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 |
Kursøkningen siste måneder kom kanskje ikke tilfeldig?
Dette må sies å være breaking news, fantastisk sterke resultater fra Vaccibody!
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PRESS RELEASE
VACCIBODY ANNOUNCES INITIAL POSITIVE CLINICAL RESPONSES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER TREATED WITH VB10.NEO NEOANTIGEN CANCER VACCINE
VB10.NEO is the first neoantigen cancer vaccine to demonstrate induction of strong cancer-specific immune responses which leads to clinical responses in several patients with locally advanced or metastatic disease.
Interim results from phase I/IIa clinical trial suggests a clear link between selection of high-quality neoepitopes, generation of strong neoepitope-specific CD8+ T cell responses and clinical responses.
Poster detailing these results to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting held in Maryland, USA, 9 November 2019
Oslo, November 5, 2019 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel cancer vaccines, today announces strong preliminary data from the ongoing VB N-01 phase I/IIa clinical trial of the VB10.NEO neoantigen cancer vaccine. The data is from the first 16 patients assessed for safety after treatment with a VB10.NEO, and the first 14 patients assessed for clinical responses.
Key highlights include:
• Clinical responses were observed after treatment start with VB10.NEO in 50% of all analysed patients across tumour types
o Lesion size reductions of 10-100% or stabilization of prior progressing lesions.
o All four head and neck cancer (SCCHN) patients, the melanoma patient, the non-small cell lung cancer (NSCLC) patient and one of eight renal cancer (RCC) patients show a clinical response after starting VB10.NEO vaccinations.
• Clinical responses correlate with high quality neoepitopes and strong de novo CD8 positive neoepitope-specific T cell responses induced by VB10.NEO.
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Prof. Dr. med. Jürgen Krauss, of the Department of Medical Oncology, National Center for
Tumor Diseases, University Hospital Heidelberg, Germany, and coordinating investigator of
the study, said:
"I am very pleased with the progress of this clinical phase I/IIa for Vaccibody’s neoantigen cancer
vaccine. The data indicate that VB10.NEO induces best in class neoepitope-specific immune
responses and the clinical responses observed in the first patients are highly intriguing. Since we
have not observed any safety concerns with this treatment so far, there is a very high interest to
broaden the patient population exposed to this innovative treatment. We are highly committed
to continue this exciting program and we hope this clinical trial will help pave the way for a novel
class of new efficacious and safe treatment for cancer patients.”
Agnete Fredriksen President and CSO of Vaccibody, commented:
“We are very excited to see a clinical response with a clear effect on both the size and the
growth of the lesions in a high number of the first patients treated with VB10.NEO as early as 9
weeks after the first dose of VB10.NEO.
Since we enrolled patients that had been treated with checkpoint inhibitor therapies for at least
5 months before the first dose of VB10.NEO, we are confident that in the cases of actual
reductions of lesion sizes this effect can be attributed to the vaccine since most responses to
checkpoint inhibitors happens within the first 3-5 months. After this period, further reductions in
lesions size are unexpected and lesions that progress usually continue to grow without further
interventions. Also, the observation of a strong correlation between high quality neoepitopes in
the vaccine and the strength of de novo CD8 neoepitope-specific immune responses that
translate into clinical responses is very encouraging. Importantly, this confirms the ability of
Vaccibody’s vaccine delivery platform to generate strong CD8 T cell responses, critical for tumour
killing.
Importantly, responses were also observed in patients with low tumour mutational burden that
progressed after long-term checkpoint inhibitor therapy.”
Michael Engsig, CEO of Vaccibody, continued:
“To our knowledge, this is the first time that a neoepitope cancer vaccine shows the ability to
actually shrink tumours, even in heavily pre-treated patients with advanced or metastatic
disease.
Taken together, we are very encouraged to build on these findings and continue development of
our neoantigen cancer vaccine program.”
Results
Before VB10.NEO vaccination, most patients had received multiple lines of prior anti-cancer
therapy and had been treated with a checkpoint inhibitor (CPI) (nivolumab or pembrolizumab)
for 5-32 months. All had stable disease or mixed progressive disease when enrolled into the
study. Five patients were progressing between enrolment and first dose of VB10.NEO and one
had a partial response, while the remaining patients were stable. Twelve of the 14 patients
3
continued treatment with a CPI during VB10.NEO treatment. A clinical response, defined as
either >10% reduction in the target lesions (as identified at screening) or converting progressive
lesions into stable lesions (<20% increase, up to 37 weeks follow-up) after starting VB10.NEO
treatment, was observed in seven of the 14 patients (4 SCCHN, 1 melanoma, 1 NSCLC and 1
RCC). The strongest clinical responses were most often seen in the lesions that were used to
select the neoepitopes.
Eleven patients had low tumour mutational burden (TMB), two patients had medium TMB and
one patient had high TMB. The top 20 neoepitopes predicted by Vaccibody’s proprietary
NeoSELECTTM algorithm were selected for each of the fully personalized VB10.NEO neoantigen
vaccines. Vaccibody’s proprietary DNA vaccine manufacturing process has so far yielded 100%
manufacturing success with the top 20 selected neoepitopes for all patients.
One RCC patient who discontinued CPI and started immunosuppressive treatment prior to first
dose of VB10.NEO was not included in the immunogenicity analyses. Immunogenicity to each
individual neoepitope was assessed in eight patients after six vaccinations by in vitro prestimulated
IFN-γ ELISpot. The breadth and the strength of neoepitope-specific T cell responses
were increased with number of vaccinations. Patients showing a clinical response also had the
strongest immune responses and the highest frequency of high quality neoepitopes.
The safety data for the 16 patients who has received at least one dose of VB10.NEO shows that
VB10.NEO is well tolerated. Most common adverse events attributable to the VB10.NEO
treatment were injection-related hypertensive episodes and injection site reactions.
Four patients with SCCHN were assessed, three with low TMB and one with medium TMB. Two
patients had progressive disease, one had stable disease and one had partial response at start
of VB10.NEO vaccination. The patients had been on CPI for 12-32 months before starting
VB10.NEO treatment. Strong neoantigen-specific T cell responses were seen in the vast majority
(60-90%) of the selected neoepitopes after VB10.NEO vaccination with up to 1000-fold increase.
A clinical response was observed in all four SCCHN patients: In the patients who had progressed
on CPI before starting VB10.NEO a stabilisation or reduction in the size of the target lesions
were observed after starting VB10.NEO treatment. In patients with stable disease or partial
response on CPI, a reduction in lesion size was observed after starting VB10.NEO treatment. If
the patients had multiple target lesions, the strongest response was observed in the lesions
used to select neoantigens for the vaccine. Eradication of tumour cells containing the mutations
targeted by the vaccine was observed in a follow-up biopsy from one of the patients.
One melanoma patient was assessed. The patient had high TMB and stable disease at start of
VB10.NEO vaccination and the patient had been on CPI for 10 months before treatment with
VB10.NEO vaccination. An increased neoantigen-specific T cell response was seen to 50% of the
selected neoepitopes after VB10.NEO vaccination with the majority being de novo responses. A
clinical response with lesion size reduction was observed in the patient.
4
One NSCLC patient was assessed. The patient had medium TMB and stable disease as best
response during nine months of CPI treatment before start of vaccination. Disease progression
was observed during vaccine manufacturing with the occurrence of a new lesion. A clinical
response in the form of rapid reduction in the target lesion was observed nine weeks after the
first VB10.NEO vaccination.
Eight patients with RCC were assessed for clinical response, all with low TMB. Two patients had
progressive disease and six had stable disease at start of VB10.NEO vaccination. One patient
was taken off CPI and started immunosuppressive therapy prior to the first dose of VB10.NEO.
Limited clinical responses have been observed until data-cut off (up to 37 weeks after first
VB10.NEO vaccination). Interestingly, only one of the RCC patients has had an increase of >20%
in the sum of target lesions and none of the lesions used to select neoantigens for the vaccine
has progressed (defined as >20% increase in size.) Correlating with the limited clinical
responses, fewer high-quality epitopes and neoepitope-specific immune responses were
observed.
The Poster
The Poster (ID: P424) will be presented at the Society for Immunotherapy of Cancer (SITC)
Annual Meeting Saturday, 9 November, 7:00 am - 8:30 pm local time in National Harbor,
Maryland. Vaccibody staff will be available during the poster session at SITC.
About Vaccibody
Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies. The company is a leader in the rapidly developing field
of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate
best-in-class therapeutics to treat cancers with a high unmet medical need. A phase I/IIa
neoantigen clinical trial is now 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 head and neck. Vaccibody has a collaboration with Nektar Therapeutics, planning
to start testing VB10.NEO in combination with bempegaldesleukin (NKTR-214) in squamous cell
carcinoma of head and neck in H2 2019. Vaccibody’s most advanced program (VB10.16) is a
therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The firstin-
human study (phase I/IIa), evaluating the safety and immunogenicity of VB10.16 in women
with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) has been finalized and has
published positive 12 months data. Vaccibody has recently started a collaboration with Roche,
exploring VB10.16 in combination with CPI atezolizumab (Tecentriq™) in up to 50 patients with
advanced or recurrent cervical cancer. First patient is expected to be vaccinated in H1
2020. Further information about the company and its drug development programs and
capabilities may be found online at http://www.vaccibody.com
About VB10.NEO
VB10.NEO, is Vaccibody’s proprietary therapeutic DNA vaccine which uses the patient’s own
neoantigens for the personalized treatment of cancer patients. A phase I/IIa neoantigen clinical
trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell
5
lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell
carcinoma of the head and neck.
About VB N-01
VB N-01 (DIRECT-01) is an open-label phase 1/2a study, designed to evaluate the safety,
immunogenicity and efficacy of administrating personalized VB10.NEO in combination with
checkpoint blockade in patients with locally advanced or metastatic solid tumors including
melanoma, NSCLC, renal cell carcinoma, urothelial cancer or head and neck cancer, who have
not achieved a complete response by at least week 12 on checkpoint blockade as respective
standard of care (NCT03548467).
Contact:
CEO Michael Engsig
Vaccibody AS
Cell: +45 6173 1509
mengsig@vaccibody.com
President and CSO Agnete Fredriksen
Cell: +47 99634215
abfredriksen@vaccibody.com
Vaccibody AS
Oslo Research Park
Gaustadalléen 21
0349 Oslo, Norway
Her er resultatene fra dagens melding oppsummert. Merk at disse resultatene ble oppnådd blant pasienter som har gått på dagens state of the art behandling, sjekkpunkthemmere (PD-L1-hemmere), Keytruda og Opdivo. Disse er mega blockbustere som selger for milliarder av dollar. Legg merke til at flere har gått på denne behandlingen i månedsvis og kun 1 av de 14 hadde PR(partial response). Vaccibody klarer altså å få det de kaller for “Clinical Response” i halvparten av disse pasientene. Clinical Response er her definert som følger:
A clinical response, defined as
either >10% reduction in the target lesions (as identified at screening) or converting progressive
lesions into stable lesions (<20% increase, up to 37 weeks follow-up) after starting VB10.NEO
treatment,
Man skal kanskje være forsiktig med å konkludere da det bare er 14 pasienter, men dette er oppsiktsvekkende resultater som vil bli lagt merke til hos Big Pharma, feks Merck, som selger Keytruda og BMS som selger Opdivo. Kan Vaccibody her ha laget noe som fungerer bedre enn disse blockbusterne? SITC konferansen blir veldig interessant. Jeg håper vi da får data på pasientnivå og klassifisering iht RECIST, feks antall CR, PR, SD osv.
Resultatene oppsummert:
Keytruda og Opdivo solgte for tilsammen over 15 mrd dollar i 2018. Ikke rart at Vaccibody økte sin markedsverdi med 1 mrd kroner idag.
Som en referanse til Vaccibodys resultater kan vi se på selskapet NextCure som utvikler behandling for lungekreftpasienter som ikke responderer på CPI. Dette er en meget god referanse, ettersom Vaccibody også behandler pasienter som ikke responderer på CPI.
Så hva slags resultater rapporterte Nextcure?
In the Phase I dose-escalation portion of an open-label Phase I/II trial, NC318 showed a best observed response rate of 27% among seven non-small cell lung cancer (NSCLC) patients, including one complete response (CR) and one partial response (PR). The CR was ongoing at 41 weeks. The disease-control rate (DCR) in the NSCLC cohort was 71%.
For å sette dette i perspektiv kan vi vise til Hva ledende CPI’er har oppnådd:
The NC318 results, however, are similar to Phase I data for the PD-1 and PD-L1 inhibitors. For example, at the American Society of Clinical Oncology (ASCO) meeting in 2014, Merck & Co. Inc. (NYSE:MRK) presented Phase Ib data for its now blockbuster Keytruda pembrolizumab, which had an ORR of 9-33% in NSCLC patients and a DCR of 40-70%, while Bristol-Myers Squibb Co. (NYSE:BMY) reported Phase Ib data for Opdivo nivolumab, which had an ORR of 22-50% and a DCR of 24-45% (see “Advantage Merck”).
Så til poenget:
Vi har til gode å se respons hos Vaccibodys pasienter iht RECIST-klassifisering, men det kommer forhåpentlig i helga.
Men - vi vet at flere pasienter hadde reduksjon i tumorstørrelse (fra 10%-100%). Kan jo ikke leses på annen måte enn at også Vaccibody hadde 1 eller flere CR?
Blir uhyre interessant å få høre om hva slags ORR de fikk.
For NextCures del betydde disse resultatet at selskapsverdien økte med hele 1,2 mrd USD! Smak på den -10 mrd kroner!
Så hva er en fornuftig økning i MCAP i Vaccibody? SÅ langt har kursen økt fra 61 til 85, som utgjør en økning i Market Cap på ca 1,3 mrd, altså bare en brøkdel av hva Nextcure økte med…
Så kanskje er kursøkningen vi har sett bare den spede begynnelsen. Som et unotert selskap i et land som ikke har noen tradisjon for biotech tar det nok noe tid før denne perlen oppdages, særlig internasjonalt. Kanskje blir SITC en arena for dem å vise seg fram. Blir interessant å se om investorer oppdager aksjen før Big Pharma oppdager dem.
Kilder:
Noen inntrykk fra dagens kapitalmarkedsdag i Vaccibody:
-
Voldsomt trøkk, vil anta ca 100 personer tilstede
-
Utrolig flott gjennomgang av Agnete Fredriksen på de ferske kliniske dataene. Bidro iallfall til at jeg fikk en dypere forståelse av dataene og hvor gode de faktisk er. De har lagt veldig mye jobb ned i designet av studie for å kunne være sikre på at de responser de ser skyldes deres vaksine og ikke CPI. De viste blant annet en slide som viste typiske responser på CPI, hvor responsene skjer de første 4-6 måneder for deretter å flate ut. Det er veldig uvanlig å se responser 12-32 mnd etter start på CPI, slik som er tilfellet med pasientene Vaccibody har behandlet.
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Synes det var interessant at de viste at de fikk inn mange pasienter med såkalt lav tumormutasjonsbyrde. Disse er det vanskeligere å få respons hos, fordi immunsystemet har vanskeligheter med å kjenne igjen disse kreftcellene. Pasientene de har fått inn i sin studie er dermed blant de mest krevende å få respons hos, noe som styrker dataene ytterligere.
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Presentasjonen til Ulrich Ganzer, som rådgiver biotech og pharmaselskaper i møte med myndigheter (500 selskaper på kundelisten) var også interessant, særlig når han kunngjorde at dette var "strongest data I have ever seen"! Smak på den! I Q&A-runden fikk han spørsmål om han kunne sammenlikne BioNTech og Vaccibody. Etter å ha snakket litt generelt om BioNTech, som han tydeligvis kjente godt(som et tysk selskap), konkluderte han med at Vaccibody har bedre data enn BioNTech. Mcap BioNTech er i skrivende stund 4 milliarder dollar…
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Ganzer mente at Vaccibody kunne komme på markedet allerede om 2 år hvis dataene fortsetter å være så sterke. Han sammenliknet Vaccibodys vaksine med CAR-T (bla Kymriah), i og med at den også er persontilpasset. Forskjellen er at CAR-T er en medisin med høy risiko, ting kan gå galt (eksempel som ble nevnt er at immunsystemet kan gå til angrep på celler i hjerte, med rask død som konsekvens). Vaccibodys vaksine derimot har en svært god sikkerhetsprofil.
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Ganzer er ekspert på å rådgi selskaper i møte med regulatoriske myndigheter. Han sier at myndighetene nå jobber med å tilpasse seg den nye persontilpassede medisinen. Randomiserte studier er i praksis ikke mulig fordi du ikke får to sammenliknbare populasjoner. Fordelen er mindre studier, ulempen er at du må bevise større klinisk effekt. Vanlig forskjell som kreves i randomiserte studier er ca 2 mnd økt overlevelse, mens man ved single-arm studier trenger større klinisk effekt.
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Snakket med analytiker Pål Falck i etterkant og han sier han kommer med en analyse på selskapet snart. De har per tid ikke dekning såvidt jeg vet.
Dette var bare et utdrag fra det jeg husker, tok ikke notater, burde gjort det. Håper selskapet legger ut presentasjonene så kan folk se selv. Håper andre som var der kan legge til det jeg glemte.
@safin Det er vel meningen at et forum skal være et forum for meningsutvekslinger og nyheter, så du kan jo vurdere om du selv burde grave litt etter nyheter og informasjon 
Selskapet skrev selv i siste kvartalsrapport følgende:
Outlook
For the upcoming twelve months, the Company’s plans include:
• Clinical Trial for cancer neoantigen vaccine (VB10.NEO)
o Continue enrolment of the clinical phase I trial of 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.
o Interim report on safety, immunogenicity and early signs of efficacy. (Post Quarter
Note: This was released in November.)
• Nektar collaboration
o Initiation of the clinical trial evaluating the combination of VB10.NEO and NKTR-214
and first patient dosed.
• Clinical Trial in cervical cancer combining VB10.16 and checkpoint inhibitor atezolizumab
in collaboration with Roche
o Submission of the clinical trial application (Ph IIa) to the relevant regulatory bodies.
o Initiation of the clinical trial evaluating the combination of VB10.16 and atezolizumab
and first patient dosed.
Fra EU databasen vet man at kombostudien med Roche er godkjent for rekruttering så der kommer nok FPD (first-patient-dosed) melding anytime.
I tillegg er kombinasjonsarmen med NKTR-214 og VB10.NEO godkjent og klar for rekruttering den også, men der tar det jo tid fra biopsi til pasienten får første dose så jeg forventer nyheten der i februar/mars.
VACCIBODY FINALIZES PATIENT ENROLMENT IN VB N-01 PHASE I/IIa TRIAL WITH ITS
NOVEL VB10.NEO NEOANTIGEN CANCER VACCINE
• Vaccibody has reached the enrolment target of 50 patients in its VB N-01 basket trial
for a variety of cancer types with high unmet medical need
• Patients have been recruited into all six arms of the basket trial, thereby optimizing the
read-outs on efficacy and safety
Oslo, Norway, August 21, 2020 – Vaccibody AS, a clinical-stage biopharmaceutical company
dedicated to the discovery and development of unique immunotherapies, today announced
that it has reached the enrolment target of 50 patients and that it has finalized recruitment of
patients to all study arms of its ongoing VB N-01 phase I/IIa clinical trial of the personalized
VB10.NEO neoantigen cancer vaccine.
Michael Engsig, CEO of Vaccibody, said: “VB10.NEO is a groundbreaking approach to
personalized cancer treatments and has a large commercial potential. We are thus very
excited to have reached this important milestone for the VB N-01 trial. The initial clinical
results presented at SITC in November 2019 were very encouraging and we will communicate
the next steps in the development of VB10.NEO in Q4 2020.”
VB N-01 is a basket trial for 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. In the trial the safety, feasibility and efficacy of treatment
with the personalized VB10.NEO vaccine is evaluated, including one study arm evaluating the
combination of VB10.NEO and bempegaldesleukin (NKTR-214) in patients with head and neck
cancer. The trial has been recruiting patients from seven clinical sites in Germany.
Siri Torhaug, Chief Medical Officer of Vaccibody adds, “We are truly grateful to the patients
for participating in the trial, to our investigators at the clinical trial sites, our supply chain
partners and the dedicated Vaccibody team who has done a great job by finalizing the
enrolment and ensuring successful manufacture of the patient specific VB10.NEO products
despite the challenging COVID-19 situation. Further, we are pleased that the recruitment of
patients distributes well across all of the six treatment arms.”
Professor Bjarne Bogen som er en av medoppfinnerne til Vaccibody sin teknologi får i dag en innovasjonspris fra UiO, I artikkelen under står det interessant nok følgende:
– Det blir spennende å se resultatene av studier hvor vaksineprinsippet anvendes på kreftpasienter. Et fase 1-studium hvor vaksineprinsippet benyttes som en influensavaksine er også på trappene på OUS, her er det forskere ved Klinmed som står bak. Vaksineprinsippet kan også kanskje brukes til å utvikle en vaksine mot COVID-19 virus, og spede forsøk er i gang, forteller Bogen.
Ser Agnete Fredriksen skal være med på World Vaccine Congress 19-21. oktober
Det eneste nye jeg har sett er at Fredriksen er ført opp som taler den 4.11 på Neoantigen Based Therapies Summit. Så det betyr at det senest kommer en oppdatering på NEO studien da. Men det er vel ett eller annet rykte/forventning som driver aksjen allerede nå.
16.30 Vaccibody’s APC Targeted Vaccine for Neoantigens; Update from the Clinical Study & Correlates With Clinical Responses
• Inducing a unique CD8-dominated T cell response by targeting antigens to chemokine receptors
• Clinical updates on the phase I/IIa VB N-01 trial in multiple indications parameters important for antitumour efficacy
Agnete Fredfiksen , Co-Founder, President & CSO, Vaccibody AS
Fant svaret selv.
Men deres andre kanditat, hvordan er data her?
“I dag har Vaccibody to kliniske produktkandidater: en kreftvaksine mot human papillomaviruskreft (HPV), som nå testes i fase II i samarbeid med Roche på livmorhalskreft”.
Fra 2009 hvor Roche kjøpte Genentech. Mulig vi bare har sett begynnelsen av Vacci eventyret.
17/8 skrev du et innlegg som jeg la merke til. Der refererte du til hva sammenlignbare selskaper av Vaccibody ble priset til i USA.
Håper med dette at jeg får din tillatelse til å lime inn det du skrev 17/8. Ja, markedsverdi og kurser kan ha endret seg siden da, men det er viktig å belyse at Vaccibody er underpriset vs. sammenlignbare selskaper.
Og de som fikk med seg presentasjonen av Agnethe og CEO i går kunne lese blant annet følgende på en slide: «Listing of Vaccibody shares at Merkur is a stepping stone with the intention to apply for a main listing at an approximate quality exchange within the next 12 months».
I den grad det er lov å spekulere, tipper jeg notering i USA within next 12 months 
Her er hva Investor skrev 17/8:
Husk at Peers som CureVac, BioNTech og Moderna er priset til 15-25x mer!
Forørvig håper jeg virkelig styret i Vaccibody følger med på biotekfeberen i USA om dagen.
Peer BioNTech IPO 15 dollar, kursen nå 70 dollar, mCAP 13,6 mrd USD
Peer CureVac IPO , kursen nå 77 dollar, mCAP 16,7 mrd USD
Og så har vi Moderna da, selve mammuten, mCAP 27,5 mrd USD
Ganske sikker på at Vaccibody kunne satt en IPO på godt over dagens market cap på 1 mrd USD.
For en fantastisk uke for Vaccibody, aksjonærene og norsk biotek. En lykke at Vaccibody har vært unotert hvis ikke hadde man vel tatt gevinst for lengst.
Se forøvrig skjerdump fra kurshistorikk fra tidligere i år. 18/3 bunnet Vaccibody på 10,- . I går ble altså aksjen handlet til 59. Viser jo hvordan det svinger i biotek og viktigheten av å være utholdende.
Når det gjelder framover er jeg rimelig sikker på at vi ikke har sett toppen. At BioNTech og Moderna er sett på som Vaccibody’s peers er ikke mine ord, men Arctics analytiker. Riktignok holder de to andre også på med mRNA, men selv om vi holder dette utenfor er det kjempestor oppside når vi sammenlikner de tre selskapene. Sist jeg sjekket var BioNTech priset til 17 mrd Dollar og Moderna 27 mrd Dollar.
Og for de som har fulgt selskapet en stund er det kjent at Ulrich Granzer ble sitert på at Vaccibody hadde de beste dataene han noensinne hadde sett og bedre enn BioNTech!
Resten er på mange måter historie, fordi vi har ikke hørt et pip om NEO-dataene siden dataslippet for nesten et år siden. Grunnen skjønner vi jo nå, for Roche har sett det samme som Granzer og selskapene har antakelig vært i dype forhandlinger i mange måneder. Det er nå opp til Roche å kommunisere på resultatene i NEO, men de er antakelig utrolig sterke, ettersom de la 7 mrd på bordet denne uke.
Hva kan Vaccibody bli verdt? Dette er jo en teknologiplattform, ( i likhet med PCIB), så mulighetene er enorme. Ønsker Roche hele butikken? Eller kommer vi til å se at Vaccibody når sin ambisjon om å bli et mellomstort pharmaselskap på noen år sikt? VI få rantakelig vite mer i løpet av Q4 hvordan strategien er. Men de milliardene selskapet nå blir tilført plasserer selskapet helt oppe i toppen av Premier League innen biotekverden.
Som referanser er det interessant å trekke fram Modernas deal fra 2013 med AstraZeneca
Up fronten var på 240 mill dollar, ikke ulikt det Vaccibody nå får. Total avtaleverdi var faktisk mindre for Moderna. VI vet jo hvilken vei Moderna har gått siden da.
Kommer til å holde på mine aksjer, dette kan bli hur stort som helst og dette vil jeg være med på.