Candel Therapeutics Partners with Bristol Myers Squibb for Melanoma Trial

TL;DR

Candel teams up with BMS for melanoma trial using CAN-2404 + Opdualag, starting H2 2024.

AI Summary

Candel Therapeutics, Inc. announced on April 4, 2024, that it has entered into a clinical trial collaboration with Bristol Myers Squibb. This collaboration will evaluate the combination of Candel's oncolytic virus product candidate, CAN-2404, with Bristol Myers Squibb's PD-1 inhibitor, Opdualag (nivolumab and relatlimab-rmbw), in patients with advanced melanoma. The trial is expected to begin in the second half of 2024.

Why It Matters

This collaboration with a major pharmaceutical company like Bristol Myers Squibb could significantly advance Candel's lead product candidate and potentially offer a new treatment option for advanced melanoma patients.

Risk Assessment

Risk Level: medium — Clinical trial collaborations carry inherent risks related to trial success, regulatory approval, and market adoption.

Key Players & Entities

• Candel Therapeutics, Inc. (company) — Registrant
• Bristol Myers Squibb (company) — Collaboration Partner
• CAN-2404 (product) — Candel's oncolytic virus product candidate
• Opdualag (drug) — Bristol Myers Squibb's PD-1 inhibitor
• nivolumab and relatlimab-rmbw (drug) — Components of Opdualag
• advanced melanoma (disease) — Target indication for the clinical trial
• April 4, 2024 (date) — Date of Report
• second half of 2024 (date) — Expected start of the clinical trial

FAQ

Key Financial Figures

• $0.01 — nge on which registered Common Stock, $0.01 par value per share CADL The Nasdaq

Filing Documents

• cadl-20240404.htm (8-K) — 51KB
• cadl-ex99_1.htm (EX-99.1) — 40KB
• img160460863_0.jpg (GRAPHIC) — 33KB
• 0000950170-24-041619.txt ( ) — 264KB
• cadl-20240404.xsd (EX-101.SCH) — 27KB
• cadl-20240404_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On April 4, 2024, Candel Therapeutics, Inc. (the "Company") issued a press release announcing positive interim data from its randomized phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer. A copy of the full press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K are furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in any such filing.

01 Other Events

Item 8.01 Other Events. On April 4, 2024, the Company announced positive interim data from its randomized phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer (as of a March 29, 2024 data cut-off): Prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable pancreatic ductal adenocarcinoma ("PDAC") (n=13) o Estimated median overall survival was 28.8 months in the CAN-2409 group versus only 12.5 months in the control group. o At 24 months, a survival rate of 71.4% was observed in CAN-2409 treated patients, after standard of care ("SoC") chemoradiation and prior to surgery, versus only 16.7% in the control group. At 36 months, a survival rate of 47.6% was estimated in patients who received CAN-2409, together with SoC chemoradiation prior to surgery, versus only 16.7% in the control group. o Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients, randomized to control SoC chemotherapy, remained alive at data cut-off (alive at 50.6 months). Previous analysis of blood and resected tumors showed consistent and robust activation of the immune response after experimental treatment with CAN-2409 o In pancreatic tissue of patients treated with CAN-2409 plus prodrug together with SoC (but not SoC alone), dense aggregates of CD8+ granzyme B positive cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were observed in the tumor microenvironment. o Increased levels of soluble granzymes B and H, as well as pro-inflammatory cytokines, including IFN-, were observed in peripheral blood after CAN-2409 administration, but not after SoC. CAN-2409 continued to be associated with a favorable safety/tolerability profile o Addition of CAN-2409 regimen to SoC was generally well tolerated, with no dose-limiting toxicities, including no

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 99.1 Press Release dated April 4, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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. Candel Therapeutics, Inc. Date: April 4, 2024 By: /s/ Paul Peter Tak Paul Peter Tak, M.D., Ph.D., FMedSci President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR