Trinity Delta Recruitment to first stage of TNBC Phase II completed ahead of schedule

Recruitment to first stage of TNBC Phase II completed ahead of schedule

Lighthouse | 19 February 2018

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BerGenBio has announced that the first stage of the BGBC007 Phase II trial in triple-negative breast cancer (TNBC) with bemcentinib (selective, oral Axl inhibitor) and pembrolizumab (Keytruda) is fully recruited with 28 patients ahead of schedule.
The study is a global study with patients with previously treated, locally advanced and unresectable or metastatic triple negative breast cancer (TNBC) or triple negative inflammatory breast cancer (TN-IBC) from the Norway, Spain, UK and US,
Interim data from the trial is expected to be reported in mid-2018
Data presented at the ASCO-SITC Clinical Immuno-Oncology Symposium from 34 patients, (including nine from the TNBC study) shows that bemcentinib in combination with pembrolizumab (Keytruda) was well tolerated, with the observed serious adverse events similar to those seen with Keytruda alone. These data also included patients from the Phase II studies in melanoma and NSCLC.

Trinity Delta view: The completion of recruitment to the first stage of this trial highlights the clinical interest in the combining bemcentinib and pembrolizumab and provides an insight into the commercial potential of the combination.Oncology research is increasingly focused on increasing the proportion of patients that benefit from treatment with PD-1/PD-L1 monoclonal antibodies, such as Merck’s pembrolizumab, and preclinical studies suggest that bemcentinib by selectively inhibiting the Axl receptor should work synergistically with PD1 inhibitors (see Initiation note from 4 January for further details).

The commercial interest in products that augment PD1/PD-L1 responses is demonstrated by the Nektar/BMS collaboration deal signed on 14 February, based on only early clinical data, in which Nektar is receiving an upfront payment of $1.85bn. This shows the kind of deal that BerGenBio could potentially sign, depending on the clinical efficacy data with bemcentinib, the first of which is expected at the ASCO meeting in June.

We value BerGenBio at NOK2,519m ($296m) or NOK50.46/share. We note that are valuation only includes potential upfront and milestone payments of $400m to be conservative.

Lighthouse

19 February 2018


Price (NOK)	48.10
Market Cap (NOKm)	2,401
Primary exchange	Oslo
Sector	Healthcare
Company Code	BGBIO

Corporate client	Yes

Company description

BerGenBio is a clinical-stage, drug development company based in Bergen, Norway and Oxford, UK. It is developing innovative anti-cancer therapies that act on the promising Axl signalling pathway. The lead oncology compound, BGB324, is in a number of Phase II trials.

Analysts

Mick Cooper PhD
mcooper@trinitydelta.org
+44 (0) 20 3637 5042

Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041

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