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Clinical Development of Therapeutic Vaccines Conference - Day 1


Clinical Development 11 Header


Day 1 | Day 2 | Download BrochureShort Course

Join the leaders of vaccine development as they address the clinical challenges facing therapeutic vaccine development, including patient selection, international outsourcing for trial completion, and navigating regulatory approval. Clinical development of these products include the use of novel clinical trial designs, identification of patient populations as well as addressing regulatory concerns. Experts from industry and academic development centers will meet to learn new strategies, network with colleagues, participate in informal roundtable discussion groups, and address crucial topics.

Wednesday, August 17

12:15 pm Registration

1:40 Chairperson’s Remarks

Stephen Litwin, Ph.D., Senior Consultant, Biologics Consulting Group

Opening Keynote Presentation

1:50 Modulating the Inhibitory Arm of the Immune System, Novel Strategies for Developing Therapeutic Vaccines

Samir Khleif, M.D., Head, Cancer Vaccine Section, Vaccine Branch, National Cancer Institute, NIH

 

CANCER VACCINES

2:30 An Introduction to Clinical Development of Therapeutic Vaccines

Stephen Litwin, Ph.D., Senior Consultant, Biologics Consulting Group

This talk will give a short introduction into the current and rapidly changing state of affairs of therapeutic vaccines, the FDA role as it is counterpoised with Oncology requirements, the distinctive features of the biology of these putative agents and as a consequence the extant hurdles and their possible remedies. A number of examples will illustrate current issues.

3:00 Patient Selection For Therapeutic Anti-Cancer Vaccine Trials

James L. Gulley, M.D., Ph.D., F.A.C.P., Director, Clinical Trials Group, Laboratory of Tumor Immunology and Biology & Principal Investigator, Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, NIH

3:30 Ice Cream Bar Refreshment Break with Exhibit and Poster Viewing

4:15 Patient Selection & Successful Outcomes

John Rothman, Ph.D., Executive Vice President, Science & Operations, Advaxis, Inc.

Patient selection is the key to a successful trial. In the recent past it was believed that immunotherapy was almost devoid of toxicity, but now we know that technologies that invoke strong immune responses may have risks that will not allow for certain types of patients to be treated. The patient selection process must evolve with experience. This talk discusses the use of a live bacterial vector engineered from a pathogen, the limitations this places on the patient selection process, and how patients are screened.

4:45 Inducing Immune Response by Targeting T Cells to Her2 and CD20 Positive Targets with Bispecific Antibodies

Lawrence G. Lum, M.D., D.Sc., Professor of Oncology, Medicine, and Immunology and Microbiology; Scientific Director of BMT and Immunotherapy, Barbara Ann Karmanos Cancer Institute

Activated T cells can be armed with bispecific antibodies directed at different tumor associated antigens. Our clinical trials suggest that infusions of targeted T cells induce “vaccine” responses to the patient’s tumors. The presentation will illustrate how bispecific antibodies targeting Her2 and CD20 can enhance targeting and cytotoxicity. Early phase I trial data will be presented.

5:15 Vaccination with Listeria Monocytogenes Controls Immune Suppression by MDSC and Metastatic Behavior of Breast and Pancreatic Cancer

Claudia Gravekamp, Ph.D., Associate Professor, Albert Einstein College of Medicine

Listeria infects both monocytic (m) MDSC and granulocytic (g) MDSC, but multiplies in a subpopulation of mMDSC only, and uses them for its delivery at the tumor site, where Listeria infects and kills tumor cells directly. Survival of Listeria in the tumor microenvironment is possible because mMDSC at the tumor site are highly immune suppressive and protect Listeria from immune clearance, while in normal tissues there is no immune suppression and therefore Listeria will be immediately cleared by the immune system. These results strongly results suggest that Listeria could be used for the selective delivery of any anti-cancer agent into the tumor microenvironment, without having an effect on normal tissues. Currently, we are analyzing whether Listeria also multiplies in human MDSC and whether Listeria polarizes immune suppressing human MDSC into an immune-stimulating phenotype in blood of cancer patients and healthy individuals.

5:45 Close of Day

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