Licensed assets enter the clinic

Two biotech assets that have been the subject of recent deal activity are now entering human studies for the first time. They are Context Therapeutics' CT-95 and Compugen/Gilead's COM503, and their respective studies have just gone live on clinicaltrials.gov.

The registry also shows first-in-human trials for two small molecules in development at Dr Reddy's Aurigene subsidiary, as well as Hansoh's attempt to follow Daiichi Sankyo/Merck & Co into CDH6-targeting ADCs. For CT-95 and COM503 there is some pressure to meet financial expectations, though it's probably fair to say that this is lower for the former than the latter.

That's because Context paid just $3.8m for CT-95, a mesothelin-targeting T-cell engager originated by Link Therapeutics. That deal was signed last July, when Context was trading around 50% below its 2021 IPO price; the company's shares have since lost another 60%.

CT-95 is Contex's second clinical project, after the anti-Claudin6 T-cell engager CTIM-76, which started phase 1 last year. The group's pipeline also includes a preclinical-stage anti-Nectin-4 T-cell engager coded CT-202/BA3362, and this was licensed from BioAtla last September for $15m.

Gilead's preclinical bet

There is more riding on the anti-IL-18BP MAb COM503, for which Gilead paid Compugen $60m in December 2023.

At the time this seemed a generous amount given the molecule's preclinical status, and its approach; the IL-18 pipeline is fairly sparse, and cytokines have generally failed to meet early promise. When the US IND for COM503 was cleared a $30m milestone became payable to Compugen; the study is due to dose its first patient next week.

Recently disclosed first-in-human studies*

Notes: *projects newly listed on the clinicaltrials.gov database between 1 and 8 Jan 2025.

Until recently the CHD6 pipeline featured just three clinical players, of which the most prominent was raludotatug deruxtecan, one subject of a monster ADC deal signed in 2023 between Merck and Daiichi.

Now a fourth ADC has joined the clinical party, in the shape of Hansoh Pharma's HS-20124. Hansoh got western validation when GSK licensed first its anti-B7-H4 ADC HS-20089, and then a B7-H3-targeting asset HS-20093; meanwhile, HS-20124 still has no western partner.

Also notable in recent first-in-human trial initiations is Bayer's actinium-225-labelled BAY 3547926, which hits GPC3, a protein whose targeting with Car-T therapy has shown recent promise. Radiopharmaceuticals continue to generate deal activity, and while Bayer might not immediately be thought of as one of the leaders here its pipeline now comprises eight clinical-stage therapeutic radioconjugates, according to OncologyPipeline.