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Expect to complete patient enrollment in the randomized Phase 1/2a SIGNAL-AD Alzheimer’s study in
Completed enrollment of 36 patients required for a pre-planned interim analysis of KEYNOTE B84 phase 1b/2 study in Head and Neck Squamous Cell Carcinoma
In 2022 and continuing in Q1 2023,
In parallel, the company continues its clinical collaboration with
- A commentary summarizing the learnings from the SIGNAL HD study and their implications for other slowly progressive neurodegenerative diseases such as Alzheimer’s was published in Clinical and Translational Medicine (January, 2023).
- The Phase 1b/2 KEYNOTE B-84 study reached required enrollment of 36 patients for a pre-planned interim analysis.
- Data from two investigator-sponsored studies in melanoma and metastatic breast cancer were presented at the
Society for Immunotherapyin Cancer 2022 Annual Meeting (SITC 2022).
Investigators from the
Winship Cancer Institute of Emory Universitypresented data from a study 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). 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. Importantly, tumors from patients receiving pepinemab combination treatments exhibited organized tertiary lymphoid structures, which facilitate productive immunity and correlated with improved recurrence free survival.
Investigators from the
Moffitt Cancer Centerpresented data from a study evaluating pepinemab in combination with adoptive cell therapy in patients with HER2+ metastatic breast cancer (NCT05378464). Preclinical studies previously showed that SEMA4D antibody blockade, in combination with a dendritic cell vaccine, improved trafficking of dendritic cells to tumors, stimulating expansion of tumor-specific B and T cells and resulting in improved regression of primary and distant tumors. A Phase 1/2 trial evaluating the combination of pepinemab and trastuzumab with a dendritic cell vaccine, followed by adoptive transfer of expanded autologous CD4+ T cells, continues to enroll patients with HER2+ metastatic breast cancer at the Moffitt Cancer Center.
- Enrollment was initiated in the Phase 1b/2 single-arm, open label study to evaluate pepinemab in combination with avelumab (Bavencio®) as second line combination therapy for patients with metastatic pancreatic adenocarcinoma (PDAC, NCT05102721). Preclinical studies in PDAC models as well as prior clinical studies suggest that treatment with the semaphorin 4D (SEMA4D) blocking antibody, pepinemab, promotes the infiltration and activation of dendritic cells and CD8+ cells in the tumor microenvironment, rendering “cold” tumors such as PDAC to become “hot”, leading to enhanced efficacy of checkpoint inhibitors such as avelumab.
Vaccinexhas exclusive global commercial and development rights to pepinemab and is a sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp.
Avelumab is being provided by
Merck KGaA, Darmstadt, Germanyand Pfizer, Inc. for the PDAC NCT05102721 study. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germanyand Pfizer Inc.
ActivMAb Platform Technology:
- The company is engaged in multiple biopharmaceutical collaborations employing this enabling technology for drug discovery. Vaccinex’s partner, Surface Oncology, announced the initiation of a Phase 1/2 study for SRF114, a fully human monoclonal antibody targeting CCR8 selected by
Vaccinex, for the potential treatment of solid tumors. SRF114 is the first clinical candidate to be selected employing the ActivMAb platform and initiation of this clinical study triggered a milestone payment.
Financial Results for the Year Ended
Research and Development Expenses. Research and development expenses for the year ended
The decline in research and development expenses reflects completion of the final analysis of the SIGNAL HD study along with 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 and continued careful cost control measures.
General and Administrative Expenses. General and administrative expenses for the year ended
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 10-K filed
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in inflammatory reactions in the brain as well as in tumor immune evasion. Data show that by preventing deleterious inflammatory gliosis 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 preclinical and clinical 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 neurodegenerative disease and oncology.
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: native presentation of complex membrane antigens including GPCRs and ion channels, antibody and antigen discovery, and protein optimization. Vaccinex has entered into an antibody license with Surface Oncology (
Forward Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding
Consolidated Balance Sheets
(in thousands, except share and per share data)
|Cash and cash equivalents||$||6,391||$||8,589|
|Prepaid expenses and other current assets||912||816|
|Total current assets||7,478||9,405|
|Property and equipment, net||189||297|
|Operating lease right-of-use asset||310||141|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current portion of long-term debt||74||74|
|Operating lease liability||164||141|
|Total current liabilities||2,537||2,256|
|Operating lease liability, net of current portion||146||-|
|Commitments and contingencies (Note 7)|
|Stockholders’ equity (deficit):|
|Common stock, par value of
|Additional paid-in capital||324,875||307,281|
|TOTAL STOCKHOLDERS’ EQUITY||5,193||7,412|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||7,977||$||9,843|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
|Costs and expenses:|
|Research and development||13,979||17,160|
|General and administrative||6,202||6,230|
|Total costs and expenses||20,181||23,390|
|Loss from operations||(19,906||)||(22,490||)|
|Gain on forgiveness of PPP loan||-||876|
|Other income (expense), net||93||43|
|Loss before provision for income taxes||(19,815||)||(22,380||)|
|Provision for income taxes||-||-|
|Net loss per share attributable to
stockholders, basic and diluted
|Weighted-average shares used in computing net loss per share
Source: Vaccinex, Inc.