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On track to report potentially pivotal Phase 2 Huntington’s disease topline data by early October
Phase 1/2 trial of pepinemab in Alzheimer’s disease to begin enrolling patients in September
Raised net proceeds of $19.8 million since June 30
ROCHESTER, N.Y., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in Huntington’s disease and cancer, today announced financial results for the second quarter ended June 30, 2020 and provided a corporate update.
Pepinemab Clinical Updates:
Huntington’s Disease. The company’s ongoing SIGNAL clinical trial is evaluating its lead drug candidate, pepinemab, for the treatment of Huntington’s disease (HD). The company remains on track to complete the trial within the previously announced time frame. Subsequent to June 30, 2020, the last two patient treatment visits have been completed, and primary efficacy data has been collected from all subjects enrolled. The company continues to anticipate that topline data will be released by early October 2020.
Non-Small Cell Lung Cancer (NSCLC). CLASSICAL-Lung clinical trial. The CLASSICAL-Lung study is evaluating pepinemab in combination with the anti-PD-L1 checkpoint inhibitor BAVENCIO® (avelumab) for the treatment of advanced (stage IIIB/IV) NSCLC. Near topline data for this trial presented at the virtual American Society of Clinical Oncology (ASCO) conference in late May 2020 suggested that immunotherapy naive and PD-L1 negative or low patients achieved higher response rates with the combination than with avelumab alone.
Head and Neck Cancer. The company is preparing to initiate a new study of pepinemab in combination with an anti-PD-1 checkpoint inhibitor to treat front line head and neck cancer. The Company expects to provide further details on this study in the third quarter of 2020.
Alzheimer’s Disease. After a delay caused by the COVID-19 pandemic, the company expects to initiate enrollment in a clinical trial of pepinemab in Alzheimer’s disease in September 2020.
Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) in additional indications including “window of opportunity” studies being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.
Other Second Quarter and Recent Accomplishments:
Presented updated interim results from CLASSICAL-Lung), at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting and at the American Association for Cancer Research (AACR) Virtual Annual Meeting.
Delivered a virtual presentation at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD™ Focus Meeting 2020 highlighting the potential of pepinemab to regulate glial cell activation and neurodegeneration in Alzheimer’s and Huntington’s disease.
“We are rapidly approaching a significant milestone for our company with top-line data from our potentially pivotal SIGNAL trial in Huntington’s disease expected by early October,” stated Maurice Zauderer, Ph.D., president and chief executive officer of Vaccinex. “In parallel, we are exploring pepinemab’s potential utility in other slowly progressive neuroinflammatory and neurodegenerative diseases and anticipate commencing enrollment in a Phase 1/2 Alzheimer’s disease trial in September. We are very appreciative of financial support from both the Alzheimer’s Association and from the Alzheimer’s Drug Discovery Foundation to advance this important trial,” Dr. Zauderer concluded.
Upcoming Expected Milestones:
Late September/Early October 2020 – Topline data expected from potentially pivotal SIGNAL Huntington’s disease study.
September 2020 - Anticipated enrollment of first patient in Alzheimer’s disease Phase 1/2 study.
Second half 2020 – Preparation expected to commence for Phase 2 study of pepinemab in combination with anti-PD-1 in head and neck cancer.
Financial Results for the Three Months Ended June 30, 2020:
Research and Development Expenses. Research and development expenses for the three months ended June 30, 2020 were $4.6 million, as compared to $7.3 million for the comparable period in 2019. This decrease was primarily attributable to decreases in expenses in the CLASSICAL-Lung and SIGNAL studies as patients have come off study.
General and Administrative Expenses. General and administrative expenses for the three months ended June 30, 2020 were $1.9 million, as compared to $1.5 million for the comparable period in 2019. The increase was due to increased stock-based compensation as a result of new option awards to employees and board members, as well as increased directors and officers insurance premiums.
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on June 30, 2020 were $0.5 million, as compared to $2.8 million on December 31, 2019. Subsequent to the end of the second quarter, the company raised total proceeds, net of discounts and commissions and before expenses, of approximately $19.8 million through four financing transactions: $6.9 million through its existing at-the-market (ATM) equity facility, $8.0 million through the sale of a senior secured convertible debenture, $4.0 million through a private placement transaction, and $300,000 through the company’s existing equity line of credit facility. The company also received $575,000 of the previously announced $750,000 grant from the Alzheimer’s Association under the 2020 Part the Cloud Program.
About Vaccinex, Inc.
Vaccinex, Inc. is pioneering a differentiated approach to treating neurodegenerative disease through the inhibition of semaphorin 4D (SEMA4D), a key driver of neuroinflammation. The company’s lead drug candidate, pepinemab, blocks SEMA4D and has potential as a disease-modifying treatment for Huntington’s, Alzheimer’s and other neurodegenerative diseases. Beyond neurology, Vaccinex believes that, in combination with checkpoint inhibitors, pepinemab has potential to increase objective responses in oncology. The company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations.
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,” “potential,” “advance,” 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 about the expected timing and results of our ongoing and future clinical trials and our expectations regarding the potential benefits, activity and effectiveness of our product candidates. Forward-looking statements may 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, uncertainties related to regulatory approval, our history of operating losses and need to raise additional capital to continue as a going concern, risks related to our indebtedness, risks related to our dependence on our lead product candidate, pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. 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 periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in our Form 10-K filed with the SEC on March 13, 2019 and subsequent periodic reports.
LifeSci Advisors, LLC
Cait Williamson, Ph.D.
LifeSci Communications, LLC