Positive Results from RhoVac's Clinical Phase I/II Study published in Journal of ImmunoTherapy of Cancer

STOCKHOLM,Nov. 13,2020 -- RhoVac announces today,November 13,2020,that the results of its clinical phase I/II study have been published in the Journal for ImmunoTherapy of Cancer (JITC). The scientifically reviewed article reports that the treatment with RhoVac's drug candidate RV001 was safe and well tolerated,and that a long-lasting immune response could be generated in the vast majority of patients. In the patients who had a measurable PSA when they started the study,a markedly increased PSA doubling time was seen,indicating cancer-specific effectiveness.

The Phase I / II clinical study included 22 patients who had previously undergone radical prostatectomy. These patients received injections subcutaneously with RV001 for a total of 30 weeks. Safety and vaccine-specific immune responses were evaluated during treatment and thereafter for a follow-up period of 13 months. As previously reported,RV001 was well tolerated,and no serious treatment-related adverse reactions were observed. Regarding immunological effects,most patients developed a strong CD4 T-cell response that lasted for at least ten months after the last injection of treatment. The RV001-induced T cells were polyfunctional and,according to the authors of the article,well equipped for anti-tumour effect. Serum levels of prostate-specific antigen (PSA) were also monitored before and after treatment and PSA doubling time was calculated. This is considered an important predictive factor for metastasis and recurrence in cancer. In those patients who had measurable PSA at the start of the study,a markedly prolonged PSA doubling time was seen after treatment. For further details,please refer to the publication - see link below.

RhoVac's drug candidate,RV001,is based on a well-proven method for antigen-based T-cell activation (cancer vaccination) but adds two new components to the concept. On the one hand,the use of a new target protein,RhoC,which is a protein that is overexpressed in metastatic cancer cells of various tissue types. As the overexpression of RhoC is not tissue-specific,the treatment concept could therefore work in many different types of cancer. Initially,however,RhoVac intends to confirm that it works in prostate cancer. The other new parameter in RhoVac's drug concept is the treatment paradigm. Previous developmental cancer vaccines have been targeted at late-stage cancer treatment,but RhoVac has done the opposite and targeted its drug candidate at early treatment,after surgery or radiation of the primary tumour,to delay or even prevent the formation of metastases.

"The study met both the primary and secondary endpoints,demonstrating an excellent safety and tolerability profile,and also that the vaccine developed with RhoC as the target protein induced a potent and long-lasting T cell immunity in the majority of patients. Based on these results,we believe that vaccination with RhoC as the target protein,after initial treatment against the primary tumour,can potentially delay or prevent recurrence and metastasis. The next step is to conduct further clinical trials to see if the substantial increase in PSA doubling time can be confirmed in a larger patient group",says Klaus Brasso,Scientific Advisor to RhoVac and Principal Investigator in the study.

Such a major trial is already well underway. A clinical phase IIb study that will include ca. 180 patients is currently ongoing in Europe (Denmark,Sweden,Finland,Germany,Belgium and the United Kingdom) and in the United States. The study is planned to be completed in early 2022 and it aims to produce results that show a solid clinical "proof of concept".

RhoVac's CEO,Anders Månsson,comments: "We are extremely pleased that the detailed analysis of the results of our Phase I/II study has now been published. This will for sure attract attention in immuno-oncology in general,and in the field of prostate cancer specifically,all around the world."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication,through the agency of the contact person,on 13-11-2020 09:35 CET.

For further information,please contact:

Anders Månsson – CEO,RhoVac AB

Phone number: +46 73-751 72 78

E-mail: info@rhovac.com

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https://news.cision.com/rhovac/r/positive-results-from-rhovac-s-clinical-phase-i-ii-study-published-in-journal-of-immunotherapy-of-ca,c3236680

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https://mb.cision.com/Main/13747/3236680/1334767.pdf

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