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Clinical Development of Therapeutic Vaccines Conference - Day 2

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Thursday, August 18

7:30 am Morning Coffee (Breakfast Sponsored Presentation – Opportunity Available)

8:25 Chairperson’s Remarks

8:30 Talk Title to be Announced

Andrew T. Parsa, M.D., Ph.D., Associate Professor in Residence of Neurological Surgery, Reza & Georgianna Khatib Endowed Chair in Skull Based Tumor Surgery; Principal Investigator, Brain Tumor Research Center, University of California, San Francisco

9:00 Development of Vaccination Strategies in Leukemia Using WT1 as an Ideal Target Antigen

Katy Rezvani, M.D., Ph.D., M.R.C.P., FRCPath, Clinical Senior Lecturer, Consultant Haematologist, Imperial College London

We have initiated a multi-center Phase II clinical trial, employing pDOM WT1 DNA vaccine as an ‘ideal’ target antigen, in patients with acute and chronic myeloid leukemia with minimal residual disease following ‘conventional’ therapy with clearly defined endpoints involving quantitative measurements of leukemia-specific transcripts such as BCR-ABL as well as immunological monitoring. It is hoped that these studies will pave the way for the development of further proof-of efficacy clinical trials of WT1 vaccination in patients with other WT1-expressing tumors.

9:30 Using Replicating Viral Vectors to Drive Anti-Tumoral Immunity

Brian D. Lichty, Ph.D., Associate Professor, Centre for Gene Therapeutics, Pathology and Molecular Medicine, McMaster University

Replicating viral vectors are attractive candidate cancer therapeutics as they can directly mediate tumour destruction via viral oncolysis while inducing anti-tumour immunity. These two means of tumour destruction work together to mediate optimal therapeutic impact and a reduction in either can reduce efficacy. It is however challenging to develop anti-tumour immune responses with replicating viral vectors as these are highly immunogenic and anti-viral immune responses will dominate. We have shown that oncolytic rhabdoviral vaccine vectors are very potent boosters of tumour vaccines able to generate massive anti-tumour immune responses in tumour-bearing hosts. The mechanisms underlying these effects and additional means to further enhance the effects will be presented.

10:00 Networking Coffee Break

10:30 Induction of Potent Immune Responses in Post-LEEP Cin 2/3 Following Immunotherapy With VGX-3100

Mark Bagarazzi, M.D., Chief Medical Officer, Inovio

We have developed SynCon(TM) DNA vaccines targeting the E6 and E7 oncogenes of HPV 16 and 18 as an immunotherapeutic vaccine for cervical dysplasias and cancer. Pre-clinical studies in tumor models in mice have demonstrated efficacy of the vaccine candidate in treating the implanted tumors. We recently completed a Phase I study in humans and will present the safety and immunogenicity data. We observed the significant induction of both cellular and humoral immune responses against all four vaccine antigens. A phase II study in pre-LEEP subjects has been initiated to assess efficacy.

11:00 Clinical Development of a Modified, Self-Potentiating HER2 Peptide Vaccine in Breast and Prostate Cancer Patients

Eric von Hofe, Ph.D., President, Antigen Express, Inc.

Several early stage trials of HER2 derived peptide vaccines suggest that they may have utility in preventing recurrence and/or progression of cancer. We are developing a peptide from the HER2 protein modified with a portion of the MHC class II-associated invariant chain for potent, antigen-specific stimulation of CD4+ T helper cells. The peptide, AE37, has demonstrated higher immunogenicity both in laboratory models and in the clinic compared to unmodified HER2 peptides. Interim results of a controlled, randomized Phase II trial of AE37 used in the adjuvant setting in breast cancer patients suggest that AE37 may help to prevent recurrences.



11:25 Chairperson’s Remarks

Denise L. Faustman, M.D., Ph.D., Director, Immunobiology, Massachusetts General Hospital; Associate Professor, Medicine, Harvard Medical School

11:30 BCG Vaccination for the Reversal of Advanced Diabetes: Mechanistic Based Trials for Disease Elimination

Denise L. Faustman, M.D., Ph.D., Director, Immunobiology, Massachusetts General Hospital; Associate Professor, Medicine, Harvard Medical School

Healthcare costs are skyrocketing yet at the stage of translational medicine, few trials are aimed at speed and ultimately cost reductions to the consumer.  In this series of trials, we are moving forward an 80-year-old vaccine, BCG, as a potential way to reverse end stage childhood diabetes. To speed the trials as well as to guide the dosing of BCG, sophisticated cell based markers from fresh human blood have been designed to track the pathogenic T cells (auto reactive T cells) and the beneficial T regulatory T cells.  These fresh blood-handling techniques have now been automated with robotics and tested in a Phase I double-blinded studies.  Therefore the combination of cheap genetics with little risk of toxicity combined with mechanistic biomarkers to facilitate dosing, will allow the rational, cost effective development of a therapy for restoration of normal blood sugars even after years of diabetes.

12:00 pm Sponsored Presentation (Opportunity Available)

12:15 Lunch on Your Own or Luncheon Presentation (Sponsorship Opportunity Available)

1:50 Clinical Development of a Diabetes Vaccine

Tihamer Orban, M.D., MRCPCH, Immunology and Immunogenetics, Joslin Diabetes Center

There is a growing body of evidence to suggest that the autoimmunity observed in type 1 diabetes mellitus (T1DM) is the result of an imbalance between autoaggressive and regulatory cell subsets. Therapeutics that supplement or enhance the existing regulatory subset are therefore a much sought after goal in this indication. A double blind, placebo controlled, phase I clinical trial of a novel antigen-specific therapeutic in 12 subjects with recently diagnosed T1DM is now completed. The study drug, human insulin B-chain in incomplete Freund’s adjuvant (IFA) was administered as a single intramuscular injection, with subjects followed for 2 years. The therapy was generally safe and well-tolerated. Mixed meal stimulated C-peptide responses, measured every 6 months, showed no statistical differences between arms. All patients vaccinated with the autoantigen, but none who received placebo, developed robust insulin-specific humoral and T cell responses. Up to two years following the single injection, in peripheral blood from subjects in the experimental arm, but not the control arm, insulin B-chain-specific CD4+ T cells could be isolated and cloned that showed phenotypic and functional characteristics of regulatory T cells. The induction of a lasting, robust immune response generating autoantigen-specific regulatory T cells provides strong justification for further testing of this therapy in type 1 diabetes.


2:20 First-In-Class HIV Vaccine Candidate Achieves Functional Cure in The Non-Human Primate Model: From Bench to Clinic With a Lentiviral Vector

Franck Lemiale, Ph.D., Pharm.D., Senior Director, Vaccines & Immunology, VIRxSYS Corporation

Our lentiviral vectors expressing HIV antigens have competed favorably with other leading vaccine candidates with respect to eliciting anti-HIV immunity, inducing sustained vaccine-specific immunogenicity and overcoming anti-vector immunity in early studies.  In final preclinical optimization in the macaque model, the vaccine has demonstrated a high and qualitatively unique immunogenicity. Following high dose intrarectal SIV challenge, vaccine responders achieved, upon study completion 18 months post-challenge, complete control of viral replication in both the periphery and lymphoid compartments, full preservation of the CD4 compartment and improved survival. Prospects for clinical development of a first in humans integrating lentiviral vaccine will be discussed.


2:50 Future Immunotherapeutics: Learning from HIV Controllers

Florencia Pereyra, M.D., Ragon Institute of MGH, MIT, and Harvard, Division of Infectious Diseases at Brigham and Women’s Hospital

A first generation HIV vaccine would be considered successful if it achieves a level of immune control such as to prevent disease progression should infection occur, and to prevent transmission to uninfected persons. Such situations of control of HIV infection exist in nature but the mechanisms for this outcome are poorly understood. We hypothesize that through the study of large cohorts of individuals exhibiting immune control of HIV the critical factors contributing to control can be identified and exploited for the development of an effective HIV immunogen.

Our goal is to address three critical interrelated issues for HIV vaccine design: quality and durability of effective immune responses, HIV heterogeneity, and the influence of host genetics on the ability to contain the virus.

3:20 Networking Refreshment Break

3:35 Clinical development of AGS-004, an autologous immunotherapy to treat HIV infection

Charles A. Nicolette, Ph.D., CSO, Vice President, Research and Development, Argos Therapeutics

AGS-004 is a completely autologous immunotherapy consisting of dendritic cells electroporated with amplified RNA encoding gag, nef, rev, and vpr proteins. The RNA antigen payload contains a complex mixture of each subject’s unique antigen quasispecies and is therefore perfectly matched to an individual’s viral load. Integrating nontraditional drug therapies into the HIV therapeutic space is particularly challenging due to the number of drugs currently available and the evolving guidance for treatment practices. Clinical options and the challenges faced with AGS-004 development will be discussed.

4:05  End of Clinical Development of Therapeutic Vaccines

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