Immunocore Announces Dosing of First Patient With ImmTAV Bispecific for HIV

Immunocore Holdings plc recently announced the dosing of the first patient in the first-in-human Phase 1 clinical trial of IMC-M113V, a new class of bispecific protein immunotherapy that is being developed for the treatment of patients with human immunodeficiency virus (HIV) infection.

IMC-M113V is the second candidate in development using Immunocore’s immune‐mobilising monoclonal T cell receptors against virus (ImmTAV) platform to enter clinical trials. IMC-M113V is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (“reservoirs”). IMC-M113V targets a peptide derived from the Gag protein that is presented by HLA*A02 on the surface of HIV infected cells. Reduction in the number of these cells is one way to potentially achieve a state of viral suppression in the absence of anti-retroviral medications, or a “functional cure.”

There are currently over 30 antiretroviral medications spanning six drug classes approved for the treatment of HIV. If started early, antiretroviral therapy (ART) provides people with HIV with a normal life expectancy, prevents immunodeficiency and stops the spread of the virus. However, this treatment does not “cure” the disease and must be continued for life to prevent relapse.

“HIV remains a major global public health challenge with the need for a functional cure,” said Lucy Dorrell MD, Head of Infectious Diseases at Immunocore. “IMC-M113V is the first soluble TCR bispecific targeting HIV to enter the clinic. We hope that the start of this study is the next step to potentially bring a transformative treatment to millions of HIV infected people around the world.”

As part of the collaboration agreement between Immunocore and the Bill and Melinda Gates Foundation, Immunocore, and the Gates Foundation are committed to working together for HIV product candidate development and ensuring that any resulting HIV product that receives necessary regulatory approval is made available to people in developing countries at an affordable price.

Professor Sarah Fidler, PhD, Imperial College of London Department of Infectious Disease, said “There are nearly 38 million people around the world living with HIV and despite the accessibility of anti-retroviral therapy (ART), this is still a significant unmet need. The potential for a TCR therapy for HIV would be a ground-breaking development which would remove the need for patients to continuously take ART- for the remainder of their lives, providing significant relief to one of the world’s largest public health issues.”

The trial is an ongoing open label study evaluating the safety, antiviral activity, and pharmacokinetics of IMC-M113V in HLA-A*02:01 positive patients with HIV who are currently receiving standard of care anti-retroviral therapy.

ImmTAV (Immune mobilising monoclonal TCRs Against Virus) molecules are novel bispecific molecules that, like ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules, are designed to enable the immune system to recognize and eliminate virally infected cells.

Immunocore is advancing clinical candidates to cure patients with HIV and hepatitis B virus (HBV). The company aims to achieve sustained control of HIV after patients stop ART, without the risk of virological relapse or onward transmission. This is known as ‘functional cure’. For the treatment of HBV, the company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with chronic HBV.

Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune, and infectious disease. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore’s most advanced oncology TCR therapeutic, KIMMTRAK (tebentafusp-tebn), has been approved by the US FDA for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM) having demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.