Medivir initiates clinical study of birinapant in combination with KEYTRUDA® (pembrolizumab) in patients with treatment-refractory solid tumours

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the first patient has been enrolled in the company’s phase I/II study of birinapant in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab), which is marketed by MSD (known as Merck & Co., Inc, Kenilworth, NJ, USA in the US and Canada). The objectives of the study are to evaluate the safety, tolerability and preliminary efficacy of this combination in patients with treatment-resistant solid tumours.

About the study

The multicentre, single arm, open label study, which is primarily being run in the US, will be conducted in two parts. In the initial dose escalation (phase I) part of the study, the objective is to identify the recommended phase II dose of birinapant for use in combination with KEYTRUDA®. This is to be achieved by administering increasing doses of birinapant in combination with the approved dose of KEYTRUDA® to cohorts of up to 6 patients with refractory solid tumours.

Once the recommended phase II dose has been identified, the second part of the study will begin. The primary objective of the phase II part is to evaluate the safety and tolerability of birinapant in combination with KEYTRUDA® in several cohorts. Each cohort will be made up of patients with the same treatment refractory tumour type. An important secondary objective in the phase II part is the preliminary evaluation of the efficacy of the combination in each of the cohorts.

Under the terms of the agreement between Medivir and MSD (through a subsidiary), MSD will provide KEYTRUDA® for this study at no cost to Medivir. Medivir retains full rights to birinapant. Additional details were not disclosed.

“The approval of immune check-point inhibitors constituted a remarkable leap forward for many cancer patients, but there still remains a substantial opportunity to improve outcomes. Recent preclinical data have provided a strong scientific rationale for combining birinapant with immune checkpoint inhibitors such as KEYTRUDA®. We are therefore very pleased to enrol the first patient in this combination study, which will allow us to determine its safety and tolerability, as well as its potential efficacy, in patients with solid tumours who have no further treatment options,” said John Öhd, Chief Medical Officer at Medivir.

About birinapant
Birinapant is a parenterally administered bivalent peptidomimetic of the SMAC protein (Second Mitochondria-derived Activator of Caspases) and is therefore known as a SMAC mimetic compound. Birinapant binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), which both enables apoptosis (programmed cell death) in tumour cells, and activates the immune system, enhancing its attack on the tumour. Birinapant has the potential, through its actions on tumour cells and cells of the immune system, to improve the treatment of several types of cancer when used in combination with other drugs including checkpoint inhibitors and DNA damaging agents.

For further information, please contact:

Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
John Öhd, CMO Medivir AB, mobile +46 (0) 725 296 200

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08.30 CET on 18 August 2017.

About Medivir
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet the unmet medical needs of cancer patients. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA


About Us

Medivir develops innovative pharmaceuticals for the treatment of cancer. The company specializes within protease inhibitor research and nucleotide/nucleoside science.The research is conducted in all phases of pharmaceutical development, from idea to clinical phase III studies. The development work is conducted both in-house and through partnerships.Medivir is listed on the Nasdaq Stockholm Mid Cap List.


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