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Coiled TherapeuticsAnnouncement

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RNS Number : 5358Z  Coiled Therapeutics PLC  08 April 2026

8 April 2026

Coiled Therapeutics plc

("Coiled Therapeutics" or the "Company")

 

Clinical Trial Update

Enhanced Efficacy Signal and Strategic Transition to Dose Expansion

 

Coiled Therapeutics plc (AIM: COIL), the clinical-stage oncology company
developing precision medicines for hard-to-treat cancers, provides an update
on its clinical trial (NCT06136884) evaluating AO-252, a first-in-class TACC3
inhibitor.

 

Key Highlights

 

·      Superior Efficacy in BID Cohort: The transition to a Twice-Daily
("BID") dosing regimen (Cohort 4b) has delivered an 80% Clinical Benefit Rate
("CBR"), a significant improvement over the 40% CBR observed in the Once-Daily
("QD") cohort. A particularly notable result has been observed in a
leiomyosarcoma patient, who achieved Stable Disease after just two cycles of
AO-252, despite having received nine prior lines of therapy.

·      Durable Clinical Responses: 80% of evaluable patients in the BID
cohort achieved tumour stabilisation or regression, with treatment durations
exceeding six months. This substantially outperforms the two to three month
benchmark typically seen with salvage therapy in this heavily pre-treated
population.

·      Benign Safety Profile Maintained: AO-252 continues to
demonstrate excellent tolerability with no serious adverse events observed to
date. The Maximum Tolerated Dose ("MTD") has not yet been reached, allowing
for continued dose escalation to optimise therapeutic impact.

·      Transition to dose expansion: Following encouraging signals, the
Company is accelerating the transition to targeted dose expansion cohorts in
ovarian and prostate cancers, with an enrolment target of 40 patients by Q3
2026.

·      Highly differential Immune-Modulatory Potential: Emerging data
confirms AO-252's unique dual-action profile, combining direct cytotoxicity
with immune-system activation via the cGAS/STING pathway.

·      Operational Milestones: On track to complete dose escalation in
H1 2026, with a next-generation formulation to optimise dosing/efficacy and
combination therapy protocols scheduled for mid-2026.

 

Sridhar Vempati, Chief Executive Officer of Coiled Therapeutics, commented:

"Following our recent successful admission to AIM, we are pleased to share a
meaningful clinical trial update that demonstrates real and tangible clinical
progress with AO-252. The data from Cohort 4b is transformative, achieving an
80% Clinical Benefit Rate and durable responses in such a heavily pre-treated
patient population validates our BID dosing strategy and underscores the
potential of TACC3 as a high value target in oncology.

 

Furthermore, the emerging evidence of AO-252's immune-modulatory activity
positions it as a rare small molecule capable of engaging both direct tumour
killing and immune activation. This would place AO-252 among a rare class of
small molecules capable of engaging both direct cytotoxic and
immune-activating mechanisms, considerably expanding its potential therapeutic
applications and combination strategies.

 

With dose escalation on track for completion in H1 2026 and multiple data
readouts expected across the year, we believe 2026 will be a transformational
year for Coiled Therapeutics with key data catalysts that will drive value. We
look forward to updating shareholders as these milestones are achieved."

 

Phase I Clinical Trial Update

Enrolment and dose escalation

The ongoing Phase I/II open-label dose escalation study of AO-252 in patients
with advanced solid tumours has enrolled 31 patients to date, of whom 25 are
evaluable for safety and dose-limiting toxicity ("DLT") assessment and 21 are
evaluable for efficacy. As previously guided, dose escalation remains on track
for completion in H1 2026.

 

Efficacy: step-change with BID dosing

The transition to a BID dosing regimen in Cohort 4b has produced a clinically
meaningful step-change in disease control. An 80% CBR has been observed in
Cohort 4b, compared to 40% in the QD Cohort 4a, reflecting the importance of
sustained drug exposure at therapeutic levels. Four out of five evaluable
patients in Cohort 4b demonstrated tumour stabilisation or regression.
Notably, treatment duration in this cohort has exceeded six months,
substantially longer than the two to three months typically achieved with
salvage therapy in these heavily pretreated populations (median of five prior
lines of therapy).

 

Immune-modulatory activity

An important and differentiated scientific observation has emerged from both
preclinical and emerging clinical data: AO-252 appears to possess meaningful
immune-modulatory activity, consistent with its known ability to stimulate the
cGAS/STING pathway and activate dendritic cells and M1 macrophages. This
positions AO-252 as a potentially rare small molecule capable of directly
activating the immune system in addition to its direct anti-tumour cytotoxic
effects. The Company believes this immune-modulatory property could
significantly enhance AO-252's utility in combination regimens, including with
immuno-oncology agents, and broadens its differentiated therapeutic profile
and commercial appeal.

 

Pharmacokinetics and formulation development

Analysis of clinical pharmacokinetic data has identified distinct drug
exposure variances between male and female patients. This finding is being
incorporated into refined dose modelling to ensure optimal efficacy and safety
parameters as the programme advances. A dedicated sub-arm of Cohort 4b is
currently evaluating the impact of food on AO-252 absorption, with efficacy
and pharmacokinetic data expected in late Q2 2026.

 

In parallel, a next-generation formulation of AO-252 is on track for
introduction in mid-2026. The refined formulation is designed to further
improve drug exposure to attain maximal efficacy and duration of therapy.

 

Combination therapy development

Leveraging AO-252's immune-modulatory backbone and its demonstrated synergy
with immuno-oncology and antibody-drug conjugate agents in preclinical
studies, the Company is actively developing a combination therapy protocol.
Study initiation is targeted for Q3 2026, with a view to exploring AO-252's
potential in multi-agent oncology regimens.

 

Outlook & Key Milestones

The Company is preparing to transition from the current broad dose escalation
strategy to targeted dose expansion cohorts focused primarily on ovarian and
prostate cancer indications where early clinical signals have been
particularly encouraging and where commercial interest from large
pharmaceutical companies is strong. The Company is targeting enrolment of 40
patients by Q3 2026.

 

Strategic engagement with Key Opinion Leaders (KOLs) continues to refine the
clinical development strategy, ensuring that study design and patient
selection remain aligned with the emerging scientific understanding of
AO-252's unique mechanism of action.

 

Key milestones for 2026 are summarised below:

·     H1 2026: Completion of Phase I dose escalation; preliminary
proof-of-concept safety and efficacy data from dose escalation phase.

·     Late Q2 2026: Food-effect sub-arm data from Cohort 4b
pharmacokinetic study.

·     Mid-2026: Introduction of refined next-generation formulation of
AO-252.

·     Q3 2026: Initiation of combination therapy protocol study;
40-patient enrolment target reached.

·     H2 2026: Comprehensive expansion cohort efficacy and safety data
readouts in ovarian and prostate cancer; potential Phase II registrational
trial planning and commercial discussions.

 

 

Enquiries:

 Coiled Therapeutics plc

 Sotirios Stergiopoulos (Chairman)                                          Via Burson Buchanan

 Sridhar Vempati (CEO)

 SP Angel Corporate Finance LLP (Nominated Adviser and Joint Broker)  +44 (0)20 3470 0470

 David Hignell / Adam Cowl / Devik Mehta (Corporate Finance)

 Vadim Alexandre / Rob Rees (Corporate Broking)

 Shard Capital Partners LLP (Joint Broker)                            +44 (0)20 4530 6926

 Damon Heath

 CPS Capital Group Pty Ltd (Joint Broker)                             +61 (0)8 9223 2222

 Jason Peterson / David Valentino

 Burson Buchanan (Public Relations)                                   +44 (0)20 7466 5000

 Henry Harrison Topham / Jamie Hooper / Toto Berger

 

 

About Coiled Therapeutics plc

Coiled Therapeutics (AIM: COIL) is an AIM-listed, clinical-stage biotechnology
company focused on developing innovative precision oncology therapies. Its
lead programme, AO-252, is a novel TACC3 inhibitor currently in Phase I
clinical trials in the USA (trials ID: NCT06136884).  Coiled Therapeutics is
actively enrolling patients to test for safety and efficacy in patients whose
cancer has progressed on other treatments.   The Company is also assessing
its STAT-6 siRNA programme for immunology indications. Coiled Therapeutics is
supported by a leadership team with a proven track record in drug development
and strategic backing from A2A Pharmaceuticals.

 

About AO-252

AO-252 is a first-in-class, orally administered, brain-penetrant small
molecule inhibitor of Transforming Acidic Coiled-Coil containing protein 3
(TACC3). TACC3 is a validated oncology target that is frequently overexpressed
in many aggressive, hard-to-treat solid tumours but is dispensable in normal
adult cells, providing a wide therapeutic window.

 

By selectively disrupting cancer-critical protein-protein interactions at the
TACC3 C-terminal domain, AO-252 induces mitotic and replication stress,
impairs DNA damage repair, and triggers cancer cell death. Notably, AO-252 has
demonstrated the ability to cross the blood-brain barrier, addressing a
significant unmet medical need for the treatment of brain metastases.

 

The asset is currently in an ongoing Phase I open-label dose-escalation study
and early clinical signals have shown encouraging anti-tumour activity and a
benign safety profile, with the Company planning to initiate dose expansion
cohorts in lead indications, including prostate and ovarian cancer, during
2026.

 

For more information, please visit: www.coiledplc.com
(http://www.coiledplc.com/)

 

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