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Candel Therapeutics Completes Enrollment in Phase 1 Clinical Trial of CAN-2409 in Combination with Opdivo® (nivolumab) for the Treatment of High-Grade Gliomas

NEEDHAM, Mass.–()–Candel Therapeutics, Inc., a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced it has completed enrollment for its Phase 1 clinical trial in patients with newly diagnosed high-grade glioma to evaluate the safety and efficacy of CAN-2409 in combination with immune checkpoint inhibitor Opdivo® (nivolumab) and standard of care radiation therapy, as well as temozolomide for patients with methylated MGMT promoters. The trial enrolled 35 evaluable patients and is being conducted in collaboration with Bristol Myers Squibb Company, manufacturer of Opdivo®, and separately the Adult Brain Tumor Consortium at Johns Hopkins University.

“The addition of CAN-2409 to immune checkpoint inhibitor treatment has the potential to train lymphocytes to specifically recognize tumor neoantigens and to change the ‘cold’, immunosuppressive tumor microenvironment, thereby synergizing with lymphocyte activation induced by nivolumab resulting in tumor cell destruction,” said Paul Peter Tak, M.D., Ph.D., President and Chief Executive Officer of Candel Therapeutics. “With a significant number of patients affected each year and limited treatment options available, there remains a critical need for effective therapies in high-grade glioma. It is our hope that CAN-2409 can create new, more effective options for this patient population, and we look forward to the readout from this study next year.”

The primary endpoints of the study are safety and tolerability of this combined treatment regimen. Secondary endpoints include overall survival, progression free survival and immunological biomarkers. For more information about this study, please visit: www.clinicaltrials.gov (NCT03576612).

Opdivo® is a registered trademark of Bristol Myers Squibb.

About CAN-2409

CAN-2409, previously known as gene-mediated cytotoxic immunotherapy (GMCI™), 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, thereby training the immune system to recognize these antigens. The activated effector T cells have the potential to migrate to distant, uninjected metastases for broad anti-tumor activity. At the same time, the adenoviral capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This adjuvant effect helps create a better immune response against the tumor neoantigens released locally. This dual mechanism of antigen unmasking and immune activation may enable CAN-2409 to generate a powerful and lasting attack against a variety of the patient’s tumor-associated neoantigens, minimizing the possibility for antigen escape and tolerance development.

Because of its versatility, CAN-2409 may have the potential to treat a broad range of solid tumors. Combination activity with standard of care radiation therapy, surgery, immune checkpoint inhibitors

(ICI) and chemotherapy has already been shown in several preclinical and clinical settings. Candel has previously published preclinical data that supports combination of CAN-2409 with ICI. In a mouse model of glioblastoma unresponsive to ICI, addition of CAN-2409 was shown to modulate the immunosuppressive, unresponsive tumor microenvironment, resulting in a synergistic effect in vivo, with significantly improved survival in mice treated with CAN-2409 and ICI combination. 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 for brain, prostate, lung, and pancreatic cancers in clinical trials.

About Candel Therapeutics

Candel is a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Our engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. Our approach combines an in-depth knowledge of viral immunotherapy with extensive clinical experience across a wide range of indications. Based on the broad range of data that we have generated from our preclinical models and clinical trials using our approach, we have observed what we believe to be a systemic immune response against locally injected tumors and their distant metastases. To learn more, visit www.candeltx.com.

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