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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
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 VirtualAnnual 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 millionwith Keystone Capital Partners, LLC. Execution of these agreements depends on share price and market conditions.
- 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- 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. Vaccinexhas 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 Universityto evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.
- 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
“In parallel, we continue to advance plans to leverage our work in Huntington’s disease and initiate a formal study of pepinemab in Alzheimer’s disease when trial sites are again permitted to safely enroll patients. Both Huntington’s and Alzheimer’s are slowly progressive neurodegenerative diseases characterized by the activation of inflammatory cells in the brain. As we recently presented at this year’s AAT-AD/PD™ Focus Meeting 2020, we believe pepinemab can block the upregulation of SEMA4D and the activation of glial cells in HD and AD patients, leading to a reduction in disease progression and improved long-term patient outcomes. We look forward to initiating our work in AD as soon as practicable,”
Upcoming Expected Milestones:
May 2020- Near topline data from the CLASSICAL-Lung non-small cell lung cancer study to be presented at the virtual ASCO conference May 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.
- Second half 2020 - Anticipated enrollment of first patient in Alzheimer’s disease Phase 1 study, subject to effects of the COVID-19 pandemic.
October 2020- Topline data from Cohort B of SIGNAL Huntington’s disease study expected.
Financial Results for the Three Months 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.