European Committee for Orphan Medicinal Products Provides Positive Opinion on INOVIO's Application for Orphan Drug Designation for INO-3107

Rhea-AI Summary

INOVIO (NASDAQ: INO) announced a positive opinion from the European Committee for Orphan Medicinal Products (COMP) regarding its application for orphan drug designation for INO-3107, intended for treating Recurrent Respiratory Papillomatosis (RRP). This rare disease, often caused by HPV types 6 and 11, leads to small growths in the respiratory tract, posing severe risks like airway obstruction. The European Commission is expected to make a final decision by late May 2023. Orphan designation is crucial for medicines targeting rare, life-threatening diseases affecting fewer than 5 in 10,000 individuals in the EU.

Positive

• Positive opinion from COMP for orphan drug designation of INO-3107.
• Potential treatment for a rare and debilitating condition (RRP) identified.
• Expected final decision from the European Commission enhances regulatory progress.

Negative

• None.

European Commission to review and make a final decision, expected late May 2023

PLYMOUTH MEETING, Pa., April 26, 2023 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Committee for Orphan Medicinal Products (COMP) has provided a positive opinion on INOVIO's application for orphan drug designation in the European Union (EU) for INO-3107. INO-3107 is the company's product candidate that may contribute to the treatment of Recurrent Respiratory Papillomatosis (RRP). The opinion is now with the European Commission, which will provide a final decision on the application within 30 days.

Orphan designation is for medicines in development for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. The Orphan Medicinal Products Regulation (Regulation (EC) No 141/2000) defines an orphan medicinal product as one intended for diseases affecting fewer than 5 in 10,000 people across the EU.

About RRP

RRP is a debilitating and rare disease caused primarily by HPV-6 and/or HPV-11. RRP is characterized by the development of small, wart-like growths, or papillomas, in the respiratory tract. While papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications. RRP can also significantly affect quality of life for patients by affecting the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the standard of care for RRP; however, the papillomas often grow back because the underlying HPV infection has not been eradicated.

About INOVIO

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device, CELLECTRA^®, to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com.

Contacts

Media: Jennie Willson (267) 429-8567 jennie.willson@inovio.com 
Investors: Thomas Hong (267) 440-4298 thomas.hong@inovio.com

Forward-Looking Statements

This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and our expectations regarding our research and development programs, including the planned initiation and conduct of clinical trials and the availability and timing of data from those trials, Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2022, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

 

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SOURCE INOVIO Pharmaceuticals, Inc.

FAQ

What is the status of INOVIO's application for orphan drug designation for INO-3107?

INOVIO received a positive opinion from the European Committee for Orphan Medicinal Products, and a final decision from the European Commission is expected by late May 2023.

What condition does INO-3107 aim to treat?

INO-3107 is intended to treat Recurrent Respiratory Papillomatosis (RRP), a rare disease caused by HPV.

What is Recurrent Respiratory Papillomatosis (RRP)?

RRP is a rare and debilitating condition characterized by wart-like growths in the respiratory tract, primarily caused by HPV types 6 and 11.

What does orphan drug designation mean for INO-3107?

Orphan drug designation is granted to medicines for rare diseases, providing benefits like market exclusivity and potential funding incentives.