10-Q – Quarterly report [Sections 13 or 15(d)]

Juno has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Juno, MAY 11, 2015, View Source [SID1234504238]).

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Medigene announces milestone payment in phase I/II trial with dendritic cell (DC) vaccines for AML

On May 11, 2015 Medigene AG (MDG1, Frankfurt, Prime Standard) reported that the progress achieved in its recently initiated clinical phase I/II trial with dendritic cell (DC) vaccines for the treatment of acute myeloid leukaemia (AML) gives rise to a milestone payment amounting to EUR 700,000 to former contributing shareholders of Medigene Immunotherapies GmbH (formerly: Trianta Immunotherapies GmbH) to be made within the next five months (Press release, MediGene, MAY 11, 2015, View Source [SID:1234506569]). Medigene intends to settle this payment through the issuance of new shares from authorised capital. The number of new shares will be calculated based on the average value of Medigene’s share price over the 30 days both before and from today’s announcement. The milestone payment was an agreed part of the purchase price in the acquisition of Trianta in January 2014.

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Medigene’s phase I/II multi-centre, open-label trial will include a total of 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene’s DC vaccines. To date, the first patients have been enrolled and a number of additional patients have been identified for inclusion in the trial. The primary objective is to prove feasibility and safety of active immunotherapy with Medigene’s DCs. Secondary objectives are induction of immune responses, control of minimal residual disease (MRD) and clinical response/time to progression (TTP).

Dr Frank Mathias, Chief Executive Officer (CEO) of Medigene AG, comments: "Reaching this milestone is once again proof of the progress Medigene has made since acquiring Trianta. The start and continuation of the clinical phase I/II trial enables us to further validate our new generation of DC vaccines in the clinic and will therefore contribute to the intrinsic value of this technology and our company."

Further studies utilizing Medigene’s DC vaccine technologies include two ongoing clinical investigator-initiated trials (IITs), a clinical phase II trial (prostate cancer) at Oslo University Hospital and a clinical phase I/II trial (AML) at the Ludwig-Maximilians University Hospital Großhadern, Munich, as well as a compassionate use programme[1] including patients with diverse malignancies.

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the three highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies.

Medigene’s dendritic cell product platform allows the design of new generation dendritic cell vaccines. Dendritic cells can take up antigens efficiently, process them and present them on their surface in a form that can induce antigen-specific T cells to proliferate and mature. This way T cells can recognize and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to become active and attack tumour cells. Scientists of Medigene Immunotherapies have developed new, fast and efficient methods for preparing autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells. The dendritic cells can be loaded with various tumour antigens to treat different types of cancer and are designed for treatment of minimal residual disease or use in combination therapies.

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

10-Q – Quarterly report [Sections 13 or 15(d)]

Halozyme has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Halozyme, MAY 11, 2015, View Source [SID1234504206]).

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CEL-SCI RECEIVES AUTHORIZATION TO CONDUCT ITS PHASE 3 MULTIKINE TRIAL IN SPAIN

On May 11, 2015 CEL-SCI Corporation (NYSE MKT: CVM)("CEL SCI" or the "Company") reported that Spain’s Agency for Medicinal Products and Medicinal Devices has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. Spain is the 22nd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment (Press release, Cel-Sci, MAY 11, 2015, View Source [SID:1234506570]).

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CEL-SCI recently announced it had reached a key milestone of receiving authorization to conduct the Phase 3 study from 21 countries, as originally planned. The Company is aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 2015, 437 patients had been enrolled in the global Phase 3 study.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

10-Q – Quarterly report [Sections 13 or 15(d)]

Ignyta has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Ignyta, MAY 11, 2015, View Source [SID1234504208]).

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