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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.
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
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
Taken together, we are very encouraged to build on these findings and continue development of
our neoantigen cancer vaccine program.”
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
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.
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
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.
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
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
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).
CEO Michael Engsig
Cell: +45 6173 1509
President and CSO Agnete Fredriksen
Cell: +47 99634215
Oslo Research Park
0349 Oslo, Norway