Panbela Therapeutics, Inc. (OTCQB: PBLA)(“Panbela”), a clinical
stage biopharmaceutical company developing disruptive therapeutics
for the treatment of patients with cancer today announces a poster
presentation highlighting the results for ivospemin (SBP-101) as a
polyamine metabolism modulator in ovarian cancer at the American
Association for Cancer Research (AACR), which took place April 10,
2024. The work reflects the Company’s on-going collaboration with
Johns Hopkins University School of Medicine.
“Ivospemin, reduces the viability of human ovarian
adenocarcinoma cell lines regardless of their platinum sensitivity
and we found that the combination treatment with doxorubicin
increases median survival, delays tumor onset, and decreases
overall tumor burden compared to either clinical or subclinical
doxorubicin dosing schemes." said Jennifer K. Simpson, PhD, MSN,
CRNP, President & Chief Executive Officer of Panbela. “The
continued work by collaborators at Johns Hopkins University School
of Medicine is providing the foundation for the initiation of our
ovarian cancer program in this year.”
"The results suggest that SBP-101 in combination with
doxorubicin may have a role in the clinical management of ovarian
cancer, in particular the difficult to treat platinum-resistant
population where few options exist,” said Dr. Simpson. “These
studies continue to support the basis for moving into a clinical
trial program in ovarian cancer with a goal of developing effective
novel therapeutics in combination with standard of care for
patients with unmet medical needs.”
The poster highlights the efficacy of SBP-101 in combination
with doxorubicin which is used to treat platinum-resistant ovarian
cancer. Treatment with doxorubicin significantly increases the in
vitro toxicity of SBP-101 in both cisplatin-sensitive and
cisplatin-resistant ovarian cancer cell lines. SBP-101 and
doxorubicin cooperatively increase polyamine catabolism and
decrease overall cell survival in vitro.
Utilizing the immunocompetent VDID8+ murine ovarian cancer model
(ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin),
the combination of SBP-101 and doxorubicin was evaluated
significantly increased median mouse survival time. Cotreatment
also results in delayed ascites formation and decreased overall
tumor burden. The combination treatment cooperatively decreases
overall ascitic polyamine content.
Immunodeficient NSG mice injected with VDID8+ ovarian cancer
cells do not receive a survival benefit from ivospemin,
doxorubicin, or a combination treatment, indicating that an intact
immune system is required for the efficacy of this therapy. The
poster concludes that the treatment of C57Bl/6 mice containing
VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin
significantly prolonged survival and decreased overall tumor
burden. Future studies will be designed to evaluate the effects of
SBP-101 in combination with other polyamine metabolism modulators
as well as with immune modulators.
Details of the presentation are as follows:
Poster Presentation
Title: Ivospemin/doxorubicin combination
modulates polyamine metabolism to improve survival in murine
ovarian cancer models Session Category:
Experimental and Molecular Therapeutics Session
Title: Novel Antitumor Agents 6Session Date and
Time: Wednesday, April 10,
9:00-12:30 Abstract #: 7154
Additional meeting information can be found on the AACR website:
https://www.aacr.org/meeting/aacr-annual-meeting-2024/abstracts/
The abstract and poster will also be available on the Company's
website
at https://panbela.com/events-presentations/.
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 eligible for quotation on the OTCQB under the symbol
“PBLA”.
Cautionary Statement Regarding Forward-Looking
StatementsThis 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,” “believe,” “can,”
“design,” “expect,” “focus,” “intend,” “looking forward,” “may,”
“plan,” “positioned,” “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 obtain a listing of our common stock
on a national securities exchange; 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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