Avacta Group plc TMAC Programme Accelerates: Clinical Trial Planned for Early 2020
June 3, 2019
Key linker element of Avacta’s novel TMAC™ drug conjugate to be
tested in humans within 12 months
CAMBRIDGE, England–(BUSINESS WIRE)–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.”
2. https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
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