B later this year.
“We believe these trials, together with ongoing investigator sponsored trials in other cancer indications, and our recent announcement that we are planning to initiate a study in Alzheimer’s disease later this year, offer multiple opportunities to demonstrate the broad potential of pepinemab in treating serious diseases,”
Upcoming Expected Milestones:
- First half 2020 – Near topline data from the CLASSICAL-Lung non-small cell lung cancer study anticipated.
June 2020(ASCO) - Interim analysis of combination Window-of-Opportunity studies at Emory University(melanoma, head and neck squamous cell carcinoma, colorectal and pancreatic cancer) expected.
- Second half 2020 – Anticipated publication of data from Cohort A of the SIGNAL Huntington’s disease trial.
- Mid-2020 - Anticipated enrollment of first patient in Alzheimer’s disease Phase 1 study
October 2020– Topline data from Cohort B of SIGNAL Huntington’s disease study expected.
Financial Results for the Three and Twelve Months Ended
Revenue. Revenue for the year ended
Research and Development Expenses. Research and development expenses for the three months ended
General and Administrative Expenses. General and administrative expenses for the three months ended
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
Source: Vaccinex, Inc.