SynOx Therapeutics announces positive topline results from the Phase 3 TANGENT study

SynOx Therapeutics Announces Positive Topline Results from the Phase 3 TANGENT Study, Supporting Emactuzumab as a Differentiated, Next-generation Treatment for Patients with Tenosynovial Giant Cell Tumor (TGCT)

  • TANGENT met its primary and secondary endpoints with a high level of statistical significance vs. placebo at 6 months, including ORR by RECIST V1.1 and Tumor Volume Score (TVS), and clinically meaningful improvements in PROMIS-PF and other patient -relevant functional measures
  • Rapid onset and significant functional improvement observed
  • Short-course regimen demonstrated sustained and durable clinical benefits , highlighting the potential to avoid chronic treatment burden
  • Emactuzumab demonstrated a manageable safety profile, highly consistent with prior clinical experience
  • These data reinforce emactuzumab’s differentiated profile as a next-generation, short-course therapy with the potential to address important limitations of chronic oral treatment approaches in TGCT
  • Biologics License Application (BLA) submission planned for H2 2026; EU Marketing Authorization Application (MAA) to follow

DUBLIN, IRELAND, OXFORD, UK, and PHILADELPHIA, PA — April 13th, 2026

SynOx Therapeutics Limited (“SynOx”) today announced positive topline results from the pivotal Phase 3 TANGENT study of emactuzumab in adult patients with TGCT.

Emactuzumab is a targeted CSF-1R inhibitor that is being developed as a short-course treatment for patients with TGCT, which is designed to deliver rapid and durable disease control without the need for continuous treatment. In the TANGENT study, patients were randomized to receive either emactuzumab or placebo. Patients assigned to the treatment arm received emactuzumab at a dose of 1,000 mg administered every two weeks, for a total of five doses over an 8-week period.

Results across the primary and key secondary endpoints demonstrated clinically meaningful and statistically significant benefit consistent with emactuzumab’s differentiated profile. These included measures of tumor volume reduction and patient-reported and functional outcomes, including PROMIS-PF, physical function, pain, range of motion, and stiffness. Importantly, these benefits were achieved rapidly in the short-course treatment cycle, were durable and were observed across clinically relevant patient segments.

Emactuzumab demonstrated a manageable safety profile in TANGENT, consistent with prior clinical experience. In a patient population with a chronic, debilitating but non-lethal disease, tolerability remains an important consideration, particularly when compared with long-term treatment approaches.

“The TANGENT results represent an important step in advancing a potential next-generation treatment for patients with TGCT,” said Dr. Ray Barlow, CEO of SynOx Therapeutics. “Emactuzumab’s combination of rapid onset, response rate, meaningful functional improvement, and a defined short-course regimen positions it as a potential alternative to chronic therapy. We believe this approach directly addresses key limitations of existing treatments and represents an important advancement for patients suffering from this debilitating disease. We look forward to engaging with the FDA as we advance toward a planned BLA submission in the second half of 2026.”

Dr. Jean-Yves Blay, Principal Investigator, commented further:

“Emactuzumab is the only short course treatment option in late-stage development for patients suffering with TGCT. These Phase 3 data provide compelling evidence of tumor response, a manageable safety profile, and most importantly for patients, of significant durable functional and quality of life benefits that allow patients struggling with TGCT to move forward with their lives, without continuous therapy.”

SynOx continues to follow patients enrolled in the TANGENT study to further characterize the durability of response, and the potential role of retreatment and crossover open label emactuzumab.

SynOx intends to present full data from the TANGENT trial at an upcoming medical meeting and in a peer-reviewed publication.

Based on these data, SynOx plans to submit a BLA to the U.S. Food and Drug Administration for emactuzumab in TGCT in the second half of 2026 and a MAA in the EU thereafter.

About the TANGENT Study:

The TANGENT clinical trial (NCT05417789) is a global, multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial evaluating the efficacy and safety of emactuzumab in patients with TGCT. Patients in the treatment arm received 1000mg emactuzumab every two weeks for a total of five doses over 8 weeks. The primary endpoint is Objective Response Rate (ORR) at 6 months as measured by RECIST v1.1. Secondary endpoints are designed to detect the effect of emactuzumab on physical function, range of motion, stiffness, pain and duration of response as measured by both physician and patient reported assessments including Tumor Volume Score (TVS), PROMIS-PF TGCT T-score, range of motion (ROM), and assessments of pain, stiffness and quality of life.

TANGENT enrollment criteria include patients with biopsy-confirmed localized or diffuse TGCT where surgical resection would be associated with predicted worsening functional limitations through surgical joint damage, and/or subjects with anticipated high risk of early recurrence, or any other morbidity associated with the surgery, and/or subjects for whom surgical treatment is not expected to improve clinical outcomes.
Following the 6-month double-blind period, patients can enter an 18-month follow-up phase during which patients who demonstrate signs of disease progression may receive open label emactuzumab.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is a rare, non-malignant, but locally aggressive and destructive tumor affecting the synovium, tendon sheaths, and bursa membranes primarily located in knee, hip, and ankle joints but can also occur in other locations such as the cervical spine. It is a chronically debilitating disease, which causes loss of function of the affected joints, as well as pain, stiffness, and limited range of motion, which can significantly impact quality of life.

TGCT is estimated to affect approximately 200,000 patients in the U.S. and 179,000 patients in the EU4 +UK, with an estimated incidence of approximately 50 per million (1). As patients are typically diagnosed between the ages of 35 and 50, TGCT is a long-term disease.

Existing treatment options for TGCT include surgery and oral systemic therapies, but both options are of limited benefit. Surgery is often the first-line approach, although it comes with a risk of surgical complications, severe morbidity, and can require a lengthy recovery. Surgical recurrence rates are also high, including 17% for those with localized disease (2) and 72% for those with diffuse disease (3). Additionally, many patients have tumors that are not amenable to surgery. Treatment with approved oral TKI therapies require long-term chronic administration (daily or biweekly).

About Emactuzumab:

Emactuzumab is a next-generation monoclonal antibody. As a high-affinity CSF1-R inhibitor, emactuzumab is designed to block receptor activation, deplete tumor-promoting macrophages and reduce inflammation in the tumor microenvironment.

Emactuzumab is designed to address the limitations of current treatment options as a short-course, targeted therapy intended to deliver rapid tumor reduction, meaningful functional improvement, durable benefit, and manageable tolerability following limited treatment exposure.

Emactuzumab has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product designation from the European Medicines Agency for the treatment of TGCT.

About SynOx Therapeutics
SynOx Therapeutics Limited is a Dublin, Oxford and Philadelphia-based, late-stage biopharmaceutical company developing emactuzumab, a next-generation, best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1-related and macrophage-driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialization. The company is backed by a strong syndicate of premier life science investors including Forbion, Gilde Healthcare, HealthCap, Bioqube Ventures, and Medicxi.

For further information please contact:
SynOx Therapeutics
Ray Barlow, CEO
Tel: +44 (0) 208 058 5619
Email: [email protected]

Investor Relations Contact
Precision AQ
Danielle Dudgeon
Email: [email protected]

References
(1) Stacchiotti S, et. al. Best clinical management of Tenosynovial Giant Cell Tumour (TGCT): A consensus paper from the community of experts. Cancer Treat Rev. 2023;112:102491. doi:10.1016/j.ctrv.2022.102491.
(2) Mastboom M, Palmerini E, Verspoor F et al. Surgical outcomes of patients with diffuse-type tenosynovial giant-cell tumours: an international, retrospective, cohort study The Lancet Oncology, 2019; 20, 877-886.
(3) Verspoor FG, Zee AA, Hannink G, van der Geest IC, Veth RP, Schreuder HW. Long-term follow-up results of primary and recurrent pigmented villonodular synovitis. Rheumatology (Oxford). 2014 Nov;53(11):2063-70. doi: 10.1093/rheumatology/keu230.

SynOx Therapeutics Strengthens Board of Directors with Leading Experts in Commercialisation and Corporate Development Amid Continued Corporate Progress

Charles “Chip” Romp and Tom Heyman join SynOx’s Board, bringing deep launch, lifecycle, and corporate development expertise as the company advances its next-generation therapy emactuzumab toward key regulatory and commercial milestones

DUBLIN, IRELAND, OXFORD, UK, and PHILADELPHIA, PA — October 21, 2025

SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced the appointments of Charles “Chip” R. Romp and Tom J. Heyman to its Board of Directors. These appointments further align SynOx’s business with its forward strategy as the company nears topline data for emactuzumab and continues its focus on regulatory and commercial activities. In August 2025, SynOx completed enrollment in the Phase 3 TANGENT clinical trial; topline data are expected in the first quarter of 2026.

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said:

“We are delighted to welcome Chip and Tom to SynOx. Chip brings an exceptional depth of commercial leadership to the Board, with a proven track record of building launch organisations, establishing new oncology standards of care, and driving lifecycle expansion across multiple blockbuster brands at Seagen and Genentech. Tom is one of the most accomplished corporate development leaders in our industry, with nearly four decades experience guiding transformational partnerships, licensing deals, and global strategic growth initiatives at Johnson & Johnson.”

“Together, their complementary expertise significantly strengthens SynOx’s readiness for commercialisation, partnering, and other strategic pathways as we continue to advance emactuzumab’s late-stage clinical program and prepare for the milestones ahead. I would also like to take this opportunity to sincerely thank Jon Edwards, who has stepped off the Board, for his invaluable contributions and guidance during an important period of SynOx’s growth.”

New Board Appointees

  • Charles “Chip” R. Romp is a seasoned oncology commercial executive with more than 25 years of experience leading U.S. and global launches and lifecycle strategies. He currently serves as President & CEO of Secura Bio and previously was EVP, U.S. Commercial at Seagen, where he was a member of the Executive Committee and helped lead the launch and commercial growth of Adcetris®, Padcev®, Tukysa®, and Tivdak®. Earlier, he spent 12 years at Genentech in senior oncology and immunology roles, including as National Sales Director for Avastin® and Rituxan®. He also serves on the Board of Minds and Assembly.
  • Tom Heyman is joining the SynOx Board as Bioqube Ventures’ representative. He spent 37 years at Johnson & Johnson, including as President of JJDC (Johnson & Johnson Development Corporation) and Global Head of Business Development at Janssen, where he led and oversaw major licensing, M&A, and strategic collaborations. He currently serves on the boards of Exelixis (NASDAQ: EXEL), Legend Biotech (NASDAQ: LEGN), Akero Therapeutics (NASDAQ: AKRO), and IMEC.

SynOx Progress and Near-Term Milestones
In August 2025, SynOx completed enrollment in TANGENT, its global, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in TGCT patients who are not amenable to or would not benefit from surgery. Top-line data are expected in the first quarter of 2026.

Emactuzumab previously received Fast Track Designation from the U.S. Food and Drug Administration for TGCT, reflecting the seriousness of the disease and the unmet medical need.

Based on clinical work to date, SynOx believes that emactuzumab represents a next-generation therapeutic option with the potential to address key patient needs by offering an effective, short-course treatment with rapid onset and a durable response — enabling individuals with TGCT to better manage their disease and move forward with their lives.

About TGCT and Emactuzumab
TGCT is a rare, locally aggressive tumour of the synovium, tendon sheaths, and bursa membranes that can cause substantial pain, stiffness, reduced mobility, and diminished quality of life; more than 50% of diffuse TGCT cases recur within three years after surgery.

Emactuzumab is a humanised monoclonal antibody targeting CSF-1R, designed to inhibit and deplete macrophages in tumour tissue; in clinical studies it has shown rapid tumour reduction, functional improvement, and a manageable safety profile in TGCT.

Additional details on TANGENT are available at ClinicalTrials.gov (NCT05417789).

About SynOx Therapeutics
SynOx Therapeutics Limited is a Dublin, Oxford and Philadelphia-based, late-stage biopharmaceutical company developing emactuzumab, a next-generation, best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1-related and macrophage-driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialization. The company is backed by a strong syndicate of premier life science investors including Forbion, Gilde Healthcare, HealthCap, Bioqube Ventures, and Medicxi.

Contacts:
SynOx Therapeutics
Ray Barlow
Chief Executive Officer
Tel: +44 (0) 208 058 5619
Email: [email protected]

 

 

SynOx Therapeutics Completes Enrollment in Registrational Phase 3 TANGENT Clinical Trial Significantly Ahead of Timeline

Top-Line Results from Study Evaluating Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT) Expected in First Quarter of 2026

DUBLIN, IRELAND, OXFORD, UK, and PHILADELPHIA, PA – August 5, 2025

SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced completion of patient enrolment in the TANGENT study. TANGENT is the company’s  global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in patients with TGCT who are not amenable to or who would not benefit from surgery. SynOx expects to report top-line data from the study in the first quarter of 2026.

Emactuzumab is a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody (mAb).  Clinical evaluation to date has demonstrated the compound to be a promising, next-generation mAb therapy with the potential to offer a short treatment cycle, rapid onset and long duration of response that differentiates it from chronically administered oral agents. This potentially best-in-class profile helped drive strong interest in the TANGENT trial among patients and clinical investigators across sites in the United States, Canada, Europe and Asia, leading to rapid study enrollment.

“Completion of enrollment in our registrational TANGENT trial marks an important milestone for SynOx and for the TGCT community,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “We are deeply grateful to the patients, families, investigators, and clinical sites whose dedication has made this study possible and allowed SynOx to fully enroll the trial significantly ahead of our projected timeline. We remain committed, data permitting, to delivering a much-needed new treatment option for this debilitating condition.”

“This is a transformational time for SynOx as we advance emactuzumab through its pivotal Phase 3 program,” said Ray Barlow, Chief Executive Officer of SynOx.  “We’re excited about the next steps and look forward to delivering top-line data that we hope demonstrate how emactuzumab can transform care for patients with this grievous disease.”

 

About the TANGENT Study

TANGENT (ClinicalTrials.gov Identifier: NCT05417789) is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of emactuzumab in patients with TGCT who are not amenable to or would not benefit from surgery. Patients who consent and meet eligibility criteria are randomized in a 2:1 fashion to receive either emactuzumab (1000 mg every two weeks for five doses) or matched placebo.

The primary endpoint is objective response rate (ORR) as assessed by RECIST criteria at six months post-randomization. Key secondary endpoints include patient-reported outcomes (PROMIS-PF), functional assessments of range of motion, pain, stiffness, durability of response, and safety. Patients are followed for two years from randomization, with those demonstrating disease progression after the six-month assessment eligible to receive open-label emactuzumab during follow-up.

 

For the full press release see here:  SynOx Completion of TANGENT Study PR

SynOx Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)

DUBLIN, IRELAND and OXFORD, UK, April 14, 2025 – SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to emactuzumab for the treatment of TGCT patients that are not amenable to or who would not benefit from surgery. Emactuzumab, a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody, is currently being evaluated in the TANGENT study, a global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial.

TGCT is a rare, non-malignant but aggressively growing tumour of the synovium, tendon sheaths and bursa membranes primarily located in knee, hip, and ankle joints and caused by excessive production of CSF-1. It is a chronically debilitating disease for patients causing loss of function of the affected joints, as well as pain, stiffness and limited range of motion. Receipt of FTD for TGCT was supported by data from Phase 1/2 clinical studies demonstrating rapid, robust tumour reduction and durable response combined with a manageable safety profile. Emactuzumab has also previously received Orphan Medicinal Project designation from the European Medicines Agency.

“The granting of FTD for emactuzumab in TGCT highlights the devastating toll that this disease has on patients, as well as the critical need that remains for new treatment options,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “Based on our clinical work to date, we believe that emactuzumab has significant potential to address key patient needs by offering an effective, short-course treatment with rapid onset and a durable response that allows individuals suffering from TGCT to better manage their disease and move forward with their lives. We look forward to completing the ongoing TANGENT study and progressing emactuzumab toward potential commercialization.”

 

About Fast Track Designation

The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.  Fast Track status allows for enhanced communication and collaboration between the FDA and drug developers, potentially speeding up the delivery of life-saving treatments to patients.

 

For the full press release see here:  SynOx U.S Fast Track Designation PR

SynOx Therapeutics Announces Board Chair Transition to Align with Advancing Regulatory and Commercialization Strategy

Newly Appointed Board Chair, Philip Astley-Sparke, Brings Transatlantic Late-Stage Development, Regulatory and Commercial Expertise

Strengthened Leadership and Expanded U.S. Presence Positions SynOx for Regulatory Filings and Commercialization of Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)

DUBLIN, IRELAND and OXFORD, UK, April 1, 2025 – SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced the execution of a planned and orderly transition of its board chair position. Philip Astley-Sparke has been appointed as new chair of the board of directors, reflecting SynOx’s ongoing evolution into a global, commercially focused biotechnology company. Mr. Astley-Sparke succeeds Ton Logtenberg, who has served as board chair since 2021, overseeing the company’s growth into a well-funded, late-stage clinical company.

With its Phase 3 registrational trial of emactuzumab in TGCT underway, SynOx has evolved its strategic focus to prioritize global regulatory filings, commercial readiness and increasing its transatlantic footprint. This builds upon recent corporate milestones including the raising of a $92 million Series B round of funding and the ongoing build-out of its US executive leadership team.

“Ton has been a steady and invaluable partner through a critical period of growth and maturation for SynOx and we are deeply indebted to him for his leadership over the past several years,” said Ray Barlow, Chief Executive Officer of SynOx Therapeutics. “As we embark on our next phase focused on regulatory and commercial activities, we are happy to welcome Philip as our new board chair. His proven experience leading late-stage, transatlantic companies and guiding assets through regulatory approval and launch preparedness will be pivotal as we prepare for the potential commercialization of emactuzumab.”

Mr. Astley-Sparke is a seasoned biotechnology executive with a distinguished track record in building and leading innovative companies across immuno-oncology and rare diseases. With over two decades of experience, he has successfully guided multiple organizations from early-stage through to BLA filing with the United States Food and Drug Administration (FDA) and accompanying commercial launch preparations. He has raised over $1.5 billion in capital and held key leadership roles at Replimune Group Inc, where he currently serves as Executive Chairman, uniQure N.V, and BioVex Group Inc. Notably, at BioVex he played a central role in the development of the first FDA-approved oncolytic virus and oversaw a $1 billion acquisition by Amgen. Mr. Astley-Sparke provides SynOx deep expertise in transatlantic biotech operations, in-house manufacturing scale-up, execution of initial public offerings (IPOs), and strategic growth.

For the full press release see here: SynOx Tx_Chair transition PR

SynOx Therapeutics Further Strengthens Executive Team with Appointments of U.S.-Based Chief Medical Officer and Chief Commercial Officer

Additions of Elyse Seltzer, M.D., as CMO and Robert Francomano as CCO Strengthen Company’s Presence in the U.S.

Seasoned Team to Drive Forward Pivotal Phase 3 Trial of Emactuzumab in Patients Suffering from Tenosynovial Giant Cell Tumours (TGCT)

DUBLIN, IRELAND and OXFORD, UK, November 7, 2024 – SynOx Therapeutics Limited (“SynOx”), a late clinical-stage biopharmaceutical company developing a novel treatment for CSF-1 related and macrophage-driven disorders, today announced the appointments of Elyse Seltzer, M.D., as Chief Medical Officer (CMO) and Robert Francomano as Chief Commercial Officer (CCO). These strategic hires come at a pivotal time as SynOx accelerates the clinical development of emactuzumab, a potentially best-in-class CSF-1R inhibiting monoclonal antibody. The company recently announced that the first patients have been dosed in its Phase 3 registrational study of emactuzumab for the treatment of Tenosynovial Giant Cell Tumours (TGCT).

Dr. Seltzer brings more than 20 years of expertise in clinical development and regulatory strategy across various therapeutic areas to SynOx. She most recently served as a Senior Therapeutic Subject Matter Expert at Biomedical Advanced Research and Development Authority (BARDA), where she supported collaborations between the U.S. government and biotech and pharmaceutical companies on treatments for emerging infectious diseases and acute respiratory distress syndrome (ARDS). Previously, Dr. Seltzer held key leadership roles including Chief Development Officer at Urogen Pharma, where she oversaw the development and approval of Jelmyto® for urologic oncology, and Chief Medical Officer at Nabriva Therapeutics, where she led the successful development of Xenleta®, approved for the treatment of community-acquired bacterial pneumonia. SynOx believes that Dr. Seltzer’s strategic experience, which spans early-stage research to late-stage clinical trials and commercialization, will be instrumental in advancing the company’s clinical programs, including the recently initiated Phase 3 TANGENT trial for emactuzumab in TGCT.

Mr. Francomano joins SynOx as a highly accomplished leader in the global commercialization of oncology and rare disease therapies. With a proven track record in driving revenue growth and executing successful global product launches, he will spearhead the company’s commercial strategy. Prior to joining SynOx, he served as CCO at SELLAS Life Sciences, where he established a fully integrated commercial framework underpinned by diagnostic and AI-driven demand generation strategies. Mr. Francomano also previously held the position of the CCO at Stemline Therapeutics, where he led the corporate transformation from a clinical-stage entity to one with a full commercial infrastructure and capability in the U.S. and EU. Successful execution led the company to exceed revenue targets and deliver one of the industry’s top-ranked product launches for first launch biotechnology organizations. SynOx expects that his experience will be vital in preparing for the potential commercialization of emactuzumab and expanding the company’s footprint in the global market.

“We are thrilled to welcome Elyse and Robert to the SynOx leadership team as we continue to work to strategically build out our presence within the key U.S. market. Their extensive expertise in clinical development and commercialization will be crucial as we advance emactuzumab towards regulatory submissions and potential commercial launch in both the U.S. and globally,” said Ray Barlow, Chief Executive Officer of SynOx Therapeutics. “With the recent closing of our $92M Series B financing and launch of the registrational TANGENT Phase 3 trial, we are working diligently to accelerate development of our clinical programs and bring novel therapies to patients suffering from TGCT and other debilitating diseases.”

SynOx recently announced the initiation of the TANGENT study, a global, multi-centre, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of emactuzumab in patients with TGCT. The study’s primary outcome measure is overall response rate (ORR). Investigators will also assess several secondary outcomes including functional and quality of life measurements, impact on tumour volume, and duration of response. Investigators expect to enrol approximately 130 patients in the trial. Additional study details can be found on ClinicalTrials.gov (Identifier: NCT05417789).

 

For the full press release see here:  SynOx CCO and CMO PR

SynOx Therapeutics Adds New Investor and Capital to Series B Financing, Raising Total to $92 Million, and Doses First Patients in Phase 3 Trial

Gilde Healthcare Leads Series B Extension, Joining Premier Syndicate of Leading Life Science Investors

Funding Supports Registrational Phase 3 TANGENT Trial of Emactuzumab, a Best-in-Class CSF-1 Receptor Targeted Antibody, for the Treatment of Tenosynovial Giant Cell Tumour

TANGENT Study Underway with First Patients Dosed

 

DUBLIN, IRELAND and OXFORD, UK, October 30, 2024 – SynOx Therapeutics Limited (“SynOx”), a late clinical-stage biopharmaceutical company developing a novel treatment for CSF-1 related and macrophage-driven disorders, today announced that it has raised additional funding in a final close of its Series B financing. The Series B extension was led by new investor Gilde Healthcare and brings the total capital raised by SynOx in the round to $92 million including earlier investments from Forbion, HealthCap and Bioqube Ventures. Proceeds from the financing are supporting a registrational Phase 3 clinical trial of emactuzumab, a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody for the treatment of Tenosynovial Giant Cell Tumour (TGCT).

In conjunction with the closing of the Series B extension, SynOx today announced that the first patients have been dosed in its Phase 3 registrational study of emactuzumab. The study, named TANGENT, is a global, multi-centre, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of emactuzumab in patients with TGCT. The study’s primary outcome measure is overall response rate (ORR). Investigators will also assess several secondary outcomes including functional and quality of life measurements, impact on tumour volume, and duration of response. Investigators expect to enrol approximately 130 patients in the trial. Additional study details can be found on ClinicalTrials.gov (Identifier: NCT05417789).

TGCT is a rare, non-malignant but aggressively growing tumour of the synovium, primarily located in knee, hip, and ankle joints and caused by excessive production of CSF-1. It is a chronically debilitating disease for patients causing loss of function of the affected joints, pain, stiffness and limited range of motion. Emactuzumab specifically inhibits CSF-1R and earlier clinical work in TGCT1 showed it to be a highly effective, next-generation therapy with a short treatment cycle, rapid onset of action and long duration of response.

“We are pleased to add Gilde Healthcare to our impressive investor syndicate and are appreciative for their support of our team and our vision for the potential of emactuzumab to address the unmet needs, and improve the quality of life, of TGCT patients around the world,” said Ray Barlow, Ph.D., Chief Executive Officer of SynOx. “The dosing of patients in the TANGENT trial marks an important milestone for SynOx and is a testament to the dedication and hard work of our team. We look forward to efficiently conducting this study and continuing to pursue our goal of advancing emactuzumab toward market for TGCT patients in desperate need of new treatment options.”

As part of the Series B extension, Arthur Franken, general partner at Gilde Healthcare, will join the SynOx Board of Directors. Mr. Franken brings more than two decades of venture and growth capital investment expertise, including several public listings and trade sales.

“We are pleased to join SynOx as an investor and help support the late-stage development of emactuzumab, which we believe has a best-in-class profile as a CSF-1R targeted antibody. Importantly, we also believe that the SynOx team is well positioned to successfully complete clinical development of emactuzumab and deliver this important treatment option to TGCT patients,” said Mr. Franken.

See the full release here: SynOx Series B Extension and 1st Patients Dosed PR

References

  1. Cassier et al., “Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour,” European Journal of Cancer 141:162-170, 2020.
  2. Lin F, et al. JHEOR, 2022.

SynOx Therapeutics secures up to $35m debt financing with Hercules Capital to progress development and commercialisation of emactuzumab

  • SynOx is developing emactuzumab – a potential best-in-class, next-generation  CSF1(R) inhibiting monoclonal antibody
  • Provides flexible loan facility to support additional clinical work and activities to drive its successful registration and commercialisation
  • Funding is additional to recent $75m Series B financing

Dublin, Ireland and Oxford, UK, 30 April 2024: SynOx Therapeutics Limited (“SynOx” or the “Company”), the late-stage clinical biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other diseases, today announces it has entered into a $35m loan facility with Hercules Capital, Inc. (NYSE:HTGC) (“Hercules”).

The transaction strengthens the Company’s balance sheet as it executes TANGENT, a registrational Phase 3 study of emactuzumab, SynOx’s potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of TGCT.

This loan facility provides SynOx with flexibility to fund additional clinical work in TGCT to augment TANGENT, activities to support the successful registration and commercialisation of emactuzumab in TGCT, and potentially to explore the use of emactuzumab in other CSF-1 driven and macrophage-mediated diseases.

The term loan facility provides up to $35m, in total, in four tranches. The initial tranche was drawn on signing, with subsequent tranches available over the medium term and upon achievement of certain clinical milestones.

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said: “This funding will provide SynOx with additional capital to fulfil its mission of establishing emactuzumab as a best-in-class drug, to address significant unmet medical needs and greatly improve the quality of life for as many patients as possible. We are grateful for the support from Hercules, which together with the $75m we raised recently in our Series B round, puts SynOx on a strong financial footing.”

R. Bryan Jadot, Senior Managing Director and Group Head – Life Sciences, Hercules, said: “We have been impressed by the quality of data SynOx has already generated on emactuzumab, which demonstrate it to be highly differentiated from other CSF-1 inhibiting drugs in development. Emactuzumab is showing great promise in treating TGCT, and we believe it has the potential to treat other related conditions as well.”

TGCT is a type of tumour that affects the soft tissue lining of joints and tendons. It is a highly debilitating disease that often impacts large, important joints such as the knee, hip and ankle. It seriously impacts quality of life by causing significant pain and stiffness in affected joints and limiting range of motion. While most patients receive surgical intervention, more than 50% of patients with diffuse disease experience tumour recurrence within three years of surgery [1].

Emactuzumab, a novel next-generation CSF-1R mAb with a potentially best-in-class profile, has demonstrated substantial clinical activity in earlier clinical work in TGCT [2], with an objective response rate (ORR) of 71%, rapid and robust tumour reduction, a long duration of effect, significant improvements in functional ability, good tolerability and a manageable safety profile. The Phase 3 TANGENT trial will assess its safety and efficacy in patients with localized and diffuse TGCT.

For the full press release, please see SynOx Hercules Financing Release

References

  1. Lin F, et. al. JHEOR, 2022.
  2. Cassier et al. “Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour” European Journal of Cancer 141:162-170, 2020

SynOx Therapeutics announces $75m Series B round to fund Phase 3 trial of potential best-in-class treatment for TGCT

  • 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

 Dublin, Ireland and Oxford, UK, 22 April 2024: SynOx Therapeutics Limited (“SynOx” or the “Company”), the late-stage clinical biopharmaceutical company, is pleased to announce the close of a $75m Series B financing. The financing was co-led by Forbion, HealthCap and new investor Bioqube Ventures.

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 50% of patients with diffuse disease experience tumour recurrence within three years of surgery1..

Emactuzumab is a novel, next-generation CSF-1R mAb with a potentially best-in-class profile.  In earlier clinical work in TGCT2. emactuzumab demonstrated substantial clinical activity with an objective response rate (ORR) of 71%, rapid and robust tumour reduction, a long duration of effect, and significant improvements in functional ability. Importantly, these studies also indicated that emactuzumab has good tolerability and a manageable safety profile. SynOx is initiating a Phase 3 trial (TANGENT) to assess the efficacy and safety of emactuzumab in patients with localized and diffuse TGCT.

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.”

For the full press release, please see SynOx Series B Press Release.

References

  1. Lin F, et. al. JHEOR, 2022.
  2. Cassier et al. “Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour” European Journal of Cancer 141:162-170, 2020

Emactuzumab designated as an Orphan Medicinal Product in Europe

  • TGCT is a debilitating disease that often impacts patients in the prime of their life
  • Designation to include both localized and diffuse forms of the disease

Dublin, Ireland, 31 August 2022: SynOx Therapeutics Limited (“SynOx” or the “Company”), the late-stage clinical biopharmaceutical company, announces a regulatory update on emactuzumab, in development for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other diseases. The European Medicines Agency (EMA) has designated emactuzumab as an orphan medicinal product in the indication of TGCT for both localized and diffuse types of the disease.

TGCT is a rare, chronically debilitating disease affecting the synovium, tendon sheaths and bursa membranes, primarily of knee, hip and ankle joints. It causes loss of function of the affected joints, pain, stiffness and limited range of motion. TGCT has an incidence of 43 cases per million patient years, of which 4 per million patient years relate to diffuse TGCT1. No systemic treatments have been approved for TGCT in the EU. Most patients receive surgical intervention, with a post-surgery recurrence rate of up to 50%2.

Emactuzumab is a novel monoclonal antibody inhibiting CSF-1R that offers a short course of treatment. Phase I/II studies indicated good tolerability and a manageable safety profile and substantial preliminary efficacy in TGCT patients with rapid, robust tumour reduction and durable response.

SynOx is planning a phase III trial (TANGENT) to assess the efficacy and safety of emactuzumab in patients with localized or diffuse TGCT where surgical removal of the tumour is not viewed as an option. More details can be found on www.clinicaltrials.gov (with trial identifier NCT05417789) and at www.tangentstudy.com.

Ray Barlow, Chief Executive Officer of SynOx, said: “We have made significant progress in the development of emactuzamab in TGCT in the last 12 months. The positive opinion regarding the orphan drug designation marks an important step in SynOx’s continuing journey to provide a potential therapeutic option for patients with this debilitating disease. We are now recruiting patients on to our phase III registrational trial (TANGENT) and look forward to providing an update on progress in the near future.”

References

  1. (Mastboom MJL et. al. Acta Orthopaedica 2017 2017; 88 (6): 688-694)
  2. (Lin F, et. al. JHEOR, 2022).