Lani - Vaccine based on Smallpox

[Joe]

How did you let this one slip by?

Clinical Trials of the breast cancer vaccine MVA-BN-HER-2

COPENHAGEN, Jan 3, 2007(Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO: Quote, Profile , Research) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.
Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.
BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.
The two studies are expected to enroll up to 60 patients and are designed to evaluate the safety and tolerability of the vaccine. Its effect on the clinical progress of the patients and on tumor growth will also be explored.
To determine how best to incorporate the vaccine into standard therapy, it will also be tested in combination with traztuzumab (Herceptin) and chemotherapy.
In Europe, the vaccine will also be tested in first-line therapy of metastatic breast cancer, Bavarian said.
From the BN ImmunoTherapeutics press release:
MVA-BN(R)-HER2 will be tested in numerous clinical settings to determine how to best incorporate it into standard therapy for the treatment of metastatic breast cancer. This will include treatment with MVA-BN(R)-HER2 in combination with trastuzumab (Herceptin(R)) and chemotherapy. The Phase I/II studies are designed to evaluate the safety and tolerability of MVA-BN(R)-HER2 and the biological activity of the vaccine by measuring HER-2 specific immune responses in treated patients. In addition, the effect of the vaccine on the clinical progress of patients and on tumor growth will also be explored. Reiner Laus, MD, President & CEO of BN ImmunoTherapeutics said: "We are excited about the potential of this vaccine for treatment of women with breast cancer. We have been able to rapidly advance our program from research into the clinical development stage, due to the strong preclinical safety and efficacy profile we have seen with this vaccine candidate. It is an important achievement in this program as well as in the development of our portfolio of vaccine candidates for the treatment of major cancers." In preclinical studies MVA-BN(R)-HER2 demonstrated efficacy by inducing multi-pronged immunity as well as anti-tumor activity. Its in vivo anti-tumor activity was shown in multiple animal models with HER-2 expressing tumors. MVA-BN(R)-HER2 also showed activity in both preventive as well as therapeutic settings. In the most dramatic model, a 14-day experimental, highly aggressive lung metastasis model, MVA-BN(R)-HER2 virtually eradicated the tumor by the 14-day evaluation point. Near eradication of an aggressive metastasis was also seen after a single injection of MVA-BN(R)-HER2 was administered three days after the intravenous induction of the experimental lung metastasis. Moreover, MVA-BN(R)-HER2 induced an extremely rapid immune response. BN ImmunoTherapeutics' core technology is a proprietary recombinant viral vector platform based on Modified Vaccinia Ankara BN (MVA-BN(R)) that is being developed as an immunotherapy for breast, prostate and other cancers. Located in Mountain View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian Nordic (CSE: BAVA), headquartered in Denmark.


Warmest Regards
Joe

[Jackie07]

http://clinicaltrials.gov/show/NCT00485277


Joe,

Lani did not post it because Eric had already posted it in 2006: [10-30-2006, 01:45 PM]

http://www.biotech-intelligence.com/...aa8194085.html

MVA-BN®-based vaccine shows promise in breast cancer modelsBavarian Nordic (DENMARK)October 30, 2006 BN ImmunoTherapeutics, Bavarian Nordic’s California-based subsidiary developing vaccines against cancer, recently presented preclinical study data with the MVA-BN®-HER2 vaccine showing exceptional and significant efficacy, both in terms of inducing broad immunity as well as anti-tumor activity. In addition, immunization with MVA-BN®-HER2 showed to induce an antigen-specific Th 1-type CD4 T-cell respons, Her-2 specific CD8 cytotoxic T-lymphocyte respons, and anti-Her-2 antibodies.

These promising results will be included in BN ImmunoTherapeutics’ current filing for an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA). The vaccine has been released from the Berlin facility and with regulatory approval, Phase I studies with MVA-BN®-HER2 are due to start before the end of 2006.

Results from the MVA-BN®-HER2 breast cancer vaccine program were presented at the 21st Annual Meeting of the International Society for Biological Therapy of Cancer in Los Angeles, California (October 26-29, 2006).

MVA-BN®-HER2 showed activity in both preventive as well as therapeutic settings in multiple animal models with Her-2 expressing tumors. In the most dramatic model (14-day experimental, highly aggressive lung metastasis model), MVA-BN®-HER2 nearly eradicated the tumor by the 14-day evaluation point. Equally impressive in this model was that a single injection of MVA-BN®-HER2 administered as late as 3 days after the intravenous induction of the experimental lung metastasis, resulted in the same effect – near eradication of an aggressive metastasis. Moreover, MVA-BN®-HER2 induced an extremely rapid antigen-specific immune response.

Peter Wulff, President & CEO, Bavarian Nordic said: “With these promising results based on our patented MVA-BN® technology,we have taken our first important step towards clinical trials with our cancer vaccines which we expect to be one of the company’s cornerstones in the future.”

Kvistgård, 30 October 2006

Asger Aamund
Chairman

Contacts:

Peter Wulff, President & CEO, Tel.: +45 33 26 83 83
UK (media): Mary Clark, Capital MS&L, Tel.: +44 20 7307 5330
USA (media): Ken Arnold, T. Dean Reed Company, Tel.: +1 202 223 3532

About Bavarian Nordic:

Bavarian Nordic (CSE: BAVA) is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer. With operations in Denmark, Germany, the USA, and Singapore, Bavarian Nordic employs over 200 people.

Bavarian Nordic’s patented technology, MVA-BN®, is as been demonstrated in clinicial studies, one of the world’s safest, multivalent vaccine vectors for the development of vaccines against various infectious diseases such as smallpox, HIV/AIDS, as well as against breast and prostate cancer.

For more information please visit www.bavarian-nordic.com

[Jackie07]

Eric posted this when the trial became available in the beginning of 2007:

http://today.reuters.com/news/articl...&from=business

COPENHAGEN, Jan 3 (Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO: Quote, Profile, Research) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.

Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.

BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.

The two studies are expected to enroll up to 60 patients and are designed to evaluate the safety and tolerability of the vaccine. Its effect on the clinical progress of the patients and on tumor growth will also be explored.



To determine how best to incorporate the vaccine into standard therapy, it will also be tested in combination with traztuzumab (Herceptin) and chemotherapy.

In Europe, the vaccine will also be tested in first-line therapy of metastatic breast cancer, Bavarian said.

[Joe]

I was aware of the trial as we had posted it on our Featured Clinical Trials Page.

I only mentioned it because Lani is from Scandanavia.

Regards
Joe

[Jackie07]

Sorry I had messed up your 'joke'. Here's one of your postings on the trial back in June 2007:


I talked at length with the researchers and this seems like it may be effective.


http://clinicaltrials.gov/show/NCT00485277


Regards
Joe

[Lani]

No, Joe I am not from Scandinavia, but often travel there.

Have been following Bavarian Nordic posts here for several years.

I thought you might have posted this as during the last week or so I posted on treatment utilizing salmonella and measles and may have previously posted on treatments based on other infectious agents

[bejuce]

Glad to have found this link. A trial for this vaccine is now enrolling in Northern California and I'm hoping to participate in it in 3 months or so.

I'd love to hear from anyone who knows more about this. In particular, what are your thoughts on the potential success of this vaccine versus the trials going on in Seattle? Any adverse effects I should be aware of?

Thanks!!!

Marcia

[Chelee]

Thanks for bringing this up Marica. Like you I will be looking forward to any information the others might have on this vaccine? I don't even know if I fit the criteria but will check it all out tomorrow. Hope someone has some encouraging info on this one.

Chelee

[Ellie F]

Hi All
The universe is working well today.
Marcia kindly offered to help me find out about this trial at Stanford. There is some CONFUSION however.
On the clinical trials website there are two trials with a very similar number. The first one is for early stage bc and is open. The second trial is NOT yet recruiting but will accept stable metastatic disease on herceptin.It is the second one that I felt I may be eligible for but it seems to be causing confusion due to similarity to the first! I have e-mailed the centre several times but the link they send is to the one for early stage!!
HELP!!

Ellie

[Midwest Alice]

Hey Ellie, I would like to locate the contact information too. Maybe someone can help.

[kiwigirl]

Hi i would like to know the difference of these trials to. I'm on the Seattle vaccine trial . You have to be ned if you are ned now at time of disease it has to be locally advanced and removed or stable disease and still on herceptin. This new trial does not sound to different. Any ideas anyone?
Jacqui

[Chelee]

Midwest Alice, Go to "clinicaltrials.gov" website and check out (NCT01158469). You will find the information there. The contact info is there also.

Chelee