Oncology and Autoimmune Pipeline.
|Preclinical||Phase I||Phase IIa||Phase IIb|
Immutep Worldwide Rights
(ex China: Eddingpharm)
MOA: APC activator (Eftilagimod alpha) + first-line chemotherapy (Paclitaxel)
MOA: APC activator (Eftilagimod alpha) + PD-1 checkpoint inhibitor (Pembrolizumab)
INSIGHT - Investigator Sponsored Clinical Trial**
MOA: APC activator – intratumoral (i.t.) and intraperitoneal (i.p.) injections
GSK Worldwide Rights
MOA: LAG-3 depleting antibody
Novartis Worldwide Rights
MOA: LAG-3 antagonist antibody
Immutep Worldwide Rights
MOA: LAG-3 agonist antibody
Cell Therapy CVac™
Divested to and Controlled
by Sydys Corporation
*Expected timing of data readouts. Actual results may differ.
** INSIGHT clinical trial controlled by lead investigator and therefore Immutep has no control over this clinical trial
*** As per clinicaltrials.gov (November 5, 2017)
**** A.I. = Autoimmune
Please click on the appropriate product for detailed information.
Our lead product candidate is eftilagimod alpha (LAG-3Ig or IMP321), a recombinant protein that may be used in combination with other agents to amplify a patient’s immune response. Eftilagimod alpha is a soluble LAG-3Ig fusion protein and an antigen presenting cell, or APC, activator boosting the immune system.
We are developing Eftilagimod alpha both on our own and jointly with Eddingpharm under a licensing agreement, between Immutep and Eddingpharm. Eddingpharm has the exclusive right to commercialize Eftilagimod alpha in China, Macau and Taiwan, while Immutep holds all rights in the rest of the world.
In 2016, we started two new clinical trials for Eftilagimod alpha. The first of our two ongoing clinical trials is “Active Immunotherapy PAClitaxel,” or AIPAC, a Phase IIb clinical study of Eftilagimod alpha’s effectiveness in treating metastatic breast cancer. The primary purpose of the AIPAC trial is to determine the clinical benefit of Eftilagimod alpha in combination with paclitaxel in terms of progression-free survival as the primary clinical endpoint in a specific patient population.
The second of our two ongoing clinical trials is “Two ACTive Immunotherapeutics in melanoma,” or TACTI-mel, a Phase I clinical trial. The purpose of this study is to determine the safety of Eftilagimod alpha in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma. The study will also evaluate the combined effects on patients’ immune responses.
Our second product candidate is IMP731, a depleting (cytotoxic) antibody that is intended to destroy LAG-3 expressing activated T cells involved in autoimmunity.
IMP731 has been licensed by Immutep to GlaxoSmithKline, or GSK, under a license and research agreement. Under this license, GSK has the exclusive development right of IMP731 and has agreed to fund all the development costs. In exchange for the grant of this license, Immutep received from GSK an undisclosed upfront payment and has the right to receive potential milestone payments up to an aggregate amount of £64 million, minus the upfront payment amount. In addition, Immutep also has the right to receive potential single-digit tiered royalty payments.
In January 2015, we collected our first milestone payment from GSK for the development of GSK2831781, an anti-LAG-3 antibody derived from IMP731. The product candidate is currently in a Phase I clinical trial.
Our third product candidate is IMP701, an antagonist (blocking) antibody targeting the LAG-3 molecule on T cells with potential applications in the treatment of cancer. It is designed to block the negative signal that may stop T cells from responding to the cancer. The product candidate was acquired through our acquisition of Immutep.
Immutep licensed the development of IMP701 to CoStim Pharmaceuticals, or CoStim, under an exclusive license and collaboration agreement for development of humanized antagonist antibodies to LAG-3. Under this license, CoStim has the exclusive development rights to IMP701, in consideration for the obligation to fund all the development costs and to make milestone and royalty payments to Immutep.
In February 2014, CoStim became a wholly owned subsidiary of Novartis. Novartis continues the development of IMP701, including the ongoing Phase I/II clinical trial that began in August 2015. According to certain publicly available records, the number of patients in that clinical trial was increased from 240 to 416 during fiscal year 2016 and topped up to 515 patients in November 2017.
In January 2017, we announced that we conducted research on a new early stage product candidate, a humanized IgG4 monoclonal antibody known as IMP761, which we believe is the first agonist antibody of LAG-3. Currently, we are conducting preclinical experiments on IMP761.
We filed a patent application in September 2016 to seek protection for this antibody.