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The FDA has granted Orphan Drug Designation to CAN-3110, Candel Therapeutics' oncolytic viral immunotherapy for treating recurrent high-grade glioma (rHGG). This designation offers developmental incentives and up to 7 years of U.S. market exclusivity upon approval. Previously, CAN-3110 received Fast Track Designation for rHGG. The company is conducting a multi-institutional Phase 1b clinical trial, with initial results indicating strong anti-tumoral responses and extended survival. Candel will present further data on CAN-3110's feasibility and safety at the 2024 ASCO Annual Meeting. CEO Paul Peter Tak emphasized the potential of CAN-3110 and the company's commitment to developing effective treatments for rHGG.
Candel Therapeutics announced promising Phase 2 trial results for CAN-2409, combined with valacyclovir, in NSCLC patients resistant to immune checkpoint inhibitors (ICI). The median overall survival (mOS) was 20.6 months, outperforming the 11.6 months mOS of standard docetaxel-based chemotherapy. The treatment significantly increased cytotoxic and memory T cells, enhancing systemic immunity, and showed efficacy on both treated and untreated tumors. Additionally, CAN-2409 maintained a favorable safety profile, with mostly mild adverse events. These findings underscore the potential of CAN-2409 in treating advanced NSCLC and will be presented at the 2024 ASCO Annual Meeting.
Candel Therapeutics (Nasdaq: CADL), a clinical-stage biopharmaceutical company, will present at the Jefferies Global Healthcare Conference on June 5, 2024, at 5:30 p.m. ET. Paul Peter Tak, Candel’s President and CEO, will provide a company overview. The presentation will be available via a live webcast on the company’s website, with a replay accessible for up to 90 days.
Candel Therapeutics will host a webcasted R&D breakfast panel during the 2024 ASCO Annual Meeting on June 3, 2024, at 7:00 AM Central Time. The event will focus on discussing topline overall survival data from the Phase 2 clinical trial of CAN-2409, a multimodal biological immunotherapy candidate for Non-Small Cell Lung Cancer (NSCLC). The panel, moderated by Candel's CEO Paul Peter Tak, will feature prominent medical and scientific leaders, including Dr. Charu Aggarwal from the University of Pennsylvania, Dr. Roy S. Herbst from Yale School of Medicine, and Dr. Daniel H. Sterman from NYU Langone Health. A live webcast and an archived replay will be available on Candel's website.
Candel Therapeutics (Nasdaq: CADL) reported its Q1 2024 financial results and corporate highlights. The company showcased positive survival data from its ongoing phase 2 clinical trial of CAN-2409 in pancreatic cancer, with a median overall survival of 28.8 months compared to 12.5 months for the control group. CAN-2409 also received FDA Fast Track and Orphan Drug Designations.
Topline survival data for CAN-2409 in NSCLC will be presented at ASCO on June 3, 2024. The company's enLIGHTEN™ platform revealed a new immunotherapy candidate at the AACR Annual Meeting.
Financially, Candel's Q1 2024 research and development expenses decreased to $4.1 million from $5.5 million in Q1 2023. General and administrative expenses also decreased to $3.8 million from $4.2 million. The net loss stood at $8.2 million, down from $8.8 million. Cash reserves were $25.7 million as of March 31, 2024, providing sufficient funds into Q4 2024.