- Emerging JANX007 data demonstrated substantial clinical
activity in 5L mCRPC patients, supporting clinical development plan
directed at pre-PLUVICTO® 2L / 3L patients
- In 16 patients JANX007 displayed:
- 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) and 63% 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
- 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 interim clinical data for its JANX007 clinical
program. Janux will host a virtual event today at 4:30 PM ET. To
register for the event, please click here.
“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; 100% of patients
achieved best PSA50 declines, 63% of patients achieved best PSA90
declines, and 31% of patients achieved best PSA99 declines.
Durability of PSA declines at a target dose ≥ 2 mg were observed;
75% of patients maintained PSA50 declines at ≥ 12 weeks and 50% of
patients maintained PSA90 declines at ≥ 12 weeks. Deep and durable
PSA responses were observed irrespective of resistance driver
aberration status, or prior treatments with a taxane or ARPi. In
RECIST-evaluable patients, anti-tumor activity was observed with
confirmed and unconfirmed partial responses in 50% (4/8) of
patients.
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 USA & Canada: (800) 715-9871
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241202674893/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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