Log in
Log in
Or log in with
GoogleGoogle
Twitter Twitter
Facebook Facebook
Apple Apple     
Sign up
Or log in with
GoogleGoogle
Twitter Twitter
Facebook Facebook
Apple Apple     
  1. Homepage
  2. Equities
  3. France
  4. Euronext Paris
  5. TME Pharma N.V.
  6. News
  7. Summary
    ALTME   NL0015000YE1

TME PHARMA N.V.

(ALTME)
  Report
End-of-day quote Euronext Paris  -  2022-11-24
1.830 EUR   -5.65%
11/23Tme Pharma N : The presentation
PU
11/21TME Pharma N.V. - POSITIVE UPDATED INTERIM RESULTS FROM NOX-A12 GLORIA PHASE 1/2 IN BRAIN CANCER PRESENTED AT THE SOCIETY FOR NEURO-ONCOLOGY 2022 ANNUAL MEETING
AQ
11/18TME Pharma Announces Positive Updated Interim Results from NOX-A12 GLORIA Phase 1/2 in Brain Cancer Presented at the Society for Neuro-oncology 2022 Annual Meeting
CI
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisionsFunds 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

TME Pharma - SAFETY CONFIRMED OF NOX-A12 AND PEMBROLIZUMAB COMBINATION IN GLORIA PHASE 1/2 BRAIN CANCER STUDY

08/26/2022 | 09:38am EST

Berlin, Germany - 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), announced that the Data Safety Monitoring Board (DSMB) validated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and the PD-1 immune checkpoint inhibitor pembrolizumab, and concluded it is appropriate to continue with recruitment of the remaining 5 patients according to the study protocol.

Aram Mangasarian, CEO of TME Pharma, commented: 'After the compelling results seen with NOX-A12 in glioblastoma patients in the GLORIA study so far, we look forward to seeing the results in additional combination with immune checkpoint inhibition as well as maturing data from the combination of NOX-A12 and bevacizumab.'

GLORIA is a Phase 1/2 dose-escalation 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). The pembrolizumab expansion arm is the second triple-combination arm of the GLORIA clinical trial. The company also evaluates NOX-A12 combined with radiotherapy and bevacizumab. The company reported promising initial data from the bevacizumab expansion arm on June 23, 2022, and plans to disclose more detailed data from the study at a scientific conference later this year.

Contact:

TME Pharma N.V.

Aram Mangasarian, Ph.D.

CEO

Bryan Jennings

CFO

Tel: +49 (0) 30 726247 0

E: investors@tmepharma.com

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.

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/nabpaclitaxel 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 'forwardlooking 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.

(C) 2022 Electronic News Publishing, source ENP Newswire

All news about TME PHARMA N.V.
11/23Tme Pharma N : The presentation
PU
11/21TME Pharma N.V. - POSITIVE UPDATED INTERIM RESULTS FROM NOX-A12 GLORIA PHASE 1/2 IN BRA..
AQ
11/18TME Pharma Announces Positive Updated Interim Results from NOX-A12 GLORIA Phase 1/2 in ..
CI
11/14Tme pharma announces publication of abstract disclosing positive interim results from b..
AQ
11/14Tme Pharma N : to host key opinion leader webinar
PU
11/11Tme Pharma N : announces publication of abstract disclosing positive interim results from ..
PU
11/11TME Pharma Announces Publication of Abstract Disclosing Positive Interim Results from B..
CI
10/26TME Pharma N.V. Reports Earnings Results for the Half Year Ended June 30, 2022
CI
10/26Tme Pharma N : Inside Information / News release on accounts, results
PU
10/26Tme Pharma N : 2022, Half-Year Financial Report as of 30 June 2022
PU
More news
Financials
Sales 2021 0,03 M 0,03 M 0,03 M
Net income 2021 -14,5 M -15,0 M -15,0 M
Net cash 2021 7,02 M 7,30 M 7,30 M
P/E ratio 2021 -1,07x
Yield 2021 -
Capitalization 2,49 M 2,59 M 2,59 M
EV / Sales 2020 405x
EV / Sales 2021 316x
Nbr of Employees 13
Free-Float 12,3%
Chart TME PHARMA N.V.
Duration : Period :
TME Pharma N.V. Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends TME PHARMA N.V.
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Mean consensus -
Number of Analysts 0
Last Close Price 1,83
Average target price
Spread / Average Target -
Managers and Directors
Aram Andrew Mangasarian Chief Business Officer
Bryan Jennings Chief Financial Officer & Statutory Director
Maurizio PetitBon Chairman-Supervisory Board
Cornelis Alexander Izeboud Member-Supervisory Board
Martine J. van Vugt Member-Supervisory Board
Sector and Competitors
1st jan.Capi. (M$)
TME PHARMA N.V.-92.18%3
MODERNA, INC.-30.55%67 769
IQVIA HOLDINGS INC.-22.03%40 859
LONZA GROUP AG-33.93%39 445
ALNYLAM PHARMACEUTICALS, INC.25.44%26 171
SEAGEN INC.-20.16%22 918