Janux Announces Doses Selected for Phase 1b Expansion Trials Supported by Encouraging Efficacy and Safety Profile Observed in Phase 1a Dose Escalation for JANX007 in mCRPC
Janux Therapeutics (NASDAQ: JANX) announced positive interim clinical data for JANX007 in metastatic castration-resistant prostate cancer (mCRPC). In 16 heavily pre-treated patients, JANX007 showed remarkable efficacy with 100% achieving PSA50 declines, 63% reaching PSA90 declines, and 31% achieving PSA99 declines. The treatment demonstrated 50% objective response rate and was well-tolerated with primarily grade 1 and 2 side effects. Based on these results, Janux has selected doses for Phase 1b expansion trials targeting pre-PLUVICTO® 2L/3L patients, with another update expected in 2025.
Janux Therapeutics (NASDAQ: JANX) ha annunciato dati clinici intermedi positivi per JANX007 nel carcinoma prostatico metastatico resistente alla castrazione (mCRPC). In 16 pazienti con precedente trattamento intenso, JANX007 ha mostrato un'efficacia straordinaria con il 100% dei pazienti che ha raggiunto una riduzione PSA50, il 63% ha raggiunto una riduzione PSA90 e il 31% ha ottenuto riduzioni PSA99. Il trattamento ha dimostrato un tasso di risposta oggettiva del 50% ed è stato ben tollerato, con effetti collaterali principalmente di grado 1 e 2. Sulla base di questi risultati, Janux ha selezionato dosi per le prove di espansione di Fase 1b mirate a pazienti pre-PLUVICTO® 2L/3L, con un ulteriore aggiornamento atteso per il 2025.
Janux Therapeutics (NASDAQ: JANX) anunció datos clínicos interinos positivos para JANX007 en cáncer de próstata metastásico resistente a la castración (mCRPC). En 16 pacientes con tratamientos previos intensos, JANX007 demostró una eficacia notable con el 100% alcanzando reducciones PSA50, el 63% alcanzando reducciones PSA90, y el 31% logrando reducciones PSA99. El tratamiento mostró un tasa de respuesta objetiva del 50% y fue bien tolerado con efectos secundarios mayormente de grado 1 y 2. Basado en estos resultados, Janux ha seleccionado dosis para ensayos de expansión de Fase 1b dirigidos a pacientes pre-PLUVICTO® 2L/3L, con otra actualización esperada para 2025.
Janux Therapeutics (NASDAQ: JANX)는 전이성 난치성 전립선암(mCRPC)에서 JANX007의 긍정적인 중간 임상 데이터를 발표했습니다. 16명의 치료 이력이 많은 환자에서 JANX007은 100%가 PSA50 감소에 도달, 63%가 PSA90 감소에 도달, 그리고 31%가 PSA99 감소에 도달하는 등 놀라운 효능을 보였습니다. 이 치료는 50%의 객관적 반응률을 나타냈으며, 주로 1도 및 2도의 부작용으로 잘 견딜 수 있었습니다. 이러한 결과를 바탕으로 Janux는 pre-PLUVICTO® 2L/3L 환자를 대상으로 하는 1b 단계 확장 시험에 사용할 용량을 선택했으며, 2025년에는 추가 업데이트가 있을 것으로 예상됩니다.
Janux Therapeutics (NASDAQ: JANX) a annoncé des données cliniques intermédiaires positives pour JANX007 dans le cancer de la prostate métastatique résistant à la castration (mCRPC). Chez 16 patients ayant subi un traitement antérieur intensif, JANX007 a montré une efficacité remarquable avec 100% atteignant des réductions PSA50, 63% atteignant des réductions PSA90 et 31% atteignant des réductions PSA99. Le traitement a montré un taux de réponse objective de 50% et a été bien toléré, avec principalement des effets secondaires de grade 1 et 2. Sur la base de ces résultats, Janux a sélectionné des doses pour des essais d'expansion de Phase 1b ciblant des patients pré-PLUVICTO® 2L/3L, avec une autre mise à jour attendue en 2025.
Janux Therapeutics (NASDAQ: JANX) hat positive interim klinische Daten zu JANX007 bei metastasiertem kastrationsresistentem Prostatakrebs (mCRPC) bekannt gegeben. Bei 16 stark vorbehandelten Patienten zeigte JANX007 bemerkenswerte Wirksamkeit mit 100%, die PSA50-Abnahmen erzielten, 63% erzielten PSA90-Abnahmen und 31% erzielten PSA99-Abnahmen. Die Behandlung zeigte eine objektive Ansprechrate von 50% und wurde gut vertragen, wobei die Nebenwirkungen hauptsächlich Grad 1 und 2 waren. Basierend auf diesen Ergebnissen hat Janux Dosen für Phase-1b-Erweiterungsstudien ausgewählt, die sich an Patienten in der pre-PLUVICTO® 2L/3L-Richtung richten, mit einem weiteren Update, das für 2025 erwartet wird.
- 100% of patients achieved PSA50 declines in Phase 1a trial
- 50% objective response rate (4/8 patients) with confirmed and unconfirmed partial responses
- 75% of patients maintained PSA50 declines at ≥12 weeks
- Well-tolerated safety profile with primarily grade 1 and 2 side effects
- Maximum tolerable dose not yet reached, indicating potential for dose optimization
- Small patient sample size (16 patients) in current trial
- to heavily pre-treated patients with median of four prior lines of therapy
Insights
The clinical trial data for JANX007 shows remarkable efficacy in treating metastatic castration-resistant prostate cancer (mCRPC). The 100% PSA50 response rate and 63% PSA90 decline rate are particularly impressive for heavily pre-treated patients. The durability metrics are strong, with
The safety profile is notably clean, with manageable CRS and treatment-related adverse events primarily to grade 1-2 in the first cycle. The absence of a maximum tolerable dose suggests potential for dose optimization. The 50% objective response rate in RECIST-evaluable patients is promising for this patient population.
The company's strategic focus on pre-PLUVICTO® 2L/3L patients could significantly expand the addressable market. The efficacy across different resistance patterns and prior treatment histories suggests broad applicability if approved.
- Emerging JANX007 data demonstrated substantial clinical activity in 5L mCRPC patients, supporting clinical development plan directed at pre-PLUVICTO® 2L / 3L patients
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In 16 patients JANX007 displayed:
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High PSA response rates:
100% achieved best PSA50 declines -
Deep PSA declines:
63% achieved best PSA90 declines;31% achieved best PSA99 declines -
Durable PSA response at ≥ 12 weeks:
75% maintained PSA50 declines;50% maintained PSA90 declines -
Encouraging anti-tumor activity:
50% ORR (4/8) and63% DCR (5/8) - Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and grades 1 and 2; Maximum tolerable dose has not yet been reached
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High PSA response rates:
- Janux to host virtual investor event today at 4:30 PM Eastern Time
“These clinical data show substantial activity with JANX007 in 5L metastatic castration-resistant prostate cancer patients and provide compelling support for the doses we’ve selected for expansion trials directed at pre-PLUVICTO® 2L and 3L patients,” said David Campbell, Ph.D., President and CEO, Janux Therapeutics. “We look forward to rapidly advancing JANX007 into second and third-line therapy where a substantial unmet need remains and where we believe JANX007’s highly differentiated profile could allow for broad usage, if approved. This is an exciting day for Janux, but more importantly the prostate cancer patients we serve.”
Updated interim, clinical data for PSMA-TRACTr JANX007 in mCRPC as of November 15, 2024
JANX007 is in a Phase 1a clinical trial in patients with advanced or metastatic prostate cancer (mCRPC). The patients enrolled in the trial were heavily pre-treated with a median of four prior lines of therapy. As of the November 15, 2024 data cutoff, 16 pre-PLUVICTO® patients have been treated once-weekly at a target dose ranging from 2 mg to 9 mg in the Phase 1a clinical trial. High prostate-specific antigen (PSA) response rates and deep PSA declines were observed across all doses;
JANX007 was well-tolerated with cytokine release syndrome (CRS) and CRS-related adverse events primarily limited to cycle 1 and grades 1 and 2. Similarly, treatment-related adverse events (TRAEs) not associated with CRS were primarily limited to cycle 1 and grades 1 and 2. The maximum tolerable dose for JANX007 has not yet been reached.
Based on these efficacy and safety results, two once-weekly step dose regimens have been identified for Phase 1b expansion trials directed at pre-PLUVICTO® 2L and 3L patients. Janux anticipates providing another update on JANX007 in 2025.
Webcast Information
Janux will host a live webcast today at 4:30 PM ET. A live question and answer session will follow the formal presentation. To register for the event, please click here.
Participant Dial-In Details
International: 1 (646) 307-1963
Conference ID: 2229349
To access the live webcast, please visit the Investors section of the Company's website. A replay of the webcast presentation will be available on the Company's website at https://investors.januxrx.com for at least 30 days.
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 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: Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (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 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, expectations regarding the timing, scope and results of Janux’s development activities, including its ongoing and planned clinical trials and that the interim data results support continued clinical development of JANX007, including in pre-PLUVICTO® 2L and 3L patients, 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 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. 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.
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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
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