On May 16, 2019 H3 Biomedicine Inc., a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported it will present four posters during the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held May 31–June 4, 2019 in Chicago (Press release, H3 Biomedicine, MAY 16, 2019, View Source [SID1234536414]).

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The presentations will include interim data from two of H3’s ongoing clinical development programs. These include a Phase 1 study of H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer; and a Phase 1 study of H3B-6527, an investigational selective, orally available, inhibitor of fibroblast growth factor receptor 4 (FGFR4), in patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). H3 will also present posters demonstrating the utilization of biomarker and companion diagnostic strategies for both programs.

The clinical data abstracts published online today for the H3B-6545 and H3B-6527 Phase 1 studies reflect data as of December 18, 2018 and January 6, 2019, respectively. Updated results from both studies will be presented at ASCO (Free ASCO Whitepaper).

The schedule for H3’s ASCO (Free ASCO Whitepaper) presentations is as follows:

H3B-6545 Presentations
Abstract Number: 1059
Title: Phase 1 dose escalation of H3B-6545, a first-in class highly Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer
Session: Breast Cancer – Metastatic
Date and Time: June 2, 2019; 8:00 – 11:00 am CDT
Presenter: Erika P. Hamilton, M.D., Director, Breast and Gynecologic Cancer Research Program, Sarah Cannon Research Institute

Abstract Number: 1052
Title: Molecular characterization and monitoring of patient circulating tumor (ctDNA) in phase I study of H3B-6545 in ER+ metastatic breast cancer
Session: Breast Cancer—Metastatic
Date and Time: June 2, 2019; 8:00 AM-11:00 AM CDT
Presenter: Victoria Rimkunas, Ph.D., Associate Director, Biomarkers and Companion Diagnostics, H3 Biomedicine

H3B-6527 Presentations
Abstract Number: 4095
Title: A phase 1 study of H3B-6527 in hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC) patients Session: Gastrointestinal (noncolorectal) cancer
Date and Time: June 3, 2019; 8:00 – 11:00 AM CDT
Presenter: Teresa Macarulla, M.D., Ph.D., Gastrointestinal Tumor Unit, Institute of Oncology Barcelona-Madrid

Abstract Number: 4121
Title: H3B-6527 clinical biomarker assay development and characterization of HCC patient samples Session: Gastrointestinal (non-colorectal) cancer
Date and Time: June 3, 2019; 8:00 – 11:00 AM CDT
Presenter: Pavan Kumar, Ph.D., Head of Biomarkers and Companion Diagnostics, H3 Biomedicine

About H3B-6545
H3B-6545 irreversibly inactivates ERα by covalently binding a cysteine residue in ERα that is not present in other nuclear hormone receptors. It is believed that binding of SERCA to ERα leads to divergent biological activity that is differentiated from classical Selective Estrogen Receptor Modulators (SERMs) and Selective Estrogen Receptor Degraders (SERDs), two classes of standard-of-care endocrine therapies.

The Phase 1 H3B-6545 study is evaluating the safety, pharmacokinetics and pharmacodynamics of H3B-6545 in women with ER-positive, HER2-negative breast cancer to identify the recommended Phase 2 dose. Patients are treated with H3B-6545 administered once daily orally over a 28-day cycle after progression on at least one hormonal therapy and at least one additional therapy/regimen. Dose escalation uses a 3+3 design with the option to backfill previously cleared doses and allows for intra-patient dose escalation.

About H3B-6527
FGF19 overexpression is hypothesized to hyperactivate FGFR4 and its downstream signaling pathway leading to enhanced tumor growth in patients with HCC or ICC. Targeting FGFR4 may have therapeutic benefit in HCC/ICC with altered FGF19 signaling. A phase 1 study was initiated to assess H3B-6527, an investigational covalent FGFR4 inhibitor.

The Phase 1 H3B-6527 study is assessing the safety, pharmacokinectics and pharmacodynamics of H3B-6527 in adult patients with advanced HCC or ICC, well compensated liver function, and who progressed after at least one prior therapy. Patients are administered H3B-6527 once daily orally on a 21-day cycle following a 3+3 design. Patients in the dose escalation phase are treated regardless of FGF19 status.

On May 16, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp) clinical data in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) have been selected for poster presentations at the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held from May 31-June 4, 2019, at McCormick Place in Chicago, Illinois. Abstracts are now available on the ASCO (Free ASCO Whitepaper) conference website (Press release, Stemline Therapeutics, MAY 16, 2019, View Source [SID1234536430]).

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Details on the presentations are as follows:

Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)

• Abstract: 7059
• Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
• Presenter: Mrinal M. Patnaik, MBBS; Mayo Clinic
• Date: Monday, June 3
• Time: 8:00 to 11:00 AM CT

Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis (MF)

• Abstract: 7058
• Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
• Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
• Date: Monday, June 3
• Time: 8:00 to 11:00 AM CT
Please visit our Stemline corporate booth (#19156) during the 2019 ASCO (Free ASCO Whitepaper) annual meeting.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On May 16, 2019 Tempest Therapeutics Inc., a clinical-stage biotechnology company developing a broad portfolio of first-in-class immunomodulatory small molecules targeting diverse cancers, reported that the first patient has been dosed with TPST-1120 in a Phase I/Ib trial to treat advanced solid tumor malignancies (Press release, Tempest Therapeutics, MAY 16, 2019, View Source [SID1234536446]).

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PPAR (peroxisome proliferator-activated receptor) alpha is a nuclear transcription factor that regulates fatty acid oxidation and lipid metabolism in the tumor microenvironment (TME). TPST-1120 is a PPAR alpha antagonist that has a two-pronged mechanism, targeting both tumor cells and suppressive immune cells in the TME dependent on fatty acid metabolism, driving a metabolic shift to glycolysis and facilitating the development of a tumor-specific effector immune cell response. In extensive animal studies, TPST-1120 therapy used as a single agent or in combination with other anti-cancer drugs resulted in significant reductions in tumor growth and stimulation of durable anti-tumor immunity.

The U.S. Phase I trial (NCT03829436) is enrolling patients with advanced solid tumors. The open-label, dose-escalation and dose-expansion study is testing oral twice-daily TPST-1120 as monotherapy and in combination with marketed cancer drugs such as PD-1 inhibitors, anti-EGFR antibodies or chemotherapy. Primary outcome measures of the trial include assessing safety and tolerability and establishing a dose range for expanded studies at specified TPST-1120 doses. Secondary outcome measures include pharmacokinetics, mechanism-based biomarkers and objective response rate.

"Today represents an exciting moment for Tempest, as we transition to a clinical-stage company that is advancing first-in-human therapies targeting new pathways to induce anti-cancer immunity. Ultimately, we hope that our new approaches to treat cancer will provide benefit to patients," said Ginna Laport, MD, CMO of Tempest.

To help facilitate the transition to a clinical-stage company, Tempest has made key appointments to its board of directors with the appointment of Mike Raab, and to its scientific advisory board with the appointment of Benjamin Cravatt, Ph.D.

Mr. Raab is president and CEO of Ardelyx Inc., a publicly traded biotechnology company focused on cardiorenal diseases. He previously was a partner at New Enterprise Associates, where he spent 15 years in commercial and operating leadership roles in the biotech and pharmaceutical industries. Before NEA, he was SVP of therapeutics and general manager of the renal division at Genzyme Corp. where he launched and oversaw the sales growth of sevelamer, the leading phosphate binder to treat hyperphosphatemia, with over $1 billion in worldwide sales in 2013. Mike also was instrumental in the worldwide launch of Genzyme’s therapies for Gaucher disease, Ceredase and Cerezyme.

Dr. Cravatt is a professor in the Skaggs Institute for Chemical Biology and Gilula Chair Chemical Biology at The Scripps Research Institute. His research group is interested in understanding the roles that enzymes play in physiological and pathological processes, especially as pertains to the nervous system and cancer. Dr. Cravatt is a co-founder and scientific advisor of multiple biotechnology companies.

"Mike Raab and Ben Cravatt are widely recognized leaders in pharma and biotechnology drug development, and each will provide significant guidance and insights to facilitate Tempest’s continuing success," said Tom Dubensky, Ph.D., president and CEO of Tempest.

On May 16, 2019 Allergan plc (NYSE: AGN) reported that Chairman and CEO Brent Saunders will participate in a fireside chat at the Bernstein 35th Annual Strategic Decisions Conference in New York, NY (Press release, Allergan, MAY 16, 2019, View Source(2) [SID1234536397]). The presentation will begin at 9:00 a.m. Eastern Time on Thursday, May 30, 2019.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: View Source;

An archived version will be available within approximately one hour of the live presentation and can be accessed at the same location for 180 days.

On May 16, 2019 ImaginAb Inc., a clinical stage immuno-oncology imaging company, reported it has enrolled its first patient for the Phase II clinical trial of its lead product, CD8 tracer 89Zr-Df-IAB22M2C, at City of Hope in Los Angeles County (Press release, ImaginAb, MAY 16, 2019, View Source [SID1234536415]). City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases based in Duarte, California, where ImaginAb co-founder Anna Wu, Ph.D., is currently Chair of Molecular Imaging and Therapy.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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89Zr-Df-IAB22M2C is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T-cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

City of Hope is one of ImaginAb’s active clinical sites conducting Phase II baseline/on-treatment clinical trials investigating the utility of 89Zr-Df-IAB22M2C to image CD8 T cells prior to (baseline) and after (on-treatment) cancer patients receive immunotherapy-based treatment. Kim Margolin, M.D., clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope, is the study’s principal investigator.

Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s goal is to provide target-specific imaging agents to predict, inform, monitor and enable treatment of cancer disease more effectively. We are delighted to have enrolled and imaged our first patient in this ongoing clinical study at City of Hope, a world-class cancer center."

The trial will enroll metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAb’s CD8 T-cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies.

For further information please contact:

ImaginAb

Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144