MVX-ONCO-1 / Release Therap - LARVOL DELTA

Overall survival of recurrent/metastatic head & neck squamous cell carcinoma patients progressing after ≥ 1 line of systemic therapy, treated with MVX-ONCO-1, a novel, first in class cell encapsulation-based immunotherapy: results of SAKK 11/16, a phase IIa trial. (PubMed, Exp Hematol Oncol) - P2 | "These findings suggest that MVX-ONCO-1 can induce a coordinated immune response with clinical benefits as a standalone treatment, leading to prolonged survival. This effect may be enhanced by previous exposure to immune checkpoint inhibitors. Trial registration (ClinicalTrials.gov): NCT02999646."

Journal • P2a data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CSF2

Long term survival data from all recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients treated with MVX-ONCO-1 during open-labelled phase I and phase IIa clinical trials (ESMO-IO 2024) - P1, P2 | "Another showed stable disease upon MVX-ONCO-1 therapy and subsequently presented a complete response upon nivolumab immunotherapy despite a PD-1 negative tumor. First line treatment with chemotherapy / pembrolizumab (Keynote 048) shows 22% OS at 3 years and median OS of 13 mos. Data on all R/M HNSCC heavily pretreated pts treated with MVX-ONCO-1 demonstrates positive survival, with 25% of pts alive after 3 years, and median OS from start of immunotherapy reaching 21.7 mos."

Clinical • Metastases • P1 data • P2a data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CSF2

A first-in-human phase I clinical study with MVX-ONCO-1, a personalized active immunotherapy, in patients with advanced solid tumors. (PubMed, Cancer Res Commun) - "Conclusion/Discussion MVX-ONCO-1 is safe, well-tolerated, and beneficial across several tumor types. Ongoing phase IIa trials target advanced R/M HNSCC patients post initial systemic therapy."

Journal • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CSF2

SAKK 11/16, a phase IIa trial evaluating overall survival (OS) for recurrent/metastatic Head & neck squamous cell carcinoma (RMHNSCC) patients (pts) progressing after ≥ 1 line of systemic therapy, treated with MVX-ONCO-1, a novel, first in class cell encapsulation-based immunotherapy (ESMO 2023) - P2 | "Partial Response (PR) and Complete Response (CR) were observed, including CR ongoing for >17 mo in a nivolumab refractory pt. Prolonged OS correlates strongly with immune education, DTH being a potential biomarker to be validated in future studies. MVX-ONCO-1 is the first cancer vaccine associated with prolonged survival in advanced chemo / IO refractory disease in monotherapy without maintenance."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2a data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CSF2

SAKK 11/16: Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Maxivax SA | Active, not recruiting ➔ Completed | Trial completion date: Dec 2027 ➔ Jun 2023

Metastases • Trial completion • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] MVX-ONCO-1 in advanced refractory cancers: Safety, feasibility, and preliminary efficacy results from all HNSCC patients treated in two ongoing clinical trials. (ASCO 2021) - P1, P2 | "Eight patients (80%) failed both Cisplatin based chemotherapy and anti-PD1 therapies prior to enrolment...While 1 PR was observed on MVX-ONCO-1, 1PR and 1CR were observed on subsequent Nivolumab therapy (both CPS0), and 1 CR was observed after carboplatin-cetuximab... Treatment with MVX-ONCO-1 is feasible, safe and well tolerated . Preliminary efficacy data shows an encouraging rate of tumor control including prolonged CR in patients subsequently treated with nivolumab or chemotherapy . Efficacy of the concurrent use of anti-PD-1 and MVX-ONCO will be assessed in a planned clinical trial."

Clinical • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • CSF2

SAKK 11/16: Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Maxivax SA | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2023 ➔ Jan 2023

Enrollment closed • Metastases • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

SAKK 11/16: Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Maxivax SA | N=41 ➔ 21 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Enrollment change • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MVX-2011-01: MVX-ONCO-1 in Patients With Solid Tumor (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: Maxivax SA | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Dec 2026 | Trial primary completion date: Dec 2021 ➔ Mar 2022

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Oncology • Solid Tumor

SAKK 11/16: Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2; N=41; Active, not recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MVX-ONCO-1 in Patients With Solid Tumor (clinicaltrials.gov) - P1; N=35; Recruiting; Sponsor: Maxivax SA; Trial completion date: Dec 2019 ➔ Dec 2021; Trial primary completion date: Dec 2019 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Sarcoma • Solid Tumor

Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2; N=41; Recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Trial completion date: Dec 2024 ➔ Dec 2027; Trial primary completion date: Jun 2020 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2; N=41; Recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (clinicaltrials.gov) - P2; N=7; Active, not recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Recruiting ➔ Active, not recruiting; N=41 ➔ 7

Clinical • Enrollment change • Enrollment closed