On May 26, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported the publication of abstract #9037 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago (Press release, Candel Therapeutics, MAY 26, 2022, View Source [SID1234615170]). The abstract summarizes initial data as of January 10, 2022, from Candel’s open-label phase 2 clinical trial evaluating CAN-2409 in combination with anti-PD-1 or PD-L1 agents in patients with stage III/IV non-small cell lung cancer (NSCLC) who have had an inadequate response to immune checkpoint inhibitor treatment. The data presented in the poster will include additional data not included in the abstract from a total of 20 patients as of April 20, 2022, including 16 patients from cohort 2.

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"The achievement of an 87.5 percent disease control rate in patients whose cancer was progressing on anti-PD-1 treatment at enrollment bolsters the evidence of CAN-2409’s potential to induce immunization against cancer neoantigens in both injected tumors and uninjected metastases so that resistance to checkpoint blockade can be overcome," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. "The occurrence of abscopal effects and clinically meaningful and durable activity, supported by significant biomarker responses and prior monotherapy activity data, strengthens our belief that this investigational agent has the potential to improve outcomes for patients with NSCLC who are progressing on anti-PD-1 agents."

Experimental treatment with CAN-2409 plus valacyclovir in combination with anti-PD-1 agents appeared to be well tolerated. The most common treatment-related adverse events were transient flu-like symptoms, such as chills, fever and fatigue, with no grade 4 and two grade 3 events reported.

Additional data highlights include:

Most patients experienced a reduction in tumor burden.
There were three objective responses in cohorts 1 and 2 (patients with stable disease or progressive disease upon entry, respectively). A fourth patient with PR initially reported in the abstract became ineligible for RECIST assessment due to an irradiated lesion; the patient still showed an absence of disease progression for more than 6 months.
Two of the three patients with a PR had PD-L1 expression below 1 percent, the third being unknown; 19 of 20 patients in the trial had negative or low PD-L1 expression.
CAN-2409 treatment induced 1) increased tumor infiltration by cytotoxic T cells, 2) a systemic increase in actively proliferating, granzyme B positive T cells, 3) an increase in interferon gamma producing effector cells in both CD4+ and CD8+ compartments, and 4) increased levels of soluble granzymes A, B and H, all consistent with the hypothesized mechanism of action of CAN-2409.
"As a physician who cares for patients with NSCLC, I am frequently confronted with the problem faced by the majority of patients with lung cancer who ultimately progress on immune checkpoint therapy," said Daniel Sterman, M.D., Professor at NYU Langone Heath, and a principal investigator for the phase 2 clinical trial. "The data from this clinical trial are incredibly exciting, suggesting that the addition of CAN-2409 to pembrolizumab or nivolumab containing treatment regimens in patients experiencing progression may offer a new therapeutic option where few good alternatives exist. Importantly, CAN-2409 was administered only two times in this setting, with intratumoral administration providing a simple and straightforward approach."

Details on the abstract are below:

Abstract Title: First report of safety/tolerability and preliminary antitumor activity of CAN-2409 in inadequate responders to immune checkpoint inhibitors for stage III/IV NSCLC

Presenter: Charu Aggarwal, MD, MPH, Associate Professor of Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania
Session Date and Time: June 6, 2022, from 8:00 – 11:00 am CDT
Session Title: Lung Cancer – Non-Small Cell Metastatic
Location: McCormick Convention Center, Hall A
Abstract Number: 9037
Candel also announced that an in-person and webcast investor event will be held on Saturday, June 4, 2022, from 6:30 – 7:45 am CDT.

Key speakers will be:

Dr. Roy Herbst, Professor of Medical Oncology and Chief of Medical Oncology at the Yale Cancer Center, and member of Candel’s Research Advisory Board
Dr. Daniel S. Sterman, Professor of Pulmonary and Critical Care Medicine, at the New York University, Director of the Multidisciplinary Pulmonary Oncology Program at NYU Langone Health, and a principal investigator on the phase 2 clinical trial
Dr. Paul Peter Tak, President and CEO of Candel Therapeutics
The webcast and slides will be accessible live under "Events and Presentations" on the Investors page of the company’s website at View Source or by clicking here. A replay will be available on the website for approximately 90 days after the event.

Dr. Charu Aggarwal is serving as the co-principal investigator of this phase 2 clinical trial. For more information on the clinical trial please visit: View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in non-small cell lung cancer, high-grade glioma, pancreatic cancer, and localized, non-metastatic prostate cancer in ongoing clinical trials.