Vaccine Research Center Seminar Series, Winter 2012

Vaccine Research Center Seminar Series, Winter 2012:

• Jan 24 Jeff Cohen NIAID, NIH - Herpes simplex virus 2 vaccines: Beyond glycoprotein
• Jan 31 Chris Walker Ohio State University - Immune control of persistent hepatitis C virus infection
• Feb 7 Fred Alt Harvard University - High throughput analysis of mechanisms that influence chromosomal rearrangements and translocations in lymphocytes
• Feb 14 Jim Crowe Vanderbilt University - Genetic and structural complexity of human antibody repertoires
• Feb 21 Ed Mocarski Emory University - Caspase-8 and RIP3-dependent death pathways: lessons from Cytomegalovirus
• Feb 28 Pat Earl NIAID, NIH - Small animal models of lethal injection for studying monkeypox virus
• Mar 6 Robin Shattock St. George’s Hosp., Univ. London - Vaginal antibodies as a determinant of HIV susceptibility
• Mar 13 Charles Mackay Monash University - Dietary and microbiome influences on gut health and inflammatory disease
• Apr 10 Rick Blumberg Brigham and Women’s Hospital - The immunological functions of the (not so) neonatal FcR for IgG
• Apr 17 Gepi Pantaleo University of Lausanne - T-cell immunity in HIV infection and vaccine development

For more information, please see http://vrc.nih.gov/cgi-shl/vrc/seminars.cfm

Sinovac Begins the Phase III Clinical Trial for its EV71 Vaccine Against Hand, Foot and Mouth Disease

Sinovac Biotech Ltd.begins the phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD). The Phase II trial, completed in November 2011, confirmed favorable safety and tolerance profiles, and good immunogenicity. According to the results of phase II clinical trial, the formulation of 400U with aluminum adjuvant was selected to be used in phase III clinical trial to evaluate the efficacy of Sinovac’s EV71 vaccine in protecting against HFMD. The Phase III clinical trial is expected to enroll up to 10,000 healthy volunteers with ages 6-35 months, and was designed as a randomization, double blinded, placebo controlled study. The vaccination schedule calls for two shots at 0 and 28 days. Sinovac anticipates the trial to be completed in the first half of 2013.

U.S. Military Research Center Develops Breast Cancer Vaccine

Military researchers here have developed a cutting-edge cancer vaccine that’s slashing breast cancer recurrence rates and giving some survivors a better shot at a cancer-free future. After more than a decade of research and testing, the cancer vaccine, dubbed E-75, soon will move on to its final phase of testing to earn Food and Drug Administration approval, said Army Col. (Dr.) George E. Peoples, director and principal investigator for the Cancer Vaccine Development Program at San Antonio Military Medical Center.

Promise of Lifetime Flu Vaccine

SEEK, a UK privately-owned drug-discovery group, reports preliminary successful trials of a new vaccine that provides lifetime protection against all influenza strains after single vaccination. The Seek’s press release says that the Universal Flu vaccine could be available for use in the next 3-5 years.

The 2012 Integrated Medical, Public Health, Preparedness and Response Training Summit, May 21-25, 2012 Nashville, Tennessee

The 2012 Integrated Medical, Public Health, Preparedness and Response Training Summit will be held May 21-25 in Nashville, Tennessee. This training summit brings together HHS partners including the National Disaster Medical System (NDMS), the Medical Reserve Corps (MRC), the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), and the United States Public Health Service (USPHS). The Integrated Training Summit is co-sponsored by the Chesapeake Health Education Program, Inc (CHEP). The 2012 Integrated Medical, Public Health, Preparedness and Response Training Summit is sponsored by the U.S. Department of Health and Human Services (HHS).

Business Strategies for Biologics: Positioning and Partnering for the Biopharmaceutical Evolution, October 5-6 2011, Boston, Massachusetts

Business Strategies for Biologics: Positioning and Partnering for the Biopharmaceutical Evolution will be held hosted October 5-6th, 2011 in Boston, Massachusetts. The two day conference will cover on-trend topics regarding the future of pharma, sourcing strategies for biologics, regulatory challenges, and opportunities in biosimilars. Speakers will include senior personnel from Merck, Novartis, Pfizer, Sanofi, Genentech/Roche, and Boehringer Ingelheim.

Kite Pharma Raises $15 Million

Kite Pharma, Inc., a biopharmaceutical company focused on developing innovative active immunotherapies for cancer, today announced that it has raised $15 million in an initial round of financing through a private placement with a syndicate of venture and qualified investors. Riverbank Capital Securities Inc., a FINRA member broker dealer, acted as placement agent in connection with the financing.

Active immunotherapy is an emerging therapeutic modality for the treatment of multiple cancer indications. Kite Pharma, Inc. is a privately held development stage biotechnology company engaged in the design and development of cutting-edge immunotherapeutic products to treat different cancer indications. Kite’s lead products include antigens associated with a wide variety of tumor types, and are initially being developed for the treatment of renal cell carcinoma and hepatocellular carcinoma. These potential therapies are designed to stimulate a patient’s own immune system to help fight cancer and could represent novel strategies for the management and treatment of these otherwise incurable diseases. Kite is based in Los Angeles, CA.

HHS releases new strategic plan to advance vaccine and immunization science and policy for the next decade

The U.S. Department of Health and Human Services today unveiled a new National Vaccine Plan to enhance coordination of all aspects of federal vaccine and immunization activities. Its goal is to ensure that all Americans can access the preventive benefits of vaccines.

The plan is a wide-ranging guide to innovating the nation’s vaccine system. It addresses such issues as research and development, supply, financing, distribution, safety, global cooperation, and informed decision-making among consumers and health care providers.

This is the first update of the National Vaccine Plan since the original version in 1994.

“Vaccines are a critical cornerstone of the public health system,” said Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. “The National Vaccine Plan articulates a vision that will ensure that the nation’s prevention strategies protect the public for the next decade and beyond.”

Despite the success of vaccines in reducing death and disability over the last century, many Americans still suffer from infectious diseases that can be prevented by vaccines. The plan offers innovative approaches to improve delivery of existing vaccines and to spur development of new products to prevent infectious disease.

The National Vaccine Plan is the product of an extensive stakeholder feedback process. It integrates input from public health and medical experts, a wide range of federal, state and local government officials, and perhaps most importantly, the public.

“This plan is a 10-year vision for the nation to more effectively prevent infectious diseases and reduce adverse reactions to vaccines,” said Director of the National Vaccine Program Office and Deputy Assistant Secretary for Health Bruce Gellin, M.D., M.P.H. “The plan is national in scope. Implementation will require a well-organized effort among stakeholders, including federal, state and local policymakers, health care providers, manufacturers, academia, philanthropic organizations, and the public.”

Next steps include a series of regional meetings with stakeholders in the spring and summer of 2011, which will focus on how to implement the strategies laid out in the National Vaccine Plan. The final implementation plan will be completed by the end of 2011.

BARDA Supports Next Steps for a New Antiviral Drug for Smallpox

A $24.8 million federal contract will support development a new antiviral drug to treat smallpox. The Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, will fund the contract with Chimerix, Inc., of Durham, N.C. The contract can be renewed for up to four additional years for a five-year total of up to $81.1 million.

Routine smallpox vaccination ended in the United States in the early 1970s so people born after routine vaccination ended are not immune to the disease. The World Health Organization declared the disease eradicated worldwide in the 1980s. The variola virus, which causes smallpox, is kept only at the two WHO-approved repositories in the United States and Russia for limited use in research. If the virus were used in a bioterrorism attack, the U.S. government estimates that up to 1.7 million people or more could need treatment before the disease could be controlled through vaccination.

Although the Strategic National Stockpile includes smallpox vaccine, vaccines only protect against disease if a person is vaccinated before or very soon after being exposed to the virus. If further development efforts are successful, CMX-001 could be available to treat people who already have smallpox symptoms. In addition, the medication potentially could be used to treat other virus infections, such as adenovirus, cytomegalovirus, and BK virus, in people with severely weakened immune systems.

The contract uses the federal government’s new approach to producing medical countermeasures – the medications, vaccines, medical equipment and supplies needed for a health emergency. On Aug. 19, HHS Secretary Kathleen Sebelius released an examination of the federal government’s system to produce medical countermeasures, along with recommendations for a better approach. The recommendations included developing dual-use drugs – drugs that can be used for bioterrorism as well as for other illnesses – and to develop more countermeasures that are safe for children, the elderly, and other vulnerable populations such as those with compromised immune systems.

Under the contract, Chimerix will continue developing CMX-001, conduct studies to show that the drug is safe and effective and that the manufacturing process is adequate to ensure the quality of the drug. This work is required for the company to apply for approval of the drug through the U.S. Food and Drug Administration.

Next Generation Vaccines Conference, October 21-22 2010,Vienna, Austria

The vaccine market represents an increasingly attractive segment characterized by promising vaccine candidates, rising global demand and preparations for the next pandemic influenza. Future potential of the vaccine market will be discussed at Jacob Fleming’s Next Generation Vaccines Conference, taking place in Vienna, Austria on 21st – 22nd October. The latest developments in the prophylactic and the therapeutic segment will be explored. Optimization of clinical trials performance, overcoming challenges in launching new vaccine candidates and much more will be discovered.

Delegates will have a chance to become a part of real-life case studies delivered by industry professionals of the best contract manufacturers and by the WHO’s Director of Vaccine Project Optimization who will reveal best practices of manufacturing and distribution.

Top vaccine experts such as Gerd Zettlmeissl, the CEO of Intercell and the winner of the Vaccine Industry Excellence Award of 2010, Danilo Casimiro, the Director of Viral Vaccine Research of Merck, Dr Farshad Guarikhoo, the Senior Director of External Research and Development of Sanofi Pasteur and Ed Geuns, the Head of Global Regulatory Affairs Liaison Vaccines of Abbott Biologicals will provide delegates with overall walkthrough of the whole Vaccine Value Chain.

The special feature of this event is an interactive Workshop day, held on 20th October. Workshop will include three unique sessions with a strong focus on accelerated process development, excellence in the proof-of concept clinical trials and vaccine manufacturing challenges.

How to obtain funding & financing for vaccines?
What are the main issues in establishing industry partnership?
And how to provide vaccination against influenza on a large scale?

All these and many other questions will be answered by Dr Jerald C. Sadoff, the experienced CMO of Crucell, Dr Hansi Dean and Dr Philip Dormitzer, the Head of the Viral Advanced Programs of Novartis.
For further information and to book your place at the event, please contact:

Peter Novak
T: +421 257 272 110
E: peter.novak@jacobfleming.com
W: www.jacobfleming.com