Syncona Limited

Anaveon announces initial clinical data from its lead programme ANV419

11 April 2022

Syncona Ltd, a leading healthcare company focused on founding, building and funding a portfolio of global leaders in life science, notes that its portfolio company, Anaveon AG ("Anaveon"), a clinical-stage immuno-oncology company, has announced that the first clinical data from the ongoing Phase I/II study of its lead programme, ANV419, will be presented in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place 8-13 April 2022 in New Orleans. Highlights include:

·    As of the data cut-off date[1], 16 patients across 7 dosing cohorts with different types of progressing cancer had received ANV419

·    ANV419 was shown to be very well-tolerated, with highly favourable safety data, robust and consistent pharmacodynamic effects, and excellent selectivity for inducing proliferation of relevant immune effector cells

·    Based on the highly encouraging mechanistic data from the Phase I/II programme, a Phase II study of ANV419 has been initiated in multiple tumour types, including melanoma, to evaluate clinical efficacy in both monotherapy and combination settings

The full text announcement is contained below and can be viewed on the company's website, along with the accompanying poster. The abstract is also available on the AACR website.

Martin Murphy, Chief Executive Officer of Syncona Investment Management Limited, said: "Anaveon has made excellent progress in delivering on its operational and clinical milestones since Syncona first invested in the company in 2019. Human IL-2 is a known treatment for metastatic melanoma and renal cancer, but the severe, dose-limiting side effects and need for frequent infusions remain challenging. ANV419 is designed to overcome these problems and we are highly encouraged by this initial clinical data showing a compelling safety and pharmacodynamic selectivity profile for ANV419. We look forward to seeing further data from the clinical programme later in 2022, which will explore the clinical activity of ANV419 in patients, with the goal of becoming a best-in-class therapy in the IL-2 space."

Christoph Bucher, MD, Chief Medical Officer of Anaveon, said: "The safety and selectivity of ANV419 observed in the pre-clinical studies have fully translated in the data in this Phase I/II study. 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."

[ENDS]

Copies of this press release and other corporate information can be found on the company website at: www.synconaltd.com 

Enquiries

Syncona Ltd

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 7714 916615

FTI Consulting

Ben Atwell / Tim Stamper

Tel: +44 (0) 20 3727 1000

About Syncona

Syncona's purpose is to invest to extend and enhance human life. We do this by founding and building companies to deliver transformational treatments to patients in areas of high unmet need.

Our strategy is to found, build and fund companies around exceptional science to create a diversified portfolio of 15-20 globally leading healthcare businesses for the benefit of all our stakeholders. We focus on developing treatments for patients by working in close partnership with world-class academic founders and management teams. Our balance sheet underpins our strategy enabling us to take a long-term view as we look to improve the lives of patients with no or poor treatment options, build sustainable life science companies and deliver strong risk-adjusted returns to shareholders.

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.

Anaveon presents compelling data from the Phase I/II study of ANV419 during the AACR Annual Meeting 2022

- 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.

The abstract is available on the AACR website and the accompanying poster will be available in the publications section of Anaveon's website.

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.

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.