Our
Pipeline

Developing the next generation of oncolytic immunotherapy.

Replimune is executing a broad, aggressive development plan with a pipeline of potent oncolytic immunotherapies now entering clinical studies for multiple types of cancer. Our goal is to realize the potential of our Immulytic™ platform to treat a wide range of solid tumors, including ‘immunologically cold’ tumor types.

RP1
RP1 is our first Immulytic™ product to enter the clinic.

RP1 is a version of herpes simplex virus type 1, the virus that generally causes cold sores or fever bilsters, which has been engineered to replicate selectively in tumors. To aid in the direct killing of tumors and in the induction of anti-tumor immune response, RP1 is ‘armed’ with two genes, a gene encoding a fusogenic protein intended to result in enhanced cell death and enhanced immunogenicity of cell death, and a gene encoding GM-CSF, a cytokine intended to aid immune activation.

RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses optimized immune co-stimulatory pathway ligands. These therapeutics provide targeted delivery to the sites of immune response initiation in the tumor and draining lymph nodes with the goal of focusing systemic immune-based efficacy on tumors and limiting off target toxicity.

Our Pipeline

DEVELOPMENT PHASE

PRE-CLINICAL

PHASE 1

PHASE 2

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Oncolytic immunotherapy armed with GM-CSF & a potent fusogenic protein (GALV-GP R-)
ARTACUS TRIAL – CSCC transplant patients: RP1 monotherapy *
REPL-001-16 TRIAL – Melanoma: RP1 + OPDIVO® † REPL-001-16 TRIAL – Non-melanoma skin cancers: RP1 + OPDIVO® † REPL-001-16 TRIAL – Anti-PD1 refractory NSCLC: RP1 + OPDIVO® (not yet recruiting) REPL-001-16 TRIAL – MSI high cancers: RP1 + OPDIVO® REPL-0016 TRIAL – Anti-PD1 refractory melanoma: RP1 + OPDIVO® * CERPASS TRIAL – Cutaneous squamous cell carcinoma: RP1 + LIBTAYO® *
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RP1 additionally expressing anti-CTLA-4
RP2 monotherapy & RP2 + OPDIVO®
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Expresses GALV-GP-R-, anti-CTLA-4, CD40L & 4-1BBL
PD1 non-responsive tumors
* Potential registration studies † Data readouts to support the registration-directed trials

Replimune Pipeline

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DEVELOPMENT PHASE

PRE-CLINICAL

PHASES

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Expresses GALV-GP R- & GM-CSF Phase 1/2 underway in ≈150 patients
REGISTRATION DIRECTED Randomized, controlled Phase 2 clinical trial in ≈240 patients with CSCC. Initiating 2019

PHASE 1

Cutaneous squamous cell transplant patients - RP1 monotherapy *

PHASE 2

Melanoma - RP1 + OPDIVO® † Non-melanoma skin cancers - RP1 + OPDIVO® † Anti-PD1 refractory NSCLC - RP1 + OPDIVO® (not yet recruiting) MSI high cancers - RP1 + OPDIVO® Anti-PD1 refractory melanoma - RP1 + anti-PD1 * Cutaneous squamous cell carcinoma - RP1 + LIBTAYO® *
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Additionally expresses an anti- CTLA-4 antibody. Phase 1 initiating 2019

PHASE 1

RP2 monotherapy & RP2 + OPDIVO®
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Expresses GALV-GP R-, anti-CTLA-4, CD40L & 4-1BBL. Phase 1 initiating 2020
For PD1 non-responsive tumors
* Potential registration studies † Data readouts to support the registration-directed trials