July 23, 2024

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Immunovant’s Stock Soars 100% with Promising FcRn Antibody IMVT-1402!

Immunovant’s Stock Soars 100% with Promising FcRn Antibody IMVT-1402!



Immunovant’s Stock Soars 100% with Promising FcRn Antibody IMVT-1402!

Immunovant CEO Matt Gline, who once grappled with cholesterol issues surrounding their flagship product Bartoli monoclonal antibody, now seems to have a superior potential alternative treatment in hand.

On September 26th, Immunovant announced the latest clinical results for IMVT-1402. Following this announcement, the company’s stock price surged by nearly 100%, reaching a market capitalization of $5.2 billion. Even Roivant, Immunovant’s parent company, witnessed a 23% increase in its stock price on the same day.

The Phase I clinical trial data for IMVT-1402 has been validated, showing dose-dependent reduction in IgG levels with subcutaneous administration. There were no dose-related changes in serum albumin or low-density lipoprotein C. Moreover, in the Multiple Ascending Dose (MAD) cohort, the average total IgG decreased by 63% from baseline.

Clearly, these trial results reinforce IMVT-1402’s position as a potential leading FcRn inhibitor in its class.

As a differentiated FcRn antibody designed for the treatment of IgG-mediated autoimmune diseases, IMVT-1402 distinguishes itself by selectively blocking the binding of Fc to FcRn and intervening in the interaction between albumin and FcRn. This mechanism positions IMVT-1402 as a potentially more potent therapeutic option for autoimmune diseases compared to Bartoli monoclonal antibody, which has been known to cause a decrease in albumin levels.

 

IMVT-1402 boasts three key product attributes:

  1. In non-clinical studies, IMVT-1402 exhibits IgG reduction similar to what was observed with Bartoli monoclonal antibody in non-clinical studies.
  2. CMC (Chemistry, Manufacturing, and Controls) and formulation work for IMVT-1402 have been completed to achieve convenient administration via subcutaneous injection, similar to Bartoli monoclonal antibody.
  3. In a head-to-head non-clinical study at doses exceeding expected human effective levels, IMVT-1402’s impact on albumin and LDL cholesterol was minimal, if not absent, when compared to Bartoli monoclonal antibody.

 

In the second quarter of 2023, the FDA approved IMVT-1402’s IND application, and following approval of the clinical trial application by regulatory agency Medsafe, Immunovant initiated Phase I clinical trials in New Zealand to assess the safety, tolerability, and pharmacokinetic properties of subcutaneous IMVT-1402.

 

Immunovant's Stock Soars 100% with Promising FcRn Antibody IMVT-1402!

 

 

 

Regarding safety, the updated trial data shows that participants receiving IMVT-1402 injections experienced only mild or moderate adverse events, with no significant decreases in serum albumin or increases in LDL-C from baseline, possibly due to the specificity of IMVT-1402’s binding site.

Notably, IMVT-1402 has a concentration of 150 mg/ml, requiring only 2 ml for injection and taking only a few seconds to administer subcutaneously. In contrast, the first approved FcRn antibody, Vyvgart Hytrulo, uses Halozyme technology, necessitating longer injections and yielding higher injection reactions. This comparison suggests that IMVT-1402 still has room for differentiation as a more convenient subcutaneous option, with the potential to become the premier drug in its class.

Gline mentioned that if the Phase I clinical trial results for Bartoli monoclonal antibody turn out positive later on, Graves’ disease could become the primary indication for IMVT-1402. Additionally, Immunovant is utilizing IMVT-1402 for a registered program targeting chronic inflammatory demyelinating polyneuropathy.

FcRn is a crucial immune regulator that controls the transport and recycling of IgG molecules. The accumulation of pathogenic IgG may lead to various autoimmune diseases. Therefore, FcRn-targeting drugs are considered revolutionary therapies for autoimmune diseases.

IgG-mediated autoimmune diseases encompass a wide range of conditions, affecting approximately 2.5% of the global population. Given this, FcRn antibody drugs have a substantial market size, provided they offer sufficient differentiation in safety and efficacy.

Although IMVT-1402 is currently only in Phase I clinical development, its demonstrated safety and efficacy appear to surpass those of other similar products.

 

 

 

Immunovant’s Stock Soars 100% with Promising FcRn Antibody IMVT-1402!

Reference:
1. Roivant’s FcRn inhibitor avoids cholesterol problem, which clouded CEO Gline’s first days in the gig.

(source:internet, reference only)


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