TESARO Announces Submission of Investigational New Drug Application for Anti-TIM-3 Antibody TSR-022 to the U.S. FDA

WALTHAM, Mass., April 25, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the submission of an Investigational New Drug (IND) Application for TSR-022 to the U.S. Food and Drug Administration. TSR-022 is a monoclonal antibody drug candidate targeting TIM-3.

“TSR-022 is poised to be the second antibody candidate from our immuno-oncology portfolio to begin clinical studies,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “Following clearance of the IND, we plan to begin a Phase 1 study in mid-2016.”

About TSR-022
TSR-022 is a monoclonal antibody candidate targeting TIM-3 and was developed as part of a collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drug candidates targeting PD-1 (TSR-042), TIM-3 (TSR-022), and LAG-3, and bi-specific antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3, in addition to a novel bispecific antibody candidate designed to target undisclosed targets.

TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions, as well as other words or expressions referencing future events, conditions or circumstances, are intended to identify forward-looking statements. Examples of forward looking statements contained in this press release include, among others, our plans to initiate a Phase 1 study of TSR-022 in mid-2016. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, patient accrual rates for clinical trials, and other matters that could affect the timing of availability of data from or initiation of our clinical trials. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015.

CONTACT: Investor/Media Contact:
Jennifer Davis
+1.781.325.1116 or jdavis@tesarobio.com