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
Real-time Estimate Tradegate  -  02:41 2022-08-15 am EDT
4.718 EUR   +0.38%
08/03TME Pharma Treats First Brain Cancer Patient In Phase 1/2 Clinical Study
MT
08/03TME Pharma Announces Enrollment of First Patient in Pembrolizumab Expansion Arm of NOX-A12 GLORIA Phase 1/2 Brain Cancer Clinical Trial
CI
07/15NOXXON PHARMA N : Inside Information / Other news releases
PU
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

NOXXON provides update on timing for upcoming trials of NOX-A12 in pancreatic and brain cancer

11/03/2021 | 01:52am EDT

NOXXON PROVIDES UPDATE ON TIMING FOR UPCOMING TRIALS OF NOX-A12

IN PANCREATIC AND BRAIN CANCER

Berlin, Germany, November 3, 2021, 08:00 a.m. CET - NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announces that due to supply-chainissues affecting its drug-supplymanufacturer, the start date of its two upcoming NOX-A12clinical trials will be delayed by up to 3 months until Q3 2022. The affected trials are the Phase 2 trial (OPTIMUS) with NOX-A12in combination with MSD's (Merck & Co., Inc., Kenilworth, N.J. USA) anti-PD-1therapy Keytruda® (pembrolizumab) as second-linetherapy in pancreatic cancer, and the planned pivotal Phase 2/3 trial of NOX-A12in combination with radiotherapy in first-linebrain cancer (glioblastoma) patients.

Due to a shortage in the US of dichloroacetic acid, a key chemical reagent necessary to synthesize NOX-A12, NOXXON has been informed by its contract active ingredient manufacturer that the NOX-A12 batches needed to initiate these two studies will only be available in Q2 2022 with first patients therefore expected to be dosed in early August 2022. These delays have impacted the overall approval timelines of NOX-A12 in glioblastoma, pushing it into early 2026, while market approval in pancreatic cancer remains unchanged and is planned in 2027.

Aram Mangasarian, CEO of NOXXON commented: "The effects of the COVID-19 pandemic continue to impact the healthcare industry in many areas, including the most essential ones like manufacturing supply chains. The NOX-A12 studies in pancreatic and brain cancer are our key clinical programs; the pancreas cancer trial is our second collaboration with MSD, a global leader in the immuno-oncology space, and the pivotal brain cancer trial is expected to deliver the data base for our first marketing authorization. We have worked with our contract manufacturer to overcome the unexpected shortages of what are usually easily sourced chemical reagents affecting these batches of NOX-A12 and are doing everything to ensure these batches will be released as soon as possible with the usual high standards of quality. We look forward to getting the trials underway and examining the potential clinical benefits of NOX-A12 in combination with Keytruda or radiotherapy for patients suffering from highly aggressive cancers."

With €13.7 million in cash and cash equivalents on June 30, 2021 and available secured financing of €10.45 million (nominal) drawable at the company's discretion as reported on October 22, 2021 with the Half-Year Financial Report 2021, updated timing of commitments for manufacturing and clinical trials extends NOXXON's financial visibility into July 2022.

For more information, please contact:

NOXXON Pharma N.V. Aram Mangasarian, Ph.D. Chief Executive Officer Tel. +49 (0) 30 726247 0 amangasarian@noxxon.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

About NOXXON

NOXXON's oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the TME, NOXXON's approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. NOXXON's lead program NOX-A12 has delivered final top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients published at the ESMO conference in September 2020 and in July 2021 the company announced 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. NOXXON is also studying NOX-A12 in brain cancer in combination with radiotherapy which has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. GLORIA, a trial of NOX-A12 in combination with radiotherapy in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy has delivered interim data from the first two cohorts showing consistent tumor reductions and objective tumor responses. The company's second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX-E36 in patients with solid tumors. Further information can be found at: www.noxxon.com.

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.

Visit NOXXON on LinkedInand Twitter.

About the GLORIA Study

GLORIA (NCT04121455) is NOXXON's dose-escalation, phase 1/2 study of NOX-A12 in combination with irradiation in first-line glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).

About the OPTIMUS Study

OPTIMUS (NCT04901741) is NOXXON's open-labeltwo-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

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.

Disclaimer

Noxxon Pharma NV published this content on 03 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 November 2021 06:51:05 UTC.


© Publicnow 2021
All news about TME PHARMA N.V.
08/03TME Pharma Treats First Brain Cancer Patient In Phase 1/2 Clinical Study
MT
08/03TME Pharma Announces Enrollment of First Patient in Pembrolizumab Expansion Arm of NOX-..
CI
07/15NOXXON PHARMA N : Inside Information / Other news releases
PU
07/15French Drugmaker Noxxon Changes Name to TME Pharma
MT
07/15NOXXON PHARMA N.V. : Change of company name
CO
07/13Noxxon pharma announces changes to its supervisory board
AQ
07/13Noxxon pharma - half-yearly report on the liquidity contract with invest securities
AQ
07/12NOXXON Pharma N.V. Announces Resignation of Gregory Weaver from its Supervisory Board, ..
CI
07/12NOXXON PHARMA N.V. : Nomination
CO
07/07NOXXON PHARMA N : Bryan Jennings
PU
More news
Financials
Sales 2022 13,4 M 13,7 M 13,7 M
Net income 2022 - - -
Net Debt 2022 - - -
P/E ratio 2022 -
Yield 2022 -
Capitalization 3,96 M 4,06 M 4,06 M
Capi. / Sales 2022 0,30x
Capi. / Sales 2023 0,06x
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
TrendsNeutralBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 1
Last Close Price 4,70 €
Average target price 83,00 €
Spread / Average Target 1 666%
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.-79.91%4
MODERNA, INC.-32.60%66 966
IQVIA HOLDINGS INC.-12.88%45 846
LONZA GROUP AG-25.13%44 851
SEAGEN INC.10.05%31 380
ALNYLAM PHARMACEUTICALS, INC.37.90%28 068