Hovedresultatene som ble flagget i New York i går er svært oppløftende:

Helt sentralt sies:
Promising interim clinical data from broad phase II programme with bemcentinib, selective AXL inhibitor Interim data from ongoing phase II trials supporting proof of concept for bemcentinib to become a cornerstone of cancer therapy

Delpunkter (som utdypes i gårsdagens foredrag):
First efficacy endpoint met: Phase II combination trial with KEYTRUDA in advanced lung cancer (NSCLC)
- Efficacy threshold of at least 4 responses in the first 22 patients exceeded in 2-stage trial
- ASCO: Interim data from first 15 evaluable patients – 6 out of 7 PD-L1 negative pts reported benefit including 2 PRs (29%)

Monotherapy efficacy reported: Phase II trial in advanced leukaemia (R/R AML and high risk MDS)
- ASCO and EHA: Superior response rates observed in biomarker subgroup analysis
- Evidence of immune activation following bemcentinib monotherapy observed in 7 out of 11 (64%) pts analysed

Biomarker correlation reported: CDx pipeline evaluating soluble and tissue marker candidates
- Tissue: AXL IHC method reported encouraging correlation data
- Blood-based biomarkers: Low plasma soluble AXL predicts patient benefit in R/R AML/MDS

Low prevalence of AXL and PD-L1 reported in TNBC:
- Phase II combination trial with 14 of 18 pts analysed negative for AXL and reported no clinical benefit
- First efficacy endpoint in 2-stage trial not met

Interessant: Ved å gå fra KEYTRUDA MONO (9% respons) til Bemcentinib + KEYTRUDA (BGBC008 trial) øker man til 29%.
Man sier derfor: "Opportunity to increase addressable market by adding bemcentinib"

Og videre:
"Potential strategic positioning of bemcentinib as cornerstone of treatment for NSCLC by combining with standard of care therapies
- Company anticipates to update the market with proposed rPh2 strategy towards the end of 2018"

Summary & Outlook: A number of significant milestones expected in H2 2018 and 2019
Her angis:

Significant milestones expected in H2 2018
- Bemcentinib NSCLC KEYTRUDA combo: presentation of completed stage 1 data and initiate stage 2
- BGB149 AXL antibody BGB149:begin phase I clinical trial

Positioned to deliver significant value in flectionpoints over the next 18 months
• Key read-outs from phase II trial PoC programme with bemcentinib in NSCLC, AML/MDS and melanoma
• Start first in man phase I clinical trial with BGB149, anti AXL antibody
• Start randomised phase II programme with bemcentinib in target indicatio

Altså: Man fortsetter å kjøre i gang oppfølgende studier til foreliggende positive funn/muligheter for å adressere nye kombinasjonsmuligheter for denne angrepsmåten (AXL-inhibitor tenkningen), og vi kan se frem til flere mulige oppløftende meldinger både i år og neste år

Neste presentasjon, som vil vise mer konkrete kliniske data, er altså Toronto 23-25 sept 2018.


Likviditet?
"Anticipated cash runway into 2020 based on current burn rate Included in the OSEBX index from 1st June"

PS: ketle homeowner la ut linker allerede i går kveld til både pfd-slides og selve foredraget til Richard Godfrey.
- Slides : https://www.bergenbio.com/wp-content/uploads/2018/09/BerGenBio_2018_Wainwright_reduced-file-size.pdf
- Foredrag: http://wsw.com/webcast/rrshq28/bgbio/