Johnson & Johnson Announces New Clinical Data on Mosaic-based HIV Preventive Vaccine Regimen

Late-breaking findings from Phase 1/2a study ASCENT presented at 10^th International AIDS Society Conference on HIV Science (IAS 2019)

MEXICO CITY, July 23, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a Phase 1/2a study evaluating an investigational mosaic-based preventive vaccine regimen against HIV-1 infection. The study, ASCENT (HPX2003/HVTN 118), found that adding a bivalent soluble protein to the regimen (a combination of Clade C and Mosaic gp140) improved the breadth of immune responses to different HIV strains circulating worldwide. The results were shared today in a late-breaking presentation at the 10^th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.

Janssen’s mosaic-based vaccine candidate contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes with the goal of delivering a global vaccine that could be deployed anywhere in the world.

“While the global genetic diversity of HIV poses a considerable scientific challenge, we believe that the mosaic vaccine approach may have the potential to address this problem,” said Hanneke Schuitemaker, Ph.D., Vice President, Head Viral Vaccine Discovery and Translational Medicine, Janssen Vaccines & Prevention B.V. “We are encouraged by the results of the Phase 1/2a ASCENT study, which support the upcoming launch of Mosaico, the first Phase 3 efficacy study for this vaccine regimen that will be conducted across three continents.”

Janssen’s investigational preventive HIV vaccine regimen involves four vaccination visits over one year. The first two vaccination visits involve a single injection of tetravalent mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV). The last two vaccination visits include Ad26.Mos4.HIV plus an injection of a soluble trimeric gp140 protein adjuvanted by aluminum phosphate.

In the ASCENT trial, a bivalent combination of Clade C and Mosaic gp140 was evaluated for immunogenicity (ability to induce an immune response) compared to single-valent Clade C gp140. In the study, both regimens induced high immune responses against a broad range of HIV-1 subtypes. But notably, the study found that bivalent gp140 enhanced immune responses to Clade B, the predominant subtype in the Americas, Western Europe and Australasia. This was achieved without diminishing immune responses to Clade C, which is prevalent in Southern Africa, the horn of Africa, and India.^[1]

To further investigate the potential of this approach, on July 15, 2019, Johnson & Johnson announced the formation of a new public-private partnership to support a Phase 3 study called Mosaico (HPX3002/HVTN 706). Mosaico will evaluate the vaccine regimen containing Ad26.Mos4.HIV, and bivalent gp140 adjuvanted by aluminum phosphate. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN) based at the Fred Hutchinson Cancer Research Center, and the U.S. Army Medical Research and Development Command (USAMRDC) are joining forces with the Janssen Pharmaceutical Companies of Johnson & Johnson to study the potential global vaccine.

Mosaico will have a target enrollment of 3,800 individuals in eight countries across North America, South America and Europe, and is expected to commence later in 2019.

About ASCENT
The ASCENT study (HPX2003/HVTN 118) was conducted in Kenya, Rwanda, and the United States in 152 healthy adults (18–50 years). Participants were vaccinated with either Ad26.Mos4.HIV and bivalent Clade C/Mosaic gp140 adjuvanted by aluminum phosphate (n=100), Ad26.Mos4.HIV and adjuvanted Clade C gp140 (n=26), or placebo (n=26).

At 52 weeks (four weeks after the last vaccination), both active vaccine regimens induced binding and functional antibodies to all antigens tested. Clade C responses were not reduced by replacing half of the clade C dose with Mosaic gp140, while clade B responses improved. The active regimens were well tolerated and there were no serious adverse events. More information about ASCENT can be found on ClinicalTrials.gov (identifier NCT02935686).

Additional Vaccine Studies at IAS
Janssen’s HIV vaccine presentations at IAS will also include the latest long-term findings from the Phase 1/2a APPROACH study, which examined two regimens of a mosaic-based viral vector with varying doses of the Clade C gp140 soluble protein. Data from an unblinded long-term extension of this study (n=65) demonstrate durable humoral and cellular immune responses through two years, with a 100% antibody response rate being maintained at week 144 (two years post last immunization). The study also found that those participants who had an immune response to the first vaccination in the regimen schedule were more likely to maintain this response over time. Additionally, no safety issues were reported.

Janssen’s commitment to HIV vaccine research includes a robust clinical trial program, as well as deep engagement with community stakeholders to help inform this effort. In another oral presentation at IAS, the company will share its learnings from implementing Good Participatory Practice (GPP) guidelines in its HIV preventive vaccine trials. The GPP guidelines were developed by UNAIDS and AVAC, and Janssen is one of the first pharmaceutical companies to formally implement them. Janssen is committed to ensuring that its HIV vaccine studies uphold GPP standards, which include a range of best practices around community engagement and communications with study volunteers.

About Janssen’s HIV Preventive Vaccine
The mosaic-based regimen utilizes Janssen’s AdVac^® adenovirus vector platform and PER.C6^® production cell line technology. In addition to the partners supporting Mosaico, other organizations who have or are supporting Janssen’s clinical trial program for the HIV vaccine include the Bill & Melinda Gates Foundation; the US Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research, with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the Ragon Institute of Massachusetts General Hospital (MGH), Massachusetts Institute of Technology (MIT) and Harvard; Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School; and the International AIDS Vaccine Initiative (IAVI).

Since 2005, Janssen Vaccines & Prevention B.V. has participated as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Professor Dan Barouch).

Visit www.jnj.com/HIV for further details on the breadth of HIV science and collaboration being undertaken by the Johnson & Johnson Family of Companies and its partners.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @jnjglobalhealth.

About the Janssen Pharmaceutical Companies
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at @JanssenGlobal. Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding development of a potential preventive vaccine for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2018 including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

^[1] Avert. HIV Strains And Types. Available at https://www.avert.org/professionals/hiv-science/types-strains. Last accessed July 2019.