PCI Biotech: First half-year 2020 results
Oslo (Norway), 26 August 2020 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announces its interim first half-year and Q2
2020 results. Please find enclosed the report and presentation.
Highlights
fimaChem
*The main priorities during the COVID-19 pandemic has been identification and
implementation of potential mitigating actions for progressing the RELEASE
study. Screening into the RELEASE study has been severely affected in the first
half of 2020 with only one patient recruited during the pandemic, and the study
has yet to enrol the first US patient. The situation is still unclear and the
long-term consequences of the pandemic are uncertain
*Good progress in Asia, with the first 8 RELEASE study sites recently opened. A
total of 44 sites are open by mid-August 2020 across EU, US and Asia and >50
sites are planned to be included into the study
*The Asian clinical sites are located in South Korea and Taiwan, providing
access to hospitals and KOL’s in a commercially interesting region with higher
prevalence of bile duct cancer than in the US and EU
*Several new initiatives to recoup long-term recruitment projections are being
implemented, with the aim to accelerate patient inclusion when the current
constraints on clinical trials inflicted by the COVID-19 pandemic are resolved.
A complete picture of the consequences for the RELEASE study and the effect of
the new initiatives are not yet available, but a delay of 6-12 months may be
anticipated. The expected timeline for the planned interim analysis by 1H 2022
is therefore extended to range from 2H 2022 to 1H 2023, and the current cash-
position may not be sufficient to reach interim read of the RELEASE study
*An article with a case report series from the Phase I study has been accepted
for publication in Endoscopy International Open. The article provides a detailed
description of treatment effects in three select patients at the dose chosen for
RELEASE
fimaVacc
*Two new US patents have been granted in 2020, providing broad coverage for the
combination of fimaVACC with various cytokines and a new important class of
adjuvants
fimaNAc
*The evaluation period under the preclinical research collaboration with
AstraZeneca has been extended by 6 months and the evaluation of the potential
for a further collaboration now runs to the end of 2020
*The research collaborations have recently been reviewed for progress and value
to PCI Biotech, and prioritised accordingly, resulting in closure of three
collaborations
Corporate
*The management team was in May 2020 strengthened by the appointment of Dr Amir
Snapir as CMO and Mr Ludovic Robin as CBO
Per Walday, CEO of PCI Biotech, comments: “Our highest priority during the
COVID-19 pandemic has been the safety of our patients, employees and
collaborators. We have previously communicated that this pandemic will result in
yet undeterminable delays and increased cost, and we now see that recruitment
into the RELEASE study has been severely affected by the COVID-19 pandemic. This
is probably due to several factors, including the study being done in busy
tertiary hospitals often requiring patient travel, involving treatment
procedures demanding key hospital resources, and CCA being a rare disease. On
the other hand, we have seen good progress in the work to ensure an optimised
study when the pandemic issues are resolved, with regulatory approval and sites
initiated in both South Korea and Taiwan, 10 new RELEASE study sites opened
since the Q1 2020 report, and good progress in our efforts to relax relevant
patient eligibility criteria. We have initiated work to include Ukraine in the
study and are also considering further Asian countries. We should now be well
positioned to accelerate the RELEASE study when the COVID-19 pandemic subsides.
Two important fimaVacc patents have been granted in the US and we are
intensifying our efforts to find partners and move this programme to clinical
proof-of-concept in a disease setting. With all these tasks at hand, we are very
pleased to have strengthened the executive team with Dr Amir Snapir as CMO and
Mr Ludovic Robin as CBO, who have both taken strong strategic and operational
ownership in the work.”
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