DALLAS, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Gradalis, a privately-held, late-stage stage biotechnology company developing immunotherapies for ovarian and other cancers, today announced the appointment of Eric Hall, CFA, as Chief Financial Officer, effective January 1, 2023.
“We are pleased to welcome Eric, a highly accomplished biopharmaceutical executive to Gradalis’ leadership team,” said Steve Engle, Chief Executive Officer of Gradalis. “His addition is very timely as Gradalis prepares to initiate a Phase 3 trial designed for product registration of our personalized cellular immunotherapy, Vigil®, in patients with ovarian cancer. This trial builds on encouraging Phase 2b results showing safety and durable overall survival in ovarian cancer patients for which there is a high unmet medical need. Vigil is designed to decloak the full repertoire of a patient’s tumor neoantigens, reactivate the immune system, and summon key effector cells to deliver a durable clinical response. We are confident that Eric’s extensive track record as a CFO and his experience with both public and privately held biotechnology companies will be invaluable as we continue to advance Vigil towards approval and commercialization.”
Mr. Hall added, “I am excited to join Gradalis at this key inflection point and help the team build on the significant clinical, regulatory, and manufacturing achievements to date. I look forward to working with the seasoned Gradalis team to create long-term value for our shareholders and achieve our mission.”
Eric Hall, CFA, has over 30 years of experience serving as Chief Financial Officer and Chief Operating Officer for a variety of public and private companies. For the past 18 years, Mr. Hall has been a Partner of FLG Partners, LLC and a member of their Management Committee. He has extensive global experience in finance and has raised over $3 billion in debt and equity financing. He has been interim CFO for multiple life science companies, and since 2019, he has helped RAPT Therapeutics, ALX Oncology, Connect Biopharma, and Elevation Oncology in their IPOs. Mr. Hall is a Chartered Financial Analyst and member of the CFA Institute and the CFA Society of San Francisco. He has an MBA in Finance from the Owen Graduate School of Management, Vanderbilt University, and a B.A. in Economics from the University of California at Davis.
About Gradalis, Inc.
Founded in 2003, Gradalis is a privately held, late-stage clinical biotechnology company developing a personalized immunotherapy called Vigil, that has been tested in multiple studies in ovarian and other cancer tumor types. Based on its Phase 2b clinical trial results, the company is preparing to initiate a Phase 3 trial designed for product registration of Vigil in patients with ovarian cancer. Vigil is the first cellular immunotherapy to demonstrate survival benefits in a randomized controlled trial of patients with ovarian cancer. The results of the company’s Phase 2b trial have been published in Lancet Oncology and presented at the American Society of Clinical Oncology. Vigil is being studied in other cancer types and has shown positive results in combination with checkpoint inhibitors.
Gradalis’ Vigil platform uses the patient’s immune system to target the entire tumor. Based on multiple clinical studies, Gradalis has developed an oncology platform that is designed to decloak the full repertoire of a patient’s tumor neoantigens, reactivate the immune system, and summon 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. Clinical trials of Vigil have also demonstrated that Gradalis’ platform is better tolerated compared to standard cancer treatments since Vigil uses the patient’s immune system operating within its natural state of balance rather than in an artificial overdrive as with some technologies. Vigil utilizes proprietary bi-shRNA technology that has been proven to silence multiple genes in a variety of cancers and has the potential to be used in other diseases.
About Vigil
Vigil® is a novel, personalized immunotherapy platform designed to achieve a Trifecta of immune anticancer activity using a unique bi-shRNA DNA based plasmid and the patient’s own tumor tissue. The Trifecta of systemic activity involves knock down of TGFβ1 and TGFβ2 which function as tumor suppressor cytokines, increased GM-CSF expression to enhance local immune function and presentation of the patient’s clonal neoantigen epitopes via use of autologous cancer tissue. 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 “clonal” tumor neoantigens. Vigil therapy has been well tolerated in Phase 1, 2a and 2b clinical studies.
In VITAL, a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial (NCT02346747), Vigil showed a positive trend in the primary endpoint of recurrence free survival (RFS) in the overall population and a statistically significant improvement in RFS and overall survival (OS), with a median time of three years to date, in a pre-planned subgroup analysis of Stage III/IV newly diagnosed ovarian cancer patients with the BRCAwt molecular profile. In patients with tumors of the HRP type, significant additional improvement was seen in RFS and OS.
Additionally, Phase 1 results in a “basket” clinical trial have shown positive signals of activity in 19 tumor types and some patients treated with Vigil remain in the trial 48 months later. The company is preparing to initiate a clinical trial intended for product registration in patients with the HRP subtype ovarian cancer.
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.
Gradalis Contact
Mark Early
(214) 442-8161
mearly@gradalisinc.com
LifeSci Advisors Contact
Joyce Allaire
+1 (617) 435-6602
jallaire@lifesciadvisors.com
