Gradalis Appoints Steven Engle as Chief Executive Officer

Dallas, Texas, UNITED STATES

DALLAS, June 02, 2022 (GLOBE NEWSWIRE) -- Gradalis, a late-stage stage biotechnology company developing immunotherapies for multiple cancer indications, announced today that Steven Engle has joined the company as its Chief Executive Officer. Steve joins Gradalis with over two decades of executive leadership experience with public biotech companies developing breakthrough products in the metabolic, autoimmune, oncologic and infectious disease areas. He succeeds founder David Shanahan, who will continue as Gradalis’ Board Chair.

“Steve is a highly accomplished healthcare executive, and we are especially happy to have him leading the Gradalis team at this important time in the company’s evolution,” said Mr. Shanahan. “With the pending start of our registration study in ovarian cancer, expanding operational capabilities, and the opportunities in our clinical and pre-clinical development pipeline, we believe Gradalis is well-positioned to become a leader in the development of therapeutics to treat a broad range of oncologic diseases. We expect that Steve’s extensive experience in R&D and commercialization, together with his track record of executing value-creating strategic transactions, will be instrumental in achieving our corporate and clinical goals.”

“In 2008, Gradalis founders had the foresight to see the need for a more effective solution to treat cancer, one that uses the patient’s immune system to target the entire tumor. Based on multiple clinical studies, Gradalis has developed an oncology platform that decloaks the full repertoire of a patient’s tumor antigens, reactivates the immune system, and summons key effector cells to deliver a durable clinical response. When combined, these are a powerful Trifecta of anti-cancer activities, potentially eliminating even the elusive metastatic cells, and as shown in Phase 2 clinical studies in ovarian cancer, a potential gamechanger in oncology,” commented Mr. Engle. “In addition, multiple clinical trials have demonstrated that Gradalis’ platform is better tolerated compared to standard cancer treatments. This is not a surprise since Vigil uses the patient’s immune system operating with its natural state of balance rather than in an artificial overdrive as with some technologies. I am very pleased to be working with the Gradalis team to realize the company’s vision. With our Phase 3 registration trial upcoming, this is an exciting time to be at Gradalis.”

Before joining Gradalis, Mr. Engle served as CEO of CohBar, a clinical-stage mitochondria-based therapeutics developer, and CEO and Board Chair of XOMA, an antibody therapeutics company that helped develop products with multiple pharmaceutical companies including Novartis, Merck, Pfizer, and Takeda. Prior to XOMA, Mr. Engle served as CEO and Board Chair of La Jolla Pharmaceutical Company, which was the first to discover the biology of B cell tolerance, developed the first B cell toleragen for lupus patients, and received an approvable letter from the FDA. While at drug delivery systems company Cygnus, he helped gain FDA approval of and launch Nicotrol for smoking cessation.

Mr. Engle currently serves on the Board of Prescient Therapeutics Ltd., AROA Biosurgery Ltd, and Author-it Software Corporation. He is a former director of BIO, BayBio and BIOCOM. Mr. Engle holds M.S.E.E. and B.S.E.E. degrees from The University of Texas with a focus in biomedical engineering.

About Vigil

Vigil is the first cellular therapy to show positive survival benefits in a randomized controlled clinical study of patients with solid tumors. Vigil® is a self-navigating cellular immunotherapy that addresses the major deficits of leading cancer treatments. Vigil® uses all of a patient’s tumor-related antigens to identify cancer cells and then enhances the training of the immune system to recognize and attack those cells. Gradalis’s proprietary bi-shRNA platform accomplishes this via three key functions: (1) it blocks furin, the enzyme that generates the immunosuppressive cytokines TGF beta types 1 and 2; (2) it activates effector cells including antigen-presenting dendritic cells and CD8+ T cells via the production of GM-CSF; and (3) it induces an immune response to the full complement of neo-antigens from the patient’s tumor via intradermal administration.

In a Phase 2b trial, Vigil showed a positive trend in the primary endpoint of recurrence free survival in the overall population and a significant improvement in recurrence free survival and overall survival in a pre-planned subgroup analysis of Stage III/IV newly diagnosed ovarian cancer patients with the BRCA wild type (BRCA-wt) molecular profile. The company is preparing to initiate a clinical study intended for product registration in patients in this subgroup. Additionally, Phase 1 results in an all comer trial have shown positive signals of activity in multiple tumor types.

About Gradalis, Inc.

Gradalis is a late-stage clinical biotechnology company developing immunotherapies for multiple cancer indications including an upcoming Phase 3 registration trial in patients with ovarian cancer. The company’s proprietary bi-shRNA therapy platform, which has been proven in its clinical studies, can be utilized to silence a broad range of genes and is applicable to multiple cancer types.

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Forward-Looking Statements 

This press release contains forward-looking statements, including, without limitation, statements regarding the success, cost, and timing of our product development activities and clinical trials, our plans to research, develop, and commercialize our product candidates, and our plans to submit regulatory filings and obtain regulatory approval of our product candidates. These forward-looking statements are based on Gradalis’ current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to: (a) the timing, costs, and outcomes of our clinical trials and preclinical studies, (b) the timing and likelihood of regulatory filings and approvals for our product candidates, and (c) the potential market size for our product candidates. These forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities.

Media Contact
Walter Chen
Gradalis, Inc.
Vice President – Corporate Development
+1 214 442 8170