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Initial data from ongoing open label study of pepinemab (VX15/2503) in combination with avelumab in non-small cell lung cancer expected in 2Q 2019
Enrollment in cohort B of the Phase 2 SIGNAL Huntington’s disease trial complete; data expected in 2H 2020
Fourth Quarter and Recent Accomplishments:
- Announced completion of enrollment in cohort B of its ongoing Phase 2, multi-center, randomized, double-blind, placebo-controlled SIGNAL study. This is a potentially pivotal registration study designed to assess the safety, tolerability, pharmacokinetics, and efficacy of pepinemab, a humanized anti-SEMA4D monoclonal antibody, in subjects with early manifest and late prodromal Huntington’s disease
- Presented preclinical data in the journal
Cancer Immunology Research demonstrating that Vaccinex’s anti-SEMA4D monoclonal antibody, on which its humanized lead compound pepinemab is based, reduces function and recruitment of myeloid derived suppressor cells within the tumor, a key mechanism of resistance to immune checkpoint blockade - Delivered a podium presentation at the
Society for Immunotherapy of Cancer Annual Meeting summarizing preclinical data on the role of anti-SEMA4D monoclonal antibody in reducing immune suppression by myeloid-derived cells, thereby restoring the ability of dendritic cells and cytotoxic T cells to migrate into the tumor - Presented an overview of pepinemab as a potential treatment for Huntington’s disease at the Huntington Study Group’s 25th Annual Meeting: HSG 2018
Pepinemab Clinical Updates:
- Non-Small Cell Lung Cancer (NSCLC). The dose escalation phase of the CLASSICAL–Lung clinical trial, in which the Company is evaluating pepinemab in combination with avelumab in NSCLC, has been completed and the recommended Phase 2 dose for the dose expansion phase was identified. The dose expansion phase has been initiated and aims to enroll a total of 50 subjects in two cohorts: 22 patients who are immunotherapy naïve and 28 patients whose tumors have progressed during or following prior treatment with immunotherapy. Primary completion for this trial and initial data are expected in the second quarter of 2019.
- Huntington’s Disease. Enrollment in cohort B of the SIGNAL trial evaluating pepinemab for the treatment of Huntington’s disease, consisting of 265 subjects, was completed in
December 2018 . The Company expects data from this study in the second half of 2020. - In addition, pepinemab is being evaluated in multiple investigator-sponsored trials (ISTs) in additional indications:
• Melanoma -The UCLA School of Medicine , in collaboration withBristol-Myers Squibb , is evaluating pepinemab in combination with the checkpoint inhibitors nivolumab and ipilumumab in two cohorts of patients with advanced melanoma whose tumors progressed during or following initial treatment with immunotherapy.
• Osteosarcoma - The National Cancer Institute’s Children’sOncology Group is evaluating pepinemab for the treatment of osteosarcoma
• Other Cancers - Multiple “window of opportunity” trials are being conducted by theWinship Cancer Institute of Emory University to evaluate pepinemab in combination with immunotherapies in colorectal, pancreatic, head and neck cancer and melanoma
“The fourth quarter caps a year of significant progress at
“In parallel, we are efficiently advancing pepinemab in our SIGNAL Phase 2 trial for our lead indication, Huntington’s disease, with enrollment in cohort B now completed. The positive results from cohort A demonstrated that pepinemab significantly increased brain metabolic activity with no concerning safety issues, and we believe suggests potential broader clinical utility in other neurodegenerative diseases as well.”
“Finally, we continue to leverage our proprietary ActivMAb antibody discovery platform which we believe offers opportunities for long-term value creation. Of particular interest to our biotech and pharmaceutical partners has been the novel capability to efficiently select antibodies to multi-pass membrane receptors such as GPCR and ion channels, an important class of pharmaceutical products that has, to date, eluded development of antibody drugs,” Dr. Zauderer concluded.
Upcoming Milestones:
- Second quarter of 2019 – Expected release of initial report of open label study of pepinemab in combination with avelumab in NSCLC
- Second half 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 Twelve Months Ended
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LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com