On June 22, 2016 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, reported it has entered into a collaboration agreement with Genentech, a member of the Roche Group, to conduct a clinical trial to investigate the anti-cancer effects of Epizyme’s EZH2 inhibitor, tazemetostat, and Genentech’s recently approved anti-PD-L1 cancer immunotherapy, Tecentriq (atezolizumab), when used in combination (Press release, Epizyme, JUN 22, 2016, View Source [SID:1234513490]). Schedule your 30 min Free 1stOncology Demo! The study will evaluate this combination regimen for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma.
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"A key part of Epizyme’s long-term vision is expanding the benefit that tazemetostat can bring to patients, and includes combining tazemetostat with checkpoint inhibitors," said Robert Bazemore, President and Chief Executive Officer, Epizyme. "We believe this study will be enhanced by our partner’s deep expertise in the field of immuno-oncology. This collaboration aligns us with a global leader in oncology and hematology, and advances Epizyme’s leadership position in the development of epigenetic therapeutics."
Under the agreement, Genentech will manage study operations for the planned clinical trial. The planned phase 1b clinical trial is expected to begin enrolling patients in the second half of 2016.
"The goal of this collaboration is to generate clinical proof-of-concept for the combination, building on tazemetostat’s activity as a monotherapy in a Phase 1 study of NHL and preclinical observations that EZH2 inhibition may have a priming effect on the immune system and improve the activity of checkpoint inhibitors," said Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. "We look forward to evaluating this combination in patients with DLBCL, and to exploring the potential to expand the therapeutic opportunities for tazemetostat, as well as Tecentriq."
Tecentriq, the first and only anti-PD-L1 cancer immunotherapy approved by the U.S. Food and Drug Administration, recently received accelerated approval for people with a specific type of advanced bladder cancer.
About Tazemetostat
Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and patients with certain genetically defined solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in dysregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non- Proprietary Name (INN) for compound EPZ-6438.
Month: June 2016
Takara Bio enters into a license and supply agreement of RetroNectin® with Kite Pharma
On June 21, 2016 Takara Bio Inc. reported that it has entered into a License and Supply Agreement with Kite Pharma, Inc. ("Kite"), United States, under which Takara Bio grants Kite a commercial license to use applicable patents relating to RetroNectin (Press release, Takara Bio, JUN 21, 2016, View Source [SID:1234513523]). Under this agreement, Takara Bio also provides Kite with reliable supplies of RetroNectin. Takara Bio now has ten licensees permitted to use RetroNectin patents commercially.
The patented technologies licensed to Kite are based on Takara Bio’s proprietary RetroNectin method, which includes a technology enabling highly efficient gene transduction to cells by retrovirus vector and expansion of T-cells with high efficiency. With such advantages, RetroNectin method is now becoming increasingly standard in protocols utilized for "Engineered T-cell Therapy", which includes promising TCR and CAR gene therapies recently raising higher expectations.
Kite is advancing clinical development of several Engineered T-cell Therapy product candidates. Under the agreement signed with Takara Bio, Kite is allowed to use RetroNectin for production of its most advanced product candidate, KTE-C19, a therapy in which a patient’s T cells are genetically engineered to express a CAR designed to target the antigen CD19 for the treatment of B-cell lymphomas and leukemias.
Takara Bio is promoting supply of RetroNectin to clinical development of Engineered T-cell Therapy actively pursued worldwide in recent years, and expects higher sales growth in the future.
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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]
On June 21, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, reported receipt of conditional approval from the New York State Department of Health (NYSDOH) for the Company’s multiple fluorescence in situ hybridization (FISH) tests for detection of amplifications or rearrangements of DNA in a number of hematologic cancers, such as leukemias, lymphomas and myelomas in order to form a diagnosis and/or to evaluate prognosis or remission of disease (Filing, 6-K, Rosetta Genomics, JUN 21, 2016, View Source [SID:1234513484]). NYSDOH approval was granted under the Company’s Molecular Oncology and Cellular Tumor Marker permit.
The laboratory is CLIA certified and CAP accredited, yet New York requires an additional permit for each test from the NYSDOH for them to be offered to patients in the state. The NYSDOH also requires the Company to provide any additional information requested within 60 business days for final approval. With this conditional approval, these assays are now available in all 50 states.
"We are delighted to be able to service clients across the State of New York with a full FISH menu for liquid tumor analysis, thus allowing them to better determine appropriate treatment options for their patients with hematologic cancers," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
"In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for these tests exceeding 155 million in the U.S. Our recognized expertise in FISH and our growing menu of tests serving the hematology-oncology and pathology markets will help strengthen our position with leading managed care plans as a provider of choice for high-quality FISH testing and should enhance our goal to sign additional participation agreements during the second half of 2016," added Mr. Berlin.
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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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Merrimack to Present New Analyses of Phase 3 NAPOLI-1 Data at the ESMO 18th World Congress on Gastrointestinal Cancer
On June 21, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that it will present new analyses of the Phase 3 NAPOLI-1 data in an oral presentation and poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer, June 29 – July 2, 2016 in Barcelona, Spain (Press release, Merrimack, JUN 21, 2016, View Source [SID:1234513483]). An oral presentation by Dr. Richard Hubner, Consultant Medical Oncologist, The Christie NHS Foundation Trust and investigator on the NAPOLI-1 trial, will compare the effects of ONIVYDE (also known as "nal-IRI") in combination with fluorouracil and leucovorin on quality of life in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy versus treatment with fluorouracil and leucovorin alone.
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Merrimack will also present an analysis of the NAPOLI-1 safety data across patient subgroups in a poster discussion session and a trials-in-progress poster on a Phase 2 study evaluating ONIVYDE containing regimens as first-line therapy for patients with metastatic pancreatic cancer.
Oral Presentation:
Effects of nal-IRI (MM-398) ± 5-fluorouracil on quality of life (QoL) in NAPOLI-1: A phase 3 study in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy (Abstract O-004)
Wednesday, June 29, 2016, 5:53 – 6:03 PM CEST
Session: Pancreatic Cancer
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Poster Sessions:
Safety across subgroups in NAPOLI-1: A phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract PD-023)
Session: Pancreatic Cancer
Poster Discussion Time: Thursday, June 30, 2016, 11:00 – 11:30 AM CEST
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine as first-line therapy in patients with metastatic pancreatic adenocarcinoma (mPAC): A randomized, open-label phase 2 study (Abstract P-287)
Session: Pancreatic Cancer
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Adaptimmune Announces Commercial Development and Supply Agreement for Thermo Fisher Scientific’s Dynabeads™ CD3/CD28 Cell Therapy System
On June 21, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has entered into a commercial development and supply agreement with Thermo Fisher Scientific (Press release, Adaptimmune, JUN 21, 2016, View Source;p=RssLanding&cat=news&id=2178965 [SID:1234513479]). The new 10-year agreement augments Adaptimmune’s exclusive license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System (CTS)* for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.
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Dynabeads CD3/CD28 CTS is designed to isolate, activate and expand human T-cells. This technology provides coordinated and simultaneous activation and co-stimulation signals to T-cells, a process that is reported to produce T-cells with enhanced proliferation and with characteristics that enable prolonged persistence in vivo**. Adaptimmune has an exclusive license for the IP associated with the use of Dynabeads CD3/CD28 to expand and activate all TCR-transduced T-cells in cancer, infectious and autoimmune diseases.
"We are delighted to expand our collaboration with Thermo Fisher and secure continuity of supply of Dynabeads through commercialization," said Gwen Binder-Scholl, Adaptimmune’s Chief Technology Officer. "Dynabeads CD3/CD28 have unique properties which we believe optimize the manufacture of our SPEAR T-cell therapies, including the generation of younger and healthier T-cells leading to prolonged persistence of therapeutic cells in the blood. We look forward to continuing to work closely with Thermo Fisher as we progress toward the commercialization of our T-cell therapeutics."
"Thermo Fisher’s market-leading cell therapy workflow solutions are enabling its customers to address the unique commercialization challenges of this market. We are pleased to expand our partnership with Adaptimmune, a leader in the T-cell immunotherapy space," said Oystein Aamellem, director of Cellular Medicine for Thermo Fisher. "This agreement demonstrates our sustained commitment to advancing the development of our Dynabead CD3/CD28 technology to support the treatment of solid tumors, as well as other conditions that threaten human health."
Adaptimmune’s SPEAR T-cell therapies are novel cancer immunotherapies that have been engineered through their T cell receptors (TCRs) to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidates, significantly impact cancer treatment and clinical outcomes of patients with solid and hematologic cancers.
The manufacturing process consists of isolating T-cells from the blood of cancer patients; transferring affinity enhanced TCRs, which have been modified to recognize cancer cells, into the cells; activating and expanding the T-cells using Dynabeads CD3/CD28; and, introducing the affinity enhanced cells back into the patient to enable the patient’s immune system to respond and attack cancer.