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.

ImmunoCellular Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, ImmunoCellular Therapeutics, MAY 11, 2015, View Source [SID1234504210]).

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Intrexon has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Intrexon, MAY 11, 2015, View Source [SID1234504211]).

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Karyopharm has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Karyopharm, MAY 11, 2015, View Source [SID1234504215]).

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On May 11, 2015 Elasmogen Ltd, the University biologics drug discovery company and Almac Discovery, a pharmaceutical company focused on identifying and developing innovative therapeutics for the treatment of cancer, reported that they have entered into an agreement to co-develop Elasmogen technology for the treatment of solid tumours (Press release, Elasmogen, MAY 11, 2015, View Source [SID1234637767]).

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Under the terms of the agreement Elasmogen and Almac will jointly manage the research and development activities aimed at developing a drug candidate to an undisclosed target. Both parties will share costs, with Almac being responsible for commercialisation.

Dr Caroline Barelle CEO and Scientific Officer of Elasmogen, said: "We are very excited about combining the expertise of our two research teams to deliver an effective therapy for patients." Dr Barelle will announce the new collaboration at BioTrinity 2015 in London tonight, 11 May 2015, which is a high profile gathering of Europe’s biotechnology, pharmaceutical and investor community.

Dr Stephen Barr, President Almac Discovery, added: "We are always looking for novel science to drive the next steps in drug development and we feel that the soloMERTM concept could be the next scientific step forward in drug conjugate approaches."

soloMERsTM are humanised versions of antibody-like proteins that were first discovered in sharks. They are chemically robust molecules that tolerate drug conjugation well. It is believed that soloMERsTM bind specifically to the cancer tissue and will penetrate inside the tumour before releasing their war-head of anti-cancer drugs, maximising the damage to the tumour and minimising the toxic effects to healthy tissues.

We are very excited about combining the expertise of our two research teams to deliver an effective therapy for patients."
Dr Caroline Barelle, CEO and CSO of Elasmogen
In February the Elasmogen team, which is part of the Scottish Biologics Drug Discovery Facility at the University of Aberdeen, further strengthened its global intellectual property (IP) position with the granting of a patent in the US, underpinning the generation of its VNAR protein drugs developed from sharks.

Dr Barelle currently leads the team of senior research scientists developing novel biologic therapeutics based on soloMERsTM. Her previous roles include Head of Single-Domain antibody Development at Pfizer and Wyeth where she led the teams isolating and progressing leads through to late pre-clinical assessment. Prior to this she was Programmes Manager at the antibody engineering company, Haptogen Ltd, acquired by Wyeth in 2007.