SYDNEY, Nov. 4, 2021 /PRNewswire/ -- Kazia
Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused
drug development company, is pleased to announce that it has
commenced enrolment to a phase I clinical trial of EVT801, an
investigational cancer therapy that Kazia licensed from Evotec SE
in April 2021.
Key Points
- EVT801 is a small molecule inhibitor of VEGFR3, and acts by
inhibiting lymphangiogenesis, the formation of new lymphatic
vessels around the tumour. It has shown compelling evidence of
activity in a wide range of preclinical cancer models and appears
broadly well-tolerated in animal toxicology studies.
- Kazia licensed EVT801 from Evotec SE, an international drug
discovery alliance and development partnership company, in
April 2021.
- The phase I study will focus primarily on understanding the
safety, tolerability, and pharmacokinetics of EVT801 across a range
of doses. It is also designed to explore preliminary signals of
clinical efficacy, and to investigate the biological activity of
the drug via a rich suite of sophisticated biomarker analyses.
- The lead clinical site in the study is L'Institut Universitaire
du Cancer de Toulouse Oncopole (IUCT-Oncopole) in Toulouse, France. The lead investigator is Dr
Carlos Gomez-Roca, a medical
oncologist with a strong background in drug development and early
phase clinical trials.
- The phase I study is expected to recruit a maximum of 60
patients, with the actual number dependent on the emergent safety
profile of the drug. Timelines to completion will depend on the
number of dose levels tested, and Kazia expects to provide further
guidance on this as the study progresses.
Dr Carlos Gomez-Roca commented,
"We are pleased to now be enrolling patients to this phase I study
of EVT801. Despite great progress in the treatment of cancer over
recent years, there remains a substantial need for new therapeutic
options in a wide range of tumours. EVT801 has shown promising
preclinical data, and we very much hope that it may now prove
beneficial to our patients."
Kazia CEO, Dr James Garner,
added, "in the six months since we licensed EVT801, the Kazia and
Evotec teams have been working assiduously to execute a
first-in-human study of this very promising drug candidate. It has
been a privilege to work with the team at the IUCT-Oncopole site in
Toulouse, which is one of the
leading cancer centres in France,
and we hope to add an additional centre in the new year. We are
delighted that the study is now open to recruitment. All of us in
Kazia firmly believe that EVT801 has enormous potential as a novel
cancer therapy, and we look forward to working closely with the
investigators to explore that potential."
Dr Cord Dohrmann, Chief Scientific Officer of Evotec SE, said,
"We are very excited to see EVT801 proceed to the clinic. The Phase
I clinical trial will be conducted by Evotec, under the sponsorship
of Kazia, at the renowned IUCT-Oncopole in Toulouse. Evotec will support the management
of the Phase I clinical trial with analyses and biomarker
development, which we anticipate will yield important data for the
validation of the approach and to further contribute to the
development of robust patient stratification strategies for the
further clinical evaluation of EVT801."
Phase I Study Design
The phase I study of EVT801 is designed in two stages. The first
stage is a multiple ascending dose (MAD) study, which is designed
to determine the maximum tolerated dose (MTD) and recommended phase
II dose (RP2D) for EVT801. Patients in the study will receive
EVT801 at low doses, and this will be progressively escalated in
subsequent cohorts as the safety profile of the drug is
determined.
The second stage of the study will recruit twelve patients, of
whom six will have been diagnosed with renal cell carcinoma and six
with soft-tissue sarcoma. All twelve patients will receive EVT801
at the RP2D determined in the first stage. These patients will
participate in intensive analyses to better understand the
biochemical activity of the drug.
In addition to conventional measures of safety, efficacy, and
pharmacokinetics, the phase I study will employ cutting edge
biomarker technologies to provide early insights into the activity
of EVT801. A rich program of tissue and blood biomarker analyses
has been developed by Evotec scientists, in collaboration with the
team at Oncopole. It is expected that these analyses will help to
better understand the effects of the drug in human subjects and may
also help to identify the most responsive patients and provide
early predictors of clinical efficacy.
Kazia is also collaborating with Radiomics, an imaging analysis
organisation based in Belgium, to
apply sophisticated AI-based analyses to the CT and MRI scans
collected during the study. Proprietary machine-learning algorithms
developed by Radiomics can provide exceptionally detailed insights
into the behaviour of the tumour while on treatment, and this
information may help to predict and understand clinical
response.
Clinical Sites
The lead site in the study is the Institut Universitaire du
Cancer de Toulouse Oncopole (IUCT-Oncopole) in Toulouse, France. IUCT-Oncopole combines
several leading clinical cancer treatment facilities with a
world-class research infrastructure, on an integrated campus that
brings together public and private stakeholders, including industry
participants. The centre treats more than 10,000 new patients each
year, and more than one in eight patients are enrolled in clinical
studies.
The lead investigator for the study is Dr Carlos Gomez-Roca, medical oncologist and Chair
of the Early Phase Unit at IUCT-Oncopole, Dr Gomez-Roca's clinical
research is focused on development of targeted therapies and
immuno-oncology drugs. He is a member of ESMO, ASCO, FITC and AACR,
and has contributed to more than 60 peer-reviewed publications,
including as first or second author, in journals such as the
Journal of Clinical Oncology and Annals of
Oncology.
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SOURCE Kazia Therapeutics Limited