Replimune (REPL) outlined of the existing problem with their immune checkpoint blockade
therapy. They explained that the majority of patients do not respond to the therapy because they
require an inflamed tumour and a pre-existing immune response to the cancer. Replimune aims
to create genetically-armed oncolytic immunotherapy products to maximally activate the
immune response against cancer in order to promote a response to immune checkpoint blockade
therapies such as anti-PD1. Officials stated that an IPO was conducted in July 2018 and they
currently have $150m, which will fund operations until H2 2021.
Replimune summarised the trials planned for the company’s most advanced oncolytic immunegene therapy, RP1, which is based on a strain of herpes simplex virus that already has a good
safety and efficacy profile demonstrated through TVEC. In collaboration with Bristol Myers
Squibb, Replimune is conducting a two-part Phase I/II trial. The first part analyses the safety and
tolerability of RPG-1 alone and then in combination with nivolumab in advanced solid tumours.
The second part analyses the efficacy of RP1 with nivolumab in four types of solid tumours in a
signal finding setting. The company has completed enrollment of the RPG-1 alone part of the
Phase I study and opened recruitment for the RPG-1 plus nivolumab part. They expect results
from the full Phase I portion of the Phase I/II trial to be released in H2 2019.
In addition, Replimune confirmed that the Phase II part will initiate in H1 2019 in patients with
melanoma and non-melanoma skin cancers, microsatellite instability high cancers and bladder
cancer. Results from this trial are expected in H2 2020 and will determine which indication they
will progress into late stage development. Officials highlighted their 50/50 cost sharing
partnership with Regeneron, where they plan to initiate a registration-directed Phase II trial in
cutaneous squamous cell carcinoma (CSCC). They pointed out that this disease has a worsening
mortality rate, which is overtaking that of melanoma. They also noted that Cemiplimab is
effective with a 50% response rate, however, the complete response rate is only 5%. As a result,
officials believe that CSCC is a good indication for initial approval of RP1 in an accelerated fashion.
The Phase II trial is set to begin in H1 2019 and will enroll approximately 240 patients, results are
anticipated for H2 2021.
Officials switched their focus from RP1 to provide an update on its pipeline product candidates
RP2 and RP3. These are similar to RP1 and deliver proteins that act as the immune response is
being generated. Replimune believes that systemic antibody approaches are suboptimal here.
They explained that RP2 expresses GALV-GP-R and GM-CSF as well as anti-CTLA-4 antibody and
aims to be used in combination with anti-PD-1/PDL-1 therapy. Officials confirmed that a Phase I
trial for RP2 alone and in combination with anti-PD1 treatment will initiate in H12019.
Furthermore, Replimune revealed that the RP3 product that will be used in Phase I trials will
express CD40L and 4-1BBL as well as anti-CTLA-4 and GALV-GP-R to promote both an innate and
adaptive immune response. Officials reiterated that a Phase I trial is expected to begin in H1
2020. The aim for these products is to target more challenging indications compared to RP1,
although these indications have not been disclosed. Finally, Replimune summarised their
manufacturing status and announced that they have leased a large facility, which is sufficient to
produce material for all commercial needs. Consequently, an additional facility will only be
needed for redundancy purpose for later stage development and commercialisation, which will
begin in H2 2020.
therapy. They explained that the majority of patients do not respond to the therapy because they
require an inflamed tumour and a pre-existing immune response to the cancer. Replimune aims
to create genetically-armed oncolytic immunotherapy products to maximally activate the
immune response against cancer in order to promote a response to immune checkpoint blockade
therapies such as anti-PD1. Officials stated that an IPO was conducted in July 2018 and they
currently have $150m, which will fund operations until H2 2021.
Replimune summarised the trials planned for the company’s most advanced oncolytic immunegene therapy, RP1, which is based on a strain of herpes simplex virus that already has a good
safety and efficacy profile demonstrated through TVEC. In collaboration with Bristol Myers
Squibb, Replimune is conducting a two-part Phase I/II trial. The first part analyses the safety and
tolerability of RPG-1 alone and then in combination with nivolumab in advanced solid tumours.
The second part analyses the efficacy of RP1 with nivolumab in four types of solid tumours in a
signal finding setting. The company has completed enrollment of the RPG-1 alone part of the
Phase I study and opened recruitment for the RPG-1 plus nivolumab part. They expect results
from the full Phase I portion of the Phase I/II trial to be released in H2 2019.
In addition, Replimune confirmed that the Phase II part will initiate in H1 2019 in patients with
melanoma and non-melanoma skin cancers, microsatellite instability high cancers and bladder
cancer. Results from this trial are expected in H2 2020 and will determine which indication they
will progress into late stage development. Officials highlighted their 50/50 cost sharing
partnership with Regeneron, where they plan to initiate a registration-directed Phase II trial in
cutaneous squamous cell carcinoma (CSCC). They pointed out that this disease has a worsening
mortality rate, which is overtaking that of melanoma. They also noted that Cemiplimab is
effective with a 50% response rate, however, the complete response rate is only 5%. As a result,
officials believe that CSCC is a good indication for initial approval of RP1 in an accelerated fashion.
The Phase II trial is set to begin in H1 2019 and will enroll approximately 240 patients, results are
anticipated for H2 2021.
Officials switched their focus from RP1 to provide an update on its pipeline product candidates
RP2 and RP3. These are similar to RP1 and deliver proteins that act as the immune response is
being generated. Replimune believes that systemic antibody approaches are suboptimal here.
They explained that RP2 expresses GALV-GP-R and GM-CSF as well as anti-CTLA-4 antibody and
aims to be used in combination with anti-PD-1/PDL-1 therapy. Officials confirmed that a Phase I
trial for RP2 alone and in combination with anti-PD1 treatment will initiate in H12019.
Furthermore, Replimune revealed that the RP3 product that will be used in Phase I trials will
express CD40L and 4-1BBL as well as anti-CTLA-4 and GALV-GP-R to promote both an innate and
adaptive immune response. Officials reiterated that a Phase I trial is expected to begin in H1
2020. The aim for these products is to target more challenging indications compared to RP1,
although these indications have not been disclosed. Finally, Replimune summarised their
manufacturing status and announced that they have leased a large facility, which is sufficient to
produce material for all commercial needs. Consequently, an additional facility will only be
needed for redundancy purpose for later stage development and commercialisation, which will
begin in H2 2020.
