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Kazia Therapeutics has 'busy and productive' June quarter with important readouts slated for second half

Published: 15:47 30 Jul 2021 AEST

Kazia Therapeutics Ltd - Kazia Therapeutics has 'busy and productive' June quarter with important readouts slated for the second half
Its cash position as at end June stood at A$27.6 million

Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA) has had a “busy and productive” June quarter as it makes great strides with the paxalisib clinical program, including the launch of two new studies. 

The oncology-focused drug development company is also expecting a number of important read-outs targeted for the second half of the year. 

All upfront payments from outbound partnering transactions in the first quarter have been received by Kazia. 

"Busy & productive" period

Kazia chief executive officer Dr James Garner said: “The second calendar quarter has been a busy and productive period for Kazia, as we bed down three substantial cross-border licensing deals.

“We have continued to make great strides with the paxalisib clinical program, with two new studies launching, and a number of important read-outs are slated for the second half.

“Meanwhile, the EVT801 program is off to a running start, and we are well on track to commence our planned Phase I study before the end of calendar 2021.

"The last two months or so have fully justified our excitement around this new asset, and we are very much looking forward to seeing it in the clinic.”

EVT801 Phase 1 on track

EVT801, a small-molecule, orally available, selective inhibitor of VEGFR3, is on track to meet the milestone of commencing Phase 1 clinical trial in patients with advanced cancer by the end of 2021.

Investigational product for use in the clinical trial has been manufactured and two hospitals in France have been selected to participate.

The study protocol has been submitted for review by L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), the French regulatory agency.

Kazia expects to provide further operational updates during the third quarter of 2021.

Paxalisib collaboration with Cornell University

The collaboration with the Joan & Sanford I Weill Medical College of Cornell University in the US will explore the use of paxalisib in combination with ketogenesis for patients with glioblastoma.

The best way to achieve this is through a ketogenic diet and metformin, and the Cornell study will examine this combination.

Professor Cantley will serve as a scientific advisor to the study and Dr Howard Fine, a highly experienced neuro-oncologist, will serve as principal investigator.

Recruitment to the study is expected to begin in the second half of 2021.

Closer to NDA submission

Kazia has initiated a specialized ‘mass-balance study’ of paxalisib, also known as an ADME (Absorption, Distribution, Metabolism, Excretion) study.

The study will be conducted in the UK and targeted to fully characterize the distribution of paxalisib within the human body and to measure the rate at which it is eliminated.

A single dose of a radiolabelled version of paxalisib will be administered to a small group of healthy volunteers, who are then carefully assessed for about one week to measure excretion of the radiolabelled material.

This data is expected by the US Food and Drug Administration (FDA) as part of a New Drug Application (NDA).

Kazia has therefore incorporated the execution of this study into its development plan for paxalisib, in parallel with GBM AGILE.

Dosing of volunteers is expected to start in August 2021.

The ADME study is technical in scope and is not expected to provide information of a material nature to investors, but Kazia may provide operational updates from time to time.

Kazia’s Garner added: “As we move ever closer to a potential NDA submission for paxalisib, the Kazia team is working hard to build a compelling and exhaustive regulatory dossier.

“GBM AGILE will of course be the centre-piece of our application, but a substantial amount of supportive information will be required to ensure success.

“This ADME study is one instance of the broader body of work required to launch a new product, and we are pleased to be performing this project in CY2021 so that the requisite data is available for our NDA filing.”

GBM AGILE makes excellent progress

GBM AGILE is recruiting ahead of schedule, with more than two dozen sites now open to the paxalisib arm, and expansion to Europe and China slated for the second half of 2021.

To date, GBM AGILE has screened over 650 patients, and this is expected to accelerate as new sites in new territories come online.

Also, the Phase II study of paxalisib in primary CNS lymphoma at Dana-Farber Cancer Institute has commenced recruitment.

As the only brain-penetrant PI3K inhibitor in mainstream development, paxalisib has unique potential in the form of this disease that occurs within the central nervous system.

The Dana-Farber study will examine this new use of the drug, with Dr Lakshmi Nayak, a neuro-oncologist with extensive clinical research experience, serving as principal investigator.

Kazia’s own Phase II study of paxalisib in glioblastoma has completed dosing, with the final patient on study drug having now experienced disease progression, after about 2.3 years on treatment.

It will now work with the investigators to bring the study to a conclusion and to seek publication of final data in a high-quality scientific journal.

Cash position improves

The company’s cash position as of June 30, 2021, stood at A$27.6 million, up from the A$19.7 million recorded at the end of third-quarter FY2021.

The increase principally reflects revenues from partnering transactions.

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