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 August 18, 2020
Commission File Number 001-35428
IMMUTEP LIMITED
(Exact Name as Specified in its Charter)
N/A
(Translation of Registrants 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 COMPLETES RECRUITMENT FOR STAGE 1 OF PART B IN 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: August 18, 2020
IMMUTEP LIMITED | ||
By: | /s/ Marc Voigt | |
Name: | Marc Voigt | |
Title: | Chief Executive Officer |
Exhibit 99.1
ASX Announcement
IMMUTEP COMPLETES RECRUITMENT FOR STAGE 1 OF PART B IN TACTI-002 STUDY
| 23 patients with second line Non-Small Cell Lung Cancer (NSCLC) participating in Stage 1, Part B |
| Total of 87 patients out of up to 109 patients (80%) are enrolled and participating in the trial, with recruitment continuing for stage 2 of Part C at present |
| Further data from TACTI-002 expected throughout calendar year 2020 |
SYDNEY, AUSTRALIA 18 August, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report it has enrolled and safely dosed the last patient for stage 1 of Part B of its TACTI-002 Phase II study, completing recruitment of stage 1 of Part B.
Based on the studys Simons two-stage clinical trial design, safety and efficacy data will be provided to the Data Monitoring Committee (DMC) for its review and recommendation regarding opening recruitment into stage 2 of Part B once all patients have undergone at least one tumour imaging after treatment.
TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) and is evaluating the combination of Immuteps lead product candidate, eftilagimod alpha (efti or IMP321) with MSDs KEYTRUDA® (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or NSCLC in first and second line.
TACTI-002 Recruitment
Recruitment details for each Part of TACTI-002 are below. At present, recruitment is ongoing for Stage 2 of Part C. Pending the DMCs recommendation, Immutep will consider opening stage 2 of Part B for recruitment.
Stage 1 (N) Actual/target |
Stage 2 (N) Actual /target |
Recruitment status | ||||
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 | 10/19 | ONGOING |
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 MSDs 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, Simons two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe and Australia.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
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. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy 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 ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.
More information about the trial can be found on Immuteps 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 immunotherapies 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 the NASDAQ (IMMP) in the United States.
Immuteps current lead product candidate is eftilagimod alpha (efti or IMP321), a soluble LAG-3Ig fusion protein which is a first-in-class antigen presenting cell (APC) activator. Efti is currently in a Phase IIb clinical trial known as AIPAC which is evaluating efti in combination with chemotherapy for the treatment of metastatic breast cancer (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 (clinical trials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).
Further information can be found on the Companys 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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