Noxxon Pharma N.V.. (7/4/17). "Press Release: Noxxon Announces First Patients Treated in Phase I/II Clinical Trial of NOX-A12 Combined with Keytruda in Metastatic Pancreatic and Colorectal Cancer". Berlin.

	Region	Heidelberg
	Country	Germany
	Organisation	Noxxon Pharma N.V. (EuroNext Growth Paris: ALNOX)
	Today	TME Pharma N.V. (EuroNext Growth Paris: ALTME)
	Group	TME Pharma (Group)
	Organisation 2	National Center for Tumor Diseases (NCT) Heidelberg (Nationales Centrum für Tumorerkrankungen)
	Product	olaptesed pegol (NOX-A12)
	Product 2	clinical research
	Person	Jungnelius, Jarl Ulf (Noxxon 201702– CMO + Vaximm 201605– CMO before Celgene + Pfizer + Lilly + Karolinska Hospital)
	Person 2	Mangasarian, Aram (Noxxon 201005 CBO before Novexel since 200511 VP BusDev before ExonHit VP BusDev)

NOXXON Pharma N.V. (EuroNext Growth Paris: ALNOX), a biotechnology company whose core focus is on improving cancer treatment by targeting the tumor microenvironment, announced today that the first patients were treated in its Phase 1/2 clinical trial in patients with metastatic colorectal and pancreatic cancer at the National Center for Tumor Diseases in Heidelberg, Germany. The goal of the trial is to evaluate safety and the effects of NOX-A12 (olaptesed pegol) as a monotherapy on immune cell infiltration into tumors in addition to safety and efficacy of NOX-A12 in combination with Keytruda® (pembrolizumab), a programmed death receptor-1 (PD-1) immune checkpoint-inhibiting antibody marketed by Merck & Co./MSD.

NOXXON and Merck & Co./MSD (NYSE: MRK) collaborated closely in the two-arm clinical trial design (ClinicalTrials.gov; Identifier: NCT03168139) that is composed of two parts: patients will receive NOX-A12 monotherapy for two weeks, followed by combination therapy of NOX-A12 plus Keytruda® for up to two years. The open-label trial is designed to include 20 patients, 10 patients for each metastatic pancreas and colorectal cancer.

Two patients have now completed part 1 of the trial in which they received NOX-A12 monotherapy for two weeks. Data from this stage will be used to analyze safety and, through tumor biopsies taken before and after NOX-A12 treatment, the ability of NOX-A12 to modulate the tumor microenvironment including the number of T-cells present in the tumors. Part 1 could, as such, provide clinical data to support the broad potential applicability for combinations of NOX-A12 not only with checkpoint inhibitors but also other T-cell based therapeutics such as CAR-T approaches. If successful, this avenue of therapeutic intervention could potentially become game-changing for a wide range of cancers. Both patients that completed part 1 have now progressed into part 2, receiving NOX-A-12 in combination with Keytruda®. Top-line data for all 20 patients from part 1 is targeted to be available in Q2 2018, and initial response-rate data in Q4 2018.

“We believe that our lead product NOX-A12 has the potential to transform cancer types that are resistant to checkpoint inhibitor therapy into checkpoint inhibitor sensitive tumors. We would like to thank the team at the National Center for Tumor Diseases in Heidelberg (Germany) for the excellent start to this trial, which will provide us with the first human data to test this hypothesis,” said Jarl Ulf Jungnelius, Chief Medical Officer of NOXXON Pharma. “Our interactions with the Merck team and the strong preclinical data we have generated underscore NOX-A12’s potential as a future component of innovative treatment for patients suffering from colorectal and pancreatic cancers.”

For more information, please contact:

NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
Tel. +49 (0) 30 726 247 0
amangasarian@noxxon.com

MC Services AG
Raimund Gabriel, Managing Partner
Tel. +49 (0) 89 210228 0
noxxon@mc-services.eu

MacDougall Biomedical
Gretchen Schweitzer or Stephanie May
Tel. +49 (0) 89 2424 3494 or +49 (0) 172 861 8540
gschweitzer@macbiocom.com

NewCap
Florent Alba
Tel. +33 (0) 1 44 71 98 55
falba@newcap.fr

About NOXXON

NOXXON Pharma N.V. is a clinical-stage biopharmaceutical company focused on cancer treatment. NOXXON’s goal is to significantly enhance the effectiveness of cancer treatments including immuno-oncology approaches (such as immune checkpoint inhibitors) and current standards of care (such as chemotherapy and radiotherapy). NOXXON’s Spiegelmer® platform has generated a proprietary pipeline of clinical-stage product candidates including its lead cancer drug candidate NOX-A12 (olaptesed pegol), which is the subject of a clinical immuno-oncology collaboration agreement with Merck & Co. / MSD (NYSE: MRK) to study NOX-A12 combined with Merck & Co.’s anti-PD-1 checkpoint-inhibiting antibody Keytruda® (pembrolizumab) in pancreatic and colorectal cancer. The clinical trial testing NOX-A12 as monotherapy and in combination with Keytruda® is being conducted at one of the leading centers for cancer research and treatment, the National Center for Tumor Diseases in Heidelberg, Germany. NOXXON is supported by a strong group of leading international investors, including TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, DEWB, NGN and Seventure. NOXXON has its statutory seat in Amsterdam, the Netherlands and its office in Berlin, Germany. Further information can be found at: www.noxxon.com

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Record changed: 2023-06-05