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Positive Results from Bionor Pharma’s vaccine Vacc-C5 Phase I, First Time in Man trial

(Oslo, Norway, 24 February 2014)  Bionor Pharma ASA (OSE: BIONOR) announces that results from its Phase I, first in man, trial of Vacc-C5. The trial met its primary endpoint which was safety. The trial also demonstrated that Vacc-C5 was able to generate C5 antibodies with effect of boosting, particularly in the top dose group.

Increase of antibodies throughout the vaccination period was observed in patients primarily with relative low levels of preexisting antibodies against C5.  No generation of antibodies was observed in patients that had undetectable C5 antibodies at baseline. In patients with high levels of preexisting C5 antibodies a slight reduction in antibodies during the vaccination period was observed. Overall 28% of the 36 enrolled patients had C5 antibodies above 4µg/ml. No differences between the two groups of adjuvants were observed.

"It is well known that patients with high levels of antibodies to this region do not progress to AIDS or do so very slowly and Bionor Pharma's recently announced trial with Vacc-4x also noted that the best responders to the vaccine with regards viral load reduction were those with the highest levels of C5 antibody” says Prof. Dr. Angus Dalgleish St. Georges University of London. “This is very exciting and consistent data that suggests that inducing a good C5 response in those with low levels of pre-existing C5 antibody may be able to greatly increase the number of patients who will respond favorably to Vacc-4x and thus become an integrated component of Bionor Pharma's advanced therapeutic HIV vaccine programme."

The Company has previously reported that HIV patients with increased levels of C5 antibodies seem to respond better to vaccination with Bionor Pharma’s lead vaccine candidate Vacc-4x leading to a greater reduction of the median viral load when compared with to patients’ historic median pre-ART viral load values. As such C5 antibodies have the potential to become a biomarker for a better response to the Vacc-4x vaccine.  “In light of the recently announced results of the possible increased effect of the Companies lead candidate Vacc-4x in the patients with increased C5-antibodies the results from this Phase I Vacc-C5 trial points to an important observation.” says CEO Dr. Anker Lundemose. "If we in future trials are able to confirm that high levels of C5 antibody improves the response to Vacc-4x, Vacc-C5 vaccination in a subset of patients with low preexisting C5 antibodies may provide for improved response to our other lead vaccine candidate Vacc-4x."

Vacc-C5 was generally well tolerated. Most adverse events were related to pain and irritation in relation to the injection site. Few patients experienced headache.

The Company will continue the evaluation and further analysis of the data from the Phase I study and will keep the market appraised of potential next steps for the Vacc-C5 and Vacc-HIV (combination of Vacc-4x and Vacc-C5) programs.

About the Trial
The Vacc-C5 Phase I, first time in man, trial was initiated in 2012. It is 36 patients, single site (Oslo, Norway), open study. The study included HIV positive patients who have a well-controlled viral load on cART and with CD4 counts above 400x106/L.

The study has two arms with different adjuvants, Vacc-C5 + GM-CSF and Vacc-C5 + Alhydrogel and dose escalation at three different dose levels.

The study objectives were:
•Establish a safe dose of Vacc-C5
•Determine whether Vacc-C5 induces anti-C5 antibodies
•Determine which of two adjuvants provide a better immune response to Vacc-C5

The study was conducted at Oslo University Hospital with Professor Dag Kvale, Department of Infectious Diseases as the principle investigator.

About Bionor Pharma ASA
Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases.

Global leader in the development of HIV vaccines
The Company has a leading position in the global research field for therapeutic HIV vaccines, and has two vaccine candidates in the clinical stage of development: Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells, and Vacc-C5 is designed to induce antibodies to HIV that can reduce the harmful hyperactivation of the immune system which can lead to AIDS. The foremost candidate, Vacc-4x, has shown a statistically significant reduction in viral load in a phase II randomized, multinational, double-blind, placebo-controlled study. The Company’s innovative technology platform is also well positioned to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human papillomavirus) and CMV (Cytomegalovirus).