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BioWorld - Thursday, December 11, 2025
Home » Topics » Clinical, BioWorld Asia

Clinical, BioWorld Asia
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Brain with clock hands, day and night background

Takeda phase IIIs win; Street still wants a visual on narcolepsy

July 15, 2025
By Randy Osborne
No Comments
Takeda Pharmaceutical Co. Ltd.’s dual phase III victories in narcolepsy type 1 (NT1) with oral orexin receptor 2 (OX2R)-selective agonist oveporexton (also known as TAK-861) had Wall Street mulling what the outcome might mean for others trying the mechanism of action, and questions linger about side effects on eyesight.
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3D rendering of CAR T therapy in cell

Imugene’s allogeneic CD19 CAR T sees 75% response rate

July 15, 2025
By Tamra Sami
No Comments
Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma patients, according to an interim analysis. The responses to date show a 75% overall response rate.
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Digital lungs illustration

Bioversys, Shionogi in CHF529M lung infection collaboration

July 8, 2025
By Nuala Moran
No Comments
Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
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Man using walker with assistance

Taiho’s pizuglanstat fails in phase III DMD trial

July 8, 2025
By Tamra Sami
No Comments
In yet another fail for the Duchenne muscular dystrophy (DMD) field, Taiho Pharmaceutical Co. Ltd.’s pizuglanstat (TAS-205) did not meet the primary endpoint in a phase III trial. The phase III Reach-DMD trial, a randomized, placebo-controlled, double-blind and open-label, extension study of pizuglanstat in patients with DMD showed no significant difference in the mean change from baseline to 52 weeks in the primary endpoint of time to rise from the floor in the ambulatory cohort of the study.
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Xia Jin, CEO and co-founder of Immuno Cure, and Dan Mallon, senior vice president of corporate development for Pharmajet

Immuno Cure, Pharmjet partner on needle-free HIV vaccine trial

June 24, 2025
By Tamra Sami
No Comments
Immuno Cure Biotech Ltd. is collaborating with Pharmajet Inc. to evaluate the safety and immunogenicity of its HIV therapeutic DNA vaccine, Icvax, delivered via Pharmajet's innovative Tropis needle-free injection system.
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Robert Paris, vice president, Moderna
Global Vaccine Forum 2025

Moderna expands mRNA tech to latent viruses, cancer, rare disease

June 24, 2025
By Marian (YoonJee) Chu
No Comments
Post pandemic, Moderna Inc. is broadening the applications of mRNA technology to cancer, rare diseases, latent viruses and respiratory viruses, “taking advantage” of the revenue generated by Spikevax (elasomeran), its mRNA-based vaccine for COVID-19.
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Red and blue bispecific antibodies

3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

June 17, 2025
By Marian (YoonJee) Chu
No Comments
3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
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Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 10, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
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Xiaolin Zhang, CEO, Dizal
ASCO 2025

Dizal's new chemical entities for lung, blood cancers

June 10, 2025
By Tamra Sami
No Comments
Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s LYN/BTK dual inhibitor, DZD-8586, saw tumor shrinkage in 94.1% of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma following Bruton's tyrosine kinase inhibitors, the company reported during an oral presentation at the American Society of Clinical Oncology (ASCO) 2025 conference.
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Daiichi and Merck pull accelerated approval BLA for ADC

June 3, 2025
By Lee Landenberger
No Comments
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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