Bayer To Showcase Data On Growing Oncology Pipeline At AACR 2017

• Results from pivotal Phase II trial of investigational compound copanlisib selected for oral presentation at Congress Minisymposium

• Early research findings from across the company’s oncology development portfolio will also be presented

Abstracts: Oral presentations 983; 984; CT149; Poster presentations 154 / 21; 160 / 27; 836 / 14; 1079 / 2; 3091 / 2; 3738 / 23; CT094 / 12; 5036 / 11; 5199 / 17; 5200 / 18; 5202 / 20; 5859 / 22

Whippany, N.J., March 22, 2017– Bayer announced today that the latest research from its growing oncology portfolio will be presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting, taking place on April 1-5 in Washington, D.C. These presentations reflect the company’s diverse pipeline, with findings from clinical and preclinical studies in a variety of hematologic and solid cancers.

Among these data are clinical results from the Phase II CHRONOS-1 trial evaluating copanlisib in patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL), which will be presented for the first time as part of the Congress’ Clinical Trials Minisymposia. Also scheduled are a series of preclinical data presentations including a number of small molecules, such as regorafenib, the pan-fibroblast growth factor receptor (FGFR) inhibitor BAY 1163877, the positive transcription elongation factor (PTEFb) inhibitor BAY 1251152 and the ataxia telangiectasia rad3-related protein (ATR) inhibitor BAY 1895344. In addition, data on Bayer’s antibody-drug conjugate (ADC) platform will be presented, including the C4.4A-ADC BAY1129980 and the FGFR2-ADC BAY 1187982, as well as data on three new chemical entities from Bayer’s emerging Targeted Thorium Conjugate (TTC) platform, which carry an alpha-particle emitting payload as a toxophore. Preclinical results of radium-223 dichloride will also be presented.

The following list comprises a selection of presentations on Bayer pipeline projects presented at AACR 2017.

Oral Presentations

• ATR inhibitor BAY 1895344 in monotherapy and combination in preclinical tumor models
o Oral presentation 983, Session: MS.CH01.01 - Novel Therapeutic Targets, Molecules, and Approaches for the Treatment of Cancer
o Sunday, April 2, 4:20 pm – 4:35 pm (ET), Room 201, Level 2

• PTEFb inhibitor BAY 1251152 for the treatment of cancer
o Oral presentation 984, Session: MS.CH01.01 - Novel Therapeutic Targets, Molecules, and Approaches for the Treatment of Cancer
o Sunday, April 2, 4:35 pm – 4:50 pm (ET), Room 201, Level 2

• Copanlisib in relapsed or refractory indolent B-cell lymphoma
o Oral presentation CT149, Session: Novel Agent and Intervention Clinical Trials Minisymposium
o Tuesday, April 4, 3:05 pm – 3:20 pm (ET), Hall D-E, Level 2

Selected Poster Presentations

• Copanlisib in B-cell lymphomas (as single agent and in combination)
o Poster 154 / 21, Session: PO.ET06.08 - Targeting the PI3K Pathway
o Sunday, April 2, 1 pm – 5 pm (ET), Section 6

• Copanlisib binding affinity with high dose intermittent schedule
o Poster 160 / 27, Session: PO.ET06.08 - Targeting the PI3K Pathway
o Sunday, April 2, 1 pm – 5 pm (ET), Section 6

• ATR inhibitor BAY 1895344 in monotherapy and combination with radium-223 dichloride in preclinical tumor models
o Poster 836 / 14, Session PO.TB09.01 - Cellular Responses to Ionizing Radiation
o Sunday, April 2, 1 pm – 5 pm (ET), Section 39

• FGFR inhibitor BAY 1163877 alone or in combination with antihormonal therapy in breast cancer
o Poster 1079 / 2, Session: PO.ET01.03 - Combination Therapy 1
o Monday, April 3, 8 am – 12 pm (ET), Section 2

• C4.4A-targeted antibody drug conjugate BAY1129980 in patient-derived xenograft models of ESCC, HNSCC and bladder cancer
o Poster 3091 / 2, Session: PO.ET01.02 - Drug Delivery Technology and Antibody Technology
o Tuesday, April 4, 8 am – 12 pm (ET), Section 4

• Pan-fibroblast growth factor receptor inhibitor BAY 1163877 tumor mRNA expression
o Poster 3738 / 23, Session: PO.CL01.04 - Clinical Laboratory and Imaging Correlates
o Tuesday, April 4, 8 am – 12 pm (ET), Section 29

• Fibroblast growth factor receptor 2 antibody-drug conjugate (FGFR2-ADC) BAY 1187982 in advanced cancer
o Poster CT094 / 12, Session PO.CT03 - Phase I Clinical Trials
o Tuesday, April 4, 8 am – 12 pm (ET), Section 33

• Regorafenib in CRC-PDX xenografts with gene expression and clinical parameters of the primary tumor
o Poster 5036 / 11, Session: PO.ET05.02 - Anticancer Precision Clinical Pharmacology
o Wednesday, April 5, 8 am – 12 pm (ET), Section 1

• FGFR2-targeted thorium-227 conjugate in preclinical models of colorectal, gastric and triple-negative breast cancer
o Poster 5199 / 17, Session PO.ET09.01 - Preclinical Radiotherapeutics
o Wednesday, April 5, 8 am – 12 pm (ET), Section 7

• PSMA targeted thorium-227 conjugate PSMA-TTC in prostate cancer
o Poster 5200 / 18, Session PO.ET09.01 - Preclinical Radiotherapeutics
o Wednesday, April 5, 8 am – 12 pm (ET), Section 7

• Radium-223 dichloride and bortezomib combination in a syngeneic 5TGM1 multiple myeloma mouse model
o Poster 5202 / 20, Session: PO.ET09.01 - Preclinical Radiotherapeutics
o Wednesday, April 5, 8 am – 12 pm (ET), Section 7

• HER2-targeted thorium-227 conjugate (HER2-TTC) in preclinical models of trastuzumab and T-DM1 resistance
o Poster 5859 / 22, Session PO.TB09.02 - Radioprotectors, Radiosensitizers, and Radiation Resistance
o Wednesday, April 5, 8 am – 12 pm (ET), Section 41

About Copanlisib

Copanlisib is a pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K- a and PI3K- d isoforms. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in NHL. Preclinically, copanlisib has been shown to inhibit both PI3K-d and PI3K-a isoforms at sub-nanomolar concentrations.

Copanlisib is an investigational compound developed by Bayer. The efficacy and safety of copanlisib has not been established. The clinical development program for copanlisib currently consists of Phase II and Phase III studies in indolent and aggressive NHL. Information about these trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

Copanlisib is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

About Stivarga® (regorafenib)

In the United States, Stivarga is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.1

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