TWO ABSTRACTS AT AACR CONFERENCE PRESENT DETAILED STUDY DESIGN AND INNOVATIVE BIOMARKER STRATEGY FOR ONGOING PHASE I STUDY OF EVT801 IN ADVANCED CANCER

Rhea-AI Summary

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) announced two poster presentations at the AACR Annual Meeting in New Orleans, detailing the phase I study of EVT801, a VEGFR3 inhibitor targeting advanced cancer. The study aims to assess safety, tolerability, and pharmacokinetics while employing innovative biomarker strategies to identify effective patient profiles. EVT801 is a promising candidate licensed from Evotec and commenced patient recruitment in November 2021, with initial data expected in the second half of 2022.

Positive

• EVT801 demonstrates preclinical efficacy in inhibiting tumor growth and shows synergy with immuno-oncology therapies.
• Phase I trial of EVT801 actively recruiting patients, indicating strong development momentum.
• Innovative biomarker strategies employed in the study could enhance understanding and optimization of future trials.

Negative

• None.

SYDNEY, April 8, 2022 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), a late stage, oncology-focused drug development company, is pleased to announce two presentations detailing the ongoing phase I study of the company's investigational novel drug, EVT801, a selective VEGFR3 inhibitor with potential application in a variety of cancers.

The poster presentations describe the study design and a highly innovative biomarker strategy employed in the study and are being delivered at the Annual Meeting of the American Association for Cancer Research (AACR), held in New Orleans, LA from 8 – 13 April 2022.

Key Points

• EVT801 is a novel inhibitor of VEGFR3, a receptor involved in the formation of new lymphatic vessels around a growing tumour. Preclinical data has demonstrated that EVT801 is able to inhibit the growth and spread of new tumours and combines synergistically with immuno-oncology therapies.
• EVT801 was licensed to Kazia by Evotec SE (FRA: EVT), a leading European drug discovery and development company, in April 2021. The two companies have collaborated to launch a phase I clinical trial with EVT801 in patients with advanced cancer (NCT05114668), which commenced recruitment in November 2021.
• In addition to characterizing the safety, tolerability, and pharmacokinetics of the drug, the phase I study employs a suite of highly innovative biomarkers to better characterize the potential efficacy of EVT801, and to identify patients who may benefit most. These novel strategies are the primary subject matter of the posters presented at AACR.

Kazia CEO, Dr James Garner, commented, "EVT801 is an exciting new drug candidate with enormous potential, and it is fitting that the study we launched in partnership with Evotec is similarly innovative. The sophisticated biomarker strategies employed in this study should give us a much richer and more detailed understanding of the drug than is usual at this stage of development, and those insights should in turn allow us to optimize future trials to enhance the likelihood of success for EVT801."

The posters will be presented in person at the meeting by Dr John Friend (Kazia Therapeutics), Dr Pierre Fons (Evotec), and Dr Marie Mandron (Evotec).

The phase I clinical trial of EVT801 is currently recruiting patients at two sites in France. Initial data is provisionally expected in 2H CY2022.

Summary of Abstracts

SESSION PO.CT01.03 - Phase I Trials in Progress 1

April 12, 2022 – 9:00am-12:30pm

Abstract CT206 / 6 - EVT801, a novel selective VEGFR-3 inhibitor targeting tumor angiogenesis, started enrollment for its phase I first-in-human study

Carlos Gomez Roca, Philippe Cassier, Marie Mandron, Myriam Estrabaut, Nathalie Delesque-Touchard, Adam C. Smith, Amy Klawitter, Leesa Gentry, Pierre Fons, Michael R. Paillasse, Lise Davenne, Michael Fitzgerald, James Garner, Jean-Pierre Delord.

Oncopole IUCT, Toulouse, France; Centre Léon Bérard, Lyons, France; Evotec, Toulouse, France; Evotec, Princeton, NJ; Kazia Therapeutics, Sydney, Australia

SESSION PO.TB05.01 - Tumor Angiogenesis

April 12, 2022 – 1:30pm-5:00pm

Abstract 3203 / 1 - Cutting edge biomarkers strategy to provide early insights into activity of EVT-801, a novel selective VEGFR-3 inhibitor that targets tumor angiogenesis during the FIH clinical trial

Michael R. Paillasse, James Garner, Michael Fitzgerald, Lise Davenne, Pierre-Benoit Ancey, Celine Poussereau-Pomie, Michael Esquerre, Gaelle Badet, Joel Tuyaret, Marie Mandron, Philippe Rochaix, Maha Ayyoub, Clara Maria Scarlata., Christine Ménétrier-Caux, Christophe Caux, Philippe Cassier, Jean-Pierre Delord, Carlos Gomez Roca, Pierre Fons.

Evotec, Toulouse, France; Kazia Therapeutics Limited, Sydney, Australia; Oncopole IUCT, Toulouse, France; Centre Léon Bérard, Lyon, Franc

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an oncology-focused drug development company, based in Sydney, Australia.

Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Eight additional studies are active in various forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.

For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.

This document was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.

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SOURCE Kazia Therapeutics Limited

FAQ

What is the purpose of the phase I study of EVT801 by Kazia Therapeutics?

The phase I study aims to assess the safety, tolerability, and pharmacokinetics of EVT801, a VEGFR3 inhibitor, in patients with advanced cancer.

When did patient recruitment for the EVT801 trial begin?

Patient recruitment for the EVT801 trial commenced in November 2021.

What key information was presented at the AACR Annual Meeting regarding EVT801?

Two presentations highlighted the study design and innovative biomarker strategies for EVT801 during the AACR Annual Meeting.

What is the expected timeline for initial data from the EVT801 trial?

Initial data from the EVT801 trial is provisionally expected in the second half of 2022.

Who are the partners involved in the development of EVT801?

Kazia Therapeutics is collaborating with Evotec SE on the development of EVT801.