Virpax Announces MMS019 Manufacturing and Supply Agreement

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ:VRPX) announced a manufacturing agreement with Seqens for the supply of MMS019, a novel drug for pain management. This collaboration ensures both clinical and long-term commercial supply, enhancing development capabilities. MMS019 utilizes advanced nanotechnology to deliver medication intranasally, showing promising preclinical results comparable to morphine without associated drug-seeking behavior. Virpax is also advancing other programs like Envelta™ for pain management and PES200 for PTSD, indicating a strong focus on innovative, non-addictive therapies.

Positive

• Collaboration with Seqens provides reliable supply for clinical and commercial needs of MMS019.
• MMS019 shows promising preclinical efficacy comparable to morphine without addiction risks.
• Virpax is advancing multiple drug development programs, indicating robust pipeline growth.

Negative

• None.

--Seqens to provide clinical and commercial supply of MMS019--

BERWYN, Pa.--(BUSINESS WIRE)-- Virpax^® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has entered into a commercial manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide and seven research and development facilities throughout the U.S. and Europe.

The agreement with Seqens provides for both the supply material for Virpax’s clinical studies as well as the long-term commercial supply of MMS019. Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts.

“Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy. Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production,” said Anthony Mack, Chairman and CEO of Virpax. “Importantly, we expect this collaboration to support future development and supply additional Molecular Envelope Technology programs under development, including Envelta™ and PES200, our post-traumatic stress disorder product candidate,” concluded Mr. Mack.

About MMS019

MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain via intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids.

About Seqens

SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients. With 24 production sites and 7 R&D centers in Europe, North America and Asia, SEQENS develops and manufactures tailor-made solutions and ingredients for the most demanding industries such as healthcare, electronics, cosmetics, food and home care.

Driven by a culture of excellence and a strong entrepreneurial spirit, our 3,200 employees are committed to providing our customers with the highest level of service and quality while acting ethically in accordance with our corporate social responsibility program.”

About Virpax Pharmaceuticals

Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval using its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal molecular-envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its MMS019 product candidate to inhibit viral replication caused by influenza or SARS-CoV-2. For more information, please visit www.virpaxpharma.com.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's planned clinical trials, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company’s operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210826005135/en/

Christopher M. Chipman, CPA

Chief Financial Officer

cchipman@virpaxpharma.com

610-727-4597



Or



Betsy Brod

Affinity Growth Advisors

betsy.brod@affinitygrowth.com

212-661-2231

Source: Virpax® Pharmaceuticals, Inc.

FAQ

What is the significance of the agreement between Virpax Pharmaceuticals and Seqens regarding MMS019?

The agreement ensures the clinical and commercial supply of MMS019, a drug candidate for pain management, supporting its development and future market readiness.

How does MMS019 compare to traditional pain management options like morphine?

MMS019 demonstrates comparable preclinical activity to morphine but without the associated drug-seeking behavior and tolerance.

What are the other product candidates Virpax is developing?

Virpax is also developing Envelta™ for pain management and PES200 for PTSD, showcasing its commitment to innovative, non-addictive therapies.

What technologies are being used in the development of MMS019?

MMS019 utilizes Molecular Envelope Technology (MET) for effective drug delivery via intranasal administration.

When was the press release about Virpax's agreement with Seqens issued?

The press release was issued on August 26, 2021.