Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors

Rhea-AI Summary

Janux Therapeutics (NASDAQ: JANX) announced the dosing of the first patient in a Phase 1 clinical trial for JANX008, targeting advanced or metastatic solid tumors, including colorectal cancer and non-small cell lung cancer. This marks the second candidate from Janux's Tumor Activated T Cell Engager (TRACTr) platform to enter human trials. Preclinical data showed promising tumor growth inhibition with reduced toxicity compared to traditional therapies. The trial aims to assess safety, pharmacokinetics, and early anti-tumor activity in patients expressing EGFR. Janux's pipeline also includes other candidates targeting various cancer types, aiming to address unmet medical needs in oncology.

Positive

• First patient dosed in Phase 1 trial for JANX008 targeting advanced solid tumors.
• Preclinical data demonstrate tumor growth inhibition and lower toxicity compared to unmasked T cell engagers.
• Second therapeutic from TRACTr platform to enter human trials, showcasing ongoing development progress.

Negative

• None.

SAN DIEGO--(BUSINESS WIRE)-- 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.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Janux’s ability to bring new treatments to cancer patients in need, the potential benefits of such treatments and the progress and expected timing of Janux’s drug development programs. Factors that may cause actual results to differ materially include the risk that compounds that appear promising in early research do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Janux may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Janux faces, please refer to Janux’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Janux assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230420005890/en/

Investors:

Andy Meyer

Janux Therapeutics

ameyer@januxrx.com

(202) 215-2579

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com

(858) 344-8091

Source: Janux Therapeutics

FAQ

What is the purpose of the JANX008 Phase 1 clinical trial?

The trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of JANX008 in patients with advanced or metastatic solid tumors expressing EGFR.

What types of cancer is JANX008 aimed at treating?

JANX008 is being studied for colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma.

What were the results of the preclinical data for JANX008?

Preclinical data indicated that JANX008 demonstrated tumor growth inhibition and lower toxicity levels compared to traditional T cell engagers.

What is the significance of dosing the first patient in the clinical trial?

Dosing the first patient represents a critical milestone for Janux, indicating advancement in their clinical program and potential for new treatment options for patients.

How does JANX008 relate to Janux's overall pipeline?

JANX008 is the second candidate from Janux's TRACTr platform to enter human trials, which reflects the company's commitment to addressing unmet medical needs in cancer treatment.