Anaveon Announces FDA Safe to proceed letter for Investigational New Drug (IND) Application for its no-alpha IL-2 agonist, ANV419

 ANAVEON Biotech Cancer IL-2 Cytokines Bispecific Phase Clinical

Basel, June 9, 2022 – Anaveon, a clinical-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND application for ANV419-101, a Phase I/II mono treatment dose confirmation and combination dose-finding, global study, in patients with advanced cutaneous melanoma.

ANV419, a potent IL-2Rbg agonist, preferentially proliferates CD8 and NK cells over regulatory T cells. The safety profile seen to date will allow for the administration of doses inducing maximal pharmacodynamic effects. The most frequent drug related AEs seen in an ongoing trial include mild Grade 1 chills and low-grade fever a few hours after dosing, which resolved with antipyretic treatment.

“We are excited to bring ANV419 to patients who are most likely to benefit from a truly IL-2Rbg-selective high-dose IL-2 approach,” said Christoph Bucher, Chief Medical Officer at Anaveon.  “We look forward to expanding our clinical program to the US and maximizing the therapeutic potential of ANV419 for patients suffering from cancer.”

About the Phase I/II Clinical Trial

The clinical trial is a Phase I/II multiple arm, open-label study in patients with unresectable or metastatic cutaneous melanoma. The study will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different monotherapy doses of ANV419, as well as in combination with anti-PD1 or anti-CTLA4. Up to 130 patients will be enrolled in the clinical trial.

ENDS

Enquiries
JW Communications
Julia Wilson
Tel: +44 (0)7818 430877
Email: julia.wilson@anaveon.com

About Anaveon:
Anaveon is a clinical-stage biopharmaceutical company, based in Switzerland, that develops biologics to modulate the function of cytokines and provide substantial therapeutic benefit to cancer patients. Our vision is to develop novel immune therapies benefiting patients suffering from a wide variety of diseases with immune pathology. For further information please visit the Company’s website at: www.anaveon.com.

Latest News

29.05.2024
Anaveon announces IND approval of ANV600-001 (EXPAND) Phase I/II clinical study ANAVEON Biotech Cancer IL-2 Cytokines Bispecific Phase Clinical

Anaveon announces IND approval of ANV600-001 (EXPAND) Phase I/II clinical study

— ANV600 combines a non-blocking αPD-1 antibody and an IL-2Rβ/γ selective agonist targeting IL-2 to tumor-specific T cells resulting in proliferation and increase of tumor-killing potential — Basel, 29 May 2024 – Anaveon, a clinical stage, immuno-oncology company, today announced that its Investigational New Drug…
Read more
14.12.2023
Anaveon announces publication of ANV419 Phase I clinical data in the Journal for ImmunoTherapy of Cancer ANAVEON Biotech Cancer IL-2 Cytokines Bispecific Phase Clinical

Anaveon announces publication of ANV419 Phase I clinical data in the Journal for ImmunoTherapy of Cancer

— ANV419 delivers high dose IL-2 to patients with a good safety and tolerability profile —
Basel, December 14, 2023 – Anaveon, a clinical stage, immuno-oncology company, today announced the publication of updated clinical data from the ongoing Phase I study of ANV419…
Read more
01.11.2023
Anaveon announces presentation of ANV600 preclinical data supporting combination therapy with therapeutic PD-1 inhibitors ANAVEON Biotech Cancer IL-2 Cytokines Bispecific Phase Clinical

Anaveon announces presentation of ANV600 preclinical data supporting combination therapy with therapeutic PD-1 inhibitors

— ANV600 is a potent, cis-signaling, IL-2Rβ/γ agonist which efficiently expands intratumoral stem-like CD8+ T cells —
Basel, November 1, 2023 – Anaveon, a clinical stage, immuno-oncology company, today announced that it will present a poster on ANV600 at the 38th Annual Meeting…
Read more
Corporate Positioning & Design, Concept, Webdesign & Code:
Schlatter corporate GmbH
Davidstrasse 45
CH-9000 St.Gallen
schlattercorporate.com
Our website uses cookies to provide you with the best online experience. By using our website, you accept the use of cookies in accordance with our Privacy Policy.
Accept