Jabez heads for the clinic

The private US biotech Jabez Biosciences was founded less than a year ago, and already it's about to put its first molecule into human trials. The asset in question, JBZ-001, features among several industry projects entering first-in-human studies, as revealed in new listings on clinicaltrials.gov.

These also include another private company, Adcendo, which is taking its second pipeline asset into the clinic; the industry's second anti-PD-1/IL-21 fusion protein; and a mystery Pfizer project. For Jabez the start of clinical trials is significant: JBZ-001 is its only pipeline project, but it underpins several combinations that the company hopes to explore.

These include combos with anti-CD38 MAbs in multiple myeloma, and with CD47-targeting MAbs in solid tumours; the company says JBZ-001, an inhibitor of DHODH, could have synergy with both approaches, and plans to raise funds to support the start of clinical trials in both settings by the second quarter of this year.

For now, however, the disclosed first-in-human trial of JBZ-001 is in various solid and haematological malignancies, and will test the molecule as monotherapy. Jabez lists Zenshine's ZX-9021 and Genase's GTX-0196 as preclinical DHODH inhibitor competitors, while Bayer tested BAY-2402234 in a phase 1 AML study before discontinuing this molecule.

Jabez acquired rights to JBZ-001 last July from Ohio State University and Hendrix College, which were developing the project as HOSU-53, and presented preclinical data at ASH 2022. Total consideration was $1m, according to SEC filings, and Jabez filed to raise up to $10m shortly afterwards.

Second fusion protein

Meanwhile, the Chinese company CD Biopharma is going into the clinic with CD-001, a fusion protein combining IL-21 with anti-PD-1 activity. IL-21 expression is sometimes built into cell therapies to enhance their activity, and among the effects of this cytokine is amplification of CD8+ T cell activity.

In general, however, biopharma's cytokine-based approaches have disappointed. CD says CD-001 is the industry's second clinical-stage PD-1/IL-21 fusion protein, presumably a reference to Amgen's similarly acting latikafusp (AMG 256); however, that molecule completed a phase 1 solid tumour study in 2023, and no longer appears in Amgen's pipeline.

Recently disclosed first-in-human studies*

Notes: *projects newly listed on the clinicaltrials.gov database between 29 and 30 Jan 2025.

Pfizer's mystery entrant is PF-08046031. So far there's nothing to indicate the mechanism of this project, whose first-in-human trial in solid tumours will have an initial focus on cutaneous melanoma.

The listings also include the private Danish biotech Adcendo, which is taking its second pipeline asset, ADCE-D01, into the clinic. ADCE-D01 is an ADC against uPARAP, an endocytic receptor overexpressed in mesenchymal cancers including soft tissue sarcoma, and ADCElerate-01, the study due to get under way this month, cleared its US IND application last October.

Shortly afterwards Adcendo raised $135m in a series B round to support its pipeline of ADC projects. Until recently the company was all in on the uPARAP mechanism, but a few months ago hedged this with a side bet on tissue factor, licensing the TF-targeting ADC ADCE-T02 from Multitude Therapeutics; ADCE-T02, a follow-on to Pfizer/Genmab’s Tivdak, is now Adcendo's lead pipeline asset.