Cell therapy weekly: T-cell therapy for post-transplant lymphoproliferative disease receives Priority Review
This week: The US Food and Drug Administration (FDA; MD, USA) grants Priority Review to Atara Biotherapeutics’ (CA, USA) Biologics License Application (BLA) for tabelecleucel (tab-cel®), Vertex Pharmaceuticals (MA, USA) licenses Orum Therapeutics’ (Daejeon, South Korea) technology to develop novel conditioning agents and AffyImmune (MA, USA) appoints a new President and CEO.
The news highlights:
- FDA grants Priority Review to Atara’s T-cell therapy for post-transplant lymphoproliferative disease
- Vertex licenses Orum’s technology to develop novel conditioning agents
- AffyImmune appoints new President and CEO
FDA grants Priority Review to Atara’s T-cell therapy for post-transplant lymphoproliferative disease
The US FDA has accepted a BLA and granted Priority Review to Atara Biotherapeutics’ allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy, tab-cel. Tab-cel is indicated for the treatment of patients with EBV positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
“The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the US,” said Pascal Touchon, President and CEO of Atara. “The FDA’s granting of priority review highlights the high unmet need in [EBV positive post-transplant lymphoproliferative], which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the US in early 2025, along with the potential label expansion multicohort Phase II EBVision trial.”
Vertex licenses Orum’s technology to develop novel conditioning agents
Orum Therapeutics has granted Vertex rights to use its Dual-Precision Targeted Protein Degradation (TPD²®) technology to develop novel targeted conditioning agents to prepare patients to receive gene editing treatment.
Orum will receive US$15 million upfront under the terms of the global, multi-target license and option agreement. The company is also eligible to receive up to US$310 million in additional option payments and milestones, in addition to royalties on future global annual net sales.
“Vertex is a leader in discovering and developing innovative medicines, including being the first to receive FDA approval of a CRISPR/Cas9 gene-edited therapy, and we are pleased they’ve selected Orum’s TPD² technology to discover novel targeted conditioning agents,” said Sung Joo Lee, CEO and founder of Orum Therapeutics. “This agreement with Vertex creates the potential to treat patients in a novel indication space with our leading targeted protein degradation approach for an exciting new therapeutic class of degrader-antibody conjugates.”
AffyImmune appoints new President and CEO
AffyImmune has announced the appointment of Daniel Janse as President and CEO.
“We are thrilled to welcome Dr Janse as the new CEO of AffyImmune,” said Simone Song, Founding Partner of ORI Capital (Hong Kong) and Board Director at AffyImmune. “His extensive experience in the biotech industry and his proven leadership in driving innovation and strategic growth make him the ideal executive to lead AffyImmune into its next phase of growth. We have full confidence in his ability to advance our mission of bringing CAR-T cell therapies to patients with solid tumors.”
The clinical-stage biotechnology company is developing a first-in-class intercellular adhesion molecule 1-targeting CAR-T therapy for solid tumors. AffyImmune’s proprietary technology utilizes lymphocyte function-associated antigen 1 on the surface of the CAR-T cells to target and bind intercellular adhesion molecule 1 on the surface of cancer cells. The company’s lead candidate, AIC100, is in Phase I trials for patients with advanced thyroid cancers.
