Development
Akeso’s ivonescimab tops Imfinzi in fifth straight positive Phase III readout
A randomized Phase III trial in China has produced the first known overall survival superiority result over an anti-PD-(L)1 plus chemotherapy regimen in...
Ivonescimab Phase III PFS benefit gets peer-reviewed backing ahead of FDA decision
Publication of the global Phase III HARMONi trial data in The Lancet Oncology gives ivonescimab its first peer-reviewed, globally conducted evidence base...
CSPC's RSV vaccine clears FDA for US trials weeks after China approval
SYS6057, a recombinant respiratory syncytial virus (RSV) vaccine candidate developed by CSPC Pharmaceutical Group (HKEX: 01093), has received FDA clearance...
Basking's BB-025 rapidly reverses stroke thrombolytic in Phase I study
Phase I data from the Study of BB-025, Alone and After BB-031, in Healthy Volunteers show that BB-025, the oligonucleotide reversal agent for Research...
Apollo's pan-rhinovirus vaccine triggers cross-species T cell responses in Phase I trial
A single dose of APL-10456, an adjuvanted recombinant protein subunit vaccine targeting rhinovirus, induced broad cross-reactive T cell responses against...
Astellas pushes CLDN18.2 bispecific ASP2138 into Phase III
Astellas Pharma (TSE: 4503) has dosed the first patient in a Phase III trial of ASP2138, its subcutaneously administered CLDN18.2 × CD3 bispecific antibody,...
Antengene preps UCB-partnered CD19 bispecific TCE for first-in-human autoimmune testing in Oz
Australia has cleared ATG-201, Antengene Corporation Limited's (HKEX: 6996.HK) CD19 × CD3 bispecific T-cell engager (TCE), to enter first-in-human testing,...
Pfizer tests undisclosed immune-modulating asset across four autoimmune diseases
Pfizer (NYSE: PFE) has registered a Phase I/II clinical trial for PF-08154225, an immune-modulating agent of undisclosed mechanism, in patients with four...
Boehringer suspends Phase I trial of oral CNS drug after safety event
A Boehringer Ingelheim Phase I multiple rising dose trial evaluating the investigational oral CNS compound BI 3031185 has been suspended following a safety...
ACTG repurposes alendronate in bid to shrink latent HIV reservoir
The AIDS Clinical Trials Group (ACTG) is evaluating an osteoporosis treatment, a bisphosphonate approved for osteoporosis, as a latency-reversing agent in...
Moderna takes RSV/hMPV vaccine back to clinic after earlier pediatric hold
Moderna (Nasdaq: MRNA) has registered a Phase I study of mRNA-1365 (Profile 2), a bivalent mRNA vaccine targeting both respiratory syncytial virus (RSV) and...
Adaptin Bio opens first-in-human trial of brain-targeted EGFRvIII T cell engager
Enrollment has opened in a first-in-human Phase I trial of APTN-101, a bispecific T cell engager developed by Charlotte, North Carolina-based Adaptin Bio,...
Akeso advances third ADC into clinical trials with B7-H3-targeting AK157D1
China-based Akeso (HKEX: 9926.HK) has received clearance from China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) to...
Luye Pharma advances therapeutic mRNA vaccine into Phase II for HPV lesions
Luye Pharma Group (HKEX: 02186) is advancing its LY01620 mRNA vaccine into Phase II trials in China for HPV16-positive cervical high-grade squamous...
AC Immune's NLRP3 inhibitor reaches brain with safety intact in first human study
AC Immune SA (Nasdaq: ACIU) reported that its oral NLRP3 inflammasome inhibitor ACI-19764 was safe and well-tolerated across single and multiple ascending...
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