REG - Avacta Group PLC - Avacta Announces Data from AVA6000 Phase 1 trial

AvactaAnnouncement

16/01/2025 07:00

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RNS Number : 5772T  Avacta Group PLC  16 January 2025

 

 

Avacta Announces Positive New Data from the AVA6000 Phase 1 trial
Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary
Gland Cancers

 

Meaningful tumor shrinkage observed in five out of 10 patients with partial
and minor responses and 90% disease control rate in patients with salivary
gland cancers

 

Phase 1b expansion cohorts screening patients in triple negative breast
cancer, soft tissue sarcoma and salivary gland cancer

 

 

LONDON and PHILADELPHIA - January 16, 2025 - Avacta Therapeutics (AIM: AVCT),
a life sciences company developing next generation peptide drug conjugates
(PDC) targeting powerful anti-tumor payloads directly to the tumor, today
announced compelling new data in patients with salivary gland cancer (SGC)
from the ongoing Phase 1a trial of AVA6000 in patients with FAP-positive solid
tumors. The data demonstrates robust and meaningful tumor shrinkage in
patients with salivary gland cancers, a disease with no standard therapy
defined in the metastatic setting.

 

AVA6000 is the first peptide drug conjugate in Avacta's pipeline and consists
of doxorubicin conjugated with Avacta's proprietary pre|CISION(®) peptide,
that is specifically cleaved by fibroblast activation protein-alpha (FAP) in
the tumor microenvironment.

 

The key findings include:

·    Among 10 patients treated at the dose of 250 mg/m(2) and above, five
patients demonstrate tumor shrinkage (one partial and four minor responses)

·    Six of these 10 patients are continuing treatment and an additional
two patients, who have reached maximum cycles, are still in follow up for
progression free survival

·    The safety profile of AVA6000 continues to demonstrate a robust
reduction in severe hematologic and cardiac toxicities that are associated
with conventional dose doxorubicin

 

Based on this favorable efficacy and safety data observed in the Phase 1a
trial, Avacta has initiated three Phase 1b expansion cohorts in triple
negative breast cancer, soft tissue sarcoma and salivary gland cancer in the
first and second line setting. Patients are screening and the first patients
to be treated in these expansions are expected imminently in the US.

Christina Coughlin MD, PhD, CEO of Avacta, commented,

"These data highlight the transformative potential of our pre|CISION(®)
peptide drug conjugates in expanding the efficacy of highly potent
therapeutics and support our growing optimism in this program.

"Salivary gland cancer is a devastating disease with no established standard
of care treatment options. AVA6000 demonstrated a clinically meaningful tumor
shrinkage in SGC patients, highlighting its potential as an important new
treatment option for patients with SGC and other solid tumors.

"We look forward to continuing to work with our investigators and the broader
community to explore its potential in SGC and other cancers. We are thrilled
to begin enrollment in the expansion cohorts, and this part of the trial will
also be conducted in less heavily pretreated patients which will allow us to
better understand the potential of AVA6000 in these disease settings with high
unmet need."

These results demonstrate preliminary evidence of durable antitumor activity
in patients with SGC, supported by ongoing RECIST(1) responses (both partial
and minor responses) in a disease setting with no standard of care.  SGC
accounts for 6-8% of head and neck cancers in the US, with approximately 2,500
cases diagnosed in the US each year(2). There is no standard of care for SGC
once patients have developed distant metastasis, with a five year survival
rate of approximately 43%.

Clinical data observations:

 

Out of 10 patients with SGC treated at the dose of 250 mg/m(2) and above, 5
patients experienced clinically meaningful disease shrinkage, including a
confirmed partial response (PR, 45% tumor shrinkage) and four minor responses
(MR, 10-19.5% tumor shrinkage) using RECIST criteria.(1) These data include
the following cases:

 

·    A durable, confirmed PR was observed at 12 weeks in a 79-year-old
male patient. The response is ongoing despite patient discontinuation due to
reaching lifetime maximum of doxorubicin exposure. This patient began their
treatment with AVA6000 in October 2023 following one line of therapy which he
experienced disease progression prior to enrolling in the AVA6000 clinical
trial.

·    Rapid and complete regression of large skin and visceral metastasis
was observed in a 74-year-old male patient experiencing a MR, despite low to
mid-level FAP expression in the cancer-associated fibroblasts alone. A 15%
reduction in parotid and lymph nodal lesions continues at the12 weeks post
scan. This patient began treatment in September 2024 following two prior lines
of therapy to which he experienced disease progression with both therapies
prior to enrolling in the AVA6000 trial.

 

Although these data are reported early in the treatment course of most
patients, it is notable that six patients (of the 10 patients with SGC),
including all five responders, remain on treatment and a further two patients
remain in progression-free follow-up after having received the maximum number
of cycles of AVA6000. Only one patient has reported disease progression as
best response resulting in the disease control rate of 90% in this group of
patients with salivary gland cancers.

 

Treatment with AVA6000 continues to be well-tolerated in both dosing arms,
once every two weeks (Q2W) and once every three weeks (Q3W), with reduced
hematologic and cardiac toxicities compared to conventional dose doxorubicin
at 75 mg/m(2) dosed every 3 weeks. A maximum tolerated dose has not been
identified in either arm of the trial.

 

 

(1) Reduction in the sum of longest diameters (SLD) is used to measure
response per RECIST 1.1 with partial responses having at least a 30% reduction
and minor responses of between >10% and <30% reduction.

(2) American Cancer Society: Key Statistics in Salivary Gland Cancers,
www.cancer.org/cancer/types/salivary-gland-cancer.html.

 

 

-Ends-

 

For further information from Avacta, please contact:

 

 Avacta Group plc                                    www.avacta.com (http://www.avacta.com/)

 Michael Vinegrad, Group Communications

 Director

 Peel Hunt (Nomad and Broker)

 James Steel / Chris Golden / Patrick Birkholm       www.peelhunt.com (http://www.peelhunt.com/)

 ICR Healthcare

 Mary-Jane Elliott / Jessica Hodgson / Max Bennett   avacta@icrhealthcare.com (mailto:avacta@icrhealthcare.com)

 Investor Contact

 Renee Leck                                          renee@thrustsc.com (mailto:renee@thrustsc.com)

 THRUST Strategic Communications

 Media Contact

 Carly Scaduto                                       Carly@carlyscadutoconsulting.com

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 Carly Scaduto Consulting

 

 

About Avacta - www.avacta.com
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Avacta Therapeutics is a clinical-stage life sciences company expanding the
reach of highly potent cancer therapies with the pre|CISION(®) platform.
pre|CISION(®) is a proprietary warhead delivery system based on a
tumor-specific protease (fibroblast activation protein or FAP) that is
designed to concentrate highly potent warheads in the tumor microenvironment
while sparing normal tissues. Our innovative pipeline consists of
pre|CISION(®) peptide drug conjugates (PDC) or Affimer(®) drug conjugates
(AffDC) that leverage the tumor-specific release mechanism, providing unique
benefits over traditional antibody drug conjugates.

 

About the pre|CISION® Platform

The pre|CISION® platform comprises an anticancer payload conjugated to a
proprietary peptide that is a highly specific substrate for fibroblast
activation protein (FAP) which is upregulated in most solid tumors compared
with healthy tissues. The pre|CISION(®) platform harnesses this tumor
specific protease to cleave pre|CISION(®) peptide drug conjugates and
pre|CISION(®) antibody/Affimer® drug conjugates in the tumor
microenvironment, thus releasing active payload in the tumor and reducing
systemic exposure and toxicity, allowing dosing to be optimized to deliver the
best outcomes for patients.

 

About AVA6000: FAP-enabled doxorubicin

The lead pre|CISION® program AVA6000, a peptide drug conjugate form of
doxorubicin, is in Phase 1 studies. It has shown an improvement in safety and
tolerability in clinical trials to date compared with standard doxorubicin and
preliminary signs of clinical activity in multiple patients.

 

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