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Agenus Announces Commencement of Phase 1/2 Clinical Trial of anti-GITR Checkpoint Antibody INCAGN1876 in Patients with Solid Tumors

On June 22, 2016 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing antibodies including checkpoint inhibitors and other checkpoint modulators, and cancer vaccines, reported that the first patient has been dosed in a Phase 1/2 clinical trial of the anti-GITR agonist antibody INCAGN1876 (Press release, Incyte, JUN 22, 2016, View Source [SID:1234513491]). The trial is being conducted by, and in collaboration with, Incyte Corporation.

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The open-label, dose-escalation portion of the trial will evaluate the safety and tolerability of INCAGN1876 in patients with advanced or metastatic solid tumors and determine the pharmacologically active and/or maximum tolerated dose of INCAGN1876. Part 2 of the trial is planned to further evaluate the recommended dose of INCAGN1876 in selected tumor types, including advanced or metastatic endometrial adenocarcinoma, melanoma, non-small cell lung cancer and renal cell carcinoma.

"This is the second product candidate from our antibody program that has advanced into clinical trials this year," said Garo H. Armen, Ph.D. Chairman and CEO of Agenus. "We expect to initiate additional clinical studies with antibodies as well as other immuno-oncology leads from our comprehensive pipeline in the next twelve months."

INCAGN1876 is an agonist antibody targeting the glucocorticoid-induced TNFR-related protein, or GITR. Upon activation, GITR, a co-stimulatory receptor, can stimulate immune cells to target and potentially destroy cancer cells. This antibody was discovered during an earlier collaboration with Ludwig Cancer Research. INCAGN1876 is being co-developed with Incyte.

"Targeted immunomodulatory therapy including anti-PD-1 and CTLA-4 drugs have demonstrated unprecedented results in cancer, but there remains significant need to improve treatment in cancer patients," said Robert B. Stein, M.D., Ph.D., Agenus’ President, Research & Development. "GITR is a unique co-stimulatory receptor which holds great promise as a new pathway for stimulating immune cells to target cancer and may be effective alone or in combination with other immuno-modulatory approaches."
Additional information about the trial can be found here.

About Checkpoint Antibodies
Promising clinical data from trials employing monoclonal antibodies that bind to checkpoint molecules, such as CTLA-4 and programmed death receptor-1 (PD-1), have generated considerable excitement in the field of cancer immunotherapy. These molecules serve as checks employed by the body to prevent a runaway immune response or allow rapid activation of the immune response when needed. Unfortunately, these necessary mechanisms of control can hinder the anti-cancer immune response. They can be harnessed by cancer cells as a defense against immune attack. Agenus is developing a broad pipeline of antibodies that bind to key checkpoint proteins and activate or block their activities for use in cancer therapy.

Epizyme Initiates Collaboration on Combination Trial of Tazemetostat and Tecentriq™ (atezolizumab) for Treatment of Non-Hodgkin Lymphoma

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]).

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.

"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.

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.

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.

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.

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