First Patient In News
We tracked seven first-patient-in milestones between 8 and 16 October. Antibody-drug conjugates led in the US, with first patients for ArriVent's dual-target ARR-002 and MacroGenics' MGC030, while Pelage started a 600-patient Phase 2/3 hair loss trial. Asia was busier than in recent weeks, with starts from Japan's Asahi Kasei, Singapore's Nuevocor and a new Phase III trial from China's Akeso. Australia had none, and in Europe Immunocore moved into autoimmune disease. At the end you'll find a summary of the trials that reached full enrollment this week. Each item links to the full release.
United States News
Antibody-drug conjugates dominated US starts. On 12 October, ArriVent BioPharma dosed the first patient in its US Phase 1 trial (NCT07755436) of ARR-002, a potential first-in-class tetravalent ADC that targets both MUC16 and NaPi2b with a site-specific vcMMAE payload. It is the second ADC from ArriVent's portfolio to reach the clinic, coming a week after its Phase 3 FURVENT lung cancer trial missed. Read the full release. On 15 October, MacroGenics dosed the first patient in a Phase 1 study of MGC030, a first-in-class ADC directed at an undisclosed target, in advanced solid tumors. Dose escalation will enroll up to 54 participants, and MGC030 is now the company's third ADC in active clinical development. Read the full release. Later-stage starts came from dermatology. On 14 October, Pelage Pharmaceuticals, a UCLA spin-out, dosed the first patient in AWAKEN, its Phase 2/3 trial of PP405, a topical gel designed to reactivate dormant hair follicle stem cells in androgenetic alopecia, the most common form of hair loss (BioSpace listing). The trial (NCT07819435) plans to enroll about 600 men aged 18 to 55, with a 24-week double-blind period followed by a long-term safety extension to week 52 (trial details).
Asia News
Japan led Asia's starts this week. On 8 October, Asahi Kasei Therapeutics, the global pharmaceutical business of Tokyo-based Asahi Kasei, dosed the first patient in a randomized, placebo-controlled Phase 2a trial (NCT07503561) of AIC468, an antisense oligonucleotide that blocks BK virus replication, in adult kidney transplant recipients. BK virus can cause nephropathy in up to 10% of kidney transplant recipients and has no approved antiviral treatment; the study is the first stage of a seamless Phase 2/3 program. Read the full release. Singapore's Nuevocor also dosed the first patient on 8 October in SUNBEAM-LMNA, a first-in-human Phase 1/2 trial (NCT07606274) of NVC-001, a one-time AAV9 gene therapy for LMNA dilated cardiomyopathy, one of the most aggressive inherited heart diseases. Nuevocor also announced FDA Fast Track designation for NVC-001, and the trial is running at US sites including Cedars-Sinai, Mayo Clinic and Brigham and Women's. Read the full story. In China, Hong Kong-listed Akeso dosed the first patient on 12 October in COMPASSION-40 (AK104-313), a Phase III trial of its PD-1/CTLA-4 bispecific antibody cadonilimab in resectable MSI-H/dMMR colon cancer. It follows Akeso's late-September start of COMPASSION-37, a global head-to-head Phase III trial of cadonilimab in advanced gastric cancer. Read the full story.
Australia News
We found no first-patient-in announcements from Australian sponsors or Australian sites between 8 and 16 October. The next one to watch is Melbourne's Arovella Therapeutics, which is screening patients at The Alfred Hospital for its first-in-human Phase 1 trial of ALA-101, a cell therapy for relapsed or refractory CD19-positive non-Hodgkin lymphoma and leukemia. Because the trial has a single dosing slot at the start, patients are screened one at a time, and Arovella now expects to dose its first patient towards the end of October. Read the full release.
Europe News
On 15 October, UK-based Immunocore dosed the first patient with type 1 diabetes in a first-in-human Phase 1 dose escalation trial (NCT07493122) of IMC-S118AI, its first candidate for autoimmune disease. The bispecific molecule is designed to calm the immune system only in the pancreas, protecting insulin-producing beta cells from T cell attack, and is being tested in HLA-A\*02:01-positive patients. It marks a move into autoimmunity for a company best known for its approved melanoma therapy. Read the full release. Just after the window, Warsaw's JJP Biologics dosed the first patients on 19 October in a European Phase 1b trial of nebaprubart, a potential first-in-class anti-CD89 antibody, in rheumatoid arthritis (full release).
What to watch
Arovella's first ALA-101 patient in Melbourne is due by the end of October. ESMO 2026 later this month will feature several Phase 3 readouts from Asian sponsors, including Akeso's ivonescimab and Innovent's IBI343 (full preview). Have a first-patient-in milestone to share? Reply to this newsletter and we will consider it for next week's edition.
Fully recruited
Six trials reached full or cohort enrollment this week. In the US, Aurion Biotech completed enrollment across all 12 sites of ASTRA, its pivotal Phase 3 study of the cell therapy AURN001 in corneal edema, ahead of a planned BLA (full story). On 14 October Rezolute said its pivotal Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism is fully enrolled, with topline data due in mid-December (full release). On 15 October, three more North American sponsors followed. Protara completed the 24-patient Phase 2b dose confirmation phase of THRIVE-3, testing IV Choline Chloride in patients on parenteral support (full release). Jasper completed the IgA nephropathy cohort of its Phase 2 basket study of vensobafusp alfa (full release), and Canada's Eupraxia reached its enrollment target in the RESOLVE study of EP-104GI in eosinophilic esophagitis (full release). In Europe, Vascudyne completed enrollment in its European feasibility study of a lab-grown coronary bypass graft, announced on 8 October at EACTS in Barcelona (full release). We found no enrollment completions from Asia-Pacific sponsors, including Australia, this week. Newron's 600-patient Phase 3 ENIGMA-TRS 1 schizophrenia trial, with sites in Europe and Asia, was guided to close around mid-October but had not been announced as of 13 October.
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