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Expert Interview

Slingshot members are talking to an expert! The topic is:

Discussing the IGNYTE study and potential of RP1 in combination with nivolumab for treating various cancers, with a focus on Melanoma.

Ticker(s): REPL

Who's the expert?

Institution: Yale

  • Clinical Director of the Early Drug Development Program, performing Phase I clinical trials of new cancer medicines
  • Manages 20-30 Breast Cancer Patients in addition to patients with melanoma.
  • Former: Medical Science Director for AstraZeneca’s Boston site, responsible for the medical and clinical aspects of development of agents from chemical lead identification through clinical proof of concept in phase II. Responsible for the design and interpretation of the entire clinical development plan for five agents.

Interview Questions
Q1.

1. Please talk about your experience and details about your clinical practice.

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Q2.

2. Please comment on the history of oncolytic viruses and what lessons can be learned from successes and failures in the field?

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Q3.

3. What is the best approach to oncolytic viruses and do you see Replimune's RP1 as differentiated or likely to succeed?

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Q4.

4. Replimune characterizes the bar for responses with SOC following PD-1 failure as 6-7%. What is typically the level of response you see in that setting? Is this different now with Opdualag and/or ipi-nivo Combo as the first line treatment?

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Q5.

5. Early data showed 37.5% ORR (6/16) and 12.5% (2/16) CR rate in PD-1 failed patients provided RP1 + opdivo. Are these numbers impressive, and does this bode well for the registrational single-arm trial?

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Q6.

6. 5 out of the 6 responses were in "Primary Refractory" patients without any response to PD-1 prior to progressing on the PD-1, before receiving RP1+Nivo. Please comment on the distinction of primary refractory.

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Q7.

7. What is the bar for Response Rates in Primary Refractory setting? If the patient population in the registrational cohort is a mix, what is the bar for efficacy if PD-1 failed patients were NOT primary refractory?

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Q8.

8. Is a single arm trial appropriate for this setting?

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Q9.

9. How did the safety profile look from early data, and in the context of toxicity profiles of existing combos?

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Q10.

10. Please comment on Replimune's slides from the Phase 1 data showing local and distal responses and the spider plots?

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Q11.

11. In the CSCC indication, the CERPASS trial is ongoing randomizing to RP1+Libtayo vs. Libtayo alone. In a small number of patients (17) in phase 1, Libtayo + RP1 resulted in ORR of 65% and CR rate of 47%. That seems very high, given Libtayo's single digit CR rates as SOC. Does this suggest the randomized trial has a good probability of success?

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Q12.

12. Please rate your level of excitement about RP1 in combination with PD-1 antibodies on a scale of 1-10 and explain the number you chose.

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