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

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."

On June 01, 2016 Portola Pharmaceuticals Inc. (NASDAQ:PTLA), reported that it recently dosed the first patient in a Phase 2a study that is evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell and T-cell malignancies who have failed multiple therapies (Press release, Portola Pharmaceuticals, JUN 1, 2016, View Source [SID:1234512916]). Cerdulatinib is an oral, dual Syk/JAK kinase inhibitor in development to treat patients with resistant or relapsed hematologic cancer. Cerdulatinib inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies.

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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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Portola recently completed a Phase 1 study of cerdulatinib, which identified the maximum tolerated dose. Pharmacokinetic and pharmacodynamic outcomes data from the Phase 1 study will be presented in a poster session at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016, which is taking place from June 3-7 in Chicago. Final results of the Phase 1 study, as well as data from two other cerdulatinib studies, will be presented in poster and e-poster sessions at the European Hematology Association (EHA) (Free EHA Whitepaper) 21st Annual Congress, which is taking place from June 9-12 in Copenhagen.

The cerdulatinib ASCO (Free ASCO Whitepaper) abstract is available at abstracts.asco.org and the EHA (Free EHA Whitepaper) abstracts are available at http://bit.ly/1U852D2. Details regarding the poster and e-poster presentations, which will include additional data not available in the abstracts, follow.

ASCO Annual Meeting 2016

Abstract Title (abstract #7557/poster board #113): Cerdulatinib (PRT062070): A dual SYK/JAK inhibitor in patients with relapsed/refractory b-cell malignancies — Pharmacokinetic and pharmacodynamic outcomes with twice-daily (BID) vs once-daily (QD) dosing
Presenting Author: Paul A. Hamlin, M.D., medical oncologist, Memorial Sloan Kettering Cancer Center
Poster Session Title: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster Presentation Date and Time: Monday, June 6, 8:00-11:30 a.m. Central Time
Location: McCormick Place, Hall A
EHA 21st Congress

Abstract Title (abstract #LB2252): Phase 1 final results and Phase 2a dose selection for cerdulatinib (PRT062070), a dual Syk/JAK inhibitor in patients with relapsed/refractory B-cell malignancies
Session Title: Chronic lymphocytic leukemia and related disorders — Clinical
E-poster Presentation Date and Time: Friday, June 10, 9:30 a.m.-Saturday, June 11, 7 p.m. CEST
E-Poster Location: Bella Center, Hall H

Abstract Title (abstract #E1017): Combined SYK and JAK inhibition by cerdulatinib induces apoptosis in CLL and overcomes resistance to ibrutinib
Session Title: Chronic lymphocytic leukemia and related disorders — Biology
E-poster Presentation Date and Time: Friday, June 10, 9:30 a.m.-Saturday, June 11, 7 p.m. CEST
Location: Bella Center, Hall H

Abstract Title (abstract #P590): The SYK/JAK inhibitor cerdulatinib shows promising in vitro activity in chronic lymphocytic leukemia
Session Title: Genomic complexity in CLL
Poster Presentation Date and Time: Saturday, June 11, 5:30-7:00 p.m. CEST
Location: Poster Area, Hall H