Panbela Therapeutics, Inc. Closes Acquisition of Cancer Prevention Pharmaceuticals, Inc.
June 16 2022 - 8:00AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company
developing disruptive therapeutics for the treatment of patients
with cancer, today announced the closing of its acquisition of
Cancer Prevention Pharmaceuticals, Inc. (CPP), a private clinical
stage company developing therapeutics to reduce the risk and
recurrence of cancer and rare diseases, for a combination of stock
and future milestone payments.
The combined entity will focus on maximizing its extensive
pipeline addressing an estimated aggregate $5 billion market
opportunity for the areas of initial focus: familial adenomatous
polyposis (FAP), first-line metastatic pancreatic cancer,
colorectal cancer prevention and ovarian cancer.
“Closing this transaction achieves our goal of creating a
diversified pipeline with an ability to hit multiple targets, four
clinical stage assets, two of which are late-stage registration
assets, thereby increasing the potential of the combined company,”
said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief
Executive Officer of Panbela. “Together, our capabilities will have
an even greater chance to help more patients. The addition of CPP
is an excellent fit that we feel produces substantial shareholder
value.”
The closing of the merger follows the satisfaction of all
customary closing conditions, including the unanimous approval by
the boards of directors of each company and the stockholders of
CPP.
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 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 power 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.” Examples of
forward-looking statements include statements we make regarding
results of collaborations with third parties and future studies.
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 complete clinical trials; (ii)
progress and success of our Phase 1 clinical trial; (iii) the
impact of the current COVID-19 pandemic on our ability to complete
monitoring and reporting in our current clinical trial and procure
the active ingredient; (iv) our ability to demonstrate the safety
and effectiveness of our SBP-101 product candidate (v) our ability
to obtain regulatory approvals for our SBP-101 product
candidate in the United States, the European Union or other
international markets; (vi) the market acceptance and level of
future sales of our SBP-101 product candidate; (vii) the cost and
delays in product development that may result from changes in
regulatory oversight applicable to our SBP-101 product
candidate; (viii) the rate of progress in establishing
reimbursement arrangements with third-party payors; (ix) the effect
of competing technological and market developments; (x) the costs
involved in filing and prosecuting patent applications and
enforcing or defending patent claims; and (xi) 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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