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ImmunoOncology

ASH: J&J’s Tecvayli Set For Stronger Competition With CAR-Ts In Myeloma

J&J's late-breaking Phase III MajesTEC-3 data at the American Society of Hematology meeting highlighted curative potential for the bispecific T-cell engager in multiple myeloma.

Phrontline’s Two-Pronged Shot At Bispecific, Dual-Payload ADCs

To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.

Next-Gen CAR-T Approaches Gain Spotlight At ASH

Next-gen CAR-T therapies showcased at the American Society of Hematology's annual meeting promise improved efficacy and safety, with Novartis, Gilead, and Kelonia advancing pivotal trials and exploring in vivo approaches.

Imvax Gets Positive Overall Survival Data From Phase IIb GBM Asset

The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.

Kelonia Draws Attention With In Vivo CAR-T Myeloma Data

The biotech will present data at the upcoming ASH meeting on three patients who achieved PRs or VGPRs with minimal residual disease negativity and no cases of neurotoxicity.

Biokin/BMS’s Iza-bren Hits First Phase III OS Endpoint, Albeit In China

Sichuan Biokin Pharmaceutical's BMS-partnered bispecific antibody-drug conjugate iza-bren had met both endpoints of PFS and OS in a China-only Phase III trial for the second-line treatment of esophageal squamous cell carcinoma.

Jazz Set To Expand Ziihera Market In Gastroesophageal Cancer

The company announced topline results from its Phase III trial in gastroesophageal adenocarcinoma and plans to seek US FDA approval in the first half of 2026.

Investors Shower Chinese In Vivo CAR-T Biotechs With Quick Cash

Byterna, Starna, Vivacta and DeliNova ride surging investor sentiment on in vivo CAR-T assets to secure venture funding.

enGene’s Detalimogene On Track For H2 2026 FDA Filing In NMIBC

The company announced data from patients enrolled after a protocol amendment designed to bring the study in line with non-muscle invasive bladder cancer (NMIBC) standards of care.

Henlius Heats Up PD-L1 ADC Playground As Pfizer Balks

Newly revealed data on HLX43’s recommended Phase II/III dose has boosted Henlius’s confidence to launch up to eight Phase III trials of the ADC in lung cancer. Phase III trials of the agent in more cancer types are also on the horizon.

ESMO 25: Higher Dosage For Kelun/Merck’s Sac-TMT Behind OS Win In China NSCLC Study

In a China-only Phase III trial, Sichuan Kelun-Biotech’s sac-TMT significantly cut the risk of death by 40% versus chemotherapy in the second-line treatment of non-squamous EGFR-mutated NSCLC. The ADC was administered at a higher dose than in Merck’s multiple Phase III trials of the same agent.

ESMO 25: IO Faces Difficult Pathway For Cylembio In Melanoma

The company presented detailed data at ESMO and said its Phase III trial might have reached statistical significance with a larger sample size.