Immutep operational update

  • AIPAC reaches ~ 72% of events and recruitment of TACTI-002 is progressing well
  • New data from TACTI-002 and INSIGHT-004 to be reported to ASCO in June 2021
  • The design of the TACTI-003 clinical trial allows the efti to be evaluated in 1st HNSCC recurrent or metastatic line patients to better understand its effect in combination with pembrolizumab
  • Robust financial position with cash flow trail to calendar year 2023, beyond several important data reads

Sydney, AUSTRALIA, May 07, 2021 (GLOBE NEWSWIRE) – Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune diseases, makes the update on its clinical and preclinical programs.

Eftilagimod alpha (“efti”) Update

AIPAC – Phase IIb vslinic trial
The Company is on track to publish final overall survival (OS) data from this metastatic breast cancer trial in the second half of calendar year 2021. Currently, the trial has reached about 72% of events, indicating 72% of the total number of patients with advanced stage cancer. had been followed to death. Immutep previously reported a trend of improving OS from initial data of about 60% of events at the San Antonio Breast Cancer Conference in December 2020.

TACTI-002 (also referred to as KEYNOTE-798) Phase II vslinic trial
The study is continuing to enroll 1st patients with non-small cell lung cancer (NSCLC) (part A), with 54 patients out of a maximum of 110 patients now enrolled and having received at least the first treatment. Immutep and its collaborative partner, Merck & Co. Inc, Kenilworth, NJ, USA (“MSD”) have extended Part A of study TACTI-002 to up to 110 patients following encouraging results presented to the Society for Immunotherapy of Cancer (SITC) Congress in November 2020.

Recruitment is also underway for patients with 2sd NSCLC line (Part B) which was extended as part of Simon’s two-step clinical trial design. Currently, 27 patients out of a total of 36 patients have received the first treatment. In 2sd Squamous cell carcinoma of the head and neck (HNSCC, part C) patient recruitment is complete.

Currently, the recruitment of TACTI-002 is going well and new clinical data of TACTI-002 is expected to be presented at the American Society of Clinical Oncology (ASCO) 2021 annual meeting (June 4-8).

TACTI-003 – one Phase IIb Clinical trial in 1st line Head and neck cancer
Subject to the approval of the relevant authorities, ethics boards and relevant institutional review boards (IRBs), TACTI-003 will assess efti in combination with MSD’s KEYTRUDA® (pembrolizumab) as first line
treatment in recurrent or metastatic unresectable HNSCC patients with PD-L1 negative and PD-L1 positive tumors (CPS ≥1). This will be a randomized, controlled clinical study involving approximately 154 first-line HNSCC patients and will take place in Australia, Europe and the United States of America at up to 35 clinical sites.

The study will assess the safety and efficacy of efi in combination with pembrolizumab, compared to pembrolizumab alone in 1st patients with metastatic or recurrent HNSCC with PD-L1 positive tumors (CPS ≥1) (cohort A), and to determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 tumors negative (CPS

The primary endpoint of the study is the overall response rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and progression free survival (PFS). Following the granting of the Fast Track designation for efti to process 1st HNSCC online patients by the US FDA in early April 2021 and the appointment of a Contract Research Organization (CRO), Immutep is on track to start the study in mid-2021.

OVERVIEW-004 – Phase I vslinic trial
The INSIGHT-004 study is expected to provide final data to ASCO 2021 in a poster discussion. INSIGHT-004 is the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as INSIGHT’s Strata D) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

Update IMP761

The Company has completed the selection of a highly productive CHO cell line for its IMP761 IgG4 mAb and is in the process of selecting a contract manufacturing organization (CMO) for the GMP manufacture of its preclinical candidate IMP761.

Financial update

Immutep continues to be in a strong financial position with a cash flow trail through to calendar year 2023, beyond the planned timeline for several important data reads from its trials.

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

Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is an activator of antigen presenting cells (APC). first-class being studied in cancer and infectious diseases. Immutep is also developing an LAG-3 agonist (IMP761) for autoimmune diseases. Other LAG-3 products, in particular antibodies for modulating the immune response, are under development by Immutep’s major pharmaceutical partners.

Further information can be found on the company’s website or by contacting:

Australian Investors / Media:
Catherine Strong, Citadelle-MAGNUS
+61 (0) 406 759 268; [email protected]

American media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; [email protected]

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