On November 4, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that held its R&D Day 2022, featuring presentations of key opinion leaders and company management on the strategic, scientific, and commercial progress at the company (Press release, Galapagos, NOV 4, 2022, View Source [SID1234623107]). The company also presented its financial results for the third quarter of 2022.
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Paul Stoffels3, CEO and Chairman of the Board of Directors of Galapagos, commented: "Today we presented our strategic vision for our future as a financially sustainable biopharma company. Building on our strong fundamentals, we are convinced that we are taking the right steps to deliver on our core mission: adding years of life and improving the quality of life of patients globally.
Focusing on our strategic therapeutic areas, we strive to push forward our deep, differentiated portfolio in immunology, build out our oncology franchise, and execute on business development opportunities with the aim to accelerate innovation and speed up time-to-patients, while creating long-term value for our stakeholders."
Strategic update
Building on our strong fundamentals, we aim to build a financially sustainable biopharma company, accelerating cutting-edge therapies to market to address unmet medical needs in our core key therapeutic areas of oncology and immunology.
Our renewed focus on two strategic therapeutic areas goes hand in hand with redirecting our resources. To further streamline our portfolio, we have decided to discontinue activities in fibrosis and kidney disease to allow for increased investments in our oncology franchise.
To shape our portfolio of innovative drugs with accelerated time-to-market, we intend to combine internal innovation with smart business development and apply deep clinical expertise to push programs through an optimal development process.
Based on these guiding principles, we presented our Vision 2028 portfolio outlook. Over the course of the next five years, we aim to build a portfolio comprising:
over 10 assets in lead optimization and five in preclinical development across different modalities (small molecules, cell therapy, biologics),
five pivotal-stage candidates forming a solid late-stage pipeline in immunology and cell therapy, and
a growing commercial presence with additional marketed indications for Jyseleca and one CAR-T therapy approved in multiple indications.
Financial vision
Aligned with our Vision 2028, we presented our financial outlook and capital allocation strategy at our R&D Day 2022. Discontinuation of our fibrosis and kidney efforts allows for reinvesting in oncology.
With Jyseleca potentially breaking even in 2024, and projected peak sales of €500 million in Europe and first oncology revenues potentially contributing to our topline later this decade, we are committed to building a sustainable financial future, with a significantly reduced cash burn by 2028.
Oncology
We also presented our Vision 2028 roadmap for oncology at our R&D Day 2022. Our core mission in the field is to broaden patient access and improve clinical outcomes by bringing best-in-class medicines to patients.
With the combined acquisitions of CellPoint and AboundBio announced earlier this year, we positioned ourselves in the cell therapy space, combining the potentially disruptive manufacturing and delivery model of CellPoint (Lonza’s Cocoon, a closed, automated manufacturing platform for cell therapy) with the ability to develop next-generation CAR-Ts, small molecules and biologics.
Short term, our aim is to validate the decentralized CAR-T delivery model with proven CAR-T therapies, and we announced the addition of a BCMA Phase 1/2 trial on the Cocoon platform. This complements the currently ongoing CD19 Phase1/2 programs in recurring/refractory Non-Hodgkin Lymphoma (rrNHL; ATALANTA study) and recurring/refractory Chronic Lymphocytic Leukemia (rrCLL; EUPLAGIA study).
In the coming years, we intend to build a pipeline of best-in-class cell therapies for hematologic malignancies and leverage our capabilities to rapidly address unmet needs in oncology.
Today, we showcased the robust process performance of the Cocoon system as well as first encouraging biomarker patient data of the CAR-T expansion profile with a 7 day-point-of-care vein-to-vein treatment. Topline Phase 1 results of both the rrNHL and rrCLL study are expected in the first half of 2023, followed by initial data of the BCMA study later in the year.
Next year, we also aim to broaden the studies to include U.S. patients, and we plan to submit Investigational New Drug (IND) applications for both the CD19 and BCMA CAR-T programs with the FDA.
Immunology
We have built up over 20 years of expertise in immunology, resulting in a deep and growing pipeline with multiple modes-of-action candidate medicines across all phases of development, from preclinical to Phase 4.
We are excited about our selective TYK2 inhibitor, ‘3667, for which we presented new data elucidating its potentially differentiating selectivity and potency profile. Ex vivo and in vivo data show that ‘3667 fully blocks the INFa pathway with once-daily dosing, while in our assays JAK2 and JAK1/3 dependent pathways are not affected. Further, no effects on hematological parameters, lipids and creatine phosphokinase (CPK) were observed, suggesting that ‘3667 does not show JAKi ‘fingerprints’ at therapeutic doses. Also based on the positive results in psoriasis patients, we presented our development plan for ‘3667, confirming the start of a Phase 2 study in dermatomyositis (GALARISSO) around year-end and the intention to start a Phase 2 study in systemic lupus erythematosus (SLE) in 2023.
We also presented an update on our SIKi portfolio, a potential novel mode-of-action in immunology. With targeted investments, we continue to make important progress in developing next-generation best-in-class candidates that reach optimal target coverage, teasing apart selectivity profiles that indicate the potential of SIK3i for rheumatological indications and SIK2/3i for inflammatory bowel disease. Our most advanced candidate, SIK3 inhibitor ‘4399, has shown strong preclinical evidence for potential in rheumatoid arthritis (RA) (EULAR 20224), with a promising pharmacological and safety profile. We are planning to start a proof-of-mechanism study in RA patients with ‘4399 mid 2023.
For filgotinib, our selective JAK1 inhibitor, we are completing a Phase 3 program in Crohn’s disease (CD), with results expected in the first half of 2023. Given the sales momentum and supportive long-term safety and efficacy data generated for filgotinib, we are currently exploring additional indications for filgotinib, and plan to start a Phase 3 study in axial spondyloarthritis (AxSpA) in 2023.
Commercial progress
Since becoming European marketing authorization holder (MAH) of Jyseleca, we successfully set up our own commercial capabilities and are currently operational throughout Europe in the current approved indications RA and ulcerative colitis (UC).
The financial results for the third quarter of 2022 show continued strong sales momentum for Jyseleca, and we further raise our net sales guidance 2022 from €75-€85 million at H1 2022 to €80-€90 million.
In the future, we aim to leverage our European commercial infrastructure beyond Jyseleca, in line with our Vision 2028, to have at least one CAR-T cell therapy on the market within five years.
Jyseleca is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies. Except for filgotinib’s approval as Jyseleca for the treatment of moderately to severely RA and UC by the relevant regulatory authorities in the European Union, Great Britain, and Japan, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.