Igniting a Systemic Immune Response to Cancer
August 2023
Safe harbor
Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the advancement, timing and sufficiency of our clinical trials, patient enrollments in our existing and planned clinical trials and the timing thereof, the results of our clinical trials, the timing and release of our clinical data, statements regarding our expectations about our cash runway, our goals to develop and commercialize our product candidates, our expectations regarding the size of the patient populations for our product candidates if approved for commercial use and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the SARS-COV-2 coronavirus as a global pandemic and related public health issues, the ongoing military conflict between Russia and Ukraine and the impact on the global economy and related governmental imposed sanctions, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
© 2023 Replimune Group Inc. | 2 |
Replimune overview
- Industry leader in tumor directed oncolytic immunotherapy (TDOI)
- Potential to be a cornerstone treatment in immuno-oncology; 3 wholly owned programs (RP1, RP2, RP3)
- RP1 data supports the emergence of a major skin cancer franchise; two registrational studies fully enrolled
- 211 patient 1L CSCC randomized controlled; primary analysis early Q4 2023
- 47% CR rate / 65% ORR with strong durability in prior study
- 141 patient study in anti-PD1 failed melanoma; data release six months post LPI - late Q4 2023
- 20% CR rate / 37% ORR in first 75 patients with activity across all disease stages and strong durability
- Broad mid-stage development planned with RP2 and RP3; responses shown in multiple unmet need indications
- Several potential fast to market opportunities
- Cost sharing collaboration with Roche in 3L CRC and 2L HCC
- Potential for the portfolio to deliver substantial commercial revenues beginning in 2025
- Capitalized to build a fully integrated biotech company; US commercial infrastructure, in-house manufacturing
- June 30 2023, cash & short-term investments c. $539m
3 3
Tumor directed oncolytic immunotherapy mechanism of action
Attenuated potent new clinical isolate of HSV-1 modified to express a fusogenic glycoprotein and immune stimulating proteins
Intact host antiviral response: Normal tissue remains undamaged
Healthy tissue
Injected tumor
Oncolytic | |
immunotherapy | M E C H A N I S M |
Dysregulated host antiviral | 1 |
response allows robust virus | |
replication and tumor lysis |
Tumor tissue
Immune response
M E C H A N I S M | Dendritic cell | |
2 | T cell | |
Tumor cell death and | Enhanced T cell | |
release of tumor antigens | priming and activation | |
Release | Local | T cell infiltration and killing of |
of virus progeny | Inflammation | distant, uninjected tumors |
Infection of more | Altering of tumor | Generating a strong and |
tumor cells | microenvironment | durable systemic anti- |
tumor immune response |
Injected
tumor
Distant tumors
Bommareddy PK et al AJCD. 2016
© 2023 Replimune Group Inc. | 4 |
RPx positioning: Platform designed to address a range of tumor types with an optimal balance of potency & safety
Payloads | GALV-GPR-,GM-CSF | GALV-GPR-,anti-CTLA-4,GM-CSF | GALV-GPR-,anti-CTLA-4, CD40L, 4-1BBL |
Target | Immunologically responsive tumor types, | Less immunologically responsive tumor | Less immunologically responsive tumor |
types (anticipated further improved | |||
including anti-PD1 failed | types | ||
compared to RP2) | |||
Intended indication(s) | Skin cancers (CSCC, anti-PD1 failed melanoma, | Various solid tumors including primary liver cancers and/or those with a high | |
prevalence of liver metastases e.g. HCC, CRC; Early disease (neoadjuvant/LA | |||
anti-PD1 failed CSCC, other NMSCs, etc) | |||
opportunities) e.g. SCCHN | |||
Clinical activity in anti-PD1 | Ongoing | ||
failed patients demonstrated | |||
Safety & good tolerability | Ongoing | ||
demonstrated | |||
Injection location | Superficial, nodal & visceral | Superficial, nodal & visceral | Superficial, nodal & visceral |
Systemic activity | Clear systemic effects seen in responding patients (un-injected tumor responses, | Ongoing | |
responses are generally highly durable) | |||
Other design considerations | Designed for more I-O sensitive tumor types | Increased I-O systemic activity, also with | Designed to maximize systemic I-O |
with excellent safety alone & in combination | excellent safety alone & in combination | activity & potency | |
© 2023 Replimune Group Inc. | 5 |
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Replimune Group Inc. published this content on 11 August 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 August 2023 15:02:07 UTC.