Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV

Johnson & Johnson today announced that The Lancet has published key early-stage data regarding an investigational mosaic-based preventive vaccine regimen against HIV-1 infection that is in development at its Janssen Pharmaceutical Companies. In the Phase 1/2a APPROACH study, based on the data generated, the vaccine regimen was safe and well-tolerated and elicited a robust HIV antibody response in all healthy volunteers receiving active vaccine. Additionally, in a parallel study in non-human primates (NHPs), the most immunogenic mosaic-based vaccine regimen in humans demonstrated similar immune responses in NHPs and afforded 67% protection against an HIV-like virus.

The Lancet paper provides the first detailed analysis of topline results presented by Janssen at the 9th IAS Conference on HIV Science (IAS 2017) in July 2017, and supports the recent advancement of the mosaic-based vaccine regimen into its first large-scale efficacy study.

“These are promising but still early-stage results. At 52 weeks, we observed that the mosaic-based vaccine regimen induced robust and comparable immune responses to HIV in humans and in nonhuman primates, and the vaccine protected against infection with an HIV-like virus in nonhuman primates,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a lead author ofThe Lancet paper.

Janssen’s investigational mosaic-based vaccine regimen contains immunogens created us-ing genes from different viral subtypes responsible for HIV infections worldwide.

“The progress made in the last thirty years in the fight against HIV is remarkable, yet HIV still persists as a global health threat affecting millions,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “The genetic diversity inherent in HIV brings many challenges, but we are committed to developing a ‘global vaccine’ effective against the multiple strains of the virus. Our quest is to develop a vaccine that would put an end to the worldwide pandemic for good.”

In addition to the results reported in The Lancet, the first long-term immunological data from the APPROACH study will be presented in an oral presentation at the 22^nd International AIDS Conference (AIDS 2018) on Tuesday, July 24, 2018 in Amsterdam, The Netherlands.

Based on results from APPROACH and other early-stage studies, in November 2017 Janssen and its global partners initiated the first efficacy study for a mosaic-based vaccine regimen. The Phase 2b trial, HVTN 705/HPX2008 (also known as ‘Imbokodo’), aims to enroll 2,600 young women aged 18-35 in five sub-Saharan African countries to see whether the vaccine is safe and able to reduce HIV infection in this at-risk population. Participants are now enrolling at clinical research sites in South Africa, Zimbabwe and Malawi. The study has been cleared to start in Zambia, and regulatory approval is pending in Mozambique. Results from HVTN 705/ HPX2008 are expected in 2021.

“The HVTN 705/HPX2008 trial is built on a partnership with our global communities, Janssen and other stakeholders who are committed to finding an effective HIV vaccine. The imperative, if we are successful, is to then make sure that the effective HIV vaccine can be taken to scale and is accessible”, says Larry Corey, M.D., Principal Investigator of the HVTN, virologist and faculty member at Fred Hutchinson Cancer Research Center.

Although great progress has been made in the fight against HIV/AIDS, a safe and effective vaccine will likely be required to truly end the HIV pandemic. In 2016, nearly 37 million people were living with HIV globally, 1.8 million people were newly infected with HIV, and 1 million people died of AIDS.ⁱ

About the APPROACH and NHP Bridging Studies

APPROACH (HIV-V-A004/NCT02315703) is a Phase 1/2a study in 393 healthy HIV-uninfected adults in the U.S., Rwanda, Uganda, South Africa and Thailand. It is evaluating the safety, tolerability and immunogenicity of various mosaic-based vaccine regimens for HIV-1. These vaccine regimens contain two prime doses (weeks 0 and 12) of the mosaic viral vector Ad26.Mos.HIV, utilizing Janssen’s AdVac^® technology based on adenovirus serotype 26 (Ad26), followed by two boosts (weeks 24 and 48) of either Ad26.Mos.HIV, MVA-Mosaic and/or different doses of the soluble protein Clade C gp140 adjuvanted with aluminum phosphate. By first priming and then boosting the immune system, the goal is to produce a strong and long-lasting immune response to HIV.

At 52 weeks, four weeks after the last vaccine dose, all vaccine regimens evaluated in APPROACH were safe and generally well-tolerated. Additionally, all regimens elicited robust humoral and cellular HIV-1 immune responses. The most immunogenic regimen in humans comprised mosaic Ad26 as the prime, and Ad26+gp140 as the boost. It elicited Env-specific binding antibody responses, antibody-dependent cellular phagocytosis responses, and T-cell responses in 100%, 80% and 83% of recipients, respectively. In a parallel bridging study in NHPs (n=72), the same Ad26/Ad26+gp140 vaccine regimen induced a similar magnitude, durability, and phenotype of immune responses, and afforded 67% protection against acquisition of infection with simian-human immunodeficiency virus (SHIV).

Janssen’s partners on the APPROACH study included Beth Israel Deaconess Medical Center (BIDMC), Harvard Medical School; the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jack-son Foundation for the Advancement of Military Medicine (HJF); the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); the Ragon Institute of Massachusetts General Hospital, MIT and Harvard; the In-ternational AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN).

Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040.

Visit www.jnj.com/HIV to learn more about the breadth of HIV science being pursued by the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners across prevention, treatment and cure research.

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 health care 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.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Janssen Vaccines & Prevention B.V. is part 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 31, 2017 including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other 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. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.