Avacta Group plc TMAC Programme Accelerates: Clinical Trial Planned for Early 2020
03 June 2019 - 7:03PM
Business Wire
Key linker element of Avacta’s novel TMAC™ drug
conjugate to be tested in humans within 12 months
Avacta Group plc (AIM: AVCT), the developer of Affimer®
biotherapeutics and research reagents, announces that it is
planning to submit an IND/CTA application early in 2020 to test the
TMAC™ linker in a phase I study in patients with selected solid
tumours.
In an acceleration of the TMAC programme, Avacta is now in a
position to test this critical TMAC linker in humans, a major
de-risking milestone for the programme, early in 2020 and well
ahead of its original plans.
Avacta’s tumour microenvironment activated drug conjugates
(TMAC) are a ground-breaking new form of cancer immunotherapy,
co-invented with Tufts University Medical School, combining
Affimers with chemotherapies in a single drug, using a linker that
is designed to only release the chemotherapy in the tumour
microenvironment. This allows extremely potent chemotherapies, too
potent to be given to patients systemically, to be combined with
Affimer immune-checkpoint therapies.
In order to test the TMAC linker in humans for the first time, a
standard-of-care chemotherapy called doxorubicin has been modified
with the linker rendering it inactive and harmless until the linker
is cleaved in the tumour, releasing active doxorubicin. Doxorubicin
has well documented safety issues limiting its dosing, and also
limiting the patient sub-group that can be treated. Despite these
issues, the global doxorubicin market is valued at $910m and is
expected to reach $1.4bn by the end of 20251. Avacta’s TMAC linker
has been shown to increase the maximum tolerated dose of
doxorubicin by a factor of six in a pre-clinical study in mice.
Avacta plans to submit an IND/CTA application for a phase I
clinical study of the TMAC linker-doxorubicin early in 2020. The
phase I trial will comprise a dose escalation study in patients
with selected solid tumours including advanced and metastatic
high-grade soft tissue sarcoma. Successful functioning of the TMAC
linker will be reflected in tumour shrinkage as a result of the
release of doxorubicin. Potentially the study will also demonstrate
improved tolerability over standard doxorubicin.
The cancer immunotherapy market is currently worth $60bn and is
predicted to double by 20252. Avacta’s TMAC and bispecific cancer
immunotherapies are designed not only to compete strongly in this
market through improved clinical benefit to patients, but also to
expand the market to patients who do not respond to single
checkpoint inhibitors. Avacta has exclusive rights to commercialise
TMAC drug conjugates.
Dr Alastair Smith, Chief Executive Officer, Avacta Group plc,
commented:
“What is so attractive about Avacta’s Affimer TMAC programme is
that it offers a way to combine chemotherapy with immune checkpoint
inhibitors without exposing the whole body to the same level of the
chemo-toxin.
Whilst immunotherapies offer great promise for cancer patients,
it is well established that only a relatively small sub-group of
patients see durable responses to single immune checkpoint
therapies. Avacta is directly addressing this urgent clinical need
with its novel Affimer TMAC and bispecific programmes.
The function of the linker in the TMAC is critical and I am
delighted that the planned phase I study will allow us to test it
well ahead of our original schedule. This is an important
de-risking step for the TMAC programme and could be a catalyst for
spin-off licensing opportunities for a range of chemotherapies with
improved tolerability. The testing of an Affimer PD-L1 inhibitor,
which will form part of the first full TMAC drug and be the
foundation for bispecific Affimer immunotherapies, will be the
subject of an IND application later in 2020.
It is a hugely exciting period for Avacta and I look forward to
keeping the market updated on our progress.”
Dr Jose Saro MD, Chief Medical Officer, Avacta Group plc,
commented:
“The TMAC linker is a key element of this ground breaking
technology and we are excited to have the opportunity to test it in
the clinic very soon. If successful, not only does it de-risk the
TMAC platform, but it has the potential to significantly increase
any chemotherapy therapeutic index allowing higher chemotherapy
exposure in the tumour microenvironment to be maintained for a
longer period with reduced systemic toxicity.
This could be one of the most important current advances in
developing safer combinations of immunotherapies with
chemotherapies and help Avacta to define a new Affimer-based
standard of care in several solid tumours.”
1.
https://ukblaze.com/2019/05/01/latest-global-doxorubicin-market-report-2019-to-talk-about-historical-development-2014-2018-and-estimated-forecast-2019-2025/
2.
https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
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