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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] , 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-2R bg
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-2R bg 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 un ique 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 .
[1] 11 March 2022
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