NEXI-003 / NexImmune - LARVOL DELTA

Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: NexImmune Inc. | Trial completion date: Aug 2025 ➔ Aug 2027 | Trial primary completion date: Jul 2024 ➔ Jul 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HLA-A

NexImmune Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "NEXI-003 HPV-Related Cancers: Announced clearance of IND by the FDA for NEXI-003 for treatment of HPV-related cancers."

IND • Oncology • Solid Tumor

Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: NexImmune Inc. | Initiation date: Dec 2022 ➔ Mar 2023

Trial initiation date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • HLA-A

Artificial Immune Modulation adoptive cell therapies for virally driven malignancies (SITC 2022) - "From 8 independent healthy donor clinical scale manufacturing runs of NEXI-003, a pentavalent specific AIM ACT against the E6 and E7 antigens of both HPV-16 and HPV-18, as well as the tumor-associated antigen Survivin, 0.28E9 to 3.79E9 cells were generated...Therefore, by directing a multivalent EBV T cell response there is the potential to treat other EBV-associated diseases using one AIM ACT product. Results reported here, will support the expansion of the AIM platform modalities for use in the treatment of virally driven malignancies, as well as potential virally associated autoimmune and infection diseases."

IO biomarker • Adult T-Cell Leukemia-Lymphoma • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • BIRC5 • CD8 • FAS • HLA-A • SELL

Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: NexImmune Inc.

New P1 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • HLA-A

NexImmune Announces IND Clearance by the US FDA for NEXI-003 for the Treatment of HPV-Related Cancers (GlobeNewswire) - "NexImmune...has received IND clearance for the Company’s first cellular therapy product candidate addressing solid tumors. NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers....The Phase 1 trial will enroll patients at multiple clinical sites across the United States."

IND • New P1 trial • Oncology • Solid Tumor

NexImmune Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "...'We plan to provide a clinical update for the NEXI-001 trial in AML during the second half of 2022, as well as provide an update on our expansion cohort in the NEXI-002 trial in relapsed / refractory multiple myeloma. Additionally, we have identified our antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies and expect to file our IND in the first half of this year'."

IND • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Solid Tumor

NexImmune Reports Third Quarter 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "NEXI-003...Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors is being presented during the Society for Immunotherapy of Cancer’s Annual Meeting (SITC 2021) in November 2021; Investigational New Drug (IND) submission planned for mid-year 2022"

IND • Preclinical • Oncology