On April 2, 2015 Coronado Biosciences reported it has formed a new subsidiary company, DiaVax Biosciences, to develop novel immunotherapies for the prevention and treatment of cytomegalovirus (CMV), a common virus that affects people of all ages (Press release, Coronado Biosciences, APR 2, 2015, View Source;FID=1500070190 [SID:1234503562]). According to the U.S. Centers for Disease Control and Prevention (CDC), while CMV is typically asymptomatic in healthy individuals, it can cause serious, often life-threatening disease in those with weakened or uneducated immune systems (including developing fetuses exposed to the virus in utero).

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The licensed immunotherapies were developed in the laboratory of Don J. Diamond, Ph.D., Chair of the Department of Experimental Therapeutics at City of Hope National Medical Center in Duarte, California. Dr. Diamond will chair the Scientific Advisory Board of DiaVax. Under the agreement with City of Hope, DiaVax secured worldwide rights to two T-cell immunotherapeutic vaccines for controlling CMV in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. Known as Triplex and PepVax, the programs are expected to enter Phase II clinical studies later this year and are supported by grants from the National Cancer Institute. In connection with the licensing of Triplex and PepVax, DiaVax further entered into an option agreement with City of Hope for exclusive worldwide rights to Pentamer, a universal immunotherapeutic vaccine being developed for the prevention of CMV transmission in utero. If DiaVax exercises its option, and successfully develops and commercializes PepVax, Triplex and Pentamer, City of Hope could receive in excess of $100MM in upfront, milestone and other payments.

Dr. Lindsay A. Rosenwald, Chairman and CEO of Coronado Biosciences, stated, "We are pleased to enter into this collaboration with City of Hope and Dr. Don Diamond. Studies have shown that CMV reactivation in HSCT recipients is linked to low levels of CMV-specific CD8+ T-cells. The vaccines we have licensed represent a promising new T-cell-based, immunotherapeutic approach for controlling CMV in patients with weakened immune systems, particularly those undergoing bone marrow and solid organ transplants. Current antiviral therapies used in this context are often toxic and merely suppress CMV during treatment. An effective vaccine could educate the body’s immune system to fight CMV. We look forward to commencing Phase II studies later this year."

George Megaw, City of Hope’s Director of the Office of Technology Licensing stated, "We are thrilled to partner with Coronado Biosciences on the formation of DiaVax Biosciences and the advancement of these exciting CMV immunotherapies. The executive team at Coronado has an impressive track-record of designing and executing clinical studies across multiple therapeutic areas in a diligent and effective manner. We are confident this collaboration will further the mission of City of Hope to alleviate human suffering and disease, particularly as it relates to CMV."

On April 1, 2015 Cancer Research Technology (CRT) reported that a group of academic organisations and funders has entered an agreement with biopharmaceutical company Basilea Pharmaceutica Ltd. to progress a new family of cancer drugs designed to block several key cancer-causing proteins at once (Press release, Cancer Research Technology, APR 1, 2015, View Source [SID1234523207]).

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The consortium, including The Institute of Cancer Research, London, the Wellcome Trust, Cancer Research Technology (CRT) and The University of Manchester, has granted Basilea exclusive worldwide rights to develop, manufacture and commercialise novel panRAF inhibitors.

The new drug class originated from research at The Institute of Cancer Research (ICR) funded by Wellcome Trust and Cancer Research UK.

The drugs have the potential to be used where a patient’s tumour has developed resistance to existing drugs targeting the BRAF protein, which is mutated in a range of cancers including 50% of melanomas and 10% of bowel cancers.

The drugs target both BRAF and the growth pathways that the cells come to rely on when they become resistant. It is hoped that the new drugs could be effective in patients who have developed drug resistance and exhausted all other available treatments.

Under the terms of the agreement, the consortium will lead phase I clinical development of the new drug, and Basilea will take over responsibility for clinical development after that. In return, the consortium will receive an upfront payment, and potentially milestone payments and royalties if the development of the drug is ultimately successful.

A phase I clinical trial is expected to start later this year at The Royal Marsden NHS Foundation Trust and The Christie NHS Foundation Trust in Manchester. The trial will be funded by the Wellcome Trust, the NIHR Biomedical Research Centre at The Royal Marsden and the ICR, and The Christie charity.

Professor Caroline Springer, Professor of Biological Chemistry at The Institute of Cancer Research, London, said:

"I’m delighted by today’s announcement, which is excellent news for research into treatments for drug-resistant cancers. The agreement provides the foundation for the clinical development of this exciting new drug class. It is an important milestone in efforts to tackle resistance to existing cancer therapies and provide new options for cancer patients."

Dr Richard Seabrook, Head of Business Development at the Wellcome Trust, said: "Resistance to existing cancer drugs can be a tragedy for patients. By targeting multiple cancer-causing proteins, these new panRAF inhibitors could help overcome this problem and have the potential to be of great value in the clinic."

Dr. Laurenz Kellenberger, Basilea’s Chief Scientific Officer, said: "We are excited about complementing our growing and maturing oncology pipeline with this novel program including a lead compound expected to enter clinical testing in 2015. The available data show that this novel class of panRAF inhibitors are active in tumours which have developed resistance to currently available RAF kinase inhibitors and have the potential to offer new treatment options for melanoma as well as additional cancer indications."

Professor Richard Marais, Director of the Cancer Research UK Manchester Institute at The University of Manchester said:

"This agreement represents the culmination of over 10 years of academic research and we are pleased to see our basic research studies being translated into patient benefit. Melanoma is a devastating disease that kills over 2,000 people each year in the UK and we hope that these new drugs will provide new lines of treatment for these patients."

Dr Keith Blundy, Chief Executive of Cancer Research Technology, said: "It’s always very rewarding to see a discovery involving Cancer Research UK funding making that vital first step into the clinic. This agreement is a great example of leading academic and clinical institutions working together with industry and the NHS to translate exciting new discoveries into new treatments that could benefit patients."

On April 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) reported that in March it has enrolled 29 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) (Press release, Cel-Sci, APR 1, 2015, View Source [SID:1234506998]). March marks the third consecutive month of record enrollment for CEL-SCI this year following January and February, 2015. 406 patients have been enrolled in the Phase III study as of March 31, 2015.

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"The accelerating pace of enrollment in our trial is very good. We expect to see continued increases in monthly patient enrollment throughout the year as new clinical centers are added and as existing centers gain more experience with Multikine," stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. 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 III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would 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. CEL-SCI’s Clinical Research Organization, who runs the study for CEL-SCI, is aiming to complete enrollment of about 880 patients to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in over 25 countries.

In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop 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.

Cancer, pancreatic; Cancer, solid, general
It is in a Phase I clinical trial in all solid tumors with expansion to pancreatic cancer (Company Pipeline, Apogee Biotechnology, MAR 31, 2015, View Source [SID:1234502922]).

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On March 31, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") reported that it has agreed to transfer its discovery library of roughly 100,000 unique compounds to the South Carolina Center for Therapeutic Discovery & Development (the Center) pursuant to a just concluded Material Transfer Agreement (Press release, AEterna Zentaris, MAR 31, 2015, View Source;q=651 [SID:1234506615]). This Agreement represents the beginning of a long-term relationship between the Company and the Center, which is part of The Medical University of South Carolina (MUSC), that will result in the continued use of the library for the discovery of drug development candidates for the Company in the areas of oncology, neurology, endocrinology and women’s health. The Center may make the library available to all investigators in the University of South Carolina system without restriction on its use and will own any therapeutic compounds discovered outside the Company’s areas of therapeutic interest.

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The Center has agreed to conduct screening and pre-clinical activities with respect to the library with a view toward submitting to the Company at least one development candidate in its areas of therapeutic interest per year during a ten-year period beginning in 2018. The Company will receive the right of first refusal to license the development candidates.

Should the Company decide to further develop a development candidate submitted by the Center, MUSC will license the compound candidate to the Company, and be entitled to a royalty on the net sales of all commercialized products developed from the development candidate.

However, should the Company decide not to further develop the development candidate submitted by the Center, MUSC shall pay to the Company a royalty on net sales of all commercialized products developed from the development candidate.

David Dodd, Chairman and CEO at Aeterna Zentaris stated, "This agreement with MUSC is another concrete step in our strategy of streamlining our internal drug discovery programs in order to focus our resources on our late-stage clinical programs, as well as on our commercial activities. This agreement will therefore make it possible to continue drug discovery activities without the costs and risks that they imply. More importantly, it is in line with our overall strategy of transitioning into a commercially operating specialty biopharmaceutical company. We look forward to working with the Center and MUSC, with which we have already established a close collaboration for our ZoptEC Phase 3 trial in endometrial cancer."

Karen Lackey, Director of the MUSC Center for Drug Discovery, added, "The ongoing research at MUSC is outstanding in basic, translational, and clinical sciences, focused on understanding disease processes. The transfer of this high quality collection of drug-like compounds will significantly increase our opportunities to find new medicines through sophisticated screening mechanisms. The Center’s mission is to discover and develop effective medicines in diseases that currently lack viable treatment options."