PCI Biotech: Update on regulatory interactions for the RELEASE trial

Oslo (Norway), 7 December 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announced that the company has concluded on the interactions with regulatory authorities in the US (US Food and Drug Administration, FDA) and Europe (European Medicines Agency, EMA) held during 2H 2021. The interactions with the FDA and EMA were initiated to explore the opportunity for a modified study design to address the retention risk in the control arm of the RELEASE study. PCI Biotech argued that enrichment of the control arm of RELEASE with external control data, using existing patient-level data from past clinical trials and real-world data from a patient registry for patients with extra-hepatic cholangiocarcinoma receiving gemcitabine-cisplatin, could address the potential retention issue and that this approach may also benefit recruitment. The company has previously reported that initial responses from the authorities suggested significant challenges for using external control data in a pivotal trial of a first line treatment. The authorities have now reiterated their position and given more granularity on their concerns. Both regulatory authorities recognised the retention and recruitment challenges for RELEASE in bile duct cancer, a rare disease with high unmet medical need. The authorities’ main concern is that the proposed modification would introduce a risk for uncontrolled bias. The feedback suggests that the validity of external control data for inferential statistical tests is not yet sufficiently corroborated for the settings of a global pivotal trial with registration intent. PCI Biotech acknowledges the feedback from the authorities and has concluded not to further pursue adoption of real-world data to supplement experimental control arm data in a randomised first line setting under the current regulatory environment. The company continue with full focus on RELEASE assessing all opportunities to address retention and recruitment. About PCI Biotech        PCI Biotech is a biopharmaceutical late-stage clinical development company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery). Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead programme fimaChem consists of a pivotal study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field. For further information, please visit: www.pcibiotech.com                 Contact information:        Per Walday, CEO        [email protected]: +47 917 93 429 Forward-looking statements        This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.