<SEC-DOCUMENT>0001193125-19-243344.txt : 20190912
<SEC-HEADER>0001193125-19-243344.hdr.sgml : 20190912
<ACCEPTANCE-DATETIME>20190912060402
ACCESSION NUMBER:		0001193125-19-243344
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20190912
FILED AS OF DATE:		20190912
DATE AS OF CHANGE:		20190912

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			KAZIA THERAPEUTICS LTD
		CENTRAL INDEX KEY:			0001075880
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-29962
		FILM NUMBER:		191089453

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077
		BUSINESS PHONE:		01161298780088

	MAIL ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NOVOGEN LTD
		DATE OF NAME CHANGE:	19981228
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d803962d6k.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<HTML><HEAD>
<TITLE>FORM 6-K</TITLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form 6-K
</B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE 13a-16 OR 15d-16 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of September, 2019 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number
<U>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Kazia
Therapeutics Limited </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of registrant&#146;s name into English) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive office) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
20-F&nbsp;&nbsp;&#9745;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Form 40-F&nbsp;&nbsp; &#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>: 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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>:
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&#146;s &#147;home country&#148;), or under the rules of the home country exchange on which the registrant&#146;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&#146;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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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&nbsp;&nbsp;&#9744;&nbsp;&nbsp;&nbsp;&nbsp; No&nbsp;&nbsp;&#9745; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If
&#147;yes&#148; is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b) </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Kazia Therapeutics Limited</B> <B></B>(Registrant) </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Kate Hill </U></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kate Hill </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Company Secretary </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date 12 September 2019 </P>
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<IMG SRC="g80396211ot1.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ASX RELEASE </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">12&nbsp;September 2019 </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>ST JUDE STUDY OF <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> IN DIPG SUCCESSFULLY COMPLETES FIRST </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>STAGE; SECOND PART OF STUDY NOW UNDERWAY </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 12</B><B></B><B>&nbsp;September 2019</B> &#150; Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology
company, is pleased to announce that St Jude Children&#146;s Research Hospital has successfully completed the first stage of its ongoing phase I study of Kazia&#146;s investigational new drug, <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in
diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas, which represent a group of childhood brain cancers with high unmet need. The study has determined an appropriate dose for paediatric use, and will now advance into the second
stage of the study, which is designed to explore preliminary signals of efficacy in this disease. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr.&nbsp;Christopher Tinkle, <FONT
STYLE="white-space:nowrap">co-Lead</FONT> Investigator on the study, commented, &#147;to date, thirteen patients have received <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in our study. We have determined a maximum tolerated dose (MTD) in the
pediatric setting of 27 mg/m<SUP STYLE="font-size:85%; vertical-align:top">2</SUP>, which we would expect to be approximately equivalent to the doses currently being explored in adult studies. The safety profile of the drug in children appears to be
broadly similar to that in adults, and we have encountered no unexpected findings in this regard. It would be premature to draw conclusions regarding potential efficacy, but we now embark on an expansion cohort to explore the clinical effects of the
drug in this patient group. My colleagues and I are very pleased with progress and look forward to reporting further data from the study.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Key
Points </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">St Jude Children&#146;s Research Hospital is conducting a phase I human trial of Kazia&#146;s <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> in diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas. The study is registered on clinicaltrials.gov as NCT03696355. </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The St Jude study is led by Dr.&nbsp;Christopher Tinkle, Assistant Member in the St Jude Department of Radiation
Oncology, and Dr.&nbsp;Amar Gajjar, Chair of the St Jude Department of Pediatric Medicine and <FONT STYLE="white-space:nowrap">co-leader</FONT> of the Brain Tumor Program. </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The study commenced recruitment in November 2018. To date, thirteen patients have received treatment with <FONT
STYLE="white-space:nowrap">GDC-0084.</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The first part of the study was designed to determine a maximum tolerated dose (MTD) in the pediatric setting.
The study will now proceed into an expansion cohort, designed to seek preliminary signals of efficacy. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The first part has now completed and has reported a pediatric MTD of 27 mg/m<SUP
STYLE="font-size:85%; vertical-align:top">2</SUP>. </P></TD></TR></TABLE> <P STYLE="margin-top:48pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Board of Directors</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Mr Iain Ross </B>Chairman,<B> </B><FONT STYLE="white-space:nowrap">Non-Executive</FONT> Director <B> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Mr Bryce Carmine </B><FONT STYLE="white-space:nowrap">Non-Executive</FONT> Director <B> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Mr Steven Coffey </B><FONT STYLE="white-space:nowrap">Non-Executive</FONT> Director <B> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Dr James Garner </B>Chief Executive Officer, Managing Director </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia CEO, Dr James Garner, commented, &#147;DIPG is a devastating illness with a poor prognosis and a
paucity of effective treatments. It has been a privilege to support the St Jude team on this incredibly important project. The study has recruited well ahead of our expectations, and we are delighted to have the first part successfully completed.
Toxicity can be a significant challenge in the treatment of childhood cancer, so it is very encouraging that <FONT STYLE="white-space:nowrap">GDC-0084</FONT> appears to have an acceptable tolerability profile. We are excited to see further data in
due course.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Background </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Diffuse midline
gliomas, including DIPG, represent one of the most aggressive childhood cancers, and several hundred new cases are diagnosed in the United States each year. Median life expectancy from diagnosis is estimated to be
<FONT STYLE="white-space:nowrap">9-11</FONT> months, and there is no approved pharmacological therapy. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The PI3K pathway is frequently activated in these
tumours, and so there is a persuasive rationale to explore a brain-penetrant PI3K inhibitor such as <FONT STYLE="white-space:nowrap">GDC-0084.</FONT> <FONT STYLE="white-space:nowrap">GDC-0084</FONT> has shown evidence of activity against a wide
range of DIPG cell lines in work undertaken by Professor Matt Dun&#146;s team at the University of Newcastle. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">St. Jude Children&#146;s Research Hospital,
based in Memphis, Tennessee, is leading the way the world understands, treats and cures childhood cancer and other life-threatening diseases. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children.
Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20&nbsp;percent to 80&nbsp;percent since the hospital opened more than 50 years ago. St. Jude freely shares the breakthroughs it makes, and every child
saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment, travel, housing and food &#151; because all a family should worry about is
helping their child live. To learn more, visit stjude.org or follow St. Jude on social media at @stjuderesearch. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Growing Focus on DIPG </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the past twelve months, Kazia has devoted increasing resources to investigating <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in DIPG. Aside from the
phase I clinical trial at St&nbsp;Jude, Kazia has an ongoing collaboration with Professor Matt Dun&#146;s team at the University of Newcastle. Professor Dun and his colleagues are undertaking cutting-edge preclinical research with <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> in DIPG. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, Kazia has recently been pleased to launch a preclinical collaboration with the
University Children&#146;s Hospital in Zurich, under the oversight of Dr.&nbsp;Javad Nazarian, Head of the DIPG Research Institute. Dr.&nbsp;Nazarian&#146;s research will examine precision medicine approaches to the potential use of <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> in DIPG. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In August 2019, Kazia was proud to sponsor the biannual DIPG Symposium, which was held in Sydney,
Australia. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">[ENDS] </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Kazia Therapeutics Limited </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes
two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Our lead program is <FONT
STYLE="white-space:nowrap">GDC-0084,</FONT> a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer in adults. Licensed
from Genentech in late 2016, <FONT STYLE="white-space:nowrap">GDC-0084</FONT> entered a phase II clinical trial in 2018. Initial safety data was released in May 2019, and efficacy data is expected in 2H 2019.
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> was granted orphan designation for glioblastoma by the US FDA in February 2018. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT> (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to
treat ovarian cancer. <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT> is currently undergoing a phase I clinical trial in Australia and the United States. Initial
data was presented at the AACR annual conference in April 2019 and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
