On June 12, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Raymond James Life Sciences and MedTech Conference taking place June 18-19, 2019 in New York, NY (Press release, Zymeworks, JUN 12, 2019, View Source [SID1234537050]).

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The Company’s presentation will be on Wednesday, June 19, 2019 at 11:30 a.m. ET.

On June 12, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported a publication titled "U2AF1 mutations induce oncogenic IRAK4 isoforms and activate innate immune pathways in myeloid malignancies" in Nature Cell Biology (Press release, Curis, JUN 12, 2019, View Source [SID1234537035]).1 The study findings demonstrate that a cancer-causing splicing variant of IRAK4 (IRAK4-L) is dominant in the majority of cases of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Additionally, specific mutations of the U2AF1 splicing factor induce IRAK4-L, which has potential therapeutic targetability by CA-4948, the Company’s small molecule inhibitor of IRAK4. The findings present inhibition of IRAK4 as a potential option for the treatment of patients with myeloid malignancies expressing IRAK4-L and with U2AF1 mutations. Isoform-switching to the oncogenic form of IRAK4 is also present in a subset of breast, lung and colon cancers.

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"We are encouraged by these findings in Nature Cell Biology, which support that CA-4948’s unique target profile may be beneficial to patients with myeloid malignancies and, in particular, those with IRAK4-L and U2AF1 mutations," said Jim Dentzer, President and Chief Executive Officer of Curis. "There is a large unmet need for further treatment options among this patient subgroup and we look forward to assessing the potential of CA-4948 to address this significant medical issue."

The Company is currently evaluating CA-4948 in an ongoing Phase 1 trial in patients with non-Hodgkin lymphoma, including those with MYD88 alterations, with interim data expected in mid-2019. In addition, the Company is further investigating the potential of CA-4948 in patients with myeloid malignancies expressing IRAK4-L and with U2AF1 mutations.

About CA-4948, a small molecule inhibitor of IRAK4

Innate immune responses orchestrated through Toll-like receptors or certain interleukin receptors are important mediators of the body’s initial defense against foreign antigens, while their dysregulation is associated with certain inflammatory conditions. Toll-like receptor and interleukin receptor signaling through the adaptor protein MYD88, results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the transcription factor NFκB. More recently, components of this pathway are recognized to be genetically altered and have important roles in specific human cancers. MYD88 gene mutations are shown to occur in approximately 30% of Activated B-Cell (ABC) subtype of diffuse large B-cell lymphomas (DLBCL) and in over 90% of the B-cell malignancy Waldenstrom’s macroglobulinemia. Due to IRAK4’s central role in these signaling pathways, it is considered an attractive target for generation of therapeutics to treat these B-cell malignancies as well as certain inflammatory diseases.

On June 12, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1/2 study evaluating the investigational agent TP-0903, an AXL receptor tyrosine kinase (RTK) inhibitor, in patients with previously treated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, Tolero Pharmaceuticals, JUN 12, 2019, View Source [SID1234537051]). The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the dose-limiting toxicities and clinical activity of oral TP-0903 administered in patients with previously treated CLL/SLL, as monotherapy or in combination with ibrutinib.

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"Although there have been significant advances in the treatment of CLL and SLL in recent years, there remains an area of clinical unmet need for patients who have had disease progression or relapse with available therapies." said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "The initiation of this study will allow us to learn more about the clinical profile of TP-0903 and the role of AXL receptor tyrosine kinase (RTK) inhibition in patients with previously treated CLL and SLL."

The primary outcome measures of the Phase 1 study are to determine dose-limiting toxicities and the incidence of treatment-emergent adverse events of oral TP-0903 administered once daily for 28 days in patients with previously treated CLL/SLL. Secondary outcome measures of the Phase 1 study include pharmacokinetics. The recommended Phase 2 dose (RP2D) will be determined in Phase 1 of the study. Phase 2 of the study will begin after the completion of Phase 1. The primary outcome measure of Phase 2 will be to determine the objective response rate according to guidelines set forth by the 2018 International Workshop on CLL. Secondary outcome measures of the Phase 2 study include assessment of duration of response and rate of overall survival.

In Phases 1 and 2 of the study, patients will be assigned to one of two defined patient groups. Patients in Group 1, which includes those who are intolerant to or have progressed on B-cell receptor antagonists and/or BCL-2 antagonists, will receive TP-0903 monotherapy. Patients in Group 2, which includes those who have progression of disease on ibrutinib and the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient, will receive combination therapy of TP-0903 and ibrutinib. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03572634).

About TP-0903
TP-0903 is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1/2 study in patients with CLL/SLL (NCT03572634) and a Phase 1b study in patients with advanced solid tumors (NCT02729298). Tolero is exploring parallel clinical development paths for TP-0903 in both solid and hematologic malignancies.

About AXL Kinase
AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.1 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.2

On June 12, 2019 Dr. Reddy’s Laboratories Ltd (BSE:500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the Goldman Sachs 40th Annual Global Healthcare Conference on Wednesday, June 12th, 2019, in California (Press release, Dr Reddy’s, JUN 12, 2019, View Source [SID1234537036]).

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Marc Kikuchi, CEO, North America Generics will present at Fireside Chat session at 2:00 p.m. PST [2:30 a.m. IST on June 13th, 2019].

Presentation material will be available on the Company’s website www.drreddys.com

On June 12, 2019 GlaxoSmithKline plc reported new data on belantamab mafodotin (GSK2857916), an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, will be presented at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, GlaxoSmithKline, JUN 12, 2019, View Source [SID1234537037]).

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The studies being presented at EHA (Free EHA Whitepaper) include:

Abstract #PS1401: Patient Reported Experience from Part 2 of the First Time in Human Study of the BCMA Antibody-Drug Conjugate GSK2857916 for Advanced Relapsed Refractory Multiple Myeloma (DREAMM-1) (Popat R, Opalinska L, Eliason J, et. al)
Abstract #PS1372: B-cell Maturation Antigen Antibody-Drug Conjugate (ADC), GSK2857916, in Relapsed/Refractory Multiple Myeloma (RRMM): Final Safety, Efficacy and Pharmacokinetic (PK) Analyses From a Pivotal Phase I Study (Popat R, Lendvai S, Trudel PM, et. al)
Abstract #PF558: The Anti-BCMA Antibody-Drug Conjugate GSK2857916 Drives Immunogenic Cell Death and Immune-Mediated Anti-Tumor Responses, and in Combination with an OX40 Agonist Potentiates in Vivo Activity (Montes De Oca R, Bhattacharya S, Vitali N, et. al)
In 2017, belantamab mafodotin was awarded Breakthrough Therapy designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency; these designations are intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

About B-cell maturation antigen (BCMA)

The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF and APRIL. This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines[i].

About the DREAMM Clinical Trial Programme for Belantamab Mafodotin (GSK2857916)

Belantamab mafodotin is an antibody-drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using technology licensed from BioWa.

Belantamab mafodotin is currently in clinical development in patients with relapsed/refractory multiple myeloma and other advanced haematologic malignancies expressing BCMA.

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology

GSK is focused on maximizing patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.