Janux Therapeutics unveiled significant progress across its multi-platform immunotherapy pipeline at its virtual R&D Day, introducing a novel bispecific platform for autoimmune diseases while advancing its oncology programs. The clinical-stage biopharmaceutical company reported strong financial positioning with $996.0 million in cash and investments to support its expanding development efforts.
Novel ARM Platform Shows Promise for Autoimmune Diseases
The company's most significant development centers on its Adaptive Immune Response Modulator (ARM) bispecific platform, designed to overcome limitations of conventional T cell engagers in autoimmune diseases. The lead CD19-ARM program demonstrated compelling preclinical results in non-human primates, achieving rapid, deep and durable B-cell depletion in both blood and lymphoid tissues with a greater than 100-fold cytokine release syndrome (CRS) safety window.
"The progress we've shared today across our TRACTr, TRACIr, and ARM platforms reflects our disciplined strategy to focus first on maximizing the benefit and value of our clinical program JANX007," said David Campbell, Ph.D., President and CEO of Janux Therapeutics.
The CD19-ARM exhibited prolonged memory B-cell depletion and immune reset from a single subcutaneous dose, reflecting durability comparable to CD19 CAR-T therapies but with enhanced safety and convenience. The program is positioned for first-in-human studies beginning in the first half of 2026.
Expanding TRACTr Platform with TROP2 Target
Janux introduced its latest trophoblast cell surface antigen 2 (TROP2) TRACTr program, engineered for potential best-in-class safety and efficacy across TROP2-expressing tumors including breast, lung and bladder cancers. The TROP2-TRACTr demonstrated strong potency across multiple tumor types and activity at low TROP2 expression levels in preclinical studies.
Notably, the candidate was well tolerated in non-human primates with no signs of cytokine release syndrome or healthy tissue toxicity, supporting a wide therapeutic window. The preclinical data also showed ability to overcome limitations of existing TROP2-targeted therapies, including antibody drug conjugates. IND-enabling activities are planned for the second half of 2025.
TRACIr Platform to Enhance JANX007 Performance
The company is advancing its CD28-based TRACIr platform designed to enhance T cell activation and durability of its CD3-based TRACTr platform. A PSMA-TRACIr is being developed for combination with JANX007, the company's lead PSMA-targeting TRACTr in development for metastatic castration-resistant prostate cancer (mCRPC).
While JANX007 has demonstrated differentiated clinical activity in late-stage mCRPC patients, the addition of PSMAxCD28-TRACIr introduces a costimulatory signal that may further enhance durability of response within the tumor microenvironment. IND-enabling studies are underway for the PSMA-TRACIr, with clinical trials in combination with JANX007 expected to begin in the second half of 2026.
Clinical Programs Continue Enrollment
JANX007 continues enrollment in its first-in-human Phase 1 clinical trial in mCRPC (NCT05519449), while JANX008 advances in its Phase 1 trial for advanced or metastatic solid tumors (NCT05783622). The company expects to present additional data from both programs at future events in the second half of 2025.
The company also achieved a clinical milestone, triggering a $10 million payment from Merck following first patient dosing in their lead collaboration program under the 2020 Research Collaboration and Exclusive License Agreement.
Strong Financial Position Supports Pipeline Expansion
For the second quarter 2025, Janux reported research and development expenses of $34.7 million, compared to $14.9 million in the comparable 2024 period, reflecting increased investment in its expanding pipeline. General and administrative expenses were $10.5 million versus $7.8 million in the prior year period. The company reported a net loss of $33.9 million for the quarter, compared to $6.0 million in Q2 2024.
With $996.0 million in cash, cash equivalents, and short-term investments as of June 30, 2025, down from $1.03 billion at December 31, 2024, Janux maintains substantial financial resources to advance its multi-platform development strategy across oncology and autoimmune diseases.
