INO-3107 Awarded the Innovation Passport Designation Under U.K. Government's Innovative Licensing and Access Pathway

Rhea-AI Summary

INOVIO (NASDAQ: INO) has announced that its lead DNA medicine candidate, INO-3107, has been awarded the Innovation Passport designation under the U.K.'s Innovative Licensing and Access Pathway (ILAP). This designation is given to innovative medicines with the potential to meet a significant unmet medical need, accelerating their development and regulatory approval process.

INO-3107 is targeted at treating Recurrent Respiratory Papillomatosis (RRP), a rare and chronic disease caused by HPV-6 and HPV-11. The Innovation Passport facilitates a streamlined roadmap for regulatory approval, offering opportunities for enhanced regulatory input and accelerated timelines.

The ILAP, driven by multiple U.K. health authorities, aims to expedite the availability of promising medicines, particularly benefiting the post-Brexit life sciences landscape.

Positive

• INO-3107 receiving the Innovation Passport designation facilitates accelerated regulatory approval in the U.K.
• Enhanced access to regulators and development tools may expedite INO-3107's time to market.

Negative

• None.

Insights

Medical Research Analyst

INO-3107 receiving the Innovation Passport designation is a significant milestone. This status, awarded as part of the U.K.'s Innovative Licensing and Access Pathway (ILAP), highlights the potential of INO-3107 in treating Recurrent Respiratory Papillomatosis (RRP), a rare and chronic respiratory disease caused by HPV-6 and HPV-11. This designation provides INOVIO with enhanced access to regulatory guidance, development tools and potentially faster market approval.

For retail investors, it's important to understand that this recognition can hasten INO-3107's journey to approval, offering a faster pathway to reach patients. The potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment and rolling reviews can be a game-changer in terms of time-to-market.

However, there are critical considerations. While the designation is promising, it doesn't guarantee eventual approval or market success. The therapy must still demonstrate clinical efficacy and safety in trials. For those new to the concept, the Innovation Passport is essentially a regulatory 'green light', indicating that the medicine has shown early potential and warrants expedited development processes.

In summary, from a market perspective, this is a positive indicator, suggesting a possibly quicker timeline to commercialization for INO-3107. Investors should monitor upcoming trial results and any further regulatory updates closely.

Financial Analyst

The Innovation Passport designation for INO-3107 may have several financial implications for INOVIO. First, it can potentially reduce the time and costs associated with bringing the drug to market. The streamlined approval process and regulatory support available through the ILAP can significantly cut down on both direct expenses and opportunity costs.

For investors, this could translate into accelerated revenue generation if INO-3107 successfully passes regulatory hurdles. The faster market entry also means earlier potential to capture market share in the limited but high-need niche of RRP treatment. Success in this area could enhance INOVIO’s reputation in the DNA medicine field, possibly leading to increased investor confidence and stock valuation.

However, the financial benefits hinge on successful clinical trial outcomes and eventual market approval. Investors should consider the inherent risks in biotechnology investments, particularly those involving drugs still in the clinical trial phase. While the expedited timeline is beneficial, there remains a level of uncertainty until trial data is fully analyzed and regulatory approval is granted.

In conclusion, this designation positions INOVIO advantageously but requires cautious optimism. Keep an eye on financial reports and clinical updates to gauge progress and evolving risk-reward profiles.

Award recognizes the potential for INO-3107 to be the first therapeutic option in the United Kingdom for patients suffering from Recurrent Respiratory Papillomatosis (RRP)

PLYMOUTH MEETING, Pa., July 11, 2024 /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 its lead DNA medicine candidate, INO-3107, has been designated an innovative medicine as part of the U.K.'s Innovative Licensing and Access Pathway (ILAP). The designation, called an Innovation Passport, was granted by the ILAP Steering Group to INO-3107 for the treatment of patients with Recurrent Respiratory Papillomatosis (RRP), a debilitating, chronic rare disease of the respiratory tract caused by HPV-6 and/or HPV-11.

"The U.K. Innovation Passport designation is yet another recognition of the promise of INO-3107 to potentially transform the treatment paradigm for RRP patients," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We are honored to receive this designation, which offers us enhanced access to regulators and development tools that could accelerate the timeline for achieving U.K. regulatory approval of INO-3107. We look forward to continuing our discussions with the ILAP partners as we work to deliver this promising DNA medicine to patients as quickly as possible."

The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the United Kingdom. The Innovation Passport provides a single, streamlined roadmap for regulatory approval and development milestones. Recipients of the Innovation Passport are granted access to a range of development tools to support the design, development and approvals process in the U.K., as well as opportunities for enhanced regulatory and other stakeholder input. Specific benefits of ILAP include the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment. The ILAP is delivered in partnership by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence and the Scottish Medicines Consortium, part of Healthcare Improvement Scotland. The MHRA launched ILAP at the start of 2021 to accelerate the development and access to promising medicines in the early stages of development. The pathway is part of the UK's plan to attract life sciences development in the post-Brexit era. For more information about the Innovation Passport and ILAP, visit: Innovative Licensing and Access Pathway - GOV.UK

About INO-3107

INO-3107 is designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells are designed to seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas. In a Phase 1/2 clinical trial conducted with INO-3107, 81.3% (26/32) of patients had a decrease in surgical interventions in the year after INO-3107 administration compared to the prior year, including 28.1% (9/32) that required no surgical intervention during or after the dosing window. Patients in the trial had a median range of 4 surgeries (2-8) in the year prior to dosing. After dosing, there was a median decrease of 3 surgical interventions (95% confidence interval -3, -2). At the outset of the study (Day 0), patients had a clinically warranted procedure to have RRP tissue surgically removed, but any surgery performed after Day 0 during the dosing window was counted against the efficacy endpoint. Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. INO-3107 was well tolerated by participants in the trial, resulting in mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue. Like other DNA medicines, INO-3107 has the ability to generate antigen-specific T cells that is not affected by anti-vector immunity impacting immunogenicity, either before administration or after the first dose unlike other T-cell generating platforms such as viral vectors. This feature of DNA medicines should allow INO-3107 to maintain T cell response and overall efficacy, which would make it an important therapeutic option for a majority of RRP patients.

The FDA granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data from its already completed Phase 1/2 trial. The European Commission has also granted INO-3107 Orphan Drug designation. INOVIO's delivery device, CELLECTRA®, received CE marking, a regulatory standard that certifies that a product has met European Union's safety, health, and environmental standards.

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. INOVIO's market research to date with patients and healthcare professionals indicates that a reduction of even one surgery matters, because every surgery poses a significant risk of causing permanent damage to the vocal cords. The most widely cited U.S. epidemiology data published in 1995 estimated that there were 14,000 active cases and about 1.8 per 100,000 new cases in adults each year.

About INOVIO's DNA Medicines Platform

INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA®. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA® delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.

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 technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.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 expectations regarding our research and development programs, including timelines and prospects for regulatory approval, as well as benefits for patients. 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, 2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, 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.

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

 

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SOURCE INOVIO Pharmaceuticals, Inc.

FAQ

What is INO-3107?

INO-3107 is a DNA medicine candidate developed by INOVIO for treating Recurrent Respiratory Papillomatosis (RRP).

What does the Innovation Passport designation mean for INO-3107?

The Innovation Passport designation under the U.K.'s ILAP program accelerates the regulatory approval process for INO-3107, providing enhanced access to development tools and regulatory input.

How does the Innovation Passport benefit INO-3107?

The designation offers a streamlined regulatory roadmap, potentially reducing the time for INO-3107 to reach the market, along with opportunities for continuous benefit-risk assessment and a 150-day accelerated Marketing Authorization Application assessment.

When was INO-3107 awarded the Innovation Passport designation?

INO-3107 was awarded the Innovation Passport designation on July 11, 2024.

What is the significance of ILAP for INO-3107's development?

The ILAP program aims to expedite the development and access to promising medicines, enhancing INO-3107's regulatory approval pathway and market entry.