BerGenBio ASA announced the presentation of data from its broad phase II clinical development programme with its selective AXL inhibitor bemcentinib (BGB324) in two posters at the ASCO-SITC Clinical Immuno- Oncology Symposium (January 25-27, San Francisco, CA, USA). One poster outlined favourable interim safety data from three phase II clinical trials with bemcentinib in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co. Inc., Kenilworth, N.J., USA (known as MSD outside the US and Canada). Furthermore, an AXL immunohistochemistry (IHC) method developed and validated by the Company was shown to clearly detect the presence of AXL on tumour and immune cells in patient samples thus holding promise as a potential future companion diagnostic. The second poster provided translational analyses from BerGenBio's phase II trial in acute myeloid leukaemia (AML), with bemcentinib used as a single agent. The results showed a clear immunomodulatory effect as a result of selective AXL inhibition, as evidenced by increased immune activity characterised by diversification of patients' T-cell receptor repertoire. The data presented strengthens the Company's proposition that its selective, first-in-class and orally bioavailable AXL inhibitor bemcentinib may hold promise as an immunomodulatory agent, both as backbone to current and emerging immune checkpoint inhibitor regimens as well as a monotherapy by demonstrating the (1) Combining bemcentinib with KEYTRUDA has thus far been well tolerated: In a poster presentation entitled: "Combination of bemcentinib (BGB324) ­ a first-in-class selective, oral AXL inhibitor ­ with pembrolizumab in patients with triple negative breast cancer and adenocarcinoma of the lung," Murray Yule (MD, PhD), Clinical Development Officer at BerGenBio, detailed: A total of 34 patients across the Company's three trials combining bemcentinib with KEYTRUDA (Trial ref. BGBC007 in triple-negative breast cancer, trial ref. BGBC008 in non-small cell lung cancer and trial ref. BGBIL006 in melanoma) have thus far been evaluable for safety of the drug combination. The spectrum of observed serious adverse events was similar to that reported for KEYTRUDA alone. (2) Treatment with bemcentinib has immunomodulatory effect: In a poster presentation entitled: "The immunomodulatory activity of bemcentinib (BGB324) ­ a first-in-class selective, oral AXL inhibitor in patients with relapsed/refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome.", Professor Sonja Loges (MD, PhD), attending physician at the University Hospital in Hamburg-Eppendorf and lead investigator of the BGBC003 trial, detailed the following: 35 patients with relapsed/refractory (R/R) AML or myelodysplastic syndrome (MDS) received bemcentinib monotherapy as part of the BGBC003 trial. Two patients achieved complete responses with incomplete recovery of peripheral counts (CRi) and five achieved partial responses (PR). Eight patients reported disease stabilisation for more than four months. Three patients remain on study at the time of data cut-off (Jan 17th 2018). Six out of nine patients analysed showed a diversification of the T-cell receptor repertoire in their peripheral blood, bone marrow or both indicative of increased immune activity as a result of AXL inhibition.