- Emerging JANX007 data illustrate a potential best-in-class
profile: promising efficacy with favorable safety profile in
heavily pretreated subjects with late-stage mCRPC
- 83% (5/6) of subjects achieved PSA50 declines with first step
dose ≥ 0.2mg
- 56% (10/18) of subjects achieved PSA50 declines with first dose
≥ 0.1mg
- No CRS greater than Grade 2 was observed in any cohort
- Early JANX008 data display differentiated safety and
encouraging signs of efficacy in heavily pretreated subjects with
different solid tumor types
- A subject with NSCLC achieved a RECIST PR maintained through
18-weeks with 100% target lung lesion reduction and elimination of
liver metastasis with no CRS or TRAEs
- No CRS greater than Grade 1 observed in any cohort
- No treatment related SAEs or DLTs have been observed
- Janux to host virtual investor event today at 4:30 PM Eastern
Time
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
positive updated clinical data for both of its clinical programs.
Janux will host a virtual event today at 4:30 PM ET. To register
for the event, please click here.
“These clinical data show encouraging safety and efficacy with
JANX007 in metastatic castration-resistant prostate cancer and with
JANX008 in late-stage solid tumors. The clinical data provide
compelling proof-of-concept for the TRACTr platform in a setting
where many other approaches have failed due to material safety
issues or lack of efficacy,” said David Campbell, Ph.D., President
and CEO, Janux Therapeutics. “Our TRACTr platform provides an entry
point to multiple, large solid tumor indications that are
intractable with conventional TCE approaches. We look forward to
continuing to advance these clinical trials and expanding to
additional TCE targets, as we look to fulfill our mission to
meaningfully address the unmet medical needs for cancer patients,
especially those with late-stage disease.”
Updated interim clinical data for PSMA-TRACTr JANX007 in
mCRPC as of February 12, 2024.
JANX007 is in a Phase 1a clinical trial in subjects with
advanced or metastatic prostate cancer (mCRPC). The subjects
enrolled in the trial were heavily pre-treated with a median of 4+
lines of therapy. As of February 12, 2024, 23 subjects were treated
with JANX007 in the dose escalation portion of the Phase 1a
clinical trial. An increasing depth of PSA declines and RECIST
responses at higher doses were observed, while a favorable safety
profile was maintained. At a starting dose ≥ 0.1 mg, 14 of 18 (78%)
subjects achieved PSA30 declines and 10 of 18 (56%) subjects
achieved PSA50 declines. At a starting step dose of ≥ 0.2 mg, 6 of
6 (100%) subjects achieved PSA30 declines and 5 of 6 (83%) subjects
achieved PSA50 declines. Initial step doses of JANX007 ≥ 0.2 mg
drove deeper and more durable PSA responses, including one subject
that achieved a PSA90 decline.
Cytokine Release Syndrome (CRS) was observed to be temporary and
mild, presenting only as low-grade 1 or 2 events, and was quickly
managed with treatment. These incidents of CRS were mainly reported
during the first treatment cycle, with no subsequent occurrences in
later cycles. Similarly, the majority of treatment-related adverse
events (TRAEs) not associated with CRS were of low severity (Grade
1 or 2) and also primarily occurred in the initial cycle. There was
a low incidence of Grade 3 TRAEs, and no Grade 4 or 5 events were
observed. JANX007 has been administered at doses up to 3mg,
significantly exceeding the anticipated maximum tolerable dose for
the parental T cell engager, while the maximum tolerable dose for
the TRACTr has not yet been established.
Based on this safety profile, we are continuing dose
optimization for JANX007 with the goal of further deepening PSA
responses, while maintaining a favorable safety profile. Janux
anticipates providing an update on doses for expansion in the
second half of 2024.
Interim clinical data for EGFR-TRACTr JANX008 in solid tumors
as of February 12, 2024.
JANX008 is in a Phase 1a clinical trial in subjects with
advanced or metastatic solid tumors known to express high levels of
the EGFR target, including colorectal cancer (CRC), squamous cell
carcinoma of the head and neck (SCCHN), non-small cell lung cancer
(NSCLC), and renal cell carcinoma (RCC). As of February 12, 2024,
11 heavily pre-treated, late-stage subjects across all four tumor
types have been enrolled. Encouraging signs of clinical activity
were observed, while a favorable safety profile was maintained. In
one subject with NSCLC treated with JANX008 at 0.15mg once-weekly,
a confirmed partial response (PR) by RECIST criteria with 100%
reduction of the target lung lesion and elimination of liver
metastasis with no CRS or TRAEs has been observed. This subject
remains on treatment and their PR has been maintained through their
week-18 scan. One subject with RCC experienced a 12% reduction in
the size of a large RCC mass and significant clinical benefit with
Grade 1 CRS.
The early safety profile for JANX008 is consistent with the
TRACTr design principles of tumor-specific activation while
avoiding healthy tissue toxicity with a broadly expressed target.
In the 11 subjects enrolled at doses up to 1.25mg, which is
significantly above the projected maximum tolerable dose of the
parental T cell engager, Grade 1 CRS was observed in only two
subjects and no Grade 2 or higher CRS was seen. The majority of
non-CRS TRAEs were also low-Grade 1 or 2 and occurred predominantly
in cycle one. No treatment related serious adverse events or
dose-limiting toxicities have been observed.
Based on this safety profile, we are continuing in the dose
escalation and optimization portion of the trial for JANX008.
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. There will also be a
dial-in:
USA & Canada - Toll-Free (800) 715-9871 International: 1
(646) 307-1963 Conference ID: 8772874
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 PSMA and is being investigated in a Phase 1 clinical trial
in adult subjects with mCRPC. Janux’s second clinical candidate,
JANX008, is a TRACTr that targets EGFR and is being studied in a
Phase 1 clinical trial for the treatment of multiple solid cancers
including non-small cell lung cancer, renal cell carcinoma,
colorectal cancer, and squamous cell carcinoma of the head and
neck. Janux is also applying its proprietary technology to develop
a TRACTr designed to target TROP2, a clinically validated
anti-tumor target that is overexpressed in various cancer types,
such as breast, lung, urothelial, endometrial, ovarian, prostate,
pancreatic, gastric, colon, head and neck, and glioma. Janux’s
TRACIr drug candidate, JANX009, is designed for targeting both the
programmed death-ligand 1 (PD-L1) receptor as well as the
costimulatory CD28 receptor on T cells for the treatment of solid
tumors. In addition to named programs, Janux is generating a number
of unnamed TRACTr and TRACIr programs for potential future
development.
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, lung, head and neck, and renal
cancers. 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 and JANX008, 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, 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. Also, interim results of a clinical trial are not
necessarily indicative of final results and one or more of the
clinical outcomes may materially change following more
comprehensive reviews of the data, as patient enrollment continues,
and as more patient data become available. 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/20240226741043/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
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