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A tale of two markets for Chinese groups

1 week ago | oncologypipeline.com | Madeleine Armstrong

While Duality Biologics defied turbulent markets to float on the Hong Kong stock exchange and double its share price on Tuesday, rumours are swirling again that Chinese companies could be delisted from US exchanges. Trouble has been brewing since 2020, with passage of the US Holding Foreign Companies Accountable Act, which focused on companies audited in foreign jurisdictions inaccessible to the Public Company Accounting Oversight Board.
J&J has a long Rybrevant road ahead

1 week ago | oncologypipeline.com | Madeleine Armstrong

For the first time, Johnson & Johnson has split out sales of Rybrevant – kind of. In its first-quarter earnings on Tuesday, the company disclosed revenues for the anti-EGFR x cMet bispecific, but only alongside its oral EGFR-TKI Lazcluze. Sales of the combo, which is approved for first-line EGFR-mutated NSCLC, totalled $327m in 2024. Presumably Rybrevant revenues are negligible in its other indications, NSCLC with EGFR exon 20 insertions, and alongside chemo in second-line EGFR-mutated NSCLC.
Ideaya upsizes neoadjuvant darovasertib plans

1 week ago | oncologypipeline.com | Madeleine Armstrong

Last September Ideaya Biosciences revealed phase 3 plans for its lead project darovasertib in neoadjuvant uveal melanoma, and now the group has disclosed that the study, due to start this half, will seek to enrol 520 patients rather than its previous estimate of 400. As expected, the trial will involve two cohorts: patients undergoing enucleation (removal of the eyeball) or brachytherapy (localised radiotherapy).
Crispr’s Car-T crunch time

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

The group could soon provide clarity on CTX112’s regulatory path. Over two years ago Crispr Therapeutics turned away from its first generation of allogeneic Car-Ts in favour of similarly acting but supposedly better projects. Soon, the company will have more data on the next-gen assets, along with news on the regulatory path forward for one, the CD19-targeting CTX112. But Crispr’s star has been waning, with its stock currently at five-year lows.
Tempest folds in the storm

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

Last year Tempest Therapeutics was talking up plans for a phase 3 trial of its PPAR⍺ antagonist amezalpat despite a lack of cash; now the group has had to face reality. Tempest said on Wednesday that it was “exploring strategic alternatives” after failing to find funds for the 700-patient study, which is listed on clinicaltrials.gov with a start date of 29 March, but is described as not yet recruiting.
MAIA throws more money at ateganosine

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

The THIO-104 study listing is live, along with questions about funding the trial. MAIA Biotechnology has become the latest biotech to push into phase 3 despite dwindling cash. A recent listing on clinicaltrials.gov shows a pivotal trial of its telomere-targeting project ateganosine set to begin in July. If all goes to plan the new study, THIO-104, in third-line NSCLC, could confirm a possible future accelerated approval based on the ongoing phase 2 THIO-101 study.
Bristol seeks another celmod use

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

Golcadomide will begin a new pivotal trial in follicular lymphoma. As the first pivotal readouts approach for Bristol Myers Squibb’s “celmod” projects the company will start another phase 3 trial of one of its contenders in the coming months, a recent clinicaltrials.gov listing reveals. The new study, Golseek-4, will test golcadomide in second-line follicular lymphoma, adding to the ongoing Golseek-1 trial in first-line large B-cell lymphoma.
Imunon looks for an IL-12 Ovation

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

The company will soon start a pivotal trial of its IL-12 gene therapy, but cash is short. Imunon is pushing into phase 3 with its IL-12 gene therapy IMNN-001, a recent clinicaltrials.gov listing has revealed – although there are questions about how the microcap will fund the study. Imunon had just $5.9m at the end of 2024, only enough to get it into late June.
J&J’s Rybrevant goes subcutaneous in Europe

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

Johnson & Johnson’s subcutaneous Rybrevant was knocked back by the FDA last December on manufacturing issues, but the EU regulator didn’t have similar qualms. The EC on Monday greenlit the subcutaneous version as monotherapy in post-platinum NSCLC with EGFR exon 20 insertions, and alongside Lazcluze in first-line EGFRm NSCLC.
DualityBio tries to float again

2 weeks ago | oncologypipeline.com | Madeleine Armstrong

The group expects to raise nearly $170m. After attempting to go public on the Hong Kong stock exchange last year, Duality Biologics is trying again – although the group has picked a tough time, as world markets reel from President Trump’s tariff announcement last week. DualityBio’s IPO document reveals that the Chinese group anticipates net proceeds of HK$1.31bn (around $168m), based on a price of HK$94.60 per share, at the low end of a range that could go as high as HK$103.20 per share.