Nouscom’s Off-the-Shelf Neoantigen Immunotherapy, NOUS-209, Continues to Elicit Potent and Sturdy Immune Responses in Lynch Syndrome Carriers Highlighting its Potential to ‘Intercept’ Most cancers

• Lynch Syndrome (LS) is a typical hereditary situation (affecting one in 300) conferring a excessive threat of creating colorectal, gastric, endometrial and different cancers
• NOUS-209 monotherapy is nicely tolerated and generates potent and long-lasting neoantigen-specific T cell responses
• Up to date information to be offered on the Society for Immunotherapy of Most cancers (SITC) 2024 Annual Assembly

BASEL, Switzerland – 5^th November 2024 – Nouscom, a medical stage immuno-oncology firm creating off-the-shelf and personalised neoantigen most cancers immunotherapies, proclaims additional promising information from the absolutely enrolled Section 1b/2 research evaluating NOUS-209 for its potential to ‘intercept’ most cancers in Lynch Syndrome (LS) carriers.

These up to date information display that NOUS-209 monotherapy induces potent, broad and sturdy immune responses in all LS carriers evaluated and continues to be well-tolerated with no treatment-related severe antagonistic occasions reported. The brand new information will likely be offered on the Society for Immunotherapy of Most cancers (SITC) Annual Assembly in Houston, TX, USA on Saturday 9^th November 2024.

NOUS-209 is an off-the-shelf immunotherapy encoding 209 neoantigens which might be shared throughout each sporadic and hereditary poor Mismatch Restore (dMMR) / Microsatellite Instable (MSI) tumors. LS carriers have a high-risk, genetic predisposition to creating MSI tumors similar to colorectal most cancers (CRC) and different kinds of life-threatening cancers, together with endometrial, gastric and ovarian. As soon as identified, folks with LS bear intensive and invasive surveillance packages that will embody pre-emptive surgical procedure however in any other case don’t have any authorised remedy choices obtainable.

Within the ongoing Section 1b/2 trial evaluating NOUS-209 as a monotherapy (NCT05078866), immune responses had been evaluated in 23 LS carriers. NOUS-209 monotherapy continued to be protected, nicely tolerated and to generate potent immunogenic CD4 and CD8 T cell responses in all 23 members. T cell responses had been proven to be potent, broad and sturdy towards a number of neoantigens encoded inside NOUS-209. These information proceed to assist future medical growth of NOUS-209 as a worthwhile intervention for intercepting most cancers in LS carriers.

Remaining information from the Section 1b/2 research are anticipated to be obtainable in mid-2025 and discussions with regulators relating to the long run medical growth of NOUS-209 in LS carriers are underway.

The research is led by researchers at The College of Texas MD Anderson Most cancers Heart, in collaboration with the Most cancers Prevention Scientific Trials Community and sponsored by the Nationwide Most cancers Institute (grant # UG1CA242609).

“Lynch Syndrome impacts about one in 300 folks, making it probably the most frequent hereditary most cancers syndromes. Vaccine growth is a major step ahead for the LS group, which at the moment depends on routine screening instruments for most cancers prevention”, stated the research’s principal investigator, Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Scientific Most cancers Prevention at MD Anderson. “The up to date information additional recommend that most cancers interception could also be doable and that NOUS-209 has the potential to develop into an necessary intervention for folks with LS, who face an elevated threat of creating life-threatening cancers, similar to colorectal, gastric, and endometrial.“
  
Dr. Elisa Scarselli, Chief Scientific Officer of Nouscom, added: “These thrilling information considerably reinforce these first offered in a late-breaking oral summary presentation at SITC final yr¹, and additional spotlight the flexibility of NOUS-209 monotherapy to securely and successfully induce long-lasting immune responses in Lynch Syndrome carriers. This strengthens our perception that the immune system might be primed to intercept pre-malignant lesions and stop the event of MSI tumors. We enormously admire the contribution and dedication of our collaborators on the US Nationwide Most cancers Institute, medical investigators and LS carriers who participated on this trial, all of whom share our dedication to intercept most cancers.”

Dr. Marina Udier, Chief Government Officer of Nouscom, commented: “The information we’re seeing from the Section 1b/2 trial with NOUS-209 as a monotherapy in Lynch Syndrome carriers are extraordinarily encouraging. Along with the beforehand revealed optimistic Section 1 information of NOUS-209 together with pembrolizumab in dMMR/MSI cancers, and our ongoing randomized Section 2 trial of NOUS-209, additionally together with pembrolizumab in dMMR/MSI metastatic CRC, NOUS-209 has demonstrated induction of highly effective neoantigen-specific immune responses. These responses may result in medical advantages and spotlight the transformative potential of NOUS-209, from most cancers interception to remedy of metastatic illness^2,3.

“Major information read-outs from each the randomized Section 2 trial in MSI mCRC and the Section 1b/2 trial in LS are anticipated by mid-2025. We’re excited to plan the long run medical growth for NOUS-209 together with a path in the direction of registration.”

Particulars of the poster offered at SITC 2024 are as follows:

• Title: Nous-209 vaccine induces shared neoantigen immunogenicity for most cancers interception in wholesome Lynch Syndrome carriers: outcomes from Section Ib/II trial
• Quantity: 638
• Date: Saturday, 9^th November 2024
• Session: Scientific Trials in Progress
• Presenter: Dr. Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Scientific Most cancers Prevention at MD Anderson

The summary might be considered on SITC’s web site here .

Ends

References

1. D’Alise M. et al. Nous-209 genetic vaccine encoding shared most cancers neoantigens is protected and elicits strong immune response in wholesome Lynch syndrome carriers: interim outcomes from Section 1 most cancers interception trial. Journal for ImmunoTherapy of Most cancers (2023);11: doi: 10.1136/jitc-2023-SITC2023.1526
2. D’Alise, M. et al. Adenoviral Primarily based-Vaccine Promotes Neoantigen Particular CD8+ T Cell Stemness And Tumor Rejection, Science Translational Drugs (2022); 14, 657
3. Overman, M. et al. Assembly Summary 2023 ASCO Annual Assembly Outcomes of section I-II bridging research for Nous-209, a neoantigen most cancers immunotherapy, together with pembrolizumab as first line remedy in sufferers with superior dMMR/MSI-h colorectal most cancers.

About Lynch Syndrome

Lynch Syndrome (LS) is a typical hereditary situation related to an elevated predisposition to develop colorectal most cancers (CRC) and different kind of cancers, together with endometrial, gastric and ovarian. LS carriers have a 50% to 80% and 40% to 60% lifetime threat of creating CRC or endometrial most cancers, respectively, with an elevated threat of creating a number of different tumor sorts (Bonadona et al. JAMA 2011).

LS is attributable to mutations in one of many 4 DNA mismatch restore (MMR) genes, resulting in tumors that accumulate numerous neoantigens. Within the common inhabitants, roughly one in 300 people have LS (Win et al 2017, Most cancers Epidemiol Biomarkers Prev). Within the US, it is estimated that just about a million people are affected by LS. Regardless of this, LS stays vastly underdiagnosed and present intervention choices are restricted to invasive surveillance and/ or prophylactic surgical procedure.

Neoantigen-targeted immunotherapy, NOUS-209, is being explored for its potential to stimulate the immune system to acknowledge and intercept tumors earlier than they happen.

About MSI Tumors

Microsatellite instability (MSI) tumors are a subset of cancers characterised by a excessive frequency of mutations inside quick, repetitive DNA sequences often called microsatellites. This instability happens as a consequence of defects within the mismatch restore (MMR) system, which usually corrects errors that come up throughout DNA replication. When the MMR system is poor (dMMR), cells accumulate genetic mutations, resulting in MSI tumors. MSI is especially frequent in colorectal, endometrial, and sure gastric cancers and is related to Lynch Syndrome.

About Nouscom

Nouscom is a clinical-stage immuno-oncology firm creating next-generation, off-the-shelf and personalised most cancers immunotherapies. Nouscom’s proprietary viral vector platform has the capability to encode for big payloads of neoantigens or different immunomodulators and clinically demonstrated to securely and potently harness the ability of the immune system.

Nouscom is at the moment advancing the medical growth of its wholly owned packages:

• NOUS-209, an off-the-shelf neoantigen most cancers immunotherapy for the remedy of MSI stable tumors together with pembrolizumab in randomized Section 2 trials.
• NOUS-209, an off-the-shelf monotherapy in Lynch Syndrome carriers with the potential to ‘intercept most cancers’ earlier than it advances. A Section 1b/2 is being carried out underneath a medical trial collaboration and provide settlement with the Nationwide Most cancers Institute (NCI).
• NOUS-PEV, a personalised most cancers immunotherapy, is predicted to enter randomized Section 2 trials in indications with excessive unmet medical want in 2025.

Nouscom has additionally solely out-licensed VAC-85135, an off-the-shelf immunotherapy developed underneath a multi-project settlement, which is at the moment underneath analysis in a Section 1 trial for the remedy of Myeloproliferative Neoplasms sponsored by Janssen Analysis & Growth and Bristol Myers Squibb.

For extra info on Nouscom, please go to the corporate’s web site at www.nouscom.com or observe us on LinkedIn.

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