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.

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

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

On May 11, 2015 CEL-SCI Corporation (NYSE MKT: CVM)("CEL SCI" or the "Company") reported that the Italian Medicines Agency (AIFA) 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 (Press release, Cel-Sci, MAY 11, 2015, View Source [SID:1234506568]). Italy is the 23rd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

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Having surpassed its originally planned milestone of receiving authorization to conduct the Phase 3 study from 21 countries, CEL-SCI is now 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.

Lilly and BioNTech Announce Research Collaboration on Novel Cancer Immunotherapies

On May 11, 2015 Eli Lilly and BioNTech reported they have entered into a research collaboration to discover novel cancer immunotherapies (Press release, Eli Lilly, MAY 11, 2015, View Source [SID:1234504196]). The companies will seek to use the power of the body’s own immune system to attack cancer cells and create possible new treatment options for cancer patients.

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Leveraging the scientific expertise between the two organizations, Lilly and BioNTech will collaborate to identify and validate novel tumor targets and their corresponding T cell receptors (TCRs) in one or more types of cancer. These tumor targets and TCRs may then be engineered and developed into potent and selective cancer therapies.

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Under the terms of the agreement, BioNTech will receive a $30 million signing fee. For each potential medicine, BioNTech could receive over $300 million in development, regulatory and commercial milestones. If successfully commercialized, BioNTech would also be eligible for tiered royalty payments up to double-digits. In addition, subject to the terms of the agreement, Lilly will make a $30 million equity investment in BioNTech’s subsidiary, Cell & Gene Therapies GmbH, which specializes in the research and development of TCR and chimeric antigen receptor immunotherapeutics. Further financial terms were not disclosed.

"In the past few years, we’ve seen some amazing breakthroughs in immuno-oncology; however, we believe these are just the tip of the iceberg," said Greg Plowman, M.D., Ph.D., vice president of Lilly Oncology Research. "Lilly’s partnership with BioNTech represents the next wave of cancer immunotherapy and is focused on the identification of functional T cell receptors that can be used to redirect a patient’s natural immune system to fight cancer."

Ugur Sahin, CEO of BioNTech, said, "We are very pleased to collaborate with a leading oncology company such as Lilly. Lilly’s expertise and track record make it an ideal collaborator for both companies to leverage the full power of BioNTech’s functional T cell receptor technologies to develop novel cancer therapies that harness the immune system." He further added, "This alliance is in line with our strategy to collaborate with companies that have a similar fascination, drive and commitment in developing and commercializing truly innovative and disruptive immunotherapies for the treatment of cancer."

Lilly has a robust oncology pipeline that includes both small molecules and monoclonal antibodies, which are being studied to treat a wide range of cancers including breast, colorectal, liver and non-small cell lung.

8-K – Current report

On May 11, 2015 CEL-SCI 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 (Filing, 8-K, Cel-Sci, MAY 11, 2015, View Source [SID:1234504177]). Spain is the 22nd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

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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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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.

Know more, wherever you are:
Latest on Head and Neck Cancer, book your free 1stOncology demo here.



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.