On November 5, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical data on its BTK inhibitor BRUKINSA (zanubrutinib) and non-clinical data on its anti-PD-1 antibody tislelizumab will be presented in an oral presentation and four posters at the 62nd American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place virtually on December 5-8, 2020 (Press release, BeiGene, NOV 5, 2020, View Source [SID1234570181]).

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BeiGene is co-sponsoring a satellite symposium entitled Addressing the Medical Need in CLL: How BTK Inhibitors Are Improving Outcomes, to be held on Friday, December 4 at 3:00 p.m. PT; registration for the symposium can be accessed at View Source

Oral Presentation:

Title:

Efficacy and Safety of Zanubrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma: Initial Results of the MAGNOLIA (BGB-3111-214) Trial

Publication #:

339

Session Title:

623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Clinical studies in Waldenström’s Macroglobulinemia, Marginal Zone Lymphoma and Hairy Cell Leukemia

Date and Time:

Sunday, December 6, 2020 at 10:15 a.m. PT

Presenter:

Stephen Opat, FRACP, FRCPA, MBBS, Monash University, Australia

Poster Presentations:

Title:

Safety and Efficacy of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Waldenström Macroglobulinemia from a Phase 2 Trial

Publication #:

2940

Session Title:

623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III

Date:

Monday, December 7, 2020 at 7:00 a.m. PT

Presenter:

Gang An, M.D., Ph.D., Chinese Academy of Medical Sciences, Blood Diseases Hospital, China

Title:

Phase 2 Study of Zanubrutinib in Patients with Relapsed/Refractory B-Cell Malignancies Intolerant to Ibrutinib/Acalabrutinib

Publication #:

2947

Session Title:

623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III

Date:

Monday, December 7, 2020 at 7:00 a.m. PT

Presenter:

Mazyar Shadman, M.D., MPH, Fred Hutchinson Cancer Research Center, University of Washington

Title:

Efficacy and Safety of Zanubrutinib in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with del(17p): Follow-up Results from Arm C of the SEQUOIA (BGB-3111-304) Trial

Publication #:

1306

Session Title:

642. CLL: Therapy, excluding Transplantation: Poster I

Date:

Saturday, December 5, 2020 at 7:00 a.m. PT

Presenter:

Jennifer R. Brown, M.D., Ph.D., Dana-Farber Cancer Institute

Title:

Tumor Microenvironment Associated with Complete Response to Tislelizumab Monotherapy in Relapsed/Refractory Classical Hodgkin Lymphoma Reveals a Potentially Different Mechanism of Action

Publication #:

1116

Session Title:

622. Lymphoma Biology—Non-Genetic Studies: Poster I

Date:

Saturday, December 5, 2020 at 7:00 a.m. PT

Presenter:

Yuqin Song, M.D., Ph.D., Peking University Cancer Hospital & Institute (Beijing Cancer Hospital), China

On November 5, 2020 InnoCare Pharma (HKEX: 09969), a clinical-stage biopharmaceutical company, reported that the company will present latest clinical data of its BTK inhibitor Orelabrutinib at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 5-8, 2020, which will be held online (Press release, InnoCare Pharma, NOV 5, 2020, View Source [SID1234570180]). The study in Patients with Relapsed or Refractory Mantle Cell Lymphoma, led by Dr. Jun Zhu, and the study in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell Leukemia, led by Dr. Jianyong Li, will be presented in three posters. This is the second consecutive year for InnoCare to present Orelabrutinib data at ASH (Free ASH Whitepaper).

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Poster Presentation 1：

Title：Pooled Analysis of Safety Data from Clinical Trials of Orelabrutinib Monotherapy in Hematologic Malignancies

Abstract Number：1140

Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I

Session Date: Saturday, December 5, 2020

Presentation Time: 7:00 AM-3:30 PM

Location: Poster Hall (Virtual Meeting)

Presenter: Yuqin Song, M.D., Ph.D.

Abstract website: View Source

Poster Presentation 2：

Title：Long-Term Safety and Efficacy of Orelabrutinib Monotherapy in Chinese Patients with Relapsed or Refractory Mantle Cell Lymphoma: A Multicenter, Open-Label, Phase II Study

Abstract Number：2048

Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Session Date: Sunday, December 6, 2020

Presentation Time: 7:00 AM-3:30 PM

Location: Poster Hall (Virtual Meeting)

Presenter: Yuqin Song, M.D., Ph.D.

Abstract website: View Source

Poster Presentation 3：

Title：Updated Results from the Phase II Study of Orelabrutinib Monotherapy in Chinese Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell Leukemia

Abstract Number：1320

Session Name: 642. CLL: Therapy, excluding Transplantation: Poster I

Session Date: Saturday, December 5, 2020

Presentation Time: 7:00 AM-3:30 PM

Location: Poster Hall (Virtual Meeting)

Presenter: Wei Xu, M.D.

Abstract website: View Source

InnoCare will release detailed Orelabrutinib clinical data during ASH (Free ASH Whitepaper) meetings.

About Orelabrutinib

Orelabrutinib is a selective BTK inhibitor for the treatment of cancers and autoimmune diseases, which has been supported by the national special project for the development of major new drugs. Currently, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profile. Orelabrutinib’s two indications have been included in priority review by the NMPA.

On November 5, 2020 Imago BioSciences, Inc., ("Imago") a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that interim data from its ongoing Phase 2b study evaluating bomedemstat (IMG-7289) for the treatment of myelofibrosis will be presented in an oral session during the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually Dec. 5-8, 2020 (Press release, Imago BioSciences, NOV 5, 2020, View Source [SID1234570179]). An abstract containing preliminary findings will be published in the meeting program on Nov. 5, with updated findings presented during the oral session.

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Oral Presentation Information:

Session: 634 – Myeloproliferative Syndromes: Clinical: New Therapies and JAKi-based Combinations for Myelofibrosis
Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Advanced Myelofibrosis
Presenter: Kristen M. Pettit, M.D., Assistant Professor of Medicine at the University of Michigan, Rogel Cancer Center, Ann Arbor, Michigan
Presentation Date: 7:30 am ET on Saturday, Dec. 5, 2020
About Bomedemstat (IMG-7289)

Bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Preliminary results were most recently presented at the 2020 European Hematology Association (EHA) (Free EHA Whitepaper). In addition to the MF study, bomedemstat is also being evaluated for the treatment of essential thrombocythemia and polycythemia vera.

Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in multiple ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141, NCT04254978 and NCT04081220). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.

On November 5, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that it will host a conference call and live webcast on Thursday, November 12, 2020 at 8:30 am ET to report financial results for the third quarter ended September 30, 2020 and provide business updates (Press release, ADC Therapeutics, NOV 5, 2020, View Source [SID1234570178]).

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To access the live call, please dial 833-249-8403 (domestic) or + 41 225675632 (international). A live webcast of the presentation will be available under "Events and Presentations" on the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available after the completion of the event and for 30 days following the call.

On November 5, 2020 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that new and updated data from CARTITUDE-1 and LEGEND-2 studies, respectively, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place virtually December 5-8, 2020 (Press release, Legend Biotech, NOV 5, 2020, View Source [SID1234570177]).

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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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CARTITUDE-1 data for oral presentation will highlight Phase 1b/2 efficacy and safety results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel). Additional poster presentations for cilta-cel data will include detailed analyses of cytokine release syndrome and health-related quality of life outcomes from CARTITUDE-1. LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will also be presented as a poster.

"We look forward to sharing new data from the CARTITUDE-1 study in the US and the LEGEND-2 study in China," said Ying Huang, PhD, interim-CEO and CFO of Legend Biotech. "With our successful clinical efforts and the Company’s collaboration with Janssen, we are uniquely positioned to deliver a novel therapy to patients with multiple myeloma."

On Saturday, December 5th, during the Myeloma session entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data for cilta-cel from the CARTITUDE-1 study will be presented.

Following are details of the five abstracts that have been accepted for presentation at the 62nd ASH (Free ASH Whitepaper) Annual Meeting & Exposition. For additional information visit: View Source

Abstract No.

Title

Date/Time

Oral Presentation

Abstract #177

CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma

Saturday, Dec. 5
12:00 p.m. PT

Poster Presentations

Abstract #1412

Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma

Saturday, Dec. 5
7:00 a.m. – 3:30 p.m. PT

Abstract #2291

Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma

Sunday, Dec. 6
7:00 a.m. – 3:30 p.m. PT

Abstract #2304

Chimeric Antigen Receptor T Cell Therapy in the Relapsed or Refractory Multiple Myeloma with Extramedullary Disease–a Single Institution Observation in China (LEGEND-2)

Sunday, Dec. 6

7:00 a.m. – 3:30 p.m. PT

Abstract #3240

Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study

Monday, Dec. 7
7:00 a.m. – 3:30 p.m. PT

About CARTITUDE-1
Cilta-cel is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study conducted in the US and Japan for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1

About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M CAR-T cells for the treatment of relapsed or refractory multiple myeloma.2

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.