Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer
22 Maio 2023 - 9:15AM
Panbela Therapeutics,
Inc. (Nasdaq: PBLA), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with urgent unmet medical needs, today
announced it has entered into a clinical trial agreement with
Moffitt Cancer Center for a Phase I/II program in STK11 mutant
non-small cell lung cancer (NSCLC). The initial goal of the Phase I
trial will be to ascertain the maximum tolerated dose of
eflornithine, while evaluating efficacy and then moving into a
Phase II efficacy trial. We anticipate data from the Phase I trial
by the end of this year with a look to start the Phase II trial at
the end of the year or early 2024.
“The relationship between polyamines and the immune system has
been highlighted in peer-reviewed journals. This clinical trial
with Moffitt seeks our first clinical proof of concept to evaluate
the modulation of the immune system by polyamines in combination
with standard of care cancer therapy,” said Jennifer K. Simpson,
PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.
“The STK11 mutant NSCLC population has historically had a poor
response to checkpoint inhibitor therapy. If the trial is
successful, it opens the door for combining polyamine targeted
therapies, such as eflornithine and ivospemin, with checkpoint
inhibitors in other tumor types where response rates have been
poor, or even improve upon reasonable response rates. It would also
open the possibility of exploring combinations of eflornithine and
ivospemin with other immunotherapies, such as CAR-T therapy.”
“There is a huge unmet need for new therapies for STK11 mutant
non-small cell lung cancer patients, given their low survival
rates. We know that STK11 mutant tumors have reduced levels of T
cells that direct immune surveillance, and they can avoid immune
detection. We are excited to partner with Panbela to determine if
modulating polyamines can restimulate the immune system to target
these hard-to-treat tumors.” said Jhanelle Gray, M.D., lead
investigator of the trial, Chair of Moffitt’s Department of
Thoracic Oncology and Co-Leader of Moffitt’s Molecular Medicine
Program.
About Panbela’s
PipelineThe pipeline consists of assets currently
in clinical trials with an initial focus on familial adenomatous
polyposis (FAP), first-line metastatic pancreatic cancer,
neoadjuvant pancreatic cancer, colorectal cancer prevention and
ovarian cancer. The combined development programs have a steady
cadence of anticipated catalysts with programs ranging from
pre-clinical to registration studies.
Ivospemin (SBP-101)Ivospemin
is a proprietary polyamine analogue designed to induce polyamine
metabolic inhibition (PMI) by exploiting an observed high affinity
of the compound for pancreatic ductal adenocarcinoma and other
tumors. It has shown signals of tumor growth inhibition in clinical
studies of metastatic pancreatic cancer patients, demonstrating a
median overall survival (OS) of 14.6 months and an objective
response rate (ORR) of 48%, both exceeding what is typical for the
standard of care of gemcitabine + nab-paclitaxel suggesting
potential complementary activity with the existing FDA-approved
standard chemotherapy regimen. In data evaluated from clinical
studies to date, ivospemin has not shown exacerbation of bone
marrow suppression and peripheral neuropathy, which can be
chemotherapy-related adverse events. Serious visual adverse events
have been evaluated and patients with a history of retinopathy or
at risk of retinal detachment will be excluded from future SBP-101
studies. The safety data and PMI profile observed in the previous
Panbela-sponsored clinical trials provide support for continued
evaluation of ivospemin in the ASPIRE trial.
Flynpovi™Flynpovi is a
combination of CPP-1X (eflornithine) and sulindac with a dual
mechanism inhibiting polyamine synthesis and increasing polyamine
export and catabolism. In a Phase III clinical trial in patients
with sporadic large bowel polyps, the combination prevented >
90% subsequent pre-cancerous sporadic adenomas versus placebo.
Focusing on FAP patients with lower gastrointestinal tract anatomy
in the recent Phase III trial comparing Flynpovi to single agent
eflornithine and single agent sulindac, FAP patients with lower GI
anatomy (patients with an intact colon, retained rectum or surgical
pouch), showed statistically significant benefit compared to both
single agents (p≤0.02) in delaying surgical events in the lower GI
for up to four years. The safety profile for Flynpovi did not
significantly differ from the single agents and supports the
continued evaluation of Flynpovi for FAP.
CPP-1XCPP-1X (eflornithine) is being developed
as a single agent tablet or high dose powder sachet for several
indications including prevention of gastric cancer, treatment of
neuroblastoma and recent onset Type 1 diabetes. Preclinical studies
as well as Phase I or Phase II investigator-initiated trials
suggest that CPP-1X treatment may be well-tolerated and has
potential activity.
About PanbelaPanbela Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing disruptive
therapeutics for patients with urgent unmet medical needs.
Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further
information can be found at www.panbela.com
. Panbela’s common stock is listed on The Nasdaq
Stock Market LLC under the symbol “PBLA”.
Cautionary Statement Regarding Forward-Looking
Statements This press release contains “forward-looking
statements,” including within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as: “anticipate,” “can,” “continue,”
“design,” “expect,” “focus,” “intend,” “may,” “plan,” “potential,”
and “will.” All statements other than statements of historical fact
are statements that should be deemed forward-looking statements.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations, and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial
condition may differ materially and adversely from the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: (i) our ability to obtain
additional funding to execute our business and clinical development
plans; (ii) progress and success of our clinical development
program; (iii) the impact of the current COVID-19 pandemic on our
ability to conduct our clinical trials; (iv) our ability to
demonstrate the safety and effectiveness of our product candidates:
ivospemin (SBP-101) and eflornithine (CPP-1X); (v) our reliance on
a third party for the execution of the registration trial for our
product candidate Flynpovi ; (vi) our ability to obtain regulatory
approvals for our product candidates, SBP-101 and CPP-1X in the
United States, the European Union or other international markets;
(vii) the market acceptance and level of future sales of our
product candidates, SBP-101 and CPP-1X; (viii) the cost and delays
in product development that may result from changes in regulatory
oversight applicable to our product candidates, SBP-101 and CPP-1X;
(ix) the rate of progress in establishing reimbursement
arrangements with third-party payors; (x) the effect of competing
technological and market developments; (xi) the costs involved in
filing and prosecuting patent applications and enforcing or
defending patent claims; (xii) our ability to maintain the listing
of our common stock on a national securities exchange; and (xiii)
such other factors as discussed in Part I, Item 1A under the
caption “Risk Factors” in our most recent Annual Report on Form
10-K, any additional risks presented in our Quarterly Reports on
Form 10-Q and our Current Reports on Form 8-K. Any forward-looking
statement made by us in this press release is based on information
currently available to us and speaks only as of the date on which
it is made. We undertake no obligation to publicly update any
forward-looking statement or reasons why actual results would
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information, future developments or otherwise.
Contact Information:
Investors:James CarbonaraHayden IR(646)
755-7412james@haydenir.com
Media:Tammy GroenePanbela Therapeutics, Inc.(952)
479-1196IR@panbela.com
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