Regulatory News:
TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announced today that the nomination of Dr. Alexandra Glucksmann to the Supervisory Board was approved at the extraordinary general meeting of shareholders (EGM), which took place on September 30, 2024, at 01:30 p.m. CEST. Shareholders representing a total of 1.79% of the total issued and outstanding share capital on September 02, 2024, were represented.
"It is a great pleasure to welcome Alexandra to the supervisory board of TME Pharma at what is a significant and exciting time for the company," said Dr. Maurizio PetitBon, Chairman of the Supervisory Board of TME Pharma. "Our NOX-A12 program has achieved unprecedented clinical results, demonstrating great potential in glioblastoma and allowing us to establish a clear roadmap for the next stage of its clinical development. It was clear from these accomplishments that the company would best be served by an expanded and enhanced supervisory board, and Alexandra's distinguished track record as a biotech executive along with her extensive scientific experience make her a fantastic addition. We are certain that with her insight and expertise, Alexandra will play a crucial role in guiding the company through the upcoming inflection points."
"I am very pleased to be joining TME Pharma as a member of its supervisory board at this pivotal moment in the company's journey. TME Pharma's innovative approach to targeting the tumor microenvironment shows great promise in addressing aggressive cancers, and the glioblastoma program in particular presents a remarkable potential to transform the treatment paradigm for brain cancer patients, for whom the current standard of care offers no cure and very limited survival benefit.," said Dr. Alexandra Glucksmann, Member of the Supervisory Board of TME Pharma. "I look forward to contributing to the company's strategic direction as it advances its clinical programs and to working alongside the talented team at TME Pharma to help navigate the challenges and opportunities that lie ahead in bringing potentially life-changing therapies to patients in need."
The presentation outlining the agenda item and voting results of the EGM is available online. The minutes of the EGM will soon be made available on the company website. The details of TME Pharma's Supervisory Board including members' bios are published on the company's website.
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 Phase 1/2 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. US FDA has approved the design of a randomized Phase 2 trial in glioblastoma and TME Pharma was awarded fast track designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) 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.
Visit TME Pharma on LinkedIn and X.
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 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab.
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/20240930573548/en/
Contacts:
For more information, please contact:
TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 16637082 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
