Aptar’s Nasal Vaccine Delivery Solutions Featured in CastleVax Phase II Clinical Trial of an Intranasal COVID-19 Vaccine Candidate

Key Terms

intranasal medical

Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.

mucosal immune response medical

A mucosal immune response is the protection your body mounts at surfaces that line the nose, throat, lungs and gut—think of it as the security guards posted at building entrances that stop threats before they get inside. For investors, measuring this response matters because therapies or vaccines that trigger strong mucosal protection can prevent infection and transmission more effectively, potentially improving clinical success, market demand and regulatory approval prospects.

mucosal immunity medical

The immune protection found on the body's moist surfaces—like the nose, throat, lungs, and gut—that acts as the first line of defense against infections by trapping or neutralizing pathogens before they enter deeper tissues. Investors care because products that boost or target this frontline defense (for example, nasal sprays or oral vaccines) can change how well diseases are prevented or treated, shaping market demand, regulatory approval chances, and revenue potential for health companies.

mRNA vaccine medical

A mRNA vaccine delivers tiny pieces of genetic instructions (messenger RNA) into a person’s cells so those cells briefly make a harmless piece of a virus—like showing the immune system a photo—so it can learn to recognize and fight the real thing. Investors care because mRNA is a fast, adaptable development platform that can shorten timelines and scale manufacturing, offering potential for repeat business and partnerships, but it also carries clinical, regulatory and market risks.

combination products medical

Combination products are medical offerings that merge two or more types of treatments or delivery systems—such as a drug with a medical device or a biological therapy with an implant—into a single product. For investors, they matter because combining parts can raise development cost and regulatory scrutiny but also create stronger competitive advantages, higher pricing power, and stickier customer adoption; think of them like a smartphone that bundles hardware and software into one sold product.

extractables and leachables technical

Chemicals that come from materials used to make, package, or deliver a drug or medical product: 'extractables' are substances that can be pulled out of those materials under strong testing, while 'leachables' are the smaller set that actually migrate into the product during normal use or storage. Investors care because these contaminants can affect safety, trigger regulatory delays, recalls, or extra testing—like finding a cleaning residue in a bowl that changes the taste and safety of the soup.

Phase II medical

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

clinical trial medical

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

The use of LuerVax® and Spray Divider™ support Aptar’s commitment to advancing drug delivery and next-generation vaccine development, backed by comprehensive regulatory and technical expertise

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)-- AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery and consumer product dosing, dispensing and protection technologies, announced that its innovative nasal vaccine delivery solutions, LuerVax® and Spray Divider™, are being utilized in CastleVax’s Phase II clinical trial of CVAX-01, a next-generation intranasal COVID-19 vaccine candidate. This milestone underscores Aptar Pharma’s commitment to advancing vaccine delivery technologies and supporting the development of novel immunization strategies. The Phase II study of CVAX-01 is assessing the safety, tolerability and systemic and mucosal immune response of CastleVax’s intranasal COVID-19 vaccine compared to an FDA-approved injectable mRNA vaccine. Around 200 U.S. adults, including high-risk individuals and those over 65, will be followed for six months to evaluate whether nasal delivery can provide strong mucosal immunity.

Aptar’s Nasal Vaccine Delivery Solutions Featured in CastleVax Phase II Clinical Trial of an Intranasal COVID-19 Vaccine Candidate

This collaboration reinforces Aptar’s position as a trusted partner in the evolving landscape of nasal vaccine delivery systems and next-generation vaccines. By leveraging its deep expertise in regulatory pathways, technical support, and innovative device design, Aptar supports pharmaceutical partners in their efforts to accelerate development and bring cutting-edge solutions to market.

Aptar supports customers throughout the nasal drug development journey: from system design and formulation compatibility to clinical trial support and regulatory guidance. Its Pharma Services platform offers expertise in combination products, device/formulation optimization, and critical testing such as extractables and leachables, helping partners manage development risks and support efforts to accelerate time-to-market.

“Our collaboration on CastleVax’s Phase II trial reflects why leading innovators choose Aptar as their trusted partner for next-generation medicine development and advanced drug delivery,” said Alex Theodorakis, President, Aptar Pharma Prescription. “By offering comprehensive regulatory guidance and technical support, we help our customers navigate complexity with confidence and accelerate the delivery of life-changing therapies to patients worldwide.”

About Aptar

Aptar is a global leader in drug delivery and consumer product, dispensing, dosing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

This press release contains forward-looking statements, including regarding the use of LuerVax® and Spray Divider™ in third-party intranasal vaccine clinical development activities. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: risks related to clinical development activities conducted by third parties; development and commercialization risks; customer adoption; regulatory requirements and compliance; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Form 10-Qs. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Aptar Investors Relations Contact:

Mary Skafidas

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+1 347 351 6407

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Source: AptarGroup, Inc.