RARITAN, NJ – July 26, 2016 -- Janssen Biotech, Inc. announced today it has entered into a clinical study collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of two immuno-oncology compounds in patients with non-small cell lung cancer (NSCLC). The Phase 2 clinical trial will evaluate the tolerability and clinical activity of the combination of Janssen’s investigational immunotherapy JNJ-64041757 and Bristol-Myer Squibb’s PD-1 immune checkpoint inhibitor, OPDIVO® (nivolumab), in NSCLC patients.
JNJ-64041757 is an antigen-presentation therapeutic, based on Live Attenuated Double-Deleted (LADD) Listeria monocytogenes strains engineered to induce an immune response against NSCLC tumors. Janssen licensed JNJ-64041757 (previously referred to as ADU-214) and another compound, JNJ-64041809 (previously referred to as ADU-741), from Aduro Biotech, Inc., in 2014. Both are currently in Phase 1 clinical development: JNJ-64041757 in lung cancer and JNJ-64041809 in prostate cancer. OPDIVO is indicated for the treatment of patients with NSCLC with progression on or after platinum-based chemotherapy.
“Cancer immunotherapy is a key aspect of our emerging lung cancer portfolio,” said Matthew Lorenzi, Ph.D., Vice President, Lung Cancer, Janssen Research & Development, LLC. “This collaboration will help extend the clinical development of JNJ-64041757 while allowing us to gather data on the immune response triggered by the combination of these two innovative approaches.”
The study will be conducted by Janssen. Information, including anticipated study start, is expected to be posted on www.clinicaltrials.gov later this year. Additional details of the collaboration were not disclosed.
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 www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.
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This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 Biotech, Inc, Janssen Research & Development, LLC or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description 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 January 3, 2016, including in Exhibit 99 thereto, 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. 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.