Positive Updated Interim Results from NOX-A12 GLORIA Phase 1/2 in Brain Cancer Presented at the Society for Neuro-oncology 2022 Annual Meeting

• 100% radiographic partial response rate achieved in patients on NOX-A12 + radiotherapy + bevacizumab, 83% with durable mRANO responses
• Two of 6 patients with tumor size reduction of >99%
• 12-month survival data expected in Q2 2023
• Key Opinion Leader webinar – November 22, 2022, at 12:00pm ET / 06:00pm CET

BERLIN–(BUSINESS WIRE)–Regulatory News:

TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announced today the presentation of updated interim results from the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab (biosimilar Avastin®) in chemotherapy-refractory (MGMT unmethylated) brain cancer (glioblastoma) in a poster presentation at the Society for Neuro-Oncology (SNO) Annual Meeting, held in Tampa, Florida, US from November 16 – 20, 2022. The company additionally disclosed newer data from the expansion arm that became available after the presentation submission cut-off date, as well as results from the completed dose-escalation part of the same clinical trial.

The poster presentation entitled “Dual inhibition of post-radiogenic angio-vasculogenesis by olaptesed pegol (NOX-A12) and bevacizumab in glioblastoma – interim data from the first expansion arm of the German phase 1/2 GLORIA trial” was presented by Dr. Frank A. Giordano. The poster as well as the most recent data highlight the following key points:

• 100% of target lesions treated with the triple combination of NOX-A12, radiotherapy and bevacizumab were reduced by more than 50%.
• 5 of 6 patients (83%) achieved durable partial responses (PR) by mRANO criteria¹, which takes into account radiographic response as well as other factors such as clinical condition of the patient. One patient experienced progressive disease (PD) due to distant failure while target lesion control was maintained.
• 2 of 6 patients achieved almost complete tumor size reduction (>99%) where contrast enhancing lesions were detectable but too small to be measured. The data for the second patient achieving >99% decrease in tumor size was obtained shortly after the data cut-off for the poster and will be presented in the webinar on November 22, 2022.
• The mean best sum of perpendicular diameters (SPD) of the tumor response was ‑74.9% (‑53.8% to -99.9%) for target lesion sums.
• The triple combination was well tolerated and safe. No dose-limiting toxicities were observed.

Although data from the expansion arm with bevacizumab suggest that adding a VEGF inhibitor to NOX‑A12 and radiotherapy provide greater clinical benefit over NOX-A12 with radiotherapy alone, the latter already showed signs of clinical efficacy. As presented at ASCO in June 2022, NOX-A12 + RT resulted in tumor size reductions in 9 of 10 patients (90%) of which 4 patients (40%) achieved partial response.

“With the safety and tolerability of this expansion arm now established, and with indications that the addition of bevacizumab could meaningfully improve the efficacy of NOX-A12 and radiotherapy in glioblastoma, we are now looking ahead to the survival data,” said Aram Mangasarian, CEO of TME Pharma. “We expect to report on survival data, including overall survival (OS), in the 2nd quarter of 2023, which will allow us to initiate discussions with regulators about the optimal regulatory path for NOX-A12. We are very encouraged and pleased to see the positive outcomes of this combination and remain convinced of the survival benefit this treatment can bring to brain cancer patients.”

“Assessing the neurological functioning of the six patients using the clinician reported Neurologic Assessment in Neuro-Oncology (NANO) scale and patient reported outcomes offer a way to assess the patients’ quality of life, which is increasingly considered important as an additional read-out for patients’ benefit from treatment” said Dr. Frank A. Giordano, Professor and Chair of the Dept. of Radiation Oncology at the University Medical Center Mannheim and the lead investigator of the GLORIA trial. “The NANO score remained stable and there were improvements in quality-of-life measures in the majority of patients, leading us to expect a positive impact on survival. With the median follow-up to date of 7.9 months, neither median PFS nor median OS have yet been reached in this cohort with known unfavorable outcome; thus we expect this population to outperform the NOX‑A12 + radiotherapy dose escalation cohorts where the median OS was 12.7 months. This makes us confident that the combination of NOX-A12, radiotherapy and bevacizumab will allow deeper and more durable responses, further increasing OS and providing the first significant treatment improvement in decades for these difficult-to-treat patients.”

A copy of the poster presentation is available on the TME Pharma website. More information about the GLORIA study (NCT04121455) can be found at ClinicalTrials.gov.

Following the SNO 2022 Annual Meeting, TME Pharma will host a key opinion leader (KOL) webinar with Dr. Giordano, who will discuss the interim results from the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab in more detail.

Details of the Key Opinion Leader webinar are as follows:

Title: NOX-A12 combination therapies in 1L GBM – the Key to the TME? Analysis of maturing data from the ongoing GLORIA trial

Presenter: Dr. Frank A. Giordano, Professor and Chair of the Dept. of Radiation Oncology at the University Medical Center Mannheim

Webinar time and date: November 22, 2022, at 12:00 p.m. EST / 06:00 p.m. CET

Registration: To register for the event, please click HERE

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 is in discussion with regulatory authorities in the United States and Europe. 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.

¹ modified Response Assessment in Neuro-Oncology

Contacts

For more information, please contact:

TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO

Bryan Jennings, CFO

Tel. +49 (0) 30 726247 0

[email protected]

Investor and Media Relations:

LifeSci Advisors
Guillaume van Renterghem

Tel. +41 (0) 76 735 01 31

[email protected]

NewCap
Arthur Rouillé

Tel. +33 (0) 1 44 71 00 15

[email protected]