TME Pharma Announces Selection of Two Clinical Abstracts on the Ongoing NOX-A12 GLORIA Phase 1/2 Trial in Glioblastoma for Presentation at ESMO 2023 Congress and SNO 2023 Annual Meeting

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), announced today that two abstracts on the ongoing NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) were selected for presentation at upcoming international scientific conferences.

The oral presentation at the European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain, on October 20-24, 2023, will highlight an in-depth analysis of how the combination of radiotherapy and NOX-A12 remodels the immune tumor microenvironment in first-line glioblastoma patients, featuring clinical data from the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO Congress website at 00.05 CEST on Monday, October 16, 2023. It will be available concurrently on the TME Pharma website.

Title: Spatial remodeling of the immune tumor microenvironment after radiotherapy and CXCL12 inhibition in glioblastoma in the Phase 1/2 GLORIA trial.
Speaker: Dr. Julian Layer
Session: Mini Oral 508MO
Lecture Time and Date: 11.15-11.20 a.m. CEST, Saturday, October 21, 2023

The 2023 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Vancouver, Canada, on November 15-19, 2023, will feature a poster presentation with a clinical update from the ongoing GLORIA Phase 1/2 trial studying NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with radiotherapy and anti-VEGF (bevacizumab). The full abstract will be published and made available on the SNO official journal Neuro-Oncology on Friday, November 10, 2023. It will be available concurrently on the TME Pharma website.

Title: Interim data on dual inhibition of post-radiogenic angio-vasculogenesis by olaptesed pegol (NOX‑A12) and bevacizumab in glioblastoma from the first expansion arm of the Phase 1/2 GLORIA trial.
Presenter: Prof. Frank Giordano, MD
Session: Poster Session
Session Time and Date: 7.30-9.30 p.m. PT, Friday, November 17, 2023

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. 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.

TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 726247 0
investors@tmepharma.com

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