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 the final median overall survival (mOS)1 for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy in the GLORIA expansion arm has reached 19.9 months.
The mOS achieved by NOX-A12 in combination with radiotherapy and bevacizumab compares very favorably to the matched standard of care reference cohort, which achieved an mOS of 10.5 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.2 The NOX-A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included in the GLORIA trial, while competing trials also included patients with complete removal of the detectable tumor who have a better expected survival outcome.
Based on these data, TME Pharma has submitted an Investigational New Drug (IND)3 application and a Fast-Track Designation4 request to the US Food and Drug Administration (FDA) for the use of NOX-A12 in the treatment of aggressive adult brain cancer, glioblastoma. TME Pharma targets approval of the IND and a decision on the Fast-Track Designation by the FDA before the end of March 2024. The goal is to have an FDA-approved clinical trial protocol in glioblastoma with an expedited regulatory path in place in order to maximize chances of securing the necessary funding for the upcoming clinical trial via partnership, investment or other strategic transaction types.
"With the survival data from the GLORIA cohort receiving NOX-A12, bevacizumab and radiotherapy reaching an unprecedented median overall survival of 19.9 months for the population of patients recruited, we see here compelling evidence of the potential of this combination to provide significant survival benefit to patients suffering from aggressive brain cancer over both standard of care and other competing therapies being developed clinically," said Aram Mangasarian, CEO of TME Pharma. "The survival data formed a key part of our regulatory interactions, and following our recent constructive advice meeting with the FDA we are confident of being able to achieve our target of an approved IND and a decision on a Fast-Track Designation for NOX-A12 by the end of Q1 2024. We believe the strong clinical data produced by the GLORIA trial along with a clear regulatory roadmap will allow us to attract the right partner and financing for NOX-A12 to achieve its potential to become the best available therapy for glioblastoma patients."
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.
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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.
Disclaimer
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 In a clinical study, measuring the median Overall Survival (mOS) is one way to assess how well a new treatment works. In the GLORIA trial the mOS was calculated based on the average of the 3 and 4th longest living patients in the cohort of six patients.
2 See annex to the TME Pharma press release published on 13 September 2023.
3 Investigational New Drug (IND), the authorization from the FDA to administer an investigational drug or biological product to patients in the US as part of a clinical trial.
4 Fast track is a process designed by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
