A briefing by
"The recent announcement of the topline data from our BCBG008 NSCLC trial corroborates the strategy we enacted and the great strides we took in 2022," said
Clinical Development
Bemcentinib
Bemcentinib is currently being developed in STK11 mutated NSCLC and severe respiratory infections including COVID-19. Its novel mechanisms of action and primary accumulation in the lungs uniquely position it to address these severe lung diseases.
Oncology: NSCLC
2L+ NSCLC Trial (BGBC008)
Subsequent to quarter end, the Company announced topline data from the BGBC008 (2L+) NSCLC trial on
- A clinically meaningful survival benefit and evidence of disease control was demonstrated with bemcentinib in combination with pembrolizumab regardless of prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI: 10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6, 9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).
- A significant (p-value < 0.05) and clinically meaningful improvement in mOS based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS > 5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6) compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI: 6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months (95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.
- The observed mOS was similar regardless of patient PD-L1 status.
- Treatment with bemcentinib in combination with pembrolizumab was well-tolerated.
2L+ NSCLC Trial (BGBIL005)
In addition to the encouraging ORR and DCR data previously presented from the Investigator Led Study phase 1 trial in which bemcentinib was combined with docetaxel, the final mPFS of 3.1 months and mOS of 12.3 months support the clinical benefit of combining bemcentinib with chemotherapy.
1L STK11m NSCLC (BGBC016)
A significant subgroup comprising approximately 20% (> 30,000 patients in US and EU5) of non-squamous NSCLC patients harbor STK11 mutations, which are associated with immunosuppression and poor prognosis with standard treatment in 1L NSCLC. Data suggests that STK11m NSCLC patients almost universally have AXL tumor expression and activation, resulting in the development of drug resistance, immune evasion, and metastases.
Topline data from the 2L+ NSCLC (BGBC008) trial show clinically meaningful mOS, mPFS and DCR with the combination of bemcentinib and pembrolizumab, regardless of prior therapy. In patients with an AXL TPS > 5, a clinically significant improvement in mOS was observed providing supporting evidence for the relevance of AXL inhibition in the treatment of NSCLC. Further, data from the 2L+ NSCLC (BGBIL005) trial indicated promising clinical benefits from administering bemcentinib with chemotherapy.
The results of the BCBG008 and BCBIL005 trials provide clinical evidence of the anti-tumor effects of bemcentinib and its ability to modulate the tumor microenvironment to enhance the effects of immunotherapy and chemotherapy and provide strong support for the ongoing 1L NSCLC trial in patients harboring STK11 mutations, that are characterized by a severely immunosuppressed, pro-tumorigenic microenvironment and AXL activation.
Screening of patients for the 1L STK11m NSCLC (BCBG016) trial is ongoing.
Oncology: Relapsed/Refractory AML
As previously announced, the Company expects to report topline results from the phase 2 BGBC003 trial in Relapsed/Refractory AML in H1 2023.
Severe Respiratory Infections (SRIs)
The Company believes that bemcentinib blocks viral entry and replication, stimulates the innate immune system, and promotes lung tissue repair positioning it for the treatment of severe respiratory infections including COVID-19.
Previously the Company has completed two phase 2 trials with bemcentinib in hospitalized COVID-19 patients, showing promising clinical activity and is currently enrolling patients into the EUSolidAct phase 2b platform trial in hospitalized COVID-19 patients.
The trial is sponsored, and majority funded by the EUSolidAct platform, a pan-European research project designed to investigate treatment options for hospitalized patients with COVID-19 and emerging infectious diseases. The sponsor and the Company are currently monitoring the evolution of the pandemic and its impact on the trial execution. Further guidance on the trial is expected in H1 2023.
Additionally, bemcentinib is being evaluated in preclinical studies for SRIs causing Acute Respiratory Distress Syndrome (ARDS) and initial results are expected during 2023.
Corporate Activities
Shareholder Loan Facility
Subsequent to the quarter end,
Fourth Quarter 2022 and Full Year Financial Highlights
(Figures in brackets = same period 2021 unless otherwise stated)
- Revenue amounted to
- Total operating expenses for the fourth quarter were
- The operating loss for the quarter came to
- Cash and cash equivalents amounted to
Webcast Details
The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.
Webcast link: https://channel.royalcast.com/landingpage/hegnarmedia/20230216_14/
Dial-in numbers:
NO: +47-21-956342
US: +1 646-787-0157
SE: +46-4-0682-0620
DK: +45 78768490
Pin: 712491
The fourth quarter and full year report and presentation are available on the Company's website in the Investors/Financial Reports section.
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Contacts
ir@bergenbio.com
rune.skeie@bergenbio.com
Investor Relations / International Media Relations
graham.morrell@bergenbio.com
Media Relations Norway
jl@lillebyfrisch.no
+47 90 55 16 98
About
Forward looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties, and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
https://news.cision.com/bergenbio-asa/r/bergenbio-reports-fourth-quarter-2022-financial-results-and-provides-business-update,c3715922
https://mb.cision.com/Public/15728/3715922/ac8c3c2aaebb2f11.pdf
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