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

On February 15, 2016 Amgen (NASDAQ:AMGN) reported that the randomized, double-blind, placebo-controlled Phase 3 Aranesp (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk MDS at the end of the blinded 25-week study period(Press release, Amgen, FEB 15, 2016, View Source [SID:1234509057]). Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication.

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Safety data was consistent with the known safety profile of Aranesp, and the adverse events were generally balanced between treatment arms. The adverse events reported in the Aranesp arm at least five percent more frequently than in the placebo group were fatigue, pyrexia, headache and myalgia.

MDS is among the most common type of bone marrow failure syndromes in adults.1 The disease occurs when immature blood cells do not mature in the bone marrow. Patients with MDS have fewer healthy white blood cells, red blood cells and platelets, and are at risk of infection, anemia or bleeding.2 Current treatments for MDS include blood transfusions, chemotherapy and stem cell transplants.

"We are pleased to see positive results from this study, as anemia treatment options for myelodysplastic syndrome are limited and can place a significant burden on patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

About the ARCADE Study
The Phase 3 ARCADE trial was a multicenter, randomized, double-blind, placebo-controlled study evaluating Aranesp in 146 patients with low or intermediate-1 risk MDS who had not previously taken ESAs or biologic response modifiers. During a 24-week period, patients received either Aranesp 500 μg (n=97) or placebo (n=49) every three weeks. At week 25, when the primary and key secondary endpoints were assessed, patients underwent an end-of-treatment period (EOTP) visit and could subsequently enter a 48-week active treatment period where all participants crossed over to receive Aranesp, with dose escalation allowed beginning on week 31. Treatment continued until week 72 or 73, and long-term follow up continues to occur every 26 weeks, for a minimum of three years.

About MDS
MDS affects more than 30,000 people in the United States annually.1 People undergoing certain types of chemotherapy or radiation treatment for cancer may be at increased risk of developing treatment-related MDS.3 Patients with MDS affecting red blood cells often experience anemia.4

About Aranesp (darbepoetin alfa) in the U.S.
Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Limitations of Use:
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:

In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
Important U.S. Safety Information for Aranesp
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.
Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions.
Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
Use ESAs only for anemia from myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs, or serious allergic reactions to Aranesp.

Use caution in patients with CKD and coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks. In controlled clinical trials of patients with cancer, Aranesp and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Control hypertension prior to initiating and during treatment with Aranesp.

Aranesp increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.

For lack or loss of hemoglobin response to Aranesp, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp is not approved). If severe anemia and low reticulocyte count develop during treatment with Aranesp, withhold Aranesp and evaluate patients for neutralizing antibodies to erythropoietin. Permanently discontinue Aranesp in patients who develop PRCA following treatment with Aranesp or other erythropoietin protein drugs. Do not switch patients to other ESAs.

Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp. Immediately and permanently discontinue Aranesp if a serious allergic reaction occurs.

Adverse reactions (≥ 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Adverse reactions (≥ 1%) in Aranesp clinical studies in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.

To see the Aranesp Prescribing Information, including Boxed Warnings, and Medication Guide visit www.aranesp.com.