Part of Adaptimmune Ltd.
Clinical Trials
38
15 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
13
34.2%
Available
1
2.6%
Completed
7
18.4%
Enrolling By Invitation
1
2.6%
Not yet recruiting
1
2.6%
Recruiting
7
18.4%
Terminated
7
18.4%
Withdrawn
1
2.6%
No approval data available
- Storm Therapeutics raised $56 million in Series C funding from investors including Pfizer Ventures, Taiho Ventures, and Fast Track Initiative to advance STC-15, a first-in-class METTL3 inhibitor. - The company has dosed the first patient in a Phase II monotherapy study evaluating STC-15 in select sarcoma subtypes, with plans for a combination study with toripalimab. - STC-15 demonstrated durable tumor regression across multiple sarcoma subtypes in Phase I trials by targeting METTL3, an RNA-modifying enzyme critical for cancer stem cell differentiation. - The Phase II study is designed to support a potential accelerated regulatory approval pathway for STC-15 and establish foundation for development in additional oncology indications.
- FDA orphan drug designation provides pharmaceutical companies with tax credits, market exclusivity, and reduced fees to offset high development costs for small patient populations. - Priority review vouchers for rare pediatric diseases have fetched prices as high as $150 million, creating substantial financial returns for reinvestment in research. - Patient advocacy groups provide essential firsthand insights that help shape drug development to better meet patient needs and accelerate therapeutic progress. - Both biotech companies and large pharmaceutical firms are increasingly focusing on rare diseases due to these regulatory incentives and growing recognition of unmet medical needs.
- Adaptimmune announced the sale of its FDA-approved cell therapy Tecelra and two late-stage assets to US WorldMeds for up to $85 million as the company faces substantial solvency concerns. - The transaction includes $55 million upfront with potential additional payments of $30 million based on regulatory and commercial milestones, while Adaptimmune will cut its workforce by 62%. - Tecelra became the first T cell receptor (TCR) therapy approved in the U.S. for synovial sarcoma in 2024, but generated only $4 million in first-quarter revenue against $29 million in R&D spending. - The deal represents a strategic retreat from commercial manufacturing for the struggling biotech, which retained only two preclinical T cell therapies after the asset sale.
- GlaxoSmithKline and Novartis have completed their $16 billion asset swap deal, with GSK exchanging its oncology portfolio for Novartis's vaccines business, while also creating a joint consumer healthcare venture. - Analysts question GSK's decision to exit oncology—a high-growth therapeutic area where its portfolio showed 32% growth in 2014—while Novartis is praised for strengthening its position in the lucrative cancer market. - The strategic realignment allows both companies to focus on core strengths, with GSK concentrating on respiratory, HIV, vaccines and consumer healthcare, while Novartis enhances its prescription medicine portfolio with particular emphasis on oncology.
- The FDA granted Breakthrough Therapy Designation to Adaptimmune's lete-cel for myxoid/round cell liposarcoma (MRCLS) treatment. - The designation is for patients who have undergone anthracycline-based chemotherapy and meet specific genetic criteria. - Lete-cel demonstrated a 43% overall response rate in MRCLS patients in the Phase II IGNYTE-ESO trial. - Adaptimmune plans to initiate a rolling Biologics License Application for lete-cel later this year, aiming for a 2026 market launch.
- Adaptimmune's lete-cel demonstrated a 42% response rate in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma in a Phase II trial. - The median duration of response was 18.3 months in synovial sarcoma and 12.2 months in myxoid/round cell liposarcoma, indicating a potential durable benefit. - Adaptimmune plans to submit a rolling Biologics License Application (BLA) to the FDA by the end of 2025, seeking approval for lete-cel in these sarcoma subtypes. - To support regulatory efforts, Adaptimmune is undertaking a cost-cutting initiative, including a workforce reduction, to prioritize key R&D programs.
- Adaptimmune's lete-cel met its primary endpoint in a Phase II trial for advanced or metastatic synovial sarcoma and myxoid/round cell liposarcoma (MRCLS). - The IGNYTE-ESO trial data showed a 42% response rate in patients treated with lete-cel, with median response durations of 18.3 months for synovial sarcoma and 12.2 months for MRCLS. - Adaptimmune plans to submit a Biologics License Application (BLA) to the FDA by the end of 2025, potentially expanding its sarcoma treatment portfolio. - The company's first FDA-approved therapy, Tecelra (afami-cel), targets metastatic synovial sarcoma, and lete-cel could increase the addressable market by 2.5 times.
- Adaptimmune's Lete-cel, a TCR-T cell therapy, demonstrated a 42% response rate in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. - The median duration of response was 12.2 months, with manageable side effects like cytopenias and cytokine release syndrome. - Adaptimmune plans to submit a rolling Biologics License Application (BLA) to the FDA by the end of 2025 for Lete-cel as a second-line therapy. - This follows Adaptimmune's recent FDA approval of afami-cel, marking a significant advancement in TCR-T cell therapy for solid tumors.
• Galapagos NV secured FDA IND clearance for GLPG5101, a CAR-T therapy, enabling U.S. patient recruitment for Phase II ATALANTA study in non-Hodgkin lymphoma. • The company is progressing over 15 programs, planning at least four IND-enabling studies in 2025, focusing on oncology and immunology. • Strategic collaborations with Blood Centers of America and Adaptimmune are expanding Galapagos' cell therapy manufacturing network and capabilities. • Galapagos maintains a strong cash position of EUR 3.3 billion, supporting its R&D efforts and business development opportunities in oncology and immunology.
- Adaptimmune's Tecelra, a novel therapy for synovial sarcoma, has received FDA approval and is poised to deliver its first patient orders, marking a significant advancement in cancer treatment. - Tecelra is the first therapy that modifies a patient’s own immune cells to target a solid tumor, offering new hope for treating this rare cancer. - Gemma Biotherapeutics is set to receive up to $100 million from Brazil’s health ministry to develop gene therapies for rare central nervous system disorders. - Pennsylvania is experiencing a surge in whooping cough cases, leading to increased masking requirements in some healthcare facilities like CHOP.
