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 divested
certain assets in its eflornithine pediatric neuroblastoma program
to
US
WorldMeds®1
(USWM), a Kentucky-based specialty pharmaceutical company.
Neuroblastoma, a rare cancer originating from immature nerve
cells, contributes to nearly 15% of pediatric cancer deaths.[1]
Panbela Therapeutics' subsidiary, Cancer Prevention
Pharmaceuticals, has extensively collaborated with leading
neuroblastoma research groups such as the Neuroblastoma
Medulloblastoma Translational Research Consortium (NMTRC) (now Beat
Childhood Cancer), New Advances in Neuroblastoma Therapy (NANT),
the Children’s Oncology Group (COG), and the National Cancer
Institute (NCI) in the clinical development of eflornithine as a
treatment for neuroblastoma. These collaborative efforts, spanning
multiple years, have resulted in the Company receiving orphan drug
designations for the use of eflornithine in the treatment of
neuroblastoma in both the United States and Europe.
Under the terms of the agreement, Panbela is entitled to receive
up to approximately $9.5 million non-dilutive funding in exchange
for the sale of certain assets within its pediatric neuroblastoma
program for eflornithine. Panbela will receive payments upon USWM’s
successful completion of milestones related to eflornithine's
clinical development, regulatory approval, and commercial
sales.
“Divesting eflornithine assets for pediatric neuroblastoma is
another milestone in executing our business plan to generate
long-term value for our shareholders. US WorldMeds’ existing focus
in neuroblastoma makes them an ideal company to further its
clinical development in that indication,” said Jennifer K. Simpson,
PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.
“This agreement further expands our portfolio of partner-funded
programs and has the potential to generate considerable development
milestone payments. We welcome US WorldMeds to our portfolio of
partners who continue the development of our product
candidates.”
“We are excited that the agreement will help address this high
unmet need through the further development of eflornithine for the
treatment of patients with neuroblastoma,” said Elizabeth
Bruckheimer, Ph.D., Vice President & Chief Scientific Officer
of Panbela. “After investigating the role of polyamines and the
therapeutic potential of eflornithine in neuroblastoma for many
years, it is comforting to be passing the baton to the capable
hands at USWM. We look forward to helping USWM with the ongoing FDA
review of their New Drug Application for eflornithine and future
research efforts for patients with neuroblastoma.”
"This transaction strengthens and expands our neuroblastoma
program data currently under FDA review and builds upon our
established partnerships to fully unleash the potential of DFMO as
a breakthrough treatment for neuroblastoma," commented Paul
Breckinridge Jones, Chief Executive Officer of US WorldMeds. "Our
agreement with Panbela supports our overarching objective of
redefining the standard of care and significantly improving
outcomes for children with this devastating disease, who are in
urgent need of new therapies."
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 Ivospemin
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. 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 Eflornithine
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
may be 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. 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”.
About US WorldMeds
US WorldMeds (USWM) is a privately held specialty pharmaceutical
company whose treatment options are making a difference in the
lives of the patients and communities it serves. USWM takes an
agile and personal approach to pharmaceuticals – pioneering
research and product development in therapeutic areas that
desperately need new solutions. Headquartered in Louisville,
Kentucky, USWM has a global presence and more than 20 years of
experience in the development, licensure, and commercialization of
unique pharmaceutical products. For more information about USWM,
visit www.usworldmeds.com.
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 ,”
“design,” “may,” “plan,” and “will.” Examples of forward-looking
statements include statements we make regarding timing of
trials and 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 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; 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 CarbonaraHayden IR(646)
755-7412james@haydenir.com
Media:Tammy GroenePanbela Therapeutics, Inc.(952)
479-1196IR@panbela.com
References: [1] Giselle L. et al. Maintenance DFMO
Increases Survival in High Risk Neuroblastoma. Scientific
Reports, 2018; 8 (1) DOI: 10.1038/s41598-018-32659-w
1 US WORLDMEDS is a registered trademark of USWM, LLC.
Panbela Therapeutics (NASDAQ:PBLA)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Panbela Therapeutics (NASDAQ:PBLA)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024