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Business Wire
3 days ago
- Business
- Business Wire
Janux Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
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 technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. 'The recent expansion of our TRACTr, TRACIr, and ARM development programs displays our ability to enact a strategy that attempts to both maximize the benefit and value of our current clinical programs, including JANX007, while continuing to advance other differentiated candidates in oncology and autoimmune disease,' said David Campbell, Ph.D., President and CEO of Janux. 'We look forward to additional clinical data from JANX007 and JANX008 expected in the second half of 2025.' RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: R&D Day highlighted pipeline progress and novel bispecific platform in autoimmune disease. In July 2025, Janux management presented multiple product candidates identified from its preclinical pipeline to move towards clinical trials. A PSMA-TRACIr designed to be combined with potentially best-in-treatment asset, JANX007, and provide CD28 co-stimulation to further differentiate depth and durability of patient responses. A TROP2-TRACTr added a first-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential. A CD19-ARM displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates. 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). Clinical milestone payment of $10 million from Merck recently triggered by first patient dosed in the lead collaboration program under the companies' 2020 Research Collaboration and Exclusive License Agreement. Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. Cash and cash equivalents and short-term investments: As of June 30, 2025, Janux reported cash and cash equivalents and short-term investments of $996.0 million, compared to $1.03 billion at December 31, 2024. Research and development expenses: Research and development expenses for the quarter ended June 30, 2025 were $34.7 million, compared to $14.9 million for the comparable period in 2024. General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2025 were $10.5 million, compared to $7.8 million for the comparable period in 2024. Net loss: For the quarter ended June 30, 2025, Janux reported a net loss of $33.9 million, compared to a net loss of $6.0 million for the comparable period in 2024. Janux's TRACTr, TRACIr and ARM Pipeline Janux's first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux's second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. For more information, please visit 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, expectations regarding the timing, scope and results of Janux's development activities, including its ongoing and planned preclinical studies and clinical trials, and the potential benefits of Janux's product candidates and platform technologies, expectations regarding the use of Janux's platform technologies to generate novel product candidates and the strength of Janux's balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Janux Therapeutics, Inc. Unaudited Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Collaboration revenue $ — $ 8,897 $ — $ 10,149 Operating expenses: Research and development 34,664 14,898 59,719 28,968 General and administrative 10,454 7,821 20,296 15,164 Total operating expenses 45,118 22,719 80,015 44,132 Loss from operations (45,118 ) (13,822 ) (80,015 ) (33,983 ) Total other income 11,260 7,863 22,649 13,264 Net loss $ (33,858 ) $ (5,959 ) $ (57,366 ) $ (20,719 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net (9 ) (1,092 ) 1,584 (2,281 ) Comprehensive loss $ (33,867 ) $ (7,051 ) $ (55,782 ) $ (23,000 ) Net loss per common share, basic and diluted $ (0.55 ) $ (0.11 ) $ (0.93 ) $ (0.40 ) Weighted-average shares of common stock outstanding, basic and diluted 61,902,411 54,451,666 61,847,372 51,750,690 Expand
Business Wire
24-07-2025
- Business
- Business Wire
Janux Therapeutics Highlights Pipeline Progress and Best-in-Class Potential of Novel Bispecific Platform for Autoimmune Diseases at Virtual R&D Day
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 technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, will host its virtual R&D Day today at 1:30 PM PT. The event will highlight the company's continued momentum in advancing its novel immunotherapy platforms—TRACTr and TRACIr, as well as ARM—designed to address significant unmet needs in oncology and autoimmune diseases. 'At Janux, we are guided by a deep commitment to scientific excellence and a belief that innovation should translate into meaningful outcomes for patients,' said David Campbell, Ph.D., President and CEO of Janux Therapeutics. 'The progress we've shared today across our TRACTr, TRACIr, and ARM platforms reflects our disciplined strategy to focus first on maximizing the benefit and value of our clinical program JANX007, second to harness the value of our clinical experience by bringing forward TRACTrs where we can potentially be first- and/or best-in-class, and third to utilize our T cell engager development expertise to enable platform technologies that address other clear gaps in the treatment landscape.' Creating an Opportunity to Further Differentiate JANX007 with TRACIr Combination Janux is advancing its CD28-based TRACIr platform designed to enhance T cell activation and durability of its CD3-based TRACTr platform. TRACIr was built on the same technology with the same tumor-activation and PK design features as TRACTr and combines tumor targeting with immune costimulation. The TRACIr platform represents a strategic extension of Janux's tumor-activated approach, designed to complement and enhance the clinical potential of its TRACTr portfolio, beginning with PSMA-TRACTr JANX007. While JANX007 has already demonstrated differentiated clinical activity in late-stage metastatic castration-resistant prostate cancer (mCRPC) patients, the addition of a PSMAxCD28-TRACIr introduces a costimulatory signal that may further enhance durability of response within the tumor microenvironment. This combination has the potential to drive more prolonged anti-tumor effects without increasing systemic toxicity, positioning Janux to further differentiate JANX007 in the mCRPC treatment landscape. IND-enabling studies are underway for the PSMA-TRACIr, with clinical trials in combination with JANX007 expected to begin in the second half of 2026. Expanding the TRACTr Platform into High-Value Oncology Indications Building upon learnings from the JANX007 and JANX008 clinical programs, Janux introduced its latest trophoblast cell surface antigen 2 (TROP2) TRACTr program. This next-generation TROP2-TRACTr was engineered for potential best-in-class safety and efficacy across a broad range of TROP2-expressing tumors, including breast, lung and bladder cancers. Janux's TROP2-TRACTr exemplifies the TRACTr technology's ability to create high-value T cell engager (TCE) product candidates directed at tumor targets that contemporary TCE technologies have been unable to access due to broad healthy tissue expression. Janux's TROP2-TRACTr product candidate demonstrated strong potency across multiple tumor types, activity at low TROP2 expression levels, and was well tolerated in non-human primates with no signs of cytokine release syndrome (CRS) or healthy tissue toxicity. This preclinical data also displayed the ability to overcome limitations of existing TROP2-targeted therapies, including antibody drug conjugates. These findings support a wide therapeutic window and the potential for best-in-class performance in TROP2-expressing solid tumors. IND-enabling activities are planned in the second half of 2025. ARM Platform Redefines T-Cell Engagers for Autoimmune Disease and Oncology Janux also introduced its Adaptive Immune Response Modulator (ARM) bispecific platform, designed to overcome the limitations of conventional TCEs in autoimmune diseases and oncology. Builds upon Janux's expertise to redesign bispecific TCEs. Differentiated non-clinical profile provides best-in-class opportunity in autoimmune diseases. Potential broad applicability across multiple disease areas. Large safety window and off-the-shelf format position it for higher dosing, rapid development and potential best-in-class performance. The lead program, a CD19-ARM, has displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates, supporting a potential best-in-class profile. ARMs exhibit differentiated durable T cell activity with reduced T cell exhaustion preclinically. The program demonstrated prolonged memory B-cell depletion and immune reset from a single subcutaneous dose, reflecting the durability seen with CD19 CAR-T therapies but with greater safety and convenience. ARMs displayed potential to dose to maximum efficacy while enabling safer, outpatient-friendly dosing. In non-human primates, CD19-ARM achieved deep and durable B-cell depletion in both blood and lymphoid tissues with a >100x CRS safety window. The CD19-ARM is on track for first-in-human studies to begin in the first half of 2026. Event Information To join the webcast, please visit this link, or the Events & Presentations page of the Investors section on the Company's website A replay of the webcast will be archived and available following the event. Participant Dial-In Numbers: USA / International Toll +1 (646) 307-1963 USA - Toll-Free (800) 715-9871 Conference ID 9235403 Janux's TRACTr, TRACIr and ARM Pipeline Janux's first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux's second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is also advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. For more information, please visit 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, expectations regarding the timing, scope and results of Janux's development activities, including its ongoing and planned clinical trials, and the potential benefits of Janux's product candidates and platform technologies. Factors that may cause actual results to differ materially include the risk that interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Business Wire
17-07-2025
- Business
- Business Wire
Janux Therapeutics to Host Virtual R&D Day on July 24, 2025
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 it will host a virtual R&D Day at 1:30 PM PT on Thursday, July 24, 2025. The event will include a presentation from management highlighting product candidates identified from its preclinical pipeline to move into clinical trials. These previously undisclosed preclinical programs utilize Janux's expertise and platform technologies to potentially address significant unmet medical needs. Event Information To join the webcast, please visit this link, or the Events & Presentations page of the Investors section on the Company's website at A replay of the webcast will be archived and available following the event. Participant Dial-In Numbers: USA / International +1 (646) 307-1963 USA - Toll-Free (800) 715-9871 Conference ID 9235403 Janux's TRACTr and TRACIr Pipeline Janux's first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with metastatic castration-resistant prostate cancer. Janux's second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline. About Janux Therapeutics Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Janux's proprietary technology enabled the development of two distinct bispecific platforms: TRACTr and TRACIr. The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. For more information, please visit 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 and expectations regarding the timing, scope and results of Janux's development activities. 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 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.
Business Wire
15-05-2025
- Business
- Business Wire
Janux Therapeutics Appoints Janeen Doyle as Chief Corporate and Business Development Officer
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 appointment of Janeen Doyle, MBA, as Chief Corporate and Business Development Officer. 'Janeen's unique blend of corporate development, strategic execution, and clinical insight makes her an ideal leader to help drive the next phase of growth at Janux,' said David Campbell, Ph.D., President and CEO of Janux. 'Her proven track record of building value through transformational partnerships and her ability to integrate business and science will be instrumental as we continue advancing our pipeline of tumor-activated therapeutics.' 'I'm thrilled to join Janux at such an exciting time as the company expands its clinical programs and continues to advance its pipeline,' said Ms. Doyle. 'The company's innovative TRACTr and TRACIr platforms and its commitment to delivering safer, more effective therapies to cancer patients present tremendous opportunities. I look forward to working with the team to shape and execute the company's corporate and business development strategy.' Ms. Doyle brings more than 24 years of broad and strategic experience spanning large pharmaceutical companies, mid-sized biotech, and high-growth venture-backed enterprises. She joins Janux from Flagship Pioneering, a life sciences-focused venture capital firm, where she served as a Senior Partner and Senior Vice President of Corporate Partnerships and Program Development. At Flagship, she was responsible for strategy and execution of collaborations between Flagship's portfolio companies and global pharmaceutical and technology partners. Prior to Flagship, Ms. Doyle spent over 15 years at Bristol Myers Squibb and Celgene in a breadth of cross-functional positions of increasing responsibility, starting in areas of medical affairs and program leadership, and most recently serving as Senior Vice President of Strategy & Business Development. In that role, she oversaw a portfolio of 300+ strategic collaborations and a broad equity investing portfolio, including serving as a board observer across investments. Her leadership encompassed partnerships from discovery through commercialization across multiple therapeutic areas. Previous to this, she held roles in clinical science and operations. Janux's TRACTr and TRACIr Pipeline Janux's first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with metastatic castration-resistant prostate cancer (mCRPC). Janux's second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline. About Janux Therapeutics Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Janux's proprietary technology enabled the development of two distinct bispecific platforms: TRACTr and TRACIr. The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. For more information, please visit 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, expectations regarding the timing, scope and results of Janux's development activities, including its ongoing and planned preclinical studies and clinical trials, the timing of and plans for regulatory filings, 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 and the strength of Janux's balance sheet and the adequacy of cash on hand. 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 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.
Business Wire
05-05-2025
- Business
- Business Wire
Janux Therapeutics Initiates Phase 1b Expansion Studies with JANX007 in Patients with Prostate Cancer and Provides Program Updates
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 initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial. ENGAGER-PSMA-01 is a first-in-human, open-label, multicenter Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 administered as monotherapy or in combination in adult patients with advanced metastatic castration-resistant prostate cancer (mCRPC). In December 2024, Janux reported positive interim clinical data from the Phase 1a dose escalation portion of the trial in 16 mCRPC patients with a median of four prior lines of therapy. At that time, the median radiographic progression-free survival (rPFS) reported was 7.4 months for all 16 patients.* As of April 21, 2025, updated results** have been achieved in the same 16 patients supporting the initiation of the Phase 1b expansion studies: Median rPFS of 7.5 months (n=16) Median rPFS of 7.9 months for patients treated at 6mg and 9mg target doses (n=9) 6-month rPFS of 65% (n=16) 6-month rPFS of 78% for patients treated at 6mg and 9mg target doses (n=9) Safety data remained consistent with the December 2024 data disclosure (n=16) *8/16 patients were noted as in-progress in the December 2024 reported results. **rPFS results based upon Kaplan-Meier estimate. In addition, Janux has selected a CRS-mitigation strategy to support the initiation of the Phase 1b expansion studies that is designed to maintain the CRS profile reported in December. The first Phase 1b expansion study will enroll taxane-naïve mCRPC patients and is designed to generate additional safety and efficacy data in this first and second line (1L/2L) patient population. This study will assess JANX007 monotherapy at two dose regimens (0.3/2/6mg and 0.3/2/9mg) with dosing administered once weekly or once every two weeks in mCRPC patients who have progressed on or after novel hormonal therapy (NHT). 'Initiation of the taxane-naïve study marks an important step as we begin to evaluate JANX007 in earlier-line mCRPC patient populations,' said Zachariah McIver, D.O., Ph.D., Chief Medical Officer of Janux. 'While therapeutic options for mCRPC have expanded, there remains a significant need for novel, non-chemotherapeutic approaches.' Janux plans to initiate three additional Phase 1b expansion studies, evaluating: JANX007 in combination with an androgen receptor inhibitor in taxane-experienced mCRPC patients JANX007 monotherapy in PARP inhibitor-resistant mCRPC patients JANX007 monotherapy in NHT- and taxane-experienced mCRPC patients designed to support OPTIMUS dose selection for registrational studies 'Improved efficacy and durability of responses has been observed by other prostate cancer drugs and TCEs when moving into earlier lines of therapy. There are also indications that safety with TCEs improve in earlier lines of therapy where disease burden is lower. We believe that these observations, coupled with the data seen in our Phase 1a dose escalation in later line patients, strongly support our decision to develop JANX007 in earlier lines of therapy,' said David Campbell, Ph.D., President and CEO of Janux. Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. Separately, Janux will host an R&D Day in mid-2025 highlighting product candidates identified from its preclinical pipeline to move into clinical trials. Janux's TRACTr and TRACIr Pipeline Janux's first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with metastatic castration-resistant prostate cancer. Janux's second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline. About Janux Therapeutics Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Janux's proprietary technology enabled the development of two distinct bispecific platforms: TRACTr and TRACIr. The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. For more information, please visit 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, expectations regarding the timing, scope and results of Janux's development activities, including its ongoing and planned preclinical studies and clinical trials, the timing of and plans for regulatory filings, the potential benefits of Janux's product candidates and platform technologies, the timing of future data releases, 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, the risks related to geopolitical events, including international tariffs, global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Janux's business operations and development activities, 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 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.
