TIDMSYNC
RNS Number : 9892Y
Syncona Limited
12 September 2022
Syncona Limited
Anaveon presents updated data from Phase I/II study of
ANV419
12 September 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 updated
clinical data from the ongoing Phase I/II study of ANV419 in
patients with solid tumours, as well as new pre-clinical data in
ANV419, in poster presentations at the European Society for Medical
Oncology (ESMO) Congress 2022, taking place in Paris, 9-13
September 2022.
Key highlights are as follows:
-- 26 patients with different cancers progressing after standard
therapy have been dosed across nine dose cohorts
-- ANV419 has demonstrated a very good safety profile relative
to native IL-2; it is well-tolerated and n o patients have
withdrawn from the study due to adverse events, whilst no dose
limiting toxicities have been observed
-- Positive pharmacodynamics and clear selectivity suggest the
company is well positioned to select a potentially effective dose
without incurring the side-effects seen with IL-2 therapies for
future studies
-- E arly signs of potential efficacy in a heavily pre-treated
population with 75% of patients achieving disease stabilisation at
the three highest dose levels; whilst notably o ne patient had a
partial response and went on to demonstrate a sustained and
deepening response with 56% shrinkage at 3 months of treatment
-- On the basis of this data, the company has now initiated a
Phase II programme of ANV419 in melanoma and multiple myeloma
Pre-clinical data for ANV419 in combination with checkpoint
inhibitors was also presented, further supporting the initiation of
Phase II clinical studies.
The full text announcement is contained below and can be viewed
on the company's website , along with the accompanying posters. The
abstracts are available on the ESMO website .
Martin Murphy, Chief Executive Officer and Chair of Syncona
Investment Management Limited, said: "The data being presented at
ESMO demonstrates a very encouraging safety, selectivity and early
potential efficacy profile for ANV419 with 75% of patients
achieving, at least, disease stabilisation at high doses. We
believe this IL-2 agonist could have the potential to make a real
difference to patients in a range of tumour types, without causing
the side effects seen by other IL-2 therapies. We are pleased with
the strong progress the business has made and look forward to the
company progressing its Phase II clinical programme which will
explore the broader potential of ANV419 in various tumour
types."
[S]
Copies of this press release and other corporate information can
be found on the company website at: www.synconaltd.com
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Julia Bradshaw / 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 updated data from the Phase I/II study of
ANV419 during the ESMO Congress 2022
- ANV419 is well-tolerated at high doses and demonstrates
notable safety with strong pharmacodynamic effects and excellent
IL-2R bg selectivity -
- A Phase II program of ANV419 has been initiated in Melanoma
and multiple combination trials, including in Multiple Myeloma, are
in preparation -
Basel, 10 September 2022 - Anaveon, a clinical-stage
immuno-oncology company, today announces updated clinical data from
the ongoing Phase I/II study of ANV419 in patients with solid
tumors, as well as new pre-clinical data further elucidating the
mode of action of this powerful and selective interleukin-2 (IL-2)
agonist, in poster presentations at the European Society for
Medical Oncology (ESMO) Congress 2022, taking place in Paris,
September 9 - 13, 2022.
26 patients in 9 dosing cohorts with different cancers
progressing after standard therapy, received ANV419 once every 14
days at doses up to 243 ug /kg in two-week cycles as an intravenous
infusion over 15 minutes without pre-medication. ANV419 is well
tolerated, and al l drug related events were reversible and
responsive to supportive care therapy. The most common drug related
AEs were low grade (G1 or G2) fever, chills, vomiting and fatigue.
No patients have withdrawn from the study due to AEs and no dose
limiting toxicities have been observed up to and including 243 ug
/kg. Dosing is ongoing in the 364 ug /kg cohort.
Pharmacodynamic evaluation of ANV419 on day 4 post-dosing (cycle
1 and 2) showed a selective and dose dependent proliferation of
CD8+ T and NK cells, with a lower increase of proliferating
Tregs.
In this heavily pre-treated population, 5 patients continue to
receive ANV419 treatment. At ANV419 doses >=108 ug/kg, 75% of
patients achieved at least disease stabilization (5 SD, 1 PR) . One
patient who is still on ANV419 treatment, had a partial response
after two weeks of ANV419 treatment, with 31% shrinkage of tumour
mass and a sustained and deepening response with 56% shrinkage at 3
months of ANV419 treatment.
Dr. Elena Garralda at the Hospital Universitari Vall d'Hebron in
Barcelona, and lead investigator on the study said, "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 in combination with checkpoint
inhibitors were also presented at ESMO. These demonstrate broad
activity of ANV419 on effector cells, supporting the initiation of
Phase II studies assessing ANV419 treatment in indications in which
CD8 T cells and NK cells are involved in tumor resolution as well
as supporting combination studies with checkpoint inhibitors and
treatments acting through antibody-dependent cellular
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 p harmacokinetic 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 are available on the ESMO website and the accompanying
posters will be available in the publications section of Anaveon's
website .
Details of the poster presentations 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, K. 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: K. 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 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.
S
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 .
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