ANV419 / Anaveon - LARVOL DELTA

Evaluation of a Pragmatic Approach to Adoptive Cell Therapy (ACT) Using an IL2 Analog (ANV419) vs High Dose IL2 After Tumor Infiltrating Lymphocytes (TIL) Therapy in Patients With Melanoma, NSCLC and Cervical Cancer (PragmaTIL) (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Vall d'Hebron Institute of Oncology | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of ANV419 Alone or in Combination with Approved Treatment in Patients with Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Anaveon AG | Recruiting ➔ Completed | N=130 ➔ 29 | Trial completion date: Dec 2024 ➔ Aug 2024

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion • Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients with Advanced Cancer. (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Anaveon AG | Recruiting ➔ Completed | N=80 ➔ 55 | Trial completion date: Jan 2025 ➔ Jul 2024

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • PD-L1

Tumor treatment with tumor-infiltrating lymphocytes and ANV419 in patients with advanced melanoma The BaseTIL-03M study (DGHO 2024) - P1 | "The study procedures include surgical collection of a tumor lesion, ex vivo TIL expansion, lymphodepletion with cyclophosphamide and fludarabine, followed by TIL transfer and subsequent in vivo TIL stimulation with two doses of ANV419 at 243 μg/kg two weeks apart... TIL-ACT with ANV419 at the dose of 243 μg/kg was feasible and manageable in the first 3 pts in the BaseTIL-03M study. The trial continues enrolment to a planned total of 10 pts."

Clinical • Metastases • Tumor-infiltrating lymphocyte • Cardiovascular • Febrile Neutropenia • Hypertension • Melanoma • Neutropenia • Pain • Solid Tumor • Ventricular Tachycardia

Evaluation of a Pragmatic Approach to Adoptive Cell Therapy (ACT) Using an IL2 Analog (ANV419) vs High Dose IL2 After Tumor Infiltrating Lymphocytes (TIL) Therapy in Patients With Melanoma, NSCLC and Cervical Cancer (PragmaTIL) (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Vall d'Hebron Institute of Oncology

New P2 trial • Cervical Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Balancing the Scales: The Dual Role of Interleukins in Bone Metastatic Microenvironments. (PubMed, Int J Mol Sci) - "Current treatment strategies, such as the use of denosumab, tocilizumab, and emerging agents like bimekizumab and ANV419, highlight the potential of interleukin-targeted therapies in mitigating bone metastases...While not exhaustive, this overview underscores the critical roles of interleukins in bone metastases and highlights the need for continued research to fully elucidate their complex interactions and therapeutic potential. Addressing these gaps will be essential for advancing our understanding and treatment of bone metastases in cancer patients."

Journal • Metastases • Review • Immune Modulation • Immunology • Oncology • Solid Tumor • CXCL8 • IL10 • IL13 • IL4 • IL6

Discovery and development of ANV419, an IL-2/anti-IL-2 antibody fusion protein with potent CD8+ T and natural killer cell-stimulating capacity for cancer immunotherapy. (PubMed, MAbs) - "ANV419 also enhances the NK cell killing capacity and increases tumor growth inhibition when used alongside trastuzumab in a Her-2+ xenograft mouse model...These data support the clinical development of ANV419 in solid tumors and hematological malignancies as monotherapy and in combination with checkpoint inhibitors or agents that induce antibody-dependent cellular cytotoxicity. ANV419 is currently in Phase 1/2 clinical development and may provide cancer patients with a wider therapeutic window than aldesleukin."

Journal • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CD8 • HER-2 • IL2 • PD-1

Combination of artLCMV and ANV419 strongly potentiates the tumor-specific T cell response resulting in complete tumor clearance in a colorectal cancer model (CIMT 2024) - "Furthermore, complete tumor clearance resulted in immunological memory as demonstrated by protection against tumor re-challenge. These preclinical data highlight the great potential of the combination of arenavirus vectors and ANV419 as a next generation cancer immunotherapy."

Preclinical • CNS Disorders • Colorectal Cancer • Gastrointestinal Cancer • Infectious Disease • Oncology • Solid Tumor • CD8 • IL2

Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors. (PubMed, J Immunother Cancer) - "In a separate clinical cohort, we retrospectively measured the residual concentration of nivolumab and pembrolizumab, revealing persistent serum concentrations of anti-PD-1/PD-L1 antibodies even months after treatment cessation. This underscores the importance of comprehensively documenting prior immunotherapy details in clinical trials. Such information is crucial for understanding potential interactions that may impact both immunological and clinical effects."

Journal • Metastases • P1 data • P1 data • Oncology • Solid Tumor • CD8 • IL2

A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Anaveon AG | Trial primary completion date: Jun 2024 ➔ Sep 2024

Combination therapy • Metastases • Monotherapy • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors. (PubMed, J Immunother Cancer) - P1 | "ANV419 at doses up to 243 µg/kg (the RP2D) was well tolerated and showed signs of antitumor activity in a heavily pretreated patient population with advanced solid tumors."

Journal • Metastases • P1 data • Hematological Disorders • Oncology • Solid Tumor • Thrombocytopenia • CD8 • IL2

Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors (J Immunother Cancer) - P1 | N=80 | NCT04855929 | Sponsor: Anaveon AG | "Forty patients were enrolled and received at least one dose of ANV419. The MTD and RP2D were determined to be 243 µg/kg....In the RP2D cohort, Grade ≥3 thrombocytopenia and fever were reported by one patient (12.5%) each. All events were manageable with standard supportive care. At doses of 243 µg/kg (RP2D/MTD), the estimated T1/2 was approximately 12 hours. At ANV419 doses ≥108 µg/kg, 64% of patients had a best response of at least SD (15 SD and 1 confirmed PR)."

P1 data • Solid Tumor

ANV419, a selective IL-2Rβ/γ agonist in patients with relapsed/refractory advanced solid tumors (ESMO 2023) - P1 | "Preliminary anti-tumor activity was observed including durable response in NSCLC. Further studies assessing the antitumor activity of ANV419 in melanoma and myeloma are ongoing."

Clinical • Metastases • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

OMNIA-1: A phase I/II study, an IL-2R-βγ targeted antibody-IL-2 fusion protein, as monotherapy or in combination with anti‑PD-1 or anti-CTLA-4 antibodies, in patients with advanced melanoma. (ASCO 2023) - P1/2 | "Recombinant IL-2 (proleukin) induces durable responses in approximately 10% of patients with melanoma...In Part 3, the efficacy and safety of ANV419 in combination with the approved doses pembrolizumab or ipilimumab will be evaluated using a Simon’s 2-stage design...Preliminary monotherapy efficacy data are expected by Q1/2024. Clinical trial information: NCT05578872."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1/2 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF • CD8 • IL2RA

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2) (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: Anaveon AG | N=52 ➔ 4 | Trial completion date: Mar 2025 ➔ Jul 2023 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Jul 2023; The study was ended due to a lack of recruitment

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

BaseTIL-03M: ACT-TIL and ANV419 for Advanced Melanoma. (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer. (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Anaveon AG | N=60 ➔ 80

Combination therapy • Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • PD-L1

OMNIA-2: Phase I/II study of ANV419, an IL-2R-βγ targeted antibody-IL-2 fusion protein, in patients with relapsed or refractory multiple myeloma. (ASCO 2023) - P1 | " The OMNIA-2 study (ANV419-102; NCT 05641324) will evaluate safety and preliminary efficacy of ANV419 as monotherapy and in combination with daratumumab (dara), or lenalidomide with low dose dexamethasone (lena/dex), in patients with relapsed or refractory multiple myeloma...OMNIA-2 is being conducted in Denmark, France, Germany, Spain, Switzerland, UK and enrolment began in January 2023 and preliminary data are expected in Q1 2024. Clinical trial information: NCT05641324."

Clinical • P1/2 data • Bone Marrow Transplantation • Hematological Malignancies • Immune Modulation • Multiple Myeloma • Oncology • Transplantation • CD8 • IL2RA

BaseTIL-03M: ACT-TIL and ANV419 for Advanced Melanoma. (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: University Hospital, Basel, Switzerland

Metastases • New P1 trial • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Anaveon announces first patient dosed with ANV419 in a Phase I/II Study of ANV419 in patients with multiple myeloma (GlobeNewswire) - "Anaveon...today announced the first patient dosed with ANV419 in the OMNIA-2 (ANV419-102) study - a Phase I/II study assessing the safety, tolerability and preliminary efficacy of ANV419 for the treatment of patients with relapsed / refractory multiple myeloma as monotherapy and in combination with daratumumab and hyaluronidase-fihj1, or with lenalidomide plus dexamethasone. ANV419 is a powerful, IL-2Rb selective IL-2 agonist, which has been specifically designed to enable the delivery of high dose IL-2."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer and Multiple Myeloma. (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Anaveon AG | Trial completion date: Jul 2023 ➔ Dec 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2) (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Anaveon AG | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2024 ➔ Mar 2025

Enrollment open • Trial completion date • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

A phase I/II study of ANV419, a selective IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, in patients with advanced solid tumors. (ASCO 2022) - P1/2 | "Overall, ANV419 is well tolerated and selectively induces expansion and proliferation of CD8 T cells and NK cells, but not Tregs up to a dose of at least 48mcg/kg. Updated data will be shared during the meeting."

Clinical • P1/2 data • Adenoid Cystic Carcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hypotension • Infectious Disease • Inflammation • Melanoma • Nephrology • Oncology • Pain • Renal Cell Carcinoma • Solid Tumor • CD8 • IL2RA

A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Anaveon AG | Not yet recruiting ➔ Recruiting | Trial primary completion date: Mar 2024 ➔ Jun 2024

Combination therapy • Enrollment open • IO biomarker • Metastases • Monotherapy • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Anaveon doses first patient in a Phase I/II Study of ANV419 as monotherapy or in combination with check point inhibitors in patients with advanced melanoma (Businesswire) - "Anaveon...announced the first patient has been dosed in the OMNIA-1 study – a Phase I/II study assessing the efficacy and safety of ANV419 for the treatment of advanced melanoma....Anaveon expects to report initial safety and efficacy data of the OMNIA-1 study by early 2024."

P1/2 data • Trial status • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor