FDA lifted a clinical hold and cleared an IND for BEAM-201, allowing Beam Therapeutics to proceed with a clinical study of the multiplex silenced, allogeneic CAR T therapy targeting CD7 to treat relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. The agency had placed the hold in early August.
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Autolus announced its obe-cel met Phase 2 endpoint, reaching a $70 million milestone
CLINICAL AND REGULATORY
Nkarta reports 70% complete response in Phase 1 clinical study
Data from additional patients in the Phase 1 study of CAR NK cell therapy NKX019 from Nkarta suggest the allogeneic platform can lead to high response rates, but whether redosing will address durability concerns remains unanswered. The company reported that seven of the 10 large B cell lymphoma patients treated with a dose of at least 1 billion NK cells expressing a CD19-targeted CAR achieved a complete response, but three of the five patients who reached eight months of follow up progressed shortly after. The company is planning retreatment for the three patients with a 1.5 billion cell dose.
Setbacks at ASH for γδ T cell therapies from Adicet and Lava
A pair of setbacks at ASH conference from Adicet Bio and Lava Therapeutics suggest the durability question for γδ T cell therapies hasn’t been resolved, and may span multiple modalities involving the cell type. Though Adicet’s allogeneic γδ T cell therapy ADI-001 led to impressive response rates in a Phase 1 study, including a 100% complete response rate in the five patients who previously relapsed on prior CAR T cell therapy for large B cell lymphoma, only two of nine treated patients with at least six months of follow up continued in complete response through six months. In a separate Phase 1 study, LAVA-051, a bispecific antibody from Lava targeting a γδ T cell receptor chain and the CD1d tumor antigen expressed on hematological malignancies, two of the 12 heavily pretreated patients remain on treatment five months into the study.
Affimed data lead company to focus on innate engager/NK cell combo
ASH results from Affimed showing higher efficacy for its innate cell engager-conjugated NK cell therapy than for the engager alone are supporting the company’s move to prioritize the combination candidate. Across 31 Hodgkin lymphoma patients and four NHL patients treated at the recommended Phase 2 dose, the CD30-targeting Fc receptor engager AFM13 pre-complexed with allogeneic NK cells showed a 94% ORR, with complete responses in 71% of patients, 63% of whom maintained a complete response at six months. The monotherapy showed an ORR of 32%, a complete response rate of 10% and PFS of 3.5 months in 108 patients with relapsed/refractory peripheral T cell lymphoma.
DEALS AND FINANCING
Autolus proposes heavily discounted follow-on after obe-cell meets in Phase 2
Autolus Therapeutics completed a follow-on after announcing that obecabtagene autoleucel (obe-cel; AUTO1) met the primary endpoint of the pivotal Phase 2 FELIX trial to treat acute lymphoblastic leukemia. Obe-cell, an anti-CD19 CAR therapy, demonstrated an ORR of 70% in an interim analysis of 50 patients with relapsed/refractory disease and a 3% rate of grade three or higher cytokine release syndrome – lower than the 26% for Tecartus brexucabtagene autoleucel from Gilead. The company also announced that it will now receive $70 million in milestone payments from Blackstone Life Sciences as part of a deal struck last year. With these positive news, Autolus raised $150 million in public offering, selling 75 million shares at $2 per share, which is unsual 33% discount compared to $3 per share price traded day prior the announcement.
