FDA approved Blincyto in CD19-positive Philadelphia chromosome-negative B-ALL

CLINICAL AND REGULATORY 

FDA approved Blincyto in CD19-positive Philadelphia chromosome-negative B-ALL 

The approval marks the third indication for BLINCYTO and is based primarily on the Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that Blincyto added to multiphase consolidation chemotherapy showed superior OS versus chemotherapy alone. The 3-year OS was 84.8% in the Blincyto plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm and 62.5% in the chemotherapy arm. 

Odronextamab recommended for EU approval by CHMP to treat follicular lymhpoma and DLBCL 

Regeneron announced that the EMA’s CHMP has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The European Commission is expected to announce a final decision in the coming months. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. In a pooled safety population, the most common serious adverse reactions were cytokine release syndrome, pneumonia, COVID-19 and pyrexia. The EMA previously granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not been approved by any regulatory authority. Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. 

DEALS AND FINANCING 

Ipsen and Marengo announced partnership to advance T cell engagers from TriSTAR platform 

Ipsen and Marengo announced the expansion of their ongoing oncology research partnership, to include TriSTAR, Marengo’s next-generation, precision T cell engager (TCE) technology. Traditional TCEs targeting ‘cold’ tumors have limited efficacy due to poor T cell quality and exhaustion. Marengo’s proprietary first-in-class TriSTAR TCEs have the potential to overcome these limitations, redirecting a new and expanded pool of highly activated memory Vβ T cells to the tumor. The teams will focus on exploring potential in ‘cold’ tumors which typically fail to trigger a strong immune response when treated with TCEs. Ipsen will assume responsibility for all activities following development candidate nomination. Marengo will receive an upfront payment and potential payments up to a total of $1.2 billion if all milestones are met in addition to tiered sales royalty payments. 

Bright Peak Therapeutics announced $90 million in Series C to advance immunoconjugates 

Bright Peak Therapeutics announced that it raised $90 million in a Series C. The round was led by JJDC, with participation from additional new investors Venrock, KB Investment, and Northleaf Capital Partners. Existing investors participating in the round include founding investor Versant Ventures along with Fidelity Management & Research Company, RA Capital Management, Qatar Investment Authority, Invus, Alexandria Venture Investments, and an undisclosed leading healthcare investment fund. Proceeds from the Series C financing will be used to advance BPT567 into a Phase 1/2a clinical trial and accelerate a pipeline of next-generation immunotherapies. BPT567 is a first-in-class PD1-IL18 immuno-conjugate designed to provide simultaneous blockade of the PD-L1 checkpoint pathway and targeted delivery of IL-18 signaling. In preclinical models, BPT567 induced profound synergistic anti-tumor activity by blocking PD-1 and specifically targeting the potent proinflammatory effects of IL-18 to effector T cells in the tumor microenvironment with more limited activation of immune cells in the periphery.