On February 16, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported it has entered into an agreement with Stanford University for an option to evaluate and license intellectual property related to the identification of T cell receptors (TCRs) developed in the laboratory of Prof. Mark Davis, Director, Stanford Institute for Immunity, Transplantation and Infection, and The Burt and Marion Avery Family Professor of Immunology at Stanford University School of Medicine (Press release, ImmunoCellular Therapeutics, FEB 16, 2016, View Source [SID:1234509067]).

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Creation of a pure population of T cells, based on targeted screening for specific features, such as affinity to tumor antigens and anti-tumor activity, enables isolation of a single population of TCRs, which can then be sequenced. The DNA from these isolated TCRs can be transferred into stem cells, such as hematopoietic stem cells that are harvested from a cancer patient, with the goal of creating a population of antigen-specific killer T cells that can target and kill tumors. Gaining access to this cutting-edge TCR identification technology has the potential to advance ImmunoCellular’s Stem-to-T-cell program and accelerate the Company’s ability to develop preclinical therapeutic candidates.

"ImmunoCellular’s Stem-to-T-cell program is a valuable asset that has the potential to advance cancer immunotherapy to the next level," said Steven Swanson, PhD, ImmunoCellular Senior Vice President, Research. "Our strategy is to integrate complementary breakthrough technologies by using modified stem cells from the patient to develop antigen-specific killer T cells that can directly attack and potentially eradicate tumors and prevent their recurrence. The option to license Stanford’s technology in this area is a major milestone along the path of advancing a pipeline of novel immune-oncology products."

"We are pleased that our Stem-to-T-cell program is leveraging the work of prestigious academic and medical institutions that include some of the major leaders in cancer stem cell research," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "We intend to continue to expand our program with additional high value collaborations and bring additional promising technologies into ImmunoCellular."

About ImmunoCellular’s Stem-to-T-Cell Program

ImmunoCellular’s dendritic cell-based immunotherapy platform and its Stem-to-T-cell platform represent complementary approaches that lead to the same result: to kill the tumor by creating a population of antigen specific T cells that can specifically recognize and kill cancer cells as well as cancer stem cells.

Dendritic cell-based immunotherapies creates a dendritic cell outside of the patient’s body, using the patient’s own white blood cells which, when reintroduced into the patient’s body, are programmed to find the killer T cells and essentially teach them what to look for in the cancer and kill cancer cells.

In contrast, based on the technology in-licensed from The California Institute of Technology last year, ImmunoCellular’s Stem-to-T-cell program starts with hematopoietic stem cells, harvested from the patient, which are then engineered outside of the patient’s body such that when they are reintroduced, they divide into themselves, and into daughter cells which are antigen-specific killer T cells.

ImmunoCellular’s Stem-to-T-cell program is designed to harness the power of the immune system in highly directed and specific ways to engineer highly antigen-specific tumor killing. At the core of the Stem-to-T-cell technology is harvesting stem cells from cancer patients and then cloning into them T cell receptors that are specific for cancer cells. These engineered stem cells will then be reintroduced into the patient and are pre-programed to produce daughter cells that are antigen specific killer T cells that are capable of identifying, binding to, and killing cancer cells. Because stem cells are immortal, these reengineered stem cells could provide a natural and perpetual source of T cells that can target and destroy cancer cells in the patient.

An important component of the Stem-to-T-cell program is identification and selection of a T cell receptor that is capable of binding to tumor cells. It is this T cell receptor that will be transferred into the hematopoietic stem cell, and that allows the stem cell to produce cytotoxic T cells that can bind and kill tumor cells.

On February 16, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that the Phase 3 clinical trial of VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351) in patients with untreated high-risk (secondary) acute myeloid leukemia (AML) has reached its pre-specified number of events required for the analysis of overall survival (Press release, Celator Pharmaceuticals, FEB 16, 2016, View Source [SID:1234509065]). The company expects to announce overall survival results later this quarter.

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The randomized, controlled, Phase 3 study (Protocol NCT01696084), conducted at 39 centers in the United States and Canada, compared VYXEOS to the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy.

Phase 3 Study with VYXEOS

The study enrolled 309 patients between the ages of 60 and 75 who had pathologically confirmed diagnosis of high-risk AML by WHO criteria including: therapy-related AML, AML with a history of myelodysplasia (MDS), AML with a history of chronic myelomonocytic leukemia (CMMoL), and de novo AML with karyotypic abnormalities characteristic of MDS.

Patients were randomized 1:1 to receive either VYXEOS (100u/m2; days 1, 3, and 5 by 90-minute infusion) or 7+3 (cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3).

The study was conducted in partnership with The Leukemia & Lymphoma Society (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.

On February 16, 2016 Bristol-Myers Squibb Company (NYSE:BMY) and Dana-Farber Cancer Institute reported that they have entered into a research collaboration agreement as part of the Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S (Press release, Bristol-Myers Squibb, FEB 16, 2016, View Source [SID:1234509063]).

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Dana-Farber Cancer Institute is the latest leading, academic-based cancer center to join the I-O RPM program, which is a multi-institutional initiative focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.

"Dana-Farber Cancer Institute and Bristol-Myers Squibb have a shared commitment to patients and to continuing to advance the science in Immuno-Oncology research," said Laura Bessen, MD, head of U.S. Medical, Bristol-Myers Squibb. "We look forward to working with them as part of the I-O RPM program."

"Recent advances in scientific research have shown the great potential of immuno-oncology agents in hematologic cancers, including myeloma," commented Dr. Paul Richardson, Clinical Program Leader and Director of Clinical Research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "We look forward to expanding on these findings through the support of the I-O RPM program with the goal of further improving patient outcomes."

As part of the I-O RPM program, Bristol-Myers Squibb and Dana-Farber Cancer Institute will conduct a range of early phase clinical studies and Bristol-Myers Squibb will support the training of young investigators who contribute to the I-O RPM program at Dana-Farber.

About I-O RPM

Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. The I-O RPM research program focuses on significant areas of high unmet need marked by poor outcomes among patients with rare population malignancies. A rare population malignancy is a subpopulation within a higher incident disease population. These patients have aggressive disease with an increased potential for early metastasis to multiple sites and/or are initially refractory or subject to early recurrences with conventional cancer therapies. Existing clinical research provide a strong rationale for further research into the potential of immunotherapies for these cancers.

The I-O RPM research program is a multi-institutional initiative with Robert H. Lurie Comprehensive Cancer Center of Northwestern University and the Northwestern Medicine Developmental Therapeutics Institute, Moffitt Cancer Center, Johns Hopkins Kimmel Cancer Center and now the Dana-Farber Cancer Institute. I-O RPM builds on Bristol-Myers Squibb’s formation in 2012 of the International Immuno-Oncology Network (II-ON), which is a global collaboration between Bristol-Myers Squibb and academia focused on facilitating the translation of scientific research findings into clinical trials and, eventually, clinical practice.

On February 16, 2016. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, reported that it has signed an agreement with the contract manufacturer EUFETS GmbH for the production and delivery of viral vectors (Press release, MediGene, FEB 16, 2016, View Source [SID:1234509059]).

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EUFETS is an experienced contract manufacturing organisation (CMO) that will take over further process development tasks and vector optimisation processes, the establishment of different cell banks, and the batch production of viral vectors for Medigene’s T-cell receptor (TCR) based cancer therapies.

These viral vectors ("gene ferries") are required for Medigene’s upcoming clinical TCR studies. Viral vectors are non-infectious virus particles that are used for an ex-vivo (outside the body) transfer of T-cell receptor DNA into the patient’s own T cells, equipping these cells with the tumour-specific T-cell receptors selected by Medigene. The modified T cells are then reintroduced into the patient’s body, where they are intended to identify and destroy the cancer cells.

Within the framework of this staggered agreement, EUFETS will also be responsible for the creation of different master cell banks that can produce vectors coding for further TCRs from Medigene’s TCR library. The agreement therefore also ensures the viral vector supply for various future clinical studies.

Prof. Dolores Schendel, CEO and CSO of Medigene, comments on the agreement: "Already last year, when the consortium for the 2016 planned investigator initiated trial on TCRs arranged the viral vector production, we realised that the world’s increased research activities in the field of immunotherapies also involves a growing demand for viral vector production capacities. There are not so many companies worldwide able to provide viral vectors in the quantity and quality required for clinical trials. Hence we are particularly pleased that we won EUFETS as a competent local partner for Medigene, able to assure production capacities for any of our planned TCR studies."

Dr. Klaus Kühlcke, Managing Director of EUFETS GmbH, adds: "At EUFETS we have years of experience in the development and optimisation of high-performance cell cultures and the design and manufacturing of state of the art retroviral vectors. I am particularly happy being able to support Medigene in preparing the planned T-cell receptor-based studies."

About Medigene’s TCR technology: Medigene’s technology for T-cell receptor-modified T cells is one of the company’s highly innovative and complementary immunotherapy platforms for adoptive T cell therapy. The TCR therapy is designed to treat patients with high tumour loads. The clinical development of Medigene’s TCRs is in preparation.

The TCR technology aims at arming the patient’s own T cells with tumour-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumour cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumour-induced immunosuppression, by activating and modifying the patient’s T cells outside the body (ex-vivo). A large army of specific T cells to fight the tumour is made available to patients within a short period of time.

In the scope of this platform, Medigene is developing a comprehensive library of recombinant T-cell receptors. Moreover, a good manufacturing practice (GMP)-compliant process for their combination with patient-derived T cells is currently being established.

Medigene is preparing the clinical development of its first product candidates. In addition, novel TCRs with specificities for promising tumour-associated antigens will be isolated and characterised. In the years ahead, Medigene plans to develop up to 10 lead candidates for the TCR technology, and to initiate up to three clinical TCR trials, the first to be started in 2016 (IIT phase I study with participation of Medigene, subject to grant funding). Medigene-sponsored trials are planned to start in 2017 and in 2018.

Further audio-visual education about Medigene’s TCR technology at: View Source