Gradalis Announces Medical Leadership Team Promotion

DALLAS, March 04, 2019 (GLOBE NEWSWIRE) -- Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, today announced the immediate appointment of Luisa Manning, MD, as the Vice President of Medical and Scientific Affairs. Dr. Manning will be responsible for creating and overseeing the medical and scientific strategies and management of the clinical trials.

Dr. Manning will lead the company’s Medical Affairs function. She will be responsible for the strategic and operational leadership of the clinical and scientific activities, including the strategic management of the existing pipeline of investigational products and the initiated Phase 3 registration study in Ewing’s Sarcoma. She will serve as the medical leader and expert resource to internal and external stakeholders.

“Based on Dr. Manning’s extensive knowledge and fast growth in medical and scientific affairs as well as supporting our Phase 1-3 clinical trials, we are confident that she will play a key role in the growth and awareness of immune-oncology, including but not limited to Vigil, a personalized cancer vaccine,” said David Shanahan, CEO of Gradalis.

About bi-shRNA platform
Cancer cells express genes coding for proteins that cause loss of antigens and immunogenicity, or directly suppress the immune response while promoting cell division. Gradalis has developed a novel bifunctional small hairpin RNA (bi-shRNA) that selectively silences expression of any cancer-promoting proteins. Bi-shRNA induces cleavage-independent mRNA degradation as well as cleavage-dependent post-transcriptional mRNA degradation. This combination more effectively blocks protein production compared with other gene silencing mechanisms.

About Vigil
Vigil® is a novel cancer cell immunotherapy that combines bi-shRNA furin, which blocks immunosuppressive protein production, with recombinant human GM-CSF, which stimulates the immune system. By utilizing the patient's own tumor as the antigen source, Vigil is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient's unique tumor neoantigens. Vigil is being studied in Ewing's sarcoma, in Ovarian cancer, as well as gynecological cancers and advanced women’s cancer in combination with PD-L1 inhibitors.

About Gradalis, Inc.
Gradalis is a late stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. We are focused on the development of the bi-shRNA platform that can be utilized to silence any gene or protein and applied to any cancer type. We utilized the bi-shRNA platform to develop Vigil, our proprietary personalized cancer in multiple advanced cancer indications with the lead program for the treatment of patients with Ewing's sarcoma.

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Forward-Looking Statements 
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Gradalis cautions investors not to rely too heavily on the forward-looking statements the company makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Gradalis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


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