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Lead candidate pepinemab (VX15) being evaluated in three ongoing clinical trials in cancer and Huntington’s Disease
Enrollment in CLASSICAL Lung Cancer trial and Cohort B of the SIGNAL Huntington’s Disease trial is On-Track; Data Expected for NSCLC in 2H 2019 and for Huntington’s disease in 2H 2020
During the quarter,
- Non-Small Cell Lung Cancer (NSCLC). In the company’s CLASSICAL study, which is evaluating pepinemab in combination with avelumab in NSCLC, the dose escalation phase of the trial is complete, and the company has identified the intended Phase 2 dose for the dose expansion phase.
Vaccinexplans to enroll 28 patients in each of two cohorts: one in which patients are immunotherapy naïve and one with patients whose tumors have progressed during or following an initial treatment with anti-PD1/PD-L1. Data from this trial is expected in 2H 2019.
- Huntington’s Disease. The company’s SIGNAL trial evaluating pepinemab for the treatment of Huntington’s Disease remains on-track to complete enrollment of 258 patients in Cohort B by the end of 2018.
Vaccinexexpects data from this study in 2H 2020.
- In addition, pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) for additional cancer indications:
-- Melanoma -
The UCLA School of Medicine, in collaboration with Bristol-Myers Squibb, is evaluating pepinemab in combination with the checkpoint inhibitors nivolumab and ipilumumab in two cohorts of patients with advanced melanoma.
-- Osteosarcoma - The National Cancer Institute’s Children’s
Oncology Groupis evaluating pepinemab for the treatment of osteosarcoma
-- Other - Multiple “Window of Opportunity” trials are being conducted by the
Winship Cancer Institute of Emory Universityto evaluate pepinemab in combination with immunotherapies in colorectal, pancreatic, head and neck cancer and melanoma.
“We believe that the third quarter was a transformational one for
Upcoming Anticipated Milestones:
- Second quarter of 2019 – Expected release of initial report of open label combination study of VX15 (pepinemab) with avelumab in NSCLC
- Fourth quarter of 2019 - Estimated primary completion date of combination study in NSCLC
- First half of 2019 – Anticipated publication of SIGNAL Cohort A data in Huntington’s Disease
- Second half of 2020 – Expected topline data from Cohort B of ongoing SIGNAL trial of pepinemab in Huntington’s Disease
Financial Results for the Three and Nine Months Ended
Revenue. Revenue 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
Cash and Cash Equivalents. Cash and cash equivalents at
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, risks related to our dependence on third parties, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate VX15 (pepinemab), risks related to competition, other matters that could affect our development plans or the commercial potential of our product candidates, expectations regarding the use of proceeds from our initial public offering, changes in costs and operations, and other risks regarding our capital requirements and results of operations. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our quarterly report on Form 10-Q filed with the
No representations or warranties are offered in connection with the data or information provided herein. This press release is intended for informational purposes only and may not be relied on in connection with the purchase or sale of any security. Any offering of our securities will be made, if at all, only upon the registration of such securities under applicable securities laws or pursuant to an exemption from such requirements.
LifeSci Advisors, LLC