- Trial to Study Patients with Colorectal and Ovarian Cancer
ThromboGenics NV (Euronext Brussels: THR) and BioInvent International AB(OMXS: BINV) 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 andovarian cancers. ThromboGenics and co-development partner BioInvent willreceive a milestone payment of EUR10 million from Roche under the terms ofthe strategic alliance agreement signed in June 2008. ThromboGenics, whichdiscovered TB-403, receives 60% and BioInvent 40% of all revenue from thealliance with Roche for this anti-cancer antibody.
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This trial is a multi-centre, open-label (monotherapy), dose-findingstudy with intravenous TB-403. The primary objective of the study will be toestablish the TB-403 concentration-pharmacodynamic (PD) effect relationshipusing DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) and toidentify the minimally PD effective dose. The trial will recruit up to 50patients across three European sites.
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With the start of this study, Roche will assume responsibility for allfuture development of TB-403, continuing the work started by ThromboGenicsand BioInvent. A Joint Steering Committee made up of representatives fromRoche, ThromboGenics and BioInvent will continue to oversee research anddevelopment activities. In addition, Roche will continue to provide fundingto ThromboGenics and BioInvent for research activities related to TB-403.
A Phase I trial found that TB-403 was well tolerated with no reporteddose limiting toxicity. The results from this Phase I study were presented atthe AACR-NCI-EORTC International Conference on Molecular Targets and CancerTherapeutics in Boston, U.S. in November 2009.
Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleasedto report today's important milestone as a result of Roche's decision to moveforward with the development of TB-403. The fact that Roche has initiatedthis study marks a positive turning point, indicating that ThromboGenics andBioInvent have successfully completed their responsibilities for clinicaldevelopment. We have always maintained that this selective anti-angiogenictherapy could play an important role in the treatment of cancer, and we verymuch look forward to reporting the results of this trial."
Svein Mathisen, CEO of BioInvent, commented: "This important milestoneunderpins our belief that TB-403 could become an important product for thetreatment of cancer. The Roche alliance has so far generated EUR65 million inrevenues to date to ThromboGenics and BioInvent. In the short term, we expectadditional payments to be made, as Roche progresses this product throughearly stage development. In total, there is the potential for a furtherEUR435 million in milestone payments plus product royalties."
Notes to Editors
The novel mechanism of action of TB-403 represents a potentiallypromising cancer therapy. It is a humanized monoclonal antibody directedtowards placental growth factor (PIGF), expected to act by blocking theformation of the new blood vessels that are required for tumour growth.Preclinical exploration of PIGF biology suggests a role in tumourangiogenesis and metastasis and a limited role in the maintenance of normalvasculature. This mode of action could result in therapeutic benefit with anacceptable side effect profile.
Legal disclaimer
This press release contains statements about the future, consisting ofsubjective assumptions and forecasts for future scenarios. Predictions forthe future only apply as of the date they are made and are, by their verynature, in the same way as research and development work in the biotechsegment, associated with risk and uncertainty. With this in mind, the actualoutcome may deviate significantly from the scenarios described in this pressrelease.
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin hascompleted its first Phase III clinical trial for the non-surgical treatmentof back of the eye diseases. Microplasmin is also being evaluated in Phase IIclinical development for additional vitreoretinal conditions. In addition,ThromboGenics is developing novel antibody therapeutics in collaboration withBioInvent International; these include TB-402 (anti-Factor VIII), a longacting anti-coagulant, and TB-403 (anti-PlGF) for cancer in partnership withRoche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listedon Eurolist by Euronext Brussels under the symbol THR. More information isavailable at http://www.thrombogenics.com.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), isa research-based pharmaceutical company that focuses on developing antibodydrugs. The Company currently has four clinical development projects withinthe areas of thrombosis, cancer and atherosclerosis. The Company has signedvarious strategic alliances around these product candidates and is developingthem in collaboration with partners including Genentech, Roche andThromboGenics.
These projects are based around a competitive and in substance patentedantibody development platform. The scope and strength of this platform isalso utilised by partners, such as ALK-Abello, Bayer HealthCare, DaiichiSankyo, ImmunoGen, Mitsubishi Tanabe, OrbusNeich, UCB and XOMA.More information is available at http://www.bioinvent.com. For further information, please contact: ThromboGenics NV Patrik De Haes, MD Stuart Laermer Chief Executive Officer Chief Business Officer Tel : +32-(0)-16-75-13-10 Tel: +1-(212)-201-0920 E-mail: [email protected] E-mail: [email protected] Citigate Dewe Rogerson Amber Bielecka, David Dible, Nina Enegren Tel: +44-(0)-207-638-95-71 E-mail: [email protected] BioInvent International AB Svein Mathisen Cristina Glad President & CEO Executive Vice President Tel: +46-(0)-46-286-85-67 Tel: +46-(0)-46-286-85-51 Mobile: +46-(0)-708-97-82-13 Mobile: +46-(0)-708-16-85-70 E-mail: [email protected] E-mail: [email protected] College Hill (media enquiries) Katja Toon, Justine Lamond, Anastasios Koutsos Tel: +44-(0)-20-7866-7857 E-mail: [email protected] ThromboGenics NV BioInvent International AB (publ) Gaston Geenslaan 1 Co. reg. No. 556537-7263, B-3001 Leuven Address: Solvegatan 41 Belgium Mailing address: SE-223 70 LUND Tel: +32-(0)-16-75-13-10 Tel: +46-(0)-46-286-85-50 http://www.thrombogenics.com [email protected] http://www.bioinvent.com
SOURCE ThromboGenics NV
