On November 14, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage bio-pharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported financial results for the quarter ended September 30, 2023, and provided a business update (Press release, BerGenBio, NOV 14, 2023, View Source [SID1234637670]).
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"We are pleased to report continued advancement of our focused strategy to study our lead compound bemcentinib, a highly selective AXL inhibitor, in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring mutations in the STK11 gene (STK11m). The increasing recognition of STK11m as a poor prognostic factor for 1L NSCLC patients, as evidenced by real-world data presented at prestigious medical conferences, continues to substantiate high unmet medical needs and our clinical data continues to validate the potential role of bemcentinib in combination with standard of care therapies to improve the outcome for these patients. During the quarter, we activated additional clinical trial sites in the US and prepared for the addition of sites in Europe in anticipation of the expected initiation of the Ph2a portion of our study in 1L NSCLC STK11m patients in the first half of 2024. Our operating expenses in the quarter amounted to NOK 28.1 million compared to NOK 62.4 million in Q3 2022 reflecting the effects of our focused strategy and cost containment implemented in connection with the Rights Issue. At 30th September 2023 our cash position stood at NOK 169.3 million. We believe that our singular focus on advancing bemcentinib in 1L NSCLC STK11m combined with the potential funding from the exercise of outstanding warrants issued in the Rights Issue enable us to generate data that can position the significant potential of bemcentinib in NSCLC," said Martin Olin, Chief Executive Officer of BerGenBio.
Clinical Development
Bemcentinib
BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, oral, highly selective inhibitor of the receptor tyrosine kinase AXL, which is expressed and activated in response to oxidative stress, inflammation, hypoxia and drug treatment, resulting in several deleterious effects in cancer and severe respiratory infections. Bemcentinib selectively inhibits AXL activation to prevent the progression of serious diseases through the modulation of resistance mechanisms and the adaptive immune system.
Bemcentinib is currently being developed in 1L 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)
We continue to advance our focused strategy through the conduct of BGBC016, a global, open-label Phase 1b/2a trial designed to determine the safety, tolerability and efficacy of bemcentinib in combination with standard of care treatments in untreated advanced/metastatic non-squamous NSCLC patients with STK11m and no actionable mutations. Sites in the US have been activated and enrollment is ongoing while expansion into European sites is well underway, with regulatory approval to proceed received from regulatory authorities in the US and several European countries.
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. To date, no significant safety concerns have arisen in the Phase 1b study. The Phase 2a expansion 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 STK11m.
A significant subgroup comprising of up to 20 % (> 30,000 patients in US and EU5) of 1L non-squamous NSCLC patients harbor STK11m, which are associated with immunosuppression and poor prognosis with standard 1L NSCLC treatment. Data suggests that STK11m NSCLC patients almost universally express AXL in tumors and/or on immune cells, resulting in the development of drug resistance, immune evasion, and metastases.
Post-quarter, the Company announced that the final data from the BGBC008 study (2L+ NSCLC, bemcentinib in combination with pembrolizumab) presented on October 23rd at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2023 Annual Meeting held in Madrid. The Company believes that these data along with study BGBIL005 (2L+ NSCLC, bemcentinib in combination with docetaxel) 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 that the reversal of the effects of AXL with bemcentinib holds the promise of providing substantial survival benefits to NSCLC patients and specifically in patients harboring STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1. We expect to report additional clinical data at upcoming major medical meetings during the remainder of 2023, including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Description of the 2L+ NSCLC Trial (BGBC008)
The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC patients who had received at least one prior line of therapy: chemotherapy, immunotherapy or the combination.
An analysis of AXL biomarker status indicates that the presence of AXL expression on either tumor cells and/or immune cells is predictive of improved survival in patients treated with bemcentinib + pembrolizumab. The vast majority (88%) of patients met the criteria for AXL presence (AXL positive patients) and obtained clinically meaningful benefits:
Median overall survival was highly statistically significant at p=0.001 in AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
Median progression free survival was 6.0 mos. in AXL positive patients vs. 5.8 AXL negative patients.
Analysis of available data for patients treated in subsequent therapies (3L+) following treatment with bemcentinib + pembrolizumab identified a higher than expected response rate, potentially pointing to long-lasting immune response benefits.
Data from the BGBC008 study also indicate that patients with PD-L1 negative (TPS score <1%) benefit from the combination treatment of bemcentinib and pembrolizumab. Currently PD-L1 negative patients respond less well to immune checkpoint inhibition, potentially providing an opportunity to expand the patient population eligible for treatment with bemcentinib.
The combination of bemcentinib and pembrolizumab appeared to benefit patients with mutations associated with poor outcome with available therapies, including STK11, KRAS, KEAP-1 and SMARCA4 mutations. These mutational patient populations may represent an incremental opportunity for bemcentinib and will be further assessed in our on-going BGBC016 study in 1L NSCLC patients.
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.
On April 25, 2023, the Company decided to pause the bemcentinib arm of the Phase 2b EUSolidAct trial evaluating bemcentinib in hospitalized COVID-19 patients due to the limited number of hospitalizations observed across all European countries. The Company and the EU-SolidAct have agreed to maintain this study on pause until and unless such time both parties agree to resume the trial arm due to increased COVID hospitalizations or should a new pandemic arise.
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 June 13, 2023, the Company completed a rights issue raising gross proceeds of NOK 250m. The proceeds from this offering including any additional proceeds from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L STK11m NSCLC patients, preclinical studies in severe respiratory infections and for general corporate purposes.
Warrants
The outstanding warrants issued in the Rights Issue can be exercised in two defined windows; from 15 November 2023 09:00 am CET to 28 November 2023 4:30 pm CET, or 1 April 2024 to 14 April 2024 at an exercise price of the volume-weighted average price (VWAP) of the Company’s shares on the Oslo Stock Exchange over the three last trading days prior to the exercise period less 30%, but in any event not less than NOK 0.10 and not higher than NOK 0.13. Additional information and instructions for exercise of warrants can be found on the Company’s website.
Our Chief Operating Officer James Barnes, decided to pursue new opportunities and will leave the company during December 2023. In connection with the implementation of the focused strategy, the role of Chief Operating Officer will not be replaced.
Third Quarter 2023 Financial Highlights
(Figures in brackets = same period 2022 unless otherwise stated)
– Revenue was NOK 0 million (NOK 0 million) for the third quarter.
– Total operating expenses for the third quarter were NOK 28.1 million (NOK 62.4 million)
– The operating loss for the quarter came to NOK 28.1 million (NOK 62.4 million)
– Cash and cash equivalents amounted to NOK 169.3 million by the end of September 2023 (NOK 226.0 million by end of June 2023).
Presentation and Webcast Details
The Q3 2023 presentation and Financial Report are available at the Company’s website.
BerGenBio’s senior management team will provide a business update today at 10:00 am CET. The presentation will webcast live. To participate in the webcast please use the following link:
https://channel.royalcast.com/landingpage/hegnarmedia/20231114_1/
A recording of the webcast will be available at www.bergenbio.com in the Investors/Financial Reports section shortly afterwards.