First patient receives new immunotherapy drug for HIV in clinical trial

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A new class of bispecific protein immunotherapy, being developed for patients with human immunodeficiency virus (HIV) infection, has been given to the first patient in a clinical trial.

Immunocare Holdings plc, a UK-based, commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases including cancer, autoimmune and infectious diseases, announced the news this week (July 11).

Bispecific protein

The patient is taking part in the first in-human phase 1 clinical trial of IMC-M113V which is a new class of bispecific protein immunotherapy being developed for the treatment of patients with HIV.

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.

The candidate is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (‘reservoirs’). It 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.’

Antiretroviral medications

There are currently more than 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.

Lucy Dorrell MD, head of infectious diseases at Immunocore said: “HIV remains a major global public health challenge with the need for a functional cure. 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.”

HIV product

As part of the collaboration agreement between Immunocore and the Bill and Melinda Gates Foundation, Immunocore and the 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.

Sarah Fidler from the 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.

Leveraging its 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.

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