Johnson & Johnson Announces Promising, Early-Stage Results for
Tetravalent Mosaic-based HIV Preventive Vaccine Regimen

- TRAVERSE data add to body of clinical evidence supporting further study of Janssen’s investigational mosaic-based vaccine regimen -

MADRID, SPAIN, 22 October 2018 – Johnson & Johnson today announced the primary analysis of immune response data for a tetravalent mosaic-based preventive vaccine against HIV-1 infection in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In the early-stage, Phase 1/2a TRAVERSE study among HIV-negative volunteers, a vaccine regimen including a tetravalent (4-valent) mosaic viral vector was compared to a regimen containing a trivalent (3-valent) mosaic vector. At 28 weeks, the tetravalent mosaic-based vaccine was well tolerated and significantly enhanced the breadth of immune responses to different HIV-1 strains compared to the trivalent version. These Phase 1/2a data will be shared this week at the 2018 HIV Research for Prevention Conference (HIVR4P) in Madrid, Spain. The tetravalent vaccine is now in large-scale efficacy testing.

“We urgently need new prevention tools to turn the tide of the HIV pandemic, and an effective preventive vaccine would be a vital asset to help us achieve an HIV-free future,” said Hanneke Schuitemaker, Ph.D., Vice President, Head Viral Vaccine Discovery and Translational Medicine, Janssen Vaccines & Prevention B.V. “Our goal is to develop a universal vaccine that could be deployed against any strain of HIV circulating in the world.”

Developing an effective vaccine against HIV has proven challenging due in part to the significant global genetic diversity of the virus. Janssen’s investigational vaccine regimen contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes. Both the trivalent and tetravalent versions of the mosaic-based vaccine contain viral vectors that deliver immunogens designed to elicit immune responses against the three main proteins of HIV (Env, Pol and Gag). But the tetravalent formulation adds a fourth immunogen, which is Env-focused and designed to enhance the breadth of immune responses against HIV-1 subtypes.

These new TRAVERSE results build on encouraging safety and immune response results for the mosaic-based vaccine from the Phase 1/2a APPROACH study that were shared at the 22^nd International AIDS Conference (AIDS 2018). Early findings from TRAVERSE and APPROACH were critical in enabling the first large-scale efficacy study for a mosaic-based vaccine regimen, HVTN 705/HPX2008 (also known as ‘Imbokodo’), to commence in November 2017. This Phase 2b study is assessing a regimen based on the tetravalent vaccine that was first clinically evaluated in the TRAVERSE study. It aims to enroll 2,600 women aged 18-35 in five sub-Saharan African countries to determine whether the vaccine is safe and efficacious in reducing HIV-1 infection in this population.

Results from HVTN 705/HPX2008 are expected in 2021. Additional large-scale studies will be needed to support licensure of the mosaic-based vaccine regimen against HIV-1.

About the TRAVERSE Study
TRAVERSE (HPX2004/HVTN117/IPCAVD011; ClinicalTrials.gov number NCT02788045) is a Phase 1/2a safety and immunogenicity study in 198 HIV-negative volunteers from the USA and Rwanda. The study is evaluating two mosaic-based, heterologous prime-boost vaccine regimens utilizing Janssen’s AdVac^® viral vector technology based on advenovirus serotype 26 (Ad26). The regimens include the trivalent vaccine Ad26.Mos.HIV (containing the three immunogens Mos1.gag-pol, Mos2.gag-pol and Mos1.Env), and the tetravalent vaccine Ad26.Mos4.HIV (which also includes a fourth immunogen, Mos2S.Env, with the goal of optimizing the breadth of immune responses to different viral strains). In the study, two prime doses of either the trivalent or tetravalent mosaic vaccine were administered (weeks 0 and 12), followed by two boosts (weeks 24 and 48) of the same mosaic vaccine plus the soluble protein Clade C gp140 adjuvanted with aluminum phosphate.

In the primary TRAVERSE analysis presented at HIVR4P, at Week 28 (four weeks after participants received the first boost), both of the mosaic-based vaccine regimens appeared to be safe and were well tolerated. Most adverse events were mild or moderate. In terms of immunogenicity, both vaccine regimens induced immune responses in all vaccine recipients. However, the breadth and magnitude of immune responses were greatest for the tetravalent-based regimen comprising Ad26.Mos4.HIV as the prime and Ad26.Mos4.HIV and Clade C gp140 as the boost. This was demonstrated by a number of humoral (antibody) immunity evaluations, including Clade C gp140 ELISA, cross-clade ELISA breadth (Clade A, B, Consensus C, Mosaic gp140), subclass response (IgG1, IgG3), and functional antibody response and breadth (ADCP across clades). Higher response rates and magnitude of responses were also demonstrated by cellular immunity evaluations, including PTE Env ELISpot, Mos1/Mos2 Env ELISpot, and Gag/Pol ELISpot.

Janssen’s partners on the TRAVERSE study include Beth Israel Deaconess Medical Center (BIDMC) at Harvard Medical School; Bill & Melinda Gates Foundation; HIV Vaccine Trials Network (HVTN); National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); Ragon Institute of Massachusetts General Hospital, MIT and Harvard; and the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).

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.

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Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding the development of a tetravalent mosaic-based preventive vaccine for HIV-1 infection. 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.