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
ROCHESTER, N.Y., Nov. 13, 2018 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ: VCNX), a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including cancer, neurodegenerative diseases, and autoimmune disorders, today disclosed its financial results for the third quarter and nine months ended September 30, 2018, and provided a corporate update.
During the quarter, Vaccinex presented preliminary data on its anti-semaphorin 4D monoclonal antibody technology at the fourth International Cancer Immunotherapy Conference. Preclinical data demonstrated the blockade of SEMA4D allowed dendritic and cytotoxic T cells to migrate into the tumor, while reversing myeloid-derived immunosuppression and enhancing the activity of co-administered immunotherapy.
- 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. Vaccinex plans 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. Vaccinex expects 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 Group is evaluating pepinemab for the treatment of osteosarcoma
-- Other - Multiple “Window of Opportunity” trials are being conducted by the Winship Cancer Institute of Emory University to 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 Vaccinex, highlighted by our successful transition to a publicly-traded company. Our August initial public offering significantly strengthened our balance sheet and provided us with the resources we believe to be necessary to advance clinical development of our lead drug candidate pepinemab in multiple indications and advance discovery of novel therapeutic candidates targeting muti-pass membrane receptors through our unique ActivMAb antibody discovery platform,” commented Maurice Zauderer, PhD, Vaccinex’s Chief Executive Officer. “With ongoing clinical trials currently evaluating pepinemab in non-small cell lung cancer, melanoma and Huntington’s Disease, in addition to ISTs in other cancer indications, we believe we have multiple opportunities to create long term shareholder value while addressing unmet needs in difficult-to-treat patient populations.”
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 September 30, 2018:
Revenue. Revenue for the three months ended September 30, 2018 were $198,000 compared to $0 for the comparable period in 2017. Revenue recognized during the quarter was principally derived from collaboration agreements with Surface Oncology, Merck and Heptares.
Research and Development Expenses. Research and development expenses for the three months ended September 30, 2018 were $5.3 million compared to $4.3 million for the corresponding period in 2017. Research and development expenses for the nine months ended September 30, 2018 were $15.3 million compared to $11.5 million for the comparable period in 2017. This increase was attributable to the increase in costs related to the company’s active clinical trials.
General and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2018 were $1.1 million compared to $1.0 million for the comparable period in 2017. General and administrative expenses for the nine months ended September 30, 2018 were $3.2 million compared to $3.4 million for the corresponding period in 2017. The decrease year-to-date was primarily attributable to a decrease in payroll related costs and decreased legal fees.
Cash and Cash Equivalents. Cash and cash equivalents at September 30, 2018 were $27.4 million compared to $4.2 million at December 31, 2017. Through the first nine months of the year, the company used $17.7 million of cash in operating activities. Vaccinex believes that its current cash is sufficient to fund its operations through the 3rd quarter of 2019.
About Vaccinex, Inc.
Vaccinex, Inc. (NASDAQ: VCNX) is a clinical-stage immunotherapy company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including cancer, neurodegenerative diseases, and autoimmune disorders, with currently active clinical trials in Non-Small Cell Lung Cancer and Huntington’s disease. Vaccinex is based in Rochester, New York.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements in this press release include, among others, statements regarding: (i) the timing and success of the commencement, progress and receipt of data from preclinical and clinical trials; (ii) our expectations regarding the potential safety, efficacy or clinical utility of our product candidates; (iii) the expected results of any clinical trial and the impact on the likelihood or timing of any regulatory approval; (iv) financial and financing expectations and opportunities and (v) the performance of third parties.
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 Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in our prospectus for our initial public offering dated August 9, 2018, filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended,.
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.
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