BERLIN--(BUSINESS WIRE)--Regulatory News:
TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces that another patient has reached the 18-month survival mark after start of therapy increasing overall survival at 18 months (OS-18) to 67% in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy.
This announcement provides an update to a recent disclosure by the company (October 10, 2023) at time of which the last patient had not yet passed the 18-month survival mark. The percentage of patients alive 18 months after the start of their therapy has thus increased from 50% to 67% (4 of 6 patients). Thus, the survival rate at 18 months of patients treated with NOX-A12 + bevacizumab (anti-VEGF) + radiotherapy outperforms by 13-fold the 18-month survival of 5% observed in the matched group of reference patients receiving standard of care1.
Median overall survival also continues to improve further and has already exceeded 18 months as the remaining patients in the GLORIA clinical trial continue to receive treatment or follow-up care2. For comparison, the matched standard of care reference cohort achieved a median overall survival of 10.5 months.
"We have reached a decisive moment in the development of our lead asset NOX-A12 in aggressive adult brain cancer with the achievement of an unprecedented 18-month survival rate of 67 percent in patients with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "We have been steadily building this compelling body of clinical evidence month by month to the point where NOX-A12-based therapies now have the potential to be the best available treatment for glioblastoma patients. It has been highly encouraging to see the data reach meaningful maturity enabling us to have a constructive discussion with regulators before the end of the year on the next steps in development and potential for access to an expedited regulatory pathway for approval of NOX-A12. We target having an IND in place and access to an expedited pathway by the end of Q1 2024, which we expect will attract significant interest from investors and potential partners."
About TME Pharma
TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TME Pharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses, and improved survival. NOX-A12 in combination with radiotherapy has received orphan drug designation for glioblastoma in the United States and glioma in Europe. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in France, Spain and the United States. The company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is considering several solid tumors for further clinical development. Further information can be found at: www.tmepharma.com.
TME Pharma® and the TME Pharma logo are registered trademarks.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
About the GLORIA Study
GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.
About the OPTIMUS Study
OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.
Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.
1 Matched reference cohort of 20 patients from Giordano et al (2022 SNO Poster),
2 In a clinical study, measuring the median Overall Survival (mOS) is one way to assess how well a new treatment works. The longer the patients remain alive, the longer it takes to reach mOS. mOS can only be calculated when more than half of patients in the study have deceased.