ALETA-001 / Aleta Biotherap - LARVOL DELTA

Aleta Biotherapeutics and Cancer Research UK’s Centre for Drug Development Announce First Patient Dosed in ALETA-001 Phase 1/2 Clinical Trial in Patients with Relapsed/Refractory B-Cell Malignancies (Businesswire) - "Aleta Biotherapeutics...announce the first patient was dosed in a Phase 1/2 clinical trial. This trial is evaluating the Company’s first-in-class biologic CAR T-Cell Engager, ALETA-001, for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19-targeting CAR T-cell therapy."

Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: Cancer Research UK | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CAR T engagers encoding immune checkpoint inhibitors and immune-relevant cytokines stimulate CAR T cell activity against hematologic and solid tumors (SITC 2023) - "ALETA-001 is a biologic CTE that binds to CD20 and displays the CD19 extracellular domain (ECD)...Notably, all these functions are incorporated into the CTE, leaving CAR T engineering as separate tool. CTEs carrying multiple domains designed to simultaneously enhance functionality are being designed and evaluated and will be presented."

CAR T-Cell Therapy • Checkpoint inhibition • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD2 • CD20 • CD276 • CD58 • TGFB2

Aleta aims for pivotal US trial with CAR T-cell engager (Clinical Trials Arena) - "Aleta Biotherapeutics is working to initiate a potentially registrational trial in the US for its CAR T-cell therapy engager (CTE) ALETA-001...The US-based immune-oncology company plans to file an investigational new drug (IND) application to the US Food and Drug Administration (FDA) at the end of H2 2024 but aims to set up a pre-IND meeting by the end of this year. Aleta hopes that the upcoming trial will be a registrational study with an estimated initiation date in Q4 2024 or early 2025, Rennert said. The company plans to enrol 125 patients with B-cell malignancies who are unresponsive after receiving an anti-CD-19 CAR T-cell therapy."

IND • New trial • Hematological Malignancies • Oncology

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies (clinicaltrials.gov) - P1/2 | N=72 | Not yet recruiting | Sponsor: Cancer Research UK

CAR T-Cell Therapy • New P1/2 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Aleta Biotherapeutics Granted MHRA Clinical Trial Authorization for Biologic CAR T-Cell Engager ALETA-001 (Businesswire) - "Aleta Biotherapeutics...announces that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) to evaluate investigational biologic ALETA-001 in a Phase 1/2 clinical trial in the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T-cell therapy....Aleta’s lead program, ALETA-001 has clinical support and funding from its collaboration partner, Cancer Research UK’s Centre for Drug Development, which has sponsored and will conduct the Phase 1/2 clinical trial."

New P1/2 trial • Hematological Malignancies • Oncology

"Cool @BioCentury wrote a nice #SITC22 review of synergy among therapeutic modalities, to better beat down cancers. Includes a profile of our lead program ALETA-001, heading into the clinic very soon. @BioAleta #celltherapy #TCE #carTcells" (@PDRennert)

CAR T-Cell Therapy • Review • Oncology

"Aleta Biotherapeutics Receives Innovation Passport Designation for Biologic CAR T-Cell Therapy Engager ALETA-001 https://t.co/yM2bjDulU5" (@NewsFromBW)

CAR T-Cell Therapy

Aleta Biotherapeutics Receives Innovation Passport Designation for Biologic CAR T-Cell Therapy Engager ALETA-001 (Businesswire) - "Aleta Biotherapeutics...announces that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) for Chimeric Antigen Receptor (CAR) T-cell therapy Engager candidate ALETA-001 for the treatment of patients suffering from the B-cell malignancies, non-Hodgkin lymphoma a (NHL) and Acute Lymphoblastic Leukemia (ALL), and who have failed to respond or have relapsed post-CD19 CAR T-cell therapy. ALETA-001 is expected to enter clinical development in 2023 with Cancer Research UK’s Centre for Drug Development sponsoring and conducting a Phase 1/2a clinical trial."

European regulatory • New P1/2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CAR-T engager proteins for the treatment of B cell cancers and acute myeloid leukemia (AACR 2022) - "ALETA-001 is a CAR-T Engager protein that contains the CD19 extracellular domain (ECD), an anti-CD20 VHH, and an anti-albumin VHH for half-life extension...Finally, CAR-T Engagers directed to AML antigens were able to bind each antigen individually, and mediated potent toxicity with the addition of CAR19 T cells.We conclude that the CAR-T Engager platform offers robust and modular anti-tumor functionality, featuring potent multi-antigen targeting for diverse indications. Finally, we can incorporate other useful immunomodulatory activities into Engager proteins."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CDR2

Characterization of Aleta-001, a CAR T Engager Designed to Optimize Responses and Prevent Relapses from CAR-19 Therapy (ASH 2021) - "Patients who are enrolled will be dosed with the Aleta-001 Engager protein every two weeks. Aleta-001 has entered GMP production and IND enabling studies and will then enter Phase 1 dose escalation clinical studies in the UK."

Hematological Malignancies • Leukemia • Lymphoma • Oncology

Aleta Biotherapeutics Announces ALETA-001 Poster Presentation at the 63rd American Society of Hematology (ASH) Annual Meeting (Businesswire) - "Extensive preclinical in vitro modeling demonstrated that ALETA-001 specifically binds to CD20-positive/CD19 negative lymphoma cells with high affinity, thereby densely coating these cancer cells with the CD19 protein. In the presence of anti-CD19 CAR T cells, ALETA-001 mediated cytotoxicity against CD19 negative lymphoma cells at sub-nM concentrations. The administration of ALETA-001 and anti-CD19 CAR T cells in vivo eliminated systemic CD19 negative lymphoma that otherwise produced lethal disease at doses of ALETA-001 as low as 0.5mg/kg....Our lead development program has won landmark clinical support from Cancer Research UK and will enter Phase 1/2 trials in 2022."

New P1/2 trial • Preclinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma

Aleta Biotherapeutics Announces ALETA-001 Presentation at 63rd ASH Annual Meeting (Businesswire) - "Aleta Biotherapeutics...announced a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting, to be held in Atlanta, Georgia and in a virtual platform on December 11-14, 2021. The presentation will feature preclinical data that support the upcoming Phase 1/2 clinical trial of ALETA-001 being run in collaboration with Cancer Research UK. Extensive preclinical in vitro modeling demonstrated that ALETA-001 specifically binds to CD20-positive/CD19 negative lymphoma cells."

Preclinical • Hematological Malignancies • Oncology

Aleta Biotherapeutics and Cancer Research UK Collaborate to Advance Blood Cancer Therapy Into the Clinic (Businesswire) - "Aleta Biotherapeutics...announced a collaboration to advance the early phase clinical development of Aleta’s CAR-T cell engager candidate, ALETA-001...Under the terms of the clinical development partnership, Cancer Research UK’s Centre for Drug Development will fund, sponsor and conduct the first-in-human Phase 1/2a clinical trial of ALETA-001...Aleta will initiate a multi-center, single arm, pivotal Phase 2 trial in the United States focused on diffuse large B-cell lymphoma (DLBCL) patients. This clinical trial will be designed to support potential accelerated approval of ALETA-001...Aleta retain the rights to further develop and commercialize ALETA-001 and will receive a licence to the results of the clinical trial from Cancer Research UK in return for undisclosed success-based milestone and royalty payments."

Licensing / partnership • New P1/2 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology