EpicentRx Announces Completion of First Cohort in Phase 1 "BETA PRIME" Trial with AdAPT-001

Cancer-targeting adenovirus enhanced with a TGFβ Trap well tolerated in patients with advanced cancer

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Sep 29, 2021, 10:05 ET

TORREY PINES, Calif., Sept. 29, 2021 /PRNewswire/ -- EpicentRx Inc., a leading-edge drug and device company with cancer and inflammatory disease-targeted platforms, today announced the completion of patient enrollment in the first cohort of a Phase 1 trial called BETA PRIME for its TGF-beta (TGFß) trap-enhanced cancer targeting adenovirus.

The study, which has successfully enrolled three patients in the first cohort, is evaluating the safety, tolerability, optimal dose level and immunogenicity for single and multiple doses of AdAPT-001 both alone and in combination with a checkpoint inhibitor when administered to advanced cancer patients.

TGFß, a protein that inhibits the activity of the immune system as a safeguard against severe inflammation and autoimmunity, is hijacked by cancer cells to escape immune elimination. Therapeutically resistant cancer is an area of high unmet medical need, which this triple combination strategy involving the AdAPT-001 cancer targeting virus armed with a TGFß trap and a checkpoint inhibitor intends to address.

The AdAPT-001 Phase 1 multi-center clinical trial is conducted in three parts starting with a single dose escalation that is followed by an expansion cohort at the highest tolerable dose prior to combination with a checkpoint inhibitor.

EpicentRx's proprietary platform of next-generation oncolytic viruses that preferentially infect and kill cancer cells has been developed with over two decades of oncolytic virus research by EpicentRx's CEO, Dr. Tony Reid, MD, PhD and VP of Viral Therapy, Dr. Christopher Larson, MD, PhD. EpicentRx's discovery pipeline of multiple differentiated oncolytic virus candidates are potent and tumor-selective.

"The completion of enrollment in cohort 1 of the BETA PRIME trial is the first step for EpicentRx on its journey to bring a first-in-class treatment to the millions of patients in America and ultimately around the world that are afflicted with resistant cancer," said Dr. Tony R. Reid, Chief Executive Officer of EpicentRx. "To date, we have seen no serious adverse events in the trial. To defeat cancer what is needed are therapeutic agents like AdAPT-001 that are not only as genetically sophisticated as the tumor itself but also that are minimally toxic."

The trial is titled "A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors." Trial design details can be found at https://clinicaltrials.gov/ct2/show/NCT04673942

About EpicentRx Inc.
EpicentRx is a leading-edge biopharmaceutical company with a complementary pipeline of small molecules and cancer targeting virus platforms that represent the next frontier in treating patients with diseases of significant unmet need. With two platforms, CyNRGY and AdAPT, EpicentRx has developed well-tolerated therapies and novel drug delivery devices that fine tune the inflammatory response, turning it ON in cancer and turning it OFF in diseases like Alzheimer's, Parkinson's, multiple sclerosis, and congestive heart failure, with emphasis on not just treating the disease but improving quality of life. For more information, visit www.epicentrx.com.

SOURCE EpicentRx, Inc.