June 26-28, 2018

Frankfurt, Germany

Day One
Wednesday 27th June, 2018

Day Two
Thursday 28th June, 2018

09.00
Chair’s Opening Remarks

Manufacturing Strategies to Produce Quality Armed Viruses to Future-Proof Plans of Large Scale Trials

09.10
Developing a CMC Strategy for Oncolytic Virus based Cancer Immunotherapy

  • Julia Pomoransky Manager, Manufacturing Sciences & Technology, Turnstone Biologics

Synopsis

  • Oncolytic vaccine development is anchored in the analytical toolbox developed
  • Applying Quality-by-Design principles, including defining a Target Product Profile
    help frame scope for development
  • Accurate assessments of potency for in the context dose (safety and efficacy),
    stability, and manufacturing productivity are critical
  • Integrating the above leads to a CMC development plan that is phase appropriate,
    and can stay ahead of your clinical development plan

09.40
Overcoming the Manufacturing Challenges in Taking Novel Oncolytic Immunotherapy Products from Design to Approval

Synopsis

  • Replimune has developed a new oncolytic immunotherapy platform which aims to maximize the robust virus-mediated destruction of tumors  combined with the stimulation of potent anti-tumor immune responses to provide systemic clinical benefit
  • With a pipeline of new oncolytic immunotherapy products the pathway from design to initial clinical trials should be rapid and robust
  • Manufacturing strategy is key to ensuring a smooth transition from early phase clinical trials in to pivotal clinical trials
  • Armed oncolytic immunotherapies will provide some unique manufacturing challenges during the approval process

10.10
Panel Discussion: Strategies to Accelerate Movement into Early Stage Clinical Development with Future Focused Plans for Mature Commercialisation

Synopsis

  • Identify the full product development of early stage clinical concepts
  • Strategies to reduce the time taken to move into clinical trials
  • Plan for success by considering regulatory strategies for mature commercialisation of viral therapies
  • Explore different manufacturing standards in Europe

10.40
Morning Refreshments and Speed Networking

Strategies to Arm the Virus to Enhance Clinical Efficacy

11.40
Durable Immunotherapeutic Effects and Abscopal Efficacy of a HER2- Retargeted IL12-Armed oHSV

Synopsis

  • HER2-retargeted oHSV are fully virulent for their HER2-pos target cells. They carry
    no deletion/mutation or genetic change other than those necessary for tropism
    modification. They are highly safe in mice
  • Unlike most o-HSVs, which fail to contrast innate response, fully-virulent oHSV elicit
    and then dampen innate response. The immunotherapeutic potential of the HER2-
    retargeted fully virulent oHSVs was unknown
  • A IL12-armed HER2-retargeted oHSV elicits a strong immunotherapeutic effect, fully
    protects from distant tumors, unleashes the immunosuppression by recruiting and
    activating NK and CD8+ cells. A durable immunity is established
  • The HER2-retargeted oHSVs act as potent anticancer vaccines

12.10
Enabling T-Cell Therapies for Solid Tumors with Armed Oncolytic Adenoviruses

  • Akseli Hemminki Founder, Chief Executive Officer & Chairman of the Board, TILT Biotherapeutics

Synopsis

  • Observations and data from Advanced Therapy Access Program and research
    conducted by Univ. of Helsinki CGTG leading to founding of TILT
  • About the lead product TILT-123, a TNFá/IL2 armed oncolytic adenovirus, for which
    100% efficacy has been demonstrated with TILs, aPD1, and CAR-T
  • Overview of TILT Biotherapeutics’ Phase I trial plans with TILT-123

12.40
Retroviral Replicating Vectors for Armed Oncolytic Immunovirotherapy

  • Asha Das Senior Vice President & Chief Medical Officer, Tocagen

Synopsis

  • Retroviral replicating vectors can efficiently deliver a wide variety of transgenes, including pro-drug activator (‘suicide’) genes, which convert systemically administered precursor pro-drugs into active cytotoxic drugs within the infected cancer cells
  • Clinical trials of Toca 511, an optimized RRV expressing the yeast cytosine deaminase prodrug activator gene, have shown highly promising evidence of therapeutic benefit.  An international Phase III trial for recurrent high-grade glioma is currently on-going, as well as a new Phase I trial for intravenous delivery of Toca 511 in systemic malignancies
  • Further clinical development of Toca 511 and Toca FC is discussed

13.10
Lunch and Networking

14.10
InvirIO® : Immuno-Armed Oncolytic Vaccinia Viruses to Reprogram the Tumor Microenvironment

Synopsis

  • Oncolytic vaccinia virus (oVV) represents an appealing engineering platform, by exploiting
    its favorable immunogenic properties, and its large genome capacity
  • Our experience with two products in clinics (PexaVec, and TG6002), and one preclinical
    product (VV-aPD1) already exemplified the feasibility of amplifying the oncolytic action
    by additional delivery of either a cytokine, an enzyme, or an antibody into the tumor
    microenvironment
  • We are currently developing recombinant oVVs that express various modalities to
    break immune tolerance in the tumor, for example by modulating the content of
    immunosuppressive cells or metabolites

14.40
Immunizing CRAd for Carcinoma of the Ovary

Synopsis

  • Current models do not allow full assessment of anti-tumor immunization of adenovirus virotherapy agents
  • We have identified a replication-permissive immunocompetent murine model of cancer of the ovary
  • The model helps identify the most potent immunotherapy arming for our tumor targeted CRAds to determine the most effective anti-tumor immunization

15.10
Afternoon Refreshments

15.40
Valo Therapeutics: Reinventing Cancer Immunotherapy

Synopsis

  • PeptiCRAd technology: A therapeutic vaccination against cancer
  • Mechanisms of Action: Educating the immune system to recognise and target
    tumour cells
  • Preliminary Data: PeptiCRAd generates a strong anti-tumor immune response

Clinical Developments of Oncolytic Bacteria

16.10
Engineered Salmonella typhimurium for Enhancement of Anti-Cancer Immunity

  • Jung-Joon Min Professor & Chair, Department of Nuclear Medicine, Chonnam National University Medical School

Synopsis

  • Payloads expressed and delivered by attenuated Salmonella for anti-cancer
    immunity
  • Mechanism of Salmonella-mediated cancer therapy
  • Strategies for imaging and monitoring Salmonella-mediated cancer therapy

16.40
Chair’s Closing Remarks

16.45
End of Day 1