Kazia Therapeutics enrols first patient to phase I clinical trial of EVT801 cancer therapy

Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA) has officially enrolled its first patient in its investigational cancer therapy trial.

The oncology-focused drug development company licensed the cancer therapy, known as EVT801, from German biotech Evotec AG in April 2021.

With the first enrolment now complete, Kazia is a step closer to getting its phase one study underway, which will take place in two stages.

Ultimately, the phase one study will focus primarily on understanding the safety, tolerability and pharmacokinetics of EVT801 across a range of doses.

As many as 60 patients will participate in the trial, with the actual number dependent on the emergent safety profile of the drug.

Completion timelines will depend on the number of dose levels tested and Kazia expects to provide further guidance on this as the study progresses.

“Very promising drug candidate”

Commenting on the milestone enrolment, Kazia CEO Dr James Garner said: “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 IUCTOncopole 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.”

Trialling potential cancer therapy

Kazia is nearing the start of its cancer therapy trial, which will see it investigate the safety and tolerability of an emerging drug candidate.

Essentially, EVT801 is a small molecule inhibitor that works against a growth factor receptor known as VEGFR3.

It acts by inhibiting lymphangiogenesis, the formation of new lymphatic vessels around the cancerous tumour.

To date, the cancer therapy has shown compelling evidence of activity in a wide range of preclinical cancer models and appears broadly well-tolerated in animal toxicology studies.

Upcoming study

The first stage of Kazia’s phase one trial is a multiple ascending dose (MAD) study, which is designed to determine the maximum tolerated dose (MTD) and recommended phase two-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 12 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.

Drug candidate heads to the clinic

Evotec SE chief scientific officer Dr Cord Dohrmann commented: “We are very excited to see EVT801 proceed to the clinic.

“The phase one 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 one 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.”

“Need for new therapeutic options”

Kazia’s trial’s lead clinical site is L'Institut Universitaire du Cancer de Toulouse Oncopole (IUCT-Oncopole) in Toulouse, France.

The facility combines several leading clinical cancer treatment facilities with world-class research infrastructure, on an integrated campus that brings together public and private stakeholders, including industry participants.

This 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 upcoming 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 developing targeted therapies and immuno-oncology drugs.

He 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.

Speaking to the pioneer enrolment, Dr Gomez-Roca said: “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.”