Gritstone Oncology Advances Solid Tumor Bispecific Antibody Program into Lead Optimization Phase; Appoints Vice President of Antibody Therapeutics to Spearhead

The BiSAb program leverages the company’s artificial intelligence platform, EDGETM, for the identification and prioritization of highly tumor-specific antigens, including neoantigens, shared between patients with various solid tumors.

December 10, 2018

EMERYVILLE, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that it is advancing its bispecific antibody (BiSAb) program under the direction of newly appointed vice president of Antibody Therapeutics, Jonah Rainey, Ph.D. The BiSAb program leverages the company’s artificial intelligence platform, EDGETM, for the identification and prioritization of highly tumor-specific antigens, including neoantigens, shared between patients with various solid tumors. To enable the development of BiSAb therapeutics directed to solid tumors, Gritstone has discovered antibodies with selective and high-affinity binding to tumor-specific peptide-HLA (Human Leukocyte Antigen) complexes (HLAp). Structural data suggest that the binding mechanism of these antibodies (termed TCR-mimetics) is similar to T-cell receptors (TCRs), which can naturally recognize HLAp targets on the tumor cell surface. In vitro data show that these proprietary antibodies, when deployed in a BiSAb format, can mobilize and redirect T-cells towards the destruction of tumor cells, and the company is accelerating the program into lead optimization.

“Recent data with BiSAb in B cell malignancies have shown their ability to elicit a potent and targeted anti-tumor response,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “To extend application of BiSAb into solid tumors, we will first identify exquisitely tumor-specific HLAp targets shared between patients, and then develop antibodies that recognize these targets specifically. Gritstone’s EDGE platform enables the first of these, including novel shared neoantigens, and we have been building out the second element of TCR-mimetic antibodies over the last year. Under the leadership of Dr. Rainey, who has extensive expertise in antibody engineering and development, we are excited about the potential of TCR-mimetic-based bispecific antibodies to impact solid tumors using a ‘drug-in-a-bottle’ approach.”

Jonah Rainey, Ph.D., Vice President of Antibody Therapeutics
Dr. Jonah Rainey joined Gritstone in 2018 to lead the bispecific antibody program. He has been actively engaged in discovery, research, and development of BiSAb for 12 years. He is an inventor on several patents and applications describing novel bispecific platforms, as well as current clinical candidates that exploit these platforms. Dr. Rainey led or had major contributions to research and early development of at least three current clinical candidates in phase 1 and 2, and led many additional advanced preclinical programs in oncology, infectious disease, autoimmunity, and other therapeutic areas. Dr. Rainey’s industry experience spans small biotech, such as MacroGenics, and large pharma settings where he led cancer BiSAb discovery at MedImmune/AstraZeneca from 2010 to 2017. He holds a Ph.D. in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute.

About Gritstone Oncology
Gritstone Oncology (Nasdaq:GRTS), a clinical-stage biotechnology company, is developing the next generation of cancer immunotherapies to fight multiple cancer types. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE™, which is designed to predict, from a routine tumor biopsy, the tumor-specific neoantigens (TSNA) that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to potentially drive the patient’s immune system to specifically attack and destroy tumors. The company’s lead product candidate, GRANITE-001, is a personalized neoantigen-based immunotherapy beginning Phase 1 clinical testing. Gritstone’s second product candidate, SLATE-001, is a shared neoantigen (“off-the-shelf”) immunotherapy which is advancing towards the clinic. The company also has a research program focused on the development of bispecific antibodies. For more information, please visit gritstoneoncology.com.

Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential to extend bispecific antibodies for the treatment of solid tumors and the advancement of a bispecifics antibody program. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, 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 drug development process, including Gritstone’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone 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 Gritstone’s most recent Quarterly Report on Form 10-Q filed on November 14, 2018 and any subsequent current and periodic reports filed with the Securities and Exchange Commission.

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