Janux Therapeutics Announces Submission of Investigational New Drug Application for JANX008, an EGFR-TRACTr for Solid Tumors

Rhea-AI Summary

Janux Therapeutics has submitted an investigational new drug (IND) application for JANX008 to the FDA, targeting EGFR-expressing solid tumors. This marks a significant milestone for their TRACTr platform aimed at overcoming challenges seen with traditional therapies, like cytokine release syndrome. Preclinical studies indicate JANX008 has enhanced safety and pharmacokinetics compared to unmasked T cell engagers. Janux is focused on developing innovative immunotherapies to treat a variety of cancers, leveraging its proprietary technology.

Positive

• Submission of IND application for JANX008 represents a critical milestone in Janux's development.
• Preclinical studies show JANX008 has enhanced safety and favorable pharmacokinetics compared to unmasked therapies.

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 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).

“We are proud to announce today the submission of Janux’s second IND – a critical milestone for our TRACTr platform as we advance our broad pipeline of next generation immunotherapies,” said David Campbell, Ph.D., President and CEO of Janux. “JANX008 is uniquely designed to overcome cytokine release syndrome and known on-target EGFR healthy tissue toxicities, potentially allowing a breadth of opportunities in EGFR-expressing cancers.”

JANX008 is a double-masked TRACTr in which the EGFR-binding domain and the T cell-specific binding domain (CD3) is masked. In preclinical studies, JANX008 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX008 support its further development as an attractive solid tumor therapeutic.

About Janux Therapeutics

Janux Therapeutics is an innovative clinical-stage biopharmaceutical company developing next-generation therapeutics based on applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms to better treat patients suffering from cancer. Janux’s initial focus is on developing a novel class of T cell engagers (TCEs), and its lead product candidates are designed to target clinically validated drug targets. While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors have faced challenges due to the limitations of prior TCE technologies, namely (i) overactivation of the immune system leading to cytokine release syndrome, (ii) on-target, healthy tissue toxicities, and (iii) poor pharmacokinetics leading to short half-life. Janux is using its TRACTr platform technology to engineer product candidates designed to overcome these limitations by offering accuracy, stability, activity, modularity, and manufacturability. Janux is developing a broad pipeline with lead TRACTr programs targeting prostate-specific membrane antigen (PSMA), epidermal growth factor receptor (EGFR), and trophoblast cell surface antigen 2 (TROP2). Janux is also applying its proprietary technology to develop a TRACIr costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) designed to further enhance the anti-tumor activity of T cells. For more information, please visit www.januxrx.com.

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, expectations regarding the timing, scope and results of Janux’s development activities, including its ongoing and planned clinical trials, the potential benefits of Janux’s product candidates and platform technologies and expectations regarding the use of Janux’s platform technologies to generate novel product candidates. 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/20221227005015/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, Inc.

FAQ

What is the significance of Janux Therapeutics submitting an IND application for JANX008?

The IND application for JANX008 is a major milestone that allows Janux to begin clinical trials for a new treatment targeting EGFR-expressing solid tumors.

What types of cancers is JANX008 targeting?

JANX008 is designed to target EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck.

How does JANX008 differ from other T cell engagers?

JANX008 is engineered to minimize cytokine release syndrome and on-target healthy tissue toxicities, offering better safety profiles compared to traditional T cell engagers.

When was the IND application for JANX008 submitted?

Janux Therapeutics submitted the IND application for JANX008 on December 27, 2022.