Janux Therapeutics has announced the dosing of its first patient in a Phase I clinical trial evaluating JANX014 for metastatic castration-resistant prostate cancer (mCRPC).
The multicentre, first-in-human, open-label trial will assess the tolerability, safety, pharmacodynamics, pharmacokinetics, and preliminary efficacy of the double-masked, prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) in adults with mCRPC.
This TCE is designed to use Janux’s tumour-activated platform for activating T cells within the tumour microenvironment.
The company is aiming to expand its portfolio of PSMA therapies to address various prostate cancer treatment settings and immune engagement mechanisms.
Initial clinical data from its earlier asset, JANX007, showed a safety profile with no Grade 3 cytokine release syndrome at clinically relevant dose levels using the current cytokine release syndrome mitigation.
These results have influenced the current development pathway for Janux's prostate cancer candidates.
JANX014 represents an exploratory expansion of Janux’s existing strategy, stemming from research initiated in early 2024 assessing multiple PSMA-directed therapeutics.
The trial may also provide insight into future use cases where improved safety and ease of administration are necessary.
Janux Therapeutics president and CEO David Campbell said: “We are pleased to have initiated clinical evaluation of JANX014. JANX007 remains our lead prostate programme, and we believe it has established a strong clinical foundation for PSMA-directed TRACTr therapy. Insights from programmes such as JANX007 and JANX008 have informed our continued platform development.
“We are building a prostate cancer portfolio designed to address patients across multiple stages of disease, including both single and combination approaches. Advancing programmes such as JANX014 reflects our strategy of expanding on that foundation while maintaining disciplined execution on our lead programme.”
In February, Janux dosed the first participant in a Phase I clinical trial of JANX011, a Cluster of Differentiation 19 (CD19)-targeted bispecific candidate designed using its adaptive immune response modulator (ARM) platform.
