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KZIA Kazia Therapeutics Limited

Filed: 12 Nov 21, 6:13am

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November, 2021

Commission File Number                         

 

 

Kazia Therapeutics Limited

(Translation of registrant’s name into English)

 

 

Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☑             Form 40-F   ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark if the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes  ☐     No  ☑

If “yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b)

 

 

 


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Kazia Therapeutics Limited (Registrant)

Kate Hill

Kate Hill

Company Secretary

Date 11 November 2021


LOGO

ASX RELEASE

11 November 2021

PNOC STUDY IN CHILDHOOD BRAIN CANCER ENROLS FIRST PATIENT

Sydney, 11 November 2021 – Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that PNOC022 (NCT05009992), a multi-drug phase II study in DIPG and diffuse midline gliomas, has been initiated at the University of California, San Francisco, with the first patient successfully enrolled to the study.

PNOC022 includes Kazia’s investigational drug, paxalisib among the experimental arms and is expected to provide valuable data on the potential use of the drug in this highly aggressive form of childhood brain cancer.

Key Points

 

  

Diffuse intrinsic pontine glioma (DIPG) is the most common of a group of childhood brain cancers known as diffuse midline gliomas (DMGs). The disease has no FDA-approved drug treatments and average survival from diagnosis is approximately 10 months.

 

  

The PNOC022 study is sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC), an international consortium focused on the development of new therapies for brain cancer. It is an adaptive platform study that will examine multiple therapies concurrently, both as single agents and in combination, to determine the optimal approach to treatment.

 

  

The lead investigator in the study is Professor Sabine Mueller, a board-certified neurologist and a pediatric neuro-oncologist with a research program focused on novel therapies for pediatric brain tumors.

 

  

Design of the study has been informed by research performed in Australia at the Hunter Medical Research Institute under the leadership of Associate Professor Matt Dun, who serves as a scientific advisor to the study.

 

  

The study has the potential to recruit up to several hundred patients, with the actual number dependent on emerging results.

 

  

Kazia’s support of the project will consist primarily in provision of study drug.


The Principal Investigator for the study, Professor Sabine Mueller, commented, “No individual drug therapy has ever shown convincing efficacy in this group of patients. We plan to apply novel trial design methodologies to understand the potential for combination therapy, using some of the most promising agents in the global pipeline, to change the outcome in this devastating disease.”

Kazia CEO, Dr James Garner, commented, “We are proud to be part of this important and innovative clinical study. Preclinical data supports the potential for paxalisib to combine well with certain other therapies, and we are keen to see if this approach is similarly promising in the clinic. There remains a desperate need for new treatment options in this disease, and we hope that paxalisib may be able to contribute to better outcomes for patients and their families.”

Clinical Trial Design

PNOC022 will enrol children and young adults with diffuse midline gliomas, a category of brain tumours that includes DIPG. The study will include separate cohorts comprising patients with newly diagnosed disease, patients who have completed initial radiotherapy, and patients who have experienced disease progression after treatment.

At the outset, all patients will be treated with ONC201, combined with either paxalisib or panobinostat. The study employs an adaptive design, in which different arms will be opened and closed based on emerging preclinical and clinical data. The primary endpoint will be the proportion of patients who are progression-free at six months (PFS6) for newly diagnosed patients, and overall survival (OS) for recurrent patients.

The lead investigator, Professor Sabine Mueller, is a board-certified neurologist and paediatric neuro-oncologist whose research focuses on novel therapies in childhood brain cancer. Professor Mueller holds an academic appointment in the Department of Neurology, Neurosurgery and Pediatrics at the University of California, San Francisco (UCSF) and serves as head of the clinical program at the DMG Centre at the Children’s Hospital of the University of Zurich. She obtained her medical degree from the University of Hamburg and also holds a PhD in molecular biology.

The design of the PNOC022 study has been extensively informed by laboratory research in DIPG, and in particular, by research undertaken at the University of Newcastle, Hunter Medical Research Institute (HMRI) in Australia by Associate Professor Matt Dun and colleagues. The HMRI team has conducted laboratory research with paxalisib for several years and has generated a powerful body of data combining paxalisib with other investigational drugs. This research has been partly funded by RUN DIPG, a not-for-profit organisation led by Associate Professor Dun, the DIPG Collaborative, Chad Tough Defeat DIPG Foundation, and the McDonald Jones Foundation.


Paxalisib Clinical Program

The initiation of this trial in PCNSL adds to the pipeline of nine ongoing clinical studies of paxalisib in different forms of brain cancer.

 

Sponsor

  

Phase

  

Indication

  

Registration

Kazia Therapeutics

  II  Glioblastoma  NCT03522298

Global Coalition for Adaptive Research

  II / III  Glioblastoma  NCT03970447

Alliance for Clinical Trials in Oncology

  II  Brain metastases  NCT03994796

Dana-Farber Cancer Institute

  II  

Breast cancer brain metastases

(with Herceptin)

  NCT03765983

Dana-Farber Cancer Institute

  II  Primary CNS lymphoma  NCT04906096

Weill Cornell Medicine

  II  Glioblastoma
(with ketogenic diet)
  TBD

Pacific Pediatric Neuro-Oncology Consortium

  II  DIPG & DMGs  NCT05009992

St Jude Children’s Research Hospital

  I  DIPG (childhood brain cancer)  NCT03696355

Memorial Sloan Kettering Cancer Center

  I  

Brain metastases

(with radiotherapy)

  NCT04192981

For More Information, Please Contact:-

 

  In the United States:  In Australia:

  Joe Green

  Edison Investor Relations

  jgreen@edisongroup.com

  Phone: +1 646-653-7030

  

Jane Lowe

IR Department

jane.lowe@irdepartment.com.au

Phone: +61 411 117 774


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.


CLINICAL TRIAL SUMMARY

 

Study Title

  Combination Therapy for the Treatment of Diffuse Midline Gliomas

Phase of Development

  Phase II

Investigational Product

  

ONC201 (Chimerix, Inc)

 

Panobinostat (SecuraBio, Inc)

 

Paxalisib (Kazia Therapeutics Limited)

Disease Area

  Diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs)

Registration

  NCT05009992

Principal Investigator

  

Professor Sabine Mueller

University of California, San Francisco

Study Description

  This is an adaptive platform study to explore the safety and efficacy of multiple combination treatment regimens in the treatment of children with DIPG and DMGs.

Number of Subjects

  Up to 216 patients

Study Design

  This is a randomized study. Patients will be allocated to one of six experimental arms, which include either monotherapy treatment with one of the investigational products, or combination of ONC201 with either panobinostat or paxalisib.

Patient Population

  DIPG and DMGs

Endpoints

  The primary endpoint of the study is progression-free survival at six months (PFS6).

Participating Centres

  

University of California, San Francisco

Other sites in the PNOC consortium will be opened as operational considerations permit

Start Date

  First Patient In: November 2021

End of Recruitment

  Last Patient In (anticipated): CY2025