Edison Oncology Holding Corp.

MENLO PARK, Calif., April 8, 2024 /PRNewswire/ -- Edison Oncology Holding Corp. ("Edison Oncology"), a privately held biopharmaceutical company, today announced the presentation of positive interim data from the company's ongoing multicenter Phase 1/2a clinical trial of Orotecan (oral irinotecan HCL, VAL-413) at the American Association of Cancer Research (AACR) annual meeting. "Intravenous irinotecan is a standard treatment for various pediatric cancers, but current intravenous regimens confine children to hospital infusion centers for 30-50% of their days during treatment, robbing them of their childhood experiences," explained Jeffrey Bacha, CEO of Edison Oncology. "We're delighted to share encouraging interim findings from our ongoing clinical trial. These results bolster the promise of Orotecan as an oral alternative to intravenous therapy. By enabling at home treatment, Orotecan holds the potential to significantly enhance quality of life and reduce treatment expenses for both pediatric and adult cancers." Irinotecan (intravenous, i.v.) is a topoisomerase-I inhibitor approved by the FDA for the treatment of colorectal cancer and used 'off label' in the treatment of a several types of cancer including gastric cancers, neuroendocrine and adrenal tumors, pancreatic cancer, small cell lung cancer, cervical cancer, ovarian cancer, esophageal cancer, soft tissue sarcomas and bone cancer. Demonstration of clinical benefit across a range of tumors has made i.v. irinotecan a key component of many standard treatment protocols. However, for recurrent pediatric cancers, patients receiving irinotecan endure daily infusions for five to ten days every two weeks, exacerbating non-adherence to treatment schedules, negatively impacting their quality of life and driving up healthcare costs. Efforts to develop oral regimens using the intravenous formulation have yielded promising results in terms of tumor response in prior clinical studies. Nonetheless, the poor taste of the intravenous formulation has resulted in reduced patient compliance and limited widespread adoption of oral irinotecan regimens. Orotecan (oral irinotecan HCL, VAL-413) is a novel, patented, oral liquid formulation of irinotecan hydrochloride designed to deliver the drug orally with improved tolerability. The current clinical trial is designed to evaluate safety, tolerability and efficacy of Orotecan given with oral temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma. Patients up to 30 years of age with recurrent pediatric solid tumors may be eligible. During the first cycle of treatment, each patient receives four daily doses of Orotecan and one daily dose of the "off-the-shelf" i.v. preparation of irinotecan taken orally (IRN-IVPO) to allow for pharmacokinetic comparison. During all subsequent cycles patients receive Orotecan once daily in 5-day courses administered every 21 days. The Company reported the following interim observations from the clinical trial: The trial is currently enrolling the highest dose (110mg/m2/day) cohort, with no dose-limiting toxicity observed in the lower dose (90mg/m2/day) cohort. The 90mg/m2/day dose matches the dose of unformulated irinotecan i.v. given orally to more than two hundred patients across multiple published investigator-initiated pediatric cancer trials conducted over several years with promising outcome results. Initial pharmacokinetic observations support equivalency between the Orotecan formulation and unformulated i.v. irinotecan given orally for both the parent compound and active metabolites SN-38 and SN-38 glucuronide. Preliminary data suggests Orotecan oral formulation is palatable and suitable for protracted out-patient (at home) dosing for adolescent patients representing a potential significant improvement in quality of life and reduced cost of treatment vs. i.v. irinotecan. The longest treatment duration to date is twelve cycles of once-per-day oral dosing at home. "We are grateful to the investigators, patients and families who have participated in this trial to date. These interim results are highly encouraging," said Mr. Bacha. "With the 90mg/m2/day Orotecan dose aligning with prior successful trials of unformulated i.v. irinotecan given orally coupled with pharmacokinetic equivalence and a palatable formulation suitable for outpatient dosing, we believe Orotecan holds immense potential to enhance the quality of life for patients while reducing treatment costs. These findings mark a significant advancement in our mission to improve outcomes for patients battling cancer." About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and pharmacology to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. SOURCE Edison Oncology Holding Corp.

MENLO PARK, Calif., April 20, 2023 /PRNewswire/ -- Edison Oncology Holding Corp. ("Edison Oncology"), a privately held biopharmaceutical company, is pleased to announce the presentation of two scientific posters at the annual meeting of the American Association of Cancer Research held in Orlando, Florida from April 14-19. In a presentation entitled "A Pilot Clinical Trial of VAL-413 (Orotecan®, oral irinotecan HCl) in Patients with Recurrent Pediatric Solid Tumors," the company reported that, to date in its ongoing Phase 1-2a clinical trial, of Orotecan, a novel oral formulation of irinotecan, no dose limiting toxicity has been observed in patients receiving Orotecan, and preliminary analysis of pharmacokinetic data suggests that plasma levels of irinotecan and its active metabolite, SN-38, are similar to levels observed following treatment with unformulated commercially available i.v. irinotecan given orally in the same patient. In a second presentation entitled "Investigating the Therapeutic Efficacy of EO3001 in Clear Cell Carcinoma of the Ovary", Edison Oncology reported that in CRISPR/Cas9 generated isogenic pairs of ovarian cancer cell lines, EO3001 selectively kills ARID1A mutant cancer cells at low nanomolar concentrations compared to "wildtype" ovarian cancer cells that do not harbor the mutation. A mechanism of action of EO3001 in ARID1A mutant ovarian clear cell carcinoma (OCCC) is also proposed. Since ARID1A mutations are known to inactivate the SWI/SNF complex and expose the DNA into an "open chromatin" structure, such cells have high DNA replication and enhanced metabolic rates. To meet this enhanced energy need such cells become dependent on oxidative phosphorylation (OXPHOS). The poster describes that by directly inhibiting the action of certain mitochondrial proteins required for the function of the OXPHOS pathway, EO3001 may result in energy deprivation and apoptosis the of metabolically overactive ARID1A mutant tumor cells. About Orotecan® (oral irinotecan HCl) Orotecan is a novel oral liquid formulation of irinotecan hydrochloride designed to deliver the drug orally with improved tolerability. Irinotecan is an intravenous (i.v.) topoisomerase inhibitor approved by the FDA for the treatment of colorectal cancer and used 'off label' in the treatment of a several types of cancer including gastric cancers, neuroendocrine and adrenal tumors, pancreatic cancer, small cell lung cancer, cervical cancer, ovarian cancer, esophageal cancer, soft tissue sarcomas and bone cancer. A standard regimen of i.v. irinotecan for the treatment of childhood tumors involves daily infusions for five consecutive days, every two to three weeks leading to significant patient inconvenience, diminished quality of life and high cost to the healthcare system. "Orotecan's oral formulation has been developed to improve tolerability and patient compliance in the treatment of rare childhood tumors, with an opportunity to expand into major adult cancers," said Jeffrey Bacha, Edison Oncology's chief executive officer. "The data we have observed in our clinical trial thus far supports our confidence that Orotecan has the opportunity to address significant unmet needs in a number of tumors where i.v. irinotecan is currently utilized as a single agent, or in combination with oral anti-cancer treatments." To date, more than 200 patients have been treated with unformulated commercially available i.v. irinotecan delivered orally with promising results in the treatment of Ewing sarcoma and other pediatric cancers; however, poor palatability of the drug has limited the widespread adoption of this approach in clinical practice. Edison Oncology's ongoing clinical trial (clinicaltrials.gov identifier: NCT04337177) is designed to examine the safety and tolerability of Orotecan and provide data assess the pharmacokinetics of Orotecan compared to current oral regimen employing unformulated i.v. irinotecan given orally. About EO3001 EO3001 is a novel small-molecule drug candidate that has been studied in prior clinical trials involving more than 1000 patients. Recent research conducted by Edison Oncology and academic researchers has demonstrated EO3001 exhibits potent and selective activity against ARID1A deficient cancer cells. Mutations in ARID1A are associated with treatment resistance and poor outcomes in several cancers including gynecologic malignancies, breast cancer, gastric cancer, colorectal cancer and pancreatic cancer. Ovarian clear cell carcinoma (OCCC) is an orphan cancer indication representing approximately 10% of ovarian cancers in North America with a higher frequency in patients of east Asian descent. OCCC is inherently resistant to standard chemotherapy and radiation treatment and currently represents the worst prognosis of any form of epithelial ovarian cancer. "According to published studies up to 60% of OCCC patients harbor ARID1-A mutations, providing a readily available biomarker for patient selection in clinical trials," said Mr. Bacha. "We look forward to advancing EO3001 as a potential treatment for this important unmet medical need." About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and pharmacology to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. SOURCE Edison Oncology Holding Corp.

MENLO PARK, Calif., Feb. 17, 2021 /PRNewswire/ -- Edison Oncology Holding Corp., a company established to develop and commercialize new therapies targeting the fight against cancer, today announced that Dennis Brown, Ph.D., chairman and Jeffrey Bacha, chief executive officer, will participate in the SVB Leerink 10th Annual Global Healthcare Conference to be held virtually on Monday, February 22 – Friday, February 26, 2021. Mr. Brown and Mr. Bacha will be available to meet with members of the investment community in virtual one-on-one meetings during the conference. About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. Safe Harbor Statement Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and research programs. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. Investor Contact: Amato and Partners, LLC Investor Relations Counsel admin@amatoandpartners.com