- Multiple patients treated with PSMA-TRACTr JANX007 have
achieved meaningful PSA drops coupled with manageable safety and
CRS
- PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008 have been generally
well tolerated at levels above the projected maximum tolerable dose
of the parental T cell engagers
- JANX007 preliminary data showed encouraging safety results
consistent with on-tumor activity with no dose-limiting
toxicities
- PK exposure demonstrated TRACTr activation with lack of TCE
accumulation
- No treatment-emergent ADA titers observed
- Janux to host virtual investor event today at 4:00 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
interim Phase 1 clinical data for PSMA-TRACTr JANX007 in adult
subjects with metastatic castration-resistant prostate cancer
(mCRPC) and provided a pipeline update. Janux will host a virtual
investor event today at 4:00 PM ET. To register for the event,
please click here.
“These data showing tumor-activated T cell engagement in
patients with prostate cancer represent the first in-human data for
the TRACTr platform and give us confidence for continuing clinical
development of JANX007 and advancing future programs from this
platform. We are encouraged by these positive interim clinical data
for JANX007, which displayed PSA reductions coupled with low-grade
and transient CRS, which we believe to be consistent with the
TRACTr mechanism of action,” said David Campbell, Ph.D. “The
concept of tumor-specific activation as a new therapeutic strategy
for T cell engagers in solid tumors has taken an important step
forward, and the JANX007 program has hit an important milestone in
its clinical development.”
Interim Clinical Data for PSMA-TRACTr JANX007 in mCRPC as of
June 28, 2023
The data from eight patients from the first three cohorts of the
dose escalation portion of the Phase 1a clinical trial, as of June
28, 2023 show that JANX007 has been generally well tolerated, with
no dose-limiting toxicities. JANX007 has been dosed at 300µg flat
dose, which is above the projected maximum tolerable dose of the
parental T cell engagers. JANX007 showed clinical activity at both
100µg and 300µg flat doses and yielded best overall PSA reductions
between 31% and 67% in four of the five patients who received a
flat dose. Grade 1 or 2 cytokine release syndrome (CRS) was
observed only in patients who demonstrated PSA reductions,
suggesting cytokine release resulting from anti-tumor activity was
associated with CRS. No Grade 3 CRS has been observed. The most
common, non-CRS related adverse event observations have been
generally consistent with tumor-specific activity and reduced
PSMA(+) healthy tissue activity. No transaminitis was observed.
JANX007 clinical development has moved into step-dosing and dose
optimization with the goal to enhance efficacy while maintaining
suitable safety results.
The TRACTr technology is designed to create potent T cell
engagers (TCEs) by tumor-specific activation via mask cleavage by
tumor proteases. Plasma levels in patients exhibited prolonged
TRACTr exposure, clear evidence of activation as measured by a
specific cleavage fragment, and lack of accumulation of the active
TCE in the blood. The lack of TCE accumulation shows consistency
with TRACTr design principles and suggest that observed PSA
reductions have been a result of tumor activation and not systemic
TCE exposure.
Conference Call Information
Janux will host a live conference call and webcast today at 4:00
PM ET. A live question and answer session will follow the formal
presentation.
Conference call participant joining details:
United States: 1 (888) 412-4131 United States (Local): 1 (646)
960-0134 International: 1 (888) 412-4131 Access code: 7426984
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 approximately 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 metastatic castration-resistant prostate
cancer (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
colorectal cancer, squamous cell carcinoma of the head and neck,
non-small cell lung cancer, and renal cell carcinoma. 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 and is being investigated in
preclinical studies for the treatment of solid tumors. 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. 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: 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, 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 supporting continued clinical development of
JANX007, 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. 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/20230717429404/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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