LEUVEN, Belgium, July 10, 2017 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR) and BioInvent International AB ("BioInvent") (OMXS: BINV) today announce that they have agreed to amend their long-standing agreement, which covers the co-development of the novel anti-PlGF monoclonal antibody products TB-403 and THR-317. The revisions to the existing agreement have been aligned with each company's strategic ambitions and therapeutic focus.
The novel anti-PIGF monoclonal antibody is currently being developed as:
- TB-403, which is being evaluated in a Phase I/IIa trial as a treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children. TB-403 is being developed by Oncurious (ThromboGenics' oncology subsidiary), in collaboration with BioInvent.
- THR-317, which is being evaluated in a phase II trial in patients with diabetic macular edema (DME). This trial is being conducted by ThromboGenics exclusively.
Under the current agreement, the split of economic value for the compounds is 60:40 (ThromboGenics: BioInvent), with a 50:50 cost split for historical and future development costs.
Under the new agreed contractual arrangement, the split of economic value and costs will be as follows:
- TB-403 - BioInvent assumes the project lead for developments of TB-403 in all oncology indications, and increases its share of the economic value from 40 to 50 percent. The parties will continue to share the costs for development of TB-403 in oncology indications at 50:50.
- THR-317 - ThromboGenics gains full and exclusive ownership of THR-317 for development and commercialization in all non-oncology indications. ThromboGenics will continue to carry all costs for the development of THR-317 in non-oncology indications, and share a 5% economic value with BioInvent.
ThromboGenics and BioInvent have entered into a binding term sheet covering the above arrangement for TB-403 and THR-317, and will be executing the definitive amended agreements by Q3 2017.
ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.
ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial evaluating multiple doses of THR-409 (ocriplasmin) to induce a total Posterior Vitreous Detachment in patients with Non-Proliferative Diabetic Retinopathy (NPDR).
THR-317, a PIGF inhibitor being developed to treat diabetic macular edema, or as a combination therapy with anti-VEGF treatments, enrolled its first patient in a phase II clinical study in January 2017. In addition, THR-149, a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics, and THR-687, an integrin antagonist, which was in-licensed from Galapagos, are in late-stage pre-clinical development.
ThromboGenics pioneered a new drug category of pharmacological vitreolysis with JETREA® (ocriplasmin) which is now approved for the treatment of vitreomacular traction in 54 countries worldwide. ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. in the US. Novartis commercializes JETREA® outside the United States.
ThromboGenics is headquartered in Leuven, Belgium, and is listed on the NYSE Euronext Brussels exchange under the symbol THR.
More information is available at http://www.thrombogenics.com
About BioInvent International
BioInvent International AB (OMXS: BINV) is focused on the discovery and development of novel and first-in-class immuno-regulatory antibodies to treat cancer. The Company's clinical programmes are BI-1206, currently in a Phase I/II for non-Hodgkin's lymphoma and chronic lymphatic leukaemia and TB-403, in cooperation with Oncurious, currently in Phase I/II for medulloblastoma. BioInvent has an exciting pre-clinical portfolio based on novel immuno-modulatory antibodies that target regulatory T cells (T-regs) and tumour-associated myeloid cells. In December 2016, the Company signed a strategic research collaboration with Pfizer Inc. BioInvent also works with leading academic institutions including the University of Southampton, Cancer Research UK, and Penn Medicine. BioInvent generates revenues from global partnerships, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma and from its manufacturing facility for the production of antibodies for research through to late-stage clinical trials.
More information is available at http://www.bioinvent.se
Important information about forward-looking statements (ThromboGenics nv)
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
For further information, please contact:
President and CEO
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+32-16-75-13-10 / +32-478-33-56- 32