Improved reimbursement for Photocure in the U.S.

Our portfolio company Photocure with more positive news from the the U.S. market. The United States Centers for Medicare & Medicaid Services (CMS) will from January 1, 2018  reimburse hospital outpatient departments for certain Blue Light Cystoscopy (BLC™) with Cysview®.

 

“The effectiveness and benefits of using Blue Light Cystoscopy (BLC) with Cysview for improved detection and management of bladder cancer are widely recognized.  It is very positive that the CMS have created a separate payment code and additional payment for Blue Light Cystoscopy with Cysview procedure as this should result in more patients having access to BLC with Cysview and should increase equality of care in the management of bladder cancer patients,” said Cheryl Lee, M.D., FACS Chair, Department of Urology, Dorothy M. Davis Chair in Cancer Research at The Ohio State University.

To ensure appropriate reimbursement for BLC with Cysview, CMS has created new and unique codes to describe Blue Light Cystoscopy with the fluorescent imaging agent, Cysview. The CMS final rule for Medicare patients is outlined in the New 2018 CMS hospital outpatient prospective payment system (OPPS) final rule.

“We are pleased that CMS has implemented new improved coverage and coding for Blue Light Cystoscopy with Cysview procedures.  We, along with many stakeholders, including the American Urological Association (AUA), Society of Urological Oncology (SUO), the patient advocacy group Bladder Cancer Advocacy Network, Hospitals and Urologists, have worked hard to secure a reimbursement path for Cysview, in order to ensure better access for Medicare patients to this leading-edge technology for the management of bladder cancer.  We estimate the new rule will positively impact approximately 50% of Medicare bladder cancer resection procedures (TURBTs), so this is an important step forward both for patients and our mission to improve the management of bladder cancer,” commented Kjetil Hestdal, President and CEO of Photocure ASA.

The effectiveness and benefits of Blue Light Cystoscopy (BLC) with Cysview for improved detection and management of bladder cancer have been recognized by the AUA/SUO. In 2016, BLC with Cysview was adopted into the AUA/SUO Non-Muscle Invasive Bladder Cancer NMIBC Guidelines.

 

About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US.1,2,3 In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer.

Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year.4,5

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. 2 NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (70%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat. 2

 

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.

More information: www.hexvix.com and www.cysview.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).

 

Source: Photocure

 

 

 

Targovax with encouraging third quarter

Our portfolio company Targovax presented third quarter results on November 2nd. Highlights included several patent grants, new collaborations and updated survival rates.

 

Highlights:

Research & Development

  • Targovax presented data from three trials at the annual meeting of the European Society of Molecular Oncology (ESMO) in September in Madrid, highlighting some of the important clinical progress from both of its two platforms
  • Targovax announced the initiation of the Phase I/II trial in ovarian and colorectal cancer, where, for the first time, ONCOS-102 will be administered intra-peritoneally. The trial is in combination with IMFINZI(TM) (durvalumab), and is a collaboration between Targovax and the Cancer Research Institute (CRI), and sponsored by Ludwig Cancer Research
  • Targovax was granted a US patent for the therapeutic use of the product candidates in its TG mutant-RAS neo-antigen cancer vaccine platform in combination with anti-metabolite chemotherapy
  • At the Nordic Life Science Days conference in Malmø in September, Targovax received the 2017 Nordic Stars award for outstanding innovation and entrepreneurial skills

Finance

  • In July, Targovax completed the private placement of NOK 200m (USD 26m) announced in June, as well as a subsequent offering raising a further NOK 6.5m(USD 0.8m)

Post-period higlights:

  • In October, Targovax reported encouraging one-year survival rate, immune activation, and safety data for the modified “second” cohort in the TG01 phase I/II trial in resected pancreatic cancer, in line with the first[1] cohort data published earlier in the year
  • In October, Targovax was granted a US patent for its product candidate TG02 and its use to stimulate the immune system of cancer patients, the 2ndgeneration product from the TG platform, which is currently under testing in a phase I trial in colorectal cancer

 

Øystein Soug, CEO, said he is pleased with progress and results generated:

 

“The momentum generated in the business this year continued in the third quarter. During the period, we initiated a very interesting collaboration trial in colorectal and ovarian cancer, where we will test intraperitoneal administration of ONCOS-102, and combine it with AstraZeneca’s checkpoint inhibitor IMFINZI. We also got an important patent granted in the US for the therapeutic use of the TG platform in combination with chemotherapy. In October, the patent position of the TG platform was strengthened further by the grant of a US product/composition of matter patent for TG02. In recent weeks, we were also pleased to see the encouraging one-year survival rate, immune activation, and safety data from the second cohort in the TG01 trial in resected pancreatic cancer, which further strengthens the potential of this program. We now look forward to an exciting period in the end of 2017 and through 2018, with several important data read-outs from our ongoing clinical trial programs.”

 

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

 

 

 

Updated results to be presented at ASH in December

Our portfolio company Nordic Nanovector will present updated results from the phase I/II trial of Betalutin in non-Hodgkin lymphoma in a poster at the American Society of Hematology (ASH) meeting, 9-12 December 2017 in Atlanta, US.

 

The dataset includes 55 evaluable patients. Data from patients receiving the two most promising dosing regimens in the phase II expansion cohorts – Arm 1 (15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing) and Arm 4 (20 MBq/kg Betalutin® after 100 mg/m2 lilotomab) – are described and will be updated at the congress.

The data continue to highlight the encouraging clinical profile of single-agent Betalutin® therapy in iNHL patients, particularly in those with follicular lymphoma (FL), the primary NHL population for which Betalutin® is being developed. These data will continue to mature up until presentation in December.

 

Key facts are:

Single-agent Betalutin® is highly active and well tolerated in recurrent iNHL:

• 64% Overall Response Rate (ORR) and 24% Complete Responses (CR) in the 55 evaluable iNHL patients

• 81% ORR (CR 28%) in 21 FL patients in Arm 1 (of 32 iNHL patients evaluated); median duration of response (DoR) of 15 months in FL patients

• No unexpected safety findings, the safety profile is both predictable and manageable

 

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

“These data are very encouraging for a primarily elderly, heavily pre-treated patient population, especially for those with relapsed FL, where the greatest need exists. The data from Arm 4, while so far evaluable in only six patients (50% ORR, CR 17%) are also very encouraging and we look forward to seeing how these data evolve with a larger patient population. These data from both arms of the study are enabling us to refine the design of the pivotal Phase 2 PARADIGME trial, which we expect to initiate this year.”

Luigi Costa, Chief Executive Officer of Nordic Nanovector, added:

“We are very excited with these results, which support the strategy course we undertook when we decided to explore alternative dosing regimens. These data strengthen our confidence in the potential of Betalutin® to be an attractive therapeutic option with the convenience of being a one-time treatment. We now have two promising dosing options, and as a result we have further strengthened the development path for Betalutin®.  We are also very encouraged that Betalutin® treatment consistently demonstrates a highly competitive profile when compared to other therapies in development or recently approved for FL.”

 

Abstract and poster details

The ASH annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.

The abstract is now available online.

Abstract 2769 Abstract title:  177Lu-Lilotomab Satetraxetan, a Novel CD37-Targeted Antibody-Radionuclide Conjugate in Relapsed Non-Hodgkin’s Lymphoma (NHL): Updated Results of an Ongoing Phase I/II Study (LYMRIT 37-01) Authors: Kolstad, A et al.

  • Session Name:  623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
  • Date:  Sunday, December 10, 2017
  • Presentation Time:  6:00 PM – 8:00 PM
  • Location:   Georgia World Congress Center, Bldg A, Lvl 1, Hall A2, Atlanta, GA, USA

 

 

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-Conjugate (ARC) designed to advance the treatment of non-Hodgkin 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.

The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. 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.

 

Source: Nordic Nanovector

 

Ultimovacs henter inn 125 millioner

Vårt porteføljeselskap Ultimovacs sikrer finansiering til videre utvikling av kreftvaksine ved å hente inn 125 millioner kroner. Selskapet er nå priset til 675 millioner.

 

Kreftvaksineselskapet Ultimovacs AS henter NOK 125 millioner til videre dokumentasjon av vaksinen til behandling av kreft og en utredning av om vaksinen også kan utvikles til å brukes som en forebyggende kreftvaksine. Eksisterende aksjonærer og ansatte investerer NOK 100 millioner og et fåtall nye investorer bidrar med NOK 25 millioner.

 

Ønsker å utvikle forbyggende vaksine

De midlene som nå er hentet inn skal blant annet brukes til gjennomføring av en ny studie hvor selskapets kreftvaksine, UV1, skal prøves i en kombinasjon med annen immunterapi som samlet øker immunsystemets mulighet til å bekjempe kreft. Studien skal gi et datagrunnlag som bekrefter at det er riktig å gjennomføre de siste, store studiene før søknad om registrering av vaksinen som nytt legemiddel.

«Vi er godt fornøyd med at vi har fått nødvendig kapital for å realisere neste steg i utviklingsplanen for selskapet», sier styreleder Ketil Fjerdingen.

Ultimovacs vurderer også hvordan vaksinen kan kombineres med annen vaksineteknologi slik at vaksinen i tillegg til å benyttes behandlende kan brukes til å forebygge kreft hos personer med spesielt høy risiko for å utvikle kreftsykdom.

«Vi følger systematisk med på hvordan det går med pasientene fra de tre første fase I-studiene. Vi har nå fulgt disse pasientene i noen år, og det går bedre med dem enn det som er vanlig for tilsvarende pasienter. Vi ser dette som klare signaler på at vaksinen har evne til å bekjempe kreft. Dette er grunnlaget for å fortsette dokumentasjonen av vaksinen som en teknologiplattform hvor den kan bidra i behandling av mange krefttyper i ulike kombinasjoner med andre legemidler. Vi har styrket staben med flere erfarne og svært kompetente medarbeidere, og vil bygge selskapet videre i 2018», sier Øyvind Kongstun Arnesen som er administrerende direktør i Ultimovacs AS.

 

Mulig børsnotering om et år

Ultimovacs er verdsatt til NOK 675 millioner før innhenting av ny kapital. DNB Markets og Arctic Securities har bistått selskapet som finansielle rådgivere og tilretteleggere av transaksjonen.

«Vi vil nå starte forberedelser til en mulig børsnotering av Ultimovacs i løpet av 12-18 måneder, slik at flere fremtidige finansieringsalternativer kan vurderes nærmere», avslutter styreleder Ketil Fjerdingen.

 

 

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 10 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.

www.ultimovacs.com

 

Kilde: Ultimovacs

Targovax reports 100 % one year survival rate from trial

Our portfolio company Targovax announces encouraging one-year survival rate and safety data in the modified cohort of the TG01 trial in resected pancreatic cancer.

The trial is an open label, phase I/II trial of the cancer vaccine TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. The trial consists of two cohorts: the main cohort of 19 patients and a second, modified cohort of 13 patients.

The purpose of the modified cohort is to build on the positive findings from the main cohort in order to further optimize the TG01 treatment regimen and safety profile of the combination therapy. Although manageable, some allergic reactions were seen in patients in the main cohort when treating with TG01 and gemcitabine in parallel. Hence, the modified cohort received fewer TG01 injections overall than the main cohort, administered non-concomitantly with gemcitabine.

The modified cohort started recruitment in 2015 (link to PR), and the last patient enrolled has now been in the trial for one year.

The one-year survival rate and safety data in the modified cohort showed that:

  • 100% of patients (13/13) were alive one year after surgery
  • TG01/GM-CSF generated an immune response in 85% of patients (11/13)
  • No serious adverse events related to allergic reactions have been reported

“We are delighted that we maintain a strong immune response and one-year survival rate with the reduced dosing regimen, essentially equivalent to and consistent with the previously reported data from the main cohort. This further strengthens the safety profile of TG01, and adds valuable understanding that will help us optimize the dosing regimen in resected pancreatic cancer patients, a condition which is notoriously difficult to treat. We look forward to see the two-year survival data for the modified cohort next year,” said Magnus Jäderberg MD, Chief Medical Officer of Targovax.

 

The data from the main cohort was presented here.

 

About Targovax

Arming the patient’s immune system to fight cancer

 Targovax 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 exclusively uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I studies 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, TG, is a target specific, neo-antigen therapeutic cancer vaccine platform that solely targets tumors that express mutated forms of the RAS protein. Mutations to this 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 a patient’s immune system to identify and then 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.

 In March 2017 the Company listed its shares on Oslo Børs (Oslo Stock Exchange, main list).

Source: Targovax

 

Targovax granted two US patents in short time

Our portfolio company Targovax has over the short time span of eight days managed to be granted not one, but two, US patents for their mutant-RAS neoantigen platform.

  • The first patent is issued to protect  Targovax’ mutant-RAS specific neoantigen vaccines, TG01 and TG02, for the treatment of cancer in combination with anti-metabolite chemotherapy. Read more about this here.
  • The second patent protects the composition of Targovax’ mutant-RAS specific neoantigen vaccine TG02, for stimulating the immune system of cancer patients with RAS mutated tumors. Read more about this here.

In relation to first patent being granted, Jon Amund Eriksen, Chief Technology Innovation Officer, and Co-founder of Targovax, said:

“We are delighted that this US patent has been granted, further strengthening Targovax’ intellectual property portfolio covering the very important mutant-RAS neoantigen. The oncology market is ever expanding, with the immuno-oncology segment expected to see the largest growth in the coming years. Securing this patent protects our innovative mutant-RAS specific cancer immunotherapy platform and strengthens our market position for treatment of RAS-mutated cancers.”

 

About Targovax

Arming the patient’s immune system to fight cancer

Targovax 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 exclusively uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I studies 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, TG, is a target specific, neo-antigen therapeutic cancer vaccine platform that solely targets tumors that express mutated forms of the RAS protein. Mutations to this 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 a patient’s immune system to identify and then 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.

In July 2016, the Company listed its shares on Oslo Axess. In March 2017, the shares moved to Oslo Børs, the main Oslo Stock Exchange.

Source: Targovax ASA

 

PCI Biotech receives US Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to our portfolio company PCI Biotech. This is a major regulatory milestone for the development of the company´s lead product candidate named fimaporfin for the treatment of patients suffering from bile duct cancer.

 

This patient population has no approved treatment alternatives today and fimaCHEM (fimaporfin) has the potential to play a role in this area of high unmet medical need.

 

“Receiving orphan status from the FDA is a crucial step in the development of this important new medicine for cancer patients in need of better local treatments. PCI Biotech’s fimaCHEM treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods.” said Dr. Per Walday, CEO of PCI Biotech.

“Orphan designation is a significant regulatory milestone and recognises the therapeutic benefits we seek to bring to the patients. It supports our further development of fimaChem in this indication and provides important development and commercialisation benefits.”

 

About Orphan Drug Designation
Under the U.S. Orphan Drug Act, the FDA’s Office of Orphan Products Development provides special status and incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation conveys up to seven years of marketing exclusivity if the drug receives regulatory approval from the FDA and offers various development incentives, including an exemption from the FDA user fee and FDA assistance in clinical trial design.

The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval and designation does not mean that marketing approval will be granted.

 

About bile duct cancer 
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 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.

Source: PCI Biotech 

Targovax positioned for important clinical read outs

Our portfolio company Targovax reports significant progress, both financially and clinically in second quarter first half year of 2017 report. 

 

 “In the first half of 2017, the Company took significant strides forward, demonstrating important clinical and financial progress, as well as strengthening our team with the hire of Erik Digman Wiklund as CFO. We are especially pleased by the recent data showing a signal of efficacy of TG01 in patients with resected pancreatic cancer, which is an important milestone for the TG program. Combined with the successful fund raising this summer of NOK 206 million (approx. $26 million), we believe we are well positioned to deliver several important clinical read-outs going forward,” says Øystein Soug, CEO Targovax. 

 

 

 

HIGHLIGHTS FOR THE SECOND QUARTER AND FIRST HALF 2017

R&D

  • In February, Targovax announced encouraging top line two-year survival data from the phase I/II TG01 clinical trial in resected pancreatic cancer patients
    • 68 percent of evaluated patients (13/19) were still alive after two years
  • Further encouraging clinical data from the phase I/II TG01 trial were presented at the 2017 ASCO Annual Meeting in June:
    • TG01 activates mutant RAS specific T cells
    • Median overall survival of 33.1 months was promising in view of previous published reports of 27.6 months for standard of care
    • The regimen was generally well tolerated
  • In April, Targovax initiated the first clinical trial with TG02, the second product from its RAS-peptide immunotherapy platform, in patients with locally recurrent RAS-mutated colorectal cancer
  • In May, Targovax recruited the first patient in its ONCOS-102 study in advanced or unresectable melanoma patients with progression following checkpoint inhibitor treatment

  

Finance

  • Targovax moved its share listing from Oslo Axess to the main board on the Oslo Stock Exchange in March
  • Targovax successfully completed a private placement, raising gross proceeds of NOK 200m (USD 25m)
  • Erik Digman Wiklund was appointed CFO of Targovax, succeeding Øystein Soug, who was promoted to CEO in November 2016. Erik took on the role in April 2017

 

POST-PERIOD HIGHLIGHTS

  • In July, Targovax raised NOK 6.4m (USD 0.8m) in a subsequent repair offering following the private placement in June

 

About Targovax:

Arming the patient’s immune system to fight cancer

 Targovax 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 exclusively uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I studies 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, TG, is a target specific, neo-antigen therapeutic cancer vaccine platform that solely targets tumors that express mutated forms of the RAS protein. Mutations to this 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 a patient’s immune system to identify and then 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.

In July 2016, the Company listed its shares on Oslo Axess. In March 2017, the shares moved to Oslo Børs, the main Oslo Stock Exchange.

www.targovax.com

Source: Targovax

Photocure with revenue growth of 55% in the US

Our portfolio company Photocure reports a Hexvix/Cysview revenue growth of 10% to NOK 37.6 million in the second quarter of 2017 . The company reported a revenue growth of 55% for the important US market, were Photocure recently has announced several significant developments.

 

“Our second quarter report shows significant progress for our US business. US is a market of strategic importance for Photocure and we were delighted to present in May positive results from our Phase 3 study in the bladder cancer surveillance setting at the AUA meeting. These data formed the basis for our recent sNDA filing aimed at expanding the label for BLC with Cysview in the US to include the broader surveillance segment. Furthermore, after the quarter, we were very pleased to learn that CMS proposes to reimburse Blue Light Cystoscopy with Cysview from 2018, with a final decision expected later this year. We and our supporters have worked tirelessly to secure better reimbursement for Cysview in US and believe it will lead to increased access and allow better management for bladder cancer patients in the future,” says Kjetil Hestdal, President and Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 39.3 million in the second quarter of 2017 (35.5), with a recurring EBITDA of NOK -4.4 million (-2.3). Net profit was NOK -4.7 million (18.1), while the cash position ended at NOK 137.0 million. Global in-market unit sales of Hexvix/Cysview decreased 2% in the second quarter, impacted by a reduction of the partner business of 6% in the quarter. The sales development in the US was strong with a unit sales increase of 37%. The EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 4.7 million in the second quarter of 2017.Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment.

The company aims to capitalize on the inclusion in the AUA guidelines, as well as the increased patient awareness and the possible changes to reimbursement of Cysview, to significantly increase penetration in the US market.Photocure reported in the second quarter that the Phase 3 study of Hexvix/Cysview in the surveillance patient segment met its primary endpoint and other major endpoints. Based on this, the company has submitted an sNDA to the US FDA, with a possible approval in 2018, for use of Blue Light Flexible Cystoscopy with Cysview in this out-patient surveillance setting.CMS (United States Centers for Medicare & Medicaid Services) released in July the Proposed Rule outlining its 2018 plan to reimburse hospital outpatients departments using Blue Light Cystoscopy with Cysview. The comment period for the proposed rule closes in early September, and CMS is expected to issue a Final Rule in the fourth quarter of 2017 effective on 1 January 2018.

“Photocure believes that in order to increase market shares in the US, an investment in the US salesforce is required. As stated previously, the company plans to double its salesforce from 2016 and increase sales and marketing expenses towards the end of 2017. The goal of these efforts is to quadruple the revenues from the US operations to a range of USD 15 million by 2020. The company is fully funded for this market strategy”, says Hestdal.

Source: Photocure

Nordic Nanovector on track to start PARADIGME

Our portfolio company Nordic Nanovector reports that all operations are on track, strong data presented at ICML confirm Betalutin®’s promising efficacy and safety profile in recurrent iNHL patients and pivotal Phase 2 study, PARADIGME will start in 2H 2017.

 

 

Nordic Nanovector reported continued solid operational progress during the second quarter, with very encouraging clinical results from the ongoing Phase 1/2 study with Betalutin® presented at the International Conference on Malignant Lymphoma (ICML) in June.

These results continue to highlight the significant potential of single dose Betalutin® for the treatment of recurrent indolent non-Hodgkin’s lymphoma (iNHL) and provide confidence that the company is on track to initiate the pivotal Phase 2 study, PARADIGME, in the second half of 2017. A phase 1 dose-escalation study in diffuse large B-cell lymphoma (DLBCL) is actively enrolling patients, and initial preparations for Phase 2 combination study of Betalutin® and rituximab as well as a Phase 1 study of Humalutin™ in iNHL patients are progressing.

 “We are very pleased with progress made during the first half of 2017 and we continue to be very encouraged by the strong data presented at ICML in June, which support Betalutin®’s potential in the treatment of patients with iNHL. The team has worked hard to lay a strong foundation for a busy and exciting second half to the year, when we anticipate initiating several new clinical studies, including the Phase 2 PARADIGME study,” comments Luigi Costa, CEO of Nordic Nanovector.

 

Operational Highlights Q2’17

• Progress continues as planned towards start of the pivotal Phase 2 study, PARADIGME in 2H 2017, to investigate Betalutin® in patients with relapsed FL

• Results presented at ICML in June highlight strong clinical profile of single dose Betalutin® in recurrent iNHL patients
o Single dose Betalutin® is highly active in recurrent iNHL, especially in FL
o Well-tolerated, no unexpected safety findings, predictable and manageable safety profile

• Safety Review Committee recommends enrolling new patients into a Phase 2 expansion cohort of Arm 4
o To validate whether a higher lilotomab pre-dosing regimen may enable the use of a higher dose of Betalutin®

• Recruitment of DLBCL patients into Phase 1 dose-escalation study with Betalutin® ongoing
o The study is actively enrolling patients in the US and Europe

• Preparations advancing for Phase 2 clinical trial to investigate the potential of Betalutin® combined with rituximab in 2nd line FL
o Phase 2 trial expected to begin in 2H 2017

• Preparations advancing for Phase 1 clinical study to investigate potential of Humalutin™ for treating 1st line NHL
o Phase 1 trial expected to begin in 2H 2017

 

Events after Q2’17

• Dr. Reza Safaei, former Head of Medical Affairs, Europe with Seattle Genetics, appointed as Head of Medical Affairs

 

Financial Highlights Second Quarter 2017
(Figures in brackets = same period 2016 unless otherwise stated)
• Revenues for the second quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the first half of 2017 were NOK 0.1 million (NOK 0.2 million).
• Total operating expenses for the second quarter were NOK 76.3 million (NOK 48.1 million). Total operating expenses for the first half of 2017 amounted to NOK 142.1 million (NOK 100.9 million)
• Comprehensive loss for the second quarter amounted to NOK 66.3 million (loss of NOK 51.1 million). Comprehensive loss for the first half was NOK 122.1 million (NOK 115.2 million)
• Cash and cash equivalents amounted to NOK 881.4 million at the end of June 2017 (NOK 933.3 million at 31 March 2017 and NOK 1 018.2 million at 31 December 2016)

 

Outlook
Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers. It intends to achieve this by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Nordic Nanovector’s operations remain on track. The company intends to maximise the value of Betalutin® across all stages of NHL and other haematological cancer indications. The company has made initial steps in preparing for the commercialisation of Betalutin®. A further element of Nordic Nanovector’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.

The profile of Betalutin® is well differentiated within the competitive landscape. Promising preliminary results and good progress in the LYMRIT 37-01 clinical study give the company confidence that it is on track to initiate the pivotal Phase 2 PARADIGME trial during the second half of 2017. Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical milestones.

Current cash resources are expected to be sufficient to take the company beyond a first regulatory submission for Betalutin® in FL in the first half of 2019 and to meet value-generating clinical milestones in its other programmes.

 

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-Conjugate (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.

The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. 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