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Celyad publishes additional pre-clinical data in support of THINK trial

On June 21, 2017 Celyad SA (EURONEXT Brussels and Paris: CYAD – NASDAQ Global Market: CYAD), a leader in the discovery and development of CAR-T cell therapies, reported it has published a special report in the peer-reviewed journal "Future Oncology" summarizing pre-clinical work undertaken on NKR-2, the CAR-T cell therapy currently tested in the company’s THINK trial(Press release, Celyad, JUN 21, 2017, View Source [SID1234519643]).

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Celyad’s special report entitled Exploiting Natural Killer Group 2D Receptors for CAR-T cell therapy discloses new results confirming the potency of CAR-T NKR-2 cells against various human cancer cell lines in vitro including leukemia, colorectal and pancreatic cancer. Furthermore, new data show the ability of CAR-T NKR-2 cells to effectively challenge established pancreatic cancer xenografts in humanized mouse models.

These pre-clinical studies were performed with Celyad’s long-term collaborator Professor Charles Sentman and further confirm the choice of indications being investigated in the ongoing THINK trial.

Dr. David Gilham, VP of Research & Development at Celyad: "This publication provides important additional pre-clinical evidence supporting the range of cancer indications being explored in the THINK trial. This is an example of our on-going work to further define and understand the mechanisms of action of CAR-T NKR2 cells that will provide greater insight to support our developing clinical program."

Dr. Christian Homsy, CEO of Celyad: "We are pleased to provide further pre-clinical evidence validating our approach in the THINK trial, in which we aim to demonstrate the potential of CAR-T NKR-2 cells as a disruptive technology in the treatment of cancer."

Celyad’s special report is available on Future Oncology’s website:
View Source

FibroGen Granted Orphan Drug Designation for Pamrevlumab in the Treatment of Pancreatic Cancer

On June 21, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status to pamrevlumab, the company’s first-in-class antibody, for the treatment of pancreatic cancer (Press release, FibroGen, JUN 21, 2017, View Source;p=RssLanding&cat=news&id=2282394 [SID1234519642]).

"This is an important regulatory milestone for FibroGen, as pamrevlumab continues to show promise in the treatment of pancreatic cancer," said Tom Neff, Chief Executive Officer of FibroGen. "Phase 2 clinical studies of pamrevlumab have produced initial positive data on median and one-year survival for patients with advanced pancreatic cancer (88% metastatic). An ongoing study in locally advanced non-resectable pancreatic cancer has shown promise in converting pancreatic cancer from non-resectable to surgically viable. In this current open-label Phase 2 randomized trial, we are evaluating pamrevlumab in combination with chemotherapy standard-of-care versus chemotherapy alone. We look forward to sharing results by early next year."

Orphan Drug Designation qualifies the sponsor for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing, to advance the evaluation and development of products that demonstrate promise for the diagnosis and treatment of rare diseases or conditions. Orphan Drug Designation can also convey up to seven years of marketing exclusivity if the compound receives regulatory approval from the FDA. FibroGen previously received Orphan Drug Designation for pamrevlumab for the treatment of idiopathic pulmonary fibrosis (IPF).

About Pamrevlumab
Pamrevlumab (formerly FG-3019) is an investigational therapeutic antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy (DMD). In desmoplastic or fibrotic cancers, such as pancreatic cancer, CTGF in the extensive fibrous stroma associated with the tumor promotes abnormal proliferation of stromal cells and tumor cells. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Moleculin Announces Significant Discovery with Potential to Treat Pancreatic Cancer

On June 21, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer (Press release, Moleculin, JUN 21, 2017, View Source [SID1234519641]).

"We’ve received a lot of attention from the scientific community for our glucose decoy technology (WP1122 Portfolio, Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, December 13, 2016) as a potential means to starve tumors to death by exploiting their hyper-dependence on glycolysis for energy production," commented Walter Klemp, Chairman and CEO of Moleculin, "and now we have identified possible new properties of our compound WP1234, a modification to WP1122. In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer."

Mr. Klemp continued: "Pancreatic cancer is still considered largely untreatable, so even modest gains in treating this disease could represent a significant clinical benefit. WP1234 improves on known inhibitors for glycolysis by increasing drug circulation time, which should increase the potential for drug uptake by and destruction of tumor cells. We are excited about the potential to pursue development opportunities with WP1234 for the treatment of pancreatic cancer. We are also pleased to report that this discovery was the direct result of our ongoing collaboration with M.D. Anderson Cancer Center and the science team there will be presenting detailed findings to the scientific community in the near future."

ImmunoCellular Therapeutics Provides Update on Strategic Review and Decision to Suspend Further Patient Randomization for ICT-107 Phase 3 Trial

On June 21, 2017 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported an update on the strategic review of its financing and development strategies for ICT-107, its patient-specific, dendritic cell-based immunotherapy for patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, JUN 21, 2017, View Source [SID1234519640]).

ImmunoCellular has determined that the Company is unable at this time to secure sufficient additional financial resources to complete the phase 3 registration trial of ICT-107. As a result, the Company intends to suspend further patient randomization in the ICT-107 trial while it continues to seek a collaborative arrangement or acquisition of its ICT-107 program. The Company plans to actively work with current collaborators to ensure that patients already randomized and receiving treatment in the phase 3 trial can be appropriately supported and followed. The suspension of the phase 3 registration trial of ICT-107 is expected to reduce the amount of cash used in the Company’s operations.

While maintaining the focus on its Stem-to-T-Cell research programs, ImmunoCellular continues its evaluation of financing and strategic alternatives for its immuno-oncology research and development pipeline and technology platform, which may include a potential merger, consolidation, reorganization or other business combination, as well as the sale of the Company or the Company’s assets.

Epizyme Announces Tazemetostat Granted Orphan Drug Designation for the Treatment of Soft Tissue Sarcoma

On June 21, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to tazemetostat, the company’s first-in-class EZH2 inhibitor, for the treatment of patients with soft tissue sarcoma (STS) (Press release, Epizyme, JUN 21, 2017, View Source [SID1234519639]).

“This is an important milestone for Epizyme, as we advance tazemetostat through clinical development,” said Robert Bazemore, president and chief executive officer, Epizyme. “We are encouraged by the positive regulatory milestones we have achieved for tazemetostat, including this Orphan Drug designation for soft tissue sarcomas. We look forward to our continued engagement with the FDA as we work to bring tazemetostat to patients with both solid tumors and hematological malignancies as quickly as possible.”

The Orphan drug status conveys eligibility for certain development incentives and market exclusivity for STS independent from Epizyme’s intellectual property protection. The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S.

STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, which can arise anywhere in the body at any age. STS is an aggressive and difficult-to-treat cancer with more than 50 subtypes, including epithelioid sarcoma, highlighting the need for effective treatment options. According to the American Cancer Society, approximately 13,000 patients will be diagnosed with STS in the U.S. in 2017.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for follicular lymphoma regardless of EZH2 mutation and for DLBCL with EZH2-activating mutations, as well as Orphan Drug designation for soft tissue sarcoma and malignant rhabdoid tumors.