NOUS-PEV / Nouscom - LARVOL DELTA

Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Nouscom SRL | Phase classification: P1b ➔ P1 | N=34 ➔ 7 | Active, not recruiting ➔ Terminated; Terminated by Sponsor

Enrollment change • Phase classification • Trial termination • Cutaneous Melanoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Personalized Viral Based Cancer Vaccine (NOUS-PEV) elicits potent neoantigen specific T cells response infiltrating the tumor (CIMT 2024) - P1b | "Personalized cancer vaccines hold promise as immunotherapeutic approach based on their capability to elicit potent and durable tumor-specific immune response. Moreover, gene signatures analysis of transcriptomic data obtained from pre-treatment biopsies were evaluated to identify biomarkers potentially associated with resistance to the combination treatment. Overall, this study demonstrated the feasibility of a novel personalized neoantigen-based vaccine that in combination with pembrolizumab was shown to be safe and able to activate tumor specific T cells trafficking to the tumor, supporting the use of this vaccine platform as a valuable therapeutic option."

IO biomarker • Tumor-specific neoantigens • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG

Rapid generation of clinical grade personalized viral vectored vaccines encoding neoantigens for cancer immunotherapy (ESGCT 2023) - P1b | "Synthetic cassettes encoding for identified neoantigens are cloned into Great Ape Adenovirus (GAd) and Modified Vaccinia Ankara (MVA) vectors, used in a Phase-I trial for prime/boost vaccination of patients with advanced Melanoma in combination with Pembrolizumab (NCT04990479)...Ex-vivo interferon-gamma ELISpot on PBMC confirmed vaccine immunogenicity in 100% of evaluable patients (n = 4), and this correlated with clinical response. This data supports feasibility and fosters future development of personalized cancer therapies based on recombinant viral vectors."

Clinical • Tumor-specific neoantigens • Viral vector • Melanoma • Oncology • Solid Tumor • IFNG

Angelini Ventures invests into extended €75.8 million ($82 million) Series C financing round for Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized cancer vaccines (GlobeNewswire) - "Angelini Ventures...is pleased to announce its participation in an extension of the Series C financing round for Nouscom...Angelini Ventures’ investment of €7 million brings the total raised by Nouscom, in its oversubscribed Series C round – first announced in November 2023 – to €75.8 million (approx. $82 million)....Readout from its ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf cancer vaccine for the treatment of Mismatch Repair/Microsatellite Instable (dMMR/MSI) Metastatic Colorectal Cancer (mCRC)....Phase 1b study completion for NOUS-PEV...in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs."

Financing • Trial status • Colorectal Cancer • Melanoma • Microsatellite Instability

Phase I trial of viral vector based personalized vaccination elicits robust neoantigen specific antitumor T cell responses. (PubMed, Clin Cancer Res) - P1b | "These findings indicate the ability of NOUS-PEV to amplify and broaden the repertoire of tumor reactive T cells to empower a diverse, potent and durable antitumor immune response. Finally, a gene signature indicative for reduced presence of activated T cells together with very poor expression of the antigen processing machinery (APM) genes has been identified in pre-treatment biopsies as a potential biomarker of resistance to the treatment."

Journal • P1 data • Tumor-specific neoantigens • Viral vector • Melanoma • Oncology • Solid Tumor • CD4 • CD8

Nouscom Raises €67.5 million ($72 million) in Oversubscribed Series C Financing Round (GlobeNewswire) - "Nouscom...announced the completion of its oversubscribed Series C equity financing raising €67.5 million ($72 million) from a syndicate of renowned international healthcare investors....The proceeds will be used to continue advancing and expanding Nouscom’s wholly owned clinical pipeline...Readout from Nouscom’s ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf vaccine targeting 209 shared neoantigens, in combination with pembrolizumab for the treatment of Mismatch Repair/Microsatellite Instable (dMMR/MSI) Metastatic Colorectal Cancer (mCRC). Final readout from the ongoing Phase 1b study and advancement of NOUS-209 monotherapy in Lynch Syndrome (LS) carriers investigating the potential to intercept, prevent or delay cancer before it occurs....Completion of a Phase 1b study evaluating NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma..."

Financing • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor

NOUS-PEV, a personalized cancer immunotherapy targeting neoantigens, induces long lasting, tumor infiltrating memory T cells (AACR 2023) - "Administration is intramuscular, with a priming Great Ape Adenovirus (GAd) vaccination, followed by Modified Vaccinia Ankara (MVA) “boosts”, administered in combination with the PD–1 blocking antibody pembrolizumab in patients with metastatic malignant melanoma and non–small cell lung cancer. Vaccine–induced TCR clonotypes were found in on–treatment tumor biopsies of 2 vaccinated patients, providing the proof–of–concept for neoantigen induced T cells homing and infiltrating into the tumor. Overall, these data show that NOUS–PEV continues to be safe, and elicits a robust long lasting immune response and clinical activity."

IO biomarker • Late-breaking abstract • Tumor-specific neoantigens • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG

Nouscom Presents New Positive Translational Phase 1b Data of NOUS-PEV, a Personalized Neoantigen Cancer Immunotherapy, in a Late-Breaking Abstract at AACR 2023 (GlobeNewswire) - P1b | N=34 | Nous-PEV (NCT04990479) | Sponsor: Nouscom SRL | "Nouscom...announced new translational and biomarker data obtained from the ongoing Phase 1b trial evaluating NOUS-PEV in patients with metastatic melanoma. The data will be presented today in a Late-Breaking session at the 2023 American Association for Cancer Research (AACR) Annual Meeting....NOUS-PEV was demonstrated to be safe, well tolerated and highly immunogenic, inducing potent neoantigen-specific CD4 and CD8 T cell responses that were detected for greater than six months in all evaluable patients. Biomarker analysis demonstrated neoantigen-specific increased T cell migration and infiltration in tumors in patients with durable clinical responses. Current clinical efficacy data from six melanoma patients with 11 months median follow up demonstrated 4 partial responses, 1 durable stable disease and 1 progressive disease."

Late-breaking abstract • P1 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Nouscom Announces AACR 2023 Late-Breaking Presentation of Translational Phase 1b Data of NOUS-PEV, a Personalized Neoantigen Cancer Immunotherapy (GlobeNewswire) - "Nouscom...announced that new translational data obtained from the ongoing Phase 1b trial evaluating NOUS-PEV in patients with metastatic melanoma has been accepted for presentation in a Late-Breaking session at the 2023 American Association for Cancer Research (AACR) Annual Meeting....The full abstract will be available on 14th April 2023 at 12pm EDT."

Late-breaking abstract • P1 data • Melanoma • Oncology • Solid Tumor

Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma (clinicaltrials.gov) - P1b | N=34 | Active, not recruiting | Sponsor: Nouscom SRL | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Cutaneous Melanoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

NOUS-PEV, a Novel Personalized Viral-based Prime/Boost Cancer Immunotherapy Targeting Patient-Specific Neoantigens: Interim Results from the First Subjects in the Phase 1b Study (SITC 2022) - P1b | "The study is a dose-confirmation and cohort expansion, phase 1b, first in human (FIH) trial ( NCT04990479 ) evaluating safety, tolerability, immunogenicity and preliminary anti-tumour activity of NOUS-PEV in combination with the PD-1 blocking antibody pembrolizumab. Data show that vaccination elicits a robust immune response which correlates with preliminary clinical activity. Trial Registration NCT04990479 Ethics Approval The study was approved by UZ Leuven Ethics Committee (Study"

Clinical • IO biomarker • P1 data • Tumor-specific neoantigens • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG • PD-L1

Nouscom's Personalized Neoantigen Cancer Immunotherapy NOUS-PEV Demonstrates Promising Safety, Immunogenicity and Anti-tumor Activity in Solid Tumors (PRNewswire) - P1 | N=34 | NCT04990479 | Sponsor: Nouscom SRL | "Nouscom...announced interim data from the Phase 1b trial evaluating NOUS-PEV which demonstrated it to be safe, well tolerated, immunogenic and with signs of anti-tumor activity. These data will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 8-12, 2022...Safety: Well tolerated with a favorable safety profile. Immunogenicity: Potent neoantigen specific immune responses were detected in all evaluable subjects with clinical responses. Biomarkers/Immune correlates of clinical efficacy: Deepening of clinical responses coincided with the increase of NOUS-PEV-induced T cells in blood; Increased T cell infiltration in the tumors; NOUS-PEV-induced neoantigen specific T cells identified in tumor biopsies in subjects with clinical responses. Clinical Efficacy: Clinical responses correlated with biomarker analyses/predictions...'We look forward to presenting further data during 2023'."

P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Nouscom announces first patient dosed in a Phase 1b Trial with NOUS-PEV, a novel personalized cancer immunotherapy, in advanced melanoma or lung cancer (PRNewswire) - "Nouscom...today announced that the first patient has been dosed in a Phase 1b clinical trial evaluating NOUS-PEV. In this first-in-human trial NOUS-PEV, a personalized neoantigen cancer vaccine, is being administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab to patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1."

Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology

Nouscom highlights innovative science behind VENUS, its novel algorithm for identifying and prioritizing patient-specific tumor neoantigens for personalized cancer immunotherapy (PRNewswire) - "Nouscom...announces the online publication of new research describing its novel and proprietary algorithm for the identification and prioritization of patient-specific tumor neoantigens, VENUS....The publication describes the predictive power of VENUS both in silico and in vivo when incorporated into Nouscom's heterologous prime boost viral vector platform....NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) is currently enrolling patients across multiple sites in Europe....'We look forward to announcing the first patient being dosed with Nouscom's personalized immunotherapy, NOUS-PEV."

Enrollment status • Preclinical • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology

Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma (clinicaltrials.gov) - P1b; N=34; Recruiting; Sponsor: Nouscom SRL

New P1 trial • Cutaneous Melanoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MRI • PD-L1 • ROS1

Nouscom receives approval to begin Phase 1b trials of NOUS-PEV, a novel personalized cancer immunotherapy (PRNewswire.co.uk) - “Nouscom…announces it has received approval from the Spanish National Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) to start a Phase 1b trial of its personalized cancer immunotherapy, NOUS-PEV…The new Phase 1b trial will evaluate the safety, feasibility, and preliminary efficacy per RESIST 1.1 criteria of NOUS-PEV in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in 28 patients with either locally advanced 1L melanoma or 1L NSCLC expressing more than 50% PD-L1. NOUS-PEV will be investigated in the study as a potential treatment for patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC).”

European regulatory • Hematological Malignancies • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology