On January 20, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY)reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to venetoclax in combination with MabThera/Rituxan (rituximab) for the treatment of people with relapsed or refractory chronic lymphocytic leukaemia (CLL) (Press release, Hoffmann-La Roche , JAN 20, 2016, View Source [SID:1234508820]). Venetoclax is an investigational medicine being developed in partnership with AbbVie. Schedule your 30 min Free 1stOncology Demo! The designation was based on results from the M13-365 study, which were presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2015 (abstract #830). Venetoclax was previously granted breakthrough therapy designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.
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Breakthrough therapy designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The combination of venetoclax and MabThera/Rituxan for the treatment of people with relapsed or refractory CLL is being further evaluated in the ongoing MURANO (GO28667) study.
About Venetoclax (RG7601, GDC-0199/ABT-199)
Venetoclax is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signalling system that tells cancer cells to self-destruct. The BCL-2 protein is linked to the development of resistance in certain blood cancers and is expressed in chronic lymphocytic leukaemia (CLL) and non-Hodgkin’s lymphoma (NHL). In collaboration with AbbVie, venetoclax is being evaluated in a robust development program as a single agent or in combination with other medicines. There are ongoing Phase II and III studies for venetoclax in CLL, and Phase I and II studies are also ongoing in several other blood cancers, including indolent NHL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukaemia (AML) and multiple myeloma (MM).
About Roche in haematology
For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera/Rituxan (rituximab) and Gazyva/Gazyvaro (obinutuzumab), Roche’s pipeline of investigational haematology medicines includes an anti-PDL1 antibody (atezolizumab/MPDL3280A), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596), a small molecule antagonist of MDM2 (idasanutlin/RG7388) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (venetoclax/RG7601/GDC-0199/ABT-199). Roche’s dedication to developing novel molecules in haematology expands beyond oncology, with the development of the investigational haemophilia A treatment emicizumab (ACE910).
Author: [email protected]
10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]
(Filing, Nuvilex, JAN 19, 2016, View Source [SID:1234508824])
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10-Q/A [Amend] – Quarterly report [Sections 13 or 15(d)]
(Filing, Nuvilex, JAN 19, 2016, View Source [SID:1234508822])
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NewLink Genetics Corporation to Present Phase 1b Data on Indoximod in Combination Therapy in Patients With Metastatic Pancreatic Cancer at ASCO GI
On January 19, 2016 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer, reported that it will present Phase 1b data from a Phase 1/2 trial that examines combination therapy of indoximod plus gemcitabine/nab-paclitaxel in treating patients with metastatic pancreatic cancer at the 2016 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco (Press release, NewLink Genetics, JAN 19, 2016, View Source [SID:1234508817]).
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Details for the presentation follow:
Abstract Title: Results of the phase 1b portion of a phase 1/2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus gemcitabine/nab-paclitaxel for the treatment of metastatic pancreatic cancer.
Abstract Number: 160257
Time: 12:30-2 p.m. and 5:30-7 p.m.
Date: Friday, Jan. 22, 2016
Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
About Indoximod
Indoximod is an orally available small molecule that has shown the potential to interfere with multiple targets within the indoleamine 2,3-dioxygenase (IDO) pathway. It is designed to be used in combination with other therapeutic agents to maximize the body’s immune response against a range of tumor types. Indoximod is currently in multiple Phase 2 clinical trials for the treatment of patients with breast, prostate, pancreatic, melanoma and brain cancers and in Phase 1 clinical trials for the treatment of pediatric patients with primary malignant brain tumors
Cellectis Enters into New Agreement with CELLforCURE for the cGMP Manufacturing of UCART123 for Hematological Malignancies
On January 19, 2016 Cellectis (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that it entered into a new agreement for the cGMP manufacturing of UCART123 clinical batches, Cellectis’ lead product candidate, with CELLforCURE, an LFB group company and the largest industrial facility for clinical and commercial production of innovative cell therapies in Europe (Press release, Cellectis, JAN 19, 2016, View Source [SID:1234508815]). CELLforCURE will be in charge of implementing cGMP manufacturing processes designed and developed by Cellectis.
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Following the recent successful production of UCART19, pursuant to this second agreement CELLforCURE will be responsible for the manufacturing of cGMP clinical batches for UCART123, the lead engineered T-cell product candidate in Cellectis’ wholly owned portfolio. UCART123 targets CD123, an antigen expressed on the surface of cancer cells in malignancies, such as acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cells neoplasm (BPDCN.
UCARTs (Universal Chimeric Antigen Receptor T-cells) are "off-the-shelf" allogeneic product candidates. Their production can be industrialized and standardized with consistent pharmaceutical release criteria, over time and from batch to batch.
Peripheral Blood Monoculear Cells from healthy donors are transduced and genetically edited with Cellectis’ TALEN technology to seek and destroy cancer cells. This approach could lead to a drug that would be cost-effective, made readily available – "off the shelf" – to broad patient populations in hospitals without need for local CAR-T processing facilities and easily distributed across all geographies.
Dr. David J.D. Sourdive, Executive Vice President Corporate Development, Cellectis, stated: "The manufacturing campaign for UCART123 consolidates Cellectis’ GMP processes and our expertise in its industrialization while allowing Cellectis to further enhance and improve the manufacturing of its UCART product candidates."
Dr. André Choulika, Chairman & CEO, Cellectis, added: "We are very pleased with our continued collaboration with CELLforCURE, a unique industrial platform dedicated to cell and gene therapies and equipped with a state-of-the-art cGMP manufacturing facility to foster the clinical development of UCART123. Cellectis’ cGMP manufacturing of allogeneic CAR T-cells is a paradigm change in cancer adoptive immunotherapies, for the patient’s benefit."
Pierre-Noël Lirsac, CEO of CELLforCURE stated: "The technical and pharmaceutical experience of the CELLforCURE team is a real asset, bringing its expertise to manufacture Cellectis’ cost-effectively CAR T-cell products, thus helping to make them broadly and immediately available to patients."
Leopold Bertea, Head of the Global bioproduction division of the LFB group, added: "This new agreement confirms the excellence of the collaboration between Cellectis and CELLforCURE. We are proud to contribute to such an exciting challenge."