Dan over Immutep:
a biotechnology company developing novel LAG-3(Lymphocyte-activation gene 3) related immunotherapy treatments for cancer and autoimmune disease.
Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.
13 clinical trials in progress.
Samenwerkingen o.a. met Merck, GSK, Novartis, Pfizer, EOC.
In de presentatie van November 2020 staat duidelijk hoe ze werken: een Immutep controlled Immunotherapy pipeline, en een out-licensed Immunotherapy pipeline.
Huidige onderdelen in pijplijn(naast de hierboven reeds vermelde TACTI-002 en INSIGHT-004 studies) o.a.:
-AIPAC studie, Efti + Chemo: Metastatic Breast Cancer(MBC)
In december dat gepresenteerd op de San Antonio Breast Cancer Symposium 2020, significante stijging van Overall Survival(OS).
Final data verwacht 2e helft van dit jaar.(Phase IIB Study)
-TACTI mel studie: Efti + Pembro(Keytruda), Phase I in Melanoma: Deep & durable responses, outperforming pembrolizumab monotherapy. 66% of patients were progression free at 6 months.
-TACTI-003 – a Phase IIb Clinical Trial in 1st line Head and Neck Cancer
Subject to approval by relevant competent authorities, ethics committees and institutional review boards(IRBs), TACTI-003 will evaluate efti in combination with MSD’s KEYTRUDA(pembrolizumab) as a first line therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 negative and PD-L1 positive (CPS=1) tumours. It will be a randomised, controlled clinical study in approximately 154 first line HNSCC patients and will take place across Australia, Europe and the United States of America in up to 35 clinical sites.
Immutep is on track to start the study in mid-2021.
- EAT COVID – Efti mono, Phase II in COVID-19, start Q4 2020
(investigator-initiated trial evaluating efti in hospitalised COVID-19 patients, Randomized, placebo controlled, University Hospital Pilsen, Czech Republic)
Up to 110 patients, 15 day Primary endpoint is patient’s clinical status at day 15(WHO recommended)
-YNP01 and YCP02 studie: Phase I in Solid Tumors & Hepatocellular Carcinoma(levercelcarcinoom), Cancer Vaccine, Controlled by Cytlimic in Japan
-IMP761 studie:
Broad potential in targeting auto reactive memory T cells with IMP761.
THE PRESENT: FIGHTING THE SYMPTOMS
THE FUTURE: FIGHTING THE CAUSE
Treating the disease process: silencing the few autoimmune memory T cells accumulating at the disease site with IMP761. Ziektebeelden die ze laten zien als target: MS, Asthma, Celeac disease, Eczeem, Arthritis, lupus, Hashimoto's disease.
The Company has completed the selection of a high-producing CHO cell line for its IMP761 IgG4 mAb and is in the process of selecting a contract manufacturing organisation (CMO) for GMP manufacturing of its preclinical candidate IMP761.
-GlaxoSmithKline, you know that we have an exclusive worldwide licensing arrangement there, they expect clinical proof of concept in first half of 2021.
GSK’781 (IMP731) for Autoimmune Diseases, exclusive WW licence to develop and commercialise GSK’781 (which is derived from Immutep’s depleting antibody known as IMP731)
Immutep's TACTI-002 trial: A solid result in this trial could see efti on the market via a special route through the US Food and Drug Administration very quickly.
8-april-2021:
Immutep Achieves Fast Track Designation From US FDA For Efti, A Soluble Lag-3 Protein, In First Line Recurrent/Metastatic Head & Neck Cancer.
(based on the promising data package from Immutep, including from Immutep’s Phase II TACTI-002 trial (Keynote-798))
Als dit overgaat in APPROVAL door de FDA, valideert dat het hele bedrijf, en zullen meerdere indicaties volgen, is de verwachting.