SynOx Therapeutics announces $75m Series B round to fund Phase 3 trial of potential best-in-class treatment for TGCT
- SynOx Therapeutics secured $75m in Series B financing to fund Phase 3 trial of emactuzumab for TGCT.
- The financing was co-led by Forbion, HealthCap, and new investor Bioqube Ventures.
- Emactuzumab demonstrated a 71% objective response rate in earlier clinical work for TGCT.
- Dr Carlo Incerti, M.D., and Jon Edwards, PhD, have joined the Board of Directors as part of the financing.
- The funding will allow SynOx to generate registrational data for emactuzumab, a next-generation therapy for TGCT.
- None.
Insights
SynOx Therapeutics' Series B funding round of $75 million earmarked for the Phase 3 trial of emactuzumab represents a pivotal moment in the company's trajectory and underscores investor confidence in its potential. The commitment from seasoned investors like Forbion and HealthCap, coupled with the introduction of Bioqube Ventures, signals market validation of the therapeutic's promise. The substantial investment suggests a robust financial foundation, enabling SynOx to navigate the costly Phase 3 trial phase without immediate capital concerns.
The focus on Tenosynovial Giant Cell Tumour (TGCT) — a niche but serious medical condition with a high recurrence rate post-surgery — highlights a strategic move to target unmet medical needs. For investors, the unique appeal lies in the significant market opportunity for a treatment that could address both localized and diffuse TGCT. The reported objective response rate (ORR) of 71% positions emactuzumab as a potentially disruptive player in the oncology segment.
However, risks remain inherent in biotech investing, particularly at this clinical stage. The transition from Phase 3 trials to regulatory approval is fraught with uncertainty and the eventual commercial success hinges on numerous factors including the final efficacy and safety profile, market penetration and reimbursement landscape. Furthermore, investor dilution is a common side effect of such capital raises and there is always the spectre of competition from other pharmaceutical entities.
The medical significance of emactuzumab cannot be understated, as it targets the CSF-1R pathway implicated in TGCT — a pathway essential for the growth of certain immune cells associated with this tumour type. From a clinical perspective, the therapeutic's ability to induce rapid tumour reduction and provide long-lasting effects offers a potential leap from the current standard of care, which is primarily surgical intervention with a high recurrence rate.
It's noteworthy that the molecule is pegged as a 'next-generation' therapy; this designation often implies an improvement over existing treatments in terms of efficacy, safety, or patient convenience. The reported manageable safety profile is equally important, as tolerability can be a limiting factor in the adoption of new oncology treatments. Still, the true test lies ahead in the Phase 3 TANGENT trial, where the drug must demonstrate sufficient clinical benefit to warrant approval by regulatory agencies like the FDA.
Given the complexity of biologic treatments like monoclonal antibodies, the scalability of production and the ability to maintain consistent quality (CMC - Chemistry, Manufacturing and Controls) will be crucial. Investors should watch for any manufacturing hiccups that could delay market entry or affect the cost structure of the drug.
Focusing on the market dynamics, TGCT, while classified as a rare disease, presents a significant commercial opportunity for SynOx, due to the lack of pharmacological options. Currently, treatment is predominantly surgical, which does not provide a permanent solution for many patients. A therapeutic like emactuzumab could become the standard of care if it proves superior in efficacy and safety, capturing a niche yet valuable market.
Market penetration will depend not only on clinical outcomes but also on how effectively SynOx can navigate the regulatory landscape and negotiate with payers. Assuming emactuzumab achieves regulatory approval, SynOx will need a robust marketing strategy to educate physicians about its benefits over surgery and to secure favorable reimbursement rates.
Tracking the company's progress through the Phase 3 trial and subsequent steps toward commercialization will be crucial. Any delays or setbacks could significantly impact investor sentiment, as the biotech market is highly sensitive to clinical trial results and regulatory decisions. Conversely, positive results could enhance SynOx's prospects for partnerships or even make it an acquisition target, offering potentially lucrative returns for early investors.
- Financing co-led by Forbion, HealthCap and new investor Bioqube Ventures
- Funds will be used for pivotal trial of potential best-in-class, next-generation treatment for Tenosynovial Giant Cell Tumour
The proceeds will be used to generate registrational Phase 3 clinical and CMC data for emactuzumab, SynOx's potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of Tenosynovial Giant Cell Tumour (TGCT).
TGCT is a type of tumour that affects the soft tissue lining of joints and tendons and is a highly debilitating disease often impacting large, important joints such as the knee, hip and ankle.
TGCT is a chronic disease which often impacts patients throughout their lives. It seriously impacts quality of life by causing significant loss of function of the affected joints, pain, stiffness, and limiting range of motion. While most patients receive surgical intervention, more than
Emactuzumab is a novel, next-generation CSF-1R mAb with a potentially best-in-class profile. In earlier clinical work in TGCT[2] emactuzumab demonstrated substantial clinical activity with an objective response rate (ORR) of
As part of the Series B financing both Dr Carlo Incerti, M.D., and Jon Edwards, PhD, have joined the Board of Directors. Dr Incerti has more than three decades of experience in the biopharmaceutical industry and brings an extensive track record in global drug development, including from his time at Sanofi Genzyme where he played a leading role in pioneering therapies for rare and genetic diseases. Jon Edwards brings a decade of therapeutic investment expertise and company creation experience, which includes several public listings and multi-billion-dollar acquisitions.
Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said: "This is a transformational time for SynOx. This substantial funding will allow us to generate registrational data for emactuzumab in TGCT. As a highly effective, next-generation therapy with a short treatment cycle, rapid onset and long duration of response, we believe that emactuzumab is differentiated from other agents in development and will provide a much needed and valuable option for patients suffering from this grievous disease."
Dirk Kersten, General Partner at Forbion, commented: "We are pleased to continue to support the SynOx team as it moves emactuzumab through to BLA and MAA submissions in TGCT. As a late-stage company with a clinically de-risked asset, focused on an attractive and underserved market, SynOx is a good example of the type of company Forbion Growth would typically invest in."
Jon Edwards, Bioqube Ventures commented: "We are excited to join the SynOx syndicate and work with this fantastic team and board. We believe this asset has the potential to generate best-in-class data and are excited to help the team develop the product through approval and launch."
Ton Logtenberg, Non-Executive Chair of SynOx Therapeutics, added: "The support of our existing and new investors is validation of SynOx's strategy and its great potential as a company. I would like to welcome Carlo Incerti and Jon Edwards to the Board of Directors. Their broad experience and knowledge, particularly in driving forward cutting-edge therapies for rare diseases, and executing deals at the highest level, complement the expertise of our existing directors and will be instrumental as we accelerate the late-stage clinical development of emactuzumab."
About SynOx Therapeutics
SynOx Therapeutics Limited is a
Carlo Incerti, M.D.
Carlo has more than three decades of experience in the biopharmaceutical industry, including in rare disease drug development. Carlo is currently an operating partner at Forbion, a life sciences venture capital firm. Previously, he held several positions of increasing responsibility during his more than 25 years at Sanofi Genzyme, including senior vice president, chief medical officer and head of global medical affairs. Before his industry career Carlo was a practicing endocrinologist and an Associate Professor at the University of Modena and
Jon Edwards
Jon recently joined the Bioqube Ventures team. Previously, he served as Managing Director at Red Tree Venture Capital and was part of the founding team at Medicxi where he was a partner in the London office. He has led multiple investments spanning company formation, syndicated deals, and late-stage crossover/IPO financings. A few notable investments include Impact Biomedicines (acquired by Celgene), Synthorx (acquired by Sanofi), Phathom Pharmaceuticals (NASDAQ:PHAT), and Checkmate Pharmaceuticals (acquired by Regeneron). Jon conducted his postdoctoral research at MIT and holds a PhD in Biochemistry and Biophysics from the University of
About Tenosynovial Giant Cell Tumour (TGCT)
Tenosynovial Giant Cell Tumour (TGCT), previously termed pigmented villonodular synovitis (PVNS), is a type of tumour that affects the soft tissue lining of joints and tendons. TGCTs are categorised as fibrohistiocytic tumours by the WHO classification and are subclassified based on growth patterns (localised- and diffuse types) and location (tendon sheath, and intra- and extra-articular forms). TGCTs are locally destructive and can be aggressive tumours. TGCT is a chronically debilitating disease which often impacts patients throughout their lives. It causes loss of function of the affected joints, pain, stiffness, limited range of motion and a significant impact on the quality of life as a result. Most patients receive surgical intervention, with 3-year post-surgery recurrence rates in more than
About CSF-1 and Emactuzumab
CSF-1 (or macrophage colony-stimulating factor) is a cytokine that binds to the CSF-1 receptor (CSF-1R), expressed on macrophages and certain other cells, with effects on production, differentiation, and function of these cells. Emactuzumab is a humanised IgG1 CSF-1R targeted antibody that inhibits and depletes macrophages in the tumour tissue. Emactuzumab was originally discovered and developed by Roche and has been tested in several phase 1/b studies as a monotherapy and in combination with other agents, including chemotherapeutics and immunotherapies. In clinical studies as a monotherapy in 63 patients with TGCT, emactuzumab has shown a substantial effect on tumour response (ORR ~
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SOURCE SynOx Therapeutics
FAQ
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