Trial to study patients with colorectal and ovarian cancer
Lund, Sweden and Leuven, Belgium | May 17, 2010 | BioInvent International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels: THR) announce today that their partner Roche (SIX: RO, ROG; OTCQX: RHHBY) will begin an imaging study with the novel anti-cancer antibody TB-403 (RG7334) in patients with metastatic, treatment-refractory, colorectal and ovarian cancer. BioInvent and co-development partner ThromboGenics will receive a milestone payment of €10 million from Roche under the terms of the strategic alliance agreement signed in June 2008. ThromboGenics, which discovered TB-403, receives 60% and BioInvent 40% of all revenue from the alliance with Roche for this anti-cancer antibody.
This trial is a multi-centre, open-label (monotherapy), dose-finding study with intravenous TB-403. The primary objective of the study will be to establish the TB-403 concentration-pharmacodynamic (PD) effect relationship using DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) and to identify the minimally PD effective dose. The trial will recruit up to 50 patients across three European sites.
With the start of this study, Roche will assume responsibility for all future development of TB-403, continuing the work started by BioInvent and ThromboGenics. A Joint Steering Committee made up of representatives from Roche, BioInvent and ThromboGenics will continue to oversee research and development activities. In addition, Roche will continue to provide funding to BioInvent and ThromboGenics for research activities related to TB-403.
A Phase I trial found that TB-403 was well tolerated with no reported dose limiting toxicity. The results from this Phase I study were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, U.S. in November 2009.
Svein Mathisen, CEO of BioInvent, commented, “This important milestone underpins our belief that TB-403 could become an important product for the treatment of cancer. The Roche alliance has so far generated € 65 million in revenues to date to BioInvent and ThromboGenics. In the short term, we expect additional payments to be made as Roche progresses this product through early stage development. In total, there is the potential for a further € 435 million in milestone payments plus product royalties.”
Dr. Patrik De Haes, CEO of ThromboGenics, also commented, “We are very pleased to report today’s important milestone as a result of Roche’s decision to move forward with the development of TB-403. The fact that Roche has initiated this study marks a positive turning point, indicating that ThromboGenics and BioInvent have successfully completed their responsibilities for clinical development. We have always maintained that this selective anti-angiogenic therapy could play an important role in the treatment of cancer, and we very much look forward to reporting the results of this trial.”
About TB-403
The novel mechanism of action of TB-403 represents a potentially promising cancer therapy. It is a humanized monoclonal antibody directed towards placental growth factor (PIGF), expected to act by blocking the formation of the new blood vessels that are required for tumour growth. Preclinical exploration of PIGF biology suggests a role in tumour angiogenesis and metastasis and a limited role in the maintenance of normal vasculature. This mode of action could result in therapeutic benefit with an acceptable side effect profile.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based
pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed
various strategic alliances around these product candidates and is developing them in collaboration with
partners including Genentech, Roche and ThromboGenics.
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.com.
SOURCE: BioInvent International AB
Post Views: 42
Trial to study patients with colorectal and ovarian cancer
Lund, Sweden and Leuven, Belgium | May 17, 2010 | BioInvent International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels: THR) announce today that their partner Roche (SIX: RO, ROG; OTCQX: RHHBY) will begin an imaging study with the novel anti-cancer antibody TB-403 (RG7334) in patients with metastatic, treatment-refractory, colorectal and ovarian cancer. BioInvent and co-development partner ThromboGenics will receive a milestone payment of €10 million from Roche under the terms of the strategic alliance agreement signed in June 2008. ThromboGenics, which discovered TB-403, receives 60% and BioInvent 40% of all revenue from the alliance with Roche for this anti-cancer antibody.
This trial is a multi-centre, open-label (monotherapy), dose-finding study with intravenous TB-403. The primary objective of the study will be to establish the TB-403 concentration-pharmacodynamic (PD) effect relationship using DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) and to identify the minimally PD effective dose. The trial will recruit up to 50 patients across three European sites.
With the start of this study, Roche will assume responsibility for all future development of TB-403, continuing the work started by BioInvent and ThromboGenics. A Joint Steering Committee made up of representatives from Roche, BioInvent and ThromboGenics will continue to oversee research and development activities. In addition, Roche will continue to provide funding to BioInvent and ThromboGenics for research activities related to TB-403.
A Phase I trial found that TB-403 was well tolerated with no reported dose limiting toxicity. The results from this Phase I study were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, U.S. in November 2009.
Svein Mathisen, CEO of BioInvent, commented, “This important milestone underpins our belief that TB-403 could become an important product for the treatment of cancer. The Roche alliance has so far generated € 65 million in revenues to date to BioInvent and ThromboGenics. In the short term, we expect additional payments to be made as Roche progresses this product through early stage development. In total, there is the potential for a further € 435 million in milestone payments plus product royalties.”
Dr. Patrik De Haes, CEO of ThromboGenics, also commented, “We are very pleased to report today’s important milestone as a result of Roche’s decision to move forward with the development of TB-403. The fact that Roche has initiated this study marks a positive turning point, indicating that ThromboGenics and BioInvent have successfully completed their responsibilities for clinical development. We have always maintained that this selective anti-angiogenic therapy could play an important role in the treatment of cancer, and we very much look forward to reporting the results of this trial.”
About TB-403
The novel mechanism of action of TB-403 represents a potentially promising cancer therapy. It is a humanized monoclonal antibody directed towards placental growth factor (PIGF), expected to act by blocking the formation of the new blood vessels that are required for tumour growth. Preclinical exploration of PIGF biology suggests a role in tumour angiogenesis and metastasis and a limited role in the maintenance of normal vasculature. This mode of action could result in therapeutic benefit with an acceptable side effect profile.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based
pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed
various strategic alliances around these product candidates and is developing them in collaboration with
partners including Genentech, Roche and ThromboGenics.
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.com.
SOURCE: BioInvent International AB
Post Views: 42
