CLINICAL AND REGULATORY
FDA approves Breyanzi as second line therapy for B cell lymphoma; EMA reviewing
Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. Breyanzi is a CD19-directed CAR T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is also now under review by EMA.
FDA lifts clinical hold on Legend’s CAR-T therapy LB-1901
FDA has lifted its clinical hold on Legend’s investigational CAR-T cell therapy LB1901, which targets malignant CD4+ T-cells, and is intended for the treatment of adult patients with relapsed or refractory T-cell lymphoma. The agency placed the clinical hold in February after a low CD4+ T-cell count was reported for the first patient dosed in the phase 1 study.
Precision’s allogeneic CAR T efficacy builds, along with safety questions
Precision Bio reported improved response rates and durability data from a Phase 1/2 study of its lead allogeneic CAR T cell candidate, PBCAR0191, since it last reported results at ASH conference in December. However, the company also reported two new deaths in the study, which it believes were caused by neurotoxicity associated with the therapy’s fludarabine pre-conditioning regimen. Precision Bio said the OS rate was a 100% among 11 evaluable patients with DLBCL in the updated dataset. Eight of the 11 patients (73%) achieved a complete response. The responses would be impressive in any patient group but are particularly notable because the study is evaluating the CD19-targeted CAR T cell therapy in patients who have relapsed after prior CD19 CAR T cell therapy. The 11 patients, who were in two dose cohorts, had a median of five prior lines including the CAR T. Precision’s early data also suggest possible durability of response, which has been a challenge for allogeneic cell therapies. Of the six patients with at least six months of follow up, three (50%) were still in response. In the study, 70% of patients had progression-free survival of greater than 2 months. Median PFS for standard of care in CAR T-relapsed patients is one to two months. Initial data from those patients were presented at ASH.
DEALS AND FINANCING
Galapagos to acquire CellPoint to boost access to next generation cell therapies
Galapagos gained the decentralized cell therapy platform of CellPoint, following its acquisition. Galapagos paid $132 million for CellPoint, with an additional $105 million to be paid upon achievement of certain milestones, to gain its CAR T therapy technology. The company has a six-day manufacturing process and a deal with Lonza Group. Its CD19 CAR T therapy is in Phase 1/2a testing.
Immatics and Editas partner to apply CRISPR to gamma-delta T cells
Immatics and Editas Medicine entered a strategic research collaboration to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer. Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property. By combining Editas’ gene editing technology with Immatics’ ACTallo allogeneic, off-the-shelf adoptive cell therapy platform based on gamma-delta T cells, gamma-delta T cells can be redirected to cancer cell targets with the goal of creating cells with enhanced tumor recognition and destruction.
Tessa raised $126 million in Series A financing to advance its cell therapies
A new $126 million series A round will recapitalize Singapore-based Tessa Therapeutics as it advances a pipeline of cell therapies, including one headed into a pivotal study. Polaris Partners led the round alongside prior investors Temasek, EDBI, Heliconia Capital and Heritas Capital. The biotech had raised at least $130 million during 2017-18, but has shifted focus to its current programs. They include autologous CD30-targeting CAR T therapy TT11, which has led to responses in a Phase 2 trial, and allogeneic therapy TT11X, which is in Phase 1 testing and uses the company’s virus specific T-cells augmented with a CD30-targeting CAR.