Nordic Nanovector receives Promising Innovative Medicine Designation

Our portfolio company Nordic Nanovector receives Promising Innovative Medicine Designation in the UK for the Treatment of Follicular Lymphoma with their lead product Betalutin®.

 

Lisa Rojkjaer MD, Nordic Nanovector Chief Medical Officer, commented:

“We are delighted by the MHRA’s decision to award PIM designation to Betalutin®. This acknowledges the high unmet medical need of this patient population as well as the potential of Betalutin® to offer therapeutic benefits to FL patients. Both the PIM and Fast Track designations (granted by the FDA in June) are very encouraging, as they provide opportunities for enhanced dialogue with health authorities and the potential to bring Betalutin® to patients more quickly.”

 

PIM designation constitutes Step 1 of the UK Early Access to Medicines Scheme (EAMS). EAMS aims to give patients in the UK early access to medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. PIM designation means that a medicinal product is a promising candidate for the EAMS, for the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with an unmet need.

 

Source: Nordic Nanovector

Om Vaccibody i NRK EKKO

NRK EKKO, NRK sitt aktuelle samfunnsmagasin på radio, har laget et eget innslag om den persontilpassede kreftvaksinen som vår porteføljebedrift Vaccibody utvikler.

 

Targovax: Reports full data set on clinical trial of cancer vaccine TG01

Our portfolio company Targovax reports encouraging disease-free survival (DFS) data from TG01 trial in resected pancreatic cancer:

  • 16.1 months median DFS with TG01 and gemcitabine combination for all 32 patients in the trial
  • 19.5 months DFS in 2nd cohort who received an optimized dosing regimen
  • 94% of patients had mutant RAS specific adaptive immune activation

The results are based on the full data set from the 32-patient phase I/II clinical trial evaluating TG01 in resected pancreatic cancer in combination with standard of care chemotherapy, gemcitabine.

 

Dr. Magnus Jäderberg, CMO of Targovax, said:

“We have previously reported strong immune activation and signal of efficacy for TG01 in resected pancreatic cancer. The median DFS data now presented further strengthens our confidence that TG01 provides a clinically meaningful benefit for this patient population, especially when in the context of historical controls. The DFS benefit appears to be more pronounced in the second cohort, which indicates that the post-chemo vaccination schedule is an optimal dosing regimen that we should select in subsequent development. It is also worth noting that median overall survival has not yet been reached in the second patient cohort, and we will continue to track how these patients perform with great interest”.

 

New CEO in Photocure

Our portfolio company Photocure ASA has appointed Daniel Schneider as Chief Exceutive Officer and President. 

Mr Schneider joins Photocure from the position of General Manager for Ablynx N.V. in North America.

Mr Schneider will commence the position upon further agreement, expected prior to 1 November 2018. Erik Dahl will continue to serve as the acting Chief Executive Officer until Mr Schneider’s commencement of his position, after which Mr Dahl will resume his previous role as the Chief Financial Officer of Photocure.

“The Photocure team has built a unique company within the field of bladder cancer, with excellent people, world leading technology and high-potential products. The company has developed a solid infrastructure in key regions, especially in the U.S. We will continue to scale and leverage on this growth platform to deliver on the commercial opportunities in the bladder cancer markets. I look forward to work with the team to expand the commercial footprint and to embark on the growth journey for Photocure”, says Mr Schneider.

 

Accelerated growth in the U.S market
“I am pleased to announce Dan Schneider as our new President and Chief Executive Officer. Photocure is entering a period of accelerated growth in the important U.S. market with strengthened focus on commercial development. Dan brings over 25 years of experience in developing and expanding rapidly growing healthcare companies in the U.S. He will further leverage on the opportunities arising from Photocure’s unique position in the bladder cancer market. I look forward working with Dan to develop Photocure into becoming the leading bladder cancer company”, says Jan H. Egberts, M.D. Chairman of the Board.

Mr Schneider follows Kjetil Hestdal as CEO, whom stepped down July 1st after being part of the company in over two decades.

“As Photocure is entering a phase with vast growth opportunities and an ambition to expand the global commercial footprint, the timing is right to inform all stakeholders that I will not lead Photocure in the company’s next era. I am proud of having been part of a company that has helped tens of thousands of bladder cancer patients in fighting their disease. Photocure is a great company with excellent people, world leading technology and products, and is perfectly positioned to be a true industry leader within the field of bladder cancer”, says Kjetil Hestdal.

Listen to our interview with Kjetil Hestdal in our podcast Radium.

 

About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in Princeton, New Jersey.

For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com

 

Source: Photocure

Update on PARADIGME from Nordic Nanovector

Our portfolio company Nordic Nanovector provided an update on its clinical development programme, including updated guidance on expected milestones for the pivotal PARADIGME trial in early April. At the same time CEO Luigi Costa informed that he would resign from his position. 

 

 

Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting Antibody-Radionuclide-Conjugates (ARC) designed to advance the treatment of non-Hodgkin’s Lymphoma (NHL). PARADIGME is a global randomised Phase 2b study comparing two Betalutin® dosing regimens in third line follicular lymphoma (3L FL) patients, which have shown a promising clinical profile in the LYMRIT 37-01 Phase 1/2a trial.

 

  • The pivotal PARADIGME study was initiated at the end of 2017 in Europe and the first patient is expected to be dosed during the first half of 2018. The trial is aiming to enrol 130 patients in 20 countries
  • To date, PARADIGME is open for enrolment at 13 sites and in six countries
  • In Norway, PARADIGME is pending approval and the company is working closely with the Norwegian regulators to address its questions
  • In the USA, the Food & Drug Administration (FDA) has completed its review of the PARADIGME study and Nordic Nanovector expects US sites to be open for enrolment during mid-2018

Lisa Rojkjaer MD, Nordic Nanovector CMO, said: “While we are encouraged with the progress being made to the start-up of the pivotal PARADIGME study, a re-analysis of the patient enrolment rate and the fact that it has taken longer than expected to enrol the first patient have led us to adjust the timelines we previously communicated. We now expect to deliver data from PARADIGME in the first half of 2020.

“The PARADIGME study reflects our conviction in the significant potential of Betalutin® based on the promising clinical data generated to-date. We therefore remain committed to completing this robust study, which is designed to select the best dosing regimen to support Betalutin® as an important new treatment option for 3L FL patients.”

 

Highlights from the update:

• A re-assessment of expected recruitment rates has led the company to revise its timelines for the pivotal PARADIGME Phase 2b trial with Betalutin® in third line (3L) follicular lymphoma (FL) patients. Results from PARADIGME are targeted for 1H 2020 (previously 2H 2019) and first regulatory filing in 2020. The first patient is expected to be dosed in 1H 2018.

• The company will focus its resources towards PARADIGME and other Betalutin® clinical programmes, which has led to the decision to postpone the start of the first-in-human clinical trial with Humalutin® for the foreseeable future; this study was being prepared to start in 2H 2018.

• Guidance is unchanged for previously reported milestones for ARCHER-1 (Betalutin® plus rituximab in second line FL; first patient dosed) and LYMRIT 37-05 (Betalutin® in R/R diffuse large B cell lymphoma, DLBCL; preliminary data read-out), both anticipated in 2H 2018.

• Financial resources are expected to be sufficient to reach data read-out from PARADIGME

 

About Nordic Nanovector

Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers.

Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting Antibody-Radionuclide-Conjugates (ARC) designed to advance the treatment of non-Hodgkin’s Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024.

Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.

The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.

Further information about the Company can be found at www.nordicnanovector.com

 

Source: Nordic Nanovector

Vaccibody with informed consent from first patient

Our portfolio company Vaccibody is ready to start the first clinical trial of their personalized neoantigen cancer vaccines to target solid tumors as the first patient has signed the informed consent.

 

The news hit the front page of the second largest newspaper in Norway, VG

 

Vaccibody AS is a clinical stage immunotherapy company focused on developing personalised neoantigen cancer vaccines to target solid tumors. The company is now ready to start the phase I/II clinical trial of the vaccines and the first patient will be enrolled in, Germany at the National Center for Tumor Diseases by principal investigator, Prof. Dr. med. Jürgen Krauss, Head of Section for Clinical Immunotherapy.

 

Dr. Agnete Fredriksen, President and Chief Scientific Officer in Vaccibody, commented “The first patient marks an important new phase in Vaccibody and we are very excited to start to tailor-make one vaccine per patient using our proprietary vaccination technology. The unique ability to induce strong CD8 T cell responses to multiple neoepitopes that we have observed in preclinical models, in addition to the manufacturing advantages essential for individualized vaccines, are basis for our enthusiasm moving this concept into clinical trials.”

 

This first-in-man trial is planned to enroll up to 40 patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder or head and neck cancer. The VB10.NEO vaccine will be given in combination with standard of care checkpoint inhibitors as a new treatment modality to help patients with cancer.

 

Prof. Dr. med. Jürgen Krauss, said, “We are very pleased to have initiated this clinical phase I/IIa for Vaccibody’s neoantigen vaccine. The neoantigen vaccine holds the potential to assist the patient’s immune system to generate specific T-cell responses to its individual cancer neoantigens and in this way may help the patient to more effectively fight the cancer. We hope this clinical trial will help pave the way for a novel class of new efficacious and safe treatment for cancer patients”

 

 

About Vaccibody AS
Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. Vaccibody is a leader in the rapidly developing field of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need.

Vaccibody’s front runner program (VB10.16) is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study (phase I/IIa), which is now fully enrolled, evaluates the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

Source: www.vaccibody.com

PCI Biotech: “A transformative year”

Our portfolio company PCI Biotech published their full year report for 2017 today. 

 

 

Per Walday, CEO of PCI Biotech, comments: “The achievements in 2017 has transformed PCI Biotech to a pivotal phase ready company with two promising assets in clinical development. The regulatory discussions last year provided important information on the requirements to bring fimaCHEM to the market and our focus is now on progression of all activities leading to start of the pivotal development phase.  The clinical translation of the fimaVACC asset has provided promising initial results, suggesting that fimaVACC can provide highly sought-after features for vaccination technologies, such as early responses and high response rates.”

 

Highlights

  • New funds raised enabling further progress in development programmes. Successful rights issue completed in January 2017, enabling PCI Biotech to progress the fimaCHEM programme in bile duct cancer towards pivotal phase.
  • Received important guidance from regulators for development of fimaCHEM in bile duct cancer.Encouraging outcome from regulatory meetings on the development for treatment of bile duct cancer.
  • Granted Orphan Drug Designation (ODD) for fimaporfin in bile duct cancer by the US FDA. ODD is a significant regulatory milestone providing important development and commercialisation benefits.
  • Promising initial clinical results for the fimaVACC programme. The initial clinical results on overall T-cell responses indicate enhanced cellular immune responses, with early and high response rates.
  • Progress in research collaborations with key players for the fimaNAc programme. Collaboration projects with key players within nucleic acid therapeutics were expanded and extended.
  • Executive management team further strengthened with Dr Olivecrona as Chief Medical Officer. Dr Olivecrona leads the execution of all clinical development programmes.

Source: PCI Biotech

Tidligere leder av Utprøvingsenheten, Steinar Aamdal, går til Ultimovacs

Vår porteføljebedrift Ultimovacs AS har nylig ansatt professor emeritus Steinar Aamdal som Senior Medical Adviser.

 

Steinar Aamdal går nå av ved aldersgrensen for stillingen som overlege ved Avdeling for kreftbehandling ved Oslo universitetssykehus. Han har etablert og ledet Utprøvingsenheten på Radiumhospitalet som utfører tidlig-fase studier av nye kreftmedisiner. De senere år har han vært leder av Seksjon for utprøvende kreftbehandling og forskningsstøtte.

 

 

Bidra med kunnskap, kompetanse og nettverk

I Ultimovacs skal Aamdal bidra med sin kunnskap, kompetanse og sitt nettverk for å utvikle Ultimovacs sin vaksineteknologi til å bli et viktig bidrag i fremtidens kreftbehandling.

Som svar på hvorfor han ønsker å arbeide i Ultimovacs sier Aamdal:

«Immunterapi har revolusjonert kreftbehandlingen. For første gang ser vi mulighetene til å kunne kurere pasienten med alvorlig kreftsykdom. Den utviklingen som skjer i Ultimovacs med sine kreftvaksiner er noe av det mest lovende og spennende som skjer innen immunterapi. Jeg ser fram til å være del av dette miljøet og å kunne bidra til videre utvikling av kreftvaksinene.»

Daglig leder Øyvind Kongstun Arnesen kommenterer:

«For oss er det svært bra å få med en kapasitet som Steinar Aamdal på laget. Vi skal ta mange viktige og komplekse beslutninger i tiden som kommer. Å få med vurderingene til Aamdal har stor betydning og gir oss trygghet. Vi har dessuten behov for å diskutere og samarbeide med eksterne miljøer. Aamdal kjenner disse fra før og vi kan raskere komme i gang med samarbeidsprosjekter.»

 

Om Ultimovacs:

Ultimovacs AS er et norsk selskap som arbeider med å utvikle immunterapi mot kreft i form av en universell kreftvaksine.  I dag har selskapet 12 ansatte som holder til i Oslo Cancer Cluster Innovasjonspark ved Radiumhospitalet.

Selskapet har avsluttet tre fase-I-studier som har dokumentert vaksinens sikkerhet og evne til å aktivere immunsystemet. Selskapet arbeider systematisk mot søknad om registrering av vaksinen som nytt kreftlegemiddel.

Ultimovacs’ største eiere er Gjelsten Holding AS, Inven2 AS, Canica AS, Radiumhospitalets Forskningsstiftelse, Sundt AS, Langøya Invest AS, og Watrium AS.

Les mer: www.ultimovacs.com

Photocure: FDA approval for new indications

Our portfolio company Photocure ASA with great news form the U.S: FDA has today approved the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes. This  means that Photocure´s drug and device for detection of bladder cancer may also be used in the ongoing surveillance of afflicted patients. 

 

The approval of this new indication is based on the results from a large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that BLC™ significantly  improves detection of patients with recurrent bladder cancer.

“This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges,” said Kjetil Hestdal M.D. Ph.D., President & CEO.

“The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”

Bladder cancer is the fifth most commonly diagnosed cancer in the U.S., and also one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year.

 

35 % more patients diagnosed 
The expanded indication includes the combination of Cysview with the KARL STORZ PDD Flexible Blue Light Videoscope System. The approval also expands the indication in the current rigid setting (TURBT) by including the detection of carcinoma in situ (CIS) in bladder cancer patients as well as the repeated use of BLC with Cysview.

“Blue light cystoscopy with Cysview, will enable physicians to provide appropriate and more accurate treatment earlier, which in my experience results in improved outcomes for my patients. In this study, an additional 35% of CIS patients were found by using BLC with Cysview alone and missed with white light,” says Gary Steinberg, M.D., The Bruce and Beth White Family Professor, Vice Chairman and Director of Urologic Oncology, University of Chicago Medicine.

In collaboration with KARL STORZ Endoscopy-America, Inc., Photocure plans to launch Cysview in combination with blue light enabled flexible video cystoscopy in mid-2018.

 

For more information on this news – please read the full press release from Photocure.

Facts:

 

About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US and the Nordic region, and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ SE & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ SE & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call (800) 421-0837 or visit the company’s website at www.karlstorz.com.

About Photocure
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO).

More information about Photocure is available at www.photocure.comwww.hexvix.comwww.cysview.com

– Productive year for Targovax

Our portfolio company Targovax ASA presents full year and fourth quarter results for 2017 today. CEO Øystein Soug says they had a productive year where they made progress with product candidates and also raised significant funding.

 

Targovax is a clinical stage company focused on developing immuno-oncology therapies to target solid tumors. 

 

Øystein Soug, CEO: “2017 was a very productive year for Targovax, in which we made significant progress with product candidates from both of our two platforms, and completed a significant fund-raising to deliver on our ongoing clinical program. In particular, the initial clinical data from the TG01 trial in pancreatic cancer were encouraging and we look forward to the complete trial results in this challenging disease in the first half of 2018. Overall, the prospects are great for 2018, where we anticipate delivery of several clinical data readouts from ongoing trials, which we expect to further demonstrate the potential of our two immuno-oncology platforms.”

 

HIGHLIGHTS FOR THE FOURTH QUARTER 2017

Research & Development

  • In October, Targovax reported encouraging one-year survival rate, immune activation, and safety data for the second cohort in the TG01 phase I/II trial in resected pancreatic cancer, in line with data from the first cohort published earlier in the year
  • In October, Targovax was granted a product composition-of-matter patent in the US for TG02
  • In December, Targovax announced that TG02 had passed the initial safety review in the first-in-man clinical trial in colorectal cancer, and also reported immune activation data in the first treated patients
  • In December, Targovax announced that the two first combination trials with ONCOS-102, in melanoma and mesothelioma, both had passed their initial, planned, safety reviews

  

Corporate

  • In November, Patrick Vink was appointed as the new chairman of the Board of Directors
  • In December, Targovax was included in the OSEBX index at the Oslo Stock Exchange

 

POST-PERIOD HIGHLIGHTS

  • In January, Targovax announced that ONCOS-102 generated immune activation in checkpoint inhibitor (CPI) refractory melanoma in four out of the first four patients treated
  • Also in January, Dr. Michael Bogenstätter was appointed Chief Business Officer of Targovax
  • In February, Targovax announced that the safety lead-in part of its ONCOS-102 trial in unresectable, malignant, pleural mesothelioma was completed without any safety concerns, and that ONCOS-102 generates immune activation in treated patients

 

Reporting material

The quarterly report and presentation are also available at the website  www.targovax.com.

 

 

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

Targovax (OSE:TRVX) is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

The Company’s development pipeline is based on two novel proprietary platforms:

The first platform, ONCOS, uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I trials it has demonstrated immune activation at lesional level which was associated with clinical benefit. In an ongoing phase I trial in advanced melanoma we expect important proof of concept data for checkpoint inhibitor refractory patients.

The second platform, TG, are neo-antigen cancer vaccines designed to specifically treat tumors that express mutated forms of RAS. Mutations to the RAS protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations. The TG platform’s therapeutic potential stems from its ability to enable the patient’s immune system to identify and destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TG platform from a clinical trial of TG01 in resected pancreatic cancer patients showed encouraging overall survival and will give guidance for the future clinical development of this platform.

Targovax’s development pipeline has three novel therapeutic candidates in clinical development covering six indications.

Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost-effective manner. Additionally, Targovax has other products in early stages of development.

Source: Targovax.