Cambridge Healthtech Institute’s Fourth Annual

Rational Combination Cancer Immunotherapy

The clinical and regulatory successes of the PD-1, PD-L1 and CTLA-4 checkpoint proteins are driving a resurgence of interest in immunotherapy as a primary form of cancer treatment, with numerous clinical studies exploring the application of these therapeutics in combinations with traditional and experimental agents. CHI’s 4th Annual Rational Combination Cancer Immunotherapy takes a forward-looking perspective on the design of drug products and treatment progressions that will build on the knowledge arising from these exploratory trials. The meeting will explore the clinical experience and key considerations for different immunotherapy combination strategies – and consider the most essential best practices for organizations wanting to successfully link their therapeutic programs to approved checkpoint inhibitors.

Final Agenda

Recommended Dinner Short Course*
SC1: Targeting the Cancer Mutanome
*Separate registration required


TUESDAY, AUGUST 30

12:00 pm Registration

1:15 Chairperson’s Opening Remarks

Arthur M. Krieg, M.D. CEO, Checkmate Pharmaceuticals


1:20 KEYNOTE PRESENTATION:
SELECTING PD-L1/PD-1 IMMUNOTHERAPY COMBINATIONS

Edward_ChaEdward Cha, M.D., Ph.D., Associate Medical Director, Cancer Immunotherapy Franchise, Genentech

Although targeted inhibition of the PD-L1 pathway enhances anti-tumor immunity, not all patients achieve benefit from single-agent immunotherapies. Determining and prioritizing effective combinations will rely on further understanding of the mechanisms that drive immune resistance across indications and individual patients.


CONSIDERATIONS IN DESIGNING IMMUNOTHERAPY COMBINATIONS

1:50 Rational Combination Immunotherapy Development Stratified by the Presence or Absence of the T Cell-Inflamed Tumor Microenvironment

Jason_LukeJason J. Luke, M.D., FACP, Assistant Professor, Medicine, Melanoma and Developmental Therapeutics Clinics, University of Chicago Medical Center

Tumors can be categorized by gene expression based on the presence or absence of a T cell-inflamed tumor microenvironment, and this correlates with either response or lack of response to immune-checkpoint blockade. Categorization of these biologically distinct subsets suggests rational immunotherapy combinations directed toward either a T cell-inflamed or non-T cell-inflamed tumor microenvironment. This approach also facilitates a framework for interrogating molecular mechanism of immune exclusion mediating non-inflamed tumors.

2:20 Programming DCs in situ for Cancer Vaccination

Omar_AliOmar Ali, Ph.D., Staff Scientist, Wyss Institute for Biologically Inspired Engineering, Harvard University

The innate components required to mediate effective vaccination against weak tumor-associated antigens remain unclear. We utilize three-dimensional and macroporous, polymeric cancer vaccines incorporating different classes of TLR adjuvants to induce tumor regression and protection in order to identify dendritic cell subsets and cytokines critical to this efficacy. Vaccine-induced tumor regression correlated to local CD8(+) DC and pDC numbers, IL-12, and G-CSF concentrations regardless of the incorporated adjuvant.

2:50 Discussion with Session Speakers

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing


4:00 Plenary Keynote Session


5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

5:30 Dinner Short Course Registration*

*Separate registration required.

WEDNESDAY, AUGUST 31

8:00 am Morning Coffee


CLINICAL UPDATES

8:25 Chairperson’s Remarks

Christopher R. Heery, M.D., Director, Clinical Trials Group, Laboratory of Tumor Immunology, Center for Cancer Research

8:30 Breaking the Suppressive Myeloid Barrier to Overcome Checkpoint Blockade Resistance

Michael_CurranMichael A. Curran, Ph.D., Assistant Professor, Immunology; Scientific Director, ORBIT Platform MD Anderson Cancer Center

While blockade of T cell immune checkpoint molecules such as CTLA-4 and PD-1 has dramatically improved therapeutic outcomes in metastatic melanoma and lung cancer, many other cancers such as those of the pancreas, prostate, and colon (MSI-low) fail to respond. We find that suppressive myeloid cells play a critical role in mediating this resistance, and that through their disruption these cancers can be sensitized to checkpoint blockade.

9:00 Novel Combinations of Immunotherapeutics Based on Preclinical Modeling and Clinical Biomarker Analysis

Christopher_HeeryChristopher R. Heery, M.D., Director, Clinical Trials Group, Laboratory of Tumor Immunology, Center for Cancer Research

This talk will discuss examples of clinical trial design based on integration of preclinical modeling and pharmacokinetic and pharmacodynamic analysis of early stage trials. The focus will be on integration of new findings as an iterative process toward optimal trial design to achieve maximal clinical benefit.

9:30 FEATURED PRESENTATION:
SUMMARY OF KEY CLINICAL COMBINATION TRIALS PRESENTED AT ASCO

Paul_RennertPaul Rennert, Ph.D., President & CSO, Aleta Biotherapeutics Inc.

ASCO 2016 will give us new insights into diverse and interesting advances in oncology therapeutics. I will report on the top studies of interest in the following areas: novel immune checkpoints and checkpoint combinations; immune checkpoint combinations with other therapies, targets in the tumor microenvironment, CAR T and TCR therapies, and other studies that enrich our understanding of immuno-oncology as a broad-based discipline for cancer therapy.

HemispheRx10:00 Rintatolimod: Enhancement of Immune Responses with a Well-Tolerated Selective TLR3 Agonist and Potential for I-O Combination

Christopher F. Nicodemus, M.D., FACP, President & CSO, AIT Strategies; Member, Scientific Advisory Board at Hemispherx

Despite dramatic advances with checkpoint inhibitors, the majority of cancer patients fail monotherapy. Rintatolimod is a selective TLR3 agonist with >900 patient dosing experience. Evidence will be reviewed that rintatolimod: modulates the human tumor microenvironment, restores cellular immune responses, synergizes with checkpoint inhibition in animal tumor models, has monotherapy activity in melanoma and renal cell carcinoma, currently in human cancers trials as a component of immunotherapy, IP protection to 2028.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

11:15 Cancer Immunotherapy: Immunomodulatory Approaches Beyond PD-1

Andrea_van_ElsasAndrea van Elsas, Ph.D., CSO, Aduro Biotech Europe, The Netherlands

T cell checkpoint inhibitors set a clinical paradigm providing significant benefit to patients diagnosed with advanced cancer. Despite success, the majority of patients do not respond to PD-1, PD-L1 or CTLA-4 blockade. Raising the number of patients benefiting from cancer immunotherapy requires novel therapeutic approaches aimed at these non-responders, for instance using novel immunomodulatory antibodies and combination with active immunization.

11:45 Panel Discussion: Best Practices for Organizations and Academic Labs Entering the Cancer Immunotherapy Space

Moderator:
Llew_KeltnerLlew Keltner, M.D., Ph.D., CEO, EPISTAT

The scientific potential of immunotherapy combinations is vast, and the clinical successes in this space have attracted significant numbers of large and small players to the field. Our panel will dissect the most important scientific and strategic considerations for those wanting to participate in these collaborations and offer audience members the opportunity for focused feedback from experts in business, regulatory, scientific, healthcare and dealmaking functions.

Panelists:

Konstantin_LinnikKonstantin M. Linnik, Ph.D., Partner, Intellectual Property, Nutter, McClennen & Fish, LLP


Kuldeep_NeoteKuldeep Neote, Ph.D., Senior Director, New Ventures, J&J Innovation Center Boston


Taylor_SchreiberTaylor Schreiber, M.D., Ph.D., CSO, Heat Biologics, Inc.


Elena_SpanjaardElena Spanjaard, Ph.D., Director, Worldwide Research & Development, Regulatory Affairs, Pfizer


12:45 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break


IMMUNOTHERAPY COMBINATION STRATEGIES

1:55 Chairperson’s Remarks

Paul Rennert, Ph.D., President & CSO, Aleta Biotherapeutics Inc.

2:00 Next-Generation Biomarkers for the Era of Combination Cancer Immunotherapy

David_KaufmanDavid Kaufman, Ph.D., Executive Director, Clinical Oncology, Merck Research Laboratories

A variety of other agents may have additive or synergistic activity in combination with PD-1 checkpoint blockade. As such regimens advance, it will be critically important to understand how to direct the right combinations to patients who stand to benefit most from them. Next-generation biomarkers are beginning to provide insight into fundamental aspects of tumor cell and immune biology that are relevant for a precision medicine approach to cancer immunotherapy combinations.

2:30 Inhibition of Immune Checkpoints and Vascular Endothelial Growth Factor as Combination Therapy for Metastatic Melanoma

Patrick_OttPatrick Alexander Ott, M.D., Ph.D., Assistant Professor, Medicine, Dana-Farber Cancer Institute

Emerging evidence indicates that immunotherapy can lead to immune-mediated vasculopathy in the tumor. While the inhibition of angiogenesis through targeting of vascular endothelial growth factor (VEGF) has been used successfully for the treatment of cancer the mechanisms of its anti-tumor activity remain poorly understood. Initial studies of the complex relationship between angiogenesis, VEGF signaling and the immune system suggest that the combination of immune checkpoint blockade with angiogenesis inhibition has potential.

3:00 Rationale for Combinatorial Immunotherapy Approaches

Alex_MorozovAlex Morozov, M.D., Ph.D., Senior Medical Director and Global Clinical Lead, Pfizer

Immunotherapy is poised to become an integral part of the cancer treatment paradigm. Cytotoxics, TKIs, other small molecules, and non-IO large molecules like ADCs will remain important treatment modalities. Understanding how these could be combined or sequenced with immunotherapy to transform cancer care is crucial. Pfizer’s immunotherapies in the clinic include those targeting PD-1, PD-L1, CTLA-4, OX-40, CD137, CCR2, and MSCF. The rationale for combinatorial strategies will be discussed.

3:30 Refreshment Break with Exhibit and Poster Viewing

4:15 Immunotherapy in Combination with Novel Tumor Vaccines

Craig_SlinglufCraig L. Slingluff, Jr., M.D., Professor, Surgery, University of Virginia School of Medicine

New approaches to cancer vaccines may use neoantigens, novel antigen formulations, or modified delivery systems. Promising findings support vaccines targeting CD4+ helper T cells, and new approaches to in situ vaccination show promise. Novel vaccine adjuvants may augment T cell responses, and combinations with a range of checkpoint blockade molecules or other systemic therapy agents may favorably modulate immune responses to vaccines and to human cancers.

4:45 Novel Combination Immunotherapy Strategies to Optimize T Cell Responses Against Cancer

Howard_KaufmanHoward L. Kaufman, M.D., FACS, Associate Director, Clinical Science, Chief Surgical Officer, Rutgers Cancer Institute of New Jersey

The remarkable success of T cell checkpoint inhibitors has highlighted the importance of promoting activation and preventing suppression of T cells for the treatment of cancer. This presentation will discuss the central importance of T cells within the tumor microenvironment, highlight some of the more promising combinations in development and provide recommendations for how to select the most promising immunotherapy agents for combination regimens.

5:15 Enhancing the Efficacy of Checkpoint Inhibition with a TLR9 Agonist Delivered in a Virus-Like Particle

Art_KriegArthur M. Krieg, M.D. CEO, Checkmate Pharmaceuticals

Checkpoint inhibitors can induce durable remissions in patients with advanced malignancies that are immunologically “hot” (have a type I IFN signature and CD8 T cell infiltrates) but they are rarely effective in the treatment of immunologically “cold” tumors. Intratumoral injection of a TLR9 agonist CpG-A oligonucleotide is expected to convert “cold”, checkpoint-unresponsive tumors into “hot” tumors, resulting in an increased response rate to combination therapy.
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5:30 Dinner Short Course Registration

5:45 Close of Rational Combination Cancer Immunotherapy


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