Biocytogen and PTK7 remain hot

China's Biocytogen, a specialist in bispecific ADCs whose profile has been growing recently, remains in the spotlight, recently moving to start a first-in-human study of yet another such asset, this one targeting HER3 and MUC1.

The trial of the project, coded DM002, is to begin on 15 January, the latest listings on clinicaltrials.gov reveal. New entries on the registry also feature an anti-PTK7 ADC Day One licensed from MabCare last year, an in vivo Car-T therapy, and an engineered T-cell receptor that after cutbacks is now Medigene's sole wholly owned active pipeline asset.

Biocytogen has been in focus in recent days, after tying up with Acepodia on the development of bispecific ADCs that carry two distinct payloads. It also has a key licensing deal with Ideaya, and has a broad pipeline that includes an anti-EGFR x HER3 ADC – a bispecific strategy that's attracted recent attention.

HER3 is also one of the targets of DM002, the Biocytogen ADC newly entering phase 1, the other being MUC1; the study doesn't mandate expression of either target, according to the clinicaltrials.gov entry.

More PTK7

Biocytogen's deal with Ideaya, struck last July and worth up to $406.5m in biodollars, concerned an ADC coded BCG034/IDE034, against B7-H3 and PTK7.

Now PTK7 is in focus again with the disclosure that Day One's DAY301 is in phase 1; this monospecific ADC came from MabCare in a deal signed in June 2024, worth $55m up front. With AbbVie/Pfizer's cofetuzumab pelidotin now discontinued, DAY301 is one of three PTK7-targeting ADCs in clinical trials, the others being Genmab's ProfoundBio-originated PRO1107/GEN1107 and Kelun's SKB518.

Recently disclosed first-in-human studies*

Notes: *projects newly listed on the clinicaltrials.gov database between 18 and 31 Dec 2024; **likely targets CD39.

Meanwhile, Medigene last November implemented a 40% staff cut, and put much of its pipeline on hold. This marked a shift from engineered T-cell receptors (TCRs) towards T-cell engager MAbs, despite which the wholly owned TCR MDG1015 remains in Medigene's active pipeline.

It's MDG1015, an HLA-A*02-restricted TCR against NY-ESO-1/LAGE-1a, that's the subject of the latest first-in-human start, though it's notable that this won't get under way until July. When announcing the cutbacks Medigene said it was delaying the start of this study while it sought partnerships; the rest of its pipeline is on hold pending additional financing.

Other approaches in focus recently include in vivo Car-T therapy, said by some analysts to be an emerging theme of the new year. Umoja's UB-VV400 is this company's second such therapy to enter the clinic, after UB-VV111, a project over which AbbVie holds opt-in rights.

Also noteworthy is Signet Therapeutics' FAK inhibitor SIGX1094R, which entered phase 1 in December. FAK inhibition has been around for a long time, but the private Chinese group claims that SIGX1094R is the first ever targeted therapy for diffuse gastric cancer.