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Tuesday, August 21 

4:00-6:00 pm Early Conference Registration

Wednesday, August 22 

7:30 am Main Conference Registration and Morning Coffee

8:25 Chairperson's Remarks

8:35 Therapeutic Inhibition of IDO Reverses Tumoral Immune Escape
George Prendergast, President, CEO, Lankenau Institute Medical Research 
Indoleamine 2,3-dioxygenase (IDO) defeats immune surveillance in cancer and chronic viral disease, allowing diseased cells to escape recognition and destruction by T immune cells. Our laboratory has shown how IDO becomes upregulated in cancer cells and how small molecule inhibitors of IDO can be used to elicit tumor regression in animals. We will present (1) the results of genetic and pharmacological experiments establishing the ability of IDO to block tumoral immune tolerance, (2) a novel IDO related gene, IDO2, that is implicated in preclinical responses to a 'lead' inhibitor entering clinical trials this summer, and (3) new structural classes of bioactive IDO inhibitors that have been identified in our laboratory, some with known anticancer properties. 

9:05 BiTE: A Novel Therapeutic Approach with the Potential to Circumvent Immune Evasion
Patrick A. Baeuerle, Ph.D., Prof., CSO and SVP R&D, Micromet, Inc.
BiTEs are CD3-binding, bispecific single-chain antibodies that can transiently link any T cell with target cells. We have shown that BiTE-recruited T cells no longer require for tumor cell lysis the expression of MHC class I and peptide antigen processing. BiTEs specific for EpCAM (CD326) can trigger T cells to lyse a great variety of human EpCAM-expressing tumor cell lines and can cure mice with established tumors derived from human cell lines or human metastatic tissue.

9:35 A Phase II Study Evaluating TG4010 (MVA-MUC1-IL2) in Association with Cisplatin and Vinorelbine in Patients with Non Small Cell Lung Cancer
Bruce Acres, Ph.D., Head of Medical Immunology and Translational Research, Department of Medical Affairs, Transgene SA
TG4010 is a recombinant viral vector expressing both IL2 and the tumor-associated antigen MUC1. The results of a phase II study in which TG4010 is assessed alone or in combination with cisplatin and vinorelbine in NSCLC patients will be presented. A multi-center randomized, two stage Simon design, two arm, phase II study in stage IIIB/IV, PS 0-1, NSCLC patients and the results are described.
Arm 1: TG4010 is combined upfront with cisplatin (100 mg/m2 J1) and vinorelbine (25 mg/m2 J1&J8). Arm 2: patients are treated with TG4010 alone, followed by TG4010 + cisplatin and vinorelbine upon disease progression.
The combination of TG4010 with standard chemotherapy shows encouraging results justifying further development of TG4010.

10:05 Networking Coffee Break, Poster & Exhibit Viewing

10:45 Combining Chemotherapy with Antibody based Cancer Immunotherapy, Recent Insights
Chrstopher Nicodemus, M.D., SVP, Research and Development, Unither 
The evaluation of cancer immunotherapeutics has been hampered by the clincial requirement for concomitant chemotherapy in early disease settings and the the refractory state of many advanced recurrent maliginancies. The assumption that chemotherapy is immune suppressive and therefore incompatible with cancer vaccine or immunotherapy administration should be chanllenged and the design of studies to assess the effects of combination chemo-immunotherapy revisited. We have recently completed a randomized phase II study of OvaRex MAB B43.13 in alternative schedules administered with front line carboplatin paclitaxel based chemotherapy and found the chemotherapy to be functioning as an immune adjuvant. This talk will review the results of this study, discuss methodology of immunotherapetic evaluation and update progress with our pivitol OvaRex studies of ovarian cancer.

11:15 Oral Talactoferrin, a Novel Anti-cancer Agent Entering Phase 3 Trials with Promising Phase 2 Data
Atul Varadhachary, M.D., Ph.D., President & COO, Agennix, Inc.
Talactoferrin, an immunomodulatory protein with a novel anti-cancer mechanism of action, showed anti-cancer activity in Phase Ib and Phase II human clinical trials. Two placebo-controlled Phase II studies were conducted in patients with non-small cell lung cancer. Patients were randomized to receive oral talactoferrin or placebo in combination with chemotherapy as first-line therapy (110 patients) or as monotherapy in refractory cancer (100 patients). In a 44-patient renal cell cancer trial, patients with disease progression after prior therapy received oral talactoferrin as a single agent. All three Phase II trials met their primary efficacy endpoints with supporting results on the secondary endpoints. Talactoferrin appears to be extremely well tolerated after oral administration to over 475 subjects. Phase 3 trials will be initiated shortly in different cancer indications.

11:45 Personalized Cancer Vaccine via Oncolytic Viratherapy
Henry Li, Ph.D., Senior Director, Drug Development, Immusol, Inc. 
Multimodal treatments are increasingly recognized as the future of cancer therapy. Oncolytic viruses have been under extensive research as a new cancer therapy in both preclinical and clinic studies, highlighted by their multi-modality natures. We have engineered a second generation HSV virotherapy with broadened modalities to improve the treatment efficacy. Extensive tests employing immunocompetent syngenic mouse tumor models have demonstrated significantly enhanced tumor responses over the earlier virotherapy, which can in part be attributed to the elevated anti-tumor immunity elicited by viral infection, based on the enhanced specific tumor CTL, cytokine production and the results derived from CD8 cell depletion and adoptive immune transfer experiments. This anti-tumor immunity was also apparently potent against tumor metastasis. Therefore, the new oncolytic virotherapy could serve as a promising personized tumor vaccine with the improved features over the current tumor vaccine strategies.

12:15 Lunch on Your Own (Luncheon Workshop Sponsorship Available) 

1:40 Chairperson's Remarks

1:45 Allovectin-7 Immunotherapy for Metastatic Melanoma
Bill Paxton, Medical Director, Vical
Allovectin-7 is a biologic that expresses the highly immunogenic class I transplantation antigen and is administered by direct intratumoral injection. The mechanisms of action, allogeneic anti-tumor response, upregulation or restoration of MHC Class I antigen, and a pro-inflammatory effect of the lipid/DNA complex, will be discussed. The efficacy and safety of Allovectin-7 for the treatment of metastatic melanoma are currently being evaluated in a Phase 3 controlled clinical trial.

2:15 Induction of Immunity to Cytochrome P450 1B1 as a Means to Target Multiple Tumor Types
Thomas M. Luby, Ph.D. , Director, Biology, MGI PHARMA
Cytochrome P450 1B1 (CYP1B1) is a novel tumor-associated antigen that is expressed on multiple cancer types while having limited expression on normal tissue. ZYC300 is a plasmid DNA based immunotherapeutic designed to induce immunity to CYP1B1 that is currently being tested in phase 1 clinical studies. Recent pre-clinical and clinical results will be described.

2:30 Technology Trends (Sponsorship Available)

2:45 Active Specific Immunotherapy of Colon Cancer: Patient Specific Therapy with an Autologus Tumor Cell Vaccine
Michael G. Hanna Jr., CEO, Vaccinogen, Inc.

3:15 Networking Refreshment Break, Poster & Exhibit Viewing

4:00 The Generation of Therapeutic Abs for Cancer (Preliminary Title)
Michael Perricone, Associate Director R&D, Genzyme 

4:30 Using Soluble High Affinity T Cell Receptors as Novel Targeting Therapeutics in Cancer
Helen Tayton-Martin, Ph.D., Senior Executive, Business Development, Medigene
In cancer, there are multiple well-known tumour-associated antigens either absent in normal tissue or over-expressed in cancerous cells which represent targets for
immunotherapies. However, since 75% of these antigens are intracellular, they are not amenable to antibody-targeting approaches and thus the only way to effectively target them is through the human leukocyte antigen (HLA) -presented peptide i.e. the natural ligand to the T cell receptor molecule (TCR). With this in mind, Medigene has spent several years developing 1) a soluble stable version of the natural TCR to a number of these tumour associated antigens (monoclonal TCRs), 2) engineering these to high-affinity to escape the anergy of the natural TCR to the cancer antigen and 3) developing fusion molecules with effector molecules such as toxins, cytokines and other effector molecules to deliver a targeted killing response to the tumour. The presentation will cover the development of these novel targeting molecules and show preliminary preclinical data of their effectiveness as potential therapeutic molecules ­ including their use to pre-screen patients before treatment.

5:00 Antibody Combination Targeting Both PDGFR-beta and VEGF Receptor 2 Leads to Synergistic Anti-tumor and Anti-angiogenic Activities
Zhenping Zhu, M.D., Ph.D., Vice President, Antibody Technology, ImClone Systems
Platelet-derived growth factor (PDGF) and its receptors (PDGFR) play important roles in tumorigenesis through both directly stimulating tumor growth and promoting pericyte recruitment and vessel maturation during angiogenesis. Here we isolated a neutralizing antibody (2C5) that binds to both human and mouse PDGFRβ from an antibody phage display library. 2C5 blocks PDGF-BB from binding to its receptors and neutralizes ligand-stimulated activation of PDGFRβ and downstream signaling molecules. Further, 2C5 significantly inhibited the growth of OVCAR-8 and NCI-H460 xenografts in nude mice. Finally, 2C5 significantly enhanced the antitumor activity of DC101, an antibody directed against mouse vascular endothelial growth factor receptor 2, in BxPC-3 model. 2C5 antibody provides an excellent reagent for investigating the antitumor and antiangiogenic activities of PDGFRβ antagonists and may have clinical application as antitumor agent, either alone or in combination with other antibodies and cytotoxic compounds.

5:30 Human Monoclonal Antibodies against IGF-II, IGF-I and IGF-IR
Yang Feng, Ph.D., Biologist, CCRNP, National Cancer Institute
Overexpression of the IGF-IR ligands, especially IGF-II, can lead to signaling through the insulin receptor (IR); in addition, the IGF-IR forms heterodimers with the IR which can be downmodulated by IGF-IR-specific antibodies. Our strategy has been to develop antibodies against the ligands, IGF-II and IGF-I. By using phage display we identified a number of fully human monoclonal antibodies specific for IGF-I, IGF-II or cross-reactive for both. In addition, we have developed two antibodies against the IGF-IR. Several of these antibodies potently inhibited signal transduction mediated by the IGF-IR and the IR interaction with IGF-II, and the IGF-IR interaction with IGF-I. Some of them also inhibited growth and motility of cancer cell lines including MCF-7. In progress are studies in xenograft tumor models. 

6:00 Networking Reception, Poster & Exhibit Viewing

7:00 End of Day One

Thursday, August 23

7:30 Morning Coffee 
(Breakfast Workshop Sponsorship Available)

8:30 Chairperson's Remarks 

9:05 Antibody-Targeted Vaccines
Tibor Keler, CSO, VP R&D, Celldex Therapeutics 
The specificity and high affinity binding of antibodies provides these molecules with ideal properties for delivering a payload to target cells. Exploiting these characteristics of antibodies, antibody-targeted vaccines (ATV) are designed to deliver disease-specific antigens to professional antigen presenting cells (APCs), thus enabling the host’s immune system to recognize and eliminate malignant or infected cells through adaptive immunity. The concept of ATVs has been in development for many years, and recently has entered clinical trials. Early studies with ATVs focused on the ability to induce humoral immunity in the absence of adjuvants. More recently, ATVs targeted to C-type lectin receptors have been exploited for induction of potent helper and cytolytic T cell responses. To maximize their stimulatory capacity, the ATVs are being evaluated with a variety of adjuvants or other immunostimulatory agents. In the absence of co-administered immunostimulatory signals, APC-targeting can induce antigen-specific tolerance and, thus, may also be exploited in developing specific treatments for autoimmune and allergic diseases, or for preventing transplant rejection. The successful clinical application of this new class of antibody-based products will clearly depend on using appropriate combinations with other strategies that influence the immune system.

9:35 Immunocytokines Targeting Melanoma and Containing TNF
Michael Rosenblum, M.D., Professor of Medicine, Department of Experimental Therapeutics, M.D. Anderson Cancer Center
This is a "first in class" molecule. We have performed all characterization and pre-IND studies and have moved this construct from "Concept to Clinic" in an Academic setting. The scFvMEL/TNF immunocytokine has been demonstrated to generate highly cytotoxic effects against target cells resistant to TNF itself. The construct modulates a series of genes which are unique compared to TNF. The efficacy of this construct against melanoma tumor xenografts is impressive.

10:05 Networking Coffee Break, Poster & Exhibit Viewing Networking

10:45 Effector and Suppressor Immune Responses Co-Exist in Cancer Patients: Implications for Immunotherapy
Gilberto Filaci, M.D., Associate Professor, Internal Medicine, University of Genoa
This presentation 

• Shows the possibility of applications but also potential limits of telomerase-specific vaccination in cancer patients;
• Makes a parallel analysis on effector and suppressor T cell responses in cancer patients;
• Pin- points phenotypic and functional roles of a population of regulatory cells, the CD8+ T suppresssor lymphocytes, whose activity in human cancer has been less characterized with respect to that of CD4+CD25+ regulatory T lymphocytes

11:15 DCVax®-Brain, A Dendritic Cell Therapeutic Vaccine for Glioblastoma Multiforme…Long-term Results
Alton L. Boynton, Ph.D., President and CEO, Northwest Biotherapeutics, Inc.
Patients with newly diagnosed GBM were treated with autologous dendritic cells loaded with their own tumor biomarkers 3x at 2 week intervals following surgery, radiation and chemotherapy standard of care (“SOC”). Longer term survivors were also administered booster injections at 3 month intervals for 12 months. To date, progression free survival was 18.1 months (6.9 month with SOC). Overall median survival was 33.8 months (14.6 months for SOC).  

11:45 Engineered Cellular Therapeutics: A Paradigm shift in Development of Potent Biological Immunotherapeutics
Madhusudan Peshwa, Ph.D., Vice President, Research & Development, MaxCyte, Inc.
The ability to specifically tailor and augment biological activity (potency) of cellular immunotherapeutic products utilizing robust and scalable manufacturing processes compliant with regulatory requirements represents a significant unmet need. Such control over cellular physiology and function also lends itself improved product characterization, expands / extends intellectual property, drives down technology / clinical / regulatory risks, reduces developmental cost / time, and leads to accelerated clinical / commercial delivery for cancer immunotherapies with enhanced potency / efficacy and favorable process economics. Specific examples outlining pre-clinical development experiences with engineered cancer immunotherapy products and initial results from phase I / II human trials will be discussed.

12:15 Lunch on Your Own

Plenary Session – Focus on Adjuvants

1:40 Chairperson's Remarks

Keynote Presentation

1:45 An FDA Perspective: Regulatory Considerations in the Non-clinical Safety Assessment of Adjuvanted Preventive Vaccines Elizabeth M. Sutkowski, Ph.D., Scientific and Regulatory Reviewer, Office of Vaccines Research & Review (OVRR), Center for Biologics Evaluation & Research, US Food & Drug Administration The Office of Vaccines Research and Review (OVRR) is responsible for regulatory review of new Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) for preventive vaccines and therapeutic vaccines for infectious disease indications. Through this review process, OVRR ensures that vaccines are safe, effective, pure, and potent, as specified in Title 21 of the Code of Federal Regulations, Sections 312, 600, and 610. This presentation will review key components in non-clinical safety assessment of preventive vaccines regulated by OVRR, with a focus on toxicity study design considerations for vaccines with novel adjuvants. In addition, relevant clinical trial considerations and the utility of the pre-IND meeting will be discussed briefly.

Featured Presentation

2:30 GSK Adjuvant Portfolio: A Global Perspective  Nathalie Garcon, Pharm.D., Ph.D., Vice President, Research and North America R&D, GlaxoSmithKline Biologicals During the past decade, GSK biologicals has developed a portfolio of adjuvant systems aiming at inducing the most appropriate immune response against various diseases, in order to overcome medical challenges (flu elderly, malaria), induce a longer and sustained protection (HPV), a broader protection (pre-pandemic flu) and allow for potential dose sparing of antigen (pandemic flu). These adjuvant systems have also opened the way to a new family of vaccines, the so-called therapeutic vaccines such as the oncology vaccines. We will present today, the history of these adjuvants and clinical results supporting their efficacy and potential toward protection and control of diseases.

3:15 Networking Refreshment Break, Poster & Exhibit Viewing

4:00 Inducing anti-tumor immunity by activating Toll-like receptor 9
Arthur M. Krieg, M.D., Founder & Chief Scientific Officer, Coley Pharmaceutical Group Inc.
The immune system detects infectious agents using a family of ten Toll-like receptors (TLR), each of which is specific for a type of molecule expressed in pathogens. TLR9 is specific for unmethylated CpG dinucleotides in pathogen DNA, and can be activated with synthetic oligodeoxynucleotides such as PF-3512676. In animal models and in human clinical trials, PF-3512676 activates dendritic cells and induces the generation of tumor-specific CD8+ T cells. PF-3512676 has anti-tumor activity as a monotherapy, or in combination with other approaches, including tumor vaccines, radiotherapy, and chemotherapy, with which it is currently in two phase III clinical trials in NSCLC. 

4:30 The New Generation Iscom-Matrix Adjuvant – A Safe and Potent Adjuvant for Demanding Applications
Karin Lövgren Bengtsson, Ph.D., Head R&D, Isconova AB
ISCOMs and the ISCOM technology has been applied in immunological research as well as in experimental and commercial vaccines for about twenty years. The technological developments during these years have been considerable, and the technology that was always regarded as highly efficacious but technically difficult, expensive, and not always satisfactorily safe, has matured into a promising candidate for broad use. Isconova’s contribution to technology developments include four animal vaccines on the market, products for laboratory animal applications, large-scale production of purified saponin fractions and Iscom-Matrix, and the new potent LowTox adjuvant with a comfortable safety profile, e.g., for human use.

5:00 A phase Ib study of FolateImmune (EC90 with GPI-0100 adjuvant followed by EC17) with low dose cytokines interleukin-2 (IL-2) and interferon - alpha; (IFN - alpha) in patients with refractory or metastatic cancer
Robert J. Amato, D.O., Medical Director, Genitourinary Oncology Program, The Methodist Hospital Research Institute
FolateImmune is a novel therapy that induces an immune response against tumor cells by marking tumor cells with a folate-hapten conjugate targeted to folate-receptor. FolateImmune therapy is comprised of 1) a vaccine containing EC90, 2) an adjuvant (GPI-0100) and 3) a folate-hapten conjugate (Folate-FITC). The folateImmune treatment begins with subcutaneous injections of EC-90 vaccine with GPI-0100 adjuvant to stimulate the production of antibodies to the flourescein hapten. Patients will then receive subcutaneous injections of EC17, an agent intended to form a molecular “bridge” between the tumor cell and the endogenous circulating anti-flourescein immunoglobulin G antibody. This may initiate an Fc-mediated immune response leading to the removal of the antibody-coated tumor cells by a mechanism commonly referred to as an antibody-dependent cellular cytotoxicity and/or phagocytosis.

5:30 PREPS and L-particles- A Novel Herpes Simplex Based Virus Like Particle for Delivery of a Wide Range of Therapeutic Proteins
Ian Pardoe, Ph.D., MB, ChB, MRCGP, Chief Executive and Medical Director, Henderson Morley plc.
As part of the natural infectious cycle, herpes simplex viruses produce virus like particles. These particles contain all of the surface and tegument proteins of the parent virus, but completely lack the nucleocapsid.
These so called L-particles facilitate the natural infection of HSV, so are able to enter cells as if they were viruses. Because of the total lack of DNA, they are unable to replicate. PREPS particles are a modification of L-particles.
Non native proteins that have been engineered into the parent virus, can be delivered functionally intact to cells using PREPS and L-particles. It is possible to engineer the virus to express several antigens simultaneously, so a multivalent cancer vaccine is therefore possible.
L-particles also enhance naked DNA transfection, and its use as an adjuvant for DNA vaccines is being explored.
This talk will briefly highlight the technology and its potential applications.

5:45 End of Day Two