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- Christopher Hill has been appointed as both CEO and CFO of Adaptimmune, succeeding Adrian Rawcliffe who departed as part of the company's restructuring efforts. - The company's board has been significantly reduced to three members following the resignation of six directors, with Lawrence Alleva taking over as Chairman from David Mott. - Adaptimmune voluntarily delisted from Nasdaq in October 2025 and is now trading on the OTC Pink market, with deregistration expected to become effective around January 26, 2026. - The restructuring follows the July 2025 divestiture of TECELRA and other key cell therapy assets to US WorldMeds, leaving Adaptimmune to focus on maximizing value from remaining PRAME and CD70-targeted programs.
- 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.
• Norgine has submitted a marketing authorization application to the EMA for eflornithine to treat high-risk neuroblastoma (HRNB). • The application follows prior submissions in Australia, Switzerland, and the United Kingdom under Project Orbis. • Eflornithine is intended as an oral maintenance therapy to reduce relapse risk in pediatric and adult HRNB patients. • FDA approved eflornithine in December 2023 based on trials showing improved event-free and overall survival.
• Orbus Therapeutics' eflornithine combination with lomustine did not meet the primary endpoint of overall survival in the Phase III STELLAR trial for recurrent IDH mutant astrocytoma. • The combination therapy showed clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to lomustine alone. • The STELLAR trial involved 343 patients and the combination therapy was well-tolerated, with common adverse events related to myelosuppression and hearing impairment. • Eflornithine, which blocks ornithine decarboxylase, previously received FDA orphan drug and breakthrough designations for anaplastic glioma.
• Eflornithine (DFMO) receives FDA approval for neuroblastoma treatment, marking a significant milestone in pediatric oncology. • Clinical trials show DFMO reduces relapse rates in neuroblastoma patients from 50% to 15% when used as maintenance therapy. • The development and trials of DFMO were largely funded by families of children affected by neuroblastoma, highlighting community support. • DFMO, initially an antiparasitic drug, has been found to suppress the MYCN gene, which drives neuroblastoma, offering a novel treatment approach.
• The FDA has approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB). • The approval is for patients who have achieved at least a partial response to prior multi-agent, multimodality therapy, including anti-GD2 immunotherapy. • Efficacy was demonstrated in an externally controlled trial, showing a significant improvement in event-free survival (EFS) and overall survival (OS). • Common adverse effects included otitis media, diarrhea, cough, and hearing loss, but the drug's manageable safety profile supported its approval.
• The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 14-6 in favor of eflornithine to reduce relapse risk in pediatric high-risk neuroblastoma patients. • The vote was based on data from Study 3b, a single-arm trial with an external control arm from the ANBL0032 trial, showing improved event-free survival. • Eflornithine's safety profile includes manageable toxicities like hearing loss, with dose adjustments potentially mitigating adverse effects. • While some panel members expressed concerns about using an externally controlled trial, the overall consensus was that the benefits outweigh the risks.
