On December 1, 2014 Calithera Biosciences presented the corporte presentation (Presentation, Calithera Biosciences, DEC 1, 2014, View Source [SID1234535306]).

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On December 1, 2014 Unum Therapeutics, a company developing a universal cellular immunotherapy to treat multiple cancers, announced today that recruitment has begun in the first clinical trial of the ATTCK20 therapy (Press release, Unum Therapeutics, DEC 1, 2014, View Source!2014dec01-unum-starts-phase-1/cyn5 [SID:1234505419]). The Phase I study will examine the feasibility, safety and potential efficacy of infusing the ATTCK20 combination therapy in patients with B-cell malignancies and persistent disease following standard therapy. The clinical program commences shortly after the company’s official launch in October 2014.

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"Despite recent advances in cancer treatments, there are still far too many individuals with B-cell malignancies who die from their disease," said Chuck Wilson, PhD, President & CEO of Unum Therapeutics. "With these unmet medical needs fueling our efforts, we are excited to see the start of clinical testing for ATTCK20. This novel therapy leverages two of the strongest immunotherapy technologies in modern medicine – engineered T-cells and monoclonal antibodies – to target cancer."

ATTCK20 Clinical Trial

Antibody-Targeted Tumor Cell Killing (ATTCK) happens when T-cells expressing an antibody-coupled T-cell receptor (ACTR) engage a tumor-targeting antibody on the surface of a cancer cell. ATTCK20 is a combination of a patient’s ACTR T-cells administered with rituximab, a monoclonal antibody targeting CD20. The first Phase I dose escalation study for ATTCK20 is taking place in Singapore at National University Hospital (NUH) and Singapore General Hospital (SGH). T-cells from patients in the study are processed at the Tissue Engineering & Cell Therapy (TECT) Laboratory at NUH. The Hematology-Oncology Research Group Trial Unit within the National University Cancer Institute, Singapore (View Source) manages and supports all aspects of the clinical trial. At present, the unit is conducting over 60 clinical trials, many of which are Phase I and II studies. The Hematopoietic Progenitor Cell Transplant Program is the only one in Asia accredited by the Foundation for the Accreditation of Cellular Therapy (FACT).

"This study is designed to translate recent laboratory findings into clinical application," said Unum’s Scientific Founder Dario Campana, MD, PhD. "The efficacy of ACTR T-cells shown in our preclinical studies, together with the demonstrated feasibility of infusing autologous T-cells, forms a compelling rationale for the clinical testing of this novel approach. We look forward to enrolling patients in the ATTCK20 study and will continue to plan for additional clinical studies to leverage our ACTR technology with tumor-targeting antibodies in other types of cancer."

ACTR AND ATTCK20

ACTR is a chimeric protein that combines components from receptors normally found on two different human immune cell types – natural killer (NK) cells and T-cells – to create a novel cancer cell killing activity. As reported earlier this year in the journal Cancer Research[1], T-cells bearing the ACTR receptor can be armed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface. CD20 is expressed on cancer cells from many patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Rituximab, an antibody specific for CD20, is currently part of standard therapy for these indications. Studies carried out in Dr. Campana’s laboratory show remarkable enhancement in the activity of rituximab when it is armed with ACTR T-cells.

Unum has built a platform for cancer treatment based upon ACTR. In contrast to other approaches that are limited to a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigen and may have applications for treating many types of cancers. The ATTCK20 study will be the first clinical trial to assess clinical candidates engineered with the ACTR technology.

On Decemebr 1, 2014 ImmunoCellular Therapeutics reported that the European Medicines Agency (EMA) has provided scientific advice supportive of advancing ICT-107 to a registrational phase III program in patients with newly diagnosed glioblastoma (GBM) (Press release ImmunoCellular Therapeutics, DEC 1, 2014, View Source [SID:1234501034]). The EMA guidance is consistent with the positive feedback the Company received from the US FDA relative to the scope, design and endpoints of the program and the inclusion of patients based on HLA and MGMT status. ImmunoCellular intends to finalize the design of the phase III program, ensuring harmony between US and EU trial protocols, with the goal of being in position to initiate the phase III program. The Company now is evaluating options for funding the phase III program, which may enable the initiation in 2015.

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"We appreciate the EMA’s support for conducting a phase III program with ICT-107, and for their detailed guidance on the treatment design and statistical elements of the program," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "The encouragement we have received from both the US and EU regulatory authorities, and from the global neuro-oncology community, increase our confidence in ICT-107’s therapeutic potential for patients with this lethal disease. We intend to complete the design of a high quality phase III program, and to explore appropriate funding alternatives to enable next steps."

Earlier this year, ICT-107 was designated as an Advanced Therapy Medicinal Product by the EU Committee for Advanced Therapies, which should provide access in Phase III to valuable services and incentives offered by the EMA, should the Company conduct the phase III program in the EU.

On December 1, 2014 Calithera Biosciences presented the corporate presentation (Poster, ASH (Free ASH Whitepaper) 2014, Calithera Biosciences, DEC 1, 2014, View Source [SID1234535307]).

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On December 1, 2014 Pharmacyclics reported the acceptance of a Type II variation application for IMBRUVICA (ibrutinib) by the European Medicines Agency (EMA) (Press release Pharmacyclics, DEC 1, 2014, View Source [SID:1234501035]). This submission, filed by strategic partner Janssen-Cilag International NV (Janssen), represents a potential label expansion for IMBRUVICA in the European Union (EU) for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM), a rare type of B-cell lymphoma for which treatment options are limited in the EU. If approved, IMBRUVICA would be the first label specifically authorized to treat WM.

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IMBRUVICA is a first-in-class, oral, once-daily, therapy being jointly developed and commercialized in the United States (U.S.) by Pharmacyclics and Janssen Biotech, Inc. Janssen affiliates will hold the marketing authorization and market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S.

"This additional application in the EU shows the priority and urgency with which we, and our collaboration partner Janssen, pursue the ongoing potential for IMBRUVICA," said Thorsten Graef, M.D., Ph.D., Vice President of Clinical Science, Pharmacyclics. "If approved, IMBRUVICA could address a very important unmet need for patients with WM in Europe, who currently have limited treatment options."

The acceptance of the WM Type II variation submission for IMBRUVICA triggers a $20 million milestone payment to Pharmacyclics under its collaboration agreement with Janssen Biotech, Inc.

The EMA WM filing follows the supplemental New Drug Application submission for IMBRUVICA to the U.S. Food and Drug Administration (FDA), which was submitted by Pharmacyclics in October 2014, for its use in the treatment of patients with WM. Both the FDA and EMA filings were based on data from a Phase II study evaluating the use of IMBRUVICA in WM patients, which was led by Dr. Steven Treon from the Dana-Farber Cancer Institute.

WM is a slow-growing, currently incurable, rare type of B-cell lymphoma for which there are no EU-wide approved drugs. The median age at diagnosis is 63-68 years of age and incidence rates among men and women in the EU are approximately 7.3 and 4.2 per million persons, respectively. WM begins with a malignant change to the B cell, a type of white blood cell (lymphocyte), during its maturation so that it continues to reproduce more malignant B cells.