Clinically, the vaccine was well tolerated with no treatment-relatedsevere adverse events. Currently, the disease has not progressed in 15 out ofthe 30 patients after a 6 month period. Also, in the group where vaccine wascombined with chemotherapy, one complete response and one partial responsewere observed. These results confirm the positive interim data reported in2008 and show that MVA-BN(R)-based, HER2 directed vaccination is abiologically active treatment for patients with HER2 positive breast cancer;however the overall immune response was moderate.
Additionally BN ImmunoTherapeutics has completed preclinical studies withan improved version of the MVA-BN(R)-HER2 vaccine. In those studies, the newvaccine induced up to 20-fold higher T-cell immune response as compared tothe original version. Furthermore, it proved to be efficacious in additionaltumour immunotherapy models in HER2 transgenic mice. The immunologicalsituation regarding HER2 in those mice strongly resembles the situation inhumans.
Based on those encouraging data from both clinical and preclinicalstudies BN ImmunoTherapeutics decided to advance the clinical development ofMVA-BN(R)-HER2 in further clinical studies with the new and improved vaccine.Specifically, a new, single-site Phase I/II study in the US will be initiatedby 2009 and evaluate 24 patients in both metastatic breast cancer as well asin an adjuvant therapy of breast cancer setting.
In order to strengthen the company’s patent portfolio in the cancertherapy field, the company has, for a minor payment, acquired from Pharmexathe families of patents that it had previously licensed.
Reiner Laus, MD, President and CEO of BN ImmunoTherapeutics, said: “I ampleased that we once again can confirm the unique safety profile of MVA-BN(R)and that we have been able to show immunogenicity in this patient groupsuffering from this severe disease. We are committed to bring this new andimproved version of the HER2 vaccine further through clinical development.”
Bavarian Nordic A/S is a leading industrial biotechnology companydeveloping and producing novel vaccines for the treatment and prevention oflife-threatening diseases with a large unmet medical need. The company’sbusiness strategy is focused in three areas: biodefence, cancer andinfectious diseases. Bavarian Nordic’s proprietary and patented technology,MVA-BN(R), has been demonstrated in clinical trials to be one of the world’ssafest, multivalent vaccine vectors. Bavarian Nordic has ongoing contractswith the US government for the late-stage development and procurement of thecompany’s third-generation smallpox vaccine, IMVAMUNE(R).
Bavarian Nordic is listed on the OMX NASDAQ under the symbol BAVA.
“Safe Harbour” Statement under the Private Securities Litigation ReformAct of 1995:
Except for the historical information contained herein, this releasecontains “forward-looking statements” within the meaning of the PrivateSecurities Reform Act of 1995. No “forward-looking statement” can beguaranteed, and actual results may differ materially from those projected.Bavarian Nordic undertakes no obligation to publicly update any”forward-looking statement”, whether as a result of new information, futureevents, or otherwise. Additional information regarding risks anduncertainties is set forth in the current Annual Report and in BavarianNordic’s periodic reports, if any, which we incorporate by reference.
SOURCE BN ImmunoTherapeutics