General Oncology Announces Promising Preliminary Phase 1 Results from SHARON Trial Presented at ESMO 2025

Novel regimen GO-4, combining melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous stem cells shows manageable adverse reactions and a strong signal of efficacy in patients with BRCA-related pancreatic cancer

BOSTON, Oct. 18, 2025 (GLOBE NEWSWIRE) -- General Oncology, Inc. (“General Oncology” or the “Company”), a clinical-stage biopharmaceutical company dedicated to pioneering first-in-class medicines for metastatic cancers, today announced preliminary results from its ongoing Phase 1 SHARON trial (NCT04150042), evaluating GO-4: the Company’s patented Advanced Redox Modulation regimen consisting of melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous stem cell infusion in patients with advanced pancreatic ductal adenocarcinoma (PDAC) or breast cancer harboring an inherited BRCA/PALB2 mutation. The data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025.

“GO-4 is a therapy designed to achieve major log reductions in tumor cell burden. BRCA-mutated cancer cells are hypersensitive to DNA cross-linking agents, but reversion mutations can lead to drug resistance. GO-4 uses Advanced Redox Modulation to impair DNA repair and sensitize resistant cells to melphalan,” said Arnold Glazier, M.D., Chief Scientific Officer of General Oncology. “We are encouraged by the data demonstrating that GO-4 has a manageable safety profile and a strong signal of efficacy, with two stage IV pancreatic cancer patients remaining progression-free, for 4 years and 2 years after two cycles of GO-4 without additional treatment. We are committed to further exploring the full therapeutic potential of this combination therapy with continued research.”

Presentation details and key highlights from the preliminary analysis are summarized below:

Title: The SHARON Trial: Melphalan, BCNU, Hydroxocobalamin, Ascorbic Acid, and Stem Cells for Pancreatic and Breast Cancer and an Inherited BRCA/PALB2 Mutation
Abstract Number: 2228P
Presenter: Kenneth H. Yu, M.D., Memorial Sloan Kettering Cancer Center, Principal Investigator
Date and Time: Sunday, October 19 at 12:00–12:45 CEST
Location: Poster Area, Hall 25
Key highlights:

• Eleven patients with metastatic PDAC and one patient with breast cancer received one to two rounds of treatment, six weeks apart; seven patients had progressive disease at enrollment.
• Safety was the primary endpoint, and no treatment-related mortality or long-term toxicities were reported.
• In patients with PDAC who had stable or responding disease at enrollment (N = 5), median progression-free survival was 14.2 months, with N = 2 free of disease at 48 and 23 months with no therapy subsequent to two cycles of GO-4.
  

Kenneth H. Yu, M.D., Memorial Sloan Kettering Cancer Center, principal investigator of the SHARON trial, added, “We are always looking to expand treatment options, particularly for patients with advanced diseases who may have limited treatment options. The preliminary data from the SHARON trial demonstrating feasibility and a strong signal of efficacy in patients with BRCA-mutated pancreatic cancer are highly encouraging. The durable responses highlight the need for further clinical evaluation of this approach.”

The SHARON trial is ongoing and will be expanding to include patients without a BRCA or PALB2 mutation, and General Oncology plans to continue evaluating outcomes and long-term follow-up in this high-need patient population.

About the SHARON Trial
The SHARON trial is a Phase 1 study designed to evaluate the safety, feasibility, and preliminary efficacy of GO-4, the Company’s patented Advanced Redox Modulation regimen consisting of melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous stem cell infusion in patients with advanced pancreatic or breast cancer. Patients enrolled to date have had an inherited BRCA/PALB2 mutation. For the remainder of the trial, patients with or without an inherited BRCA/PALB2 mutation will be able to enroll.

About General Oncology, Inc.
General Oncology is a clinical-stage biopharmaceutical company dedicated to pioneering first-in-class medicines for metastatic cancers and other proliferative diseases. The Company is developing GO-4, an investigational therapy for metastatic cancers, currently completing the Phase 1 SHARON trial (NCT04150042) for metastatic cancers in the setting of a BRCA1/2 or PALB2 mutation. With a commitment to innovation, General Oncology is focused on advancing transformative therapies for cancer patients. For more information about General Oncology, please visit www.generaloncology.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 and applicable securities laws. Forward-looking statements can be identified by words such as “designed to,” “will,” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the expectations, plans, and prospects generally, and specifically for the SHARON trial, and General Oncology’s drug development programs. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our management’s current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the development and regulatory approval of investigational therapies, patient enrollment, trial execution, safety and efficacy outcomes, and other risks that may be detailed in General Oncology’s filings with the Securities and Exchange Commission. Any forward-looking statements made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. General Oncology undertakes no obligation to update or revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact:
Abid Ansari
(617) 468-4646
ir@generaloncology.com

Media Contact:
Madelin Hawtin
mhawtins@lifescicomms.com

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