NEXI-002 / NexImmune - LARVOL DELTA

Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=9 | Suspended | Sponsor: NexImmune Inc. | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Nov 2023 ➔ Nov 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • HLA-A

In vivo and in vitro characterization of AIM ACT, a novel nanoparticle-based technology, expanded MART-1 specific T cells (SITC 2021) - P1/2 | "The AIM ACT platform is currently being used for generating T cell products for our current clinical trials, NEXI-001 (NCT04284228) and NEXI-002 (NCT04505813), and our pre-clinical development for HPV-associated malignancies. The findings support initiating Phase I trials of adoptive T cell therapy in solid tumors."

Preclinical • Melanoma • Oncology • Solid Tumor • CD8 • FAS

Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=9 | Suspended | Sponsor: NexImmune Inc. | Trial completion date: Nov 2022 ➔ Dec 2023 | Terminated ➔ Suspended | Trial primary completion date: Aug 2022 ➔ Nov 2023

Trial completion date • Trial primary completion date • Trial suspension • Hematological Malignancies • Multiple Myeloma • Oncology • HLA-A

Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: NexImmune Inc. | N=22 ➔ 9 | Recruiting ➔ Terminated; Lack of accrual

Enrollment change • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology • HLA-A

Phase 1/2 Study of Nexi-002 Autologous Multi-Antigen-Specific CD8+ T Cells for the Treatment of Relapsed or Refractory Multiple Myeloma (ASH 2021) - "Bridging anti-MM treatment was permitted during the manufacture of the cellular product with a wash-out period of at least 14 days prior to lymphodepletion (LD) chemotherapy (intravenous fludarabine 30 mg/m 2 and cyclophosphamide 300 mg/m 2 ), which was administered on Days -5, -4, and -3 prior to the infusion of the NEXI-002 product up to 72 hours later (Day1). RNA Seq transcriptional profiling of the CD8+ T cells is planned. Additional patients have recently received NEXI-002 infusions and the trial will continue to be expanded to gain additional safety, immunologic, and clinical activity experience."

P1/2 data • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Multiple Myeloma • Oncology • CD4 • CD8 • CTAG1B • SDC1 • WT1

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 Announces Preliminary Phase 1/2 NEXI-002 Results in Patients with Multiple Myeloma (GlobeNewswire) - P1/2, N=22; NCT04505813; Sponsor: NexImmune Inc.; "Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition...In this heavily pre-treated patient group (n=6 with an average of 7.6 lines of prior therapy), the clinical data suggests that NEXI-002 is well-tolerated without dose-limiting toxicities (no grade ≥3 CRS or any grade of ICANS). Biomarker data show that the NEXI-002 product candidate contains CD8+ antigen-specific T cells with key memory phenotypes which, after administration, are detected in peripheral blood and bone marrow of treated individuals and proliferate and persist over time."

Biomarker • P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

NexImmune Reports Third Quarter 2021 Financial Results and Provides Business Updates (GlobeNewswire) - P1/2, N=22; NCT04505813; Sponsor: NexImmune Inc; "NEXI-001...Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first half of 2022; NEXI-002...NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events....Further clinical data from the Phase I/II trial is expected to be announced at the American Society of Hematology (ASH) Annual Meeting in December 2021"

P1/2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

[VIRTUAL] PRELIMINARY ANALYSIS OF A PHASE 1 STUDY OF NEXI-002 AUTOLOGOUS MULTI-AGENT-SPECIFIC CD8+ T CELLS FOR THE TREATMENT OF RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) (EHA 2021) - "Results Three patients were treated with single infusions of 80 to 100 million cells of NEXI-002 following lymphodepleting chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 on Days -5 to -3). Due to these encouraging findings, the trial will be expanded to gain greater safety and activity experience with NEXI-002. Updated data will be available."

P1 data • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology • CD4 • CD8 • SDC1 • WT1

NexImmune Reports First Quarter 2021 Financial Results and Recent Updates (GlobeNewswire) - "NEXI-001 and NEXI-002 are both in Phase 1/2 clinical trials. The Company will share preliminary data from the initial safety cohorts of both trials at the 2021 ASCO Annual Meeting and EHA2021 Virtual Congress for NEXI-001 and NEXI-002, respectively, with additional results for each trial in Q421."

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

The Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP) Announces Five New Investments Supporting Next Generation Cell Therapies and a Novel Immune Checkpoint Inhibitor (PRNewswire) - "The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP) today announced five new investments aimed at speeding the development of new and improved immunotherapies for the treatment of blood cancers...Today's investments include three companies that have novel immunotherapies in early human clinical trials and two companies with promising programs in preclinical development for blood cancers."

Commercial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

First Patient Dosed in NexImmune Phase 1/2 Clinical Trial of NEXI-002 in Multiple Myeloma (GlobeNewswire) - “NexImmune…announced today that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma (MM)-specific antigen targets….Investigators will enroll between 22 to 28 patients in the prospective, multi-center, open-label, single-arm Phase 1/2 study.”

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

NexImmune Completes Dosing of First Cohort in Phase 1/2 Clinical Trial of NEXI-001 in Relapsed Acute Myelogenous Leukemia (AML) (GlobeNewswire) - "NexImmune’s two lead T cell therapy programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to >3 prior lines of therapy, respectively. The Company expects initial data in the fourth quarter of 2020 for both indications."

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

Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2; N=22; Recruiting; Sponsor: NexImmune Inc.

Clinical • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

NexImmune to initiate phase 1/2 trial of NEXI-002 cell therapy for RRMM patients (Myeloma Research News) - "'Although we have made significant progress in treating patients diagnosed with multiple myeloma, we continue to need novel treatment strategies and, in particular, effective immune therapy. For that reason, a significant unmet need remains for the vast majority of our patients,' said Paul Richardson, MD...'Novel immune-based therapies like NEXI-002 may represent a promising and practical option for those patients that have either relapsed after, or are refractory to, currently available treatment. We are excited to be a lead site for this trial and look forward to dosing our first patients,' added Richardson..."

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