Phase I
With the antibody drug conjugate market projected to hit $28 billion by 2028, some companies are looking to harness the drugs for immunotherapy.
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
After back-to-back failures in 2021, Wave Life Sciences has finally aced a Phase Ib/IIa Huntington’s disease trial and is looking to a potential accelerated approval for its investigational antisense oligonucleotide.
Zealand Pharma’s petrelintide cut body weight by more than 8% on average, with a good overall safety and tolerability profile.
Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein.
National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents.
The hold on BioNTech and MediLink’s antibody-drug conjugate candidate BNT326/YL202 has halted enrollment in a Phase I U.S. trial in patients with non-small cell lung cancer or breast cancer, following multiple deaths.
Biomea Fusion’s early-stage investigational diabetes treatment BMF-291 has been slapped with a full FDA clinical hold on its Phase I/II trials due to concerns over liver toxicity.
LSD, ketamine, ibogaine and related treatments are moving forward in clinical trials for substance use disorders, including alcohol use disorder and opioid use disorder.
Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
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