Anaveon presents updated data from the Phase I/II study of

– ANV419 is well-tolerated at excessive doses and demonstrates notable security with robust pharmacodynamic results and glorious IL-2Rbg selectivity –

– A Phase II program of ANV419 has been initiated in Melanoma and a number of mixture trials, together with in Multiple Myeloma, are in preparation –

BASEL, Switzerland, Sept. 10, 2022 (GLOBE NEWSWIRE) — Anaveon, a clinical-stage immuno-oncology firm, immediately proclaims updated scientific data from the ongoing Phase I/II study of ANV419 in sufferers with strong tumors, in addition to new pre-clinical data additional elucidating the mode of motion of this highly effective and selective interleukin-2 (IL-2) agonist, in poster shows at the European Society for Medical Oncology (ESMO) Congress 2022, going down in Paris, September 9 – 13, 2022.

26 sufferers in 9 dosing cohorts with completely different cancers progressing after normal remedy, obtained ANV419 as soon as each 14 days at doses as much as 243 µg/kg in two-week cycles as an intravenous infusion over quarter-hour with out pre-medication. ANV419 is properly tolerated, and all drug associated occasions have been reversible and conscious of supportive care remedy. The commonest drug associated AEs have been low grade (G1 or G2) fever, chills, vomiting and fatigue. No sufferers have withdrawn from the study as a consequence of AEs and no dose limiting toxicities have been noticed as much as and together with 243 µg/kg. Dosing is ongoing in the 364 µg/kg cohort.

Pharmacodynamic analysis of ANV419 on day 4 post-dosing (cycle 1 and a couple of) confirmed a selective and dose dependent proliferation of CD8+ T and NK cells, with a decrease improve of proliferating Tregs.

In this closely pre-treated inhabitants, 5 sufferers proceed to obtain ANV419 remedy. At ANV419 doses ≥108 µg/kg, 75% of sufferers achieved no less than illness stabilization (5 SD, 1 PR). One affected person who remains to be on ANV419 remedy, had a partial response after two weeks of ANV419 remedy, with 31% shrinkage of tumour mass and a sustained and deepening response with 56% shrinkage at 3 months of ANV419 remedy.

Dr. Elena Garralda at the Hospital Universitari Vall d’Hebron in Barcelona, and lead investigator on the study stated, “These early data are encouraging and I believe ANV419 has the potential to be a clinically important therapy for patients with different tumor types, both as monotherapy and in combination.”

Preclinical data for ANV419 together with checkpoint inhibitors have been additionally introduced at ESMO. These reveal broad exercise of ANV419 on effector cells, supporting the initiation of Phase II research assessing ANV419 remedy in indications by which CD8 T cells and NK cells are concerned in tumor decision in addition to supporting mixture research with checkpoint inhibitors and coverings appearing by way of antibody-dependent mobile cytotoxicity.

“We are very excited by the safety, selectivity and preliminary efficacy of ANV419 which builds on the data that we presented at AACR earlier this year,” added Christoph Bucher, MD, Chief Medical Officer of Anaveon. “At doses equivalent to high dose IL-2, ANV419 maintains a safety and pharmacokinetic profile which will enable us to select the most effective dose level without incurring the side effects seen by other IL-2 therapies. We will now initiate our Phase II program investigating the efficacy of ANV419 in Melanoma and Multiple Myeloma and look forward to demonstrating the full therapeutic potential of ANV419 for patients.”

Abstracts can be found on the ESMO web site  and the accompanying posters will probably be accessible in the publications part of Anaveon’s web site.

Details of the poster shows are:

Abstract Title: “ANV419, a selective IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, in patients with advanced solid tumors, a phase I/II study”
Presentation Number: 479P
Location: Poster Area Hall 4
Authors:  H. Läubli, G. Alonso, J. Lopez, E. Calvo, M. Jörger, V. Sanchez, D. Di Blasi, A. Nair, Ok. Richter, Ch Huber, J Mouton, S. Costanzo, S. Jethwa, Ch Bucher and E. Garralda
Date/Time: 12 September 2022 at 9:00 CEST – 18:30 CEST

Abstract Title: “ANV419 is a novel CD122-biased IL-2/anti-IL-2 fusion protein with potent CD8 T cell and NK cell stimulating capacity that shows additive efficacy in combination with checkpoint inhibitors and treatments acting through antibody dependent cellular cytotoxicity”
Presentation Number: 39P
Location: Poster Area Hall 4
Authors:  Ok. Richter, N. Egli, L. Petersen, P. Murer, A. Katopodis and Ch. Huber
Date/Time: 11 September 2022 at 9:00 CEST – 18:30 CEST

Anaveon is enterprise a Phase I/II study to judge the security, dosing and scientific exercise of its lead program, ANV419, a robust and selective interleukin-2 (IL-2) agonist in sufferers with strong tumors. The Company is pursuing a number of parallel Phase II packages so as to discover the full therapeutic potential of ANV419. In addition, Anaveon continues its work in creating follow-on compounds to increase on the success of ANV419 by delivering the IL-2 agonist to tumor preventing cells and thus increase the therapeutic potential into much less immunogenic tumors. Alongside this, the Company is constructing on its cytokine engineering experience with preclinical-stage packages harnessing the energy of cytokines for therapeutic functions.

Enquiries
JW Communications
Julia Wilson
Tel: +44 (0)7818 430877
Email: [email protected]

About Anaveon:
Anaveon is a clinical-stage biopharmaceutical firm, based mostly in Switzerland, that develops biologics to modulate the perform of cytokines and supply substantial therapeutic profit to most cancers sufferers. Our imaginative and prescient is to develop novel immune therapies benefiting sufferers struggling from all kinds of ailments with immune pathology. For additional data please go to the Company’s web site at: www.anaveon.com.