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Excellent Progress in Pepinemab Clinical Programs
Promising responses in Phase 1b segment of the open-label KEYNOTE B84 study of pepinemab with KEYTRUDA® in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC);
Phase 2 enrollment underway
Enrollment underway in Phase 1/2a study of pepinemab in Alzheimer’s disease
“I am pleased to report that Vaccinex’s clinical programs for oncology and neurodegenerative disease have made substantial progress this year. In oncology, we were gratified to report promising Phase Ib safety results and to observe two complete responses (CRs) in the first three patients enrolled in the open label, Phase 1b/2 KEYNOTE-B84 trial. The trial is evaluating the use of pepinemab in combination with KEYTRUDA® (pembrolizumab) as first-line treatment for patients with advanced recurrent or metastatic head and neck cancer. We are hopeful that, with continued positive results, this combination may represent a novel option for patients with head and neck cancer, including those whose tumors express low levels of the PD-L1 biomarker and who have limited treatment choices,” said
Pepinemab Clinical Updates and Upcoming Milestones:
Oncology: Head and Neck Cancer
Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 immune checkpoint therapy KEYTRUDA (pembrolizumab) in recurrent or metastatic head and neck cancer.
Multiple prior studies1-3 suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication.
The KEYNOTE-B84 study is planned to enroll up to 65 subjects across 18 U.S. trial sites and will assess whether combination immunotherapy with pepinemab and pembrolizumab can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival.
Next Data and Trial Completion: Data read-outs are expected in H2:2022. Enrollment is expected to be completed and topline data presented in H1:2023.
ASCO Abstract Publication: An abstract of the Phase 1b segment of the study of pepinemab, an inhibitor of semaphorin 4D, in combination with pembrolizumab as first-line treatment of recurrent or metastatic head and neck cancer (KEYNOTE-B84) will be published with the ASCO proceedings on
Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the
Alzheimer’s Disease. Enrollment continues in the Phase 1/2a SIGNAL-AD trial of pepinemab in early Alzheimer’s disease which is being funded in part by the Alzheimer’s
The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 15 U.S. trial sites.
Next Data and Trial Completion: Enrollment is expected to be completed by year-end 2022 and topline data are expected in H2:2023.
Huntington’s disease. The Phase 2 double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD) has been completed and we believe the program is Phase-3 ready.
While the Phase 2 study did not meet the prespecified primary endpoints, pre-specified exploratory and post-hoc analyses supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild cognitive deficits:
- Highly significant improvement (p=0.007) in the (Huntington’s Disease Cognitive Assessment Battery (HD-CAB) Composite score
- Significant benefit in reducing apathy severity (p=0.017, 1-sided)
- Reduced atrophy (p=0.017) in caudate region of striatum
- A striking increase in brain metabolic activity as measured by FDG-PET in most brain regions
Next Steps: The company intends to publish the results of the SIGNAL study in mid-2022. In addition,
As previously announced, we have entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb antibody discovery platform to address difficult to drug G-protein Coupled Receptors (GPCRs) and ion channels known to be strongly associated with diseases.
In April, 2022,
Financial Results for the Three Months Ended
Research and Development Expenses. Research and development expenses for the quarter ended
Research and Development expenses are lower in 2022 compared to 2021 primarily attributed to reduced clinical trial costs as a result of the completion of the CLASSICAL-Lung and SIGNAL studies, partially offset by setup expenses for the KEYNOTE B84 and SIGNAL-AD studies as well as a large production run of pepinemab completed in Q1:21.
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 in light of inflationary pressures.
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-Q filed
- Shafique MR,
Fisher TL, Evans EE, Leonard JEE, Pastore DRE, Mallow CL, Smith E, Mishra V, Schroder A, Chin KA, Beck JT, Baumgart MA, Govindan R, Gabrial NY, Spira AI, Seetharamu N, Lou Y, Mansfield AS, Sanborn RE, Goldman JW, Zauderer M. A Phase Ib/2 Study of Pepinemab in Combination with Avelumab in Advanced Non–Small Cell Lung Cancer. Clin Cancer Res2021, doi: 10.1158/1078-0432.CCR-20-4792
- Clavijo PE, Friedman J, Robbins Y, Moore EC, Smith ES, Zauderer M, Evans EE, Allen CT. Semaphorin4D inhibition improves response to immune checkpoint blockade via attenuation of MDSC recruitment and function. Cancer Immunol Res. 2019 Feb;7(2):282-291
- Evans EE, Jonason AS Jr, Bussler H, Torno S, Veeraraghavan J, Reilly C, Doherty MA, Seils J, Winter LA, Mallow C, Kirk R, Howell A, Giralico S, Scrivens M, Klimatcheva K, Fisher TL, Bowers WJ, Paris M, Smith ES, Zauderer M. Antibody blockade of semaphorin 4D promotes immune infiltration into tumor and enhances response to other immunomodulatory therapies. Cancer Immunol Res. 2015 Jun;3(6): 689-701. http://www.ncbi.nlm.nih.gov/pubmed/25614511
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 cell interactions in the brain. Preclinical and clinical data show that pepinemab promotes infiltration/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.
Pepinemab is being evaluated in studies in oncology and neurodegenerative disease. In oncology, pepinemab is being evaluated in the Phase 1b/2 open label KEYNOTE-B84 study, in combination with KEYTRUDA (pembrolizumab), in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNCC). In neurodegenerative disease, pepinemab is being evaluated in a Phase 1/2a randomized, double-blinded, placebo-controlled trial in people with early Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease.
The company has also developed a proprietary drug discovery platform, ActivMAb, that it intends to use to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels.
Forward Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|Cash and cash equivalents||$||16,803||$||8,589|
|Prepaid expenses and other current assets||963||816|
|Total current assets||17,766||9,405|
|Property and equipment, net||256||297|
|Operating lease right-of-use asset||99||141|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Senior secured convertible debt, net||-||-|
|Current portion of long-term debt||74||74|
|Operating lease right-of-use liability||99||141|
|Total current liabilities||1,777||2,256|
|Commitments and contingencies (Note 7)|
|Stockholders’ equity (deficit):|
|Common stock, par value of
shares issued as of
42,664,051 and 30,801,110 shares outstanding as of
|Additional paid-in capital||320,651||307,281|
|TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)||16,188||7,412|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||18,121||$||9,843|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
|Three Months Ended
|Costs and expenses:|
|Cost of revenue||-||-|
|Research and development||2,966||5,513|
|General and administrative||1,628||1,577|
|Total costs and expenses||4,594||7,090|
|Loss from operations||(4,594||)||(6,240||)|
|Gain on forgiveness of PPP loan||-||-|
|Other income (expense), net||(0||)||(2||)|
|Loss before provision for income taxes||(4,595||)||(6,574||)|
|Provision for income taxes||-||-|
|Net loss attributable to noncontrolling interests||-||-|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares used in computing net loss per share attributable to Vaccinex, Inc. common stockholders, basic and diluted||38,758,283||25,216,788|
The accompanying notes are an integral part of these condensed consolidated financial statements.
Source: Vaccinex, Inc.