Zelluna Immunotherapy appoints Miguel Forte as CEO

Our portfolio company Zelluna Immunotherapy has appointed Miguel Forte as chief executive officer (CEO) to drive Zelluna through next stage of international clinical-phase development.

Zelluna Immunotherapy is a biotechnology company specializing in T-cell receptor (TCR) immunotherapies targeting a broad range of solid cancers with a high unmet medical need.

“Zelluna has a very strong foundation, based on over 30 years of cutting edge research. As a result, Zelluna now has a unique offering, both in the sourcing of its TCRs and its development partnerships and pathways,” said Miguel Forte, CEO, Zelluna.

“I wished to join Zelluna to combine my experience to the considerable potential of Zelluna to position it as an international immunotherapy leader and bringing serious therapeutic options to patients of the most common and fatal solid cancers.”

Zelluna selected Miguel Forte as CEO due to his extensive commercial experience in the regenerative medicine, cell therapy, medical and regulatory affairs industries. Miguel is also currently chief commercialization officer and chair of the commercialization committee for the International Society of Cellular Therapy, the global society of clinicians, researchers, regulatory specialists, technologists and industry partners in the cell therapy sector. Zelluna will utilize Miguel’s operational expertise in the development pipeline, from early and late stage clinical trials to market authorization and the launch of new biologic products for various indications.

Unique company developing TCRs based on long-time survivors

“Zelluna is developing a unique immunotherapy portfolio of non-engineered tumor specific T-cell receptors (TCRs) isolated from long term survivors from cancer vaccine trials conducted by former professor Gustav Gaudernack’s group at the Oslo University Hospital. This enables Zelluna to target some of the most common cancer antigens and cancer types. Its established partnerships also grant critical support including all capabilities of TCR development, one of Europe’s largest academic GMP cell therapy production facilities headed by professor Gunnar Kvalheim, and access to patients and clinical trial support through a dedicated Clinical Trial Unit,” said Anders Tuv, chairman of the board, Zelluna.

One of the main initial tasks for Miguel will be to lead Zelluna through its next stage of development by driving clinical translation of the TCR pipeline, developing new international scientific and commercial partnerships and forging relationships with the international investor communities. This includes positioning Zelluna’s therapeutic candidates in the context of the adoptive cell therapy market for targeted lymphocytes, development of off-the-shelf cell products and soluble TCR based biologics.

“Appointing a CEO with the international experience and profile of Miguel Forte will be critical to further enhance the therapeutic, development and commercial potential of Zelluna, and push its leadership position in the international TCR and immunotherapy marketplaces,” said Tuv.

Specifically, Miguel’s experience at Bone Therapeutics and TxCell will be important, where he contributed to transforming TxCell into a quoted cell therapy company and major commercial and scientific partnerships. Miguel  will also contribute his experience forged at the European Medicines Agency, Bristol-Myers Squibb, Abbott and Wellcome Laboratories (now part of GSK), Nabi Pharmaceuticals and UCB.

About Zelluna Immunotherapy

Zelluna Immunotherapy specializes in immunotherapies targeting a broad range of solid cancers with a high unmet medical need. The company is developing a unique portfolio of non-engineered tumor specific T-cell receptors (TCRs) isolated from long term surviving patients from cancer vaccine trials. The TCRs combine specificity and affinity to have the potential for a safe and efficient therapy to target a variety of common cancer types. Zelluna has a long term CRADA with the Department for Cell Therapy at Oslo University Hospital (OUH), providing comprehensive capabilities of TCR development, ranging from lead discovery to clinical translation. The owners of Zelluna are Radforsk, Inven2, Birk Venture, RO Invest and Prieta.

For more information, please visit www.zelluna.com.

Source: Zelluna Immunotherapy 

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

Kronikk i Aftenposten

Sent i september hadde Jónas Einarsson en kronikk i Aftenposten der han ber myndigheter og legemiddelindustri komme opp av skyttergravene og snakke med hverandre.

Årsaken er at det nåværende systemet for innkjøp og prissetting ikke fungerer, og at pasientene blir de skadelidende. Du kan lese hele kronikken nedenfor.


Ikke kjeft. Snakk med hverandre

Av Jónas Einarsson, administrerende direktør Radiumhospitalets Forskningsstiftelse

Mediaoppslag rundt kreftpasienter og nye medisiner er blitt hverdagskost. I 2012 sto 20 år gamle Matias Wilberg fram da han ikke fikk immunterapibehandlingen ipilimumab mot sin føflekkreft. Etter Wilberg har vi gjennom mediene møtt et utall kreftpasienter som venter på kreftmedisiner som er godkjente, men som ikke blir tatt i bruk i Norge. Selv om helseminister Bent Høie har tatt viktige grep, så gjør han ikke nok. Dagens modell for innkjøp og prissetting av legemidler fungerer ikke.

Bekymret på vegne av kreftpasientene: Jeg har arbeidet som allmennlege i 18 år og ledet Radiumhospitalets Forskningsstiftelse, Radforsk, i 17 år. Radforsk er et investeringsselskap som etablerer og utvikler bedrifter som kommersialiserer kreftforskning. Vi har 11 selskaper i vår portefølje, noen av dem med produkter på markedet, noen i klinisk utvikling. Vi fungerer som en eviggrønn investor, og alt overskudd blir pløyd tilbake til kreftforskning. Vi står og bak Oslo Cancer Cluster, Oslo Cancer Cluster Inkubator og Oslo Cancer Cluster Innovasjonspark.

Paradigmeskifte fra død til kronisk sykdom: Vi som lever i dag er så heldige at vi får oppleve et paradigmeskifte innen utvikling av ny kreftbehandling. Selv om for mange dør av kreft, så øyner vi en ny ære. Ny kreftbehandlinger kurerer flere kreftpasienter og gjør mange til kronikere. Paradigmeskiftet skyldes en dypere biologisk forståelse av hva kreft egentlig er. En kø av kreftlegemidler utvikles nå basert på immunterapi. Vi går bort fra å behandle kreft i organer, til å sikte rett på målet, uavhengig av hvor svulsten sitter.

Samfunnskontrakt for utvikling av medisiner: Å utvikle legemidler er dyrt, det er høy risiko og det tar lang tid. Derfor er det laget en samfunnskontrakt mellom offentlig og privat sektor for utvikling av legemidler. Det offentlige står for den medisinske grunnforskningen. Privat sektor, ved investorer, biotekselskaper og legemiddelindustri, står for finansieringen fram til markedet. Det private får kompensasjon av myndighetene i form av patentering eller markedekslusivitet for legemiddelet i én tidsperiode. Etter dette kan konkurrenter få tilgang til oppskriften, og utvikle sine egne produkter billigere, såkalt generika. Novartis lanserte Glivec for behandling av blodkreftsydkommen KLM i 2001. Glivec var en revolusjon. Over 90 % lever fem år etter diagnosen. Tidligere var sykdommen en dødsdom. I 2016 gikk patentet på Glivec ut i USA. En studie* estimerer at kostnaden ved å bruke legemiddelet for én pasient vil gå fra 60 000 USD per år til 6 000 USD med bruk av generika. Prisen vil etter all sannsynlighet gå ned i samme størrelsesorden i Norge.

Industrien må jenke seg og myndighetene må komme dem i møte: Tidligere kunne det ta 10-20 år, koste opp mot én milliard dollar å utvikle en medisin. Nå går denne utviklingen raskere fordi medisinene testes på færre pasienter. Det betyr at kostnadene går betraktelig ned. Derfor er det ikke lengre bærekraftig å kreve én million kroner for ett legemiddel. Legemiddelindustrien skal dog få godt betalt, slik at overskuddet brukes til å utvikle nye medisiner.

Kan ikke si både ja og nei: Det store paradokset i Norge nå, er at politikerne på den ene siden ser til helsenæringen som ny næring. Myndigheten sier på den andre siden at de ikke ønsker å betale for produktene som næringen utvikler. Min oppfordring nå er; Myndighetene, legemiddelindustrien og fagfolk må begrave stridsøksen og sammen utvikle en ny modell for innkjøp og prissetting av legemidler. Konsekvensen av å ikke ta dette på alvor, kan være at samfunnskontrakten mellom det private og det offentlige for utvikling av nye legemidler kollapser. De skadelidende blir helsenæringen vi bygger opp i Norge og kreftpasienter, som vi vil fortsette å møte i media.

* https://academic.oup.com/jnci/article/108/7/djw003/2412626/Cost-effectiveness-of-Tyrosine-Kinase-Inhibitor?searchresult=1

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 

View video´s from our events @ Oslo Innovation Week

Radforsk co-hosted three cancer-related events during Oslo Innovation Week and Forskningsdagene. If you missed out, you may watch them now.

Together with our partners the Norwegian Cancer Society, Oslo Cancer Cluster, IBM Norway, Cancer Research UK, Norway Health Tech and EAT, we hosted these events.

We had great audiences during our three events on the 27th and 28th of September. If your were not among them, sitting in the brand new science centre of the Norwegian Cancer Society, you may view them below:

Breakfast meeting on 27. September:
“Antibiotic resistance and cancer – current status, and how to prevent a potential apocalyptic scenario”:

Antibiotic resistance and cancer – Current status, and how to prevent a potential apocalyptic scenario #OIW2017

Posted by Kreftforeningen on Tuesday, September 26, 2017

Evening meeting 27. September:
“Cancer research and innovation – benefit for patients”:

Cancer research and innovation – benefit for patients #OIW2017

Posted by Kreftforeningen on Wednesday, September 27, 2017

Breakfast meeting 28. September:
How big data may transform the development of cancer treatments:

How Big Data may transform the development of cancer treatments #OIW2017

Posted by Kreftforeningen on Wednesday, September 27, 2017

PCI Biotech progressing positively

Our portfolio company PCI Biotech reports important progress in their half year presentation of 2017. The progress especially applies for the fimaCHEM programme , with early promising signs of effect in Phase I. The study has also provided encouraging interim overall survival data averaging 15.6 months per end July 2017 (median 14.4 months), with 25% of the patients still being alive.

These promising results may be further strengthened by repeating the treatment. Safety for repeated treatment will be investigated in a Phase I extension study and the first patient in this study was treated in August. Regulatory interactions to clarify the fastest way to market and subsequent preparations for Phase II will run in parallel with the extension study, thereby minimising time to initiation of a potential pivotal Phase II study with repeated treatment.

 “After the rapid initiation of the fimaCHEM Phase I extension study, we now have full focus on effective completion of this study and the regulatory interactions to clarify fastest route to market.  We are also eagerly awaiting the initial results on overall T-cell responses from the fimaVACC Phase I study and will revert to the market as soon as these are available,” comments CEO Per Walday.

Clinical translation of the fimaVACC asset is progressing with tolerability being established and the initial results on overall T-cell responses from the study are expected to be available during 2H 2017.

The fimaNAc programme has showed positive progress and the research collaborations with RXi Pharmaceuticals and a top-10 pharma company have both entered into new stages during 2017.

The rights issue completed in Q1 2017 enables PCI Biotech to progress the fimaChem programme through regulatory interactions to determine the fastest way to market, as well as the Phase I extension study and other preparations for initiation of Phase II. The proceeds, together with a grant from the Norwegian Research Council, will also cover the clinical translation of the promising fimaVACC asset. The organisation will be strengthened with Dr Olivecrona as Chief Medical Officer (CMO) from October 2017.

Highlights
fimaCHEM

  • Encouraging interim overall survival data from Phase I
  • First patient treated in the Phase I extension study

fimaVACC

  • Tolerability of the vaccination technology established – awaiting initial results on overall T-cell responses

fimaNAc

  • RXi Pharmaceuticals collaboration expanded into the field of immuno-oncology
  • Top-10 pharma collaboration extended and entered into in vivo studies

Corporate

  • Dr Hans Olivecrona appointed as Chief Medical Officer
  • Completed the fully underwritten rights issue of NOK 70 million
  • Awarded up to NOK 14.3 million in public grants for further development of the vaccination platform

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 Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVACCapplies 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.

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