SAN DIEGO, CA, USA I April 20, 2023 I Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today 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. JANX008 is an epidermal growth factor receptor (EGFR) directed T cell engager (TCE) and is the second product candidate utilizing Janux’s TRACTr platform to be administered in humans.
“We are excited to initiate the clinical evaluation of our second product candidate from our TRACTr platform. JANX008 is designed to achieve tumor-selective T-cell activation and tumor killing while sparing healthy tissues,” said Wayne Godfrey, M.D., Chief Medical Officer at Janux. “Our preclinical data with JANX008 demonstrated tumor growth inhibition and lower toxicity levels, when compared to an unmasked T cell engager.”
Marwan Fakih, M.D., Professor, Medical Oncology and Therapeutics Research, Judy and Bernard Briskin Distinguished Director in Clinical Research and the principal investigator from City of Hope, 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.”
“JANX008 is the second therapeutic from our TRACTr platform to enter a first-in-human clinical trial, demonstrating the potential of our platform and the commitment of our team to address critical and urgent unmet needs for patients with advanced or metastatic solid tumors,” said David Campbell, Ph.D., President and CEO of Janux. “We are grateful to our team and clinical investigators for their support in bringing another new therapeutic with a novel mechanism of action into the clinic.”
About the JANX008 Phase 1 Clinical Trial
The Phase 1 clinical trial is a first-in-human, Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05783622.
Janux’s TRACTr and TRACIr Pipeline
JANX008 is a TRACTr that targets EGFR and is being studied in a Phase 1 trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s lead candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.
About Janux Therapeutics
Janux is a clinical-stage biopharmaceutical company developing next-generation bispecific immunotherapies with the goal of fighting cancers by killing tumor cells while allowing healthy tissues to remain unharmed. Janux’s proprietary platforms develop unique Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr) and support the building of a broad pipeline of drugs designed to direct and guide the patient’s immune system to eradicate tumors while minimizing safety concerns. The company’s innovative technology currently focuses on the engineering of bispecific antibodies functional only in the tumor, providing safety advantages compared to earlier generations of bispecific immunotherapies. For more information, please visit www.januxrx.com and follow us on LinkedIn.
SOURCE: Janux Therapeutics
Post Views: 311
SAN DIEGO, CA, USA I April 20, 2023 I Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today 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. JANX008 is an epidermal growth factor receptor (EGFR) directed T cell engager (TCE) and is the second product candidate utilizing Janux’s TRACTr platform to be administered in humans.
“We are excited to initiate the clinical evaluation of our second product candidate from our TRACTr platform. JANX008 is designed to achieve tumor-selective T-cell activation and tumor killing while sparing healthy tissues,” said Wayne Godfrey, M.D., Chief Medical Officer at Janux. “Our preclinical data with JANX008 demonstrated tumor growth inhibition and lower toxicity levels, when compared to an unmasked T cell engager.”
Marwan Fakih, M.D., Professor, Medical Oncology and Therapeutics Research, Judy and Bernard Briskin Distinguished Director in Clinical Research and the principal investigator from City of Hope, 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.”
“JANX008 is the second therapeutic from our TRACTr platform to enter a first-in-human clinical trial, demonstrating the potential of our platform and the commitment of our team to address critical and urgent unmet needs for patients with advanced or metastatic solid tumors,” said David Campbell, Ph.D., President and CEO of Janux. “We are grateful to our team and clinical investigators for their support in bringing another new therapeutic with a novel mechanism of action into the clinic.”
About the JANX008 Phase 1 Clinical Trial
The Phase 1 clinical trial is a first-in-human, Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05783622.
Janux’s TRACTr and TRACIr Pipeline
JANX008 is a TRACTr that targets EGFR and is being studied in a Phase 1 trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s lead candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.
About Janux Therapeutics
Janux is a clinical-stage biopharmaceutical company developing next-generation bispecific immunotherapies with the goal of fighting cancers by killing tumor cells while allowing healthy tissues to remain unharmed. Janux’s proprietary platforms develop unique Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr) and support the building of a broad pipeline of drugs designed to direct and guide the patient’s immune system to eradicate tumors while minimizing safety concerns. The company’s innovative technology currently focuses on the engineering of bispecific antibodies functional only in the tumor, providing safety advantages compared to earlier generations of bispecific immunotherapies. For more information, please visit www.januxrx.com and follow us on LinkedIn.
SOURCE: Janux Therapeutics
Post Views: 311
