Bayer Data at AACR 2019 Underscores Company’s Commitment to Advancing the Future of Cancer Care

Bayer is committed to expanding its precision oncology portfolio by bringing additional projects in this field forward

Originally Published by Bayer U.S.

Bayer will present research from its growing oncology portfolio at the American Association for Cancer Research (AACR) 2019 Annual Meeting, taking place March 29 to April 3 in Atlanta. The presentations highlight new findings on the company’s key areas of investigation: Oncogenic Signaling, Alpha Therapies and Immuno-Oncology (IO). With a total of 30 presentations, including three oral presentations, the research underscores Bayer’s commitment in oncology to advancing projects, many of which have the potential to be the first in class and address the underlying cause of cancer growth and spread. Bayer has two promising compounds in its precision oncology portfolio and is committed to expanding this portfolio. 

Among the data presented will be an oral presentation on the Phase I and expanded access experience of BAY 2731954 (formerly LOXO-195), an oral investigational TRK inhibitor. BAY 2731954 is currently in Phase I clinical development and designed for patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and have progressed or were intolerant to prior TRK inhibitors. NTRK gene fusions are genomic alterations resulting in constitutively-activated tropomyosin receptor kinase (TRK) fusion proteins, which may lead to tumor growth.

In February 2019, Bayer announced that the company would obtain the exclusive licensing rights for the global development and commercialization, including in the U.S., for Vitrakvi®(larotrectinib) and BAY 2731954. Vitrakvi was approved by the U.S. FDA in November 2018. The option was triggered by the acquisition of Loxo Oncology by Eli Lilly and Company.

In another oral presentation, new pre-clinical data on the investigational androgen receptor (AR) antagonist darolutamide will be presented. Bayer recently submitted darolutamide for approval in the U.S., EU and Japan based on the data from the Phase III ARAMIS study, which investigated darolutamide in non-metastatic castration-resistant prostate cancer. At AACR, new findings will be presented on the pre-clinical data of darolutamide in different prostate cancer models in monotherapy and in combination with Bayer’s investigational ataxia telangiectasia mutated and rad3-related kinase (ATR) inhibitor BAY 1895344. Darolutamide is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

In the area of IO, Bayer will present data on an oral investigational aryl hydrocarbon receptor (AhR) inhibitor as a therapeutic approach to enhance anti-tumoral immune responses. The AhR inhibitor was discovered and is being developed in collaboration with the German Cancer Research Center (DKFZ, Heidelberg, Germany).

Additional research to be presented includes pre-clinical data on the following investigational agents:

  • Rogaratinib, a pan-fibroblast growth factor receptor (FGFR) inhibitor currently in Phase II/III clinical development is being investigated for urothelial carcinoma and other FGFR-positive tumors.
  • The dihydroorotate dehydrogenase (DHODH) inhibitor BAY 2402234, derived from the collaboration with the Broad Institute (Cambridge, Massachusetts), that is currently in Phase I clinical trials in patients with acute myeloid leukemia. Research presented includes pre-clinical investigations in colorectal cancer and lymphoma.
  • The ATR inhibitor BAY 1895344, a DNA damage response inhibitor currently in Phase I clinical trials.
  • In the area of IO, the CEACAM6 function blocking antibody currently investigated in Phase I clinical trials, which was derived from Bayer’s strategic collaboration with the DKFZ.
  • Bayer’s emerging Targeted Thorium Conjugate (TTC) platform (a form of antibody Targeted Alpha Therapy). Research presented includes data on BAY 2315497, a TTC targeting the prostate-specific membrane antigen (PSMA), and BAY 2287411, the mesothelin-targeting TTC. Both development candidates are currently in Phase I clinical trials.
  • Anetumab ravtansine, a mesothelin targeting antibody-drug conjugate. Research presented includes data on anetumab ravtansine as monotherapy in non-small cell lung cancer (NSCLC) pre-clinical models.

Following is a list of oral and poster presentations at AACR 2019:

Oral presentations:

  • The androgen receptor antagonist darolutamide shows strong anti-tumor efficacy in patient- and cell line-derived xenograft prostate cancer models
    • Oral presentation 924, Session: MS.EN01.01 – Endocrine-Related Cancer Research
    • Sunday, March 314:20 PM – 4:35 PM (EDT), Room C302 – Georgia World CC
  • Phase I and expanded access experience of LOXO-195 (BAY 2731954), a TRK inhibitor (TRKi)
    • Oral presentation CT127, Session: CTMS02 – The Next Generation of Clinical Trials in Molecularly-driven Therapy
    • Monday, April 13:05 PM – 3:20 PM (EDT), Marcus Auditorium, Building A – Georgia World CC
  • Identification of BAY-218, a small molecule AhR inhibitor, as a modality to counteract tumor immunosuppression
    • Oral presentation 4454, Session: MS.CH01.01 – Next-Generation Small Molecules: From Hits to Leads to Candidates
    • Tuesday, April 23:50 PM – 4:05 PM (EDT), Room B206 – Georgia World CC

Poster presentations:

  • Discovery of BAY 2402234 by phenotypic screening: A humanDihydroorotate Dehydrogenase (DHODH) inhibitor in clinical trials for the treatment of myeloid malignancies
    • Poster presentation 2, Session: PO.CH01.01 – Novel Small Molecules for Cancer Therapy
    • Sunday, March 311:00 PM – 5:00 PM (EDT), Section 1
  • Synergistic activity of the ATR Inhibitor BAY1895344 in combination with immune checkpoint inhibitors in preclinical tumor models
    • Poster presentation 272, Session: PO.ET04.01 – Cell Death and DNA Repair Pathways
    • Sunday, March 311:00 PM – 5:00 PM (EDT), Section 11
  • Preclinical analysis of biodistribution and PET imaging of a zirconium-89 labeled PSMA-targeted antibody-chelator-conjugate
    • Poster presentation 1141, Session: PO.TB07.01 – Novel Imaging Targets
    • Monday, April 18:00 AM – 12:00 PM (EDT), Section 7
  • Increased T cell- activation resulting from the combination of the anti-CEACAM6 function-blocking antibody BAY 1834942 with checkpoint inhibitors targeting either PD-1/PD-L1 or TIM-3
    • Poster presentation LB-075, Session: LBPO.IM01 – Late-Breaking Research: Immunology 1
    • Monday, April 18:00 AM – 12:00 PM (EDT), Section 41
  • Activity of pan-FGFR inhibitor rogaratinib and PI3K inhibitor copanlisib in preclinical urothelial bladder cancer models
    • Poster presentation 3080, Session: PO.ET06.03 – Novel Antitumor Agents 1
    • Tuesday, April 28:00 AM – 12:00 PM (EDT), Section 14
  • BAY 2402234: Preclinical evaluation of dihydroorotate dehydrogenase (DHODH) inhibitor for the treatment of diffuse large B-cell lymphoma (DLBCL)
    • Poster presentation 3597, Session: PO.MCB08.04 – Targeting Metabolism for Cancer Therapy
    • Tuesday, April 28:00 AM – 12:00 PM (EDT), Section 39
  • BAY 2402234: Preclinical evaluation of dihydroorotate dehydrogenase (DHODH) inhibitor for the treatment of colorectal carcinomas
    • Poster presentation 3599, Session: PO.MCB08.04 – Targeting Metabolism for Cancer Therapy
    • Tuesday, April 28:00 AM – 12:00 PM (EDT), Section 39
  • Preclinical activity of PSMA-Targeted Thorium Conjugate(BAY 2315497) in combination with androgen receptor antagonists in prostate cancer models
    • Poster presentation 3726, Session: PO.TB09.02 – Radiation Tissue Tolerance, Immunity, and in Vivo Effects of Radiation
    • Tuesday, April 21:00 PM – 5:00 PM (EDT), Section 5
  • MSLN-TTC (BAY 2287411) induces immunogenic cell death and secretion of pro-inflammatory cytokines in vitro and triggers an immune memory effect against a mouse tumor model
    • Poster presentation 3926, Session: PO.ET09.01 – Preclinical Radiotherapeutics
    • Tuesday, April 21:00 PM – 5:00 PM (EDT), Section 15
  • Radium-223 α-particle radiation: Characterization of the in vitro effects on cancer cells in monotherapy and in combination with DNA repair inhibitors
    • Poster presentation 3927, Session: PO.ET09.01 – Preclinical Radiotherapeutics
    • Tuesday, April 21:00 PM – 5:00 PM (EDT), Section 15
  • Efficacy of single agent radium-223 in the syngeneic MBT-2 bladder cancer bone growth model in mice
    • Poster presentation 3936, Session: PO.ET09.01 – Preclinical Radiotherapeutics
    • Tuesday, April 21:00 PM – 5:00 PM (EDT), Section 15
  • MSLN-TTC (BAY 2287411) demonstrates increased activity in comparison to standard of care chemotherapy in models of acquired drug resistance
    • Poster presentation 3937, Session: PO.ET09.01 – Preclinical Radiotherapeutics
    • Tuesday, April 21:00 PM – 5:00 PM (EDT), Section 15
  • Preclinical evaluation of the combination rogaratinib andcopanlisib in HNSCC and HCC in preclinical in vitro and in vivo models
    • Poster presentation 4793, Session: PO.ET06.05 – Novel Antitumor Agents 3
    • Wednesday, April 38:00 AM – 12:00 PM (EDT), Section 13
  • Anetumab ravtansine has monotherapy efficacy in mesothelin positive patient-derived NSCLC tumor models and in a syngeneic tumor model in immunocompetent mice
    • Poster presentation 4816, Session: PO.ET07.01 – Targeted Therapies
    • Wednesday, April 38:00 AM – 12:00 PM (EDT), Section 14
  • Darolutamide impairs prostate cancer growth by altering chromatin conformation and transcriptional activity of genes involved in cell proliferation and survival
    • Poster presentation 520, Session: PO.MCB04.01 – Mechanisms and Consequences of Transcriptional Deregulation
    • Wednesday, April 38:00 AM – 12:00 PM (EDT), Section 36

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