TME Pharma Announces New Data From NOX-A12 GLORIA Phase 1/2 Study in Glioblastoma to Be Presented at ASCO Annual Meeting in June 2023

27 Apr 2023 08:00 CEST

• Selection for presentation by ASCO highlights the strength of TME Pharma’s science and the importance of results emerging from the GLORIA trial
• New elements and data to be unveiled on this occasion

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 new data from the GLORIA Phase 1/2 clinical trial evaluating NOX-A12 in brain cancer (glioblastoma) will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from June 2-6, 2023.

"We are very pleased that the ASCO Scientific Program Committee has chosen the GLORIA trial for presentation at this year's ASCO Annual Meeting, which is one of the highest-profile and most selective conferences where researchers from around the world come to learn about clinical trials of promising new cancer therapies. We look forward to sharing these groundbreaking new data and analysis coming from the GLORIA study at the ASCO conference," said Aram Mangasarian, CEO of TME Pharma.

Details of Presentation:
Title: Potential predictive biomarker for response to radiotherapy and CXCL12-inhibition in glioblastoma in the phase 1/2 GLORIA trial (abstract #2048)
Presenter: Dr. Frank A. Giordano, Professor and Chair of the Department of Radiation Oncology at the University Medical Center Mannheim, Germany, and the lead investigator of the GLORIA trial.
Session Type: Poster Session
Session Title: Central Nervous System Tumors
Session Date and Time: June 3, 2023, 01:15-04:15pm CST
Registration: To register to the event, please click here

The full abstract will be published online by ASCO on May 25, 2023, at 05.00 p.m. EDT (11.00 p.m. CEST). TME Pharma will share the details of the presentation as they become publicly available by the annual meeting organizer.

ASCO is the world's leading professional organization for physicians and oncology professionals caring for people with cancer. Its flagship event, the Annual Meeting, promotes cutting-edge research and attracts more than 40,000 oncology professionals from around the world every year.

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 and Spain and is in discussion with regulatory authorities in 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.

Visit TME Pharma on LinkedIn and Twitter.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230426005833/en/

For more information, please contact:

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

Investor and Media Relations:

LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com

NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr