Results from Neuroblastoma Phase II vaccine study indicate promising adjuvant (SBG®) effect

The ongoing vaccine study with Soluble Beta-Glucan (SBG®) from Biotec Pharmacon as an oral adjuvant shows very promising treatment effects in children with relapsed high-risk neuroblastoma. The immuno-oncology investigators in New York, interpret a promising adjuvant effect of SBG® on cancer vaccine.

“The results (outlined below) offer further hope for children with Neuroblastoma. Additionally, this vaccine/SBG® treatment regime has an excellent safety profile with no observable side-effects”, states Chief Scientific Officer, Rolf Engstad.

The investigator team for the ongoing vaccine study with anti-GD2 vaccine combined with oral administered SBG® has presented new data from 84 patients with relapsed high-risk neuroblastoma at the “Advances in Neuroblastoma Research 2018” conference in San Francisco.

The new data strongly support the initial findings presented in 2014 from the 15-patient population cohort in the phase I part of the trial, where the two-year overall survival rate was as high as 92%. In the current phase II part of the study, having treated additional 84 patients, the 2-year overall survival (OS) rate was still 90%, with a progression free survival (PFS) rate of 51%.

The long-term survival rate in this patient population, with relapsed high-risk neuroblastoma, has been less than 20% before introduction of immunotherapeutic treatment regimes. The study thus gives promise for a significant improvement in survival rate in this patient group.

When investigating the antibody response to the vaccine, a strong correlation was observed between high antibody titre to the vaccine, and prognosis for both improved progression free survival and overall survival. In this high response subgroup, the overall survival is currently 100% five years into the trial.

Furthermore, a strong increase in the antibody response was observed with the start of administering SBG® as an oral adjuvant in the combined treatment. The initial justification of using SBG® in this combination was to strengthen the effector functions after an initial immune response was established, but the new data now indicate that SBG® also contributes in inducing an improved immune response to the vaccine itself. This holds promise for the potential use of SBG® as an oral adjuvant to increase the protective effects of other vaccines.

The role of SBG® as an adjuvant to improve the initial immune response to the vaccine, will be investigated in a follow-up trial.

“The results presented by the investigators are very promising. Biotec Pharmacon will now use the results from the Phase II trial to investigate how to further develop SBG® from both a clinical and strategic point of view”, says CEO Christian Jørgensen.