Month: June 2016

Infinity Announces Launch Of Disease Awareness Campaign For Hematologic Malignancies

On June 1, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported the launch of a mechanism of disease (MOD) awareness initiative designed to educate community and academic hematologists/oncologists about the role of the tumor microenvironment in patients with certain hematologic malignancies, or blood cancers (Press release, Infinity Pharmaceuticals, JUN 1, 2016, View Source;p=RssLanding&cat=news&id=2173919 [SID:1234512925]). With more research emerging about the role of the tumor microenvironment in hematologic malignancies, Infinity developed this campaign to contribute to the emerging knowledge of this scientific concept and its clinical relevance. The initiative will be showcased in the Infinity booth (#22415) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from June 3 – June 7, 2016. Additional information and resources on the tumor microenvironment are available on a newly launched website: www.manipulatedTME.com.

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In B-cell malignancies, the tumor microenvironment is made up of healthy, non-cancerous cells that are recruited by malignant (cancerous) B-cells to promote tumor survival.[1] The tumor microenvironment is thought to support key characteristics of cancer, including disease progression, resistance to cell death and sustained proliferation.[2]

"Research suggests that the tumor microenvironment may provide protection and support for malignant B-cells that hinder treatment effectiveness, resulting in poor responses to treatment," said Nathan Fowler, M.D., Associate Professor, Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center. "As hematologists and oncologists continue to conduct research and develop treatment plans for patients living with incurable B-cell malignancies, this online resource may provide insights as to why patients continue to relapse."

The campaign artwork is centered around a sinister character, representing a malignant B-cell, who is supported by cells in the tumor microenvironment, such as macrophages, endothelial cells, and immune cells. The B-cell character is shown to have manipulated these healthy cells to form the tumor microenvironment, a network of support and protection for malignant B-cells that may enable tumor growth and proliferation.

Learn more about the MOD campaign at www.manipulatedTME.com.

Delcath Announces Launch of CHEMOSAT at the HM Sanchinarro University Hospital in Madrid

On June 1, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the General and Digestive Surgery team at HM Sanchinarro University Hospital, led by Emilio Vicente, M.D. and Yolanda Quijano, M.D., has successfully launched the hospital’s Hepatic Chemosaturation Program (Press release, Delcath Systems, JUN 1, 2016, View Source;p=RssLanding&cat=news&id=2173899 [SID:1234512920]). The Sanchinarro team successfully performed three procedures with Delcath’s proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (CHEMOSAT or Melphalan/HDS). The team at HM Sanchinarro is using the CHEMOSAT procedure in peripheral cholangiocarcinoma, neuroendocrine tumours and colorectal liver metastases. HM Sanchinarro University Hospital is the second center in Spain to offer the treatment.

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"This is an exciting approach for the treatment of liver tumors," said Drs. Vicente and Quijano. "We believe that the administration of high-dose melphalan directly to the liver has great promise in the treatment of a variety of tumor types, and the associated side effects are also minimized and more manageable. In recent years, the successful development of this percutaneous procedure has been a breakthrough, as it significantly reduces the technique’s morbidity rate. We are very excited about adopting this new procedure at HM Sanchinarro University Hospital."

Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems Inc., said, "We are extremely pleased that the HM Sanchinarro Hospital has commenced its Chemosaturation Program with our CHEMOSAT Delivery System. HM Sanchinarro is one of the leading cancer centers in Spain, both in terms of treatment and research. This underscores how CHEMOSAT continues to be increasingly accepted as an effective therapy for patients with liver metastasis who would otherwise have few, if any, treatment options."

Atreca to Present at the Jefferies 2016 Global Healthcare Conference

On June 1, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that Tito Serafini, Ph.D., President, Chief Executive Officer, and Co-­‐Founder, will present at the Jefferies 2016 Global Healthcare Conference on Wednesday, June 8, 2016 at 3:00 p.m. Eastern Time in New York, NY (Press release, Atreca, JUN 1, 2016, View Source [SID1234522966]). Dr. Serafini will provide an overview of Atreca and business update.

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Kite Pharma Granted Access to Priority Medicines (PRIME) Regulatory Support for KTE-C19 in the Treatment of Chemorefractory Diffuse Large B-Cell Lymphoma (DLBCL)

On June 1, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Kite Pharma, JUN 1, 2016, View Source [SID:1234512941]). PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational therapy in which a patient’s T-cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

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"We are honored to be among the first sponsors selected by the CHMP and CAT to participate in an innovative program that fosters development of therapies for patients with serious diseases that have no or only unsatisfactory therapeutic options," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "The potential for KTE-C19 to address the substantial unmet medical need of patients with chemorefractory DLBCL is now recognized by designations from the U.S. and EU regulatory agencies. We look forward to working closely with the CHMP and CAT as we advance our multi-center ZUMA studies and move toward the KTE-C19 marketing authorization application process."

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to KTE-C19 for the treatment of patients with DLBCL, primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL) in December 2015.

About the Priority Medicines Initiative

Access to the Priority Medicines initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with unmet medical need. The criteria for the Priority Medicines initiative require early clinical evidence that the therapy offers a therapeutic advantage over existing treatments or benefits patients without treatment options. This designation provides appointment of a rapporteur, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review earlier in the application process.

About Kite’s ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T-cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies. In addition to the EMA Priority Medicines Designation, the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19 for the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). KTE-C19 has also secured Orphan Drug Designation in the U.S. and the EU for DLBCL, PMBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL).

Study Phase Indication Status
ZUMA-1
NCT02348216 Phase 2 Pivotal
(N=112) Refractory DLBCL, PMBCL, TFL Phase 2 enrolling
ZUMA-2
NCT02601313 Phase 2 Pivotal
(N=70) Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4
NCT02625480 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Pediatric ALL Phase 1/2 enrolling

DLBCL = diffuse large B-cell lymphoma
PMBCL = primary mediastinal B-cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia

Incyte and Moffitt Cancer Center Establish Multi-Year Oncology Research Alliance

On June 1, 2016 Incyte Corporation (Nasdaq: INCY) and Moffitt Cancer Center reported that they have entered into a research support and collaboration agreement, whereby Incyte has agreed to provide funding to conduct three new Moffitt Cancer Center research programs over a period of three years (Press release, Incyte, JUN 1, 2016, View Source [SID:1234512940]). The research programs will be focused on specific blood cancers, including myeloproliferative neoplasms (MPNs), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL) and chronic myelomonocytic leukemia (CMML). The objective of this alliance is to develop an improved understanding of basic cancer biology in the areas of focus, and interrogate specific therapeutic hypotheses involving Incyte’s proprietary small molecule therapeutics, both as single agents and in combination.

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"Having access to Incyte’s diverse pipeline of targeted cancer therapies represents a unique and exciting opportunity for Moffitt researchers to expand our efforts to advance medical research in oncology and improve medical care for patients with cancer," said Jarett Rieger, Senior Director of Moffitt’s Office of Innovation and Industry Alliances and Associate General Counsel. "A huge strength of Moffitt is our ability to form inter-disciplinary research teams, and this exciting research alliance, involving numerous faculty members, is a testament to our team science culture."

Incyte will provide financial support for three research programs over the three year period of the collaboration.

"Incyte and Moffitt are both committed to improving the lives of patients with cancer through the discovery and development of novel medicines. This research alliance will enable new and important research into multiple blood cancers in a manner that both leverages and extends our current drug discovery efforts," stated Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "We are pleased to expand our growing network of academic collaborations and join forces with the world class investigators from Moffitt to advance the landscape of cancer treatment."