Nouscom to present interim data from Phase 1 trial evaluating NOUS-209, an 'off-the-shelf' neoantigen cancer vaccine for the treatment of MSI-H solid tumors

Results presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

BASEL, Switzerland, Nov. 10, 2021 /PRNewswire/ -- Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, today announced that promising interim safety, immunogenicity, pharmacokinetic, pharmacodynamic, and clinical activity data from the Phase 1 trial evaluating NOUS-209 will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 10-14, 2021). NOUS-209 is an off-the-shelf cancer vaccine based on shared neoantigens, administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, for the treatment of Microsatellite Instable High (MSI-H) gastric, colorectal and gastro-esophageal junction solid tumors.

Dr Michael Overman, MD Principal Investigator (PI) of the trial and Professor in the Department of Gastrointestinal Medicine at the University of Texas MD Anderson Cancer Center, said: "It is really encouraging to see these interim Phase 1 data presented at SITC build positively and add to the initial results seen a couple of months ago at ESMO. These data, now obtained from 12 metastatic MSI-H GI patients, show that NOUS-209 continues to demonstrate a favorable safety profile, high levels of vaccine immunogenicity and early signs of clinical efficacy."

Dr Marina Udier, Chief Executive Officer of Nouscom, added: "We are extremely pleased with the continued safety and tolerability profile of NOUS-209 and the convincing evidence of strong immunogenicity in metastatic cancer patients. The increase in effector CD8 T cells and decrease in Tregs seen in tumor biopsies of responding patients and the signs of durable clinical efficacy in multiple metastatic patients, including one in clinical remission, is exciting early evidence highlighting the potential of NOUS-209. We look forward to further data from this trial to support the development of NOUS-209 as potentially the first neoantigen off-the-shelf cancer vaccine targeting MSI-H tumors."  

Poster Presentation Details:

• Title: Phase 1 Interim Study Results of Nous-209, an Off-the-Shelf Immunotherapy, with Pembrolizumab, for the Treatment of Tumors with a Deficiency in Mismatch Repair/ Microsatellite Instability (dMMR/MSI) (#410)
• Date: 13^th November 2021
• Time: 12:30-14:00 and 19:00-20:30 EST
• Location: Poster Hall, Walter E. Washington Convention Center, Washington, D.C.
• Presenter: Dr Dung Thi Le, MD, Senior Investigator of the trial and Professor of Oncology at the John Hopkins University School of Medicine

The abstracts will be publicly available at 8am EST on 9^th November 2021, and available in the Journal for ImmunoTherapy of Cancer (JITC) supplement.

About NOUS-209

Nous-209 is an off-the-shelf immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic frame shift peptides (frameshift mutations, FSPs) that are not found on healthy tissue.

NOUS-209 is designed to comprise 209 shared FSP neoantigens, selected by Nouscom's proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm, on the basis that an average of 50 neoantigens on any patient's tumor will be shared with those in NOUS-209. Nouscom's heterologous prime/boost platform clones these FSPs into Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) vectors, combined with other immunomodulators to harness the full power of the immune response, to generate the viral-vectored vaccine.

NOUS-209 is in Phase 1 clinical trial (NCT04041310), a multicenter, open label, multiple cohorts, first-in-human clinical study of NOUS-209 in combination with pembrolizumab, designed to evaluate safety, tolerability and immunogenicity and to detect preliminary evidence of anti-tumor activity.

About Nouscom

Nouscom is a clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Nouscom's proprietary technology platform harnesses the full power of the immune response by combining viral vectored vaccines based on multiple neoantigens with other immunomodulators.

Nouscom is currently advancing the clinical development of its programs:

• NOUS-209 (lead), an off-the-shelf cancer immunotherapy for the treatment of MSI-H solid tumors, and
• NOUS-PEV, a personalized vaccine for the treatment of advanced melanoma or lung cancer

Nouscom is led by an experienced management team with deep roots in the pharma and biotech industry and are veterans in the field of viral vectored vaccines.

Nouscom, which was founded in 2015 and is headquartered in Basel, Switzerland with operations in Rome, Italy, is backed by international life sciences investors.

For more information on Nouscom, please visit the company's website at www.nouscom.com or follow us on LinkedIn at www.linkedin.com/company/nouscom-ag/

Contacts

Nouscom
Rick Davis, CBO
E : info@nouscom.com
T : +41 61 201 1835

MEDiSTRAVA Consulting
Sylvie Berrebi, Eleanor Perkin
E : nouscom@medistrava.com
T : +44 (0) 7714 306525