Panbela Announces Publication of Preclinical Data Titled: Expanded Potential of the Polyamine Analogue SBP-101 (Diethyl Dihydroxyhomospermine) as a Modulator of Polyamine Metabolism and Cancer Therapeutic
June 28 2022 - 8:00AM
Panbela Therapeutics,
Inc.- (Nasdaq: PBLA), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with urgent unmet medical needs, today
announced the publication of preclinical data from studies of
SBP-101 that demonstrated a 42% increase in median survival in a
mouse model of VDID8+ ovarian cancer. Data published in the
International Journal of Molecular Sciences also showed SBP-101
delayed tumor progression and decreased the overall tumor burden.
SBP-101 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. The company expects to initiate an ovarian cancer
clinical program for SBP-101 during 2022.
“This data highlights the importance of polyamines as a cancer
therapeutic. These preclinical studies are foundational to the
expansion of our clinical development program. We look to expand
SBP-101 into ovarian cancer, and later the potential for other
cancers. This compliments our current clinical development program
with SBP-101’s ongoing global randomized trial (ASPIRE) in
first-line metastatic pancreatic cancer, and eflornithine in
combination with an anti PD-1 into non-small cell lung cancer
(NSCLC) to begin later this year,” said Jennifer K. Simpson, PhD,
MSN, CRNP, President & Chief Executive Officer of Panbela. “We
look forward to advancing our development program for SBP-101 and
eflornithine into the clinic for ovarian cancer and NSCLC
indications to help as many patients as possible.”
About our Pipeline
The 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 catalysts
with programs ranging from pre-clinical to registration
studies.
SBP-101
SBP-101 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. The molecule has shown signals of tumor growth
inhibition in clinical studies of US and Australian metastatic
pancreatic cancer patients, demonstrating a median overall survival
(OS) of 14.6 months which is final, and an objective response rate
(ORR) of 48%, both exceeding what is seen typically with 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, SBP-101 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 current
Panbela sponsored clinical trial provides support for continued
evaluation of SBP-101 in a randomized clinical trial. For more
information, please
visit https://clinicaltrials.gov/ct2/show/NCT03412799 .
Flynpovi
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac
with a dual mechanism inhibiting polyamine synthesis and increase
polyamine export and catabolism. In a Phase 3 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 (GI) tract anatomy in the recent Phase 3 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), Flynpovi 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-1X
CPP-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 1 or
Phase 2 investigator-initiated trials suggest that CPP-1X treatment
is well tolerated and has potential activity.
About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing disruptive therapeutics for patients with urgent
unmet medical needs. The company’s lead assets are SBP-101 and
Flynpovi. Further information can be found
at www.panbela.com. Panbela
Therapeutics, Inc. 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: “believe,” “design,” “expect,” “feel,”
“intend,” “may,” “plan,” “scheduled,” 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: SBP-101 and eflornithine (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 eflornithine 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 eflornithine; (viii) the cost and delays in
product development that may result from changes in regulatory
oversight applicable to our product candidates, SBP-101 and
eflornithine; (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; and (xii) 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 differ from those
anticipated in any such forward-looking statement, whether
written or oral, whether as a result of new
information, future developments or otherwise.
Contact Information:
Investors: James Carbonara Hayden IR (646)
755-7412 james@haydenir.com
Media: Tammy Groene Panbela Therapeutics,
Inc. (952) 479-1196 IR@panbela.com
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