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FDA Slaps a Full Clinical Hold on BioInvent (BOVNF)'s Phase II Multiple Myeloma Study

11/8/2016 5:23:51 AM

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BioInvent Reports Clinical Hold on BI-505 Phase II Study

LUND, Sweden--()--Regulatory News:

BioInvent International (STO:BINV) has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma. BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.

The clinical study is being conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the United States and aims to document the ability of BI-505 to deepen therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan.

BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report.

Notes to editors:

About BioInvent

BioInvent International AB (OMXS: BINV) is focused on developing a first-in-class and best-in-class pipeline of antibody immunotherapeutics against cancer. The company’s two lead clinical programmes are BI-505, in Phase II development for multiple myeloma, and BI-1206, in Phase I/II for non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. BioInvent also has its own manufacturing facility for the production of antibodies for research through to late-stage clinical trials. The Company has research collaborations with leading academic institutions including Penn Medicine, Cancer Research UK, and the University of Southampton. BioInvent generates revenues from its eight global partnerships, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma.

BioInvent International AB (publ)

Co. reg. No. 556537-7263

Visiting address: Sölvegatan 41

Mailing address: 223 70 LUND

Phone: +46 (0)46 286 85 50

The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 12.00 a.m. CET, on 8 November, 2016.

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Michael Oredsson
President and CEO
+46 (0)46 286 85 67
+46 (0)707 16 89 30
Citigate Dewe Rogerson
David Dible/Katja Stout/ Marine Perrier
+44 (0)20 7638 9571

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