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Vaccibody announces positive clinical trial results

Vaccibody has announced 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.

“The first time that a neoepitope cancer vaccine shows the ability to actually shrink tumours”

“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,” says Agnete Fredriksen President and CSO of Vaccibody.

“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,” says Michael Engsig, CEO of Vaccibody.

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