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Promising initial responses in Phase 1b/2 open-label KEYNOTE B84 study of pepinemab with KEYTRUDA® in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Patient enrollment continues in the Phase 1b/2 KEYNOTE B84 oncology and Phase 1/2a SIGNAL-AD Alzheimer’s studies
Several posters and presentations expected at November Medical Meetings, the
“Vaccinex continues to advance clinical development of our proprietary product candidate, pepinemab, a SEMA4D inhibitor, in oncology and neurodegenerative disease,” said
Recent Milestones:
Oncology:
- Data from an investigator-sponsored study at
The Winship Cancer Institute of Emory University evaluating neoadjuvant treatment with pepinemab in combination with nivolumab and/or ipilimumab in resectable Stage III melanoma followed by surgical resection and adjuvant treatment with nivolumab alone (NCT03769155) was presented at the 2022European Society for Medical Oncology (September 2022 ). 100% of patients who received neoadjuvant treatment with the triple combination of pepinemab, nivolumab and ipilimumab were recurrence free at 24 months. This contrasted with recurrence free survival of less than 40% in patients who received neoadjuvant treatment with the dual combination of pepinemab and nivolumab or pepinemab and ipilimumab.
Neurodegenerative Disease:
- Full results of the Phase 2 SIGNAL-HD study were published in Nature Medicine (Feigin et al., August 2022)
- Results of detailed pepinemab mechanism of action studies in neurodegenerative disease were published in the
Journal of Neuroinflammation (Evans et al.,August 2022 ) - Posters related to the ongoing Phase 1/2a SIGNAL-AD study were presented at the Alzheimer’s Association International Conference (
July 2022 ) - Poster related to the Phase 2 SIGNAL study of pepinemab as a treatment for early HD was presented at the European Huntington’s Disease Network 2022 (
September 2022 )
ActivMAb Platform Technology:
- The company is engaged in multiple biopharmaceutical collaborations employing this enabling technology for drug discovery. An IND for the first such clinical product is expected to be filed in 2023.
Upcoming Milestones:
Head and Neck Cancer: Phase 1b/2 KEYNOTE B84 study and Oncology updates
- Presentation of biomarker data from the investigator-sponsored study evaluating neoadjuvant pepinemab in combination with nivolumab and/or ipilimumab in resectable Stage III melanoma to be presented at the
Society for Immunotherapy of Cancer (SITC) 2022:November 11, 2022 - Poster related to “Phase I Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab/Trastuzumab in Patients with Metastatic HER2-Positive Breast Cancer (MBC)” presented at SITC 2022:
November 10-11, 2022 - Interim analysis of KEYNOTE B84: Expected Q1 2023
Alzheimer’s Disease: Phase 1/2a SIGNAL-AD study
- Completion of enrollment: Expected in H1 2023 with topline results of 12-months treatment with pepinemab expected in 2024.
Financial Results for the Three Months Ended
Cash and
Research and Development Expenses. Research and development expenses for the quarter ended
The essentially flat level of research and development expenses reflects consistent clinical trial costs to support the pepinemab Phase 1b/2 KEYNOTE B84 study in R/M HNSCC and Phase 1/2a study in Alzheimer’s Disease study along with continued careful cost control measures.
General and Administrative Expenses. General and administrative expenses for the quarter ended
Essentially flat level of general and administrative expenses reflects careful cost control measures.
Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended
Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10Q filed
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in tumor immunity and in inflammatory reactions in the brain. Preclinical and clinical data show that by preventing inflammatory reactivity of pepinemab during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the development and maintenance of neurons in the brain. Additional data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T-cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in oncology and neurodegenerative disease.
About ActivMAb®
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique multi-pass membrane target capabilities. The ActivMAb technology now has four main applications: complex membrane antigen presentation, antibody or antigen discovery, and protein optimization. Vaccinex has entered into an antibody license with Surface Oncology (
About Vaccinex, Inc.
Forward Looking Statements
To the extent that statements contained in this presentation 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. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington’s and Alzheimer’s diseases and other indications, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “hope”, “planned,” “poised,” “promising,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “suggest”, “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical and 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, our ability to continue as a going concern, our ability to maintain the listing of our common stock on Nasdaq, the impact of inflation on our expenses and business, uncertainties inherent in the execution, cost, enrollment and completion of preclinical studies and clinical trials, uncertainties related to regulatory approval, 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 the Company’s most recent year-end Annual Report on Form 10-K and subsequent filings with the SEC.
Investor Contact:
617-429-3548
jmullaly@lifesciadvisors.com
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share data)
| As of |
As of |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,186 | $ | 8,589 | ||||
| Accounts receivable | 50 | - | ||||||
| Prepaid expenses and other current assets | 789 | 816 | ||||||
| Total current assets | 8,025 | 9,405 | ||||||
| Property and equipment, net | 236 | 297 | ||||||
| Operating lease right-of-use asset | 351 | 141 | ||||||
| TOTAL ASSETS | $ | 8,612 | $ | 9,843 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 494 | $ | 1,061 | ||||
| Accrued expenses | 1,256 | 980 | ||||||
| Current portion of long-term debt | 74 | 74 | ||||||
| Operating lease liability | 163 | 141 | ||||||
| Total current liabilities | 1,987 | 2,256 | ||||||
| Long-term debt | 119 | 175 | ||||||
| Operating lease liability, net of current portion | 188 | - | ||||||
| TOTAL LIABILITIES | 2,294 | 2,431 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, par value of as of shares issued as of 42,664,051 and 30,801,110 shares outstanding as of and |
4 | 3 | ||||||
| Additional paid-in capital | 320,923 | 307,281 | ||||||
| (11 | ) | (11 | ) | |||||
| Accumulated deficit | (314,598 | ) | (299,861 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 6,318 | 7,412 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 8,612 | $ | 9,843 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands, except share and per share data)
| Three Months Ended |
Nine Months Ended |
|||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 50 | $ | 50 | $ | 50 | $ | 900 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 3,429 | 3,629 | 10,238 | 13,206 | ||||||||||||
| General and administrative | 1,413 | 1,484 | 4,599 | 4,666 | ||||||||||||
| Total costs and expenses | 4,842 | 5,113 | 14,837 | 17,872 | ||||||||||||
| Loss from operations | (4,792 | ) | (5,063 | ) | (14,787 | ) | (16,972 | ) | ||||||||
| Interest expense | (1 | ) | (142 | ) | (2 | ) | (825 | ) | ||||||||
| Other income (expense), net | 34 | (1 | ) | 52 | 48 | |||||||||||
| Loss before provision for income taxes | (4,759 | ) | (5,206 | ) | (14,737 | ) | (17,749 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | (4,759 | ) | (5,206 | ) | (14,737 | ) | (17,749 | ) | ||||||||
| Net loss attributable to noncontrolling interests | - | - | - | - | ||||||||||||
| Net loss attributable to |
$ | (4,759 | ) | $ | (5,206 | ) | $ | (14,737 | ) | $ | (17,749 | ) | ||||
| Comprehensive loss | $ | (4,759 | ) | $ | (5,206 | ) | $ | (14,737 | ) | $ | (17,749 | ) | ||||
| Net loss per share attributable to stockholders, basic and diluted |
$ | (0.11 | ) | $ | (0.17 | ) | $ | (0.36 | ) | $ | (0.63 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to diluted |
42,664,051 | 30,801,110 | 41,362,128 | 28,198,559 | ||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
Source: Vaccinex, Inc.