UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): March 18, 2019
Vaccinex, Inc.
(Exact name of Registrant as specified in its charter)
| Delaware | 001-38624 | 16-1603202 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 1895 Mount Hope Avenue, Rochester, New York | 14620 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (585) 271-2700
N/A
(Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
On March 18, 2019, Vaccinex, Inc. (the “Company”) updated the corporate presentation available on its website located at www.vaccinex.com under the heading “Investors” and subheading “Events & Presentations.” A copy of the Company’s updated corporate presentation is attached to this Current Report on Form 8-K (the “Report”) as Exhibit 99.1.
The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities under such section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | March 18, 2019 corporate presentation of Vaccinex, Inc. | |
Neither the filing of any exhibit to this Report nor the inclusion in such exhibit or this Report of a reference to the Company’s Internet address shall, under any circumstances, be deemed to incorporate the information available at such address into this Report. The information available at the Company’s Internet address is not part of this Report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
| Vaccinex, Inc. | ||||
| Date: March 18, 2019 | By: | /s/ Scott E. Royer | ||
| Scott E. Royer | ||||
| Chief Financial Officer | ||||
Exhibit 99.1 Science in the Service of Medicine Unique Targets. Novel Mechanisms. New Medicines. VX15 (pepinemab) Antibody Treatment for Cancer and Huntington’s Disease 1Exhibit 99.1 Science in the Service of Medicine Unique Targets. Novel Mechanisms. New Medicines. VX15 (pepinemab) Antibody Treatment for Cancer and Huntington’s Disease 1
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. 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 presentation 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 presentation 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 presentation 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. 2 March 2019 I 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. 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 presentation 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 presentation 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 presentation 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. 2 March 2019 I
Investment Summary Novel mechanistic Lead program, VX15 (pepinemab), is a humanized monoclonal antibody that binds to and blocks a unique target, Semaphorin 4D (SEMA4D) approach • Huntington’s Disease – fully enrolled ongoing randomized, placebo-controlled, potentially pivotal trial • Encouraging early signs of efficacy from Cohort A Multiple clinical programs • Granted Orphan Drug and Fast Track designations in Huntington’s Disease • NSCLC – ongoing open-label Phase 1/2 in combination with avelumab (with Merck KGaA) anticipate completing enrollment in May 2019 and Oncology • Melanoma – ongoing open-label Phase 1/2 in combination with nivolumab and with ipilimumab (with Ribas Group at UCLA and with BMS) • Sustainable engine for value creation Proprietary mAb selection platform • Collaboration opportunities (Surface Oncology and others) 3 March 2019 I Investment Summary Novel mechanistic Lead program, VX15 (pepinemab), is a humanized monoclonal antibody that binds to and blocks a unique target, Semaphorin 4D (SEMA4D) approach • Huntington’s Disease – fully enrolled ongoing randomized, placebo-controlled, potentially pivotal trial • Encouraging early signs of efficacy from Cohort A Multiple clinical programs • Granted Orphan Drug and Fast Track designations in Huntington’s Disease • NSCLC – ongoing open-label Phase 1/2 in combination with avelumab (with Merck KGaA) anticipate completing enrollment in May 2019 and Oncology • Melanoma – ongoing open-label Phase 1/2 in combination with nivolumab and with ipilimumab (with Ribas Group at UCLA and with BMS) • Sustainable engine for value creation Proprietary mAb selection platform • Collaboration opportunities (Surface Oncology and others) 3 March 2019 I
Vaccinex Product Pipeline Research/Preclinical Phase 1 Phase 2 Phase 3 SEMA4D Antibody Platform VX15 (pepinemab) Huntington’s Disease (Orphan Disease and Fast Track Designation) CLASSICAL – Lung VX15 (pepinemab) Non-Small Cell Lung Cancer (with Merck KGaA) (with BMS and UCLA) VX15 (pepinemab) Melanoma (with Children’s Oncology Group VX15 (pepinemab) Osteosarcoma and National Cancer Institute) ActivMAb Antibody Platform VX5 Anti-CXCL13 for Autoimmune Diseases 4 March 2019 I Vaccinex Product Pipeline Research/Preclinical Phase 1 Phase 2 Phase 3 SEMA4D Antibody Platform VX15 (pepinemab) Huntington’s Disease (Orphan Disease and Fast Track Designation) CLASSICAL – Lung VX15 (pepinemab) Non-Small Cell Lung Cancer (with Merck KGaA) (with BMS and UCLA) VX15 (pepinemab) Melanoma (with Children’s Oncology Group VX15 (pepinemab) Osteosarcoma and National Cancer Institute) ActivMAb Antibody Platform VX5 Anti-CXCL13 for Autoimmune Diseases 4 March 2019 I
Introduction to Semaphorin 4D (SEMA4D) SEMA4D signals through PLXNB1 and PLXNB2 receptors SEMA4D to regulate the cell cytoskeleton Crosslinking and signaling PLXNB1/ PLXNB2 VX15 (pepinemab) antibody binds to SEMA4D and blocks its signaling activity R-Ras, RhoA and ROCK-kinase Cytoskeletal reorganization, migration and differentiation 5 March 2019 I Introduction to Semaphorin 4D (SEMA4D) SEMA4D signals through PLXNB1 and PLXNB2 receptors SEMA4D to regulate the cell cytoskeleton Crosslinking and signaling PLXNB1/ PLXNB2 VX15 (pepinemab) antibody binds to SEMA4D and blocks its signaling activity R-Ras, RhoA and ROCK-kinase Cytoskeletal reorganization, migration and differentiation 5 March 2019 I
VX15 (pepinemab) Anti-SEMA4D Antibody for CancerVX15 (pepinemab) Anti-SEMA4D Antibody for Cancer
SEMA4D Expression is Concentrated at Invasive Margin of Tumor Colorectal (Colon26) Mammary carcinoma (Tubo.A5) SEMA4D Pseudo color SEMA4D at the Antibodies against invasive margin of the SEMA4D neutralize tumor forms a barrier this barrier and “open that restricts the the gates” of the tumor infiltration of anti-tumor to the immune system immune cells 7 March 2019 I SEMA4D Expression is Concentrated at Invasive Margin of Tumor Colorectal (Colon26) Mammary carcinoma (Tubo.A5) SEMA4D Pseudo color SEMA4D at the Antibodies against invasive margin of the SEMA4D neutralize tumor forms a barrier this barrier and “open that restricts the the gates” of the tumor infiltration of anti-tumor to the immune system immune cells 7 March 2019 I
SEMA4D Controls Infiltration of Antigen Presenting Dendritic Cells into Tumor Antigen Presenting Cells (APC) • Dendritic cells (DC) express PLXNB1 receptor for SEMA4D. Control • Binding of SEMA4D immobilizes DC and restricts penetration into tumor. • Antibody blockade of SEMA4D enhances CD11c F4/80 migration and differentiation of DC within tumor • Colon26 tumor bearing mice were treated with control antibody or with anti-SEMA4D αSema4D • Tumors were harvested 27 days post inoculation and Antibody stained for CD11c marker of DC lineage or F4/80 marker of macrophage lineage 8 March 2019 I Evans EE et al. Cancer Immunol Research 2015;3(6): 689-701SEMA4D Controls Infiltration of Antigen Presenting Dendritic Cells into Tumor Antigen Presenting Cells (APC) • Dendritic cells (DC) express PLXNB1 receptor for SEMA4D. Control • Binding of SEMA4D immobilizes DC and restricts penetration into tumor. • Antibody blockade of SEMA4D enhances CD11c F4/80 migration and differentiation of DC within tumor • Colon26 tumor bearing mice were treated with control antibody or with anti-SEMA4D αSema4D • Tumors were harvested 27 days post inoculation and Antibody stained for CD11c marker of DC lineage or F4/80 marker of macrophage lineage 8 March 2019 I Evans EE et al. Cancer Immunol Research 2015;3(6): 689-701
Anti-SEMA4D Antibody Increases Cytotoxic T Cells in Tumor T cell exclusion in Colon26 tumor Stroma Tumor Stroma Tumor Control group Anti-SEMA4D antibody CD8+ T cells (red) do not penetrate the tumor. Most CD8+ CD8+ T cells infiltrate the interior of the tumor cells are within the stroma and vessels 9 March 2019 I Anti-SEMA4D Antibody Increases Cytotoxic T Cells in Tumor T cell exclusion in Colon26 tumor Stroma Tumor Stroma Tumor Control group Anti-SEMA4D antibody CD8+ T cells (red) do not penetrate the tumor. Most CD8+ CD8+ T cells infiltrate the interior of the tumor cells are within the stroma and vessels 9 March 2019 I
Anti-SEMA4D treatment shifts the balance of cytokines and chemokines in the tumor microenvironment CCL2/ 10 March 2019 I Immunosuppressive Factors Tumoricidal FactorsAnti-SEMA4D treatment shifts the balance of cytokines and chemokines in the tumor microenvironment CCL2/ 10 March 2019 I Immunosuppressive Factors Tumoricidal Factors
Anti-SEMA4D Antibody Enhances Activity of Immune Checkpoint Inhibitors Anti-CTLA-4 Anti-LAG3 Combination with anti-SEMA4D Head & Neck Cancer Colorectal Cancer Colorectal Cancer Colon26 Control Control αSEMA4D αCTLA-4 αSEMA4D αSEMA4D + αLAG3 αCTLA-4 αLAG3+αSEMA4D 11 March 2019 I Anti-SEMA4D Antibody Enhances Activity of Immune Checkpoint Inhibitors Anti-CTLA-4 Anti-LAG3 Combination with anti-SEMA4D Head & Neck Cancer Colorectal Cancer Colorectal Cancer Colon26 Control Control αSEMA4D αCTLA-4 αSEMA4D αSEMA4D + αLAG3 αCTLA-4 αLAG3+αSEMA4D 11 March 2019 I
T cell infiltration into tumor bed Neoadjuvant therapy: Colorectal cancer metastasis to liver No treatment Pepinemab Pepinemab + Ipilimumab T cells penetrate into the tumor bed and. . T cells are trapped at margin and are Tumor content is reduced and appears to The tumor bed consists mainly of stroma largely excluded from tumor bed be replaced by stroma. and necrotic areas. Normal liver Tumor Bed Necrotic 12 CD8+ T cells March 2019 I Margin of tumor bed Tumor nodulesT cell infiltration into tumor bed Neoadjuvant therapy: Colorectal cancer metastasis to liver No treatment Pepinemab Pepinemab + Ipilimumab T cells penetrate into the tumor bed and. . T cells are trapped at margin and are Tumor content is reduced and appears to The tumor bed consists mainly of stroma largely excluded from tumor bed be replaced by stroma. and necrotic areas. Normal liver Tumor Bed Necrotic 12 CD8+ T cells March 2019 I Margin of tumor bed Tumor nodules
Phase 1b/2 Combination Trial with Avelumab in NSCLC VX15/2503 (pepinemab) in combination with avelumab (Anti-PD-L1) DOSE ESCALATION PHASE EXPANSION PHASE NSCLC To determine the recommended Phase 2 Patients will be stratified but unselected for immunotherapy naïve dose of VX15 (pepinemab) PD-L1; pre- and post-treatment biopsies in combination with avelumab mandatory Up to 28 patients at recommended dose NSCLC Progressed following immunotherapy COMPLETED IN PROGRESS • Study to enroll up to ~62 subjects with advanced NSCLC Co-funded by: Trial to evaluate immune infiltration in tumor biopsies and ORR, DoR, PFS Open-label design allows for periodic data updates 13 March 2019 I Phase 1b/2 Combination Trial with Avelumab in NSCLC VX15/2503 (pepinemab) in combination with avelumab (Anti-PD-L1) DOSE ESCALATION PHASE EXPANSION PHASE NSCLC To determine the recommended Phase 2 Patients will be stratified but unselected for immunotherapy naïve dose of VX15 (pepinemab) PD-L1; pre- and post-treatment biopsies in combination with avelumab mandatory Up to 28 patients at recommended dose NSCLC Progressed following immunotherapy COMPLETED IN PROGRESS • Study to enroll up to ~62 subjects with advanced NSCLC Co-funded by: Trial to evaluate immune infiltration in tumor biopsies and ORR, DoR, PFS Open-label design allows for periodic data updates 13 March 2019 I
T :T Ratio effector regulatory CLASSICAL-Lung: Pepinemab+Avelumab Pre-treatment • Pre-treatment tissue shows infiltrating malignant cells • Post-treatment biopsy demonstrates reactive alveolar Post-treatment parenchyma and inflammation. No evidence of tumor. Post-treatment 14 + + March 2019 I CD8 T FoxP3 T Tumor effector regulatoryT :T Ratio effector regulatory CLASSICAL-Lung: Pepinemab+Avelumab Pre-treatment • Pre-treatment tissue shows infiltrating malignant cells • Post-treatment biopsy demonstrates reactive alveolar Post-treatment parenchyma and inflammation. No evidence of tumor. Post-treatment 14 + + March 2019 I CD8 T FoxP3 T Tumor effector regulatory
Combination Melanoma Trial with Nivolumab and with Ipilimumab VX15/2503 (pepine mab) combination with nivolumab (Anti-PD-1) or ipilimumab (Anti-CTLA-4) VX15/2503 (pepinemab) DOSE ESCALATION PHASE + nivolumab VX15 (pepinemab) dose will be escalated from 10 to 20 mg/kg, Q4W, with nivolumab EXPANSION PHASE at 480 mg Q4W VX15/2503 (pepinemab) or 18 patients/cohort + ipilimumab up to 20 mg/kg VX15 (pepinemab) Q3W pre- and post-treatment biopsies mandatory with ipilimumab 3 mg/kg Q3W x4 Collaboration with Antoni Ribas group at UCLA and with BMS providing nivolumab in groups of 3-6 patients and ipilimumab IN PROGRESS • Randomized Phase 1 study to enroll up to 60 patients with advanced (stage III or IV) melanoma who have progressed on anti-PD1/L1 based checkpoint inhibitors • Trial to evaluate immune infiltration in tumor biopsies, ORR, DoR and PFS Open-label design allows for periodic data updates 15 March 2019 I Combination Melanoma Trial with Nivolumab and with Ipilimumab VX15/2503 (pepine mab) combination with nivolumab (Anti-PD-1) or ipilimumab (Anti-CTLA-4) VX15/2503 (pepinemab) DOSE ESCALATION PHASE + nivolumab VX15 (pepinemab) dose will be escalated from 10 to 20 mg/kg, Q4W, with nivolumab EXPANSION PHASE at 480 mg Q4W VX15/2503 (pepinemab) or 18 patients/cohort + ipilimumab up to 20 mg/kg VX15 (pepinemab) Q3W pre- and post-treatment biopsies mandatory with ipilimumab 3 mg/kg Q3W x4 Collaboration with Antoni Ribas group at UCLA and with BMS providing nivolumab in groups of 3-6 patients and ipilimumab IN PROGRESS • Randomized Phase 1 study to enroll up to 60 patients with advanced (stage III or IV) melanoma who have progressed on anti-PD1/L1 based checkpoint inhibitors • Trial to evaluate immune infiltration in tumor biopsies, ORR, DoR and PFS Open-label design allows for periodic data updates 15 March 2019 I
VX15 (pepinemab)/Anti-Semaphorin 4D for Huntington's DiseaseVX15 (pepinemab)/Anti-Semaphorin 4D for Huntington's Disease
Huntington’s Disease (HD) HD is an autosomal dominant neurodegenerative disease caused by mutation in a single gene • Neuronal degeneration and severe atrophy is observed in multiple brain regions • Symptoms usually appear between the ages of 30 to 50 Estimated patient population ~30,000 manifest disease and 100,000 pre-manifest with inherited mutation (prodromal) in the U.S. Similar number in EU 5 There are currently no approved treatments to alter the course of HD 17 March 2019 I Huntington’s Disease (HD) HD is an autosomal dominant neurodegenerative disease caused by mutation in a single gene • Neuronal degeneration and severe atrophy is observed in multiple brain regions • Symptoms usually appear between the ages of 30 to 50 Estimated patient population ~30,000 manifest disease and 100,000 pre-manifest with inherited mutation (prodromal) in the U.S. Similar number in EU 5 There are currently no approved treatments to alter the course of HD 17 March 2019 I
Astrocytes reach out to touch and interact with other brain cells Astrocyte “arms” provide essential functional support to neurons. • Fully cover capillaries and facilitate glucose uptake from circulation • Cradle synapses and recycle glutamate • Positioned to couple energy metabolism with neuronal activity 18 March 2019 I Astrocytes reach out to touch and interact with other brain cells Astrocyte “arms” provide essential functional support to neurons. • Fully cover capillaries and facilitate glucose uptake from circulation • Cradle synapses and recycle glutamate • Positioned to couple energy metabolism with neuronal activity 18 March 2019 I
Astrocytes Undergo Inflammatory Transformation that Aggravates Brain Damage in HD • CNS damage triggers a dramatic change in astrocyte morphology and function • Shift from direct contact with other cells to secretion of inflammatory mediators • this is beneficial in the context of acute focal injury such as stroke • but becomes maladaptive in broad chronic injury such as that caused by mHTT aggregates in HD 19 March 2019 I Astrocytes Undergo Inflammatory Transformation that Aggravates Brain Damage in HD • CNS damage triggers a dramatic change in astrocyte morphology and function • Shift from direct contact with other cells to secretion of inflammatory mediators • this is beneficial in the context of acute focal injury such as stroke • but becomes maladaptive in broad chronic injury such as that caused by mHTT aggregates in HD 19 March 2019 I
Astrocytes Undergo Inflammatory Transformation that Aggravates Brain Damage in HD • How do astrocytes recognize and respond to damage? • Astrocytes express high levels of receptors for SEMA4D • SEMA4D is upregulated at site of injury • SEMA4D triggers depolymerization of F-actin associated with transformation of astrocytes from normal to inflammatory state Hypothesis: blocking F-actin depolymerization will reduce inflammatory transformation and increase glucose uptake 20 March 2019 I Astrocytes Undergo Inflammatory Transformation that Aggravates Brain Damage in HD • How do astrocytes recognize and respond to damage? • Astrocytes express high levels of receptors for SEMA4D • SEMA4D is upregulated at site of injury • SEMA4D triggers depolymerization of F-actin associated with transformation of astrocytes from normal to inflammatory state Hypothesis: blocking F-actin depolymerization will reduce inflammatory transformation and increase glucose uptake 20 March 2019 I
SEMA4D Inhibits Cell Migration and Process Extension A B F-actin Normal Control rSEMA4D Untreated rSEMA4D C PlexinB1 DAPI PHALLOIDIN DAPI PHALLOIDIN DAPI 21 March 2019 I Mean phalloidin area/cellSEMA4D Inhibits Cell Migration and Process Extension A B F-actin Normal Control rSEMA4D Untreated rSEMA4D C PlexinB1 DAPI PHALLOIDIN DAPI PHALLOIDIN DAPI 21 March 2019 I Mean phalloidin area/cell
Clinical Trial: FDG-PET Treatment Effect - Mean Change Over 6 Months FDG PET V(7-0)-P(7-0) FDG PET V(7-0)-P(7-0) A B % Change VX15 vs Placebo: REGION AVEs Difference in LS Means: Region AVEs CAUDAL MIDDLE FRONTAL CAUDAL MIDDLE FRONTAL PARSORBITALIS POSTCENTRAL PRECENTRAL PRECENTRAL ROSTRAL MIDDLE FRONTAL PARSORBITALIS POSTCENTRAL ROSTRAL MIDDLE FRONTAL PARSOPERCULARIS SUPRAMARGINAL SUPRAMARGINAL PARACENTRAL PARSTRIANGULARIS PARSOPERCULARIS PARACENTRAL PARSTRIANGULARIS POSTERIOR CINGULATE POSTERIOR CINGULATE TRANSVERSE TEMPORAL CAUDAL ANTERIOR CINGULATE CAUDAL ANTERIOR CINGULATE MEDIAL ORBITO FRONTAL PRECUNEUS TRANSVERSE TEMPORAL MEDIAL ORBITO FRONTAL ROSTRAL ANTERIOR CINGULATE LINGUAL PRECUNEUS SUPERIOR FRONTAL LINGUAL ROSTRAL ANTERIOR CINGULATE SUPERIOR FRONTAL LATERAL OCCIPITAL LATERAL OCCIPITAL MIDDLE TEMPORAL SUPERIOR TEMPORAL SUPERIOR PARIETAL SUPERIOR PARIETAL INFERIOR PARIETAL MIDDLE TEMPORAL SUPERIOR TEMPORAL INFERIOR PARIETAL PERICALCARINE INFERIOR TEMPORAL CUNEUS PERICALCARINE INFERIOR TEMPORAL CUNEUS PUTAMEN PUTAMEN PALLIDUM HIPPOCAMPUS HIPPOCAMPUS PALLIDUM AMYGDALA CAUDATE CAUDATE AMYGDALA THALAMUS THALAMUS -0.5 -0.3 -0.1 0.1 0.3 0.5 -30 -20 -10 0 10 20 30 FAVORS PLACEBO FAVORS VX15 FAVORS VX15 FAVORS PLACEBO Effect Size (difference in LS means) 22 % Change in FDG PET (VX15 vs Placebo) March 2019 I 22Clinical Trial: FDG-PET Treatment Effect - Mean Change Over 6 Months FDG PET V(7-0)-P(7-0) FDG PET V(7-0)-P(7-0) A B % Change VX15 vs Placebo: REGION AVEs Difference in LS Means: Region AVEs CAUDAL MIDDLE FRONTAL CAUDAL MIDDLE FRONTAL PARSORBITALIS POSTCENTRAL PRECENTRAL PRECENTRAL ROSTRAL MIDDLE FRONTAL PARSORBITALIS POSTCENTRAL ROSTRAL MIDDLE FRONTAL PARSOPERCULARIS SUPRAMARGINAL SUPRAMARGINAL PARACENTRAL PARSTRIANGULARIS PARSOPERCULARIS PARACENTRAL PARSTRIANGULARIS POSTERIOR CINGULATE POSTERIOR CINGULATE TRANSVERSE TEMPORAL CAUDAL ANTERIOR CINGULATE CAUDAL ANTERIOR CINGULATE MEDIAL ORBITO FRONTAL PRECUNEUS TRANSVERSE TEMPORAL MEDIAL ORBITO FRONTAL ROSTRAL ANTERIOR CINGULATE LINGUAL PRECUNEUS SUPERIOR FRONTAL LINGUAL ROSTRAL ANTERIOR CINGULATE SUPERIOR FRONTAL LATERAL OCCIPITAL LATERAL OCCIPITAL MIDDLE TEMPORAL SUPERIOR TEMPORAL SUPERIOR PARIETAL SUPERIOR PARIETAL INFERIOR PARIETAL MIDDLE TEMPORAL SUPERIOR TEMPORAL INFERIOR PARIETAL PERICALCARINE INFERIOR TEMPORAL CUNEUS PERICALCARINE INFERIOR TEMPORAL CUNEUS PUTAMEN PUTAMEN PALLIDUM HIPPOCAMPUS HIPPOCAMPUS PALLIDUM AMYGDALA CAUDATE CAUDATE AMYGDALA THALAMUS THALAMUS -0.5 -0.3 -0.1 0.1 0.3 0.5 -30 -20 -10 0 10 20 30 FAVORS PLACEBO FAVORS VX15 FAVORS VX15 FAVORS PLACEBO Effect Size (difference in LS means) 22 % Change in FDG PET (VX15 vs Placebo) March 2019 I 22
SIGNAL Cohort A Data Highlights VX15 (pepinemab) treatment significantly increases metabolic activity as detected by FDG-PET: • Previous studies in Alzheimer’s Disease concluded that glucose metabolism is a sensitive measure of change in cognition and functional ability and has value in predicting future cognitive decline or as an outcome measurement for monitoring clinically-relevant change over time*. • Encouraging treatment effects on preservation of brain matter (reduced atrophy) and improvement in multiple motor and cognitive assessments were also seen in Cohort A No concerning safety signals were identified 23 March 2019 I * Landau et. al., Neurobiol Aging. 2011; 32(7): 1207–1218SIGNAL Cohort A Data Highlights VX15 (pepinemab) treatment significantly increases metabolic activity as detected by FDG-PET: • Previous studies in Alzheimer’s Disease concluded that glucose metabolism is a sensitive measure of change in cognition and functional ability and has value in predicting future cognitive decline or as an outcome measurement for monitoring clinically-relevant change over time*. • Encouraging treatment effects on preservation of brain matter (reduced atrophy) and improvement in multiple motor and cognitive assessments were also seen in Cohort A No concerning safety signals were identified 23 March 2019 I * Landau et. al., Neurobiol Aging. 2011; 32(7): 1207–1218
Huntington’s Disease Clinical Trial Design: Cohort B Double- blind Database lock and 179 early manifest subjects Cohort B treatment with analysis for 1 month randomized 1:1 Drug:Placebo VX15 Group 1 safety Cohort B (pepinemab) follow-up 18 months 2020 Double- blind Database lock and Cohort B 86 late prodromal subjects treatment with analysis for 1 month randomized 1:1 Drug:Placebo Group 2 VX15 safety Cohort B (pepinemab) follow-up 18 or 36 months 2020 Enrollment in Cohort B expected to be completed by December 31, 2018 Last patient last visit anticipated around July, 2020 24 March 2019 I Program granted Orphan Drug and Fast Track Designation by the FDA Division of Neurology ProductsHuntington’s Disease Clinical Trial Design: Cohort B Double- blind Database lock and 179 early manifest subjects Cohort B treatment with analysis for 1 month randomized 1:1 Drug:Placebo VX15 Group 1 safety Cohort B (pepinemab) follow-up 18 months 2020 Double- blind Database lock and Cohort B 86 late prodromal subjects treatment with analysis for 1 month randomized 1:1 Drug:Placebo Group 2 VX15 safety Cohort B (pepinemab) follow-up 18 or 36 months 2020 Enrollment in Cohort B expected to be completed by December 31, 2018 Last patient last visit anticipated around July, 2020 24 March 2019 I Program granted Orphan Drug and Fast Track Designation by the FDA Division of Neurology Products
Antibody Selection to Multi-Pass Membrane ReceptorsAntibody Selection to Multi-Pass Membrane Receptors
® ActivMAb Viral envelope expression technology to display multi- pass membrane receptors so as to enable antibody selection against this important class of pharmaceutical targets® ActivMAb Viral envelope expression technology to display multi- pass membrane receptors so as to enable antibody selection against this important class of pharmaceutical targets
Research Collaboration with • Announced January 2018 • Utilizes Vaccinex’s ActivMAb platform to discover and select monoclonal antibodies to two undisclosed membrane targets • Surface Oncology has the option to obtain exclusive worldwide rights to antibodies discovered during the research program • Vaccinex received an upfront payment and ongoing research funding • Vaccinex also entitled to license fees, development and clinical milestones, and royalties from net sales of products developed from the licensed antibodies 27 March 2019 I Research Collaboration with • Announced January 2018 • Utilizes Vaccinex’s ActivMAb platform to discover and select monoclonal antibodies to two undisclosed membrane targets • Surface Oncology has the option to obtain exclusive worldwide rights to antibodies discovered during the research program • Vaccinex received an upfront payment and ongoing research funding • Vaccinex also entitled to license fees, development and clinical milestones, and royalties from net sales of products developed from the licensed antibodies 27 March 2019 I
Robust Patent Estate VX15 (pepinemab) US Patents and Patent Applications US No. 8,496,938 issued 7/30/13) Key Composition of Matter Claims Expected Exclusivity to 2030 (before patent term extension) US No. 9,243,9068 issued 1/26/16 Key Additional Method of Use US No. 9,249,227 issued 2/2/16 Claims for Treatment of Cancer and Filed: 2014 – 2015 Neurodegenerative Diseases Expected Exclusivity to 2035 (before patent term extension) Total Patent Franchise US EU Granted / allowed 26 11 Pending 15 13 28 March 2019 I Robust Patent Estate VX15 (pepinemab) US Patents and Patent Applications US No. 8,496,938 issued 7/30/13) Key Composition of Matter Claims Expected Exclusivity to 2030 (before patent term extension) US No. 9,243,9068 issued 1/26/16 Key Additional Method of Use US No. 9,249,227 issued 2/2/16 Claims for Treatment of Cancer and Filed: 2014 – 2015 Neurodegenerative Diseases Expected Exclusivity to 2035 (before patent term extension) Total Patent Franchise US EU Granted / allowed 26 11 Pending 15 13 28 March 2019 I
Anticipated Milestones Event Timing Antibody Platform: Expected delivery of selected antibodies to Surface Oncology Q4 2018 Publish SIGNAL Cohort A Data in Huntington’s Disease H2 2019 ASCO 2019, Anticipated Initial Report of Open Label combination study of VX15 June 2019 (pepinemab) with avelumab in NSCLC Estimated Primary Completion Date* of combination study in NSCLC Q4 2019 Estimated Primary Completion Date* of SIGNAL Cohort B study in HD Q3 2020 Estimated Primary Completion Date* of combination study in Melanoma H2 2020 * 29 March 2019 I The primary completion date is the date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure Anticipated Milestones Event Timing Antibody Platform: Expected delivery of selected antibodies to Surface Oncology Q4 2018 Publish SIGNAL Cohort A Data in Huntington’s Disease H2 2019 ASCO 2019, Anticipated Initial Report of Open Label combination study of VX15 June 2019 (pepinemab) with avelumab in NSCLC Estimated Primary Completion Date* of combination study in NSCLC Q4 2019 Estimated Primary Completion Date* of SIGNAL Cohort B study in HD Q3 2020 Estimated Primary Completion Date* of combination study in Melanoma H2 2020 * 29 March 2019 I The primary completion date is the date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure
Vaccinex Corporation Clinical-stage immunotherapy company focused on the discovery and development of antibody therapies for neurodegenerative diseases and cancer VCNX (NASDAQ) Recent close $5.00 (2/8/2019) Shares outstanding 11.5M Market cap $57.5M Headquarters Rochester, NY Employees 44 (34 in R&D) IPO August 2018 Proceeds: Gross/Net $40M/$35M Underwriters Oppenheimer, BTIG, Ladenburg 30 March 2019 I Vaccinex Corporation Clinical-stage immunotherapy company focused on the discovery and development of antibody therapies for neurodegenerative diseases and cancer VCNX (NASDAQ) Recent close $5.00 (2/8/2019) Shares outstanding 11.5M Market cap $57.5M Headquarters Rochester, NY Employees 44 (34 in R&D) IPO August 2018 Proceeds: Gross/Net $40M/$35M Underwriters Oppenheimer, BTIG, Ladenburg 30 March 2019 I
Executive Management Team Maurice Zauderer, Ph.D. Formerly Professor at University of Founder, President & Chief Executive Officer Rochester and at Columbia University. Scott E. Royer, CFA, MBA Formerly CFO, Medical Films Division Chief Financial Officer of Carestream Health. John E. Leonard, Ph.D. Formerly VP Product Development at SVP Development & Officer IDEC and Biogen-IDEC. John Parker, Ph.D. Formerly Senior VP for RA/QA in VP, Regulatory Affairs & Quality Systems several assurance/compliance roles. Ernest S. Smith, Ph.D. Formerly Research Scientist at SVP Research & Chief Scientific Officer University of Rochester. Formerly Director of Operations, Raymond E. Watkins Australasia at Life Technologies SVP & Chief Operating Officer (Invitrogen). 31 March 2019 I Executive Management Team Maurice Zauderer, Ph.D. Formerly Professor at University of Founder, President & Chief Executive Officer Rochester and at Columbia University. Scott E. Royer, CFA, MBA Formerly CFO, Medical Films Division Chief Financial Officer of Carestream Health. John E. Leonard, Ph.D. Formerly VP Product Development at SVP Development & Officer IDEC and Biogen-IDEC. John Parker, Ph.D. Formerly Senior VP for RA/QA in VP, Regulatory Affairs & Quality Systems several assurance/compliance roles. Ernest S. Smith, Ph.D. Formerly Research Scientist at SVP Research & Chief Scientific Officer University of Rochester. Formerly Director of Operations, Raymond E. Watkins Australasia at Life Technologies SVP & Chief Operating Officer (Invitrogen). 31 March 2019 I
Vaccinex Board of Directors Chairman, President and CEO of Friedberg Mercantile Group, a Toronto-based commodities and Albert D. Friedberg investment management firm he founded in 1971. He served as Chairman of the Toronto Futures Exchange from March 1985 to June 1988. Alejandro M. Berlin, M.D., MSc. Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto. Partner at Polaris Partners. Served as Founder and/or has played a significant role as CEO in Alan L. Crane building five Polaris companies, including Cerulean Pharma and Momenta. Prior to Polaris, Alan was Senior Vice President of Global Corporate Development at Millennium Pharmaceuticals. Jacob B. Frieberg Principal, The WTF Group. J. Jeffrey Goater CEO of Surface Oncology, Formerly, CFO of Voyager Therapeutics. Founder (or co-founder) of Quantum Dot Corporation, SurroMed, Biometric Imaging, Lumisys Inc., Bala S. Manian, Ph.D. Molecular Dynamics and, most recently, ReaMetrix. CFO of Colgate Rochester Crozer Divinity School. Formerly, Managing Partner at Gerald E. Van Strydonck PricewaterhouseCoopers. Barbara Yanni Formerly, Vice President and Chief Licensing Officer at Merck & Co., Inc. Vaccinex Founder, President and Chief Executive Officer. Formerly, Professor at University of Maurice Zauderer, Ph.D. Rochester and at Columbia University. 32 March 2019 I Vaccinex Board of Directors Chairman, President and CEO of Friedberg Mercantile Group, a Toronto-based commodities and Albert D. Friedberg investment management firm he founded in 1971. He served as Chairman of the Toronto Futures Exchange from March 1985 to June 1988. Alejandro M. Berlin, M.D., MSc. Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto. Partner at Polaris Partners. Served as Founder and/or has played a significant role as CEO in Alan L. Crane building five Polaris companies, including Cerulean Pharma and Momenta. Prior to Polaris, Alan was Senior Vice President of Global Corporate Development at Millennium Pharmaceuticals. Jacob B. Frieberg Principal, The WTF Group. J. Jeffrey Goater CEO of Surface Oncology, Formerly, CFO of Voyager Therapeutics. Founder (or co-founder) of Quantum Dot Corporation, SurroMed, Biometric Imaging, Lumisys Inc., Bala S. Manian, Ph.D. Molecular Dynamics and, most recently, ReaMetrix. CFO of Colgate Rochester Crozer Divinity School. Formerly, Managing Partner at Gerald E. Van Strydonck PricewaterhouseCoopers. Barbara Yanni Formerly, Vice President and Chief Licensing Officer at Merck & Co., Inc. Vaccinex Founder, President and Chief Executive Officer. Formerly, Professor at University of Maurice Zauderer, Ph.D. Rochester and at Columbia University. 32 March 2019 I