On May 12, 2022 Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that new clinical data on its lead investigational high-precision cell therapy, Orca-T, will be shared in an oral presentation at the hybrid European Hematology Association (EHA) (Free EHA Whitepaper) Congress from June 9-17, 2022, in Vienna, Austria (Press release, Orca Bio, MAY 12, 2022, View Source [SID1234614424]).

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Oral Session: Clinical Studies in Transplantation

Title: Orca-T, an Engineered Allograft, Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies
Abstract Number: S237
Date and Time: Sunday, June 12, at 11:30–12:45 CEST / 5:30AM–6:45AM EDT
Location: Hall Stolz 1-2

The presentation will highlight results from the single-center Phase 2 and multi-center Phase 1b trials of Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS). Data included in the abstract will be updated at the time of presentation.

The oral session will take place in Vienna and will be livestreamed on the EHA (Free EHA Whitepaper) Congress platform.

About Orca-T

Orca-T is an investigational, high-precision allogeneic cell therapy derived from the stem and immune cells from either related or unrelated HLA-matched donors. Orca-T is intended to safely replace a patient’s compromised blood and immune system with that from a healthy donor. Orca-T is currently being evaluated in a Phase 3 clinical trial for the treatment of multiple hematologic malignancies and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

On May 12, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver transformative therapies for rare cancers, reported two abstracts have been accepted into the program for the 2022 Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Sierra Oncology, MAY 12, 2022, View Source [SID1234614423]). An abstract presenting the full data from the pivotal phase 3 MOMENTUM study in myelofibrosis patients who are symptomatic and anemic has been selected for oral presentation. Additionally, a subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation.

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"We are excited and honored to have the MOMENTUM data selected for an oral presentation at EHA (Free EHA Whitepaper) which demonstrates that momelotinib achieved statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints," said Barbara Klencke, MD, Chief Medical Officer of Sierra Oncology. "In addition, we are pleased to present the subset analysis in a poster presentation which indicates momelotinib may be safely administered and provide an improvement in symptoms, spleen and anemia in anemic myelofibrosis patients who present with low platelet counts. The data to be presented further expand upon the potential of momelotinib as a treatment option for myelofibrosis patients who are symptomatic and anemic."

Abstract: S195: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

The primary and all key secondary results, as well as safety data, from the MOMENTUM pivotal Phase 3 trial of momelotinib will be presented in an oral presentation by Srdan Verstovsek, MD, PhD, co-Principal Investigator of the study. Topline results from the study were announced in January 2022. Key data to be presented include:

Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095)
Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority)
Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006)
The rate of Grade 3 or worse adverse events in the randomized treatment period was 54% in the MMB arm and 65% in the control arm. Serious treatment emergent adverse events were 35% in the MMB arm and 40% in the control arm.
Mean baseline characteristics for all patients were TSS of 27, Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L
Presentation Details

Abstract: S195
Title: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor
Presenter: Srdan Verstovsek, MD, PhD, The University of Texas MD Anderson Cancer Center
Session Title: Treatments and Complications in MPN
Location: Hall Lehar 1-2
Date and Time: Saturday, June 11, 2022, 11:30 am – 12:45 pm CEST

Abstract: P1050: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Abstract P1050 will highlight an analysis of MOMENTUM patients with baseline platelet counts of <150 x 109/L on key symptom, anemia and spleen volume endpoints at 24 weeks. Results to be presented are consistent with the overall intent-to-treat analysis set. Momelotinib was superior to danazol for symptom responses, transfusion requirements and spleen responses, and showed a trend toward improved overall survival up to Week 24 was seen with momelotinib versus danazol [95% CI = 0.490 (0.195, 1.235)].

Presentation Details

Abstract: P1050
Title: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]
Presenter: Alessandro Vannucchi, MD, Center Research and Innovation for Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Italy
Session Title: Poster Session
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 pm CEST

On May 12, 2022 Ultivue, Inc., an industry leader in multiplexing assays and analytics solutions for tissue biomarker studies, reported multiple collaborations for AI-powered spatial phenomics solutions for translational research groups and Biopharma (Press release, Ultivue, MAY 12, 2022, View Source [SID1234614422]).

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Ultivue develops unique workflows for use in both multiplex immunofluorescence (mIF) imaging and spatial phenomics. Its proprietary InSituPlex technology is designed for fast and comprehensive exploration of biologically relevant targets, up to 12-plex, with same slide-H&E analysis in precious tissue samples. It combines the power of computational pathology & spatial biology to guide translational science in immuno-oncology.

Image and data analysis of rich spatial information from mIF images can accelerate tissue biomarker discovery and validation. Different capabilities are needed depending on the scientific question under investigation, the size of cohorts and the stage of the biomarker development program. Ultivue is complementing its own Image Data Services with capabilities provided by trusted partners to offer end-to-end support for customers. Flexible image analysis solutions as provided by Visiopharm and Indica Labs can effectively be used to provide rich readouts from bespoke mIF assays developed to address a scientific question. These solutions can be used at Ultivue, by the customer or at OracleBio – in GCP-compliant workflows. Co-marketing agreements with Aignostics, Keen Eye, and Nucleai, enable Ultivue to offer AI solutions that optimally complement mIF assays for the efficient analysis of larger cohorts. Hands-on time per image and consistency of readouts can be significantly improved and results can be reviewed in web-based viewers – a viewer optimized for mIF and same-slide H&E has been co-developed with Aignostics. Ultivue is also collaborating with Paige to bring AI-based analytics into clinical workflows and with Zegami leveraging AI to interactively explore image and analysis data from large cohorts for quality control and scientific interpretation.

All these agreements enable Ultivue to present a cohesive workflow to biopharma customers that combines the power of mIF and AI development ensuring a seamless integration of assay coupled to analysis. As noted by Florian Leiss, VP Digital Health Strategies, "Leveraging the full potential of mIF and AI for translational science and in clinical trials will require different capabilities at different stages. We are excited to work with trusted partners to complement mIF assays with image and data analysis across the entire spectrum of tissue biomarker development. We jointly accelerate the journey for our biopharma customers and enable them to focus on the science in a way no single player could alone."

On May 12, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present new preclinical data highlighting the anti-tumor activity of Wugen’s lead memory natural killer (NK) product candidate WU-NK-101 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress being held June 9-12, 2022, virtually and in-person in Vienna, Austria (Press release, Wugen, MAY 12, 2022, View Source [SID1234614421]).

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The data highlight preclinical activity of WU-NK-101 supporting its clinical development for acute myeloid leukemia (AML). WU-NK-101 displayed activity against AML cell lines both in vitro and in vivo, and improved homing to the bone marrow. Further, the functional characteristics of WU-NK-101 support the potential development of WU-NK-101 for solid tumors, with data showing resistance to an adverse and immunosuppressive tumor microenvironment (TME).

The details of Wugen’s poster presentation at EHA (Free EHA Whitepaper) are as follows:

Title: WU-NK-101, An Allogeneic Memory NK Cell, for the Treatment of Relapse or Refractory (R/R) Acute Myeloid Leukemia (AML)
Session date and time: Friday, June 10, 2022, from 4:30 – 5:45 p.m. CEST
Abstract Number: P1426
Presenting Author: Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer, Wugen
Additional meeting information can be found at www.ehaweb.org/congress.

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On May 12, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported 20 presentations from the Company’s global clinical development programs in hematologic malignancies at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress being held June 9 – 12, 2022 in Vienna, Austria (Press release, BeiGene, MAY 12, 2022, View Source [SID1234614420]).

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"With an oral presentation for the ROSEWOOD trial of zanubrutinib in follicular lymphoma and 19 poster presentations describing clinical data and patient-focused endpoints, our scientific presence at EHA (Free EHA Whitepaper) demonstrates BeiGene’s commitment to improving patient-care through innovative research"

"With an oral presentation for the ROSEWOOD trial of zanubrutinib in follicular lymphoma and 19 poster presentations describing clinical data and patient-focused endpoints, our scientific presence at EHA (Free EHA Whitepaper) demonstrates BeiGene’s commitment to improving patient-care through innovative research," said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. "We look forward to sharing data pointing to the promise of our pipeline in areas of high unmet need for people with hematologic malignancies."

BeiGene presentation highlights

Zanubrutinib

ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial
ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia
SEQUOIA: Patient-reported outcomes from a Phase 3 randomized study of zanubrutinib versus bendamustine plus rituximab (br) in patients with treatment-naïve (tn) chronic lymphoctic leukemia (CLL)/ small lymphocytic lymphoma (SLL)
ALPINE: Health-related quality of life outcomes associated with zanubrutinib vs ibrutinib monotherapy in patients with relapsed/refractory (rr) CLL/SLL: results from the randomized Phase 3 ALPINE trial
Early-stage pipeline

Two poster presentations for BCL-2 inhibitor BGB-11417
Monotherapy and combination with zanubrutinib: Phase 1 data in CLL, non-Hodgkin’s lymphoma and acute myeloid leukemia (AML)
Monotherapy: preliminary safety and efficacy in AML
Presentation details

Abstract Title and Number

Session/Location

Date and Time
(all times CEST)

Presenting Author

BeiGene Hematologic Malignancies Clinical Data at EHA (Free EHA Whitepaper)2022 Hybrid Congress

Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial

Abstract Number: S205

Session Title: Indolent and mantle cell lymphoma;

Session room: Hall C1

Saturday, June 11

11:30 AM – 12:45 PM

Pier L. Zinzani, M.D., Ph,D.

ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib vs ibrutinib in patients with Waldenström macroglobulinemia (WM)

Abstract Number: P1161

Friday, June 10

16:30 – 17:45 PM

Alessandra Tedeschi, M.D.

Results of a Phase 2 expanded access study of zanubrutinib in patients with Waldenström macroglobulinemia

Abstract Number: P1160

Friday, June 10

16:30 – 17:45 PM

Jorge J. Castillo, M.D.

Zanubrutinib in older patients (pts) with relapsed/refractory marginal zone lymphoma: subgroup analysis of the Magnolia study

Abstract Number: P1162

Friday, June 10

16:30 – 17:45 PM

Prof. Stephen Opat

Tislelizumab, a PD-1 inhibitor for relapsed/refractory mature T/NK-cell neoplasms: results from a Phase 2 study

Abstract Number: P1239

Friday, June 10

16:30 – 17:45 PM

Emmanuel Bachy. M.D., Ph.D.

A Phase 1 study with the novel B-cell lymphoma 2 inhibitor BGB-11417 as monotherapy or in combination with zanubrutinib in patients with B-cell malignancies: preliminary data

Abstract Number: P687

Friday, June 10

16:30 – 17:45 PM

Prof. Stephen Opat

Preliminary safety and efficacy of BGB-11417, a potent and selective B-cell lymphoma 2 (BCL2) inhibitor, in patients with acute myeloid leukemia

Abstract Number: P590

Friday, June 10

16:30 – 17:45 PM

Prof. Jake Shortt

A Phase 1 first in-human study of BGB-16673, a Bruton tyrosine kinase protein degrader, in patients with B-cell malignancies (trial in progress)

Abstract Number: P686

Friday, June 10

16:30 – 17:45 PM

Constantine S. Tam, M.B.B.S., M.D., F.R.A.C.P., F.R.C.P.A.

Zandelisib on intermittent dosing as a single agent or in combination with rituximab or zanubrutinib in relapsed/refractory follicular lymphoma: results from a multi-arm Phase 1b study

Abstract Number: P1114

Friday, June 10

16:30 – 17:45 PM

Felipe Samaniego, M.D.

BeiGene Patient-Reported Outcomes (PRO), Real-World Evidence (RWE) and Health Economics & Outcomes Research at EHA (Free EHA Whitepaper)2022 Hybrid Congress

Patient-Reported Outcomes from a Phase 3 Randomized Study of Zanubrutinib versus Bendamustine Plus Rituximab (BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Abstract Number: P662

Friday, June 10

16:30 – 17:45 PM

Paolo Ghia, M.D., Ph.D.

Health-Related Quality of Life Outcomes Associated With Zanubrutinib Versus Ibrutinib Monotherapy In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (RR CLL/SLL): Results from the Randomized Phase 3 ALPINE Trial

Abstract Number: P663

Friday, June 10

16:30 – 17:45 PM

Peter Hillmen, M.B., Ch.B., Ph.D.

Population-Wide Patterns of Care in Chronic Lymphocytic Leukemia in Australia: An Analysis of the Pharmaceutical Benefits Scheme Dataset

Abstract Number: P661

Friday, June 10

16:30 – 17:45 PM

Constantine Tam, M.B.B.S., M.D., F.R.A.C.P., F.R.C.P.A.

Real world evidence of impact of atrial fibrillation (AF) on clinical and economic outcomes in patients (pts) with chronic lymphocytic leukemia (CLL)

Abstract Number: P685

Friday, June 10

16:30 – 17:45 PM

Asher Chanan-Khan, M.B.B.S., M.D.

Real-world treatment patterns and comparative effectiveness of Bruton tyrosine kinase inhibitors (BTKi) in patients (pts) with mantle cell lymphoma (MCL)

Abstract Number: P1157

Friday, June 10

16:30 – 17:45 PM

Bijal D. Shah, M.D.

Real-world treatment (tx) patterns and economic burden of patients (pts) with Marginal Zone Lymphoma (MZL)

Abstract Number: P1158

Friday, June 10

16:30 – 17:45 PM

Bijal D. Shah, M.D.

BeiGene Online Only Abstracts at EHA (Free EHA Whitepaper)2022 Hybrid Congress

Zanubrutinib in acalabrutinib-intolerant patients with B-cell malignancies

Abstract Number: PB1890

Online Only

Mazyar Shadman, M.D., M.P.H.

Efficacy of First-Line Treatment for Chronic Lymphocytic Leukemia: A Bayesian Network Meta-Analysis

Abstract Number: PB1888

Online Only

Asher Chanan-Khan, M.B.B.S., M.D.

Network Meta-Analysis of Progression Free Survival in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia

Abstract Number: PB1887

Online Only

Asher Chanan-Khan, M.B.B.S., M.D.

Population-Wide Patterns of Care in Mantle Cell Lymphoma in Australia: An Analysis of the Pharmaceutical Benefits Scheme Dataset

Abstract Number: PB2082

Online Only

Constantine Tam, M.B.B.S., M.D., F.R.A.C.P., F.R.C.P.A.

Treatment persistence and adherence to ibrutinib in patients with WM: a German claims data analysis

Abstract Number: PB2081

Online Only

Prof. Christian Buske

About BRUKINSA
BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 45 countries and regions, including the United States, China, the EU, and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.