TME Pharma NV

BERLIN--( BUSINESS WIRE )-- 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), announces its plan to externalize and monetize the company's second clinical stage asset NOX-E36 – an L-stereoisomer RNA aptamer inhibiting the CCL2 chemokine. This decision leverages the compound’s potential, as shown by clinical and preclinical data, to safely address significant unmet medical needs in ophthalmic diseases impacted by fibrosis. The presence of the target of NOX-E36, CCL2, has been shown to predict early failure of glaucoma surgical intervention in patients and inhibition of the pathway targeted by NOX-E36 in preclinical models of glaucoma surgery prevents fibrosis thereby prolonging the success of the intervention 1 . NOX-E36 has already been administered to 175 clinical trial participants with an excellent safety and tolerability profile and showing activity on its target, already derisking a number of steps in early clinical development. Fibrosis is a significant cause of treatment failure or increased severity in many clinically important eye diseases 2 with unmet needs such as diabetic retinopathy (9.6 million cases in the US, of which 1.84 million vision-threatening 3 ), age-related macular degeneration (20 million cases in the US, of which 1.5 million vision-threatening 4 ), and primary open angle glaucoma (>3 million cases in the US 5 ). Click here to read the full press release 1 Chong (2017) Invest Ophthalmol Vis Sci 58:3432 & Chong (2010) Ophthalmology 117:2353 2 Sorenson (2024) Frontiers in Ophthalmology 2024 Vol. 4 3 Lundeen (2023) JAMA Ophthalmol. 2023;141(8):747-754 4 Rein (2022) JAMA Ophthalmol. 2022;140(12):1202-1208 5 US National Eye Institute Glaucoma Tables, Link

BERLIN--( BUSINESS WIRE )-- 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 an abstract featuring results from the NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) has been selected for presentation at the European Society for Medical Oncology (ESMO) Congress taking place in Barcelona, Spain, September 13-17, 2024. The oral presentation will provide further analysis of the dual inhibition of NOX-A12 and bevacizumab in glioblastoma in the expansion arm of the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO Congress website . 00:05 a.m. CEST on Monday, September 09, 2024. It will be available concurrently on the TME Pharma website. Title: Dual inhibition of postradiogenic angio-vasculogenesis in glioblastoma: Results of the phase 1/2 GLORIA trial Presenter: Dr. Frank A. Giordano, Chair of the Department of Radiation Oncology, University Medical Center Mannheim, Germany Session: Mini oral session: CNS tumors Time and Date: 08.30-8.35 a.m. CEST, Sunday, September 15, 2024 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.

Brings over 20 years of clinical experience, including management of Phase 1-2 clinical trials in a variety of indications such as ophthalmology Will oversee all R&D operations with focus on clinical development and operations KENSINGTON, MD / ACCESSWIRE / October 25, 2023 / Galimedix Therapeutics, Inc. ("Galimedix"), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, today announced the appointment of Luciana Summo, PhD, as Vice President, R&D Operations. In this newly created position, she will oversee all activities related to R&D operations, with an emphasis on clinical development and operations. This includes spearheading the design, planning, and execution of clinical trials. Dr. Summo reports to Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer. "We are delighted to welcome Luciana to Galimedix," said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman . "She brings strong experience setting up and running clinical trials and ensuring that all of the proper support structures are put in place. As we move our lead product candidate, GAL-101, into Phase 2 testing for the treatment of dry age-related macular degeneration, her skill set is the perfect fit for this next stage in our development. Luciana will play a pivotal role in defining Galimedix's overall R&D strategy and driving our R&D initiatives forward. All of us very much look forward to working with her as we contribute to advancing innovative healthcare solutions that have the potential to improve the lives of patients." Dr. Summo has over 20 years of experience in clinical development and operations, including the management of Phase 1-2 clinical trials in several indications such as ophthalmology, cardiology, and oncology. Prior to joining Galimedix, she worked in positions of increasing responsibility in the clinical departments at OMEICOS Therapeutics GmbH, NOXXON Pharma AG, and Berlin-Chemie AG/ Menarini Group. She is well versed in setting up and overseeing clinical trials on a global scale and has played a key role in transitioning programs from pre-clinical to clinical stage. She has experience with the entire spectrum of activities related to R&D operations, with a special emphasis on clinical development and clinical operations, including also quality management and CMC. She works closely with cross-functional teams, including CROs, scientists, clinicians, regulatory affairs specialists, and different stakeholders, to ensure that trials are conducted in accordance with rigorous scientific standards and regulatory guidelines. Dr. Summo has experience in submitting Clinical Trial Applications (CTAs) in Europe and Investigational New Drug (IND) applications in the US and prepared for and participated in pre-IND meetings with the US Food and Drug Administration (FDA), as well as regulatory agency meetings in Europe. She also has set up from scratch and run a clinical operations department. Luciana Summo, PhD, Vice President, R&D Operations , added: "I am truly excited to be joining Galimedix at this important point in the Company's growth. The programs in ophthalmology and Alzheimer's disease have the potential to change the treatment paradigm, and I look forward to working with the rest of the team to bring them forward in the clinic." About Galimedix Therapeutics, Inc. Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix's groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in dry age-related macular degeneration (AMD), glaucoma and Alzheimer's disease - Galimedix's initial areas of focus. The Company's approach targets toxic Aβ oligomers and protofibrils. Many studies have indicated that these oligomers and protofibrils are an underlying cause of neurodegenerative diseases of the eye. And, recent approvals and promising Phase 3 results of anti-Aβ drugs also have validated them as a key target in Alzheimer's disease. Compelling pre-clinical data support the potential of Galimedix's product candidates to slow or stop neurodegeneration and also restore lost neuronal function. A Phase 2 proof-of-concept study in dry AMD with lead program, topical GAL-101, is in preparation with strong support from partner, Théa Open Innovation (TOI). Clinical studies in other indications are planned. Contact Alexander Gebauer, MD, PhD Galimedix Therapeutics, Inc. Co-founder and Executive Chairman info@galimedix.com Media inquiries: Anne Hennecke / Lydia Robinson-Garcia U.S. MC Services AG Laurie Doyle Tel: +49 (0)170 7134018 Tel: +1-339-832-0752 galimedix@mc-services.eu SOURCE: Galimedix Therapeutics, Inc. View source version on accesswire.com: