- All patients enrolled in the Phase II study with the MVA nef vaccine against HIV.
- The MVA-BN® polytope vaccine is expected to enter clinical trials in the first quarter of 2006.
- IMVAMUNE™ smallpox vaccine shown to be safe and effective in Phase II study in persons with atopic disorders
- Three new Phase II studies with IMVAMUNE™ in more than 1,200 persons initiated.
- As agreed to and planned with NIH officials, 500,000 doses of IMVAMUNE™ to be delivered in the first quarter of 2006.
- Bavarian Nordic’s cancer vaccine development program now in operation in Mountain View, California, USA.
- Establishment of Singapore office.
HIV Vaccine Franchise
MVA nef vaccine
In December 2005, Bavarian Nordic completed enrolment of 75 HIV-infected subjects in a Phase II study with the MVA nef vaccine. The study will compare two doses of the MVA nef vaccine (5x10 E8 and 10E8) with IMVAMUNE™ (10E8) in subjects with CD4 counts down to 250 cells/microliter. This group of patients has a more advanced state of the HIV disease than those patients studied in the company’s earlier Phase I/II study.
To-date, no serious or unexpected reactions were seen in these patients after vaccination with the MVA nef vaccine or IMVAMUNE™. In addition, initial data confirms that the vaccine is strongly immunogenic and thereby reinforces the promising results that were seen in the previous Phase I study of the vaccine’s ability to increase the patient’s number of CD4 cells. At present 9 of the 75 patients have interrupted their HAART therapy and as planned T-cell activity and virus concentration will now be monitored. According to the approved study protocol, patients decide if they want to interrupt their HAART therapy. The company expects that approximately 50 patients will decide to interrupt their HAART therapy. Additional results are expected to be reported in the second quarter of 2006.
Results from this study are equally important for the safety data package Bavarian Nordic is accumulating for the registration of IMVAMUNE™ as a safe smallpox vaccine for persons that should not be vaccinated with traditional replicating smallpox vaccines. HIV-infected persons and AIDS patients are in the high-risk group of persons subject to experience the serious and life-threatening side-effects associated with traditional smallpox vaccines.
MVA-BN® polytope and MVA-BN® multiantigen vaccines
As described in Bavarian Nordic’s third-quarter 2005 report, the MVA-BN® polytope vaccine is expected to be released for clinical studies in the first quarter of 2006 and to be followed with the start of four clinical studies during the year. The MVA-BN® multiantigen vaccine will be ready for clinical trials during 2006.
IMVAMUNE™ smallpox vaccine
Persons suffering from atopic dermatitis are in the high-risk group to develop the life-threatening side-effect, eczema vaccinatum, after vaccination with traditional replicating smallpox vaccines. The occurrence of atopic dermatitis has significantly increased in recent years and now accounts for 10-15% of the general population making it also the largest risk group for traditional smallpox vaccines. As part of the Bavarian Nordic’s programme to register IMVAMUNE™ as a safe smallpox vaccine for persons who should not be vaccinated with traditional replicating smallpox vaccines, the company has carried out a Phase I/II study in 60 persons with atopic disorders.
The study is the first controlled investigation ever conducted in this patient group. Initial data shows that the vaccine was well-tolerated and did not reveal any serious or un-expected side-effects. The data also showed that the immune response in persons who suffer from atopic dermatitis is comparable with the immune response in healthy volunteers. All those vaccinated sero-converted (generated vaccinia-specific anit-stof) after the first vaccination with IMVAMUNE™ and showed that IMVAMUNE™ induced a fast-acting immune response after only one vaccination.
Three additional Phase II trials started
Bavarian Nordic submitted in December applications to the US Food and Drug Administration (FDA) to begin three Phase II studies with IMVAUMNE™, one of which to be performed in Europe. The three trials include a double-blind placebo-controlled study in 800 healthy volunteers, a study in 165 persons that will evaluate the safety of IMVAMUNE™ in persons with a more advanced state of HIV-infection, and a study with IMVAMUNE™ in 260 persons to evaluate safety and immunogenicity in atopic dermatitis patients.
These studies are in addition to an ongoing trial in the 150 subjects the company started in October 2005 to investigate the safety of IMVAMUNE™ in HIV-infected patients.
Status on delivery of 500,000 doses of IMVAMUNE™ under RFP-II contract
The RFP-II contract with the National Institute of Health (NIH) includes the delivery of 500,000 doses of IMVAMUNE™ produced according to the fully-validated cGMP production process. In agreement and cooperation with NIH, Bavarian Nordic decided to carry out an additional study to detail all the critical process parameters in the production process.
This study, which included 20 full-scale production runs at Bavarian Nordic’s contract manufacturing partner IDT, was completed in August 2005. In addition to providing valuable information on the production process, the study also generated approximately half a million doses of IMVAMUNE™. After process validation, an additional 500,000 doses of IMVAMUNE™ were produced at IDT. These doses are now in the final phase of release testing before their delivery to NIH under the RFP-II contract.
Bavarian Nordic has produced to-date one million doses of IMVAMUNE™.
Measles vaccine programme
The company’s MVA-BN® measles vaccine candidate has been cloned and a clinical batch manufactured at the Berlin facility is expected to be released in the first quarter of 2006. The first clinical investigation will be initiated after toxicology and preclinical efficacy studies in animals have been completed.
BN ImmunoTherapeutics
BN ImmunoTherapeutics will assume its new research and development facility in Mountain View, California during the first week of January 2006. Research and development of the MVA-BN® Her-2 vaccine against breast cancer and the MVA-BN®-based vaccine against prostate cancer are proceeding according to plan.
Flavivirus Infections (Japanese Encephalitis and Dengue Fever programmes)
Bavarian Nordic has produced a clinical batch of the MVA-BN® JEV vaccine against Japanese encephalitis and completed the necessary toxicological studies in rabbits. The vaccine has not yet been released for clinical investigations. To expedite the development of vaccines against flavivirus infections (Japanese Encephalitis and Dengue Fever), Bavarian Nordic is currently investigating opportunities to establish a partially-owned Bavarian Nordic company in Southeast Asia with the involvement of local venture capital funding under the leadership of Bavarian Nordic’s collaborative partner in Malaysia, Professor Mary Jane Cardosa. If the investigations result in a positive decision, the company expects to establish an appropriate business entity during the first-half of 2006.
Establishment of Singapore representative office
To strengthen the company’s marketing activities in the Southeast Asian region, Bavarian Nordic has established a representative office in Singapore. Bavarian Nordic has employed a professional with a number of years of pharmaceutical marketing and sales experience within the region to lead the office.
Webcast presentation
As of 1 January 2006, Bavarian Nordic has been included in the Copenhagen Stock Exchange’s MidCap Index and will accordingly hold a webcast presentation on 26 January 2006.
Kvistgård, 22 December 2005
Asger Aamund
Chairman
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