"We recently reported the positive readout of several clinical trials that strongly validate our strategy to concentrate our efforts on evaluating bemcentinib to treat Non-Small Cell
Clinical Development
Bemcentinib
Bemcentinib is currently being developed in STK11 mutated NSCLC and severe respiratory infections. Its novel mechanisms of action and primary accumulation in the lungs uniquely position it to address these severe lung diseases.
Oncology: NSCLC
1L STK11m NSCLC (BGBC016)
The Company announced on
The Phase 1b portion of the study is evaluating the safety and feasibility of three different doses of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the safety and efficacy of up to two doses of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
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 expression and activation in tumors and/or on immune cells, resulting in the development of drug resistance, immune evasion, and metastases.
The results of the BGBC008 (2L+ NSCLC, bemcentinib in combination with pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with docetaxel) 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. We believe this provides strong support for the ongoing BGBC016 1L NSCLC trial in patients harboring STK11 mutations.
2L+ NSCLC Trial (BGBC008)
In February 2023 the Company announced topline data from the Phase 2 BGBC008 2L+ NSCLC trial and provided additional results from pre-planned analyses after quarter end 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 IHC tumor scores was observed. Patients with AXL score > 5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6) compared to patients with AXL < 5, who achieved a mOS of 9.9 months (95% CI: 6.7, 17.4). In addition, patients with an AXL > 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 < 5. The ORR for AXL > 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.
- Pre-planned biomarker analyses of patients in BGBC008 indicate that the combination of bemcentinib and pembrolizumab in patients with mutations associated with poor outcome with available standard of care therapies, including STK11, KRAS, KEAP-1 and SMARCA4 mutations, may respond as if they have no mutations in these genes.
At the 2023 AACR meeting,
2L+ NSCLC Trial (BGBIL005)
In Q4 2022, we announced that in addition to the encouraging ORR and DCR data previously presented from the Investigator Led Study phase 1b/2a trial in which bemcentinib was combined with docetaxel, the final mPFS of 3.1 months and mOS of 12.3 months further support the clinical benefit of combining bemcentinib with chemotherapy.
Oncology: Relapsed/Refractory AML/MDS
Following the end of the quarter, the Company held a business update conference call on
- Two cohorts of patients in BGBC003 were treated with bemcentinib as a single agent (monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R) AML, (n=11), bemcentinib provided an ORR of 18.2% and a mOS of 18 months. In Cohort B4, in patients with relapsed/high risk MDS, bemcentinib monotherapy provided an ORR of 18.8% with a mOS of 9.2 months. The Company believes the mOS achieved is substantially longer than historical comparators in these same patient populations, providing evidence of single-agent efficacy of bemcentinib.
- Furthermore, bemcentinib in combination with LDAC appeared to provide substantial mOS benefit to patients with R/R AML (n=27) achieving an ORR of 18.5% and a mOS of 8 months. Although these findings are encouraging, the Company has decided not to further pursue clinical trials in this indication given the change in standard of care therapies in these patient populations.
Oncology: Mesothelioma
The topline results of the investigator led BGBIL011/MiST3 mesothelioma trial were presented post-quarter on
MiST, the Mesothelioma Stratified Therapy umbrella trial, is a
- 26 patients with relapsed mesothelioma were enrolled in MiST3 and all received at least one dose of bemcentinib and pembrolizumab.
- The primary endpoint of disease control rate at 12 weeks (DCR12w) was met: 46.2% (90% CI: 29.2, 63.4).
- Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of 38.5% (95% CI: 20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95% CI: 4.4, 34.9).
- The combination of bemcentinib and pembrolizumab was generally safe and well-tolerated.
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 well for the treatment of severe respiratory infections.
Bemcentinib is currently being evaluated in preclinical studies for SRIs causing Acute Respiratory Distress Syndrome (ARDS) and initial results are expected during 2023.
Corporate Activities
Rights Offering
On
Focused organizational structure aligned with strategy
Post quarter the Company has taken measures to further reduce its operational costs including a significant reduction in workforce and total compensation to the executive management and the board of directors. These prudent actions will reduce total operating expenses by at least 30% compared to historic operational expenses when fully implemented.
In
First Quarter 2023 Financial Highlights
(Figures in brackets = same period 2022 unless otherwise stated)
- Revenue was
- Total operating expenses for the first quarter were
- The operating loss for the quarter came to
- Cash and cash equivalents amounted to
The Company provided a business update 15 May and a presentation hosted by
The Q1 2023 Financial Report is available at the Company's website.
-End-
Contacts
ir@bergenbio.com
rune.skeie@bergenbio.com
Media Relations
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 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-first-quarter-2023-financial-results-and-provides-business-update,c3792200
https://mb.cision.com/Public/15728/3792200/bed08fdec0b6a0c2.pdf
(c) 2023 Cision. All rights reserved., source