What makes Immunovant’s approach to treating autoimmune diseases different from existing treatments?
Immunovant is a biotech company dedicated to immunology, specifically targeting autoimmune conditions driven by harmful IgG autoantibodies. This subset of immunology has been challenging to address with targeted therapy. For individuals suffering from conditions caused by harmful IgG autoantibodies, the current treatment options are broad-spectrum immunosuppressants, which can be limited in efficacy, but also come with significant side effects. Immunovant is developing monoclonal antibodies that target the neonatal Fc receptor (FcRn) and present promising treatments for these conditions, offering hope where traditional therapies have fallen short.
Can you explain how the technology behind anti-neonatal Fc receptors work for a non-specialized audience?
The anti-neonatal Fc receptor technology is surprisingly straightforward, resting on a key function within immunology. Among the potential malfunctions in the immune system—cytokines, immune cells, and antibodies—antibodies are crucial. Nature has evolved a system, through the Fc receptor, to transfer antibodies from mother to fetus, providing newborns with initial immunity. This receptor also recycles antibodies in adults, conserving energy for the body. However, for individuals with harmful antibodies, this recycling process exacerbates their conditions. By inhibiting this receptor, Immunovant's technology aims to reduce the presence of these detrimental antibodies, offering a balance between risk and benefit for people with autoimmune diseases.
How disruptive are the diseases Immunovant aims to treat, and can you share patient experiences to illustrate this?
Conditions like myasthenia gravis and thyroid eye disease, two of the diseases Immunovant has in pivotal trials, can severely disrupt patients' lives. For instance, we heard from a person living with myasthenia gravis who experienced sudden muscle weakness during dinner. This led to a choking incident that was not only terrifying for him, but also left a significant emotional impact on his children. Another person with thyroid eye disease faced social isolation and emotional distress due to the physical manifestations of her condition. These anecdotes underscore the profound effects autoimmune diseases can have on individuals' daily lives and well-being.
Between batoclimab and IMVT-1402 in Immunovant’s portfolio, how do their approaches to blocking the Fc receptor vary, especially regarding how they are administered, their ability to reduce harmful antibodies, and their effects on albumin?
Immunovant's pipeline features batoclimab and a second asset, IMVT-1402, both designed to block the Fc receptor but with distinct characteristics. Batoclimab can be administered via a simple subcutaneous injection, similar to a Humira injection, and has shown deeper reduction of harmful IgG autoantibodies compared to other anti-FcRn agents. However, batoclimab can lower albumin levels, leading to side effects in some patients. In contrast, IMVT-1402 was engineered to avoid this albumin reduction issue. Ultimately, 1402 offers an advantage in not impacting albumin levels, presenting a promising alternative for patients.
When can we expect these treatments to be available to the public?
Batoclimab is currently in Phase three trials in myasthenia gravis and thyroid eye disease, with expectations to conclude for myasthenia gravis by the end of 2024 and for thyroid eye disease in the first half of the following year. Before it can be made available to those patients, it will need to go through regulatory approval processes following the trials' completion. For IMVT-1402, leveraging a unique property of this class, the Phase 2 dose finding stage can be integrated into the Phase 1 trials, accelerating the overall development process. Immunovant anticipates starting pivotal registration programs for IMVT-1402 within the year, positioning both treatments as promising advancements for autoimmune diseases in the near future.
How has the market reacted to the potential of Immunovant's treatments in terms of investments and collaborations?
Immunovant has attracted significant attention and investment from the market, highlighted by a $200 million investment from Roivant Sciences in August of 2021 and a $450 million capital raise in October of 2023.
Roivant, owning approximately 55% of Immunovant, has been a pivotal supporter since its inception. The broad-based enthusiasm from investors reflects confidence in Immunovant's approach to autoimmune disease treatment, underpinning the potential impact of its drug development efforts. This support enables Immunovant to pursue its goal of addressing a wide range of autoimmune conditions, demonstrating the market's optimistic outlook on the company's contributions to the field.
