First Patient In News
This week at a glance
At least a dozen first-patient-in milestones were announced between 30 September and 7 October, led by the first in vivo Prime Editing trial in Wilson disease and a new wave of dual-payload and bispecific ADCs out of China. Australia again proved the go-to launchpad for overseas sponsors, while Europe saw two companies, Orion and CHARM, become clinical-stage in biologics and AI-designed drugs. Each item below links to the full release.
United States News
Gene editing led the US week. On 5 October, Prime Medicine dosed the first patient in its global, first-in-human Phase 1/2 trial of PM577a, an in vivo Prime Editor for Wilson disease patients carrying the H1069Q mutation. It is the company's first in vivo Prime Editing study and the first test of its liver franchise; the trial will also assess whether patients can stop standard-of-care chelators or zinc. Read the full release. The same day, Lisata Therapeutics subsidiary Marea Therapeutics dosed the first patient in a Phase 2 trial of MAR002, a growth hormone receptor-blocking antibody for acromegaly that may allow dosing every two weeks instead of daily injections; about 72 patients will be enrolled across three dose arms (full story). In neurology, Jupiter Neurosciences dosed the first patient in its Phase 2a RESET trial of JOTROL in Parkinson's disease, a roughly 30-patient, 12-week placebo-controlled study sponsored by Georgetown University (full release). Oncology starts were also busy. Immunome dosed the first patient in a first-in-human Phase 1 trial of IM-3050, a FAP-targeted radioligand therapy for advanced solid tumours, and Maryland-based Immunomic Therapeutics, a US subsidiary of Korea's HLB, dosed the first participant in a Phase 1 trial of ITI-5000, a therapeutic vaccine for triple-negative breast cancer. Both are summarised on Business Wire's clinical trials newsroom.
China News
China's headline start this cycle was another next-generation ADC. On 30 September, Hangzhou-based Phrontline Biopharma dosed the first patient in its global, first-in-human Phase I/II study of TJ102, a bispecific FRα × CDH6 antibody-drug conjugate carrying two different payloads, aimed at ovarian and other solid tumours. The study runs under both a US FDA IND and a China NMPA clinical trial approval, the dual-filing model that is now standard for Chinese biotechs with global ambitions. Read the full release. Chinese sponsors are also increasingly choosing Australia for their first patient. Last month Adlai Nortye dosed its first patient in Australia with AN4035, a first-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor payload, alongside US FDA IND clearance and a planned NMPA filing (full release). Expect this China-to-Australia-to-US sequencing to keep appearing in these pages.
Japan, Korea and Hong Kong News
Japan and Korea were quieter this week, so we look at the most recent milestones. Daiichi Sankyo dosed the first patient in a global first-in-human Phase 1 trial of DS1025, a CD25-directed ADC for advanced or metastatic solid tumours, on 27 August (PharmaJapan). Korea's presence showed up in the US instead: HLB subsidiary Immunomic Therapeutics dosed the first participant with its TNBC vaccine ITI-5000 in Maryland, covered in the US section above. For sponsors choosing Asian sites, PharmaBoardroom's review of the region's trial hubs is worth reading. It notes Japan has scrapped the mandatory Japanese Phase I study, so sponsors can go straight to later-phase work with PMDA agreement. It also reports that HKU's Faculty of Medicine reached global first-patient-first-visit in a Novartis Phase 1/2 prostate cancer study in 77 days, ahead of every other site. Read the full analysis.
Australia News
Australia again hosted a US company's first patient. On 7 October, Boston-based Seaport Therapeutics dosed the first patient in a six-week Phase 2a trial in Australia of GlyphAgo, a prodrug of agomelatine, in adults with generalised anxiety disorder and sleep disturbance. Patients are randomised to 16 mg or 32 mg a day, with sleep measured by the Insomnia Severity Index and EEG; topline data are expected in early 2028. Read the full release. Among ASX-listed companies, Entropy Neurodynamics dosed the first patient in Cohort 2 of its Phase 2 binge eating disorder study, using a shortened 60-minute TRP-8803 infusion (Stockhead). PYC Therapeutics recently dosed the first patient in the open-label extension of its polycystic kidney disease study (Kalkine). Melbourne's Telix, meanwhile, dosed its first US patients with Pixclara, its now FDA-approved glioma PET agent; this is commercial use rather than a trial, but a milestone for an Australian sponsor in the US (full release).
Global and Europe News
Two European companies crossed into the clinic for the first time. Finland's Orion Pharma dosed the first patient in its BICIDES Phase 1/2 trial of ODM-216, a PVRIG × PD-L1 bispecific antibody for advanced solid tumours and the company's first biologic in humans (full release). London's CHARM Therapeutics dosed and fully enrolled the first cohort of its Phase I/II trial of CHM-029, an AI-designed menin inhibitor for AML, less than 24 months after first synthesis (full release). In immunology, Vial dosed the first patient in a Phase Ib asthma study of its IL-13 × TSLP bispecific, after five healthy-volunteer dose cohorts from 15 mg to 800 mg supported twice-yearly dosing (Clinical Trials Arena). Faron Pharmaceuticals dosed the first patient in BLAZE, an investigator-initiated Phase 1/2 trial pairing bexmarilimab with nivolumab in PD-1-resistant lung cancer and melanoma (full release).
What to watch
Bio Japan 2026 runs in Yokohama from 7 to 9 October, and BIX 2026 follows in Seoul from 28 to 30 October, both likely sources of new Asian trial-start news (Asia Business Daily). We will also be tracking Atom Therapeutics, which plans to start its US and global Phase 3 trials of lingdolinurad for chronic gout in Q4 2026 (full release). Have a first-patient-in milestone to share? Reply to this newsletter and we will consider it for next week's edition.
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