Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical-stage
biopharmaceutical company developing disruptive therapeutics for
the treatment of patients with urgent unmet medical needs, today
announced an Issue Notification for the European patent 2019213664
titled “METHODS FOR PRODUCING (6S,15S)-3,8,13,18-
TETRAAZAICOSANE-6,15-DIOL”. This patent, developed in collaboration
with Syngene International Ltd., an integrated research,
development, and manufacturing services company, claims a novel
process with a reduced number of synthetic steps from seventeen to
six to produce SBP-101, a lead investigational product.
The patent is valid until 2039 and is undergoing individual country
validations.
Jennifer K. Simpson, PhD, MSN, CRNP, President
& Chief Executive Officer of Panbela Therapeutics, commented,
“We’re excited to have this patent issued in Europe and look
forward to individual country validations. With the addition of
Europe to the previous issuance in the US and Australia, this
further expands our patent portfolio and supports our global
clinical programs.” First issued in the United States in 2021 and
now in several other territories, this patent covers a shorter
synthesis of SBP-101. Which provides many benefits including a
scalable, efficient and cost-effective manufacturing process to
enable future commercialization. Jonathan Hunt, Managing Director
and Chief Executive Officer, Syngene International Ltd., said, “We
have been partnering with Panbela for the last decade and we are
proud of the successful collaboration. Syngene's dedication to
optimizing efficiency and accelerating medicine delivery is evident
in the development of the novel process, which reduces the
synthetic steps from seventeen to six. Reducing the number of steps
in production and simplifying the manufacturing process means that
the drug will reach patients faster. The patent issued in multiple
markets and now in Europe is a testament to our combined expertise
and commitment to improving patient outcomes."
Dr. Simpson added, “We are pleased with the
continued growth of our patent portfolio with this latest patent
issuance. The process in this patent utilizes a pharmaceutical
starting material that is more widely available, increasing the
availability of drug supply moving forward to support of our
clinical programs.”
About our 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, ovarian cancer and diabetes. The combined development
programs have a steady cadence of catalysts with programs ranging
from pre-clinical to registration studies.
SBP-101 IvospeminIvospemin
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 EflornithineCPP-1X (eflornithine) is
being developed as a single agent tablet or high dose power sachet
for several indications including prevention of gastric cancer 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 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”.
About Syngene
Syngene International Ltd. is an integrated research, development
and manufacturing services company serving the global
pharmaceutical, biotechnology, nutrition, animal health, consumer
goods and specialty chemical sectors. Syngene’s scientists offer
both skills and the capacity to deliver great science, robust data
management and IP security and quality manufacturing at speed to
improve time-to-market and lower the cost of innovation. With a
combination of dedicated research facilities for significant
pharmaceutical firms as well as substantial specialist discovery,
development and manufacturing facilities, Syngene works with
biotech companies pursuing leading-edge science as well as
multinationals. For more details, visit www.syngeneintl.com.
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,”
“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) our lack of diversification the
corresponding risk of an investment in our Company; (iii) our
ability to maintain our listing on a national securities exchange;
iv) progress and success of our clinical development program; (v)
our ability to demonstrate the safety and effectiveness of our
product candidates: ivospemin ( SBP-101 ),
Flynpovi, and eflornithine (CPP-1X) (v) our ability to
obtain regulatory approvals for our product candidates, SBP-101,
Flynpovi 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,
Flynpovi 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, Flynpovi
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 (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 CarbonaraHayden IR(646)
755-7412james@haydenir.com
Media:Tammy GroenePanbela Therapeutics, Inc.(952)
479-1196IR@panbela.com
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