REG - Syncona Limited - iOnctura presents clinical data update

SynconaAnnouncement

11/12/2024 10:45

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RNS Number : 6962P  Syncona Limited  11 December 2024

11 December 2024

 

Syncona Limited

 

iOnctura presents new data and provides clinical update in uveal melanoma

 

Syncona Ltd, ("Syncona") a leading life science investor focused on creating,
building and scaling global leaders in life science, today notes that its
portfolio company iOnctura announced a clinical update and the presentation of
new data from the completed Phase I DIONE-01 study of their lead asset,
roginolisib, at the European Society for Medical Oncology Immuno-Oncology
(ESMO-IO), taking place in Geneva, Switzerland, from 11-13 December 2024.

 

Roginolisib is a first-in-class allosteric (indirect) modulator of PI3K delta
(PI3Kδ), which has potential application across a variety of solid tumour and
haematological cancers. Its unique chemical structure and binding mechanism
makes it highly specific for PI3Kδ, giving it an advantageous pharmacology
and safety profile compared to previous generations of PI3Kδ inhibitors.
Roginolisib is being investigated in solid and haematological cancers
including uveal melanoma (UM), a rare cancer of the eye.

 

Key highlights from the data presentation include:

·      The Phase I DIONE-01 study met its primary objective of
determining the safety of the anticipated optimal biologically effective dose
(BED) of roginolisib

·      Roginolisib was shown to be well tolerated over long periods of
treatment (up to 4.5 years) and was well tolerated at the recommended Phase II
dose (RP2D) of 80mg

·      Median overall survival (OS) was 16 months for the 29 patients
with UM that were treated with roginolisib. These patients previously received
a median of two prior therapies. This exceeds the median of seven months OS
observed in historical controls in patients receiving immunotherapies as
second line treatment 1 

·      Median progression free survival (PFS) was five months for
patients treated with roginolisib versus less than three months for historical
controls 1 

 

Following these positive results iOnctura is initiating its OCULE-01 Phase II
study of roginolisib in UM. A data readout from this trial is expected in
CY2026 and is a key value inflection point for iOnctura 2 .

 

Roel Bulthuis, Managing Partner and Head of Investments of Syncona Investment
Management Limited and Board Director of iOnctura, said: "Data from the Phase
I DIONE-01 study validate roginolisib's differentiated profile as an
allosteric PI3Kδ inhibitor. These early positive results suggests that
iOnctura could potentially become the first company to develop a clinically
meaningful medicine targeting the PI3K cancer pathway, which no company has
been able to target with sufficient precision to date. We look forward to
initial data from the Phase II OCULE-01 study, as well as the expansion of
roginolisib's utility to other indications, including primary myelofibrosis
and non-small cell lung cancer."

 

iOnctura's announcement is copied below and can be accessed at the company's
website at https://www.ionctura.com/ (https://www.ionctura.com/) .

 

 ENDS 

 

Enquiries

 

Syncona Ltd

 

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 20 3981 7912

 

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
creating, building and scaling companies to deliver transformational
treatments to patients in areas of high unmet need.

We aim to build and maintain a diversified portfolio of 20-25 globally leading
life science businesses, across development stage, modality and therapeutic
area, for the benefit of all our stakeholders. We focus on developing
treatments that deliver patient impact by working in close partnership with
world-class academic founders and experienced 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.

Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment in
Syncona Limited, including the information in our published documentation,
before investing.

 

About Key Value Inflection Points

A key value inflection point is a material de-risking event for a portfolio
company that has the potential to drive significant NAV growth for Syncona,
for example by increasing the possibility of a realisation event, such as
M&A. These milestones can also enable companies to access significant
capital including through financings and IPOs, which may take place at
valuation uplifts and underpin progression to a subsequent key value
inflection point which has the potential to drive greater value. M&A or
capital access is unlikely to occur immediately following a key value
inflection point.

 

 

iOnctura reaches new clinical milestones in uveal melanoma

 

·   Completed Phase I DIONE-01 study demonstrates clinical activity and
long-term safety of roginolisib, a unique allosteric modulator of PI3Kδ

·   Patients with uveal melanoma showed a doubling of overall survival
compared to historical controls

·   Site activation ongoing for randomized Phase II OCULE-01 study in uveal
melanoma

 

Geneva, Switzerland and Amsterdam, The Netherlands, 11 Dec 2024 - iOnctura, a
clinical-stage biopharmaceutical company combating neglected and hard-to-treat
cancers, today provides a clinical update on its lead asset, roginolisib.
Results from the completed Phase I DIONE-01 study are due to be presented at
the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) annual
congress tomorrow, 12 December at 12:30 CET (presentation 164P).

Allosteric modulator of PI3Kδ, roginolisib, has a unique chemical structure
and binding mechanism which makes it highly specific for PI3Kδ, giving it an
advantageous pharmacology profile and an unprecedented safety profile compared
to previous generations of PI3Kδ inhibitors.

Roginolisib is being investigated in solid and hematological malignancies
including uveal melanoma (UM), a rare cancer of the eye. Eye melanoma is a
rapidly growing market which is projected to be worth USD 9.56B by 2032( 3 
(#_ftn3) ).

The two-part Phase I study (https://clinicaltrials.gov/study/NCT04328844)
DIONE-01, firstly evaluated continuous daily dosing of roginolisib [at 10, 20,
40 and 80 mg] in 24 patients with pretreated solid tumors and follicular
lymphoma (FL), and secondly evaluated a dose confirmation cohort in 20 UM
patients.

Results from DIONE-01 show:

·      Study met its primary objective to determine the safety of the
anticipated optimal biologically effective dose (BED): Roginolisib was well
tolerated at the recommended Phase II dose (RP2D) of 80mg, with <7% Grade
3/4 treatment-emergent adverse events (TEAEs) considered to be related to
roginolisib. TEAEs did not result in immune-related toxicity, or dose-limiting
toxicity, in either solid tumor or hematological patients. In contrast to
prior PI3Kδ inhibitors, roginolisib dosing did not require dose
modifications.

·      Roginolisib is well tolerated over long periods of treatment, up
to 4.5 years.

·      Median overall survival (OS) was 16 months for the 29 patients with
UM treated with roginolisib, who had previously received a median of two prior
therapies. This exceeds the median OS of 7 months observed in historical
controls in patients receiving immunotherapies as second line treatment(1
(#_ftn1) ).

·      Median progression free survival (PFS) was 5 months for patients
treated with roginolisib versus less than 3 months for historical controls(
(#_ftn1) 1).

·      Clinical findings validate the mechanism of action of
roginolisib: roginolisib reduces immune-suppressive immune cells and
chemokines, UM-related tumor clones (ctDNA) and PI3K-related signaling
indicating a rebalancing of the immune system.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "The Phase I
DIONE-01 data highlight the benefits of roginolisib for patients with uveal
melanoma and advanced cancers. Roginolisib's unique allosteric binding
mechanism has translated into a differentiated beneficial clinical profile,
including a doubling of overall survival compared to historical controls in
uveal melanoma. We are delighted to announce these data support progression of
roginolisib into a randomized Phase II study."

Professor Michele Maio, University of Siena and Principal Investigator of the
roginolisib studies, added: "Being able to continue to investigate roginolisib
in a randomized Phase II study is a positive step to understand more about
this already well tolerated molecule. Roginolisib has given prolonged disease
stabilization to patients with uveal melanoma who have exhausted all other
therapeutic options. So far, these patients have maintained a good quality of
life without major limitations. I'm looking forward to seeing what the Phase
II trial delivers over the coming months."

Activation of trial sites for the Phase II OCULE-01 study (NCT06717126
(https://clinicaltrials.gov/study/NCT06717126?cond=NCT06717126&rank=1) )
investigating roginolisib versus investigator's choice in the second-line+
treatment of uveal melanoma is ongoing.

 
                ENDS

For more information contact:

 

iOnctura

Catherine Pickering

Chief Executive Officer

T: +41 79 952 72 52

E: c.pickering@iOnctura.com

 

Optimum Strategic Communications

Mary Clark / Vici Rabbetts / Elena Bates

T: +44 208 078 4357

E: ionctura@optimumcomms.com

 

 

About iOnctura

iOnctura is a clinical-stage biopharmaceutical company combating neglected and
hard-to-treat cancers with precision oral small molecules that target cancers
in novel ways. The bold new treatments extend lives and improve healthspans,
changing the outlook for patients and their families. Two therapeutic
candidates have progressed into mid-stage clinical development: roginolisib is
the first allosteric modulator of PI3Kδ; and cambritaxestat is the only
autotaxin inhibitor in clinical development to treat cancer. iOnctura BV is
headquartered in Amsterdam, The Netherlands with its wholly owned Swiss
subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by
specialist institutional investors including Syncona, EIC Fund, M Ventures,
Inkef Capital, VI Partners and Schroders Capital.

 

About roginolisib

Roginolisib is an allosteric modulator of PI3Kδ with a unique chemical
structure and binding mode. The PI3K signaling pathway is one of the most
commonly dysregulated pathways in cancer and the precise targeting of the
PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity
profile. Clinical data have demonstrated roginolisib's excellent safety
profile and sustained clinical activity in uveal melanoma (UM), a rare eye
cancer with few available treatments. Site activation for the randomized Phase
II OCULE-01 study in uveal melanoma is ongoing, and Phase II studies in other
cancers, including non-small cell lung cancer and myelofibrosis, are in
planning.

 

 

 

 1  Rantala et al., Melanoma Res., 2019 Dec 29(6):561-568

 2  See definition of key value inflection points in the note section

 3  Emergen Research, Jan 2024

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