NEXI-001 / NexImmune - LARVOL DELTA

Multi-antigen Specific CD8+ T Cells With Decitabine and Lymphodepleting Chemotherapy for the Treatment of Patients With Relapsed or Refractory AML or MDS Following an Allogeneic Hematopoietic Cell Transplantation From a Matched Donor (clinicaltrials.gov) - P1 | N=31 | Not yet recruiting | Sponsor: City of Hope Medical Center | Initiation date: Dec 2024 ➔ Jun 2025

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Multi-antigen Specific CD8+ T Cells With Decitabine and Lymphodepleting Chemotherapy for the Treatment of Patients With Relapsed or Refractory AML or MDS Following an Allogeneic Hematopoietic Cell Transplantation From a Matched Donor (clinicaltrials.gov) - P1 | N=31 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT (clinicaltrials.gov) - P1/2 | N=22 | Active, not recruiting | Sponsor: NexImmune Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Mar 2025 | Trial primary completion date: Oct 2022 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • HLA-A • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1

NexImmune Announces Presentations at The Society for Immunotherapy of Cancer’s 38th Annual Meeting (GlobeNewswire) - "NexImmune, Inc...today announced that three abstracts have been accepted for poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA , being held November 1-5, 2023."

Preclinical • Oncology • Solid Tumor

An analysis of a first-in-human study of NEXI-001 donor-derived antigen-specific CD8+ T-cell treatment of relapsed AML after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2023) - P1/2 | "Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity."

P1 data • Acute Myelogenous Leukemia • Graft versus Host Disease • Hypotension • Immunology • Inflammation • Respiratory Diseases • Transplantation • CCNA1 • CD4 • CD8 • PRAME • WT1

NexImmune Presents Initial Positive Data from the NEXI-001 Phase 1 Trial for Relapsed/Refractory Post Allo-HSCT AML at the American Society of Clinical Oncology 2023 Annual Meeting (GlobeNewswire) - P1/2 | N=22 | NCT04284228 | Sponsor: NexImmune Inc. | "NexImmune, Inc...today announced results from its Phase 1/2 clinical trial of NEXI-001 in patients with relapsed/refractory acute myeloid leukemia (AML) post-allogeneic hemopoietic stem cell transplant (allo-HSCT). In this clinical trial to date, NEXI-001 is well tolerated with a favorable safety profile while eliciting an immune response to target antigens and a clinical effect in some patients....Patients treated with NEXI-001 experienced rapid reconstitution of both CD8+ and CD4+ T-cell subtypes after lymphodepletion chemotherapy. Clinicians observed persistence of antigen-specific T cells in both peripheral blood and bone marrow with evidence of clinical activity including tumor burden reduction, increased chimerism and improved ECOG scores."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

NexImmune Announces Presentation of Phase 1/2 Clinical Data at the 2023 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "NexImmune...announced that clinical data from its Phase 1/2 dose escalation study of NEXI-001 will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago, June 2 - June 6, 2023."

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

NexImmune Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates (Yahoo News) - "Full enrollment and dosing in the final safety cohort of NEXI-001 completed; Plan to announce data for currently enrolled patients at or around an upcoming conference in mid-2023; Continue to explore opportunities to advance NEXI-001 with potential collaborators and investigators..."

Enrollment status • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

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

Phase 1/2 Study of Nexi-001 Donor-Derived Multi-Antigen Specific CD8+ T Cells for the Treatment of Relapsed Acute Myeloid Leukemia (AML) after Allogeneic Hematopoietic Transplantation (ASH 2021) - "Bridging anti-AML 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 ) that was administered on Days -5, -4, and -3 prior to the infusion of the NEXI-001 product up to 72 hours later (Day1). At least two cycles of 200M NEXI-001 cells weekly x 3 weeks of a 4-week cycle is planned for the next dose-escalation cohort. Early data suggest that the NEXI-001 product has the potential to enhance a GvL effect with minimal GVHD-associated toxicities."

P1/2 data • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Sarcoma • Solid Tumor • Transplantation • CCNA1 • CD4 • CD8 • PRAME • WT1

Initial Characterization of Nexi-001, a Donor-Derived T-Cell Product, for the Treatment AML Patients That Have Relapsed after Allogeneic Hematopoietic Stem Cell Transplant (ASH 2022) - "In summary, we have developed a novel AIM np-based T cell expansion platform for the rapid, streamlined generation of clinically relevant number of tumor-specific, multi-antigen, memory CD8+ T cells in 14 days. The results reported here support the development of additional multi-institution phase 1 /2 clinical trials of adoptive T cell transfer in hematologic and solid cancers."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Solid Tumor • Transplantation • CCNA1 • CD8 • PRAME • WT1

NexImmune Reports Third Quarter 2022 Financial Results and Announces Strategic Update (GlobeNewswire) - "NEXI-001 Relapsed Refractory AML Post Allo-HSCT: Announce data for currently enrolled patients, which is expected in the first quarter of 2023."

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

NexImmune Reports First Quarter 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "NEXI-001: Enrollment continues, and updated clinical results are expected to be announced in the second half of 2022."

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

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) - 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 1/2 study of NEXI-001 donor-derived multi-antigen-specific CD8+ T-cells for the treatment of relapsed acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2021) - P1/2 | "NEXI-001 has the potential to enhance GvL effect without the associated toxicities of GVHD, cytokine release syndrome, and neurotoxicity . Due to these encouraging results, the trial will proceed with an evaluation of repeated NEXI-001 dosing"

P1/2 data • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Leukemia • Oncology • Sarcoma • Solid Tumor • Transplantation • CCNA1 • CD8 • PRAME • WT1

NexImmune Announces Presentation of Preliminary Phase 1/2 Clinical Data at the 2021 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "NexImmune...today announced that clinical data from its Phase 1/2 dose escalation study of NEXI-001 will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting being held virtually from June 4 – June 8, 2021."

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

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

Preliminary Results from NexImmune’s Phase 1/2 Trial of NEXI-001 in AML Presented at 62nd ASH Annual Meeting and Exposition (GlobeNewswire) - P1/2, N=22; NCT04284228; Sponsor: NexImmune Inc.; "NexImmune...today announced that City of Hope’s Monzr Al Malki, M.D., delivered an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition featuring initial data from the Phase 1/2 trial of NEXI-001 in AML. Entitled 'Preliminary Results of the First-in-Human Study of NEXI-001, a Multi-Antigen Specific CD8+ T Cell Product, in Acute Myeloid Leukemia (AML) Patients with Relapsed Disease after Allogeneic Hematopoietic Cell Transplantation (Allo-HSCT) Demonstrate Early Signs of Safety, Tolerability and Robust Immune Responses'...'NEXI-001...is well-tolerated and capable of triggering early, robust and persistent cell-mediated immune responses,'...the expansion phase of the trial, which is expected to begin in [the first quarter] of 2021."

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

NexImmune Establishes Research Initiative with City of Hope to Focus on Novel Immunotherapeutic Approaches to Leukemia - "City of Hope will combine its world-leading expertise with NexImmune technology to explore tumor escape mechanisms and to identify unique leukemia stem cell targets for next generation immunotherapeutics....'NexImmune has developed a unique and versatile technology platform that lends itself very effectively to important areas of ongoing research in the field of AML,” said Guido Marcucci, M.D."

Media quote

NexImmune to Highlight Preliminary Results from Phase 1/2 Trial of NEXI-001 via Oral Presentation at 62nd ASH Annual Meeting (GlobeNewswire) - "NexImmune...announced today that an abstract containing preliminary data from its first-in-human study of NEXI-001, a multi-antigen specific CD8+ T cell product, in acute myeloid leukemia (AML) patients with relapsed disease has been selected for an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting to be held from December 5-8, 2020."

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

NexImmune Establishes Research Initiative with City of Hope to Focus on Novel Immunotherapeutic Approaches to Acute Myeloid Leukemia (GlobeNewswire) - "NexImmune...announced...that it has signed a research initiative related to its AIM nanoparticle technology with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases....City of Hope is a participating clinical site in the ongoing Phase 1/2 study of NEXI-001. The cancer center will leverage both patient samples from the ongoing NexImmune Phase 1/2 clinical study of NEXI-001 in acute myeloid leukemia (AML) patients with relapsed disease after allogeneic stem cell transplantation and the center’s tumor repository bank of primary leukemia samples, one of the largest collections in the world, to drive the research....'NexImmune has developed a unique and versatile technology platform that lends itself very effectively to important areas of ongoing research in the field of AML,' said Guido Marcucci..."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • 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

NexImmune Completes Dosing of First Cohort in Phase 1/2 Clinical Trial of NEXI-001 in Relapsed Acute Myelogenous Leukemia (AML) (GlobeNewswire) - “NexImmune…announced today that it has completed dosing of the first safety cohort (n=3) in its Phase 1/2 clinical trial for NEXI-001, representing a significant milestone for the Company….The prospective, multi-center, open-label, single-arm, dose-escalating Phase 1/2 study will enroll between 22 to 28 patients.”

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology