PCIB - Annual report 2018
The Board of Directors of PCI Biotech Holding ASA has approved the Annual Report 2018 and the report is attached. The Annual Report 2018 is also available on the company’s website www.pcibiotech.com.
For further information, please contact:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 940 05 757
About PCI Biotech
PCI Biotech is a biopharmaceutical 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 fimaChem programme consists of a clinical Phase I/II clinical 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
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Attachment
2018 Annual report PCI Biotech Holding ASA
https://ml-eu.globenewswire.com/Resource/Download/82751277-a911-4dfe-9838-7512e2f8035e
For further information, please contact:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 940 05 757
About PCI Biotech
PCI Biotech is a biopharmaceutical 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 fimaChem programme consists of a clinical Phase I/II clinical 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
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Attachment
2018 Annual report PCI Biotech Holding ASA
https://ml-eu.globenewswire.com/Resource/Download/82751277-a911-4dfe-9838-7512e2f8035e
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OUTLOOK
PCI Biotech believes that the proprietary PCI technology has the possibility to unlock the true potential of certain classes of innovative medicines. Supported also by external collaboration partners opinion, the PCI technology has the opportunity of playing a significant role in the realisation of several new therapeutic modalities, including immunotherapy (fimaVACC) and nucleic acid therapeutics (fimaNAc).
Although the company’s focus is three-pronged, divided over the three programmes, most resources are currently spent on progressing the lead project of fimaCHEM, which is the clinical development programme of fimaporfin with gemcitabine for the treatment of inoperable extrahepatic bile duct cancer; a rare disease with high unmet medical need. Based on the encouraging early signs of efficacy in Phase I, the company worked with the key regulators in Europe and the U.S. receiving important guidance which informs the design for a pivotal phase study. The final pivotal study design has thus been determined and funding expected to finance the study beyond interim read-out is now in place. During this next step, the company will maintain its full commitment of advancing the programme with the ambition of helping the patients currently left without effective treatment options achieve a good quality of life.
In parallel, the two other programmes, fimaVACC and fimaNAc, are proceeding in accordance with the established development strategy. The clinical validation of the fimaVACC technology is essential for PCI Biotech’s role within the immunotherapy space and the Phase I study in healthy volunteers will provide results on clinical translation of the technology into humans. The initial results are encouraging, and the study is expected to provide key data to support decisions of the programme’s further development strategy. The fimaNAc programme continues to follow a collaborative approach, by pursuing out-licensing opportunities.
In short, the main priorities of PCI Biotech at this time are to:
Effectively drive the fimaCHEM development programme in inoperable extrahepatic bile duct cancer towards the market;
Complete the clinical translation of the fimaVACC technology and determine the further development strategy
Manage alliance and partnering activities across all commercially interesting areas for the PCI platform.
PCI Biotech believes that the proprietary PCI technology has the possibility to unlock the true potential of certain classes of innovative medicines. Supported also by external collaboration partners opinion, the PCI technology has the opportunity of playing a significant role in the realisation of several new therapeutic modalities, including immunotherapy (fimaVACC) and nucleic acid therapeutics (fimaNAc).
Although the company’s focus is three-pronged, divided over the three programmes, most resources are currently spent on progressing the lead project of fimaCHEM, which is the clinical development programme of fimaporfin with gemcitabine for the treatment of inoperable extrahepatic bile duct cancer; a rare disease with high unmet medical need. Based on the encouraging early signs of efficacy in Phase I, the company worked with the key regulators in Europe and the U.S. receiving important guidance which informs the design for a pivotal phase study. The final pivotal study design has thus been determined and funding expected to finance the study beyond interim read-out is now in place. During this next step, the company will maintain its full commitment of advancing the programme with the ambition of helping the patients currently left without effective treatment options achieve a good quality of life.
In parallel, the two other programmes, fimaVACC and fimaNAc, are proceeding in accordance with the established development strategy. The clinical validation of the fimaVACC technology is essential for PCI Biotech’s role within the immunotherapy space and the Phase I study in healthy volunteers will provide results on clinical translation of the technology into humans. The initial results are encouraging, and the study is expected to provide key data to support decisions of the programme’s further development strategy. The fimaNAc programme continues to follow a collaborative approach, by pursuing out-licensing opportunities.
In short, the main priorities of PCI Biotech at this time are to:
Effectively drive the fimaCHEM development programme in inoperable extrahepatic bile duct cancer towards the market;
Complete the clinical translation of the fimaVACC technology and determine the further development strategy
Manage alliance and partnering activities across all commercially interesting areas for the PCI platform.