Needham, MA, May 18, 2020 — Candel Therapeutics, a clinical-stage biotechnology company, developing novel immune-based cancer therapeutics, today announced the presentation of data with the Company’s lead product candidate, GMCI, at the 23rd annual meeting of the American Society of Gene and Cell Therapy. The study, led by Dr. Sean Lawler and Dr. Marilin Koch (Brigham and Women’s Hospital, Harvard Medical School, Boston, MA), demonstrated for the first-time that the use of GMCI along with an ATR inhibitor (ATRi), a DNA repair checkpoint protein, have synergistic anti-tumor effects. Targeting DNA repair has emerged as an important cancer therapeutic strategy, with several PARP inhibitors approved or in development for multiple indications, including ovarian, breast, pancreatic, prostate and brain cancer. Unfortunately, most of these DNA damage response (DDR) inhibitors slow down tumor growth but are not curative.
GMCI has also shown very promising results in many tumor types, including tumors targeted by DDR inhibitors, like prostate, brain and pancreatic cancer. GMCI works by promoting cytotoxicity through DNA damage and a robust anti-tumor immune response. In prostate cancer, GMCI is being analyzed in a Phase 3 study in combination with radiation therapy. In a recent Phase 2 study in malignant glioma, GMCI demonstrated a significant overall survival benefit, especially in patients where the tumor load had been substantially reduced by surgery. In the current study, an ATR inhibitor was assessed in combination with GMCI in an orthotopic syngeneic murine glioblastoma model. The combination proved to be synergistic in cytotoxicity assays and led to an increase in long-term surviving animals. While the ATR inhibitor by itself had no impact on long-term survivors (>40d) compared to untreated controls, the combination of ATRi with GMCI led to an increase in survival compared to GMCI alone (from 50% to 67%), a result that was highly significant compared to controls (p=0.0022), making it a promising future approach for the treatment of glioblastoma.
“These results point to a new opportunity for improving outcomes in patients being treated with DNA damage response inhibitors,” said Dr. Estuardo Aguilar-Cordova, Chief Executive Officer of Candel. “GMCI has shown that, when used alone, it stimulates the immune system and has a potent anti-cancer effect. However, cancer is a large number of diseases and most likely it will take a combination of weapons to be defeated. GMCI is well tolerated and its cytotoxicity and immune stimulation effects co-opt many standard-of-care modalities. It has shown synergistic effects with radiation, surgery and now with this new class of DDR inhibitor drugs, like PARPs.”
About Candel Therapeutics
Candel Therapeutics is a Massachusetts based biotechnology company developing its proprietary immuno-oncology platforms, including its Gene Mediated Cytotoxic Immunotherapy (GMCI™) platform and rQNestin34.5 platform, for the treatment of solid tumors.
GMCI™ is an “off the shelf” low toxicity adenovirus based immunotherapy that causes immunogenic tumor cell death, stimulating a hyper-immunogenic microenvironment and generating a personalized, robust and precise systemic response from the patient’s own immune system against his or her cancer. GMCI™ has been evaluated in 11 completed clinical trials and 5 ongoing clinical trials across multiple indications including prostate, brain, pancreas and lung cancers. With over 1,200 patient doses in 650 patients, GMCI™ has meaningful evidence suggesting it is well tolerated and safe. These studies include a registration clinical trial for the treatment of localized prostate cancer patients under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. If proven efficacious, this product candidate will be the first and only therapeutic pharmaceutical available for localized prostate cancer patients.
rQNestin34.5 is an immuno-oncology approach that uses a genetically modified oncolytic herpes simplex virus engineered for enhanced potency. Conditional ICP34.5 expression in the presence of Nestin greatly improves replication and oncolytic activity of HSV. This product candidate is currently being tested in a Phase 1 clinical study in patients with recurrent malignant glioma.
For more information about our clinical programs, visit www.clinicaltrials.gov or click the following link: https://clinicaltrials.gov/ct2/results?cond=&term=advantagene&cntry=&state=&city=&dist=
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