Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors
21 April 2023 - 6:01AM
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
first patient has been dosed at City of Hope in a Phase 1 clinical
trial of JANX008 in subjects with advanced or metastatic solid
tumors including colorectal cancer, squamous cell carcinoma of the
head and neck, non-small cell lung cancer, and renal cell
carcinoma. JANX008 is an epidermal growth factor receptor (EGFR)
directed T cell engager (TCE) and is the second product candidate
utilizing Janux’s TRACTr platform to be administered in humans.
“We are excited to initiate the clinical evaluation of our
second product candidate from our TRACTr platform. JANX008 is
designed to achieve tumor-selective T-cell activation and tumor
killing while sparing healthy tissues,” said Wayne Godfrey, M.D.,
Chief Medical Officer at Janux. “Our preclinical data with JANX008
demonstrated tumor growth inhibition and lower toxicity levels,
when compared to an unmasked T cell engager.”
Marwan Fakih, M.D., Professor, Medical Oncology and Therapeutics
Research, Judy and Bernard Briskin Distinguished Director in
Clinical Research and the principal investigator from City of Hope,
notes, “EGFR is a validated therapeutic target in several tumor
types and highly expressed in many other tumor types, so the
opportunity to target EGFR from the T-cell engager axis would be
meaningful to address unmet medical needs in various disease types
in oncology. We look forward to clinically exploring the safety and
activity of JANX008.”
“JANX008 is the second therapeutic from our TRACTr platform to
enter a first-in-human clinical trial, demonstrating the potential
of our platform and the commitment of our team to address critical
and urgent unmet needs for patients with advanced or metastatic
solid tumors,” said David Campbell, Ph.D., President and CEO of
Janux. “We are grateful to our team and clinical investigators for
their support in bringing another new therapeutic with a novel
mechanism of action into the clinic.”
About the JANX008 Phase 1 Clinical Trial
The Phase 1 clinical trial is a first-in-human, Phase 1/1b,
open-label, multicenter dose escalation and dose expansion study to
assess the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD), and preliminary anti-tumor activity of
JANX008 in adult subjects with advanced or metastatic carcinoma
expressing EGFR. For additional information about the trial, please
visit clinicaltrials.gov using the identifier NCT05783622.
Janux’s TRACTr and TRACIr Pipeline
JANX008 is a TRACTr that targets EGFR and is being studied in a
Phase 1 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 lead
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
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
next-generation bispecific immunotherapies with the goal of
fighting cancers by killing tumor cells while allowing healthy
tissues to remain unharmed. Janux’s proprietary platforms develop
unique Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated
Immunomodulators (TRACIr) and support the building of a broad
pipeline of drugs designed to direct and guide the patient’s immune
system to eradicate tumors while minimizing safety concerns. The
company's innovative technology currently focuses on the
engineering of bispecific antibodies functional only in the tumor,
providing safety advantages compared to earlier generations of
bispecific immunotherapies. 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, the potential benefits of
such treatments and the progress and expected timing of Janux’s
drug development programs. 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
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/20230420005890/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
Janux Therapeutics (NASDAQ:JANX)
Historical Stock Chart
From Apr 2024 to May 2024
Janux Therapeutics (NASDAQ:JANX)
Historical Stock Chart
From May 2023 to May 2024