Oslo (Norway), 13 December 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announced that the Independent Data Monitoring Committee (IDMC) has reviewed the safety data collected thus far in the RELEASE trial and recommends that the trial continues with up to two fimaChem treatments as stated in the protocol.

The ongoing pivotal RELEASE trial with registration intent was initiated with a planned safety review for the first eight patients receiving two fimaChem treatments. In the previously completed Phase I study a total of five patients received two treatments and now with additional eight patients reviewed for safety after two treatments, the RELEASE trial seamlessly continues to enrol patients for up to two fimaChem treatments.

Per Walday, CEO of PCI Biotech, said: “With this positive initial safety clearance for repeated treatments, PCI Biotech continue to focus on execution of the pivotal trial and we are eager to see the benefits fimaChem hopefully can provide to the patients in need of better local treatment options. So far, a clear majority of patients eligible to receive two treatments in RELEASE opted for the second treatment, which is an early encouraging sign on the acceptability of the treatment modality, both from a patient- and clinician perspective."

The IDMC consists of international experts in bile duct cancer and medical statistics and is chartered to monitor the safety of participants in the RELEASE trial. The primary purpose of the IDMC is the protection of participants in the trial and the maintenance of trial integrity. The IDMC recommendation is based on a review of the available trial safety data, including data from eight patients that had undergone two fimaChem treatments.

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 perihilar and distal 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        
pw@pcibiotech.no
Mobile: +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.