Oslo, September 26, 2018. Positive results from the 6-months Interim analysis of the phase IIa clinical study in high grade cervical dysplasia provides Proof-of-Concept for Vaccibody’s immunotherapy platform.
Vaccibody AS today announced positive 6-months interim results from the phase IIa part of the clinical study VB C-01. This study is a first human dose, open-label, multicenter phase I/IIa study of VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV16). 12-months data will be announced in Q1, 2019.
The phase IIa enrolled 18 CIN 2/3 patients, 1 patient was withdrawn and 17 patients each received four doses of 3 mg of VB10.16 at week 0, 3, 6 and 16 weeks. The primary objective of the study was to evaluate the safety and tolerability of VB10.16. The secondary objectives were to assess T cell mediated immune responses in the peripheral blood and to evaluate early signs of efficacy by means of CIN regression and HPV clearance. The vaccine was delivered with a pain-less PharmaJet® Stratis Needle-free Injection System.
The treatment with the four doses of VB10.16 was well tolerated in the phase IIa part as it was in the phase I part of the study. No serious adverse advents (SAEs) or unexpected adverse events were reported. The most frequently reported AEs were transient mild to moderate reactions at the injection site.
Immunological analyses of the peripheral blood demonstrated a strong HPV16-specific T cell immune response in 17 of 17 patients evaluated. The response was induced by the vaccine in 16 of 17 patients against both antigens used in the vaccine (HPV16 proteins E6 and E7). One patient had a strong baseline response and thus was not further induced by the vaccine. These results constitute a proof-of-concept for the Vaccibody DNA vaccine technology delivered by jet injection regarding its ability to generate a rapid, strong and long-lasting response.
One patient had conization at 4 months and could not be assessed at 6 months. Of the remaining 16 patients, 15 patients showed a partial or complete response at 6 months (13 partial responders, 2 complete responders, 1 stable disease). 14 patients showed a reduction in lesion size from colposcopic examination at 6 months (median reduction for these 14 patients was 50%). Histopathological regression to low grade neoplasia (CIN 1) or no disease was seen in 8 patients. Of the 8 patients that has not regressed to CIN1 or less at 6 months, 6 patients showed upregulation of PD-L1 in the lesions which may delay or inhibit elimination of all affected cells. Three of these patients had also persistent co-infection with other high-risk HPV strains, including one patient which had cleared HPV16.
Adding a 4th vaccination at 4 months significantly boosted the T cell response and the strongest response was observed at 6 months. Change in lesion size and CIN regression will be monitored until 12 months after first vaccination.
Martin Bonde, CEO of Vaccibody, commented: We are very pleased with the data we have seen so far. The vaccine has an excellent safety profile and the T cell immune responses observed indicate that VB10.16 induces a stronger HPV16-specific immune response than what we have seen reported in the literature and the 4th dose significantly boosts and thus prolongs the T cell response where we observe the strongest response at 6 months (at the time of this interim analysis). While other DNA vaccines developed for this indication require delivery with in vivo electroporation, which requires more investment in equipment and is reported to be quite painful, VB10.16 is delivered by a simple needle-free, painless jet injection which we believe improves patient compliance tremendously and will be a significant asset in further development of this product. The fact that we see a high response rate, with significant lesion size reduction shows that most patients truly benefit from the strong T cell response induced by VB10.16 monotherapy. Moreover, we observe CIN regression in a high percentage of these patients at 6 months. The fact that we observe PD-L1 upregulation in response to vaccination in the patients that do not have CIN regression before 6 months, substantiates the mechanism of action of the vaccine and invites to pursue potential synergistic effects by combining therapeutic Vaccibody cancer vaccines and checkpoint inhibitors, like we have observed in preclinical experiments. We are currently exploring opportunities for the combination of the VB10.16 vaccine with a checkpoint inhibitor in order to treat established HPV16+ cervical cancer, head and neck cancer, anal cancers and other HPV16+ cancers.
The VB C-01 is the first clinical study utilizing Vaccibody’s Vaccine Platform Technology and the positive results can have a significant impact not only on the development of the company’s lead product, VB10.16, but very importantly also represent a proof of principle for the technology and the potential to use this platform in further indications. One such example is our cancer neoantigen study VB N-01 in patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck.
Er vel som med oncoinvent, så lenge investorene de har på laget er fornøyde og bidrar med all den kapital som trengs, så er det vel bare ulempe for selskapet og ledelsen med børsnotering egentlig.
OSLO, OCTOBER 10, 2018.
VACCIBODY UPDATES ON CANCER NEOANTIGEN PHASE I/IIA CLINICAL TRIAL: FIRST 10 PATIENTS ENROLLED, AND VACCINATIONS STARTED.
Vaccibody AS, a clinical stage immunotherapy company focused on developing personalized neoantigen cancer vaccines to target solid tumors, today announces that the first 10 patients have been enrolled in its phase I/IIa cancer neoantigen vaccine trial and that vaccinations with VB10.NEO have started. The trial is planned to enroll up to 40 patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. The VB10.NEO vaccine is given in combination with standard of care checkpoint inhibitors.
Mads Axelsen, MD, Chief Medical Officer in Vaccibody, said “We are very pleased with the enrolment in the neoantigen trial and with the interest we are experiencing from clinical investigator and from patients. To that end I would like to thank the experienced cancer experts and investigators in this trial namely Prof. Jürgen Krauss from Heidelberg, Prof. Angela Krackhardt from Munich and Prof. Elke Jäger from Frankfurt. Together with their dedicated teams they are doing an outstanding job with the neoantigen trial”
Litt info om det spennende samarbeidet med Nektar. I motsetning til NANO og PCIB, har altså Vaccibody både klart å holde seg til guidingen ogi tillegg fått til en spennende avtale om klinisk studie med viktig aktør.
Hadde PCIB presentert noe tilsvarende (feks på fimaVacc) hadde kursen gått 50+% tvert.
Her skjer det ting. Kom under min radar da jeg var på PCI Biotech sin presentasjon. En del av oss sto og snakket med Per Walday, men rett bortenfor sto Jonas Einarsson, så jeg spisset ører da jeg hørte de snakket opp Vaccibody og Roche i samme setning…
Vaccibody announces collaboration to study VB10.16 and atezolizumab (Tecentriq®) in advanced cervical cancer
Oslo, Norway, 13 February, 2019 – Vaccibody AS, a clinical stage immuno-oncology company, announced today that it has entered into a collaboration with Roche to explore a combination of Vaccibody’s VB10.16 and the PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq®) in patients with advanced cervical cancer. Vaccibody expects to start a phase II study with up to 50 patients in the second half of 2019.
Martin Bonde, CEO of Vaccibody, said: “We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with advanced cervical cancer.” Agnete Fredriksen, President and CSO of Vaccibody added: “The combination of VB10.16 and atezolizumab is building on the positive data VB10.16 has generated as monotherapy in patients with precancerous cervical lesions. In this study, it was observed that VB10.16 creates a target for PD-1/PD-L1 checkpoint inhibitors, thereby providing a sound scientific rationale for combining VB10.16 with an immune-checkpoint inhibitor like atezolizumab in cervical cancer patients.”
The planned study will assess the safety, tolerability, immunogenicity and efficacy of the VB10.16-atezolizumab combination in patients with advanced cervical cancer.
Hvis Vaccibody går hele veien og blir kjøpt opp kan penger flyte til de andre norske biotechs. Som vi har diskutert trengs det en suksess her nå. Begynner å bli en stund siden Algeta.
Ser ut som om det var høy kvalitet på de som kjøpte seg inn her. En del kjente navn nedover.
DNB Asset Management Norway 1 195 000,00 47 800 000,00
Datum Invest AS Norway 500 000,00 20 000 000,00
Canica AS Norway 500 000,00 20 000 000,00
Danske Kapital Norge Norway 300 000,00 12 000 000,00
Norron Sicav Sweden 250 000,00 10 000 000,00
Norda ASA Norway 250 000,00 10 000 000,00
P53 Invest AS Norway 250 000,00 10 000 000,00
Portia AS Norway 250 000,00 10 000 000,00
Om Holding Norway 175 000,00 7 000 000,00
Toluma, Tudor,Wingana Norway 150 000,00 6 000 000,00
Skøien AS Norway 125 000,00 5 000 000,00
Vatne Capital Norway 125 000,00 5 000 000,00
Alden AS Norway 125 000,00 5 000 000,00
T.D. Veen Norway 125 000,00 5 000 000,00
Hortulan AS Norway 115 000,00 4 600 000,00
Altitude Capital AS Norway 100 000,00 4 000 000,00
Cressida AS Norway 90 000,00 3 600 000,00
Arepo AS Norway 90 000,00 3 600 000,00
Lani Invest AS Norway 85 500,00 3 420 000,00
Fougner Invest Norway 85 000,00 3 400 000,00
Tigerstaden AS Norway 75 000,00 3 000 000,00
NHO (BLOCK) Norway 70 000,00 2 800 000,00
Sandnes Investering AS Norway 60 000,00 2 400 000,00
Adrian AS Norway 60 000,00 2 400 000,00
Adrigo Small & Midcap Sweden 50 000,00 2 000 000,00
Viola AS Norway 50 000,00 2 000 000,00
Middelborg AS Norway 40 000,00 1 600 000,00
Borgano AS Norway 40 000,00 1 600 000,00
Vitamar AS Norway 30 000,00 1 200 000,00
Cipriano AS Norway 25 000,00 1 000 000,00
Carucel Holding AS Norway 25 000,00 1 000 000,00
Trapesa AS Norway 25 000,00 1 000 000,00
Bajas Holding AS Norway 20 000,00 800 000,00
Strigen AS Norway 20 000,00 800 000,00
Kai Lotherington Norway 15 000,00 600 000,00
For Lise AS Norway 15 000,00 600 000,00
Stoko AS Norway 15 000,00 600 000,00
Cosimo AS Norway 15 000,00 600 000,00
Jahatt AS Norway 12 500,00 500 000,00
Storfjell AS Norway 12 500,00 500 000,00
Spar Kapital Investor AS Norway 12 500,00 500 000,00
Acme AS Norway 11 500,00 460 000,00
GTBA Forvaltning AS Norway 10 000,00 400 000,00
Erik Wahlstrøm Norway 10 000,00 400 000,00
Castor Invest AS Norway 10 000,00 400 000,00
Yip Timothy Churk Yue United Kingdom 10 000,00 400 000,00
Nian AS Norway 6 500,00 260 000,00
LBM Invest AS Norway 6 500,00 260 000,00
Arne Gunnar Framnes Norway 6 500,00 260 000,00
IFG Holding AS Norway 6 500,00 260 000,00
Blueberry Capital AS Norway 6 500,00 260 000,00
Grum Invest AS Norway 6 500,00 260 000,00
Lekang AS Norway 6 500,00 260 000,00
Kristian Hodne Norway 6 500,00 260 000,00
Norlink AS Norway 6 500,00 260 000,00
Drexciya AS Norway 6 500,00 260 000,00
Orakel AS Norway 6 500,00 260 000,00
Vestland Holding As Norway 6 500,00 260 000,00
Haug Invest AS Norway 6 500,00 260 000,00
Kristian Falnes AS Norway 6 500,00 260 000,00
Larsen Dag Henning Norway 6 500,00 260 000,00
Kaaba Invest AS Norway 6 500,00 260 000,00
Scan Chemicals AS Norway 6 500,00 260 000,00
T M Dahl Eiendom AS Norway 5 000,00 200 000,00
Kambiz Karimiha Norway 3 750,00 150 000,00
Tore Jahnsen Norway 2 500,00 100 000,00
Per. J. Holding AS Norway 2 000,00 80 000,00
Kjersti Nygaard Norway 1 000,00 40 000,00
Jens Christian Rivenes AS Norway 750,00 30 000,00
Ny imponerende pressemelding fra Vaccibody i dag. De har fått godkjent ikke mindre enn fire poster presentasjoner på 2019 AACR.
Vaccibody AS to present data on VB10.NEO and VB10.16 at upcoming American Association for Cancer Research Annual Meeting
Poster presentations of Vaccibody’s two lead candidates: 6M interim clinical data on VB10.16, and preclinical data on VB10.NEO alone and in combination with bempegaldesleukin (NKTR-214)
Oslo, Norway, February 27th, 2019 – Vaccibody AS today announced that clinical and preclinical data will be presented at the upcoming 2019 American Association for Cancer Research (AACR) Annual Meeting, which will be held from March 29- April 3, 2019 in Atlanta, Georgia. The abstracts will be published in advance of the AACR Annual meeting at the AACR Online Itinerary Planner: https://www.abstractsonline.com/pp8/#!/6812.
“We are excited that four separate abstracts presenting Vaccibody’s pipeline have been accepted for poster presentation at this year’s AACR Annual Meeting,” said Agnete Fredriksen, PhD, President and CSO of Vaccibody. Two of the abstracts cover Vaccibody’s two lead candidates VB10.16 and VB10.NEO and are presenting the 6M interim data and the clinical design, respectively. In addition, two abstracts present preclinical data for VB10.NEO that demonstrates the progress we have made characterizing the unique Vaccibody platform and its ability to induce strong tumor protective immune responses alone and in combination with bempegaldesleukin (NKTR-214).
For litt mer detaljer se:
http://www.vaccibody.com/vaccibody-as-to-present-data-on-vb10-neo-and-vb10-16-at-upcoming-american-association-for-cancer-research-annual-meeting/
Skal forsøke å skrive litt mer om mitt syn på selskapet og mine forhåpninger om videre utvikling i løpet av noen dager.
Utover sjefen for kreftforskningen ved OUS sin optimisme rundt Vaccibody sin teknologi er det vel disse avsnittene i artikkelen som er viktig å bite seg merke i:
Terapeutisk vaksine
Samarbeidet vil teste vaksinen for de som har utviklet aggressiv livmorhalskreft. For pasientene vil det si at man kan får en vaksine i armen flere ganger.
Med en terapeutisk vaksine tilsetter man noe som allerede finnes i kreftcellene, og får immunforsvaret til å gjenkjenne kreftcellene som har dette i seg. Da vil immunforsvaret drepe kreftcellene.
– Kort fortalt, så fjerner Roche sin vaksine den bremsen som gjør at immunforsvaret gir opp kampen mot kreften, mens vår vaksine sørger for at riktig immunforsvar tar seg av kreften.
Kan komme i 2023
Vaccibody regner med å begynne å behandle pasienter med den nye samarbeidsvaksinen rundt nyttår 2019. Da blir det omtrent 50 personer som kan prøve ut den nye kreftvaksinen.
– Vi planlegger å behandle alle innen et år. Da kan vi få ganske raske data på hvor godt det fungerer, sier Fredriksen.
Dersom vaksinen har en dramatisk effekt, kan man komme fortere inn på markedet og begynne å behandle pasienter. Fungerer vaksinen bra, kan man derfor forvente å se den på markedet mellom år 2023 og 2025.
– Det er flere andre som går den veien nå, fordi forståelsen for immunterapi har kommet i det siste. Tidligere har mange kreftvaksiner stanget mot veggen fordi man har forsøkt å få immunforsvaret til å reagere på kreftceller samtidig som friske celler. Og det er vanskelig.
Så langt har Vaccibody ikke hatt noen problemer med bivirkninger, og Roche sin medisin har nå i mars blitt godkjent for bruk i trippel negativ brystkreft tilfeller i USA så den er det også grunn til å anta er sikker. Jeg tror derfor vi kan anta kombinasjonen også vil være safe, og at studien derfor har en god sannsynlighet for å lykkes.
Vaccibody har hittil levert on-time og med bedre resultater enn forventet på alt de har satt i gang, og 2023-25 er faktisk ikke så lenge til. Så dette er en spennende utvikling både for pasienter og aksjonærer.
Når det gjelder vurderingen av aksjen, så er jo HPV vaksinen VB10.16 bare et av produktene til Vaccibody, og det potensielt mest verdifulle er den persontilpassede neoantigen vaksinen som kan brukes i en mengde kreftformer.
Det er vrient å lage noen sikre regnestykker på det kommersielle potensialet til Vaccibody. Prisingen av medisinen er jo en stor ukjent X, men produksjonskostnaden av den standardiserte VB10.16 vaksinen oppgis å være lav, og også være rimelig enkel og håndtere. Kostnaden for å analysere og produsere den individuelle VB10.NEO vaksinen blir selvsagt noe helt annet, men de har i løpet av fase 1 studien hatt en 100 % suksessrate i produksjonen av vaksinen. Så det ser ut til at de får til den praktiske delen av den studien.
PS!
Link til pressemelding fra Roche om godkjennelse for bruk innen brystkreft: https://www.roche.com/media/releases/med-cor-2019-03-11.htm
Tecentriq / atezolizumab er i fase 2 for bruk i livmorhalskreft.
Morgendagens FA:
HELSE:Vaccibody skrur opp prisingen nye 30 prosent, og nå ser kreftvaksineselskapet mot børs slik at Jan Haudemann-Andersen kan synliggjøre en kjempegevinst.
– Vi har nå gått ut og sagt at vi innen 12 måneder skal vurdere børsnotering, sier styreleder Tom E. Pike i Vaccibody til Finansavisen.
Selskapet gjorde nylig en emisjon på 230 millioner kroner. Til tross for at selskapet igjen skrudde prisingen kraftig i været, rapporterer de om stor interesse fra både nye og eksisterende investorer.
Jan Haudemann-Andersen har vært med i en årrekke og er selskapets største private aksjonær med aksjer for hele 166 millioner kroner.
Prising: 2,2 mrd.
Ved årsskiftet 2016/2017 var hele selskapet priset til 400 millioner kroner før en emisjon på 220 millioner. Det tilsvarte 12,50 kroner pr. aksjer. I fjor vår var emisjonskursen satt til 31 kroner, og selskapet var priset til 1,5 milliarder. Nå er kursen hevet til 40 kroner, og selskapet fremstår med en prising på nær 2,2 milliarder kroner etter emisjonen.
– Emisjonskursen er basert på handel i aksjen i mellomtiden. Aksjen er omsatt på dette nivået i forkant av emisjonen, sier Pike.
Vaccibody er ikke notert på noen markedsplass, men handles sporadisk i meglerapparatet. Emisjonen ble gjennomført med ABG Sundal Collier og Arctic Securities som finansielle rådgivere.
Gevinst: 130 mill.
Jan Haudemann-Andersen har uansett vært med på en formidabel reise. Investoren gikk inn i selskapet i 2014 – da sammen med såkornselskapet Sarsia Seed, Radiumhospitalets Forskningsstiftelse, universitets- og sykehusselskapet Inven2 og Kreftforeningen.
Den gang var selskapet priset til 42 millioner kroner før penger og 78 etter, hvilket tilsvarte en aksjekurs på drøye 3 kroner. Det innebærer at Haudemann-Andersen må ha brukt rundt 10 millioner kroner på å tilegne seg aksjeposten på den gang 12,9 prosent i selskapet. Senere har han deltatt noe i etterfølgende emisjonsrunder, men ikke økt aksjeantallet vesentlig. Følgelig er hans kostpris særdeles lav.
Når selskapet går på børs ligger det følgelig an til at Haudemann-Andersen vil få synliggjort verdier for 166 millioner kroner, hvorav mellom 130 og 140 millioner vil være ren gevinst.
Roche-samarbeid
Den største gevinsten vil dog komme hvis Vaccibody lykkes i sitt prosjekt som går ut på å lage en vaksine som skal hjelpe pasientens immunforsvar til å gå til angrep på skader i kreftcellene. Vaksinen kan brukes på alle kreftformer, men i første omgang er det snakk om å bruke den på lunge, føflekk- blære, nyre, og hode-halskreft.
– Selskapet har en veldig positiv utvikling på utviklingsprosjektene. Det er det ingen tvil om, sier Tom Pike.
Nylig meldte Vaccibody at de hadde inngått samarbeid med Roche om å utforske en kombinasjon av flere behandlinger hos pasienter med livmorhalskreft. Fase II-studier med opptil 50 pasienter skulle igangsettes i andre halvdel av 2019.
Pengene fra emisjonen skal brukes til disse fase II-studier med Vaccibodys neoantigenprogram samt til vanlig arbeidskapital i selskapet.
Det Erna skriver her så useriøst at det egentlig burde forbigås i stillhet, men om det er noen som ikke kjenner Vaccibody så godt kan det vel være greit å skrive ned et par fakta.
- Vaccibody sin DNA terapeutiske vaksine mot livmorhalskreft VB10.16 har vist fantastisk gode resultater i fase IIa, og skal nå gå i videre tester sammen med Roche sin immune-checkpoint inihibitor. VB10.16 er en standardisert vaksine som er “enkel” å produsere og livmorhalskreft er en stor og dødelig kreft variant. Vaccibody oppgir følgende informasjon: About cervical cancer
Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide. An estimated 45,800 cases of cervical cancer will be diagnosed in the US and EU in 2019 and similarly an estimated 18,400 deaths from cervical cancer will occur in 2019. Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer. - Den individuelle VB10.NEO vaksinen testes ut på melanom, lunge, blære, nyre og hode/hals kreft. Alle disse kreftformene gir et enormt potensiale, for dette er dessverre får vi si store og alvorlige kreftformer. Det er selvfølgelig vanskelig å vite hva produksjonskostnaden for en individualisert medisin vil bli, men i forsøkene deres har de til nå klart å produsere og levere/behandle alle pasientene med en vaksine tilpasset den enkelte pasientens tumor.
Vaccibody har hatt fokus på at deres produkter skal kunne bli en kommersiell og praktisk gjennomførbar behandling, og så langt har de levert på både effekt og resultater. Så at dette bare skal være et nisjeprodukt og bli et “jallaselskap” må argumenteres bedre for og ikke bare vise til et annet selskap vedkommende har tro på.
Se forøvrig ny pressemelding om den endelige analysen av fase IIa forsøket. http://www.vaccibody.com/news/
Positive 12-month results from phase IIa clinical study in high grade cervical dysplasia provides Proof-of-Concept for Vaccibody’s immunotherapy platform and lead candidate VB10.16.
Oslo, March 25, 2019 Vaccibody AS today announced positive 12-month results from the phase IIa part of the clinical study VB C-01. This study is a first human dose, open-label, multicenter phase I/IIa study of VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV16). The primary objective of the study was to evaluate the safety and tolerability of VB10.16. The secondary objectives were to assess T cell mediated immune responses in the peripheral blood and to evaluate early signs of efficacy by means of CIN regression and HPV clearance. The vaccine was delivered with a PharmaJet® Stratis Needle-free Injection System.
The phase 1 part of the trial has previously been reported. It was completed in 2017 and showed that VB10.16 was well tolerated with no clinical important safety signal, the optimal vaccine schedule was identified (week 0, 3, 6) and suggested adding a fourth vaccination to maintain the strong immunogenic response.
The phase 2a study enrolled 18 CIN2/CIN3 patients, 1 patient was not HPV16 positive and thus 17 patients received four doses of 3 mg VB10.16 at week 0, 3, 6 and 16. The treatment with the four doses of VB10.16 was well tolerated. No serious adverse advents (SAEs) or unexpected adverse events were reported. The most frequently reported AEs were transient mild to moderate reactions at the injection site.
Two patients had conization and one patient withdrew after 9 months and could not be assessed at 12 months visit. Of the remaining 14 patients 12 patients showed a reduction in the lesion size; 8 had more than a 50% reduction in lesion size. Presence of HPV16 was evaluated from immunohistochemistry (p16) and COBAS (Roche diagnostics), all patients had positive HPV16 at study entry and 8 of the 14 patients had negative HPV16 in one or both of the two tests at 12 months, indicating clearance of the HPV16 infection. Histopathological regression to low grade neoplasia (CIN1) or no disease was seen in 8 patients. Of the 6 patients that has not regressed to CIN1 or less at 12 months, 5 patients showed upregulation of PD-L1 in the lesions which may delay or inhibit elimination of all affected cells. Three of these patients had also persistent co-infection with other high-risk HPV strains, including one patient which had cleared HPV16.
Immunological analyses of the peripheral T cell responses demonstrated a strong HPV16-specific T cell immune response in 17 of 17 patients. The response was increased after vaccination in 16 of 17 patients against both HPV16 E6 and E7 antigens used in the vaccine. One patient had a strong baseline response and the response was not further increased.
These results constitute a proof-of-concept for VB10.16 and the Vaccibody DNA vaccine technology delivered by jet injection to induce rapid, strong and long-lasting immune responses which can lead to elimination of pre-malignant and malignant cells. Interestingly, the observed PD-L1 upregulation provides a strong rationale for moving VB10.16 into HPV16 positive cancer in combination with anti- PD-1/PD-L1 checkpoint inhibitor therapy.
Martin Bonde, CEO of Vaccibody, commented: We are very pleased with the 12-months results from the phase IIa clinical study in high grade cervical dysplasia. The data support what we have reported earlier and delivers a solid clinical proof-of-concept for Vaccibody’s immunotherapy platform and lead
candidate VB10.16. The fact that we observe PD-L1 upregulation in response to vaccination in the patients that do not have CIN regression at 12 months, substantiates the mechanism of action of the vaccine and invites to pursue potential synergistic effects by combining therapeutic Vaccibody cancer vaccines and checkpoint inhibitors, like we have observed in preclinical experiments. We are therefore very excited about our newly entered collaboration with Roche to explore a combination of Vaccibody’sVB10.16 and the PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq®) in patients with advanced cervical cancer. Based on the above data Vaccibody plans to start a phase II study with up to 50 cervical cancer patients in the second half of 2019.
About cervical cancer
Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide. An estimated 45,800 cases of cervical cancer will be diagnosed in the US and EU in 2019 and similarly an estimated 18,400 deaths from cervical cancer will occur in 2019. Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer. It has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It is detected in up to 60% of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers). Gardasil® and Cervarix® are preventive HPV vaccines which prevent infection of HPV, but these do not have an effect in already infected patients. A high percentage of the eligible population for the preventive vaccines does not get vaccinated, thus HPV infection and HPV+ cancer still requires effective therapeutic interventions. There is currently no available therapy treating HPV specifically.
About Vaccibody
Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. The company is one of the leaders in the rapidly developing field of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need. A phase I/IIa neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial or squamous cell carcinoma of the head and neck. Vaccibody’s most advanced program (VB10.16) is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. Further information about the company and its drug development programs and capabilities may be found online at http://www.vaccibody.com
Contact:
Martin Bonde CEO
+45 2025 3560
Vaccibody AS
Oslo Research Park Gaustadalléen 21 0349 Oslo, Norway
Vaccibody AS and Nektar Therapeutics Present New Preclinical Data from their Immuno-Oncology Collaboration at the American Association for Cancer Research (AACR) Annual Meeting 2019
Oslo/San Francisco, April 1, 2019 – Vaccibody AS and Nektar Therapeutics (Nasdaq: NKTR) today announced presentation of new preclinical data for VB10.NEO, a personalized neoantigen cancer vaccine, combined with bempegaldesleukin (NKTR-214 or bempeg), a CD122-preferential IL-2 pathway agonist. These data were presented today in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2019.
"We are excited to present these novel preclinical data that show combining bempeg with VB10.NEO synergize to increase both the breadth and the depth of the neoantigen-specific immune response. These unique and non-overlapping mechanisms produced an expansion of the VB10.NEO elicited neoantigen-specific T cells and demonstrated enhanced anti-tumor efficacy in mice. We look forward to evaluating this novel immuno-oncology combination in a clinical study in patients with advanced or metastatic squamous cell carcinoma of head and neck later this year,” said Agnete B. Fredriksen, Ph.D., Vaccibody’s President and Chief Scientific Officer.
VB10.NEO is designed to specifically activate a patient’s immune system to tumor-specific antigens, called neoantigens. Bempeg is designed to expand and proliferate tumor antigen-specific T cells in the tumor microenvironment. Addition of bempeg to VB10.NEO is intended to drive maximal expansion of vaccine-induced neoantigen-specific T cells for the treatment of cancer.
“Personalized T cell vaccines could play a critical and central role in cancer immunotherapy. These preclinical data highlight the potential of combining a personalized cancer vaccine with a T cell proliferator to induce maximal expansion of vaccine-induced T cell clones and durable responses and specific anti-tumor immunity,” said Jonathan Zalevsky, Ph.D., Chief Scientific Officer at Nektar. “We are highly encouraged by these results and look forward to testing this unique approach to personalized cancer treatment in patients with squamous cell carcinoma of the head and neck.”
Details of the poster presentation at AACR are as follows and will be available for download at the time of presentation at http://www.vaccibody.com/scientific-presentations/ and https://www.nektar.com/download_file/662/0.
Abstract #
Dette ser utrolig spennende ut, se klipp fra posteren under.
Økningen i respons for både CD8 og CD4 øker jo fantastisk mye bedre når VB10.NEO og NKTR-214 kombineres. Så får vi håpe at effekten på mennesker kan bli like bra som for disse heldige små hvite musene.
Den nye biotech analytikeren i Arctic, Pål Falck, har lagt ut en kort presentasjon av Vaccibody som kanskje kan være interessant som en kort innføring/oppdatering på selskapet for de som ikke har fulgt det tidligere.
Etter hva jeg har hørt har det blitt omsatt ca 150’ aksjer på 44,- de siste to ukene.
VACCIBODY ANNOUNCES STRONG NEOANTIGEN-SPECIFIC T CELL RESPONSES
INDUCED IN CANCER PATIENTS WITH LOW MUTATIONAL BURDEN AFTER VB10.NEO
VACCINATION.
Oslo, June 26, 2019 Vaccibody AS today announced strong immunogenicity data from the
neoantigen cancer vaccine clinical trial VB N-01. Immunogenicity was assessed in two patients
with renal cell carcinoma (RCC) and two patients with squamous cell carcinoma of the head and
neck (SCCHN) after treatment with a VB10.NEO in combination with checkpoint inhibitor
therapy as per protocol. Before VB10.NEO vaccination, these patients had been treated with the
checkpoint inhibitor nivolumab for 12-32 months with stable disease as best response. One
patient was progressing at start of vaccination. All patients had low tumour mutational burden
ranging from 1.7-3.2 mutations/Mb. The top 20 neoepitopes predicted by Vaccibody’s
proprietary NeoSELECTTM algorithm was selected for each of the fully personalized VB10.NEO
neoantigen vaccines. Immunogenicity to each individual neoepitope has so far been assessed
after 3 to 6 vaccinations of VB10.NEO by an in vitro stimulated IFN-γ ELISpot. Strong T cell
responses were observed in all these first four patients tested. T cell responses were
significantly increased in post-vaccination samples towards 63% of the neoepitopes. The
response to the vaccine was very solid with an average increase of more than 1200 SFU per
million PBMC which is on average a 250-fold increase from baseline. The breadth and the
strength increased with number of vaccinations. An amplification of existing neoepitope-specific
T cells as well as de novo responses were observed in all patients.
Agnete Fredriksen President and CSO of Vaccibody, commented: We are very pleased to see the
strong T cell responses observed in all of the first four patients at the initial assessments. We are
excited to see that the vaccine was able to induce so strong T cell responses even in the patients
with a history of many lines of previous treatment and no objective response to long-term
treatment with anti-PD-1. All these first patients had low tumour mutational burden (TMB)
leaving the number of mutations limited for selection of immunogenic neoepitopes, hence we
believe the high percentage of the neoantigen-specific immune responses observed
substantiates Vaccibody’s unique neoepitope prediction method and delivery mechanism. We
are very intrigued by the de novo responses induced by the vaccine. The baseline responses and
hence the number of de novo responses were surprisingly different between the patients
assessed so far and we are looking forward to characterizing the T cells in more detail and follow
the clinical responses in these patients.
En relativt liten populasjon?
De tester nå i indikasjonene:
- Melanoma
- NSCLC
- RCC
- Urothelial
- SCCHN
Meget kostbart produkt?
Så i mine øyne er dette verken små indikasjoner eller en veldig dyr medisin å produsere.
Og når det gjelder sannsynlighet for godkjennelse så er det vel alt for mange selskap hvor investorene overvurderer sjansen for suksess.
Har bare tall fra 2 kvartalsrapporten sammenlignet med 1. kvartal:
Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, will host its capital markets day on November 12 and is pleased to invite investors, analysts and press to presentations by the members of the company’s executive management team and by Ulrich Granzer, PhD, founder of Granzer Regulatory Consulting & Services. Dr. Granzer has a wide range of experience in all aspects of drug development and regulatory affairs, with particular focus on bringing novel therapies to market.
Venue: Forskningsparken, Gaustadalléen 21, 0349 Oslo. Meeting room Faros.
Date: Tuesday, 12th November 2019
Agenda:
| 14.00-14.10 | Introduction | Michael Engsig |
|---|---|---|
| 14.10-15.00 | Update on the VB N-01 study including the clinical data | Agnete Fredriksen |
| 15.00-15.45 | Status of the cancer vaccine field and development of novel immunotherapies | Ulrich Granzer |
| 15.45-16.05 | Company update | Michael Engsig |
| 16.05-16.30 | Questions & Answers | All |
| 16.30-17.30 | Mingling, snacks and drinks | All |