REG - Syncona Limited - Anaveon announces initial clinical data

SynconaAnnouncement

11/04/2022 07:00

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RNS Number : 8657H  Syncona Limited  11 April 2022

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  (#_ftn1) , 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 (https://anaveon.com/publications/) , along with the
accompanying poster. The abstract is also available on the AACR website
(https://www.aacr.org/meeting/aacr-annual-meeting-2022/) .

 

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 (http://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 (http://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
(https://www.aacr.org/meeting/aacr-annual-meeting-2022/) and the accompanying
poster will be available in the publications
(https://anaveon.com/publications/) section of Anaveon's website
(https://anaveon.com/publications/) .

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 (mailto: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 (http://www.anaveon.com) .

 

 

 

 

 1  (#_ftnref1) 11 March 2022

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