Aktis takes a second asset into human trials
The recent Nasdaq entrant prepares to move AKY-2519 into the clinic.
The recent Nasdaq entrant prepares to move AKY-2519 into the clinic.
Aktis Oncology, a biotech that braved financial turmoil to complete an upsized Nasdaq flotation to bring in $318m in January, is preparing to take its second pipeline project into clinical trials.
This asset is a B7-H3-targeting radiopharmaceutical, AKY-2519, which features among several industry projects whose first-in-human studies have recently been listed on the clinicaltrials.gov registry. The markets haven’t been especially kind to Aktis, whose stock has sunk 28% since the IPO, during which time the Nasdaq biotech index has traded flat; but the group still carries a market cap above $1bn.
AKY-2519 will follow Aktis’s lead, AKY-1189, an anti-Nectin-4 project that entered phase 1 last year; both projects use the alpha emitter actinium-255 as their radioisotope. While AKY-1189 is being tested in Nectin-4-positive cancers, AKY-2519’s phase 1 trial, due to begin in July, concerns metastatic castration-resistant prostate cancer all-comers, including patients exposed to Novartis’s Pluvicto.
Relay’s second too
Another company taking its second pipeline asset into human testing is Relay Therapeutics, which is best known for the pan-mutant PI3Kα inhibitor zovegalisib, but which is now advancing a molecule coded RLY-8161.
Relay claims that in RLY-8161 it has designed the first NRAS-selective inhibitor, its aim being to address the liabilities of current pan-RAS inhibitors by only binding to NRAS, while sparing KRAS and HRAS. The company has picked out NRAS-mutant melanoma as a key focus for RLY-8161, though its clinicaltrials.gov listing shows the molecule being tested broadly in NRAS-mutant solid tumours.
Recently disclosed first-in-human studies*
| Project | Mechanism | Company | Trial | Scheduled start |
|---|---|---|---|---|
| RLY-8161 | NRAS inhibitor | Relay | NRASm solid tumours | 9 Mar 2026 |
| Unnamed | CRLF2-R Car-T | NCI | CRLF2-R/TSLPR-overexpressing ALL | 13 May 2026 |
| CRPA1A2 | Mage-A1 x HLA-A*02:01 T-cell engager | Corregene Biotechnology | Mage-A1 & HLA-A*02:01 +ve solid tumours | 29 May 2026 |
| JH021 | EGFR x cMet MAb | Biotech Pharmaceutical | Solid tumours | 30 May 2026 |
| 4A10 | CD127 MAb | Allterum Therapeutics | T or B-cell ALL | May 2026 |
| 225Ac-AKY-2519 | B7-H3 radioconjugate | Aktis Oncology | Bactinium-1, mCRPC (pre & post-Pluvicto) | Jul 2026 |
Note: *these projects were first listed on the clinicaltrials.gov database between 7 and 14 May 2026.
First-in-human trial starts also include two bispecifics: the Rybrevant me-too JH021 from China/Cuba’s Biotech Pharmaceutical; and an anti-Mage-A1 x HLA-A*02:01 T-cell engager from China’s Corregene. The latter could offer greater convenience than an engineered T-cell receptor approach, but is similarly limited to patients carrying a specific HLA type.
Meanwhile, the NCI is advancing a Car-T therapy against CRLF2-R, the cytokine receptor-like factor 2 also known as TSLPR. OncologyPipeline reveals no industry work on this target, and one possibility is that the NCI’s project will be spun into a biotech company by way of technology transfer.
A private US biotech separately features among the first-in-human trial entrants, courtesy of an anti-CD127 antibody coded 4A10 in development at Allterum Therapeutics. This appears to be the first clinical project for Allterum, a Houston-based group that’s so far relied on seed financing and grant funding.
OncologyPipeline shows a handful of other anti-CD127 projects in development, but 4A10 is the first in clinical development run by a commercial entity.
394