UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 12, 2022, Vaccinex, Inc. (the “Company”) presented at the ESMO Congress 2022. A copy of the presentation presented by the Company is furnished herewith as Exhibit 99.1 and is available on the Company’s website located at www.vaccinex.com under the heading “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 |
Description | |
| 99.1 | Neoadjuvant Pepinemab in Combination with Nivolumab and/or Ipilimumab in Resectable Stage III Melanoma | |
| 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: September 13, 2022 | ||||||
| By: | /s/ Scott E. Royer | |||||
| Scott E. Royer | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1 Neoadjuvant Pepinemab in Combination with Nivolumab and/or Ipilimumab in Resectable Stage III Melanoma NCT03769155 Michael Lowe, MD, MA, FACS, FSSO Associate Professor of Surgery Emory University School of Medicine Atlanta, GA, USA 09.12.2022
DECLARATION OF INTERESTS Michael Lowe Research Funding: Amgen,BMS, Delcath, Merck, Regeneron, Stryker,Vaccinex Advisory Board: BMS Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Background Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Background No treatment Patient 1 Patient 2 Patient 3 Pepinemab Pre- Treatment On- Treatment CD8+ T cells Tumor (Cytokeratin+) Tumor CD8+ T cells MSS Colorectal cancer metastasis to liver Tumor margin Winship Cancer Institute, Emory University Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Trial Design Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Trial Design • Primary Objective: • Effect of pepinemab on T cell infiltrate into the tumor microenvironment in lymph nodes and blood • Secondary Objectives: • Assess safety and tolerability of the combination of pepinemab with checkpoint inhibitors in patients with resectable stage III melanoma • Document pathologic response rates of the Nivolumab 360mg combination of pepinemab with checkpoint inhibitors Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Pathologic Responses Cohort Drug N pCR* pMR^ A Nivolumab/pepinemab 8 25.0% 37.5% B Ipilimumab/pepinemab 8 12.5% 12.5% C Nivolumab/ipilimumab/pepinemab 8 62.5% 75.0% D Nivolumab 7 28.5% 42.9% *Pathologic complete response: No viable tumor ^ Major pathologic response: pCR plus near pCR (<10% viable tumor) Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
K Ka ap pl la an n- -M Me ei ie er r P Pl lo ot t Recurrence-free Survival W Wi it th h N Nu um mb be er r o of f S Su ub bj je ec ct ts s a at t R Ri is sk k 1 1..0 0 + Censored Logrank p=0.0097 Nivolumab/pepinemab 0 0..8 8 Ipilimumab/pepinemab 0 0..6 6 Nivolumab/ipilimumab/ 0 0..4 4 pepinemab 0 0..2 2 Nivolumab 0 0..0 0 A A 8 8 6 6 5 5 3 3 2 2 2 2 2 2 0 0 B B 8 8 7 7 4 4 3 3 3 3 2 2 2 2 0 0 C C 8 8 8 8 8 8 7 7 2 2 0 0 7 7 5 5 0 0 D D 0 0 6 6 1 12 2 1 18 8 2 24 4 3 30 0 3 36 6 4 42 2 R Re ec cu ur rr re en nc ce e- -f fr re ee e s su ur rv vi iv va al l ( (m mo on nt th hs s f fr ro om m D Da ay y 1 1 t tr re ea at tm me en nt t) ) A A B B C C D D C Co oh ho or rt t Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. S Su ur rv vi iv va al l P Pr ro ob ba ab bi il li it ty y
Recurrence-free Survival by Response K Ka ap pl la an n- -M Me ei ie er r P Pl lo ot t W Wi it th h N Nu um mb be er r o of f S Su ub bj je ec ct ts s a at t R Ri is sk k 1 1..0 0 + Censored Logrank p=0.0129 0 0..8 8 0 0..6 6 0 0..4 4 0 0..2 2 0 0..0 0 1 18 8 1 13 3 7 7 5 5 3 3 2 2 2 2 0 0 N No o Y Ye es s 1 13 3 1 13 3 1 10 0 8 8 4 4 2 2 2 2 0 0 0 0 6 6 1 12 2 1 18 8 2 24 4 3 30 0 3 36 6 4 42 2 R Re ec cu ur rr re en nc ce e- -f fr re ee e s su ur rv vi iv va al l ( (m mo on nt th hs s f fr ro om m D Da ay y 1 1 t tr re ea at tm me en nt t) ) R Re es sp po on nd de er r N No o Y Ye es s Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. S Su ur rv vi iv va al l P Pr ro ob ba ab bi il li it ty y
Toxicity • All patients safely underwent surgery without delay • Grade 3 adverse events: • Nivolumab/pepinemab: 1/8 (arthralgias) • Ipilimumab/pepinemab: 3/8 (AI, thrombocytopenia, transaminitis) • Nivolumab/ipilimumab/pepinemab: 5/8 (dermatitis, colitis, enteritis, nephritis, AI) • Nivolumab: 1/8 (AI) • Three patients did not receive adjuvant therapy due to AEs Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Conclusions • Pepinemab is well-tolerated and adds no additional toxicity to PD-1 and CTLA-4 inhibitors in the neoadjuvant setting • The triple combination of nivolumab, ipilimumab and pepinemab shows excellent response rates and with short follow up prolonged RFS compared to doublet therapies • Further studies needed to assess durability of response, but this combination could serve as a viable regimen in larger studies • Correlative biomarker data will be presented at 2022 SITC Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Thank you to the Congress organizers and the Discussant Michael Lowe mlowe3@emory.edu European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org