Janux Therapeutics Announces FDA Clearance of Investigational New Drug Application for JANX007, a PSMA-TRACTr for Metastatic Castration-Resistant Prostate Cancer

Rhea-AI Summary

Janux Therapeutics has received FDA clearance for its investigational new drug application for JANX007, a PSMA-TRACTr targeting metastatic castration-resistant prostate cancer (mCRPC). This marks a significant milestone for the company as it prepares to initiate a Phase 1 clinical trial in the second half of 2022. Designed to improve on existing therapies, JANX007 aims to provide a safer and more effective treatment option with enhanced safety profiles and reduced toxicities, based on positive preclinical results.

Positive

• FDA clearance of IND application for JANX007, enabling Phase 1 trial initiation.
• JANX007 demonstrates enhanced safety and pharmacokinetics in preclinical studies.
• Potential to address unmet needs in mCRPC treatment.

Negative

• Risks associated with clinical trial performance and regulatory approvals.
• Dependence on future funding for drug development.

– Phase 1 clinical study of PSMA-TRACTr (JANX007) expected to initiate in 2H 2022 –

SAN DIEGO--(BUSINESS WIRE)-- Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a 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 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.

“We are proud to announce today the clearance of Janux’s first IND – a critical milestone for our TRACTr platform and for the Company as we advance a broad pipeline of next generation immunotherapies to address unmet needs and improve the treatment of cancer,” said David Campbell, Ph.D., President and CEO of Janux. “JANX007 is uniquely designed to overcome the clinical limitations of existing TCE approaches, potentially providing mCRPC patients a safer therapeutic option, while also generating potent anti-tumor activity by enabling the delivery of a higher concentration of active drug. With this IND acceptance, we are on track to advance JANX007 into the clinic in the second half of this year.”

Unlike existing TCE approaches to prostate cancer that have been limited to-date by dose-limiting toxicities, poor pharmacokinetic (PK) profiles and attenuated efficacy, JANX007 is designed as a safer, highly potent anti-tumor approach to mCRPC. In preclinical studies, JANX007 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 JANX007 support its further development as an attractive mCRPC therapeutic.

About Janux Therapeutics
Janux Therapeutics is an innovative 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). 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, 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/20220531005194/en/

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com

(858) 344-8091



Investors:

Christina Tartaglia

Stern Investor Relations, Inc.

christina@sternir.com

(212) 362-1200

Source: Janux Therapeutics, Inc.

FAQ

What is JANX007 and its significance for Janux Therapeutics?

JANX007 is a PSMA-TRACTr investigational drug cleared by the FDA for the treatment of metastatic castration-resistant prostate cancer, marking a crucial milestone for Janux.

When will the Phase 1 clinical trial for JANX007 start?

The Phase 1 clinical trial for JANX007 is expected to begin in the second half of 2022.

How does JANX007 compare to existing T cell engager therapies?

JANX007 is designed to be safer and more effective, addressing limitations such as dose-limiting toxicities and poor pharmacokinetic profiles seen in existing T cell engagers.

What are the risks associated with Janux Therapeutics' drug development?

Risks include the potential for compounds to fail in late-stage trials, and reliance on outside financing and third-party partnerships for clinical studies.