ILiAD Biotechnologies and hVIVO Partner to Advance BPZE1 Vaccine Development

ILiAD Biotechnologies, LLC, a biotechnology company specializing in vaccine development, has taken a significant step toward bringing its next-generation pertussis vaccine, BPZE1, to market. The company recently announced that following a Type C meeting with the United States Food and Drug Administration (FDA) in December 2024, it has signed a Letter of Intent (LOI) with hVIVO plc to conduct a pivotal Phase 3 human challenge trial. hVIVO, a contract research organization (CRO) with expertise in human challenge models, will lead the study.

The Significance of a Human Challenge Trial

Traditional Phase 3 clinical trials for vaccines often face logistical challenges, particularly for diseases like pertussis (whooping cough), where outbreaks occur unpredictably. Conducting a human challenge trial allows researchers to study BPZE1’s effectiveness under controlled conditions, bypassing the uncertainties of natural infection patterns. Given that pertussis remains prevalent both in the United States and worldwide, this study holds considerable importance.

Keith Rubin, M.D., CEO and Founder of ILiAD, expressed optimism about the partnership: “We are excited to collaborate with hVIVO, a company with a strong track record in conducting human challenge studies, particularly in the field of infectious respiratory diseases. This Phase 3 trial represents a critical milestone in BPZE1’s development, bringing us closer to our goal of delivering this innovative vaccine to global markets and ultimately eliminating disease caused by B. pertussis.”

Next Steps in BPZE1 Development

ILiAD and hVIVO are currently working to finalize the formal agreement, with ILiAD concurrently pursuing funding initiatives to support the trial. Enrollment for the study is anticipated to commence in the second half of 2025, contingent upon securing the necessary financial resources.

Commentary by SuppBase Columnist Alice Winters

The development of BPZE1 is an important and timely endeavor in the vaccine landscape, given the persistent burden of pertussis. However, several key considerations must be addressed before this vaccine can be deemed a game-changer in infectious disease prevention.

Strengths of BPZE1 and the Human Challenge Model

BPZE1’s intranasal delivery system differentiates it from current acellular pertussis vaccines, which are typically administered via injection. This approach could enhance mucosal immunity, a critical factor in preventing bacterial colonization and transmission. If BPZE1 proves successful, it could provide longer-lasting immunity compared to existing pertussis vaccines, which have shown waning effectiveness over time.

The decision to conduct a human challenge trial is also strategic. Traditional field trials for pertussis vaccines are complicated by the sporadic nature of outbreaks, making it difficult to gather robust efficacy data in a timely manner. By directly exposing trial participants to B. pertussis under controlled conditions, researchers can obtain clearer insights into BPZE1’s protective capabilities.

Potential Risks and Challenges

Despite its promise, BPZE1 faces several hurdles. First and foremost, the human challenge model, while efficient, carries inherent ethical and safety concerns. Intentionally exposing individuals to B. pertussis requires stringent oversight to ensure participant safety, particularly given the disease’s potential severity.

Additionally, ILiAD’s reliance on securing financing before initiating enrollment poses a financial risk. Delays in funding could push back the timeline, potentially impacting market entry at a time when pertussis outbreaks continue to pose public health challenges.

Market and Regulatory Considerations

If BPZE1 successfully navigates Phase 3 trials and gains FDA approval, its market positioning will be critical. Given that current pertussis vaccines are already part of routine childhood immunization schedules, BPZE1 will need to demonstrate clear advantages in durability, efficacy, and ease of administration to gain widespread adoption.

Moreover, while the U.S. remains a key target market, global accessibility will be essential. Pertussis remains a major health threat in many low- and middle-income countries, where vaccine distribution infrastructure varies significantly. Pricing and supply chain logistics will be critical factors influencing BPZE1’s success on a global scale.

Final Verdict

BPZE1 represents an innovative step forward in pertussis prevention, with the potential to address the shortcomings of existing vaccines. However, its success will hinge on the outcomes of the Phase 3 human challenge trial, the ability to navigate regulatory hurdles, and effective financial and market strategies. The coming years will determine whether BPZE1 can truly redefine pertussis vaccination or if it will face setbacks that limit its impact.