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Immutep Announces TACTI-mel Phase I Clinical Trial Data for Unresectable or Metastatic Melanoma

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Australia-based Immutep Limited (IMMP) reported its more mature data relating to Pat B of its ongoing I TACTI-mel clinical study of eftilagimod alpha (“efti” or “IMP321”) in patients with melanoma.  The industry sponsor presented its data at the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 in London on May 17, 2019 by  Frédéric Triebel, Chief Scientific Officer and Chief Medical Officer of Immutep.

TACTI-mel Trial

The ongoing TACTI-mel  (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multicenter, open-label study evaluating the combination of eftilagimod alpha (“efti”) with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (identifier NCT 02676869).

This clinical trial evaluates the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. A multi-center, open label clinical trial involving four cohorts of six patients, each cohort testing different dosages of efti, including 1 mg and 30mg, in combination with pembrolizumab. Part B of the study includes a cohort of 6 patients at 30 mg of efti in combination with pembrolizumab, starting at cycle 1, day 1 with a treatment duration of 12 months.

Research Sites

  • Immutep has recruited the following sites for this study.
  • Royal Brisbane Women’s Hospital, Brisbane, Australia
  • Princess Alexandra Hospital, Brisbane, Australia
  • Greenslopes Private Hospital, Brisbane, Australia
  • Flinders Medical Centre, Adelaide, Australia
  • Ballarat Hospital, Victoria, Australia
  • Alfred Hospital, Melbourne, Australia
  • Fiona Stanley Hospital, Western Australia

About Immutep

Financials

Immutep is listed on the Australian Securities Exchange (IMM) and the NASDAQ (IMMP) in the US. Immutep is a thinly capitalized microcap traded stock.  It operates at a loss of approximately $12.1 million and maintains cash reserve of approximately $23.4 million according to Yahoo Finance.

Science

They focus on developing novel immunotherapy treatments for cancer and autoimmune disease with operations with in Europe. They claim to be a global leader in understanding of and in the development of therapeutics that modulate Lymphocyte Activation Gene-3 (LAG-C), a cell surface molecule which plays a vital role in regulating T cells and which was discovered by their CFO and CMO Dr. Frederic Triebel. They seek to harness and strengthen the power of patients’ immune systems through therapeutic intervention for the benefit of patients’ health.

Pipeline

They have one pre-clinical and thee clinical LAG-3 product candidates under development; this includes two antibodies for modulating immune responses in autoimmunity and cancer through pharma partnerships with Novartis and GSK.

Their lead product candidate is eftilagimod alpha (LAG-31g or IMP321) a first-in-class antigen presenting cell (APC) activator current being investigated in clinical trials as a treatment (in combo with chemotherapy immunotherapy) for breast cancer and melanoma.

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