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Gamida Cell to Present New Data from Key Programs at 2017 ASH Annual Meeting

On November 1, 2017 Gamida Cell, a leading cellular and immune therapeutics company, reported that two oral presentations on new data from the company’s pipeline programs will be presented during the 59th Annual Meeting of the American Society for Hematology (ASH) (Free ASH Whitepaper) (Press release, Gamida Cell, NOV 1, 2017, View Source [SID1234521461]).

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The oral presentations will highlight safety and efficacy data for a completed phase 2 study of the company’s lead clinical asset, NiCord, as a single cord blood graft, and proof-of-concept data for the advancement of natural killer cells (NK cells) as an immunotherapeutic modality for patients with cancer. These abstracts are now available on the ASH (Free ASH Whitepaper) conference website.

Oral Presentations

NiCord Single Unit Expanded Umbilical Cord Blood Transplantation (UCBT): Final Results of a Multicenter Phase I/ II Trial

Date & Time: Monday, December 11, 2017 at 4:30 p.m. ET

Session Name: Clinical Allogeneic Transplantation: Results: Donor Selection in the Haplo Transplant Era

Abstract Number: 847

Location: Georgia World Congress Center, Building C, Level 2, Room C202-204

Enhanced In Vivo Persistence and Proliferation of NK Cells Expanded in Culture with the Small Molecule Nicotinamide: Development of a Clinical-Applicable Method for NK Expansion

Date & Time: Monday, December 11, 2017 at 11:00 a.m. ET

Session Name: Cell Collection and Processing: Optimization of Hematopoietic Graft Using Small Molecules in Culture

Abstract Number: 657

Location: Georgia World Congress Center, Building B, Level 2, Room B216-217

Vedanta Biosciences to Advance Cancer Immunotherapy Candidates Based on Microbiome-Derived Live Biotherapeutics that Induce CD8+ T Cells

On November 1, 2017 Vedanta Biosciences, an affiliate of PureTech Health (LSE: PRTC) developing a new category of therapies for immune and infectious diseases based on rationally designed consortia of human microbiome-derived bacteria, reported that it has exclusively sub-licensed key intellectual property from JSR Corporation to develop and commercialize microbiome-derived cancer immunotherapies based on live biotherapeutics (Press release, Vedanta Biosciences, NOV 1, 2017, View Source [SID1234521457]). These live biotherapeutics have been shown to activate CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy. The sub-licensed intellectual property is based on the pioneering research of Dr. Kenya Honda, Professor, of Keio University School of Medicine and his collaborators in the University of Tokyo in Japan. An IND filing for the lead product candidate is planned in 2018.

“Dr. Honda’s research suggests an entirely new approach to cancer immunotherapy harnessing the human microbiome, which has the potential to significantly enhance the effectiveness of cancer therapies,” said Bernat Olle, PhD, Chief Executive Officer of Vedanta Biosciences. “We are actively developing product candidates containing defined bacterial consortia that activate CD8+ T cells and stimulate the immune system to fight cancer alone and in combination with checkpoint inhibitors. This license to additional intellectual property from Dr. Honda’s institution further strengthens Vedanta’s leading IP position in the microbiome field.”

In validated pre-clinical models of cancer, Vedanta’s orally administered product candidates containing defined bacterial consortia induced CD8+ T cells, potentiating the immune system’s attack of tumor cells. The tumor fighting effects of a variety of checkpoint inhibitors were significantly amplified when combined with the bacterial consortia, suggesting a potentially novel approach for combination cancer immunotherapy.

About Key Intellectual Properties
Keio University and The University of Tokyo joined the Leading Advanced Projects for Medical Innovation (“LEAP”), part of Advanced Research and Development Programs for Medical Innovation at The Japan Agency for Medical Research and Development (“AMED”), in 2016. Their research and development is focused on the development of therapeutic cocktails of bacteria isolated from the gut microbiota. The licensed intellectual properties were developed as a part of the AMED-LEAP Research Program and are exclusively licensed to JSR Corporation (TSE: JSR) from Keio University and The University of Tokyo.

New Data of Emicizumab Presented at The American Society of Hematology 2017

On November 1, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that oral and poster presentations will be given with regard to emicizumab at The American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 in Atlanta, Georgia, United States. Emicizumab is a bispecific antibody under development for hemophilia A (Press release, Chugai, NOV 1, 2017, View Source [SID1234521451]).

Data from additional six-month follow-up of global Phase lll studies in hemophilia A with inhibitors to factor VIII, HAVEN 1 study (NCT02622321) and HAVEN 2 study (NCT02795767), will be shown at the conference. The HAVEN 2 will be presented at 7:30 EST on December 9 as part of the official Press Program at ASH (Free ASH Whitepaper). Both studies have been conducted in collaboration with Roche and Genentech, while HAVEN 1 is for adults and adolescents and HAVEN 2 is for children.

In addition, preliminary data from HAVEN 4 study (NCT03020160), a Phase lll study with hemophilia A patients with or without inhibitors which examines emicizumab prophylaxis administered subcutaneously once every four weeks, and real-world data from a non-interventional trial in children under 12 years of ages with hemophilia A with inhibitors will be presented.

BeiGene Announces Oral Presentation and Posters at the 59th American Society of Hematology Annual Meeting

On November 1, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present data on its Bruton’s Tyrosine Kinase (BTK) inhibitor at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, BeiGene, NOV 1, 2017, View Source [SID1234521450]). ASH (Free ASH Whitepaper) will take place December 9-12, 2017 in Atlanta, GA.

Oral Presentation, Abstract #152

Title: Safety and Activity of the Highly Specific BTK Inhibitor BGB-3111 in Patients with Indolent and Aggressive Non Hodgkin’s Lymphoma

Presenter: Constantine Tam, MD

Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma – Clinical Studies: Mantle Cell Lymphoma, New Therapies
Date & Time: 12:15pm EST, Saturday, December 9, 2017
Location: Georgia World Congress Center, A411-A412

Poster, Abstract #1745

Title: BGB-3111 in Combination with Obinutuzumab in Patients with Chronic Lymphocytic Leukemia and Follicular Lymphoma

Presenter: Constantine Tam, MD

Session: 642. CLL: Therapy, excluding Transplantation: Poster I
Date & Time: 5:30pm-7:30pm EST, Saturday, December 9, 2017
Location: Georgia World Congress Center, Hall A2

Poster, Abstract #4057

Title: Safety and Activity of the Highly Specific BTK Inhibitor BGB-3111 in Combination with the PD-1 Inhibitor BGB-A317 in Patients with B-Cell Lymphoid Malignancies

Presenter: Gavin Cull, MD

Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma – Clinical Studies: Poster III
Date & Time: 6:00pm-8:00pm EST, Monday, December 11, 2017
Location: Georgia World Congress Center, Hall A2

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib, a BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency, based on biochemical assays, higher exposure than ibrutinib based on their respective Phase 1 experience in separate studies, and sustained 24-hour BTK occupancy in both the peripheral blood and lymph node compartments.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for BGB-A317 for solid tumors.

Alpine Immune Sciences to Present at Two Upcoming Investor Conferences in November

On November 1, 2017 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for autoimmune diseases and cancer, reported that the company will present at two upcoming investor conferences in November (Press release, Alpine Immune Sciences, NOV 1, 2017, View Source [SID1234521449]).

Stifel 2017 Healthcare Conference
Tuesday, November 14, 2017, at 3:30 p.m. Eastern Time in New York.

29th Annual Piper Jaffray Healthcare Conference
Wednesday, November 29, 2017, at 10:50 a.m. Eastern Time in New York.

A live webcast of each presentation will be available online by visiting the investor relations page of the Company’s website, at View Source An archive of each webcast will be available on the Company’s website for 30 days.