December 5-7th, 2017

Miami, FL

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Day One
Tuesday December 5th, 2017

Day Two
Wednesday December 6th, 2017

08.00
Breakfast & Registration

09.00
Chair’s Opening Remarks

Combination Therapies: Checkpoint Modulation & Beyond

09.30
Development Strategy of HF10, a Spontaneous Mutant Herpes Simplex Virus

  • Robert Andtbacka Co-Director Melanoma Program & Melanoma Clinical Research Program , Huntsman Cancer Institute

Synopsis

  • HF10 is the spontaneous mutant strain of HSV-1 with attenuated virulence and lack of neuroinvasiveness. Because of no exogenous gene (ex. GM-CSF), there is less regulatory hurdles
  • Oncolytic viruses are categorized as regenerative medicine products in Japan, and could be approved based on the limited endpoint data, if the product has an effect that is reasonably likely to predict clinical benefit
  • The combination of HF10 and Ipilimumab demonstrated a favorable benefit/risk profile and encouraging antitumor activity in patients with stage IIIB, IIIC, or IV unresectable or metastatic melanoma
  • Neoadjuvant HF10 and Nivolumab in resectable metastatic melanoma is being investigated, and is likely to yield clinical benefit
  • Endoscopic ultrasound guided HF10 injection in pancreatic cancer has also been established

10.30
Morning Refreshments & Speed Networking

OVs and the Tumor Microenvironment

11.30
An Oncolytic Virus Expressing a FAP-Specific T-Cell Engager to Target Stroma-Rich Tumors

Synopsis

  • Enadenotucirev (EnAd) is a chimeric oncolytic group B adenovirus with potent and selective anti-tumor activity against a range of epithelial cancer cells, with a blood stability profile that enables systemic dosing and has been administered intravenously to over 100 cancer patients
  • Cancer-associated fibroblasts (CAFs) play a pivotal role in the development of solid carcinomas by facilitating invasion, coordinating angiogenesis and establishing and maintaining an immune suppressive microenvironment in the tumor stromal tissue
  • As an approach to immunogene therapy targeting stromal rich tumors, transgenemodified variants of EnAd expressing a bi-specific T-cell engager (BiTE) molecule recognizing human fibroblast activating protein (FAP) on cancer associated fibroblasts (CAFs) and CD3 on T-cells have been produced
  • Clinical candidates are in preparation to test whether production of BiTE proteins by virus infected tumor cells could be an effective way of modifying the stromal microenvironment to drive effective anti-tumor immunity and would bypass delivery and safety issues related to systemic dosing of BiTE proteins

12.00
PeptiCRAd™: An Innovative Oncolytic Vaccine Platform to Refocus the Immune Response from Virus to Tumor

  • Sari Pesonen VP, Scientific & Clinical Development , Valo Therapeutics

Synopsis

  • Our results clearly show that PeptiCRAd is superior to oncolytic virus or peptide vaccinations
  • With the PeptiCRAd approach, tumour specific peptides were efficiently cross-presented in an MHC-I restricted manner. In addition, both the frequency of dendritic cells cross-presenting the PeptiCRAd peptides and the frequency of peptide-specific CD8+ T-cells were clearly elevated in PeptiCRAd treated animals compared to virus alone or virus with non-complexed peptide
  • PeptiCRAd technology combines peptide vaccination and oncolytic virus-based immunotherapy, to deliver a highly synergistic anti-tumor effect
  • This strategy can be used to rapidly and cost efficently target different tumors and antigens without the need to manipulate the viral backbone
  • Phase I/II clinical trial is in preparation

12.30
T-StealthTM Technology Promotes Synergy Between Oncolytic Viruses and Immuno-Stimulatory Agents

Synopsis

  • The immune system is both friend and foe to OV: OV need the immune system to attack and kill uninfected tumor cells, but the immune system is best at eliminating viruses rather than cancer
  • To be successful, regimens combining OV and immune-stimulatory agents must deal with the downsides of anti-viral innate and adaptive immune responses in the tumor microenvironment  without affecting anti-tumor immunity
  • BeneVir platform OV encode T-StealthTM Technology, which hides OV from both innate and adaptive immunity in order to mitigate the downsides of anti-viral immunity without negatively affecting anti-tumor immune responses

13.00
Lunch & Networking

OVs to Elicit True Immune Responses

14.00
Introducing Replimune’s Next Generation “Immulytic™” Oncolytic Immunotherapy Platform

Synopsis

  • Oncolytic immunotherapy requires the robust virus-mediated destruction of tumors by immunogenic cell death, with the accompanying release of tumor antigens (including neoantigens),  ombined with the stimulation of potent anti-tumor immune responses to provide systemic clinical benefit
  • Replimune has developed a new oncolytic immunotherapy platform which aims to maximize each of these properties and therefore maximize the clinical benefit which can be achieved
  • This is intended to generate a potent and practical tumor neoantigen vaccine in situ within the patient which is potentially appropriate for the treatment of all solid tumor types, particularly
    in combination with other therapies such as those targeting PD-1/L1
  • In addition to providing enhanced tumor cell death and viral spread within the tumor, Replimune’s Immulytic platform delivers multiple potent immune activating proteins directly to tumors and draining lymph nodes, focusing on the targeting of pathways which may best be activated or inhibited at the site of immune response initiation, rather than through the use of
    systemic antibody approaches
  • This includes the delivery of optimized versions of the ligands for the immune co-stimulatory pathways and antibody-like molecules targeting CTLA-4, both of which Replimune has found
    to be very powerful means by which to augment systemic effects and the “Immulytic” delivery of which Replimune believes may supersede other approaches to addressing these targets. Replimune’s first product, RP1, has recently initiated a large Phase 1/2 clinical trial in multiple tumor types, including in combination with anti-PD1 therapy

14.30
Roundtable Discussion: Preclinical Drug Safety

Synopsis

  • Species selection
  • Biodistribution and shedding
  • Translation of preclinical dosing to FIH
  • Assessment of immunogenicity

15.30
Chair’s Closing Remarks

16.00
End of Day 1