<SEC-DOCUMENT>0001193125-23-001142.txt : 20230104
<SEC-HEADER>0001193125-23-001142.hdr.sgml : 20230104
<ACCEPTANCE-DATETIME>20230104060730
ACCESSION NUMBER:		0001193125-23-001142
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20230104
FILED AS OF DATE:		20230104
DATE AS OF CHANGE:		20230104

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			IMMUTEP Ltd
		CENTRAL INDEX KEY:			0001506184
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				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:		23504291

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 12, 95 PITT STREET
		CITY:			SYDNEY, NEW SOUTH WALES
		STATE:			C3
		ZIP:			2000
		BUSINESS PHONE:		612 9276 1224

	MAIL ADDRESS:	
		STREET 1:		LEVEL 12, 95 PITT STREET
		CITY:			SYDNEY, NEW SOUTH WALES
		STATE:			C3
		ZIP:			2000

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Prima BioMed Ltd
		DATE OF NAME CHANGE:	20101119
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d422770d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" 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>Dated January 4, 2023 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number 001-35428 </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>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> <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>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 33, 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>
<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;&#9746;&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">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">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&nbsp;&nbsp;&#9744;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;No&nbsp;&nbsp;&#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 12g3-2(b): Not applicable. </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>EXHIBIT INDEX </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<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>


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<TD HEIGHT="8" COLSPAN="2"></TD></TR>
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<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"><A HREF="d422770dex991.htm">Immutep Achieves 50% Enrollment Milestone in Randomised Phase IIb TACTI-003 Trial for First Line Head &amp; Neck Cancer </A></TD></TR>
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 <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">Dated: January 4, 2023 </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top" COLSPAN="3">IMMUTEP LIMITED</TD></TR>
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<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<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>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d422770dex991.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">
 <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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g422770g47m60.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>ASX/Media Release </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Immutep Achieves 50% Enrollment Milestone in Randomised Phase IIb TACTI-003 Trial for First Line Head&nbsp;&amp; Neck Cancer </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>SYDNEY, AUSTRALIA &#150; 4</B><B></B><B>&nbsp;January 2023 &#150;</B> <U>Immutep Limited</U> (ASX: IMM; NASDAQ: IMMP) (&#147;Immutep&#148; or &#147;the
Company&#148;), a clinical-stage biotechnology company developing novel <FONT STYLE="white-space:nowrap">LAG-3</FONT> immunotherapies for cancer and autoimmune disease, today announces that it has enrolled and randomised over 50% of the planned 154
patients in the <FONT STYLE="white-space:nowrap">TACTI-003</FONT> Phase IIb trial. <FONT STYLE="white-space:nowrap">TACTI-003</FONT> is evaluating Immutep&#146;s
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> soluble <FONT STYLE="white-space:nowrap">LAG-3</FONT> protein eftilagimod alpha (&#147;efti&#148;), 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> therapy KEYTRUDA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (pembrolizumab) as 1st line treatment of recurrent or
metastatic head and neck squamous cell carcinoma (1L HNSCC). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Marc Voigt, CEO of Immutep stated: &#147;We are pleased to reach this important milestone
and extend our sincere appreciation to our investigators, clinical team, partners, and most importantly patients, that have participated in this study. As clinical evidence showing the compelling benefits of combining efti with immune checkpoint
therapies such as pembrolizumab continues to grow, we are increasingly excited about efti&#146;s potential to safely deliver superior clinical outcomes and meaningfully expand the population of cancer patients that respond to treatment.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The 1:1 randomised, controlled multinational <FONT STYLE="white-space:nowrap">TACTI-003</FONT> trial is currently accruing patients at over 25 centers in the
United States, Australia, and Europe, and is expected to be fully recruited by <FONT STYLE="white-space:nowrap">mid-2023.</FONT> Based largely on the promising data in 2nd line HNSCC from the Phase II
<FONT STYLE="white-space:nowrap">TACTI-002</FONT> trial <FONT STYLE="white-space:nowrap">(KEYNOTE-798),</FONT> including encouraging overall response rates regardless of <FONT STYLE="white-space:nowrap">PD-L1</FONT> expression and five complete
responses (CR), eftilagimod alpha was granted Fast Track designation by the FDA in April 2021 for treatment of 1L HNSCC. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As recently announced, the
Independent Data Monitoring Committee (IDMC) for the <FONT STYLE="white-space:nowrap">TACTI-003</FONT> trial reviewed initial safety data and recommended continuing the trial with no modifications. The IDMC also reviewed initial efficacy data,
although this was not the primary focus of the analysis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">HNSCC is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000
deaths reported in 2018.<SUP STYLE="font-size:75%; vertical-align:top">1</SUP><SUP STYLE="font-size:75%; vertical-align:top">,</SUP><SUP STYLE="font-size:75%; vertical-align:top">2</SUP><SUP STYLE="font-size:75%; vertical-align:top">,</SUP><SUP
STYLE="font-size:75%; vertical-align:top">3</SUP> HNSCC is an aggressive, genetically complex, and difficult to treat cancer.<SUP STYLE="font-size:75%; vertical-align:top">4</SUP> Furthermore, HNSCC is associated with high levels of psychological
distress and compromised quality of life (QOL).<SUP STYLE="font-size:75%; vertical-align:top">5</SUP> As such, HNSCC patients are in need of improved treatment options. </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="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:11%">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">1</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Ferlay, J. et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods.
<I>Int. J. Cancer</I> 144, 1941&#150;1953 (2019). </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">2</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Bray, F. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36
cancers in 185 countries. <I>CA&nbsp;Cancer&nbsp;J. Clin.</I> 68, 394&#150;424 (2018). </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">3</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Ferlay, J. et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on
Cancer (accessed 18&nbsp;September 2020). <I>IARC</I> https://gco.iarc.fr/today (2018). </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">4</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Alsahafi, E., Begg, K., Amelio, I. <I>et al.</I> Clinical update on head and neck cancer: molecular biology and
ongoing challenges. <I>Cell Death Dis</I> 10, 540 (2019). </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">5</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Johnson, D.E., Burtness, B., Leemans, C.R. <I>et al.</I> Head and neck squamous cell carcinoma. <I>Nat Rev Dis
Primers</I> 6, 92 (2020). </P></TD></TR></TABLE>
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<IMG SRC="g422770g47m60.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Eftilagimod Alpha (Efti) </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Efti is Immutep&#146;s proprietary soluble <FONT STYLE="white-space:nowrap">LAG-3</FONT> clinical stage candidate that is a <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">first-in-class</FONT></FONT> antigen presenting cell (APC) activator for the treatment of cancer, capitalising on <FONT STYLE="white-space:nowrap">LAG-3&#146;s</FONT> unique characteristics to stimulate both innate and
adaptive immunity. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the
expression of key biological molecules like CXCL10 that further boost the immune system&#146;s ability to fight cancer. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Efti is under evaluation for a
variety of solid tumours including <FONT STYLE="white-space:nowrap">non-small</FONT> cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2&#150;/HR+ metastatic breast cancer. Its favourable safety profile enables various
combinations, including with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">anti-PD-[L]1</FONT></FONT> immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the
United States Food and Drug Administration (FDA). </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About <FONT STYLE="white-space:nowrap">TACTI-003</FONT> </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-right:4%; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap">TACTI-003</FONT> is a Phase IIb clinical trial in 1st line head and neck squamous cell carcinoma (HNSCC). The
study will evaluate efti in combination with MSD&#146;s KEYTRUDA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (pembrolizumab) as a 1st line therapy in metastatic or recurrent HNSCC patients with
<FONT STYLE="white-space:nowrap">PD-L1</FONT> negative and <FONT STYLE="white-space:nowrap">PD-L1</FONT> positive (CPS &#8805;1) tumours. It is a randomised, controlled clinical study in approximately 154 patients and will take place across
Australia, Europe and the United States of America in up to 35 clinical sites. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The study will evaluate the safety and efficacy of efti in combination
with pembrolizumab, compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with <FONT STYLE="white-space:nowrap">PD-L1</FONT> positive (CPS &#8805;1) tumours (cohort A), and determine the efficacy and safety of efti plus
pembrolizumab in patients with <FONT STYLE="white-space:nowrap">PD-L1</FONT> negative tumours (CPS &lt;1) (cohort B). According to the current plans, about 130 patients in cohort A will be randomised 1:1 to receive either efti plus pembrolizumab or
pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab. The primary endpoint of the study is Overall Response Rate (ORR) according to RECIST 1.1. Secondary endpoints include Overall
Survival (OS) and Progression Free Survival (PFS). For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027). </P> <P STYLE="margin-top:18pt; 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 clinical stage biotechnology company leading the development of <FONT STYLE="white-space:nowrap">LAG-3</FONT> related
immunotherapy products for the treatment of cancer and autoimmune disease. The Company is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Immutep&#146;s lead product candidate is eftilagimod alpha (&#147;efti&#148; or &#147;IMP321&#148;), a soluble <FONT STYLE="white-space:nowrap">LAG-3</FONT>
fusion protein <FONT STYLE="white-space:nowrap">(LAG-3Ig),</FONT> which is a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> antigen presenting cell (APC) activator being explored in cancer in multiple
clinical trials. The Company is also developing an agonist of <FONT STYLE="white-space:nowrap">LAG-3</FONT> (IMP761) for autoimmune disease. Additional <FONT STYLE="white-space:nowrap">LAG-3</FONT> product candidates, including antibodies for immune
response modulation, are licensed to and being developed by Immutep&#146;s large pharmaceutical partners. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Further information can be found on the
Company&#146;s website <U>www.immutep.com</U> or by contacting: </P>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always">
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g422770g47m60.jpg" ALT="LOGO">
 </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">Catherine Strong, Citadel-MAGNUS </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+61 (0)406 759 268;
<U>cstrong@citadelmagnus.com</U> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>U.S. Media: </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Tim
McCarthy, LifeSci Advisors </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1 (917) 679 9282; <U>tim@lifesciadvisors.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 CEO of Immutep Limited. </P> <P STYLE="font-size:120pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="font-size:120pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:120pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Immutep Limited,</B> Level&nbsp;33, Australia Square, 264 George
Street, Sydney NSW 2000, Australia </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">ABN: 90 009 237 889 </P>
</DIV></Center>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
