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April 5, 2017 - Tolero Pharmaceuticals Presents Preclinical Data on CDK9 Inhibitor Alvocidib and its Prodrug, TP-1287, at AACR 2017 Line January 26, 2017 - Sumitomo Dainippon Pharma Completes Acquisition of Tolero Pharmaceuticals, Inc. Line December 21, 2016 - Sumitomo Dainippon Pharma to Acquire Tolero Pharmaceuticals, Inc. 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Line November 12, 2015 - Tolero Pharmaceuticals Presents Positive Clinical and Preclinical Data on Programs in Leukemia and Anemia... Line November 9, 2015 - Tolero Pharmaceuticals Executes Exclusive License with Eutropics for Novel Companion... Line November 9, 2015 - Tolero Pharmaceuticals Presents Results Providing Strong Rationale for Combining Alvocidib with... Line September 21, 2015 - Tolero Pharmaceuticals Announces Mechanistic Data Describing the Activity of Alvocidib... Line September 14, 2015 - Tolero Pharmaceuticals to Present Alvocidib Regimen Data at Upcoming Medical Conferences Line June 16, 2015 - Tolero Pharmaceuticals Presents Positive Preclinical Data that Inhibition of AXL Kinase Restores Tumor Response to Retinoic Acid Line June 16, 2015 - Tolero Pharmaceuticals Presents Positive Preclinical Data on Hepcidin Inhibition for the Treatment of Anemia... Line June 4, 2015 - Tolero Pharmaceuticals to Present Preclinical Pipeline Data at the 20th Congress of European Hematology Association, EHA Line June 2, 2015 - Tolero Pharmaceuticals and Eutropics Announce Results Demonstrating the Predictive Potential of a Biomarker... Line May 21, 2015 - Tolero Pharmaceuticals to Present Alvocidib Data at the 2015 American Society of Clinical Oncology Annual Meeting Line April 24, 2015 - Tolero Pharmaceuticals Presents Data Demonstrating Profound Synergy of Alvocidib and Bromodomain Protein Inhibitors... Line April 14, 2015 - Tolero Pharmaceuticals to Present Positive Advancement of Clinical and Preclinical Programs... Line February 27, 2015 - Tolero Pharmaceuticals Receives EMA Orphan Drug Designation for Alvocidib... Line January 9, 2015 - Tolero Pharmaceuticals, Inc., to Present at Biotech Showcase 2015 Line November 17, 2014 - Tolero Pharmaceuticals' Alvocidib Selected as 'Top 10 Most Interesting Oncology Project... Line November 13, 2014 - Tolero Pharmaceuticals Presents Positive Preclinical Data... Line November 5, 2014 - Tolero Pharmaceuticals Completes Second Tranche of Series B Financing... Line August 12, 2014 - Tolero Pharmaceuticals and Eutropics Announce Data Demonstrating Clinical Utility of Praedicare Dx... Line August 7, 2014 - Tolero Pharmaceuticals Closes $14.2 Million Series B Financing Line June 30, 2014 - Tolero's PIM Kinase Inhibitor Demonstrates Promising Activity in Preclinical Models... Line June 4, 2014 - Tolero Pharmaceuticals Presents Positive Interim Phase 2 Clinical Trial Results... Line May 15, 2014 - Tolero Pharmaceuticals Highlights Alvocidib Data to be... Line Apr 23, 2014 - Tolero Pharmaceuticals Receives FDA Orphan Drug Designation... Line Apr 7, 2014 - Tolero 2014 AACR Presentation Describes Relationship... Line May 1, 2013 - Tolero Pharmaceuticals announces Worldwide Agreement... Line Apr 10, 2013 - Tolero's Drug Development Pipeline Highlighted in... 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Tolero Pharmaceuticals Presents Preclinical Data Demonstrating Synergistic Activity with a Combination of Alvocidib and Azacytidine

Data Presented in Oral Presentation at the 57th ASH Annual Meeting and Exposition

SALT LAKE CITY, UT - December 7, 2015 - Tolero Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing treatments for serious hematological diseases, today announced that its lead clinical candidate, alvocidib, demonstrated profound synergistic activity with 5-azacytidine in nonclinical models of hematological malignancies. These data were presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida. Alvocidib, a potent cyclin-dependent kinase-9 (CDK9) inhibitor, has proven to be a clinically active agent, particularly when combined with cytarabine, an agent frequently used to treat acute myeloid leukemia (AML). To further explore additional clinical development strategies for alvocidib, the Company conducted nonclinical combination studies with the hypomethylating agent, 5-azacytidine the standard of care for the treatment of myelodysplastic syndromes (MDS). The drug combination led to synergistic activity when measuring both cell viability and apoptosis. The mechanism for the synergy relies on alvocidib’s ability to inhibit CDK9 and thereby downregulate MCL-1 expression which has emerged as a known marker of resistance to 5-azactydine.

"The combined synergistic activity we have observed is consistent with our understanding that alvocidib is a potent inhibitor of CDK9 which controls the expression of MCL-1 and that it primes cells to more readily undergo apoptosis when combined with agents such as 5-azacytidine," said David J. Bearss, Ph.D., Chief Executive Officer at Tolero. "We are planning to further explore the medical utility behind these findings by conducting a clinical study with this drug combination in MDS patients, as part of a strategy to realize the broader therapeutic applications for alvocidib’s ability to inhibit CDK9 and suppress MCL-1."

Tolero is beginning to conduct a randomized Phase 2 biomarker-driven clinical trial with alvocidib, cytarabine, and mitoxantrone in patients with AML (clinicaltrials.gov - NCT02520011).

About Alvocidib
Alvocidib is a potent small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) in development as a combination therapy for frontline and relapsed/refractory AML. CDK9 is a protein critical to the regulation of gene expression including the MCL-1 gene and other important genes involved in cancer. Given the key role CDK9 de-regulation plays in expression of cancer-associated genes related to cell division and proliferation, CDK9 is an attractive target for the treatment of various cancers.

About Tolero
Tolero Pharmaceuticals is a clinical stage biopharmaceutical company developing treatments to improve and extend the lives of patients with serious oncological and hematological diseases. Our diverse pipeline targets important biological drivers of blood disorders to treat leukemias and anemia as well as important targets of drug resistance and transcriptional control.

Contact:
Joe Nilson
Tolero Pharmaceuticals, Inc.
801-285-6003
bizdev@toleropharma.com

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