<SEC-DOCUMENT>0001193125-25-174644.txt : 20250807
<SEC-HEADER>0001193125-25-174644.hdr.sgml : 20250807
<ACCEPTANCE-DATETIME>20250806191415
ACCESSION NUMBER:		0001193125-25-174644
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20250805
FILED AS OF DATE:		20250807
DATE AS OF CHANGE:		20250806

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			IMMUTEP Ltd
		CENTRAL INDEX KEY:			0001506184
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			C3
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35428
		FILM NUMBER:		251191113

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 32, SUITE 32.07 AUSTRALIA SQUARE
		STREET 2:		264 GEORGE STREET
		CITY:			SYDNEY,
		STATE:			C3
		ZIP:			NSW 2000
		BUSINESS PHONE:		612 8315 7003

	MAIL ADDRESS:	
		STREET 1:		LEVEL 32, SUITE 32.07 AUSTRALIA SQUARE
		STREET 2:		264 GEORGE STREET
		CITY:			SYDNEY,
		STATE:			C3
		ZIP:			NSW 2000

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Prima BioMed Ltd
		DATE OF NAME CHANGE:	20101119
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d27591d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
</HEAD>
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<Center><DIV STYLE="width:8.5in" align="left">
<DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;
</DIV><DIV STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</DIV> <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><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM&nbsp;6-K </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></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&nbsp;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>Date as August 05, 2025 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number&nbsp;001-35428 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>IMMUTEP LIMITED </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact
Name as Specified in its Charter) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>N/A </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of
Registrant&#146;s Name) </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Level&nbsp;32, Australia Square </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>264 George Street, Sydney </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>NSW 2000, Australia </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><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></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&nbsp;20-F or Form&nbsp;40-F. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form 20-F&#8194;&#9746;&#8195;&#8195;&#8195;Form 40-F&#8194;&#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&nbsp;6-K in paper as permitted by Regulation&nbsp;S-T Rule&nbsp;101(b)(1):&#8194;&#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&nbsp;6-K in paper as permitted by Regulation&nbsp;S-T Rule&nbsp;101(b)(7):&#8194;&#9744; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule&nbsp;12g3-2(b) under the Securities Exchange Act of 1934. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Yes&#8194;&#9744;&#8195;&#8195;&#8195;No&#8194;&#9746; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If &#147;Yes&#148; is marked, indicated below the file number assigned to the registrant in connection with Rule&nbsp;12g3-2(b): Not applicable. </P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;
</DIV><DIV STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</DIV>
</DIV></Center>


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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>EXHIBIT INDEX </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


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<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="94%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Exhibit</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Description&nbsp;of&nbsp;Exhibit</B></P></TD></TR>


<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">99.1</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><A HREF="d27591dex991.htm">Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer
 with CPS&nbsp;&lt;1 </A></P></TD></TR>
</TABLE>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always"> </p>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; 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">Date: August 05, 2025 </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="40%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt">


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<TD WIDTH="12%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="87%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" COLSPAN="3">IMMUTEP LIMITED</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Marc Voigt</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Marc Voigt</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Chief Executive Officer</TD></TR>
</TABLE></DIV>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d27591dex991.htm
<DESCRIPTION>EX-99.1
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<TITLE>EX-99.1</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">

<div style ="background-color:#f7f7f7; max-width:100%">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:4pt; font-family:Times New Roman" ALIGN="right"><B>&#8195; </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="right">


<IMG SRC="g27591dsp004.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#8195; </P>
</div>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Immutep Receives
Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Neck Cancer with CPS&nbsp;&lt;1
</B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>SYDNEY, AUSTRALIA &#150; August 5th, 2025 &#150;</B> <U>Immutep Limited</U> (ASX: IMM; NASDAQ: IMMP) (&#147;Immutep&#148; or &#147;the
Company&#148;), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of
its <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> MHC Class&nbsp;II agonist, eftilagimod alfa (&#147;efti&#148;), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma
(1L HNSCC) patients who have <FONT STYLE="white-space:nowrap">PD-L1</FONT> expression below 1 (Combined Positive Score [CPS] &lt;1). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Based on its review
of the encouraging data in 1L HNSCC with CPS &lt;1 from the <FONT STYLE="white-space:nowrap">TACTI-003</FONT> <FONT STYLE="white-space:nowrap">(KEYNOTE-C34)</FONT> Phase IIb trial evaluating efti in combination with MSD&#146;s (Merck&nbsp;&amp; Co.,
Inc., Rahway, NJ, USA) <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">anti-PD-1</FONT></FONT> KEYTRUDA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (pembrolizumab), the FDA agreed on the potential of efti in
combination with KEYTRUDA to address the high unmet need in this CPS &lt;1 patient segment and is supportive of the combination&#146;s further development. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Paths for future clinical development and potential accelerated approval in light of the FDA&#146;s Project FrontRunner include a randomised registrational
trial evaluating efti in combination with KEYTRUDA against <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> therapy or alternatively a smaller <FONT STYLE="white-space:nowrap">single-arm</FONT> study
(e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We are pleased with the FDA&#146;s feedback and guidance that underscores the high unmet need of head and neck cancer patients whose <FONT
STYLE="white-space:nowrap">PD-L1</FONT> expression level is below one. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved
patient population,&#148; said Marc Voigt, CEO of Immutep. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;Our primary focus clearly remains the pivotal
<FONT STYLE="white-space:nowrap">TACTI-004</FONT> Phase III evaluating efti as first line therapy for <FONT STYLE="white-space:nowrap">non-small</FONT> cell lung cancer and we are excited with its progress to date and the consistent, encouraging
feedback we hear from physicians. This focus and additional considerations will be reviewed internally and discussed with stakeholders and potential strategic partners in regards to forward paths in head and neck cancer,&#148; added Mr Voigt. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Project FrontRunner</U> is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to
develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of
therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients&#146; lives. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Patients with CPS &lt;1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to 20% of 1L HNSCC patients have CPS &lt;1 and despite
immunotherapy&#146;s progress in fighting cancer, <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">anti-PD-1</FONT></FONT> therapy alone (without chemotherapy) is only approved for patients who express
<FONT STYLE="white-space:nowrap">PD-L1</FONT> (CPS <U>&gt;</U>1). All currently available treatment options for patients with <FONT STYLE="white-space:nowrap">PD-L1</FONT> CPS &lt;1 include chemotherapy. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt">


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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Immutep </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease<I>.</I> The Company is a pioneer in the
understanding and advancement of therapeutics related to Lymphocyte Activation <FONT STYLE="white-space:nowrap">Gene-3</FONT><B> </B><FONT STYLE="white-space:nowrap">(LAG-3),</FONT> and its diversified product portfolio harnesses <FONT
STYLE="white-space:nowrap">LAG-3&#146;s</FONT> ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders.
For more information, please visit <U>www.immutep.com</U>. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">KEYTRUDA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> is a registered trademark
of Merck Sharp&nbsp;&amp; Dohme LLC, a subsidiary of Merck&nbsp;&amp; Co., Inc., Rahway, NJ, USA. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Australian Investors/Media: </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Eleanor Pearson, Sodali&nbsp;&amp; Co. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+61 2 9066 4071;
<U>eleanor.pearson@sodali.com</U> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>U.S. Investors/Media: </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Chris Basta, VP, Investor Relations and Corporate Communications </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1 (631) 318 4000; <U>chris.basta@immutep.com</U> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This
announcement was authorised for release by the Board of Immutep Limited. </P> <P STYLE="margin-top:0pt;margin-bottom:0pt">


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