0001193125-20-249813.txt : 20200921 0001193125-20-249813.hdr.sgml : 20200921 20200921100028 ACCESSION NUMBER: 0001193125-20-249813 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20200918 FILED AS OF DATE: 20200921 DATE AS OF CHANGE: 20200921 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: 201185371 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 6-K 1 d45754d6k.htm 6-K 6-K

 

 

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

Dated September 18, 2020

Commission File Number 001-35428

 

 

IMMUTEP LIMITED

(Exact Name as Specified in its Charter)

 

 

N/A

(Translation of Registrant’s Name)

Level 12, 95 Pitt Street

Sydney, 2000 New South Wales, Australia

(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):  ☐

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):  ☐

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 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ☐            No  ☒

If “Yes” is marked, indicated below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable.

 

 

 


EXHIBIT INDEX

 

Exhibit

  

Description of Exhibit

99.1    Immutep Reports Improving Results from INSIGHT-004 Trial
99.2    Immutep Announces Improving Results from Stage I of Phase II TACTI-002 Study


SIGNATURES

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.

Dated: September 18, 2020

 

IMMUTEP LIMITED
By:  

/s/ Marc Voigt

Name:   Marc Voigt
Title:   Chief Executive Officer
EX-99.1 2 d45754dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

ASX/Media Release

Immutep Reports Improving Results from INSIGHT-004 Trial

 

 

41.7% of patients showed a Partial Response to the combination therapy of eftilagimod alpha and avelumab (previously 33%)

 

 

Encouraging early anti-tumour activity signals in a variety of cancer indications not typically sensitive to immune checkpoint inhibitor (ICI) therapy

 

 

Combination of eftilagimod alpha and avelumab continues to be safe and well tolerated

SYDNEY, AUSTRALIA – 18 September 2020 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) is pleased to report further interim data from its ongoing INSIGHT-004 Phase I clinical trial. The data were presented at the ESMO Virtual Congress 2020 on 17 September 2020, CEST (poster ID number 1032P) by trial investigator at Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF), PD Dr. Thorsten Götze.

INSIGHT-004 is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (“IMP321” or “efti”) with avelumab (Bavenico), a human anti-PD-L1 antibody, in 12 patients with different solid tumours, primarily gastrointestinal. It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., which are co-developing and co-commercialising avelumab. INSIGHT-004 is the fourth arm (Stratum D) of the investigator-initiated INSIGHT trial which is conducted by IKF in Frankfurt, Germany.

Prof Salah-Eddin Al-Batran, INSIGHT-004 trial investigator and Director of IKF said: “It is encouraging to see the range of patients with different solid cancers that are responding to the combination of efti and avelumab, including PD-L1-negative cervical cancer, squamous anal cell carcinoma and mesothelioma. These tumours are not typically responsive to immune checkpoint therapy and warrant further investigation.”

Results Summary (data cut off 12 June 2020)

 

 

41.7% of patients (5 / 12) showed a partial response (PR) to the combination therapy according to RECIST 1.1. Previously 33% showed a PR (June 2020).

 

 

Encouraging durable deep responses in PD-L1 negative cancer.

 

Tumor response – according to

RECIST 1.1

  

Total

N (%)

Total (N=12)

 

Complete Response (CR)

     0 (0)

Partial Response (PR)

     5 (41.7%)

Stable Disease (SD)

     1 (8.3%)  

Progressive Disease (PD)*

     5 (41.7%)  

Not Evaluable (NE)**

     1 (8.3%)  

Objective Response Rate (ORR)

     5 (41.7%)  

Disease Control Rate (DCR)

     6 (50%)  

 

*

Includes 2 patients with clinical progression

**

Response assessment not yet performed

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889


LOGO

 

Safety

Interim results from INSIGHT-004 show that the combination of efti and avelumab is well tolerated with no dose limiting toxicities, building on efti’s strong safety profile to date.

IKF INSIGHT Trial Poster

IKF also presented data from the broader INSIGHT trial at ESMO showing that intratumoral and intraperitoneal administration of efti up to 30 mg displayed signals of clinical and cytokine responses. Both IKF posters are appended below and are available on the Company’s website at https://www.immutep.com/investors-media/presentations.html.

About INSIGHT-004

INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab. It is the first combination trial of an approved and marketed anti-PD-L1 drug and efti.

Patients in cohort 1 receive 6mg doses of efti every two weeks with the standard dose of avelumab (800mg every two weeks), while patients in cohort 2 receive a higher dose of efti, 30mg, with avelumab.

About Immutep

Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.

Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein (LAG-3Ig) based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT02614833); a Phase II clinical trial being conducted in collaboration with MSD, Kenilworth, NJ, USA (known as “Merck & Co., Inc.” in the United States and Canada) referred to as TACTI-002 to evaluate a combination of efti with KEYTRUDA® (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinicaltrials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).

Additional LAG-3 products, including antibodies, for immune response modulation in autoimmunity and cancer are being developed by Immutep’s large pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.

Further information can be found on the Company’s website www.immutep.com or by contacting:

Australian Investors/Media:

Catherine Strong, Citadel-MAGNUS

+61 (0)406 759 268; cstrong@citadelmagnus.com

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889


LOGO

 

U.S. Media:

Tim McCarthy, LifeSci Advisors

+1 (212) 915.2564; tim@lifesciadvisors.com

This announcement was authorised for release by the Board of Immutep Limited.

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

EX-99.2 3 d45754dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

 

ASX/Media Release

Immutep Announces Improving Results

from Stage I of Phase II TACTI-002 Study

 

 

Three complete responses (complete disappearance of all lesions) reported: two in 2nd line head and neck squamous cell carcinoma (HNSCC) and one in 1st line non-small cell lung cancer (NSCLC)

 

 

Five responses in patients (both indications) with negative (< 1%) or moderate PD-L1 expression where pembrolizumab monotherapy does not work well

 

 

Median Progression Free Survival (PFS) of 4.3 months in HNSCC patients and 47% progression free at 6 months in this very aggressive late stage disease

 

 

PFS continues to improve in 1st line NSCLC patients with median PFS of 11.8 months and patients with responses have durable ones

SYDNEY, AUSTRALIA – 18 September 2020 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) announces new interim data from its ongoing Phase II TACTI-002 study. The data was presented in two poster presentations at the ESMO Virtual Congress 2020 on 17 September 2020 and relates to the cut-off date of 21 August 2020.

The posters are available on Immutep’s website at https://www.immutep.com/investors-media/presentations.html

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). The study is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with 2nd line head and neck squamous cell carcinoma (HNSCC, Part C) or non-small cell lung cancer (NSCLC) in 1st and 2nd line (Parts A and B, respectively).

Principal investigator, Dr Martin Forster, University College London Hospital, said: “We are very encouraged by the results in this patient group with resistant late stage Head & Neck Cancers where the likelihood of response to other treatments is small. The durability of responses and the two patients with a complete response are extremely promising signals and this combination should be further investigated.”

Immutep CSO and CMO, Dr Frederic Triebel said: “The combination of efti and pembrolizumab is reporting encouraging progression free survival in patients with HNSCC and NSCLC, improving on the results from separate historical trials. For example, in comparable studies, HNSCC patients receiving pembrolizumab monotherapy had a PFS of 2.1 months, or 2.3 months if given chemotherapy1,2. This compares to a PFS of 4.3 months in HNSCC patients from the TACTI-002 trial, thus far. To have these very good and durable responses in both groups and without the use of chemotherapy is highly encouraging for efti.”

Stage 1 of Part C (2nd line HNSCC, N=18):

 

 

Median PFS of 4.3 months, with 47.1% of patients progression free at 6 months of treatment

 

 

iORR maintained at 38.9% (7 / 18 patients and iORR of 43.75% in evaluable patients), including:

 

   

2 patients recorded a Complete Response (iCR) according to iRECIST

 

 

1 

Keynote-040 results: available from https://www.esmo.org/newsroom/press-office/KEYNOTE-040-Evaluates-Pembrolizumab-in-Head-and-Neck-Cancer

2 

RL Ferris et al.: Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med 2016;375:1856-67.

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889


LOGO

 

   

5 patients recorded a Partial Response (iPR) including 1 iPR after pseudo progression

 

   

6 / 7 responders still receiving treatment for 8+ to 17+ months, indicating durable responses

 

   

67% of patients alive at 9 months with a minimum follow-up of 8+ months

 

 

All three PD-L1 subgroups enrolled in Stage 1, indicating PD-L1 all comer study

 

Tumour response – iBOR

as per iRECIST

  

N (%)

Total (N=18)

 

Complete Response (iCR)

     2 (11.1)  

Partial Response (iPR)

     5 (27.8)  

Stable Disease (iSD)

     2 (11.1)  

Progressive Disease (iPD)

     7 (38.9)  

Not evaluable

     2 (11.1)  

iORR in evaluable pts (iORR)

     7 (43.75)  

Objective Response Rate (iORR)

     7 (38.9)  

Stage 1 of Part A (1st line NSCLC, N=17):

 

   

Continued improvement in PFS, with median PFS of 11.8 months and 45% of patients progression free at 12 months

 

   

All three PD-L1 subgroups present, indicating the trial is a PD-L1 all comer study. Includes 4 responses in patients with PD-L1 expression of < 50%; 1 response in PD-L1 negative patients

 

   

iORR maintained at 52.9%, including:

 

   

1 patient with an iCR and 8 patients with iPRs; 8 of them confirmed

 

   

2 late responders after 8 and 11 months

 

   

35% (6/17) of patients were still under treatment at data cut-off, all have received 12+ months of therapy

 

Tumour response – iBOR

as per iRECIST

  

N (%)

Total (N=17)

 

Complete Response (iCR)

     1 (5.9)  

Partial Response (iPR)

     8 (47.1)  

Stable Disease (iSD)

     4 (23.5)  

Progressive Disease (iPD)

     4 (23.5)  

Objective Response Rate (iORR)

     9 (52.9)  

Safety

The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.

TACTI-002 Recruitment Update

Trial recruitment continues to progress well, with 89 patients out of up to 109 already enrolled at 12 clinical sites across Australia, Europe, the UK and US.

Recruitment details for each Part of the trial are shown below and are current as at 17 September 2020.

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889


LOGO

 

At present, recruitment is ongoing for Stage 2 of Part C. Pending the Data Monitoring Committee’s recommendation, Immutep will consider opening Stage 2 of Part B for recruitment.

 

    

Stage 1 (N)

Actual/target

  

Stage 2 (N)

Actual / target

    

Part A (1st line NSCLC)

   17/17    19/19    COMPLETE

Part B (2nd line NSCLC)

   23/23    -/13    TBA

Part C (2nd line HNSCC)

   18/18    12/19    ONGOING

Next Results

Immutep expects to report first data from Stage 2 and more mature data from Stage 1 at a conference later this calendar year.

About the TACT-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across Australia, Europe, the UK and US.

Patients participating in three parts:

 

   

Part A - First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

 

   

Part B - Second line NSCLC, PD-X refractory

 

   

Part C - Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³ 50% (Tumour Proportion Score or TPS) and in HNSCC: < 1%, 1-19% and ³ 20% (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first line NSCLC patients with a TPS score ³ 1% (US) and ³ 50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively. Pembrolizumab monotherapy is registered in the US (regardless of PD-L1 expression) and EU (³ 50% TPS score) for second line HNSCC patients.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323)

About Immutep

Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889


LOGO

 

Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein (LAG-3Ig) based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT02614833); a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) referred to as TACTI-002 to evaluate a combination of efti with KEYTRUDA® (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinicaltrials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).

Additional LAG-3 products, including antibodies, for immune response modulation in autoimmunity and cancer are being developed by Immutep’s large pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.

Further information can be found on the Company’s website www.immutep.com or by contacting:

Australian Investors/Media:

Catherine Strong, Citadel-MAGNUS

+61 (0)406 759 268; cstrong@citadelmagnus.com

U.S. Media:

Tim McCarthy, LifeSci Advisors

+1 (212) 915.2564; tim@lifesciadvisors.com

This announcement was authorised for release by the Board of Immutep Limited.

 

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

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