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IMMUNOTHERAPY PIPELINE

Immutep Controlled
Autoimmune & Oncology Pipeline*.


Oncology

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

Preclinical Phase I Phase II Late Stage (7)

AIPAC (1) (Chemo-IO Combo) Metastatic Breast Cancer

 
 
 
 
Commercial Rights/Partners


Immutep
Global Rights

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

TACTI-003 (2) (IO-IO Combo) HNSCC (2nd)

 
 
 
 

Immutep Global Rights

 

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

TACTI-002 (2) (IO-IO Combo) NSCLC (1st/2nd L.) HNSCC (2nd)

 
 
 

Immutep Global Rights

 

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

INSIGHT-004 (3), (4a) (IO-IO Combo) Solid Tumors

 
 


Immutep
Global Rights
 
  

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

INSIGHT-005 (3), (4b) (IO-IO Combo) Solid Tumors

 
 


Immutep
Global Rights
     

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

INSIGHT-003 (3), (IO-IO-Chemo) Solid Tumors

 
 

Immutep Global Rights

Eftilagimod Alpha
(LAG-3lg or IMP321), APC activating Soluble LAG-3 Protein

EOC 202 (6) (Chemo-IO Combo) Metastatic Breast Cancer

 
 

Chinese Rights


 

Autoimmune Diseases

IMP761
(Agonist AB)

Preclinical Phase I Phase II Late Stage (7)

 

 


Immutep
Global Rights

 


* Information in pipeline chart current as at May 2021
(2)In combination with KEYTRUDA® (pembrolizumab) in non-small cell lung carcinoma (“NSCLC”) or head and neck carcinoma (“HNSCC”)
(3) INSIGHT Investigator Initiated Trial (“IIT”) is controlled by lead investigator and therefore Immutep has no control over this clinical trial 
(4) a) In combination with BAVENCIO® (avelumab); b) in combination with Bintrafusp alfa
(5) The TACTI-mel trial has been completed
(6) EOC Phama is the sponsor of the EOC 202 clinical trial which is being conducted in the People’s Republic of China.
(7) Late stage refers to Phase IIb clinical trials or more clinicalyl advanced clinical trials

 

Out-Licensed Autoimmune & Oncology Pipeline*.

Oncology

LAG525
(Antagonist AB)

Preclinical Phase I Phase II Late Stage (1)

IO-IO Combo: Solid Tumors + Blood Cancer

 
 
 
Commercial Rights/Partners

Global Rights

LAG525
(Antagonist AB)

Chemo-IO Combo: Triple Negative Breast Cancer

 
 
 

Global Rights

LAG525
(Antagonist AB)

IO-IO-Small Molecule Combo: Melanoma

 
 
 

Global Rights

 

LAG525
(Antagonist AB)

IO-IO Combo: Solid Tumors

 
 
 

Global Rights

LAG525
(Antagonist AB)

Chemo-IO-Small Molecule Combo: Triple Negative Breast Cancer

 
 

Global Rights

 

Autoimmune Diseases

GSK‘781
(Depleting AB)

Preclinical Phase I Phase II Late Stage (1)

Ulcerative Colitis(2)

 
 
 

Global Rights


GSK‘781
(Depleting AB)

Healthy Japanese and Caucasian Subjects

 
 

Global Rights


GSK‘781
(Depleting AB)

Psoriasis(3)

 
 

Global Rights



* Information in pipeline chart current as at May 2021
(1) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials
(2) Discontinued in Jan 2021
(3) Reflects completed Phase I study in healthy volunteers and psoriasis

 


Please click on the appropriate product for detailed information.

Eftilagimod alpha (efti or IMP321) Clinical Development

Our lead product candidate is eftilagimod alpha (efti or IMP321), a recombinant protein that may be used in combination with other agents to amplify a patient’s immune response. Efti is a soluble LAG-3Ig fusion protein and an antigen presenting cell, or APC, activator boosting the immune system.

We are developing efti both on our own and jointly with EOC Pharma ("EOC") under a licensing agreement, between Immutep and EOC. EOC has the exclusive right to commercialise efti in China, Macau, Hong Kong and Taiwan, while Immutep holds all rights for the rest of the world.

In 2016, we started two new clinical trials for efti. The first ongoing clinical trials is “Active Immunotherapy PAClitaxel,” or AIPAC, a Phase IIb clinical study of efti's effectiveness in treating metastatic breast cancer. The primary purpose of the AIPAC trial is to determine the clinical benefit of efti in combination with paclitaxel in terms of progression-free survival as the primary clinical endpoint in a specific patient population.

The second clinical trial is “Two ACTive Immunotherapeutics in melanoma,” or TACTI-mel, a Phase I clinical trial that has been completed. The purpose of this study was to determine the safety of efti in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma. The study also evaluated the combined effects on patients’ immune responses. The results of TACTI-mel trial have been published in the Journal for Immunotherapy of Cancer.

TACTI-002, TACTI-003 & INSIGHT:

In addition, Immutep commenced its TACTI-002 (Two ACTive Immunotherapies, also designated KEYNOTE-798) Phase II clinical trial in 2018. This ongoing trial 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 MSD’s KEYTRUDA® (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

Immutep is also preparing to commence a new Phase IIb trial in 1st line Head and Neck Cancer. Subject to ethical and regulatory approval, 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 United States of America in up to 35 clinical sites.

Immutep’s INSIGHT-004 trial (also known as INSIGHT Stratum D) is an ongoing Phase I clinical trial which the Company commenced in 2019. It is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. INSIGHT-004 is being conducted under Immutep’s collaboration with Merck KGaA and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialised by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

IMP761 Clinical Development

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 undertaking cell line development.

We filed a patent application in September 2016 to seek protection for this antibody and the results of in vitro and in vivo testing were recently published in the Journal of Immunology.

LAG525 Clinical Development

Our third product candidate is IMP701 (LAG525), 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. 

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 and the antibody is being evaluated in five Phase I and/or II trials.

GSK`781 Clinical Development

Our fourth product candidate is IMP731 (GSK`781) , 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 ("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.