Panbela Announces Validation of European Patent in UK, Italy, Germany, France, and Spain for Claims of a Novel Process for the Production of SBP-101
31 Outubro 2023 - 9:15AM
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 validation for the European patent 2019213664 titled
"METHODS FOR PRODUCING (6S,15S)-3,8,13,18-
TETRAAZAICOSANE-6,15-DIOL" in the United Kingdom, Italy, Germany,
France, and Spain. 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.
Jennifer K. Simpson, PhD, MSN, CRNP, President
& Chief Executive Officer of Panbela Therapeutics, commented,
"We're excited to have this European patent now validated in
individual countries." 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, "Our
partnership with Panbela exemplifies Syngene's commitment to
fostering innovation and collaboration in the pharmaceutical
industry. Reducing the manufacturing steps of SBP-101 from
seventeen to just six not only accelerates the delivery of this
promising drug to patients but also underscores Syngene's
dedication to improving efficiency. This patent validation in
certain European countries is a testament to our combined expertise
and commitment to improving patient outcomes. We are proud to stand
alongside Panbela as we continue to push the boundaries of
pharmaceutical innovation."
Dr. Simpson added, "We are pleased with the
continued growth of our patent portfolio with the validation in
several European countries. With a pharmaceutical starting material
that is more widely available and a process that is effective and
scalable, this ensures a stable drug supply for current clinical
trials and future endeavors."
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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