JANX008 / Janux Therapeutics - LARVOL DELTA

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

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 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

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

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

Enrollment status • P1 data • Solid Tumor

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) - P1/1b | N=130 | NCT05783622 | Sponsor: Janux Therapeutics | "As of February 12, 2024, 11 heavily pre-treated, late-stage subjects across all four tumor types have been enrolled. Encouraging signs of clinical activity were observed, while a favorable safety profile was maintained. In one subject with NSCLC treated with JANX008 at 0.15mg once-weekly, a confirmed partial response (PR) by RECIST criteria with 100% reduction of the target lung lesion and elimination of liver metastasis with no CRS or TRAEs has been observed. This subject remains on treatment and their PR has been maintained through their week-18 scan. One subject with RCC experienced a 12% reduction in the size of a large RCC mass and significant clinical benefit with Grade 1 CRS."

Cytokine release syndrome • P1 data • Colorectal Cancer • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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

Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors (Businesswire) - "Marwan Fakih, M.D...notes, 'EGFR is a validated therapeutic target in several tumor types and highly expressed in many other tumor types, so the opportunity to target EGFR from the T-cell engager axis would be meaningful to address unmet medical needs in various disease types in oncology. We look forward to clinically exploring the safety and activity of JANX008.'"

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Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors (Businesswire) - "Janux Therapeutics...announced the first patient has been dosed at City of Hope in a Phase 1 clinical trial of JANX008 in subjects with advanced or metastatic solid tumors including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Janux Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: Janux Therapeutics

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Janux Therapeutics Announces Submission of Investigational New Drug Application for JANX008, an EGFR-TRACTr for Solid Tumors (Businesswire) - "Janux Therapeutics, Inc....announced that the Company has submitted the investigational new drug (IND) application for JANX008 to the U.S. Food and Drug Administration, an EGFR-TRACTr in development for the treatment of EGFR-expressing solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN)."

IND • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Preclinical Activity and Safety Profile or JANX008, a Novel EGFR-Targeting Tumor-Activated T Cell Engager for Treatment of Solid Tumors (SITC 2022) - "Finally, the cleavable albumin-binding domain extended the half-life of JANX008 to ~94h, relative to the ~1.3h half-life of non-masked TCE, supporting its weekly clinical dosing. Conclusions Preclinical data demonstrate key characteristics of JANX008, including cleavage-dependent activity, half-life extended PK, the potential for superior safety, and manufacturability properties that could mitigate significant limitations of TCEs and support JANX008 clinical development."

Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • EGFR • KRAS • PIK3CA

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 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 Reports First Quarter 2022 Financial Results and Business Highlights (Businesswire) - "Janux expects to submit an IND application to the FDA for its PD-L1xCD28 TRACIr in 2023....Janux expects to submit an IND application to the FDA for its EGFR-TRACTr (JANX008) in the second half of 2022."

IND • Oncology • Solid Tumor

Janux Therapeutics to Present Preclinical Data at the 18th Annual PEGS Boston for PSMA-TRACTr and EGFR-TRACTr (Businesswire) - "JANX008 is a novel TRACTr therapeutic targeting epidermal growth factor receptor (EGFR) for the treatment of multiple solid cancers including, metastatic colorectal cancer (mCRC), squamous cell carcinoma of the head and neck (SCCHN), and non-small cell lung cancer...GMP manufacturing has been completed to support a planned Phase 1 clinical trial...Preclinical data demonstrate key characteristics of JANX008 including cleavage-dependent activity, half-life extended PK, potential for superior safety, and manufacturability properties that could mitigate major limitations of TCEs and support JANX008 clinical development; Janux plans to submit an IND application for JANX008 with the FDA in the second half of 2022."

IND • New P1 trial • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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