ANV600 / Anaveon - LARVOL DELTA

ANV600 is a novel PD-1 targeted IL-2Rβγ agonist that selectively expands tumor antigen-specific T cells and potentiates PD-1 checkpoint inhibitor therapy. (PubMed, J Immunother Cancer) - "ANV600 represents a novel approach to delivering IL-2Rβγ agonism specifically to PD-1+ cells while preserving the binding site for PD-1 checkpoint inhibitors. By targeting a non-blocking epitope on PD-1, ANV600 enables the selective expansion of tumor-reactive CD8+ T cells while allowing independent and optimized dosing of both agents. This design ensures combinability with PD-1 inhibitors at clinically relevant doses, including in patients previously treated with checkpoint blockade. These findings support the clinical development of ANV600 as both a monotherapy and a combination therapy in cancer immunotherapy."

Checkpoint inhibition • Journal • Melanoma • Oncology • Solid Tumor • CD8 • IL2

EXPAND-1, a phase I/II study with ANV600, a novel PD-1 targeted IL-2R-βγ agonist, in monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "Research Sponsor: ANAVEON AG. ClinicalTrials.gov Identifier: NCT06470763."

Clinical • Combination therapy • Metastases • Monotherapy • P1/2 data • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8 • IL2RA

ANV600, a cis-signaling αPD-1/IL-2Rβ/γ agonist, expands both CD4+ and CD8+ tumor-specific T cells by acting in the tumor microenvironment and draining lymph nodes (SITC 2024) - P1/2 | "ANV600 has received IND approval for Phase I/II clinical trials to further evaluate its safety and efficacy in cancer patients as monotherapy and in combination with pembrolizumab (NCT06470763). Ethics Approval All animal experiments carried out at Anaveon were approved by the Cantonal Veterinary Office of Basel, Switzerland, and performed in accordance with the Swiss laws for animal welfare and protection and the 'Ethical Principles and Guidelines for Experiments on Animals by the Swiss Academies of Arts and Sciences'. The animal studies performed by Wuxi Biologics or CrownBio were approved by the respective Institutional Animal Care and Use Committees (IACUC)."

Biomarker • IO biomarker • Tumor microenvironment • Oncology • CD4 • CD8 • CX3CR1 • GZMB

Anaveon announces presentation of new data on development compounds ANV700 and ANV600 at the Society for Immunotherapy of Cancer 2024 Annual Meeting (GlobeNewswire) - "Anaveon...today announced that it will present posters on ANV700 and ANV600 at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting being held from Friday, November 8, 2024, to Sunday, November 10, 2024, in Houston, Texas."

Clinical • Oncology • Solid Tumor

A Study Evaluating ANV600 Single Agent or in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (EXPAND-1) (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: Anaveon AG | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor

A Study Evaluating ANV600 Single Agent or in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (EXPAND-1) (clinicaltrials.gov) - P1/2 | N=240 | Not yet recruiting | Sponsor: Anaveon AG

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor

Anaveon announces IND approval of ANV600-001 (EXPAND) Phase I/II clinical study (GlobeNewswire) - "Anaveon...today announced that its Investigational New Drug (IND) application to conduct a Phase I/II study evaluating the safety and clinical activity of ANV600 has been accepted by the FDA. The Company will initiate the first two dose escalation cohorts with ANV600 monotherapy and combination with MSD’s...anti-PD-1 therapy KEYTRUDA (pembrolizumab) as part of a multi cohort study to evaluate the safety and efficacy of ANV600 in multiple cancer indications."

IND • Oncology • Solid Tumor

ANV600 is a novel PD-1 targeted IL-2Rβ/γ agonist that is combinable with therapeutic PD-1 inhibitors (SITC 2023) - "For efficacy studies transgenic human PD-1 mice were implanted subcutaneously with B16F10 or MC38 mouse tumor cells and were treated with ANV600 monotherapy or combination with pembrolizumab or nivolumab. Our data demonstrate proof of concept in mouse tumor models. ANV600 is currently in late preclinical development and the promising combination therapy data presented here warrants its clinical development as co-treatment with established PD-1 CPIs."

Oncology • CD8 • IL2 • PD-L1 • STAT5

Anaveon announces presentation of ANV600 preclinical data supporting combination therapy with therapeutic PD-1 inhibitors (Anaveon Press Release) - "ANV600 combines a unique non-blocking PD-1 targeting approach with an IL-2Rβ/γ selective agonistic principle. This is a first example of a PD-1 targeted cytokine agonist which enables therapeutic combination of existing PD-1 inhibitors with novel PD-1 directed stimulatory cytokines."

Preclinical • Oncology • Solid Tumor

ANV600 is a potent, Cis-signaling, non-alpha IL-2 agonist which efficiently expands intratumoral stem-like CD8 T cells (AACR 2023) - "Non-alpha IL-2-based therapeutic modalities with preferential signaling through the IL-2 beta(CD122)/gamma(CD132) receptor are in clinical development and have the potential to substantially increase the therapeutic index of recombinant IL-2 (aldesleukin) for cancer therapy. ANV600 has potent and selective effects on antigen-experienced CD8 T cells both in human PBMCs and mouse syngeneic tumor models. This agent may be a promising anti-tumor therapeutic against poorly immunogenic tumors and warrants further pharmaceutical development."

Oncology • CD4 • CD8 • FCGR2A • FCGR2B • STAT5

Anaveon announces presentation of a novel development compound at the 2023 American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Anaveon...announced that it will present a poster on ANV600 at the American Association for Cancer Research (AACR) 23rd Annual Meeting being held from Friday, April 14, 2023, to Wednesday, April 19, 2023, in Orlando, Florida....The abstract will be published on Friday, March 31 on an online-only Proceedings supplement to the AACR journal Cancer Research. The accompanying poster will be on display on Anaveon’s website on April 14, 12:00 pm EDT."

New trial • Preclinical • Oncology