Immunovant Awarded U.S. Patent for IMVT-1402

Rhea-AI Summary

Immunovant, Inc. (IMVT) secures U.S. Patent for IMVT-1402 until 2043, a promising antibody for autoimmune diseases. The patent covers composition of matter, methods of use, and manufacturing claims. IMVT-1402 shows potential best-in-class profile in Phase 1 trial.

Biotechnology Patent Expert

The issuance of a composition of matter patent for Immunovant's IMVT-1402 represents a significant milestone for the company. This type of patent is crucial in the biotechnology industry as it provides protection for the unique chemical makeup of a new compound, in this case, a second-generation antibody. The coverage until 2043 without considering potential extensions, affords Immunovant a long-term competitive edge by preventing other companies from creating generic versions of their antibody.

Furthermore, the inclusion of methods of use and manufacturing in the patent claims enhances the company's intellectual property portfolio, safeguarding the proprietary processes and potential therapeutic applications. This comprehensive patent protection is instrumental for Immunovant in securing partnerships, attracting investments and deterring competition, which can have a positive impact on the company's market valuation and investor confidence.

Pharmaceutical Market Analyst

The potential of IMVT-1402 to treat autoimmune diseases with a best-in-class profile is noteworthy. Comparisons to batoclimab suggest that IMVT-1402 could be a strong contender in the market for immunoglobulin G (IgG) reducing therapies. IgG reduction is a key therapeutic mechanism for certain autoimmune conditions and achieving steady levels without affecting serum albumin and LDL cholesterol could position IMVT-1402 favorably among both physicians and patients.

Given the promising Phase 1 clinical trial results, the market outlook for Immunovant could see a positive shift. The ability to maintain steady IgG levels may translate to a more consistent efficacy profile, which is highly valued in the management of autoimmune diseases. This could lead to increased market share and higher revenue projections for Immunovant, provided subsequent trials confirm these initial findings and the treatment receives regulatory approval.

Clinical Trials Specialist

The mention of IMVT-1402's Phase 1 clinical trial results is a critical piece of information for stakeholders. While the initial data is promising, it is important to note that the drug is still in the early stages of development. The transition from Phase 1 to later-stage trials will be a key inflection point for the company. Success in Phase 2 and 3 trials will be essential to validate the safety and efficacy profile of IMVT-1402 for treating autoimmune diseases.

Investors should be aware of the risks and timelines associated with clinical development. The journey from clinical trials to market approval is fraught with challenges and setbacks can have significant impacts on company valuations. However, a successful progression through clinical trials can lead to substantial rewards. It will be crucial to monitor upcoming trial designs, patient recruitment and interim results to better understand the potential of IMVT-1402 to meet its clinical endpoints and to anticipate its path to market.

• Composition of matter patent issued with coverage until June 2043
  
  
• Patent also includes methods of use and methods of manufacturing claims
  

NEW YORK, March 12, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 11,926,669 (“the ‘669 patent”) for IMVT-1402, the Company’s second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn). The allowed claims cover composition of matter for the binding sequence of IMVT-1402 to FcRn, method of use of the antibody for treating autoimmune disease, as well as methods for its manufacturing. Not including any potential patent term extension, the ‘669 patent will expire on June 23, 2043. IMVT-1402 is being developed by Immunovant based on antibody discovery efforts by HanAll Biopharma.

IMVT-1402 delivered subcutaneously has demonstrated potentially best-in-class profile in a Phase 1 clinical trial in healthy adults, with initial data demonstrating a deep immunoglobulin G (IgG) reduction that is similar to batoclimab, but with no or minimal changes in serum albumin and LDL cholesterol, consistent with placebo. Immunovant believes that IMVT-1402 administered weekly can achieve steady reductions in IgG and further believes that steady reductions in IgG lowering are needed to avoid fluctuations in efficacy.

About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit www.immunovant.com. 

Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s intellectual property portfolio; Immunovant’s belief regarding the impact to IgG with IMVT-1402 administered on a weekly basis; and potential benefits of IMVT-1402’s unique product attributes and potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as the post-COVID-19 environment, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of batoclimab and IMVT-1402; Immunovant is at an early stage of development for IMVT-1402 and in various stages of clinical development for batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q filed with the SEC on February 12, 2024, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Chau Cheng, PhD, MBA
Vice President, Investor Relations
Immunovant, Inc.
info@immunovant.com

What is the patent number issued to Immunovant for IMVT-1402?

The United States Patent and Trademark Office issued U.S. Patent No. 11,926,669 for IMVT-1402.

When will the '669 patent for IMVT-1402 expire?

The '669 patent is set to expire on June 23, 2043, without any potential patent term extension.

Who is developing IMVT-1402?

IMVT-1402 is being developed by Immunovant, based on antibody discovery efforts by HanAll Biopharma.

What are the key findings of IMVT-1402 in the Phase 1 clinical trial?

IMVT-1402 delivered subcutaneously has shown a potentially best-in-class profile with deep IgG reduction similar to batoclimab, minimal changes in serum albumin and LDL cholesterol, and consistent efficacy.

What does Immunovant believe regarding the administration of IMVT-1402?

Immunovant believes that weekly administration of IMVT-1402 can lead to steady reductions in IgG levels, crucial for maintaining efficacy without fluctuations.