AXL opportunities opening up
Outlook | 8 January 2020
BerGenBio is steadily accumulating compelling clinical data with bemcentinib in non-small cell lung cancer (NSCLC) with pembrolizumab and acute myeloid leukaemia (AML). Its competitive position is being enhanced just as the potential of targeting AXL is being increasingly validated. In NSCLC, bemcentinib appears to significantly boost the activity of pembrolizumab in tumours with normal or no PD-L1 expression. In AML, promising responses have been observed with bemcentinib monotherapy and in combination with low-dose cytarabine (LDAC). BerGenBio is planning to initiate randomised Phase II trials in NSCLC and AML in 2020, though the precise trial design will not be finalised until additional data from the ongoing trials has been analysed. We raise our valuation of BerGenBio to NOK3.31bn (NOK54.20/share).
|Year-end: December 31||2017||2018||2019E||2020E|
|Adj. PBT (NOKm)||(182.2)||(197.7)||(240.1)||(250.2)|
|Net Income (NOKm)||(182.2)||(197.7)||(240.1)||(250.2)|
|Adj. EPS (NOK)||(4.0)||(3.6)||(4.1)||(4.1)|
8 January 2020
|Shares in issue||61.1m|
BerGenBio is a clinical-stage, biopharmaceutical company based in Bergen, Norway and Oxford, UK. It is developing innovative therapies for aggressive cancers by way of inhibiting the Axl signalling pathway. The lead oncology compound, bemcentinib, is in multiple Phase II trials.
Dr Mick Cooper
+44 (0) 20 3637 5042
+44 (0) 20 3637 5043
BerGenBio is a clinical stage biopharmaceutical company focussed on exploiting its knowledge of the AXL signalling pathway as a drug target. It was founded in 2007 by Prof James Lorens of the University of Bergen, Norway. His pioneering work in understanding the role and biology of AXL has led to the company becoming a leader in the field, with a first-in-class selective AXL inhibitor, bemcentinib (BGB324) and a collaboration with Merck & Co. Bemcentinib is being evaluated in a broad “proof of concept” clinical programme as both a single agent and as combination therapy. The company is also assessing two other approaches to AXL inhibition: a monoclonal antibody (tilvestamab, BGB149), and an antibody-drug conjugate (ADCT-601). In April 2017, BerGenBio listed on the Oslo Exchange, raising NOK400m gross, with a further NOK187m raised in April 2018 and NOK74m in July 2019. The company has research facilities in Bergen and clinical development functions in Oxford, UK.
BerGenBio is a classic biotechnology company and is well suited to valuation using an rNPV model. We have ascribed a risk-adjusted value to bemcentinib in each indication that BerGenBio is currently pursuing, which generates our core valuation of the company. A review of our model, reflecting the promising progress seen across AML/MDS and NSCLC with pembrolizumab being partially offset by factors such as the slower than hoped for progress with some of the investigator-initiated trials, sees our valuation increase to NOK3.31bn or NOK54.20/share from NOK3.21bn or NOK53.13/share. BerGenBio’s shares have performed well of late, but still appear to be underappreciated. There are several share catalysts expected in FY20, including more data from the ongoing trials, potential partnering of bemcentinib, and disclosure of plans for BGB149.
BerGenBio had a cash position of NOK289.5m at Q319, after raising NOK74.0m (gross) in June 2019. The operating loss was NOK47.5m for Q3 and NOK145.3m YTD, versus NOK38.1m and NOK143.6m respectively in 2018. The company is keeping a tight control of its expenses, with 80% of operating spend directed to R&D, and the available resources should allow it to operate into Q420. The expected news flow should provide opportunities for additional funding.
Typical industry risks associated with clinical trials, regulatory hurdles, financing, possible partnering discussions, and eventually pricing and commercialisation apply. Promising data from various clinical trials has reduced the clinical trial risk associated with bemcentinib; however, results to date are so far from a limited number of patients and Axl is still a novel therapeutic target. Successful clinical development of bemcentinib, BGB149 and ADCT-601 would clearly position BerGenBio at the forefront of an exciting, and attractive, area; however, inevitably such innovation still carries higher risk. The key near-term sensitivities relate to the results of various oncology trials currently underway, and whether BerGenBio opts to out-license bemcentinib; at this stage, we expect they will seek a partner.
There is a growing body of clinical evidence indicating the potential of targeting AXL, and in particular BerGenBio’s bemcentinib, in oncology. More small molecules and antibodies that target AXL are consequently being developed in oncology, but bemcentinib stands out as the leading selective oral inhibitor of AXL. At the same time, BerGenBio is reporting consistently impressive data from the Phase II trials in non-small cell lung cancer (NSCLC) and acute myeloid leukaemia (AML). Bemcentinib is set to advance into Phase IIb development in 2020 in both indications; however, the final design of those trials will depend on the data that is still being generated in the current Phase II studies. We value BerGenBio at NOK3.31bn, $389m or NOK54.20/share.
BerGenBio is a leader in the field of AXL, having been founded to develop drugs that target AXL, just as the potential of this receptor as an oncology target is being recognised. Its pipeline is made up solely of three AXL-targeting compounds, including the most advanced selective oral AXL inhibitor, bemcentinib, in development (Exhibit 1). The company has been built on the deep scientific knowledge of Prof James Lorens (University of Bergen, Norway and co-founder) and his pioneering work on AXL signalling.
AXL signalling interacts with multiple signalling pathways and is associated with a poor prognosis for patients in various cancers (Exhibit 2). The signalling pathway appears to play an important role in the formation of aggressive cancers (including metastasis) and the development of resistance by tumour cells to immuno-oncology, chemotherapeutic and targeted-therapeutic agents. Interestingly, the AXL receptor is rarely mutated, unlike other tumour-associated tyrosine kinase receptors, and has limited activity in normal tissues.
The AXL receptor is a member of the TAM (TYRO3, AXL, MER) receptor tyrosine kinase family. It is closely associated with inflammation and prevalence in malignancy, and particularly with aggressive tumours, while having limited function in normal tissues The AXL receptor is activated by its sole ligand GAS6, which in turn can lead to the activation of different signalling pathways depending on the cell type affected. Notably from an oncology perspective, AXL signalling can result in immuno-suppression (via STAT1 signalling), promote cell survival (via mTOR signalling), and epithelial-to-mesenchymal transition (EMT, via Twist and Snail activation).
The net effect of AXL signalling in tumours is that it can:
To enable tumour cells to escape immuno-surveillance, there are three key changes that occur during EMT of tumour cells. Firstly, there is reduced expression of MHCI proteins (Major Histocompatibility Class I protein), the proteins that present protein fragments to cytotoxic T-cells. Secondly, EMT cells do not form effective immunological synapses with cytotoxic T-cells, which prevents their destruction. Thirdly, mesenchymal tumour cells promote an immunosuppressive tumour microenvironment. In preclinical studies with radiation sensitive and resistant tumour cell lines, AXL inhibition was shown to increase infiltration by cytotoxic T-cells.
Additionally, AXL is an innate immune checkpoint. During an immune response, the STAT1 pathway is activated in macrophages and dendritic cells by the cytokine IFN-γ binding to the IFN receptor. This is crucial in stimulating an innate response to an infection, but to prevent an excessive immune response, there is also a ‘safety switch’ triggered by the increased expression of AXL. This results in the activation of SOCS3 genes that down regulate pro-inflammatory cytokines, which are important for the action of cytotoxic T-cells.
Bemcentinib is a highly selective inhibitor of AXL. It has a 250x and >1,000 greater binding affinity for AXL than MER and TYRO3, respectively, the two other members of the TAM receptor family. This results in bemcentinib having a clean safety profile, which was demonstrated in a Phase I study in healthy volunteers in which bemcentinib was well-tolerated up to 1.5g per day (a dose of 200mg per day is being used in the current Phase II clinical trials). It also means that bemcentinib can be combined with other oncology therapies (including pembrolizumab, erlotinib, and docetaxel) with limited, if any, adverse events being caused by bemcentinib.
Bemcentinib is the most advanced such molecule in clinical development. BerGenBio is well positioned to maintain bemcentinib’s position (Exhibit 3), because of its deep scientific knowledge of AXL signalling and its biomarker programme. BerGenBio has identified several proprietary biomarkers, which need to be validated, but that appear to be predictive of likely responders to bemcentinib treatment.
It appears that the greatest competition to bemcentinib is likely to come from Mirati’s sitravatinib in solid tumours (Phase III in 2L NSCLC in immunotherapy-experienced patients started in Q219) and Astellas’ gilteritinib (Xospata) in AML, which is approved for FLT3 mutation–positive relapsed or refractory AML and there is a Phase I ongoing in newly diagnosed AML, regardless of FLT3 status. Neither of these products have associated companion diagnostic programmes or have as clean a safety profile as bemcentinib.
On top of the studies being conducted by BerGenBio with bemcentinib, there are also several investigator-initiated trials (IIT) ongoing, in various oncology indications and in combination with different therapies. The IIT are in glioblastoma (monotherapy), NSCLC (with docetaxel), metastatic melanoma (with pembrolizumab or dabrafenib/trametinib), pancreatic cancer (with chemotherapy), MDS/AML (monotherapy), and mesothelioma (with pembrolizumab). These studies indicate the clinical interest in bemcentinib and could help to broaden the potential of the compound.
The other two AXL-targeting assets in BerGenBio’s pipeline are the monoclonal antibody tilvestamab (BGB149) and the antibody-drug conjugate (ADC) BGB601 or ADCT-601. Tilvestamab is currently in a single-ascending-dose Phase I trial in 36 healthy volunteers, which is due to complete in Q120; BerGenBio is yet to disclose which indications it plans to target with the antibody. BGB601 is in a Phase I study (dose-escalation stage followed by dose-expansion phase) in 75 patients with advanced solid tumours; ADC Therapeutics, which in-licensed the ADC) has reported initial results from the study that suggest BGB601 has an acceptable safety profile and has shown preliminary evidence of anti-tumour activity.
In NSCLC, BerGenBio is collaborating with Merck & Co to explore the potential of combining bemcentinib with pembrolizumab in a Phase II trial in the second-line (2L) settings in patients with different exposures to IO therapies (BGBC008, Exhibit 4). All the data reported to date indicates that bemcentinib acts synergistically with pembrolizumab, with notable responses seen in those patients with PD-L1 low/- tumours, who would not be expected to benefit much from pembrolizumab monotherapy. BerGenBio has also identified biomarkers, that could be used to enrich patient groups for those likely to benefit from bemcentinib/pembrolizumab therapy.
In Cohort A of the NSCLC trial, there were 2L patients, who had not been treated previously with IO therapy (checkpoint inhibitors). The overall survival (OS), overall response rate (ORR) and PFS data are detailed in Exhibits 5, 6 and 7.
Merck conducted two clinical trials in NSCLC with pembrolizumab as monotherapy, KEYNOTE 001 and KEYNOTE 010, against which the results from Cohort A can be compared. KEYNOTE 001 was a large Phase I study with various cancers including NSCLC and PD-L1 all-comers; and KEYNOTE 010 was a Phase III study in NSCLC comparing pembrolizumab monotherapy versus docetaxel in PD-L1-positive patients only, c 97% of patients were IO naïve and c 70% had 2L tumours. The results from these trials are summarised in Exhibit 7. It should be noted that 82% of the NSCLC patients in KEYNOTE 001 had already received at least two lines of systemic treatment (≥4 lines in 21% of patients), whereas all the patients in the current trial are in the 2 or 3L setting.
The results of Cohort A compare very favourably to those seen in KEYNOTE 001 and 010, taking into account the usual caveats associated with meta-analyses and the number of patients in the current trial. By all the metrics, ORR, PFS and OS, it appears that bemcentinib enhances the activity pembrolizumab in NSCLC patients with tumours classed as PD-L1 positive or negative (PD-L1 TPS <49%).
The data is particularly impressive in those patients classed as having AXL positive tumours using a new composite AXL score. In this group of patients from Cohort A, the mPFS was 8.4 months, which is longer than that seen in either KEYNOTE 001 or 010 in patients with strong PD-L1 positive tumours.
The composite AXL score is designed to better identify those patients likely to respond to benefit from bemcentinib and pembrolizumab treatment than immunohistochemistry (IHC) detection of AXL expression in tumours. Precise details of the test have not been disclosed, but it takes into account AXL expression in both tumour and immune cells.
BerGenBio developed the composite AXL score after conducting a detailed analysis of gene expression of tumour tissue (including immune cells) that showed AXL expression in tumour and immune cells, genes associated with the epithelial-mesenchymal transition (EMT) of tumour cells, and activation of myeloid immune cells (eg. macrophages) were linked to a clinical benefit (Exhibit 9). Interestingly, PD-L1 status was not found to be predictive, and Merck has found that EMT genes and TGF-β expression (produced by M2 macrophages) are associated with resistance to pembrolizumab treatment, such as the analysis of tumour samples from urothelial cancer patients in the KEYNOTE-052 study.
In Cohort A, bemcentinib with pembrolizumab was well-tolerated. The safety profile of the drug combination is very similar to that seen with pembrolizumab monotherapy.
In Cohort B of the NSCLC trial, there were 2L and 3L patients, who had been treated previously with IO therapy. The arm is fully recruited, and data from this patient group is due to be reported in H120.
The data analysis of this cohort will include the prospective assessment patients according to their composite AXL score, which will provide useful validation of the utility of the composite biomarker.
In Cohort C, the potential of bemcentinib with pembrolizumab is being assessed in 2L patients, who have been treated previously with IO therapy in combination with chemotherapy. Recruitment to this arm of the trial is ongoing, and initial data is expected to be reported in mid-2020.
Data from the current Phase II NSCLC already justifies the further development of bemcentinib, and BerGenBio aims to initiate a randomised Phase II in this indication in H220. However, the company prudently wants to see data from all three cohorts before deciding in which 2L setting to focus the development of bemcentinib in NSCLC.
The decision will primarily be based on scientific reasons, however commercial considerations could influence the matter. Patients with PD-L1 positive or negative tumours are increasingly being treated with checkpoint inhibitors in the first-line setting if a patient is not suitable for targeted therapy (eg ALK or EGFR inhibitors). Having said that, the IO-naïve setting in 2L NSCLC could still be an attractive opportunity for bemcentinib as PD-1/PD-L1 inhibitors have limited efficacy in patients with PD-L1 low or negative tumours, approximately two thirds of NSCLC patients.
The trial will also be used to validate the composite AXL score as a companion diagnostic tool. The new composite score will not be used as a selection criterion for the trial, however the analysis of patients stratified using the score will be prespecified.
BerGenBio is conducting a Phase II trial in AML/MDS (BGBC003) to assess the compound’s potential as a monotherapy and in combination with chemotherapy (Exhibit 10). The data from the monotherapy arm of the trial already warrants the further development of bemcentinib in AML, but the company is awaiting further data from the low-dose cytarabine (LDAC) arm before finalising the design of the randomised Phase IIb study due to start in 2020.
The last reported data from the Phase II trial in patients receiving bemcentinib monotherapy was at ASH 2018, detailed in Exhibits 11 and 12. It indicated that there was promising activity with bemcentinib monotherapy, in particular in those patients with low levels of soluble AXL (sAXL, inversely related to levels of AXL signalling) biomarker. Six of the 27 AML/MDS patients achieved a clinical response with bemcentinib monotherapy, and all of those patients were classed as having low sAXL in their blood.
Immunological data from the trial also indicates that the observed benefit is in part due to better anti-tumour immune surveillance. There was a diversification of the T-cell repertoire in seven of the 11 patients assessed following bemcentinib monotherapy, and a similar diversification of the B-cell repertoire in two of those patients (Exhibit 13). These results also lend support for combining bemcentinib treatment with a checkpoint inhibitor, such as pembrolizumab.
Data from patients treated with bemcentinib and LDAC is immature, but the data so far is very promising. The latest data from 14 evaluable patients were published at ASH in December 2019 and so far the ORR is 36% (five of 14 patients), compared to an expected ORR with LDAC alone of <20%. Four of the responders were among the six newly diagnosed AML patients (ORR=66%, Exhibit 14). The median duration of response for the CR/CRi (complete response/CR with incomplete haematologic recovery) patients was >9.9 months.
Notably, one of the responders was a 76-year-old man with newly-diagnosed AML, but he was initially classed as having PD (progressive disease) at c 3 months. He continued bemcentinib/LDAC therapy and achieved a partial response (PR) by month 6 and disease control has been maintained beyond month 10. This further suggests that part of bemcentinib’s anti-tumour activity in AML is via the immune system, as it takes time for immune responses to develop.
Low levels of sAXL, found to be a predictive biomarker during the bemcentinib monotherapy arm of the trial, was still found to be predictive of responses with six of the seven responders having low sAXL before treatment. BerGenBio has also found an undisclosed serum biomarker, named as BGBM033, which appears to be predictive of responders in AML to bemcentinib (monotherapy or with LDAC). Interestingly, BGBM033 was also reported as being be predictive of responders in the current Phase II trial in NSCLC with bemcentinib and pembrolizumab, potentially negating the need for a difficult tumour biopsy.
Immature data from the bemcentinib/decitabine arm was published at ASCO in June 2019 and showed that there was a 25% response rate (three of 12 patients, Exhibit 15). At this stage, there only appears to be a modest benefit of adding bemcentinib to decitabine therapy and patients are likely to respond better to bemcentinib and LDAC, so we do not expect BerGenBio to continue with the development of bemcentinib with decitabine in AML.
Data from the trial so far suggests that bemcentinib has most potential in AML as a monotherapy or in combination with LDAC. BerGenBio is waiting for the data from the LDAC arm of the current study to mature, before deciding whether to conduct the randomised Phase II AML study (due to start in 2020) with bemcentinib monotherapy or with LDAC, and in which precise AML (or MDS) setting.
The next trial will also be used to validate sAXL and BGBM033 as biomarkers that are predictive of responders to bemcentinib therapy. This could be useful in providing bemcentinib with a significant competitive advantage over gilteritinib. Having said that, it is already apparent that bemcentinib has a much cleaner safety profile than gilteritinib, which has a black box warning on its label for differentiation syndrome as it inhibits FLT3, and not just AXL.
The potential of bemcentinib monotherapy in high-risk MDS is also being assessed in the investigator-led Phase II BERGAMO study, which was recently initiated.
We have conducted a detailed review of our rNPV valuation of BerGenBio. Our revised valuation reflects the progress that has been made in AML/MDS and in NSCLC with pembrolizumab, and also the slower than hoped for progress with some of the investigator-initiated trials (IIT). The net effect of the amendments is that we are raising our valuation from NOK3.21bn (NOK53.13/share) or $378m to NOK3.31bn (NOK54.20/share) or $389m, as shown in Exhibit 16.
The main changes to our model include increasing the likelihood of success for bemcentinib in AML/MDS and NSCLC with pembrolizumab to 40% from 30%, and increasing the peak sales forecast to $453m from $126m and to $1.59bn from $1.21bn in the two indications, respectively. To be conservative, we have delayed the launch year (when first significant sales are made) in both indications from 2023 to 2025. To reflect the uncertainty, despite the promising data reported, about the progress and potential further development in the indications being assessed in IIT studies, we have reduced the likelihood of success from 30% to 15%, reduced peak sales by c 50%, and delayed the launch year by three years to 2026. We have also delayed the first sales from bemcentinib being used more broadly as an immuno-oncology therapy by two years to 2027.
BerGenBio’s share price has almost doubled over the last six months; as the company’s potential is better recognised. However, our valuation suggests that the shares are still materially undervalued. Our valuation of bemcentinib alone in AML and NSCLC, with potential risk-adjusted milestones is NOK31.09/share and our core valuation of the company is NOK37.20/share, even before the value of bemcentinib’s broader use is considered.
There is additional upside to our valuation from tilvestamab (BGB149), which is being studied in a Phase I trial in healthy volunteers. BerGenBio is yet to disclose its development plans for the antibody, which has potential in oncology and in fibrotic indications.
There are no changes to our financial estimates.
 EMT is the process by which a cell changes from being a polarised epithelial cell, tightly joined to neighbouring cells, to become a mesenchymal cell, which is more amorphous in shape and more likely to migrate. During EMT, the expression of hundreds of genes change enabling the acquisition of new cellular characteristics.
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|Stein Holst Annexstad||Non-Executive Chairman||Joined in February 2016. He has senior industry experience, both at executive and Board levels. A former executive of Dyno Industrier AS (fine chemicals), and became CEO of pharmaceutical firm Nycomed AS (subsequently merged with Amersham Plc and thereafter merged with GE). He was head of AS Isco Group, Executive Search and Corporate Advisory. In 1996, co-founded NorgesInvestor AS, an Oslo-based Private Equity firm, and was in 2008 the first Chairman of Investinor AS (the VC of the Norwegian State). Also Chairman of Algeta ASA, the pharmaceutical start-up that developed Xofigo and was acquired by Bayer in 2014. Other Chairman positions include commercial banking, business school, public R&D and industrial enterprises.|
|Richard Godfrey||CEO||Joined as Chief Executive Officer in 2008. Over 25 years’ industry experience in drug development and commercialisation. Previously served as CEO of Aenova Inc, a specialist biopharmaceutical company, and Managing Director of DCC Healthcare Ltd. Also held positions at Catalent, Eli Lilly and Reckitt Benckiser in R&D and commercial roles. Qualified as a Pharmacist from Liverpool University and received his MBA from Bath University.|
|Rune Skeie||CFO||Joined in 2018 as CFO. Over 20 years of financial management, corporate development, corporate governance and advisory experience with public and private companies across multiple sectors. Prior roles include CFO of REMA Franchise Norge, and various roles of increasing responsibility at EY, most recently as Executive Director. He is a Registered Accountant and a State Authorised Public Accountant.|
|Prof Hanni Gabra||CMO||Joined in September 2019 as CMO, based in Oxford, UK. Previously Vice President in Early Clinical Development at AstraZeneca in Cambridge, UK, and Professor of Medical Oncology at Imperial College London. Also, since 2003, Honorary Consultant in Medical Oncology at Imperial College Healthcare NHS Trust and, since 2016, Adjunct Professor at the Centre for Cancer Biomarkers at University of Bergen. Also previously Head of Medical Oncology, Director of the Ovarian Cancer Action Research Centre, and Head of Imperial College Cancer Clinical Trials Unit. Author of more than 200 peer reviewed publications and patents, with over 15,000 citations associated with his publications.|
|Prof James Lorens||CSO||Co-founder and a Professor at the Department of Biomedicine at the University of Bergen. He leads a large internationally active academic research laboratory comprising 22 researchers, that is focused on cancer research. Prof. Lorens is an author of more than 70 peer-reviewed articles and numerous patents. He worked at Rigel after completing his postdoctoral studies at Stanford University and has managed many large collaborations with major pharmaceutical and biotechnology companies.|
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