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Juno Ends JCAR015 Development In ALL, Cementing Third Place CAR-T Position

 
• By Mandy Jackson

Juno and partner Celgene closed the ROCKET study for JCAR015, which has been on clinical hold since November, and ended development in ALL in favor of its new and improved CD19-targeting CAR-T therapies.

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Juno Therapeutics Inc. has ended development of its CD19-targeting chimeric antigen receptor T-cell (CAR-T) therapy JCAR015 for the treatment of acute lymphoblastic leukemia (ALL) due to safety concerns, answering with certainty the question of whether the company could catch up to its competitors, which will be seek approvals for their CAR-T therapies any day now.

Juno said on March 1 in its fourth quarter and year-end 2016 earnings report that the company and its partner Celgene Corp. ended the pivotal ROCKET clinical trial that had been placed on clinical hold multiple times due to severe neurological side effects and patient deaths. The company will focus its efforts in ALL on its defined cell technology instead, including the CD19-targeting JCAR017, which it has been promoting as better and safer than JCAR015 since the first ROCKET clinical hold

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First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 
• By Alaric DeArment

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

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Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

Lilly And Alchemab Tap Into Resilient Individuals To Develop ALS Drug

 
• By Andrew McConaghie

The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.