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6 stories mentioning ASX:SPLUpdated 22d ago

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Asia

Starpharma Completes Manufacturing of HER2-Positive Cancer Therapy Candidate Precursor Ahead of First-in-Human Trial

Starpharma Holdings (ASX:SPL) completed the GMP manufacturing of the DEP HER2 precursor dendrimer during the June quarter, supporting the first-in-human first phase clinical study commencement in the second half of the year, according to a Wednesday Australian bourse filing.It completed the preclinical data package for DEP HER2-lutetium, its proprietary radiopharmaceutical therapy candidate for patients with advanced HER2-positive cancers.It is working with the selected lead clinical trial site in Europe to finalize the study procedures and logistics.Its shares fell 2% in recent trading on Wednesday.

ASX:SPL
Asia

Starpharma Holdings to Raise AU$32 Million Via Entitlement Offer; Shares Down 3%

Starpharma Holdings (ASX:SPL) will issue about 56 million new shares at a price of AU$0.57 each under a fully underwritten pro rata entitlement offer to raise gross proceeds of about AU$32 million, according to a Wednesday filing with the Australian bourse.The new shares will be offered on a 1-for-7.5 pro rata basis to eligible shareholders of record as of July 20, per the filing.Proceeds from the offer will support the development of the company's oncology assets and extend its cash runway into fiscal 2028.Starpharma shares fell 3% in recent Wednesday trade.

ASX:SPL
Asia

Starpharma Says Radiopharm Theranostics Collaboration Milestone Triggers AU$500,000 Option Fee

Starpharma Holdings (ASX:SPL) achieved a milestone under its collaboration with Radiopharm Theranostics (ASX:RAD), triggering an AU$500,000 option fee payable to Starpharma, according to a Friday filing with the Australian bourse.The milestone advances the collaboration into an option period during which Radiopharm may take an exclusive license to Starpharma's proprietary DEP dendrimer technology for a radiopharmaceutical asset.If Radiopharm exercises that option, Starpharma will be eligible to receive up to AU$91 million, including an upfront payment and various milestone payments, in addition to royalties on net sales, per the filing.

ASX:RADASX:SPL
Asia

Starpharma Holdings Reports 'Encouraging' Preclinical Anti-Tumor Activity for Radiotherapy Candidate

Starpharma Holdings (ASX:SPL) said its DEP HER2-targeted radiotherapy candidate showed "encouraging anti-tumor activity" in support of a planned first-in-human phase one clinical study in the second half of the year, according to a Thursday filing with the Australian bourse.In preclinical HER2-positive cancer models, the radiotherapy candidate demonstrated "strong" tumor uptake and retention, low kidney accumulation, and short blood circulation time, the company said.The candidate also showed a statistically significant survival benefit, with the effects comparable to the already approved Enhertu cancer drug in those models, per the filing.Phase one preparations are well advanced, and feedback from drug regulators supports the proposed development pathway, Starpharma said.The company's shares gained 1% in recent Thursday trade.

ASX:SPL
Asia

Starpharma Holdings Files Patent Application for DEP Technology in Radioligand Therapy; Shares Gain 4%

Starpharma Holdings (ASX:SPL) submitted a new patent application to support the use of its proprietary DEP technology in radioligand therapy, according to a Thursday filing with the Australian bourse.The application follows "encouraging preclinical findings" across multiple oncology targets, where the DEP radiopharmaceutical platform showed improved biodistribution, enhanced tumor uptake and retention, and reduced off-target accumulation, the company said.Starpharma is considering partnership opportunities with specialist radiopharmaceutical and oncology firms to leverage the technology.The company's shares gained 4% in recent Thursday trade.

ASX:SPL
Asia

Starpharma Says US FDA Supports First-in-Human Study of Cancer Radiotherapy Candidate; Shares Gain 7%

Starpharma Holdings (ASX:SPL) has received positive feedback from the US Food and Drug Administration (FDA) on the proposed design of its first-in-human phase 1 clinical study of the DEP HER2 radiotherapy candidate, according to a Tuesday filing with the Australian bourse.The company is developing the candidate to treat certain gastric/gastro-oesophageal junction cancers and other advanced cancers in patients who have previously received targeted therapy.The US FDA feedback supports plans to launch the phase one study, which is on track to begin in the second half of the year.The FDA also confirmed that the radiotherapy candidate is targeting a population with a significant unmet medical need, indicating the potential for a fast-track designation or other accelerated development pathways, Starpharma said.The company's shares were 7% higher in recent Tuesday trade.

ASX:SPL

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