Horizon 2020 continues to invest in CombiGeneÂŽs epilepsy project
With the third payment from Horizon 2020, the EU program has so far invested EUR 2.85 million out of a total of EUR 3.36 million on CombiGeneâs epilepsy project CG01
On 15 May 2018, CombiGene announced that Horizon 2020 â EUâs Framework Programme for Research and Development â is investing EUR 3.36 million in CombiGeneâs continued development and commerzialisation of the gene therapy project CG01, which is developed to treat drug-resistant focal epilepsy.
The Horizon 2020 program runs for several years, and the initial payment amounted to EUR 1.51 million. The second payment, made in November 2019, amounted to EUR 1.21 million.
After careful review of the CG01 project by the EU and their external auditors, CombiGene has today received a third payment of EUR 130,000.
In total, CombiGene has received 85 percent of the total grant. CombiGene expects to receive an additional one to two payments before the total amount of EUR 3.36 million has been reached.
âThe payment from Horizon 2020 is further confirmation of the progress made in the CG01 project, not least the work we are carrying out to develop a commercially viable and future-proof production method,â says Karin Agerman, Chief Research and Development Officer at CombiGene. âIn addition to having our project report approved and the money paid out, we have also received positive feedback and valuable recommendations from Horizon 2020âs external reviewers. The fact that our epilepsy project is one of the projects that Horizon 2020 has chosen to invest in means a lot to CombiGene. In addition to the capital provided to the project, it is also a significant seal of quality on our development work and our commercial opportunities.â
CombiGene reaches a new milestone in its CGT2 project aimed at developing a gene therapy treatment for partial lipodystrophy. A first selection of drug candidates has been made in in vitro experiments with liver cells and the biotechnology company is now taking the next step by initiating in vivo studies to evaluate which protein expression can be achieved in experimental models. BioStock reached out to CombiGenes CEO Jan Nilsson to learn more about the goal of initiating proof-of-concept studies during 2021.
Read the full interview with CombiGenes CEO Jan Nilsson at biostock.se:
CombiGene tecknar avtal med brittiska Neurochase om optimerad administration av CG01, en genterapi som utvecklas för behandling av fokal epilepsi
nov 23, 2020
CombiGene tecknar avtal med brittiska Neurochase om optimerad administration av CG01, en genterapi som utvecklas för behandling av fokal epilepsi CombiGene har tecknat avtal med Neurochase â ett brittiskt CRO-bolag specialiserat pĂ„ AI-baserad neurokirurgi â om optimerad administration av genterapin CG01 som utvecklas av CombiGene för behandling av lĂ€kemedelsresistent fokal epilepsi. CG01 Ă€r avsedd att injiceras direkt in i den mĂ€nskliga hjĂ€rnvĂ€vnaden och det Ă€r denna process som Neurochase nu ska optimera för maximal sĂ€kerhet och effekt.
Neurochase Ă€r specialiserat pĂ„ att administrera lĂ€kemedel till det centrala nervsystemet med hjĂ€lp av en teknologi som kallas âConvection Enhanced Deliveryâ (CED). Inom ramen för avtalet med CombiGene kommer Neurochase att genomföra prekliniska studier för att optimera injektionsstrategin för CG01 sĂ„ den potentiellt banbrytande epilepsi-behandlingen kan administreras till mĂ€nniska pĂ„ ett sĂ€kert sĂ€tt.
âAvtalet med Neurochase Ă€r ytterligare en viktig milstolpe i vĂ„rt epilepsiprojektâ , sĂ€ger Annika Ericsson, Senior Project Manager pĂ„ CombiGene. âAtt CG01 kan administreras till patienter pĂ„ ett sĂ€kert sĂ€tt Ă€r en central del i utvecklingen av en effektiv behandling av fokal epilepsi och en förutsĂ€ttning för att vi ska kunna genomföra det kliniska studieprogrammet.â
Professor Steven Gill , grundare av Neurochase, kommenterar: âVi Ă€r mycket glada över att stödja CombiGenes prekliniska epilepsiprogram. Neurochase Ă€r övertygade om att en sĂ€ker och riktad administration av CG01 kommer att möjliggöra en fortsatt utveckling av projektet till det kliniska studieprogrammet. Vi ser verkligen fram emot att arbeta tillsammans pĂ„ vad vi hoppas i slutĂ€ndan kommer att leda till en effektiv behandling av fokal epilepsi.â
Om CG01
CG01 Ă€r en genterapi som utvecklas för behandling av lĂ€kemedelsresistent fokal epilepsi. Varje Ă„r berĂ€knas cirka 47 000 lĂ€kemedelsresistenta patienter med denna typ av epilepsi tillkomma i USA, EU5, Japan och Kina. CombiGene gör bedömningen att det Ă€r realistiskt att 10â20 procent av dessa patienter skulle kunna behandlas med bolagets genterapi. Den globala marknaden för lĂ€kemedelskandidaten CG01 uppskattas till 750 â 1 500 miljoner USD Ă„rligen.
Om Neurochase
Neurochase, som grundats av professor Steven Gill, har som mĂ„l att tillgĂ€ngliggöra banbrytande riktade terapier för patienter med neurologiska sjukdomar med hjĂ€lp av spjutspetsteknologi. Neurochase team Ă€r specialiserat pĂ„ att skapa skrĂ€ddarsydda terapeutiska strategier för direkt administration av lĂ€kemedel med hjĂ€lp av sĂ„ kallad âConvection Enhanced Deliveryâ (CED). Bolaget tillhandahĂ„ller korrekt, mĂ„linriktad och sĂ€ker direkt administration av lĂ€kemedel till det centrala nervsystemet och utvecklar globalt skalbara behandlingsstrategier och lösningar för lĂ€kemedels- och biotechindustrin.
Major shareholders and management demonstrate their faith in CombiGene by participating in the warrants of series TO4 and TO5
November 16 to November 30, 2020, is the subscription period for CombiGeneâs warrants in series TO4 and TO5. Both major shareholders and board members and former board members have informed the company that they intend to subscribe for shares in CombiGene.
Participation in series TO4
CombiGeneâs largest owner Ivar Nordqvist has announced his intention to exercise his series TO4 warrants. Peter Nilsson (board member of CombiGene), Arne Ferstad (former Chairman of the Board) and Jan Nilsson (CEO and board member of CombiGene) have all informed the company that they intend to exercise all of their warrants.
Participation in series TO5
Series TO5 was created in connection with the directed issue to NYIP (Nyenburgh Holding BV) carried out in August 2020. TO5 has the same terms and conditions as the series TO4 warrants. NYIP, a leading Dutch life-science investor, has informed CombiGene of its intention to fully subscribe for the TO5 series.
âIt is very gratifying that major shareholders such as Ivar Nordqvist and NYIP have informed us that they intend to participate in subscription series TO4 and TO5 respectively. It means a lot financially and creates additional energy in the company. Similarly, it is very encouraging that Peter Nilsson of CombiGeneâs Board of Directors and CombiGeneâs former Chairman Arne Ferstad are also participating in the TO4 series,â says CombiGene CEO Jan Nilsson in a comment.
PÞser pÄ. Veldig spennende at de skal levere inn planen for hvordan den klinisk studien skal se ut i lÞpet av innevÊrende Är. Utrolig moro.
CombiGene, together with gene therapy manufacturer Viralgen, has successfully completed the first large-scale production of CG01
CombiGene, together with the Spanish gene therapy manufacturer Viralgen, has successfully completed the first large-scale production of the gene therapeutic drug candidate CG01, which is developed for the treatment of drug-resistant focal epilepsy. CombiGene will now, together with Viralgen, carry out extensive quality analyses of the produced material to meet all aspects of the requirements that the pharmaceutical authorities will impose on future production of materials intended for clinical studies. This work is expected to be completed sometime around the turn of the year of 2020/2021.
Final preclinical studies in 2021
When the comprehensive quality analyses are completed, the produced material will be used to conduct the CG01 projectâs final preclinical studies, including the important biodistribution and safety studies. These studies will be conducted by CombiGeneâs American CRO partner NBR.
Clinical studies 2022
Once the final preclinical studies have been conducted and analysed with documented positive results, CombiGene will be ready to apply for approval to start the first study in humans, a so-called clinical study. CombiGene is currently working with interested clinics and doctors to design the first clinical study. CombiGene also plans to present its plan for the study to the Swedish regulatory agency LĂ€kemedelsverket and British MHRA (Medicines & Healthcare Products Regulatory Agency) in the final quarter of 2020.
The CG01 project has high commercial potential
Unlike many gene therapies, which are developed for the treatment of rare diseases, CG01 caters to a large population of patients. Epilepsy is a major global problem. Every year, approximately 47,000 drugresistant patients with focal epilepsy are estimated to be added in the US, EU4 + UK, Japan and China. CombiGene believes that it is realistic that 10-20% of these patients could be treated with the drug candidate CG01. Assuming, for example, that the therapy cost per patient is somewhere between $134,000 and $200,000 (which compared to approved gene therapy drugs is low), it provides sales between $750-$1,500 million annually.
About Viralgen www.viralgenvc.com
Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners, combining decades of technology and drug development experience in multiple platforms to support best-inclass service offerings to the gene therapy market.
Viralgen was created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics and to contribute to the advancement of health and human welfare around the world. The company specializes in the production of rAAV viral vectors, and have built an optimized facility in San Sebastian, Spain that maximizes throughput and efficiency of the proprietary Pro10âą suspension manufacturing platform, enabling industry-leading scalability, reproducibility, and speed to market.
Through a superior technology platform, Viralgen deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimize the cost-of-goods, and accelerate clinical development and commercialization of life-saving genetic medicines.
ViralgenÂŽs new commercial facility will be in production
by the end of 2021 in San Sebastian (Spain).
Edit SÄ kom det ogsÄ artikkel i biostock ogsÄ hvor det legges frem informasjon om det som har skjedd den siste tiden. Link nedenfor.
Biostock med ny analyse av Combigene. Link til analysen i artikkene. Denne som sender kursen opp igjen vil jeg anta. Veldig spennende.
Sitat fra analysen:
âGivet de framsteg som CombiGene hittills har gjort, utgör bolaget en attraktiv mĂ„ltavla för eventuella uppköp och licensaffĂ€rer under de kommande Ă„ren. Att CombiGene dĂ€rtill Ă€r det enda noterade bolaget pĂ„ den svenska aktiemarknaden och med en nischad exponering inom det snabbvĂ€xande genterapiomrĂ„det, betraktar vi som en exklusiv position.â
ForÞvrig etter min mening ganske sprÞtt. Sliter med Ä forstÄ dagens mcap nÄr en faktisk ser pÄ hva de er pÄ vei mot.
Ser ut til at det gÄr mot reprising dette. Liker ogsÄ at ordrebildet ser sÄpass bra ut som det gjÞr til tross for den siste tidens oppgang. Virker Ä vÊre litt trykk fra folk som Þnsker flere aksjer. Veldig moro.
Ellers ble ikke den siste videon fra AktieportefÞlje lagt ut her sÄ slenger den pÄ.
CombiGeneâs warrants of series TO4 and TO5 utilized to 98.4 per cent
On 18 February 2020, and on 24 April 2020, CombiGene AB (publ) (âCombiGeneâ) issued, inter alia, a total of 30,284,180 warrants of series TO4 in a rights issue and in a private placement to Modelio Equity AB (publ) and Oscar Molse. Thereafter, on 4 August 2020, CombiGene issued, inter alia, 21,588,125 warrants of series TO5 in a private placement to the Dutch specialized Life Science investor Nyenburgh Holding BV. On 30 November 2020, the period for exercising the warrants for subscription of shares ended. When the subscription period ended, 29,466,723 warrants of series TO4 and 21,588,125 warrants of series TO5, in total 51,054,848 warrants, had been exercised for subscription of the same number of shares. This equals an aggregated utilization rate of 98.4 per cent. Given the subscription price of SEK 0.5, CombiGene thus raised SEK 25,527,424 before transaction costs.
The subscription entails that the number of shares in CombiGene increases with 51,054,848 shares, from 178,222,176 shares to 229,277,024 shares and that the share capital increases by SEK 5,105,484.80 from SEK 17,822,217.60 to SEK 22,927,702.40.
The shares added as a result of the exercise of warrants of series TO4 and TO5 entails a dilution effect of approximately 22 per cent. Dilution effect refers to the number of newly issued shares as a result of exercised warrants of series TO4 and TO5 in relation to the total number of shares in CombiGene after the new shares have been registered.
Last week, CombiGene reported that the companys two warrants were exercised at 98.4 percent, which thus added just over SEK 25 million to the company. In addition, one of the companys co-founders, Associate Professor David Woldbye, published a peer-reviewed article in Frontiers in Molecular Neuroscience, concerning CombiGenes epilepsy project CG01. BioStock reached out to CEO Jan Nilsson for a comment.
Read the full interview with CombiGenes CEO Jan Nilsson at biostock.se:
Ny ansettelse i forbindelse med de fremtidige kliniske studiene.
Med rekryteringen av Martin Linhult inleder CombiGene processen att stÀrka bolaget inför de kliniska studierna i epilepsiprojektet CG01
CombiGenes epilepsiprojekt CG01 kommer under 2021 att fokusera pÄ de avslutande prekliniska studierna, inte minst de viktiga biodistributions- och toxikologistudierna, med mÄlsÀttningen att pÄbörja studie i mÀnniska, sÄ kallade kliniska studier, under 2022. Ett centralt omrÄde för sÄvÀl de avslutande prekliniska studierna som kommande kliniska studier Àr GMP-tillverkning av CG01. CombiGene har dÀrför rekryterat Martin Linhult, som bolagets CMC-expert (Chemistry, Manufacturing and Controls) med tilltrÀde i december 2020. Utöver sin expertis inom CMC-omrÄdet kommer CombiGene ha stor nytta av hans erfarenhet av ta lÀkemedelsprodukter hela vÀgen till marknad.
Martin Linhult har doktorerat inom molekylÀrbiologi vid KTH i Stockholm (1998-2003) och har en Master of Chemical Engineering frÄn samma lÀrosÀte. DÀrutöver har Martin en gedigen erfarenhet frÄn ett antal seniora positioner inom svensk lÀkemedelsindustri och Àr van vid att interagera med regulatoriska myndigheter pÄ internationell nivÄ, bland annat FDA och EMA. Martin har arbetat inom alla delar av produktionen av biologiska lÀkemedel och var ansvarig för att bygga upp produktionsenheten pÄ Octapharma. Martin kommer primÀrt att arbeta med de olika aspekterna av tillverkningen av lÀkemedelskandidaten CG01 som nu gÄr in i ett mycket intensivt utvecklingsskede. Martin kommer att rapportera till CombiGenes Chief Research and Development Officer Karin Agerman .
âJag Ă€r otroligt glad att vi lyckats rekrytera Martin Linhult till CombiGeneâ, sĂ€ger Karin Agerman . âMartin har precis den djupa kunskap inom alla delar av produktion av biologiska lĂ€kemedel som vi söker och har utöver detta erfarenhet av att ta en produkt hela vĂ€gen till marknad. Hans breda internationella erfarenhet av regulatoriska frĂ„gor kommer att vara till stor nytta i den fortsatta utvecklingen av CG01.â
CombiGene fortsÀtter nu processen att stÀrka bolaget med ytterligare en till tvÄ personer.
Nye ansettelser i selskapet i forberedelsene i forhold til Ă„ beve seg mot klinisk fase. Ser ut til at de finner bra folk. Erfaring fra Merck er sikkert ikke dumt.
With the recruitment of Pernilla Fagergren, CombiGene strengthens the company further for the clinical studies in the epilepsy project CG01
In 2021, CombiGeneâs epilepsy project CG01 will focus on the final preclinical studies. In parallel, the company will intensify preparations for studies in humans, known as clinical studies, which are scheduled to begin in 2022. CombiGene has now recruited Pernilla Fagergren to the positon as Clinical Project Manager, which means that Pernilla will be responsible for preparing and running the first clinical study.
Pernilla Fagergren has a broad experience from academia and industry. She holds a PhD at Karolinska Institutet in Stockholm and has conducted research at Mount Sinai School of Medicine in New York, USA. Pernilla comes most recently from Merck AB where she worked as a medical advisor and manager in neurology. Prior to that, she worked as a researcher with early pharmaceutical projects at Karo Bio AB. Her expertise covers key areas such as drug development, project management and neuropharmacology. Pernilla also has extensive experience in national and international collaboration with physicians and leading medical opinion leaders. Pernilla will report to CombiGeneâs Chief Research and Development Officer KarinAgerman .
âI am incredibly pleased that we have succeeded in recruiting Pernilla Fagergren to CombiGeneâ , says Karin Agerman . âPernilla has just the deep knowledge of drug development and clinical studies that we are looking for. Her experience from international work in both industry and academia will be crucial as we step up the preparation work for the first study in human within our epilepsy project CG01.â
En fra CombiGene facebook gruppa som har fÄtt aksjonÊrliste fra selskapet. Riktig nok en mÄned gammal. Uansett, gir ihvertfall et visst oversblikk. ABN Amro er da Nyenburgh. Blir spennende Ä fÞlge med aksjeutviklingen der. Satser pÄ at de tar et litt langvsiktig eierskap her og er med pÄ Ä fylle pÄ mer penger i kassa senere sÄ finansieringen trygges fremover til tross for erfaringen med PCIB tidligere.
Og snakk om sola, samme minuttet som jeg postet listen kom det melding
Svar frÄn de svenska och brittiska lÀkemedelsmyndigheterna konfirmerar CombiGenes plan för CG01:s avslutande prekliniska studier
I december 2020 genomförde CombiGene separata möten med svenska lÀkemedelsverket och dess brittiska motsvarighet MHRA (Medicines & Healthcare products Regulatory Agency). Mötena Àgde rum efter det att de bÄda myndigheterna gÄtt igenom dokumentation avseende nuvarande status för CombiGenes epilepsiprojekt CG01 vad gÀller det prekliniska programmet och etablering av tillverkningsplattform samt utformningen av de planerade studierna inom toxikologi och biodistribution. Utöver detta hade CombiGene ocksÄ lÀmnat in en preliminÀr version av utformningen av den första kliniska studien.
BÄda myndigheterna har nu konfirmerat CombiGenes upplÀgg av studierna inom toxikologi och biodistribution, vilket innebÀr att bolaget kan gÄ vidare som planerat utan Àndringar i utformningen av studierna. De bÄda studierna berÀknas inledas sÄ snart det producerade CG01-materialet har genomgÄtt ordinarie kvalitetsgranskning. Myndigheterna gav ocksÄ vÀrdefulla rÄd angÄende kommande GMP-produktion och den första kliniska studien. CombiGene kommer nu att fortsÀtta diskussionerna med kliniker som Àr intresserade av att vara delaktiga i den första kliniska studien som Àr planerad att inledas under 2022. Myndigheterna framhöll ocksÄ möjligheten till ytterligare möte nÀr CombiGene utarbetat ett mer slutgiltigt studieprotokoll för den kliniska studien för mer rÄdgivning.
âJag Ă€r mycket nöjd med diskussionerna med de bĂ„da lĂ€kemedelsmyndigheternaâ, sĂ€ger Karin Agerman , Chief Research and Development Officer pĂ„ CombiGene. âJag Ă€r ocksĂ„ mycket glad över möjligheten till fortsatt dialog med myndigheterna angĂ„ende det kliniska studieprogrammet.â
Om CG01
CG01 Ă€r en genterapi som utvecklas för behandling av lĂ€kemedelsresistent fokal epilepsi. Varje Ă„r berĂ€knas cirka 47 000 lĂ€kemedelsresistenta patienter med denna typ av epilepsi tillkomma i USA, EU4, UK, Japan och Kina. CombiGene gör bedömningen att det Ă€r realistiskt att 10-20 procent av dessa patienter skulle kunna behandlas med bolagets genterapi. Den globala marknaden för lĂ€kemedelskandidaten CG01 uppskattas till 750 â 1 500 miljoner USD Ă„rligen.
Moro og ikke minst helt ellevill omsetning i aksjen i dag. Startet vel dagen pÄ mcap pÄ 155 MSEK og dagens omsetning pÄ aksjen var pÄ utrolige SEK 22 840 272. Det er rimelig villt. Utrolig moro og se ogsÄ at det ble en oppgang pÄ 12% ut av dette ogsÄ. Krysser fingrene for at vi for en fin tid videre. ForhÄpentligvis er det flere som har fÄtt Þynene opp for selskapet nÄ.
CombiGeneâs lipodystrophy project receives EUR 882,500 in development funding from the EU Eurostar program
CombiGene is awarded EUR 481,000 in project grants and broadens cooperation in the lipodystrophy project to include the University Medical Center Hamburg-Eppendorf and the CRO company Accelero, who receives EUR 265,000 and EUR 136,500 respectively within the same project grant
CombiGenes project CGT2 aims to develop a gene therapy for the treatment of the rare disease partial lipodystrophy. Thanks to funding from Eurostars, CombiGene can now expand the cooperation within the CGT2 project to include the University of Hamburg and Accelero. At the University Medical Center Hamburg-Eppendorf there is a research group with experts in lipid research that now will be linked to the CGT2 project. Accelero is a German CRO company that will help develop analytical methods to measure the effect of CGT2. EUâs Eurostar program, aimed at SMEs wishing to cooperate in research and development projects, has now allocated a total of EUR 882,500 in development funding to the CGT2 project. The money is distributed to CombiGene with EUR 481,000, Accelero with EUR 136,500 and the University Medical Center Hamburg-Eppendorf with EUR 265,000.
Eurostars is the largest international financing program for SMEs wishing to cooperate on R&D. Competition is high and funding is only allocated to projects that come high in the rankings.
âThe news that CombiGeneâs lipodystrophy project CGT2 is awarded approximately SEK 9 million is of course extremely gratifying,â says CombiGeneâs Preclinical Project Manager Annika Ericsson . âThe grant itself is important because it allows us to drive the project forward at full pace. Our high ranking among the companies that have applied for funding from the Eurostars program, I also see as confirmation of the projectâs scientific height and CombiGeneâs ability to, in cooperation with external partners, run an effective and successful development work. This is a great day for CombiGeneâs lipodystrophy project and for all those patients who are waiting for effective treatment of this severe disease.â
About the lipodystrophy project CGT2
The CGT2 project aims to develop a gene therapy treatment for partial lipodystrophy. The project was inlicensed from Lipigon Pharmaceuticals AB in 2019 and is in early preclinical development with a focus on the design and testing of gene therapy vectors.
Lipodystrophy is a rare disorder that is characterized by abnormal distribution of fat in the body. Patients suffer from lipoatrophy, which means that body fat is lost. In the absence of normal body fat different organs begin to accumulate fat, which subsequently leads to serious metabolic complications, among them, extreme insulin resistance, hypertriglyceridemia (elevated levels of the blood fat triglyceride) and hepatic steatosis (fatty liver disease).
There are currently a few treatments that can alleviate the symptoms of lipodystrophy, but no form of therapy that is targeted directly at the fundamental cause of the disorder. For patients suffering from partial lipodystrophy there are currently no treatments whatsoever.
About the University Medical Center Hamburg-Eppendorf (UKE)
UKE is an important research facility and hospital in Hamburg. UKE researches in five main areas; neuroscience, oncology, cardiovascular research, health sciences research and immunology. Professor Jörg Heeren and his team have significant expertise in the target protein of CGT2, its function in the adipose tissue and its influence on lipid metabolism.
About Accelero
Accelero Bioanalytics is a GLP certified laboratory specializing in delivering bioanalytical services for the drug development industry since 2011 and located in Berlin, Germany.
Veldig gode nyheter dette. Synes de gjÞr en veldig bra jobb med Ä fÄ progresjon og stÞttemidler. Skulle Þnske jeg hadde frie midler pÄ zero kontoen nÄ sÄ skulle jeg plukket med litt mer her. De midlene vil nok dekke de kostnadene de har med lipodystrofi studien den neste tiden da det pre-kliniske arbeidet ikke er sÄ dyrt Ä finansiere. Med epilepsistudien i siste Är fÞr de skal i klinikken sÄ tenker jeg at det etterhvert vil gradvis tynnes ut blant selgerne. De som er langsiktige kan jeg ihvertfall ikke se for meg at selger nÄ. FÄr se hvordan utviklingen blir nÄ fremover. Utrolig spennende.
