Protara Therapeutics, Inc.
(Nasdaq: TARA), a
clinical-stage company developing transformative therapies for the
treatment of cancer and rare diseases, today announced that dosing
is now underway in its Phase 1b/2 ADVANCED-2 trial evaluating
intravesical instillation of TARA-002, the Company’s
investigational cell-based therapy, for the treatment of high-grade
non-muscle invasive bladder cancer (NMIBC) patients with Bacillus
Calmette-Guérin (BCG)-naïve and BCG-unresponsive carcinoma in situ
(CIS). In addition, dosing is progressing in the ongoing
ADVANCED-EXP trial started earlier this year with preliminary
results expected in the first half of 2024.
“The ADVANCED-2 trial in NMIBC is an exciting opportunity to
build on the favorable anti-tumor and safety data of TARA-002
presented earlier this year,” said Tom Jayram, M.D., Director,
Advanced Therapeutics Center, Urology Associates, P.C., TN and
study investigator for the ADVANCED-2 trial. “There is significant
need for new intravesical approaches for NMIBC, which can recur and
progress to invasive disease with current treatments. This trial
looks at the potential clinical benefit of TARA-002 as a possible
new therapy for NMIBC, across both BCG-naïve and BCG-unresponsive
patient populations.”
The initiation of this trial follows the positive results of the
ADVANCED-1 clinical trial of TARA-002 presented in April
2023 at the American Urological Association Annual
Meeting. In the dose-escalation component of that study, 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 complete response (CR).
“Following positive preliminary results from the ADVANCED-1
trial, we are pleased to have dosed the first patient in the
ADVANCED-2 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 and look
forward to progressing the trial in parallel with our ongoing
ADVANCED-1EXP study.”
ADVANCED-2 (NCT05951179) is a Phase 1b/2 open-label trial
evaluating intravesical TARA-002 in up to 102 patients with CIS (±
Ta/T1) who are BCG-naïve (N=27) and BCG-unresponsive (N=75). Trial
subjects will receive an induction with or without a reinduction
course of six weekly intravesical instillations of TARA-002,
followed by a maintenance course of three weekly installations
every three months in the BCG-unresponsive cohort.
The ongoing ADVANCED-1EXP trial is a Phase 1b open-label
expansion trial evaluating intravesical TARA-002 in 12 CIS
patients, including BCG-naïve, BCG-unresponsive, and
BCG-inadequately treated patients.
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. 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.
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
clinical trials; statements related to expectations regarding
interactions with the FDA; Protara’s financial position; statements
regarding the anticipated safety or efficacy of Protara’s product
candidates; and Protara’s outlook for the remainder of the year.
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 that Protara’s financial guidance may not be as expected, as
well as 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; the loss of key members of management; the impact of
general U.S. and foreign, economic, industry, market,
regulatory, political or public health conditions; 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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