Latest news with #JANX007
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.
Yahoo
03-03-2025
- Business
- Yahoo
Janux Therapeutics price target lowered to $41 from $62 at Scotiabank
Scotiabank lowered the firm's price target on Janux Therapeutics (JANX) to $41 from $62 and keeps a Sector Perform rating on the shares. While the dose-escalation results for the company's ongoing Phase 1 trial of JANX007 look promising, the firm does not believe all benchmarks required for establishing a competitive edge and potential pharma acquisition have been achieved, the analyst tells investors. The firm is lowering its price target to reflect a more muted outlook on JANX007 potential. See what stocks are receiving Strong Buy ratings from top-rated analysts. Filter, analyze, and streamline your search for investment opportunities with TipRanks' Stock Screener. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on JANX: Analyst Recommends 'Buy' for Janux Therapeutics Inc. Amid Share Price Decline and Promising Clinical Outlook Promising Potential of Janux Therapeutics' Lead Asset and Strategic Plans Justify Buy Rating Janux Therapeutics price target raised to $76 from $75 at Wedbush Janux Therapeutics reports Q4 EPS (36c), consensus (45c) Janux Therapeutics names Zachariah McIver, D.O., Ph.D. as Chief Medical Officer
Yahoo
27-02-2025
- Business
- Yahoo
Janux Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
Recently presented positive Phase 1 clinical trial data for PSMA-TRACTr JANX007 in mCRPC Enrollment ongoing for JANX007 and JANX008 Update on JANX007 and JANX008 data is anticipated in 2025 R&D Day is anticipated in 2025 to disclose new programs moving toward the clinic $1.03 billion in year-end cash, cash equivalents, and short-term investments SAN DIEGO, February 27, 2025--(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 reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. "2024 was an exceptional year for Janux as we displayed the potential power of our TRACTr platform in the clinic. We believe the data recently presented from JANX007 demonstrated substantial clinical activity in late line mCRPC patients, supporting our future clinical development plans directed at earlier line patients. With our substantial cash runway, we feel well-positioned to execute on our clinical plans, as well as bring new programs towards the clinic that could provide substantial value to both Janux, and more importantly, the patients we serve," said David Campbell, Ph.D., President and CEO of Janux. RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in December 2024. As of the November 15, 2024, data cutoff in 16 patients JANX007 displayed: High prostate-specific antigen (PSA) response rates: 100% achieved best PSA50 declines. Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines. Durable PSA declines maintained at ≥ 12 weeks: 75% maintained PSA 50 declines; 50% maintained PSA90 declines. Encouraging anti-tumor activity: 50% ORR (4/8) and 63% DCR (5/8) (including confirmed and unconfirmed). Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and lower grades. Gross proceeds of approximately $402.5 million (before deducting underwriting discounts and commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in December 2024. Janux to host R&D Day in 2025. Janux plans to provide an update on pipeline programs selected for clinical development. 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). Zachariah McIver, D.O., Ph.D. promoted to Chief Medical Officer. Dr. McIver has been instrumental in executing on Janux's clinical programs. Dr. McIver continues to lead cross-functional teams in the design, implementation, and execution of clinical and correlative study strategies. An accomplished physician-scientist with over 15-years of experience in clinical research, Dr. McIver joined Janux after serving as Amgen's Executive Medical Director for over 4 years. An update on JANX007 and JANX008 data is anticipated in 2025. Janux will also be hosting an R&D Day in 2025. FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of December 31, 2024, Janux reported cash and cash equivalents and short-term investments of $1.03 billion compared to $344.0 million at December 31, 2023. Research and development expenses: Research and development expenses were $20.8 million for the quarter and $68.4 million for the year ended December 31, 2024, compared to $12.2 million and $54.9 million for the same quarter and year in 2023. General and administrative expenses: General and administrative expenses were $8.2 million for the quarter and $41.0 million for the year ended December 31, 2024, compared to $6.4 million and $26.1 million for the same quarter and year in 2023. Net loss: Net loss was $20.2 million for the quarter and $69.0 million for the year ended December 31, 2024, compared to $11.8 million and $58.3 million for the same quarter and year in 2023. 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, 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. Janux Therapeutics, Balance Sheets(in thousands) December 31, Assets 2024 2023 Current assets: Cash and cash equivalents $ 430,605 $ 19,205 Short-term investments 594,568 324,823 Prepaid expenses and other current assets 8,493 5,213 Total current assets 1,033,666 349,241 Restricted cash 816 816 Property and equipment, net 4,864 7,003 Operating lease right-of-use assets 19,286 20,838 Other long-term assets 2,884 2,509 Total assets $ 1,061,516 $ 380,407 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 4,026 $ 2,424 Accrued expenses 11,684 7,387 Current portion of deferred revenue — 1,705 Current portion of operating lease liabilities 1,749 1,517 Total current liabilities 17,459 13,033 Operating lease liabilities, net of current portion 21,276 23,025 Total liabilities 38,735 36,058 Total stockholders' equity 1,022,781 344,349 Total liabilities and stockholders' equity $ 1,061,516 $ 380,407 Janux Therapeutics, Statements of Operations and Comprehensive Loss(in thousands, except share and per share data) Three Months EndedDecember 31, Year EndedDecember 31, 2024 2023 2024 2023 Collaboration revenue $ — $ 2,461 $ 10,588 $ 8,083 Operating expenses: Research and development 20,806 12,241 68,388 54,922 General and administrative 8,216 6,357 41,047 26,140 Total operating expenses 29,022 18,598 109,435 81,062 Loss from operations (29,022 ) (16,137 ) (98,847 ) (72,979 ) Total other income 8,806 4,379 29,853 14,686 Net loss $ (20,216 ) $ (11,758 ) $ (68,994 ) $ (58,293 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net (5,668 ) 1,840 1,498 2,200 Comprehensive loss $ (25,884 ) $ (9,918 ) $ (67,496 ) $ (56,093 ) Net loss per common share, basic and diluted $ (0.36 ) $ (0.25 ) $ (1.28 ) $ (1.32 ) Weighted-average shares of common stock outstanding, basic and diluted 56,832,374 46,683,613 53,751,480 44,016,283 View source version on Contacts Investors: Andy MeyerJanux Therapeuticsameyer@ (202) 215-2579 Media: Jessica Yingling, Dog Communications (858) 344-8091 Sign in to access your portfolio
