JANX007 / Janux Therapeutics - LARVOL DELTA

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

Janux Therapeutics to Host Virtual Event Discussing Updated Clinical Data for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008 (Businesswire) - "Janux Therapeutics...announced it will host a virtual event discussing updated clinical data for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008 on Monday, February 26th, 2024, at 4:30PM ET. David Campbell, Ph.D., President & Chief Executive Officer will discuss interim clinical updates for JANX007, a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 dose escalation clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC) and JANX008, a TRACTr that targets epidermal growth factor receptor (EGFR) and is being investigated in a Phase 1 dose escalation clinical trial in adult subjects with non-small cell lung cancer, renal cell carcinoma, colorectal cancer, and squamous cell carcinoma of the head and neck....The company anticipates providing an update on identifying doses to be evaluated in expansion cohorts for JANX007 in 2H 2024."

P1 data • Colorectal Cancer • Metastatic Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

JANX007: “Flat-doses (100 & 300ug) yielded >30% best PSA reductions in 4 of 5 patients”; Castration-resistant prostate cancer (Janux Therapeutics) - Corporate Presentation: “PSA reductions -31% to -67%”

P1 data • Oncology • Prostate Cancer

Janux Therapeutics Announces Positive Interim Clinical Data from Phase 1a Dose Escalation for PSMA-TRACTr JANX007 and an Update on Pipeline Programs (Businesswire) - P1a | N=90 | ENGAGER-PSMA-01 (NCT05519449) | Sponsor: Janux Therapeutics | "Janux Therapeutics...announced interim Phase 1 clinical data for PSMA-TRACTr JANX007 in adult subjects with metastatic castration-resistant prostate cancer (mCRPC) and provided a pipeline update....The data from eight patients from the first three cohorts of the dose escalation portion of the Phase 1a clinical trial, as of June 28, 2023 show that JANX007 has been generally well tolerated, with no dose-limiting toxicities....JANX007 showed clinical activity at both 100µg and 300µg flat doses and yielded best overall PSA reductions between 31% and 67% in four of the five patients who received a flat dose. Grade 1 or 2 cytokine release syndrome (CRS) was observed only in patients who demonstrated PSA reductions....JANX007 clinical development has moved into step-dosing and dose optimization with the goal to enhance efficacy while maintaining suitable safety results."

Cytokine release syndrome • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights (Businesswire) - "Interim clinical update from Phase 1 trial of JANX007 expected in 2H 2023; PD-L1xCD28 TRACIr (JANX009) on-track for an IND submission in 2023."

IND • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Preclinical Activity and Safety Profile of JANX007, a Novel PSMA-Targeting Tumor-Activated T Cell Engager for Treatment of Metastatic Castration-Resistant Prostate Cancer (SITC 2022) - "Finally, the cleavable albumin-binding domain extended the circulating half-life of JANX007 to ~120h in NHPs, relative to the 2h half-life of non-masked TCE, supporting its projected once-weekly clinical dosing. Conclusions Cleavage-dependent activity, half-life extended PK, the potential for superior safety and manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights (Businesswire) - "We anticipate providing an interim clinical update from the PSMA-TRACTr (JANX007) trial in the second half of 2023, submitting an IND for our EGFR-TRACTr (JANX008) in the second half of 2022, and selecting a development candidate for our TROP2-TRACTr in 2023. In addition, we selected a PD-L1xCD28 TRACIr development candidate in the fourth quarter of 2021 and we expect to submit an IND for this product candidate (JANX009) in 2023."

IND • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Announces First Patient Dosed with JANX007 in First-in-Human Phase 1 Clinical Trial in Patients with Prostate Cancer (Businesswire) - "Janux Therapeutics, Inc...announced the first patient has been dosed in a Phase 1 clinical trial of JANX007 in subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) and is the first product candidate utilizing Janux’s TRACTr platform to be administered in humans....The first patient was dosed at Sarah Cannon Research Institute (SCRI)."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Janux Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Janux Therapeutics

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights (Businesswire) - "TRACTr candidate pipeline advancing with a Phase 1 clinical trial for JANX007 expected to initiate in 2H 2022 and an IND submission for EGFR-TRACTr (JANX008) in 2H 2022....Janux expects to submit an IND application to the FDA for its PD-L1xCD28 TRACIr in 2023."

IND • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Announces FDA Clearance of Investigational New Drug Application for JANX007, a PSMA-TRACTr for Metastatic Castration-Resistant Prostate Cancer (Businesswire) - "Janux Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer (mCRPC). JANX007 is the Company’s lead novel T cell engager (TCE) therapeutic from its TRACTr platform. Janux plans to initiate a Phase 1 clinical trial for JANX007 in the second half of 2022."

IND • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Janux Therapeutics to Present Preclinical Data at the 18th Annual PEGS Boston for PSMA-TRACTr and EGFR-TRACTr (Businesswire) - "JANX007 exhibits enhanced safety and PK properties relative to the PSMA-TCE; In a repeat dose, GLP toxicity study in non-human primates (NHPs) JANX007 demonstrated an enhanced safety profile featuring a decrease in cytokine CRS-associated proinflammatory cytokines and no signs of healthy tissue toxicity with no-observed-adverse-effect-level (NOAEL) ≥ 1.5 mg/kg/dose IV bolus once-weekly (QW) x5; Cleavage-dependent activity, half-life extended PK, potential for superior safety, and manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic...GMP drug substance and drug product production has been completed to support a planned Phase 1 clinical trial....Janux plans to submit an investigational new drug (IND) application for JANX007 with the U.S. Food and Drug Administration (FDA) in the first half of 2022."

IND • New P1 trial • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Janux Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results (Businesswire) - "In the first half of 2022, Janux expects to submit an IND for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA), for the treatment of metastatic castration-resistant prostate cancer (mCPRC)....In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2)."

IND • Genito-urinary Cancer • Oncology • Prostate Cancer

Janux Therapeutics Reports Business Highlights and Third Quarter 2021 Financial Results (Businesswire) - "TRACTr product candidates advancing as planned: (i) In the first half of 2022, Janux expects to submit an Investigational New Drug (IND) application for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA); (ii) In the second half of 2022, Janux expects to submit an IND application for its EGFR-TRACTr candidate, targeting epidermal growth factor receptor (EGFR); (iii) In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2)."

IND • Oncology