– ANV419 is very well-tolerated and demonstrates exceptional safety with strong pharmacodynamic effects and excellent IL-2Rbg selectivity –
– A Phase II program of ANV419 has been initiated in multiple tumor types, including melanoma, alongside multiple combination trials –
Basel, 8 April, 2022 – Anaveon, a clinical-stage immuno-oncology company, today announced first clinical data from the ongoing Phase I/II study of ANV419, a powerful and IL-2Rbg selective agonist, in patients with solid tumors, in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, Louisiana, April 8 to April 13, 2022.
As of the March 11, 2022 data cut-off date, 16 patients in 7 dosing cohorts with different types of progressing cancer received ANV419 every 14 days. ANV419, administered intravenously over 15 minutes was exceptionally well tolerated with most patients experiencing a mild Grade 1 infusion-related reaction with chills and low-grade fever a few hours after dosing, which resolved with antipyretic treatment. No patients experienced a Grade 3 or worse drug related AE and no patients have withdrawn from study due to AEs. No dose limiting toxicities have been observed.
Pharmacodynamic (PD) evaluation on day 4 after ANV419 showed a dose dependent increase of Ki-67 positivity in CD8+T cells and NK cells but not regulatory T cells.
In this heavily pre-treated population, 5 patients continue on ANV419 treatment, with 2 patients achieving stable disease beyond 10 weeks.
Based on the favorable ANV419 safety data across the Phase I/II study and the robust and consistent PD and Pharmacokinetic (PK) data over multiple cycles, a Phase II program of ANV419 has been initiated in multiple tumor types, including melanoma, to evaluate efficacy as monotherapy as well as in multiple combination studies.
Dr. Elena Garralda at the Hospital Universitari Vall d’Hebron in Barcelona, and lead investigator on the study said, “ANV419 has the potential of being a best-in-class IL-2 therapy for the treatment of multiple tumor types, both as a stand-alone and as a combination therapy.”
“The safety and selectivity of ANV419 observed in the pre-clinical studies have fully translated in the data in this Phase I/II study,” added Christoph Bucher, MD, Chief Medical Officer of Anaveon. “The long half-life of ANV419, we believe, has the potential to allow us to select the most appropriate dose level without incurring the side effects seen by other IL-2 therapies. The unique characteristics of ANV419 point to its potential as a transformational therapy for patients with cancer, both as monotherapy and in combination with other therapies.”
Details of the poster presentation are:
Poster Title: “ANV419, an IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, induces selective effector cell proliferation in patients with progressed cancer”
Presentation Number: CT140
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 35
Poster Board Number: 7
Authors: Elena Garralda, Guzman Alonso, Juanita Lopez, Heinz Läubli, Emiliano Calvo4, Christoph Huber, Nicole Egli, Kirsten Richter, Laetitia Petersen, Carlo Lanza, Sangeeta Jethwa, Silvio Costanzo, Aswathy Nair, Julie Mouton, Daniela Di Blasi, Christoph Bucher
Date/Time: April 11, 2022 at 1:30 pm – 5:00 pm ET
Anaveon is undertaking a Phase I/II study to evaluate the safety, dosing and clinical activity of its lead program, ANV419, a powerful and selective interleukin-2 (IL-2) agonist in patients with solid tumors. The Company is pursuing multiple parallel Phase II programs in order to explore the full therapeutic potential of ANV419. In addition, Anaveon continues its work in developing follow-on compounds to expand on the success of ANV419 by delivering the IL-2 agonist to tumor fighting cells and thus expand the therapeutic potential into less immunogenic tumors. Alongside this, the Company is building on its cytokine engineering expertise with preclinical-stage programs harnessing the power of cytokines for therapeutic purposes.
Tel: +44 (0)7818 430877
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.
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