Protara Therapeutics Announces Presentation of Additional Encouraging Data from Phase 1a ADVANCED-1 Trial of TARA-002 in NMIBC at the 24th Annual Meeting of the Society of Urologic Oncology
November 30 2023 - 8:30AM
Protara Therapeutics, Inc.
(Nasdaq: TARA), a
clinical-stage company developing transformative therapies for the
treatment of cancer and rare diseases, today announced additional
encouraging data from the Phase 1a dose-escalation component of its
ongoing ADVANCED-1 clinical trial of TARA-002, the Company’s
investigational cell-based therapy, for the treatment of patients
with high-grade non-muscle invasive bladder cancer (NMIBC). In
addition, the study design for its ADVANCED-2 trial will be
presented. The data will be featured during a poster session at the
24th Annual Meeting of the Society of Urologic Oncology (SUO) being
held in Washington, D.C. from November 28, 2023 through December 1,
2023.
“We are pleased to share additional data from
the ADVANCED-1 trial which continue to support the potential for
TARA-002 to provide a meaningful benefit to patients with NMIBC,”
said Jesse Shefferman, Chief Executive Officer of Protara
Therapeutics. “We look forward to reporting preliminary results
from the expansion portion of the ADVANCED-1 trial of TARA-002,
which we expect in the first half of 2024, and remain focused on
continuing to execute on the totality of our NMIBC program,
including the ongoing ADVANCED-2 trial.”
Study Results
- TARA-002 was
generally well tolerated at all three dose levels evaluated in the
trial, and no dose limiting toxicities were observed. While a
maximum tolerated dose was not determined, the Company has selected
the 40KE1 dose for use in subsequent clinical trials.
- The majority of
reported adverse events were Grades 1 and 2 across all dose levels,
and treatment-related adverse events, as assessed by study
investigators, were in line with typical responses to bacterial
immunopotentiation, and included fatigue, headache, fever, and
chills. The most common urinary symptoms were urinary urgency,
urinary frequency, urinary tract pain/burning, incomplete emptying,
and bladder spasm. Most bladder irritations resolved soon after
administration or in a few hours to a few days.
- A total of nine patients were
enrolled in the study, including three patients with carcinoma in
situ (CIS) who reached the three-month efficacy assessment. Of
those three patients with CIS, one heavily pre-treated Bacillus
Calmette-Guérin (BCG)-unresponsive patient achieved a complete
response (CR) at the 20KE dose, and tumor regression was observed
in the other two patients.
- New results from six patients with high-grade, non-invasive
papillary (HGTa) tumors showed five of six patients with high-grade
recurrence free survival (HGRFS) at week 12. The patient who did
not achieve HGRFS was dosed at 10KE, the lowest dose of TARA-002
offered in the trial.
The Company remains on track to report
preliminary results from the expansion portion of the ADVANCED-1
trial in the first half of 2024.
Supported by data from the Phase 1a study, the
Company commenced ADVANCED-2 (NCT05951179), a Phase 2 open-label
trial evaluating intravesical TARA-002 in up to 102 NMIBC patients
with CIS (± Ta/T1) who are BCG-naïve (n=27) and BCG-unresponsive
(n=75). Trial subjects received 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. Additional details on the trial design will be
featured in a Trial in Progress poster at the SUO meeting.
A copy of the SUO posters will be available in
the Events and Presentations section of the Company’s
website: https://ir.protaratx.com.
About Non-Muscle Invasive Bladder Cancer
(NMIBC)
Bladder cancer is the sixth most common cancer
in the U.S., with NMIBC representing approximately 80% of
bladder cancer diagnoses. NMIBC is cancer found in the tissue that
lines the inner surface of the bladder that has not spread into the
bladder muscle. Approximately 65,000 patients are diagnosed with
NMIBC in the U.S. each year.
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 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.
References
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 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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