Cambridge Healthtech Institute第5屆

Adoptive T Cell Therapy 2: Development

( 過繼T細胞免疫療法2:開發 )

2018年8月30日~31日


本單元以過繼T細胞療法藥物的開發為主題,聚焦於利用嵌合抗原受體(CAR)、T細胞受體(TCR)、腫瘤內浸潤淋巴球(TIL)的療法實用化方面之必要步驟。臨床研究的進展、個案研究、在使過繼T細胞療法能有效發揮功能上具備重要意義的要素等議題也將被包含在內。


Final Agenda

THURSDAY, August 30

7:45 am Registration & Morning Coffee

HEMATOLOGIC CANCERS: CLINICAL PROGRESS

8:25 Chairperson's Opening Remarks

Amy Hines, BSN, RN, Director, Collection Network Management, Be The Match BioTherapies


8:30 FEATURED PRESENTATION: A Translational Perspective of Development of Yescarta (Axicabtagene Ciloleucel), a First-in-Class CAR T Cell Product for Diffuse Large B Cell Lymphoma

Adrian Bot, MD, PhD, Vice President, Translational Sciences, Kite, a Gilead Company

Yescarta (Axicabtagene Ciloleucel) is an anti-CD19 CAR T cell therapy that received approval for treatment of relapsing or refractory DLBCL. This presentation describes key elements of the translational program, correlates of toxicities and durable objective response, product characteristics, patient conditioning, and importance of tumor microenvironment. It also showcases major lessons learned and challenges in developing cell-based immunotherapies.

9:00 Presentation to be Announced

9:30 Engineered Natural Killer Cells Expressing Enhanced Fc Receptors for Cancer Cell Killing

Bruce Walcheck, PhD, Professor, Immunology, University of Minnesota

A key anti-tumor function of natural killer (NK) cells is antibody-dependent cell-mediated cell cytotoxicity (ADCC) induced upon their engagement of tumor-bound antibodies. Many clinically successful tumor-targeting therapeutic monoclonal antibodies (mAbs) utilize ADCC as a mechanism of action. These mAbs are exclusively recognized by CD16A (FcγRIIIA) on NK cells, which is a low affinity Fc receptor. We have engineered NK cells expressing a novel chimeric Fc receptor that binds tumor-targeting mAbs with high affinity and induces robust ADCC. Advantages of this approach is that the engineered NK cells can bind to a broad array of therapeutic mAbs, which serve as diverse targeting elements for various tumor antigens and malignancies.

10:00 Coffee Break in the Exhibit Hall (Last Chance for Poster Viewing)

10:45 Facing the Challenges of Apheresis Network Management

Amy Hines, BSN, RN, Director, Collection Network Management, Be The Match BioTherapies

For companies working in cell therapies, managing and maintaining your apheresis (cell collection) network is a critical challenge. How do you know which center is best equipped to handle your needs? How do you evaluate their compliance with FDA and international regulations? Hines discusses the key questions to ask and gives you the tools you'll need to evaluate centers, secure your supply chain and advance your cell therapy program.

11:15 Solving the Challenges of Large-Scale GMP T Cell Manufacturing

Steven L. Highfill, PhD, Assistant Director, Product Development and Management, Center for Cellular Engineering, Clinical Center, National Institutes of Health

This presentation covers current, ongoing GMP manufacturing efforts at the NIH. Highlights focus on CAR T cell manufacturing and some of the challenges that we had to overcome specifically when using autologous patient-derived starting material. In addition, I discuss some newer closed-system manufacturing platforms that will make it easier for academic institutes to provide cell therapy options to their patients.

11:45 Sponsored Presentation (Opportunity Available)

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

12:45 Session Break

NEXT-GENERATION APPROACHES FOR SOLID TUMORS

1:40 Chairperson's Remarks

Adrian Bot, MD, PhD, Vice President, Translational Sciences, Kite, a Gilead Company


1:45 FEATURED PRESENTATION: Stress-Resistant T Cell Therapy for Solid Tumors

Prasad S. Adusumilli, MD, FACS, FCCP, Associate Attending and Deputy Chief, Thoracic Surgery; Head, Solid Tumors Cell Therapy, Cellular Therapeutics Center; Director, Mesothelioma Program, Memorial Sloan Kettering Cancer Center

CAR T cell therapy efficacy in solid tumors is limited by PD-1/PD-L1 pathway. We have shown that exhausted CAR T cells can be rescued by anti-PD1 agents or by a decoy receptor, PD-1 dominant negative receptor cotransduced with CAR T cells to promote functional persistence. The presentation focuses on cell-intrinsic and extrinsic methods in overcoming checkpoint blockade in cellular immunotherapy.

2:15 TRAP CAR T & Related Cell Therapies: Can Local Delivery Solve Efficacy and Safety Challenges in Solid Tumor Immuno-Oncology?

Janet R. Rea, MSPH, RAC, Senior Vice President, Regulatory, Quality & Clinical Affairs, Atossa Genetics

This presentation reviews cell therapy evolution and challenges. It includes considerations of local delivery options using breast cancer as a model.

2:45 Sponsored Presentation (Opportunity Available)

3:15 Refreshment Break

3:45 Eutilex's 4-1BB CTL Adoptive T Cell Therapy: Clinically Safe and First Efficacy in Solid Tumors

Agustin de la Calle, PhD, CBO, Eutilex Co., Ltd.

Eutilex's 4-1BB CTL therapy is the autologous T cell therapy proven safe in man without treatment-related toxicity and no CRS. Efficacy in hematological cancers and solid tumors: brain, breast, lung, tracheal, pancreatic cancers, CRC and melanoma. Complete remissions were observed in Hodgkin's and NK/T cell lymphomas. Phase I safety accepted single dose in terminal patients but relapsed patients became responsive again to further treatments. Leader in COGS: simple outpatient procedure.

4:15 Engineering NK Cells for Enhanced Potency and Persistence

James B. Trager, PhD, Senior Vice President, R&D, Nkarta, Inc.

NK cells form a first line of defense against cancer, and they can be formidable mediators of cytotoxicity and adaptive immunity. Efforts to maximize their potential as cancer therapeutics are hampered by difficulty in expanding NK cells, relatively short in vivo persistence, and the ability of tumor cells to evade NK recognition. We discuss recent progress in overcoming these barriers to successful therapeutic application of NK cells.

4:45 FEATURED PRESENTATION: Tricked-Out CARs: Next-Generation Approaches to Enhance and Optimize CAR T Cell Function

Benjamin Boyerinas, PhD, Senior Scientist, Immunotherapy, bluebird bio

Genetically engineered CAR T cells can be further engineered to survive and overcome immune evasion mechanisms employed by tumors. We have been developing a novel TGF-β signal conversion platform that provides a T cell supportive signal upon exposure to TGF-β within the hostile tumor microenvironment. This approach, combined with other methodologies such as gene editing and drug-regulated activation, have the potential to enhance specific activity within solid tumors.

5:15 End of Day

FRIDAY, August 31

8:00 am Breakout Discussion Groups with Continental Breakfast

This session features discussion groups that are led by a moderator who ensures focused conversations around the key issues listed. Attendees choose to join a specific group, and the small, informal setting facilitates sharing of ideas and active networking. Details on the topics and moderators are available on the conference website.

CLINICAL PROGRESS OF CAR, NK, TCR, AND TIL

9:00 Chairperson's Remarks

Paul Rennert, PhD, President & CSO, Aleta Biotherapeutics, Inc.

9:05 GOLD: Activation-Induced Payload Delivery for T Cell Therapies

Gus Zeiner, PhD, CSO, Chimera Bioengineering

GOLD is an endogenous post-transcriptional gene regulatory node that couples T cell metabolic states to transgenic payload outputs. Conditional payload expression is induced by signaling through either the native T cell receptor or a CAR. GOLD is payload-agnostic, and enforces low basal payload expression in resting T cells with a wide dynamic range in activated T cells. GOLD-mediated regulation is non-immunogenic, making GOLD-enabled T cell therapeutics compatible with long-term persistence.

9:35 Developing Tumor Infiltrating Lymphocytes for the Treatment of Cancer

Maria Fardis, PhD, President & CEO, Iovance Biotherapeutics

Recent FDA approvals of Kymriah and Yescarta show that cell therapies are viable options for treatment of hematological malignancies. Incidence of solid tumors are, however, approximately 10 times higher than hematological malignancies. Available therapies for solid tumors include chemotherapy, radiotherapy, and immunotherapy. Immunotherapies, such as Anti-PD-1 antibodies, have shown promise, but in many cases, although the overall response rate is not high, discontinuation due to adverse events remains an issue. Iovance is developing -infiltrating lymphocytes (TIL), a one-time cell therapy treatment that leverages and enhances the body's natural defenses against certain aggressive solid tumors. TIL is currently under investigation in several multi-center Phase II clinical trials and preliminary results have demonstrated safety and efficacy in melanoma, head and neck and cervical cancer patients with multiple prior therapies which constitutes unmet medical need.

10:05 PM21-NK Cells for Cancer Therapy

Robert Igarashi, PhD, President, CytoSen Therapeutics

CytoSen is advancing NK cell therapy for treatment of cancer. CytoSen's methods for stimulating NK cells with membrane bound (IL21), originally developed by Dr. Dean A. Lee, produces NK cells with high anti-tumor potency and can generate the highest doses. We plan to leverage our particle-based platform, that has logistical advantages, to pursue clinical studies in leukemia.

10:35 Coffee Break

11:00 A TCR-Based Chimeric Antigen Receptor

Even Walseng, PhD, Staff Scientist, Experimental Immunology Branch, National Cancer Institute, National Institutes of Health; Department of Immunology, Hospital Radiumhospitalet, Institute for Cancer Research, University of Oslo

Although CARs are very potent, the recognition is limited to membrane antigens which represent around 1% of the total proteins expressed, whereas TCRs have the advantage of targeting any peptide resulting from cellular protein degradation. To expand the horizon of TCR use, we have successfully fused a soluble TCR construct to a CAR-signaling tail. We demonstrate that the TCR-CAR redirection is not restricted to T cells and hence opens therapeutic avenues combing the killing efficiency of NK cells with the diversified target recognition of TCRs.

11:30 Hijacking CAR19 T Cells to Address Critical Issues in Cell Therapy: Application to Diverse Indications

Paul Rennert, PhD, President & CSO, Aleta Biotherapeutics, Inc.

The Aleta platform addresses critical issues in cell therapy including CAR persistence, antigen escape and antigen heterogeneity, and provides important solutions for treating both hematologic and solid tumors. The key element of our technology is the use of novel fusion proteins to redirect CAR T specificity. Our lead programs are directed to B cell malignancies, AML and solid tumors.

12:00 Close of Adoptive T Cell Therapy 2: Development

* 活動內容有可能不事先告知作更動及調整。

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