PCI Biotech: Successful Investigational New Drug application

PCI Biotech has received clearance by the United States Food and Drug Administration (FDA) to include patients in the US in its Phase II clinical programme for fimaporfin (Amphinex®).

Fimaporfin is in clinical development for inoperable bile duct cancer and the opening of the IND is in accordance with the previously communicated plan to expand the bile duct cancer programme to the USA following the promising early signs of efficacy in Phase I.

PCI Biotech is one of Radium Hospital Research Foundation´s portfolio companies.

www.pcibiotech.com

 

 

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 siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.


Nordic Naonvector raised 497 MNOK

Nordic Nanovector raised  MNOK 497 in gross proceeds through a private placement. The Private Placement was completed at a subscription price of NOK 114 per share, which was determined through an accelerated book-building process.

The Private Placement was oversubscribed and attracted strong interest from both existing shareholders and new institutional investors.

Nordic Nanovector intends to use the net proceeds:

  •   To fund a Phase 2 combination study of Betalutin® and Rituximab CD20
  •   To fund a Phase 1 study and GMP manufacturing for 177Lu-conjugated chimeric antibody (anti-CD37 ARC)
  •   Develop new proprietary antibody production technology
  •   Accelerate pipeline of pre-clinical assets to clinical trials
  •   Prepare for commercial launch of Betalutin®
  •   General corporate purposes

 

Please go to Nordic Nanovector`s latest investor presentation.

 

About Nordic Nanovector:

Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.

Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab, conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.

Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its pipeline of innovative targeted immunoconjugate therapies for multiple selected cancer indications.

 

 

Nordicna Novector

Nordic Nanovector appoints Dr Lisa Rojkjaer, MD as Chief Medical Officer

Nordic Nanovector ASA (OSE: NANO) is pleased to announce that Lisa Rojkjaer, MD has joined the company today as Chief Medical Officer (CMO) and as a member of the Executive Management Team. Dr Rojkjaer will lead all clinical development strategy and execution and support the company’s efforts to identify opportunities to expand its pipeline of innovative targeted therapies for haematological cancers.

Dr Rojkjaer is a board-certified haematologist with more than 15 years of global and regional clinical development and medical affairs expertise in the biotech and pharma industries, and has extensive experience in the development of both biologics and small molecules in haematology and immunology. She joins Nordic Nanovector from Novartis Pharmaceuticals where she held the position of Global Clinical Program Head, Oncology Global Development. Her previous roles also include CMO at Molecular Partners (Switzerland), Vice President, Head of Clinical Development at Morphosys AG (Germany), and Head of Global Medical Affairs, Biopharmaceuticals and Director of Clinical Development, Hematology in the US for Novo Nordisk.

Dr Rojkjaer holds a medical degree from the University of Toronto and received board certification in both internal medicine and hematology.

Dr Rojkjaer commented: “I am delighted to join Nordic Nanovector at this exciting time in its development. The company’s lead candidate Betalutin® is demonstrating in clinical studies its potential to become an important new therapy for the treatment of NHL patients. Its technology is also providing multiple exciting new pipeline opportunities. I look forward to working with the management team and contributing to the future growth of the company.”

Luigi Costa, Chief Executive Officer, added: “I am very pleased to welcome Lisa to the team. She brings on board strong expertise in clinical development of novel cancer treatments, particularly in the field of haematology. Lisa’s knowledge and leadership will be key to the development of Betalutin® as well as to support the growth of Nordic Nanovector’s promising pipeline.”

Photocure ASA: Third Quarter 2016

Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, reported a revenue growth of 17 % to NOK 31.6 million in the third quarter of 2016 (Q3 2015: NOK 27.0) for the Hexvix/Cysview commercial franchise and a corresponding EBITDA of NOK 8.0 million.

“As in the previous two quarters, Photocure continued to grow sales revenues in third quarter. The Hexvix/Cysview sales revenue increase for the quarter and first nine months was double digit. It is encouraging to see the positive momentum of volume growth and increased adoption of Cysview in the US, both in the quarter and year to date,” says Kjetil Hestdal, president and CEO.

Photocure reported total revenues of NOK 35.2 million in the third quarter of 2016 (35.9), with an EBITDA of NOK -1.6 million (-1.6). Net profit was NOK 0.1 million (-5.0), while the cash position ended at NOK 93.9 million. The underlying sales revenue growth of 17 % for the Hexvix/Cysview franchise was driven by increased demand in the US, price increases and foreign exchange rates. Total Hexvix/Cysview global in-market sales increased 12% to NOK 181 million year to date with a year to date in-market unit sales growth of 5%

In the US, third quarter revenue increased 46% and year to date revenue increased 43% compared to same periods the prior year. The increase was driven by volume growth, positive foreign exchange rates and price increase. In constant currency, year to date revenue grew 35% compared to the same period in 2015.

“The US growth was driven both by the number of permanent blue light cystoscopes (BLCs) installed at leading US hospitals/urology centers and by increased average usage per center. In addition, several new and key medical publications on the medical benefits of Blue Light Cystoscopy with Hexvix/Cysview were announced in the third quarter, including studies published in Bladder Cancer, World Journal of Urology and The Journal of Urology, documenting clinical benefits for bladder cancer patients by using Hexvix/Cysview,” says Hestdal.

Photocure expects to increase unit sales for Hexvix/Cysview through continued positive sales development of Cysview in the US, launch in new markets as well as growth in key mature markets. The company will continue to expand its commercial presence in urology by furthering the Hexvix/Cysview opportunity in the bladder cancer surveillance market with finalization of the new phase 3 clinical trial.

The company expects this trial to cost USD 7.5 million in total, down from originally planned USD 8.5 million. Photocure is entitled to receive EUR 4 million from Galderma in the fourth quarter of 2016, as the final payment related to the 2009 Metvix asset purchase agreement.

“The patient enrollment in the phase 3 clinical study of Blue Light Flexible Cystoscopy with Cysview is progressing according to plan and expected to be fully recruited by the end of 2016. Our cash position is expected to remain solid throughout 2016 including committed deferred payments and milestones. We are also working closely with our advisor and remain fully committed to establish strategic partnerships for our non-urology pipeline products, Visonac and Cevira”, says Hestdal.

Please see link to the full financial report and presentation.

Photocure ASA will present its interim report today at Hotel Continental, Oslo, Norway.  Continental, Oslo, Norway. The presentation will begin at 08.30 (CET) and representatives from the company will be Kjetil Hestdal, President & CEO, Erik Dahl, CFO. The presentation will be publicly available at www.photocure.com. It will be possible to follow the presentation through a live webcast.

Photocure will additionally host an audio webcast and conference call today in English at 17:00 CET / 16:00 GMT / 12:00 EST.

Please join the event conference 5-10 minutes prior to the start time using the number and confirmation code below:

  •   NORWAY:       +47 2350 0296
  •   UK:                  +44(0)20 7026 5967
  •   USA:                +1 719 325 2213

Confirmation code: 9330000

It is possible to listen to a replay of the conference call on the following numbers:

  •   NORWAY        +47 2350 0077
  •   UK                   +44 (0)207 984 7568
  •   USA                 +1 719 457 0820

Confirmation code: 9330000

Oncoimmunity, Vaccibody, Nextera and Nordic Nanovector granted BIA-funding

The Norwegian Research Council granted  Oslo Cancer Cluster member companies Oncoimmunity, Vaccibody, Nextera and Nordic Nanovector funding through the Programme for User-Driven Research Based Innovation (BIA).

In total, the Norwegian Research Council will grant 532 MNOK to 50 Norwegian companies, of which 10 are within biomedicine.

Oncoimmunity, Vaccibody, Nextera and Nordic Nanovector will receive between 15-20 million NOK each over 4 years, depending on the outcome of the contract negotiations between the council and the companies. Funding from the BIA programme is a quality stamp since the companies compete in “open class” where all sectors are represented.

 

Titles for the granted innovation projects:

  • Vaccibody: Targeted Personalized Therapeutic Cancer Vaccines
    Press release from Vaccibody
  • Nordic Nanovector: Development of Two New Antibody Radionuclide Conjugates for Treatment of Malignant Lymphoma and Leukemia
  • Oncoimmunity: Software for profiling tumor neo-antigens to empower cancer immunotherapy
  • Nextera: Novel targeted therapy for treating Leukemia