DNAtrix Presents Positive Results from the Phase 2 CAPTIVE/KEYNOTE-192 Study of DNX-2401 in Combination with Pembrolizumab for Glioblastoma at the 2019 SNO Annual Meeting

- DNX-2401 and Pembrolizumab Combination Shows Clinical Benefit in Recurrent Glioblastoma -

- Data Show Interim Median Overall Survival of 12.3 Months -

HOUSTON, TX, USA I November 24, 2019 I DNAtrix, a leader in the development of oncolytic viruses for cancer therapy, today presented updated safety and efficacy data from the fully-enrolled Phase 2 CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev), DNAtrix's oncolytic adenovirus, followed by pembrolizumab for patients with recurrent glioblastoma. The data demonstrate that the therapy elicits durable clinical activity and has a favorable safety profile. These results are being presented at the Society for Neuro-Oncology (SNO) Annual Meeting held from November 22-24, 2019 in Phoenix, Arizona.

A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.

"The data hold great promise for patients afflicted with glioblastoma, the most common form of adult brain cancer. Glioblastoma is a disease associated with near uniform fatality. The results are striking in this context," said Clark Chen, MD, PhD, Professor, Lyle French Chair in Neurosurgery and Department Head at the University of Minnesota, presenting author for the CAPTIVE / KEYNOTE-192 study. "The results suggest that the combination of DNX-2401 and pembrolizumab has the potential to revolutionize the care of glioblastoma patients. I look forward to the rigorous studies aimed to validate the efficacy of DNX-2401."

"These interim data from our CAPTIVE trial are a significant milestone for us in the development of DNX-2401 as an innovative treatment for glioblastoma," said Frank Tufaro, PhD, CEO of DNAtrix. "Importantly, these data suggest that DNX-2401 has a superior clinical benefit and safety profile compared to currently approved chemotherapy for recurrent glioblastoma, and we are particularly pleased that, together with pembrolizumab, DNX-2401 elicited a number of robust and durable antitumor responses."

About CAPTIVE / KEYNOTE-192
CAPTIVE / KEYNOTE-192 is a Phase 2 multicenter study evaluating a single intratumoral injection of DNX-2401 (tasadenoturev) followed by standard dosing with pembrolizumab every three weeks to determine the safety and efficacy in patients with recurrent glioblastoma.

About DNX-2401 (Tasadenoturev)
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and kill cancer cells to elicit an immune response. Prior clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 is currently being evaluated in several clinical trials, including a multicenter Phase 2 study evaluating DNX-2401 with pembrolizumab for adult patients with recurrent glioblastoma. DNX-2401 has been granted PRIME and Orphan designation by the EMA, and Fast Track and Orphan designation by the FDA.

About DNAtrix
DNAtrix is a privately held, clinical stage, biopharmaceutical company developing oncolytic virus immunotherapies for cancer. Its oncolytic adenovirus platform is based on genetic modifications to the common cold virus that allows for the virus to specifically infect and kill cancer cells while leaving healthy cells unharmed.  The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at www.DNAtrix.com.

SOURCE: DNAtrix

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