Protara Therapeutics, Inc.
(Nasdaq: TARA), a
clinical-stage company developing transformative therapies for the
treatment of cancer and rare diseases, today announced that patient
dosing is now underway in its Phase 1b ADVANCED-1EXP expansion
trial evaluating TARA-002, the Company’s investigational cell-based
therapy, for the treatment of patients with high-grade non-muscle
invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS).
“Following positive preliminary results from the
ADVANCED-1 trial, we are pleased to have dosed the first patients
in our ADVANCED-1EXP trial,” said Jathin Bandari, M.D., Chief
Medical Officer of Protara Therapeutics. “We believe TARA-002
has the potential to play a meaningful role in the NMIBC treatment
landscape, as there continues to be limited treatment options for
this highly recurrent disease. We look forward to gaining
additional clinical experience with TARA-002 in NMIBC patients with
CIS.”
ADVANCED-1EXP is a Phase 1b open-label expansion
trial, which is evaluating intravesical TARA-002 at the 40KE1 dose
in 12 CIS patients, including Bacillus Calmette-Guérin (BCG)-naïve,
BCG-unresponsive and BCG-inadequately treated patients. Trial
participants will receive six once-weekly intravesical
instillations of TARA-002. The primary objective of the trial is to
evaluate the safety, tolerability and signs of anti-tumor activity
of TARA-002, and the planned primary endpoint is the complete
response (CR) rate at three months.
In April 2023 at the American
Urological Association Annual Meeting, the Company announced
positive preliminary results from the Phase 1a dose-escalation
component of the ADVANCED-1 clinical trial of TARA-002 for the
treatment of patients with high-grade NMIBC. The clinical data
indicate that TARA-002 was generally well tolerated and anti-tumor
activity was observed, including tumor regression in all three
evaluable patients with CIS, including one heavily pre-treated
BCG-unresponsive patient who achieved a CR.
Based on these results, Protara plans to
initiate ADVANCED-2, a Phase 1b/2 open-label trial evaluating
intravesical TARA-002 in up to 102 patients with CIS. The Phase 1b
trial is expected to enroll 27 patients with CIS (± Ta/T1),
BCG-Naïve or BCG-exposed who have not received intravesical BCG for
at least 24 months prior to CIS diagnosis. The Phase 2 trial is
expected to enroll 75 patients with BCG-unresponsive CIS (± Ta/T1).
ADVANCED-2 is expected to initiate in the second half of 2023.
About TARA-002
TARA-002 is an investigational cell therapy in
development for the treatment of NMIBC and of LMs for which it has
been granted Rare Pediatric Disease Designation by the U.S. Food
and Drug Administration (FDA). TARA-002 was developed from the same
master cell bank of genetically distinct group A Streptococcus
pyogenes as OK-432, a broad immunopotentiator marketed as
Picibanil® in Japan and approved in Taiwan by Chugai Pharmaceutical
Co., Ltd. Protara has successfully shown manufacturing
comparability between TARA-002 and OK-432.
When TARA-002 is administered, it is
hypothesized that innate and adaptive immune cells within the cyst
or tumor are activated and produce a strong immune cascade.
Neutrophils, monocytes and lymphocytes infiltrate the abnormal
cells and various cytokines, including interleukins IL-2, IL-6,
IL-8, IL-10, IL-12, interferon (IFN)-gamma, and tumor necrosis
factor (TNF)-alpha are secreted by immune cells to induce a strong
inflammatory reaction and destroy the abnormal cells.
About Non-Muscle Invasive Bladder
Cancer
Bladder cancer is the 6th most common cancer
in the United States, with NMIBC representing
approximately 80% of bladder cancer diagnoses. Approximately 65,000
patients are diagnosed with NMIBC in the United
States each year. NMIBC is cancer found in the tissue that
lines the inner surface of the bladder that has not spread into the
bladder muscle.
About Protara Therapeutics,
Inc.
Protara is committed to advancing transformative
therapies for people with cancer and rare diseases. Protara’s
portfolio includes its lead program, TARA-002, an investigational
cell-based therapy being developed for the treatment of non-muscle
invasive bladder cancer and lymphatic malformations, and IV Choline
Chloride, an investigational phospholipid substrate replacement for
patients dependent on parenteral nutrition. For more information,
visit www.protaratx.com.
Reference:
1. Klinische Einheit, or KE, is a German term indicating a
specified weight of dried cells in a vial.
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are "forward
looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Protara may, in some cases, use
terms such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “designed,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words or expressions referencing future events, conditions or
circumstances that convey uncertainty of future events or outcomes
to identify these forward-looking statements. Such forward-looking
statements include but are not limited to, statements regarding
Protara’s intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things, Protara’s
business strategy, including its development plans for its product
candidates and plans regarding the timing or outcome of existing or
future non-clinical studies and clinical trials, and statements
regarding the anticipated safety or efficacy of Protara’s product
candidates. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Factors
that contribute to the uncertain nature of the forward-looking
statements include: risks and uncertainties associated with:
Protara’s development programs, including the initiation and
completion of non-clinical studies and clinical trials and the
timing of required filings with the FDA and other regulatory
agencies; general market conditions; changes in the competitive
landscape; changes in Protara’s strategic and commercial plans;
Protara’s ability to obtain sufficient financing to fund its
strategic plans and commercialization efforts; having to use cash
in ways or on timing other than expected; the impact of market
volatility on cash reserves; and the risks and uncertainties
associated with Protara’s business and financial condition in
general, including the risks and uncertainties described more fully
under the caption "Risk Factors" and elsewhere in Protara's filings
and reports with the United States Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made and are
based on management's assumptions and estimates as of such date.
Protara undertakes no obligation to update any forward-looking
statements, whether as a result of the receipt of new information,
the occurrence of future events or otherwise, except as required by
law.
Company Contact:Justine O'MalleyProtara
TherapeuticsJustine.OMalley@protaratx.com646-817-2836
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