PCI Biotech with positive opinion for Orphan Drug Designation

Oslo Cancer Cluster member PCI Biotech has received positive opinion from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) for its lead product candidate, fimaporfin. Firmaprofin is intended to be used in the treatment of bile duct cancer,  cholangiocarcinoma.

Fimaporfin (AmphinexTM) is in clinical phase I/II development for inoperable bile duct cancer, a disease without approved medicinal treatment and a high need of better local treatment alternatives.

 

About bile duct cancer (cholangiocarcinoma)  
The bile duct drains bile from the liver into the small intestine. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death. Currently, surgery is the only curative option for these patients; yet the majority of the tumors are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. The combination of gemcitabine and cisplatin has shown promising results and has become standard treatment in some regions, but there is still a need for better treatments to increase overall survival and quality of life.

 

About PCI Biotech         
PCI Biotech is a cancer focused biopharmaceutical company headquartered in Norway and listed on the Oslo Stock Exchange (Axess). The company is developing therapeutic products based on its proprietary photochemical internalisation (PCI) technology. The PCI technology works by inducing triggered endosomal release and may be used to unlock the true potential of a wide array of therapeutic modalities, such as small molecules, vaccines and nucleic acids.  The company has a clinical Phase I/II program in bile duct cancer.

The company is also developing PCI as a vaccination technology. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines. The PCI technology is also very well suited for intracellular delivery of nucleic acids, such as RNA therapeutics. By releasing nucleic acid compounds from endosomes where they are trapped following administration, PCI addresses one of the major bottlenecks facing this emerging and exciting field.  PCI Biotech follows a strategy to create value by improving the effect of existing cancer drugs and by realising the large potential in new therapeutics.

 

Targovax presents encouraging preclinical data on ONCOS-102

The International Journal of Cancer has recently published preclinical in vivo data in a mesothelioma xenograph model, demonstrating synergy of ONCOS-102 with pemetrexed and cisplatin, the current standard of care in malignant pleural mesothelioma. 

 

“These findings give a strong rationale for the clinical testing of ONCOS-102 in combination with pemetrexed and cisplatin in patients suffering from malignant mesothelioma. In fact, we recently started a clinical trial in malignant mesothelioma where this combination will be evaluated” says Lukasz Kuryk of Targovax Research & Development.

Malignant mesothelioma is a rare cancer type, often caused by exposure to asbestos. There are no curative treatments, although surgery, chemotherapy and radiotherapy can sometimes help to improve patient prognosis and life expectancy. Pemetrexed and cisplatin is the standard of care chemotherapy for malignant mesothelioma, but the median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is only approximately 12 months.

ONCOS-102 is a purposefully engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce a systemic anti-tumor T-cell response in cancer patients. In a previous Phase I trial, ONCOS-102 treatment induced tumor specific immune activation both at systemic and lesional level. The immune activation was associated with clinical benefit.

In the present preclinical study, an evaluation was made of the antitumor activity of combination treatment with chemotherapy (pemetrexed, cisplatin, carboplatin) and ONCOS-102 in a xenograft BALB/c model of human malignant mesothelioma. The study demonstrated that ONCOS-102 is able to induce immunogenic cell death of human mesothelioma cell lines in vitro and showed anti-tumor activity in the treatment of the in vivo xenograft model. While chemotherapy alone showed no anti-tumor activity in the xenograph model, ONCOS-102 slowed down the tumor growth. When both ONCOS-102 and chemotherapy were combined, a synergistic anti-tumor effect was observed.

Targovax is currently studying ONCOS-102 in combination with pemetrexed and cisplatin in a randomized Phase Ib/II clinical trial of up to 30 patients with malignant pleural mesothelioma. The trial has a phase Ib safety lead-in cohort of 6 patients. The trial dosed its first patient in June 2016. During 2016, Targovax will also initiate three other clinical trials in various solid tumor indications to study ONCOS-102 in combination with other treatments such as immune checkpoint inhibitors and DC therapy.

 

About Targovax:
Arming the patient’s immune system to fight cancer

Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.

ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system’s capacity to recognize and attack cancer cells.

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.

Find more info on www.targovax.no 

 

Targovax recruits the first patient in a trial with the oncolytic virus ONCOS-102 in malignant pleural mesothelioma

Oslo 1 July 2016: Targovax today announced that the first patient has been dosed in a phase Ib/II clinical trial evaluating ONCOS-102 for the treatment of malignant pleural mesothelioma (MPM), a rare type of cancer in the lining of the lung, in combination with pemetrexed and cisplatin.

 

“New therapies are needed to provide better care for patients with mesothelioma, a highly malignant cancer with poor prognosis” says Dr Magnus Jaderberg, CMO of Targovax. “This clinical trial will provide data to evaluate the efficacy and safety of ONCOS-102 in first and second line mesothelioma patients, and we hope that our immunotherapy can provide additional benefit to chemotherapy, the existing standard of care.,

 

“In addition, treating the first patient in the first oncolytic virus trial of the merged company is of course an exciting moment for Targovax and all its stakeholders” adds Dr Jaderberg.

 

The trial is a randomized phase I/II clinical trial of 30 patients, with a phase Ib safety lead-in cohort of six patients, in first line and second line MPM patients who are eligible for treatment with pemetrexed and cisplatin. The trial’s main objectives are determination of safety, immune activation at lesional level and in peripheral blood, clinical response and the correlation between clinical outcome and the immunological activation. Several investigational sites in Europe will participate in this study. In addition to this trial, Targovax plans to initiate three immunotherapy combination trials with ONCOS-102 and one with its RAS peptide vaccine TG02 during the second half of 2016.

 

Malignant mesothelioma is a rare type of cancer often caused by exposure to asbestos. There are no curative treatments although surgery, chemotherapy and radiotherapy can sometimes help to improve patient prognosis and life expectancy. Pemetrexed and cisplatin is the only standard of care chemotherapy for malignant mesothelioma, but the median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is only approximately 12 months.

 

ONCOS-102 is a purposefully engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce systemic anti-tumor T cell response in cancer patients. In a previous Phase I trial, ONCOS-102 treatment induced tumor specific immune activation both at systemic and lesional level. The immune activation was associated with clinical benefit.

For further information, please contact:

 

Gunnar Gårdemyr, CEO
Phone: +46 73 083 77 79
Email: ggardemyr@targovax.com

 

Øystein Soug, CFO
Phone: +47 906 56 525
Email: oystein.soug@targovax.com

 

Arming the patient’s immune system to fight cancer
Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.

 

ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system’s capacity to recognize and attack cancer cells.

 

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

 

These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.

Photocure: First patient enrolled in Hexvix®/Cysview® Phase 3 study on bladder cancer

Doctor and nurse assessing the treatment of a cancer patient.

Oslo Cancer Cluster member Photocure announces that the first patient has been enrolled in the Hexvix/Cysview Market Expansion Phase 3 study on bladder cancer. The study will investigate the use of Hexvix/Cysview in the outpatient / surveillance setting and is designed to fulfill the FDA post marketing commitments. Results from the Phase 3 study are expected to be available in 2017.

The study is a prospective, multicenter Phase 3 study comparing the detection and potential positive impact on patient management of bladder cancer in the outpatient setting with Hexvix/Cysview using Blue Light enabled flexible cystoscopy versus white light flexible cystoscopy. Eighteen top rated cancer hospitals in the USA will participate in the study, which is planned to enroll approximately 360 patients with non-muscle invasive bladder cancer.

There are approximately 1.2 million flexible cystoscopy procedures conducted on a yearly basis in the United States. The use of Blue Light Flexible Cystoscopy with Hexvix/Cysview in the outpatient / surveillance setting could allow Urologists to detect recurrences at an earlier stage, which is of great clinical benefit. Furthermore, as has been demonstrated with the current use of Hexvix/Cysview during bladder cancer resection with blue light rigid cystoscopes, the addition of Hexvix/Cysview in the surveillance of bladder cancer patients may lead to better and earlier patient management decisions resulting in improved clinical outcomes and health economic savings.

Dr. Raj Pruthi, Professor and Chair, Department of Urology, University of North Carolina, Chapel Hill said: “The positive benefits of Hexvix/Cysview are well documented in numerous trials for patients undergoing bladder cancer resections during cystoscopy examination in the operating room. We are looking forward to conducting the study with Blue Light Flexible Cystoscopy with Hexvix/Cysview to confirm the benefits of this technology also in the outpatient setting. Early detection of more lesions is expected to result in better treatment decisions as well as more appropriate referrals and follow-up regimens, which in turn will reduce the burden on patients and the health care system.”

Kjetil Hestdal, President & CEO said: “This is an important milestone for Photocure as we seek to expand the use of Hexvix/Cysview into the bladder cancer surveillance market. Enabling Blue Light flexible cystoscopy with Hexvix/Cysview in the surveillance setting will allow patients with non-muscle invasive bladder cancer access to optimal treatment earlier, resulting in improved long-term benefits for these patients. While this trial is ongoing in the USA, we will be obtaining additional clinical and health economic data in EU from the use of Hexvix/Cysview in the same setting in order to optimize best clinical practices and patient outcomes.”

For more information about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT02560584

 

 

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions in disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions that can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue-light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white-light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence. Hexvix®/Cysview® is approved in Europe, Canada and the USA.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)