Panbela Presents Clinical Data on Phase 1b Clinical Trial of SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic PDA at 2022 ASCO GI Meeting
January 24 2022 - 9:00AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage
biopharmaceutical company developing disruptive therapeutics for
the treatment of patients with cancer today announced the
presentation of interim clinical data from its Phase 1b combination
therapy study of SBP-101, a proprietary polyamine analogue, with
gemcitabine and nab-paclitaxel in patients with metastatic
pancreatic ductal adenocarcinoma (PDA), at the American Society of
Clinical Oncology (ASCO) Gastrointestinal (GI) Meeting that took
place January 20-22, 2022.
Jennifer K. Simpson, PhD, MSN, CRNP President & Chief
Executive Officer of Panbela Therapeutics, commented, “We are
excited to share interim data from cohort 4 and the expansion. A
median overall survival (OS) of 12.0 months which is not yet final,
and an objective response rate (ORR) of 48%, both exceeded
historical rates reported for gemcitabine + nab paclitaxel and
supports the continued development of SBP-101 as an addition to
first-line treatment for advanced PDA and as neo-adjuvant treatment
for patients with potentially resectable disease.”
“The conclusion of the abstract is that SBP-101 may enhance
first-line treatment with gemcitabine and nab-paclitaxel patients
with metastatic PDA. We are encouraged by this conclusion even
under sub-optimal conditions, including dose interruptions, which
confounded results. Cohorts 2 and 3 did not have the dose
interruptions that cohort 4 had, and cohort 2 had an objective
response rate of 71%,” continued Dr. Simpson. “We intend to
continue development of SBP-101 and look forward to executing our
global randomized phase 2 study in metastatic PDA.”
At the Phase 1b dose and schedule (N=30), CA19-9 levels
decreased 60-99% in 70% of evaluable patients, with 1/29 (3%)
achieving a complete remission, 13/29 evaluable patients achieving
partial responses (45%) and 10/29 achieving stable disease at 8
weeks (34%). PFS was 6.0 months. While PFS may be confounded by
SBP-101 dosing holds implemented to investigate potential toxicity,
the rates for 6-month PFS was 52% and for 12 month PFS was 10%.
Nine subjects are in survival follow up as of the date the poster
was presented at the ASCO GI meeting. Median OS is 12.0 months and
is not final.
The safety population includes all subjects who received at
least one dose of SBP-101 (N=50). The most common Grade
≥3 adverse events (AEs) related to any study medication were
neutropenia in 20 subjects (19 attributed to G+A and 1 attributed
to all 3) and elevated liver function tests in 14 subjects (5
attributed to SBP-101 and 9 attributed to all 3).
SBP-101-related increases in LFTs were asymptomatic in all but 2
subjects and reversed in all subjects when SBP-101 administration
was interrupted and dose-reduced or discontinued. Additionally,
seven subjects experienced serious vision adverse events (4
possibly related to SBP-101, 1 related to gemcitabine and 2 related
to all 3 based on PI assessment). All were considered by the
sponsor to be possibly related to SBP-101; 5 had findings
consistent with retinopathy.
The company has just begun a randomized trial to study SBP-101,
as an addition to first-line treatment for metastatic PDA, will
begin a neoadjuvant pancreatic trial this quarter and will begin an
Ovarian Cancer program mid-year.
Additional meeting information can be found on the ASCO website
at https://meetings.asco.org/gi/ .
After presenting at ASCO GI, the poster will be available on the
company's website on January 24, 2022.
About SBP-101SBP-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
potential signals of tumor growth inhibition in clinical studies of
US and Australian metastatic pancreatic cancer patients, suggesting
potential complementary activity with an existing FDA-approved
standard chemotherapy regimen, if SPB-101 receives approval in the
US. 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 observed in the Company’s recently
completed Phase 1a/1b clinical trial 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 .
About PanbelaPanbela Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing disruptive
therapeutics for patients with urgent unmet medical needs. The
company’s initial product candidate, SBP-101, is for the treatment
of patients with metastatic pancreatic ductal adenocarcinoma, the
most common type of pancreatic cancer. Panbela Therapeutics, Inc.
is dedicated to treating patients with pancreatic cancer and
exploring SBP-101’s potential for efficacy in combination with
other agents in other cancer indications. 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
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: “believe,” “expect,” “intend,” “may,”
and “plan.” Examples of forward-looking statements include
statements we make regarding our approximate enrollment
period. 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 a randomized clinical trial; (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 ext. 170
IR@panbela.com
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