Gemcitabine Hydrochloride

TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications Berlin, Germany , April 16, 2026, 08.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for braincancer and eye diseases, is pleased to announce a Nature Communications article on the results from the Phase 1/2 expansion Arm A cohort of the GLORIA trial testing NOX-A12 + radiotherapy + anti-VEGF “triple therapy” in glioblastoma patients. The article in the scientific peer-reviewed high-impact journal, Nature Communications, describes results of the expansion cohort Arm A in TME Pharma’s Phase 1/2 GLORIA trial. In this arm, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients with residual tumor after surgery received NOX-A12 + radiotherapy + anti-VEGF (bevacizumab) “Triple Therapy”. The authors noted that overall survival (OS) of patients receiving NOX-A12 Triple Therapy significantly outperformed two different cohorts of similar patients external to the trial who received standard of care treatment, and further noted that due to the conservative trial design, the study “likely underestimates survival compared with most contemporary trials.” As already disclosed in the March 5, 2024 press release, the GLORIA trial has been amended to allow inclusion of 100 additional patients in a randomized, controlled Phase 2 part of the trial composed of 5 additional arms (Expansion Group Arms D through H) to assess three different doses of NOX-A12 in the Triple Therapy, one dose of NOX-A12 + radiotherapy and standard of care. It is planned to initiate this Phase 2 part of the trial once appropriate partnerships are in place. The findings described in the publication demonstrate the potential and value of TME Pharma’s NOX-A12 asset. TME Pharma remains confident in its strategy to search for a strategic partner to outlicense NOX-A12with the goal of bringing NOX-A12 to market authorization. As communicated on January 5, 2026, TME Pharma continues its active discussions with potential partners for the NOX-A12 program. As indicated in its press release of March 9, 2026, TME Pharma’s financial runway now extends to Q2-2027, providing the company with the flexibility to identify the optimal partnership for NOX-A12. Diede van den Ouden, CEO of TME Pharma , said: "We are encouraged by the publication in Nature Communications, which underscore the scientific validity of our approach. We remain fully committed to bringing NOX-A12 to success and believe that a strategic partnership is the optimal path forward. With our extended cash runway, we are well-positioned to continue our negotiations with potential partners." The full article can be found for reading through the TME Pharma website. Through the TME Pharma website > Scientific Approach > Scientific Publications and on the landing page. For more information, please contact: TME Pharma N.V. Diede van den Ouden, CEO ir@tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been 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. The Company’s two lead assets are: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have 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. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO) Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company Leveraging tax loss carry forwards Potentially gaining exposure to digital assets Further information can be found at: . 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. Management will now iParallel to its core biotechnology activities, the company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company's flagship products, NOXA12 and NOX-E36. Attachment ENG_TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1_2 Expansion Arm A Findings from GLORIA trial in Nature Communications

Phase 1/2 RAINFOL™-01 data showed the combination of rinatabart sesutecan (Rina-S®) and bevacizumab was tolerable, with no new safety signals in patients with advanced ovarian cancer The ongoing Phase 3 RAINFOL-04 trial will further evaluate the combination in patients with recurrent platinum-sensitive ovarian cancer (PSOC) Genmab A/S (Nasdaq: GMAB) announced today new data demonstrating that rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL™-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in San Juan, Puerto Rico. “Advanced ovarian cancer is a complex and difficult-to-treat disease, and the ability for investigational therapies such as Rina-S to be safely combined with bevacizumab can provide clinicians with more options to help improve disease control and manage resistance,” said Cara Mathews, M.D., study investigator and Associate Professor, Obstetrics and Gynecology at the Women and Infants Hospital, Brown University. “Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care therapy such as bevacizumab without significantly increasing the risk of additional side effects.” As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S (120 mg/m2) plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events (AEs). The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common (≥25%) treatment-emergent AEs (TEAEs) included nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients (15.0%), and TEAEs leading to Rina-S dose reductions occurred in 11 patients (27.5%). Rina-S and bevacizumab discontinuation occurred in two patients (5%). No fatal TEAEs were reported. “Today’s safety results from RAINFOL-01 add to the growing body of clinical evidence supporting further development of Rina-S in advanced ovarian cancer, including its potential to be used in a combination regimen,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “Rina-S has the potential to meaningfully expand treatment possibilities for patients with certain gynecologic cancers, and we look forward to further investigating additional opportunities, alone and with other therapies, as Rina-S advances through late-stage clinical development.” Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial (NCT06619236) in patients with platinum-resistant ovarian cancer (PROC), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, and the Phase 3 RAINFOL-04 trial (NCT07225270) in patients with recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy. Rina-S is also being evaluated in the Phase 2 RAINFOL-05 study (NCT07288177) in patients with non-small cell lung cancer (NSCLC). RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of Rina-S Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part D combination therapy cohorts. Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Standard of care for PROC typically involves single-agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel) and mirvetuximab for FRα-positive (≥75% positive tumor cells) patients.iv,v Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.vi Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vii,viii Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial and other cancers with unmet need. Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody-drug conjugates (ADCs), immune-modulating antibodies, and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. i World Cancer Research Fund International. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/. Accessed Oct 2025. ii World Ovarian Cancer Coalition. https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/. Accessed Oct 2025. iii Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival - Population cohort study in the 'no screen' arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002. iv Eskander RN, Moore KN, Monk BJ, Herzog TJ, Annunziata CM, O’Malley DM and Coleman RL (2023) Overcoming the challenges of drug development in platinum-resistant ovarian cancer. Front. Oncol. 13:1258228. v National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients®: Ovarian Cancer. Version 3.2024. July 15, 2024. https://www.nccn.org/patients/guidelines/content/PDF/ovarian-patient.pdf vi Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/ vii European Institute of Women's Health. https://eurohealth.ie/policy‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/. Accessed Oct 2025. viii American Cancer Society. Stages of Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html. Accessed Oct 2025. The content above comes from the network. if any infringement, please contact us to modify.