JANX007 / Janux Therapeutics - LARVOL DELTA

PSMA-013-001: Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Janux Therapeutics

First-in-human • New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

PSMA-013-001: Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janux Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

ENGAGER-PSMA-01: A Phase 1 Study of JANX007, a Tumor-Activated, Prostate-Specific Membrane Antigen (PSMA)-Directed CD3 Bispecific T-Cell Engager (TCE), in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (ESMO 2026) - No abstract available

Bispecific • Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Upcoming Milestones (Businesswire) - "Clinical initiation of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, expected in the second half of 2026. Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027."

New trial • P1 data • Castration-Resistant Prostate Cancer

Clinical & Pipeline Progress: JANX007 (PSMA-TRACTr) (Businesswire) - "JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients. An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC."

Enrollment status • Castration-Resistant Prostate Cancer

Upcoming Milestones (Businesswire) - "(i) Janux expects to provide additional clinical data for JANX007 at a future medical congress in the first half of 2027; (ii) Janux plans to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers in the second half of 2026; (iii) Janux plans to initiate clinical development of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, in the second half of 2026."

New trial • P1 data • Castration-Resistant Prostate Cancer

ProTCE-PSMA, a novel therapeutic PSMA/CD3 prodrug for prostate cancer (AACR 2026) - "JANX007, a phase Ib stage PSMA/CD3 prodrug, achieved the first clinical PoC of conditionally activated TCE, yet its CRS profile and clinical efficacy were still not satisfying. Indeed, in a H2H exploratory toxicity study in cynomolgus monkeys, at 1.5mpk, ProTCE-PSMA induced 10-fold lower cytokine levels than HRP358, and AST and ALT were maintained within the normal range.In conclusion, ProTCE-PSMA is a novel TCE prodrug which demonstrated potent in vivo antitumor activity, satisfying PK profiles and superior therapeutic index. IND filling is expected in Q1, 2026."

Late-breaking abstract • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor • FOLH1

Janux Announces Encouraging Efficacy and Safety Profile from Ongoing Phase 1 Clinical Trial for JANX007 in mCRPC (Businesswire) - "Phase 1 data demonstrates durable responses and rPFS coupled with a manageable safety profile. rPFS of 7.9-8.9 months in heavily pre-treated mCRPC patients. Preliminary results are encouraging with deep PSA reductions and a promising CRS profile in taxane-naïve Phase 1b expansion study. Initial results support a patient-friendly Q2W dosing schedule."

P1 data • Castration-Resistant Prostate Cancer

Janux Therapeutics to Host Virtual Event Discussing Updated Phase 1a and Phase 1b Clinical Data for JANX007 in mCRPC (Businesswire) - "The virtual event will take place on Monday, December 1, 2025, at 4:30 PM ET."

P1 data • Castration-Resistant Prostate Cancer

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES (Businesswire) - "JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622). Additional data from JANX007 and JANX008 will be presented at future Janux events in the fourth quarter of 2025."

P1 data • Trial status • Castration-Resistant Prostate Cancer

Janux Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights (Businesswire) - "JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622). Clinical milestone payment of $10 million from Merck recently triggered by first patient dosed in the lead collaboration program under the companies’ 2020 Research Collaboration and Exclusive License Agreement. Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025."

Enrollment status • Financing • P1 data • Castration-Resistant Prostate Cancer

Janux Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights (Businesswire) - "Janux plans to initiate three additional Phase 1b expansion studies with JANX007, evaluating: (i) JANX007 in combination with an androgen receptor inhibitor (ARi) in taxane-experienced, ARi-naïve mCRPC patients; (ii) JANX007 monotherapy in PARP inhibitor-resistant mCRPC patients; (iii) JANX007 monotherapy in NHT- and taxane-experienced mCRPC patients designed to support OPTIMUS dose selection for registrational studies....Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025."

New P1 trial • P1 data • Castration-Resistant Prostate Cancer

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) (clinicaltrials.gov) - P1 | N=272 | Recruiting | Sponsor: Janux Therapeutics | N=105 ➔ 272 | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Jul 2025 ➔ Jul 2027

Enrollment change • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Additional data from JANX007 and JANX008 (Janux Therapeutics) - "Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025."

P1 data • Castration-Resistant Prostate Cancer

Janux Therapeutics Initiates Phase 1b Expansion Studies with JANX007 in Patients with Prostate Cancer and Provides Program Updates (Janux Therapeutics) - P1 | N=105 | ENGAGER-PSMA-01 (NCT05519449) | Sponsor: Janux Therapeutics | "Janux Therapeutics, Inc...today announced the initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial....As of April 21, 2025, updated results** have been achieved in the same 16 patients supporting the initiation of the Phase 1b expansion studies: Median rPFS of 7.5 months (n=16); Median rPFS of 7.9 months for patients treated at 6mg and 9mg target doses (n=9); 6-month rPFS of 65% (n=16); 6-month rPFS of 78% for patients treated at 6mg and 9mg target doses (n=9)....Janux plans to initiate three additional Phase 1b expansion studies, evaluating: JANX007 in combination with an androgen receptor inhibitor in taxane-experienced mCRPC patients; JANX007 monotherapy in PARP inhibitor-resistant mCRPC patients; JANX007 monotherapy in NHT- and taxane-experienced mCRPC patients designed to support OPTIMUS dose selection for registrational studies."

P1 data • Trial status • Castration-Resistant Prostate Cancer

Janux Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights (Businesswire) - "JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622)....An update on JANX007 and JANX008 data is anticipated in 2025."

Enrollment status • P1 data • Castration-Resistant Prostate Cancer

JANX007: “Deep PSA declines coupled with predictable, transient and easily managed CRS in 5L pts”; Castration-resistant prostate cancer (Janux Therapeutics) - JANX007 Clinical Data Update: “Encouraging anti-tumor responses in RECIST evaluable 5L patients supports progression to Ph1b studies”

P1 data • Oncology • Prostate Cancer

Janux Announces Doses Selected for Phase 1b Expansion Trials Supported by Encouraging Efficacy and Safety Profile Observed in Phase 1a Dose Escalation for JANX007 in mCRPC (Businesswire) - P1a/1b | N=105 | ENGAGER-PSMA-01 (NCT05519449) | Sponsor: Janux Therapeutics | "Emerging JANX007 data demonstrated substantial clinical activity in 5L mCRPC patients, supporting clinical development plan directed at pre-PLUVICTO 2L / 3L patients. In 16 patients JANX007 displayed: High PSA response rates: 100% achieved best PSA50 declines; Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines; Durable PSA response at ≥ 12 weeks: 75% maintained PSA50 declines; 50% maintained PSA90 declines; Encouraging anti-tumor activity: 50% ORR (4/8) and 63% DCR (5/8); Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and grades 1 and 2; Maximum tolerable dose has not yet been reached."

P1 data • Metastatic Castration-Resistant Prostate Cancer

Janux Therapeutics to Host Virtual Event Discussing Updated Clinical Data in Phase 1a Dose Escalation for JANX007 in mCRPC and Doses Selected for Phase 1b Expansion Studies (Businesswire) - "Janux Therapeutics...announced it will host a virtual event on Monday, December 2, 2024, at 4:30 PM ET. David Campbell, Ph.D., President & Chief Executive Officer, will provide an update on JANX007 Phase 1a dose escalation data and doses selected for Phase 1b expansion studies in adult subjects with metastatic castration-resistant prostate cancer (mCRPC)."

P1 data • Metastatic Castration-Resistant Prostate Cancer

Janux Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights (Businesswire) - "RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: The company continues to enroll patients in the first-in-human Phase 1 clinical trials of JANX007 in mCRPC (NCT05519449) and JANX008 in advanced or metastatic solid tumors (NCT05783622). Janux anticipates providing an update on JANX007 data and doses selected for expansion cohorts in 2024. An update on JANX008 data is expected in 2025."

Enrollment status • P1 data • Castration-Resistant Prostate Cancer

Janux Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights (Businesswire) - "The company continues to enroll patients in the first-in-human Phase 1 clinical trial of JANX007 in mCRPC (NCT05519449) and JANX008 in advanced or metastatic solid tumors (NCT05783622). Janux anticipates providing an update on JANX007 data and doses selected for expansion cohorts in the second half of 2024. An update on JANX008 data is expected in 2025."

Enrollment status • P1 data • Metastatic Castration-Resistant Prostate Cancer • Solid Tumor

Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: Janux Therapeutics | Trial completion date: Mar 2025 ➔ Dec 2026 | Trial primary completion date: Aug 2024 ➔ Jul 2025

Metastases • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights (Businesswire) - "JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC...An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024."

Enrollment status • P1 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

JANX007: “PSA responses deepening with increased doses while maintaining low grade CRS”; Castration-resistant prostate cancer (Janux Therapeutics) - Corporate Presentation: “JANX007 combination of PSA reduction and CRS addresses safety and efficacy limitations of prior PSMA-TCEs”

P1 data • Oncology • Prostate Cancer

Janux Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for PSMAxCD3-TRACTr JANX007 in mCRPC and EGFRxCD3-TRACTr JANX008 in Solid Tumors (Businesswire) - P1a | N=105 | ENGAGER-PSMA-01 (NCT05519449) | Sponsor: Janux Therapeutics | "As of February 12, 2024, 23 subjects were treated with JANX007 in the dose escalation portion of the Phase 1a clinical trial. An increasing depth of PSA declines and RECIST responses at higher doses were observed, while a favorable safety profile was maintained. At a starting dose ≥ 0.1 mg, 14 of 18 (78%) subjects achieved PSA30 declines and 10 of 18 (56%) subjects achieved PSA50 declines. At a starting step dose of ≥ 0.2 mg, 6 of 6 (100%) subjects achieved PSA30 declines and 5 of 6 (83%) subjects achieved PSA50 declines....Cytokine Release Syndrome (CRS) was observed to be temporary and mild, presenting only as low-grade 1 or 2 events, and was quickly managed with treatment."

Cytokine release syndrome • P1 data • Metastatic Castration-Resistant Prostate Cancer