UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) | |||
(Registrant’s telephone number, including area code)
(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)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
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. |
Vaccinex, Inc. (the “Company”) will present at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 10:30 a.m. Eastern Time. A copy of the corporate presentation that will accompany the presentation is furnished to this Current Report on Form 8-K as Exhibit 99.1 and is available on the Company’s website located at www.vaccinex.com under the heading “Investors” and subheading “Presentations.”
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 1944, as amended, or the Exchange Act.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | June 2022 corporate presentation of Vaccinex, Inc. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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: June 10, 2022 | ||||||
| By: | /s/ Scott E. Royer | |||||
| Scott E. Royer | ||||||
| Chief Financial Officer | ||||||
KEYNOTE-B84 Study in HNSCC June 10, 2022 Pepinemab – Anti-SEMA4D Antibody for Cancer Immunotherapy Exhibit 99.1
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. Such statements include, but are not limited to, statements about the Company’s plans, expectations and objectives with respect to the results and timing of clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Head and Neck cancer, Huntington’s and Alzheimer’s disease and other indications, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “planned,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “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 the Company’s 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, the risks related to the Company’s dependence on its lead product candidate pepinemab, the ability to leverage its ActivMAb® platform, the impact of the COVID-19 pandemic, and other matters that could affect the Company’s development plans or the commercial potential of its product candidates. Except as required by law, the Company assumes 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 the Company’s 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.
WHY DOES IMMUNE RESPONSE FAIL IN TUMORS? Sema4D is expressed at tumor margin Sema4D binds PLXN receptors on DCs and restricts penetration T-cells are excluded from tumor Pro-inflammatory cells are excluded from tumor and build up at the invasive edge CD8 T cells align with Sema4D at the invasive edge of the tumor. Most of these excluded T-cells express Sema4D. Dendritic Cells express receptors for SEMA4D and are heavily excluded at the invasive edge. Human metastatic colorectal tumor, in collaboration with Emory University (NCT03373188) Immune Exclusion Activated T-cells and dendritic cells can’t penetrate tumor SEMA4D Tumor Tumor Dendritic Cells (CD11c) CD8+ CD4+ T Cells
UNIQUE MECHANISM No treatment Low CD8+ T cells High Tumor content and MDSC Pepinemab High CD8+ T cells Low tumor content and MDSC Biopsies from patients with metastatic MSS Colorectal Cancer Human metastatic colorectal tumor, in collaboration with Winship Cancer Institute, Emory University integrated biomarker study (NCT03373188), Wu et al. Ann Surg Oncol. 2021 ↑ cytotoxic T cells Myeloid Derived Suppressor Cells (MDSC) Tumor CD8+ T cells Pepinemab: 1 2 ↓ inhibitory suppressor cells
RATIONALE FOR TREATMENT OF HNSCC Head and Neck cancer (HNSCC) Data suggest that SEMA4D is strongly expressed in HNSCC & induces high levels of myeloid derived suppressor cells (MDSC) Relatively low (17-19%) response rate to immune checkpoint therapy in HNSCC NSCLC HNSCC MDSC Density NSCLC vs HNSCC Hypothesis: Inhibiting MDSC with pepinemab may enhance response to pembrolizumab in HNSCC Myeloid Derived Suppressor Cells (MDSC)
Topline Data Objective Response JUL 2021 JAN 2022 2H 2022 2H 2023 Interim Report ~midpoint of enrollment ~ November ‘22 Safety Period KEYNOTE B84 HEAD AND NECK CANCER TRIAL All patients receive standard of care Keytruda®, plus pepinemab for first- line treatment Ph1b Safety: COMPLETE Appeared to be well tolerated RP2D: 20mg/kg pepi and 200mg pembro, Q3W Ph2 Expansion: Accruing 17 of 18 sites in USA now actively enrolling Open-label, continuous monitoring Phase 1b Safety Review: Complete 2 CR observed KEYNOTE B84: pepinemab + Keytruda® for first-line treatment of recurrent or metastatic head and neck cancer Phase 1b: Safety Phase 2: Expansion Phase PD-L1 high (CPS ≥20) Total: up to 62 patients Total of 3 patients PD-L1 low/negative (CPS <20)
KEYNOTE-B84: Case studies to illustrate differences in positive response profiles Left Lung Right Lung Pre-treatment 9 weeks 15 weeks Adverse Events Pre-treatment 9 weeks 15 weeks Biomarkers PD-L1 CPS<20 HPV negative 19% decrease, SD 100% decrease, CR Confirmed, CR Now 42 Weeks week 5 week 9 week 15 week 21 NO malignancy PD-L1 CPS<1 HPV negative 100% decrease, CR Confirmed, CR Continued CR Now 27 Weeks NO malignancy PD-L1 CPS≥20 HPV negative 6% decrease, SD Not available Biopsy Scans none of notable severity Grade 1 rash Case Study # 1: CR (confirmed) Oropharyngeal cancer Target lesions: metastases to lung (Left 11mm, Right 15mm) Case Study # 2: CR (confirmed) Larynx cancer with direct invasion into thyroid and neck Target lesions: neck mass (37mm) Case Study # 4: PR (unconfirmed) Oropharyngeal cancer Target lesions: metastases to lung (Left 24 mm, Right 23 mm) Case Study # 1 Scans: Complete Response (confirmed) 72% decrease, PR Anticipated July ‘22 none of notable severity
Fresno, CA California Cancer Associates for Research and Excellence Steven Hager San Francisco, CA UCSF Medical Center at Mission Bay Alain Algazi Celebration, FL Advent Health Celebration George Simon Orlando, FL Advent Health Orlando Tarek Mekhail Canton, OH Gabrail Cancer Research Center Nashat Gabrail St Louis, MO Siteman Cancer Center - Washington University Medical Campus Douglas Adkins Atlanta, GA Emory Saint Joseph's Hospital Nabil Saba Conor Steuer Lake Success, NY Northwell Health - Centers for Advanced Medicine Nagashree Seetharamu Rochester, NY University of Rochester Megan Baumgart Pittsburgh, PA Allegheny General Hospital Larisa Greenberg New Haven, CT Yale Cancer Center Barbara Burtness Bethesda, MD American Oncology Partners of Maryland Mark Goldstein Fairfax, VA Virginia Cancer Specialists Alexander Spira Louisville, KY Norton Cancer Center Jaspreet Grewal Harvey, IL Primary Health Associates Mark Kozloff Springdale, AR Highlands Oncology Group Joseph Beck Asheville, NC Messino Cancer Centers Christopher Chay Baton Rouge, LA Hematology/Oncology Clinic Michael Castine KEYNOTE B84 Site Map Total of 18 sites planned
Pepinemab – Anti-SEMA4D Antibody for Huntington’s and Alzheimer’s Disease Unique Targets Novel Mechanisms New Medicines
SEMA4D IS UPREGULATED IN NEURONS DURING ALZHEIMER’S AND HUNTINGTON’S DISEASE PROGRESSION Human autopsy sections of frontal lobe Huntington’s Disease Normal Alzheimer’s Disease Human autopsy sections of frontal lobe Sema4D Neuron (HUC/HUD) Semaphorin 4D is upregulated in neurons of diseased brains and triggers astrocyte reactivity Elizabeth E Evans, Vikas Mishra, Crystal Mallow, Elaine Gersz, Leslie Balch, Alan Howell, Ernest S. Smith, Terrence L. Fisher, Maurice Zauderer* Journal of Neuroinflammation, 2022, In Press.
LS Mean Difference Estimate (95% CI) One-sided p-value Favors Pepinemab Critical value 0.13 (0.03, 0.23) 0.007 Yes Yes [0.025] HD-CAB Composite Index: Pre-specified Exploratory Two-item HD Cognitive Assessment: Pre-specified Co-Primary COGNITIVE ASSESSMENT BATTERY (HD-CAB) Co-Primary and pre-specified Exploratory analysis LS Mean Difference Estimate (95% CI) One-sided p-value Favors Pepinemab Critical value OTS: -1.98 (-4.00, 0.05) PTAP: 1.43 (-0.37, 3.23) 0.028 0.060 Yes No [0.025] LS Mean Difference Estimate (95% CI) One-sided p-value Favors Pepinemab Critical value SDMT: 0.62 (-1.35, 2.59) 0.27 Yes No EMO 0.37 (-0.55, 1.30) 0.22 Yes HVLT-R 0.44 (-1.59, 2.47) 0.34 Yes TMT-B -7.21 (-19.09, 4.66) 0.12 Yes HD-CAB Composite Index of 6 Cognitive Assessments Placebo Pepinemab Andrew Feigin et al. Nature Medicine, 2022, In Press.
COGNITIVE ASSESSMENT BATTERY (HD-CAB) Exploratory and Post-hoc analysis p=0.007 p=0.0025 pepinemab placebo pepinemab placebo prodromal early manifest Pepinemab antibody blockade of SEMA4D in early Huntington’s Disease: the randomized, placebo-controlled, phase 2 SIGNAL trial Andrew Feigin, Elizabeth E. Evans, Terrence L. Fisher, John E. Leonard, Ernest S. Smith, Alisha Reader, Vikas Mishra, Richard Manber, Kimberly A. Walters, Lisa Kowarski, David Oakes, Eric Siemers, Karl D. Kieburtz, Maurice Zauderer*, and the Huntington Study Group SIGNAL investigators Nature Medicine, 2022, In Press. “Learning effect” is lost when HD symptoms become manifest Pepinemab treatment restores the ability to benefit from experience (ie, to learn)
ALZHEIMER’S DISEASE Phase 1b/2 Trial Design n=20 placebo Monthly X12 months Safety Follow-up n=20 pepinemab Monthly 40 mg/kg X12 months Safety Follow-up 2H 2023 Data Safety Monitoring Board meeting - Complete, Feb 2022 Funding by Topline Data Randomized 1:1 Double-blind Phase 1b: Safety n=4 JUL 2021 1Q, 2022 Mild AD (CDR=0.5 or 1.0, MMSE 18-26) Topline Data: Safety and tolerability Cognitive Function measures CDR-SB, ADAS-Cog13, MMSE, CDRS Biomarker Outcomes Brain Volume (vMRI) Metabolic imaging (FDG-PET) 14 planned sites in US Phase 2: Expansion NCT04381468
San Diego, CA Pacific Research Network, Inc Stephen Thein Dixie Creager Signal-AD Site Map Delray Beach, FL Brain Matters Research Mark Brody Jennifer Blasi Stuart, FL Brain Matters Research-Satellite Site Mark Brody Jennifer Blasi Rochester, NY University of Rochester Anton Porsteinsson Asa Widman Fairway, KS University of Kansas Medical Center Research Institute Jeffrey Burns Sarah King Washington, DC Georgetown University Raymond Turner Jessica Mallory Fort Myers, FL Neuropsychiatric Research Center of Southwest Florida Wendy Bond Indianapolis, IN Indiana University SOM Martin Farlow Isabell Mwaura Lake Worth, FL JEM Research Institute Mark Goldstein Valerie Nevins New York, NY Columbia University Irving Medical Center Lawrence Honig Katrina Cuasay Fairfax, VA Re-Cognition Health R.Scott Turner Monica Bland Amherst, NY Dent Neurological Research Horacio Capote Shanita Jones West Palm Beach, FL Premiere Research Institute Palm Beach Neurology Paul Winner Ashley Poulette Lady Lake, FL Charter Research Alexander Smirnoff Jessica Sletten
Vaccinex, Inc. (Nasdaq: VCNX) is a publicly traded clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases with unmet medical needs, including cancer and neurodegenerative diseases. INCORPORATED 2001 HEADQUARTERS Rochester, NY EMPLOYEES 39 IPO NASDAQ VCNX August 2018 CAPITAL RAISE FEBRUARY 2021 $32.0, JANUARY 2022 $13.2 M CASH BALANCE* $16.8 M SHARES OUTSTANDING* 42.66 M ANALYSTS BTIG (T.Shrader) *as of 31MAR2022 $VCNX
Research/Preclinical Research/Preclinical Phase 1 Phase 2 Phase 3 Partner/Funding Milestone Pepinemab Antibody Platform (anti-Semaphorin 4D Mab) Oncology Complete, Published 2021 Ongoing Next data 2H 2022 Neurology Complete, Nat. Med in press Ongoing Data 2H 2023 Pepinemab COMBO with Pembrolizumab in Head and Neck Cancer Pepinemab in Alzheimer’s Disease Merck, MSD Merck, KGaA Darmstadt All Studies Sponsored by: PIPELINE and MILESTONES Pepinemab COMBO with Avelumab in Non Small Cell Lung Cancer Pepinemab in Huntington’s Disease (Orphan Drug and Fast Track Designations) CLASSICAL- Lung KEYNOTE-B84