Panbela Announces Publication of Abstract Titled: Evaluation of Myeloma Cell Lines Viability Following Administration of SBP-101 and DFMO Polyamine Inhibitors
04 12월 2023 - 10:00PM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with urgent unmet medical needs, today
announces the publication of preclinical data from studies of
ivospemin (also known as SBP-101) and eflornithine (also known as
CPP-1X or DFMO) research in multiple myeloma (cell lines). Data
published in the November supplemental issue of the Journal Blood
investigated the effects of polyamine inhibition by ivospemin and
CPP-1X on myeloma cell lines growth and viability in vitro. Results
showed that ivospemin and CPP-1X treatment significantly decreased
cell proliferation and induced apoptosis in a panel of multiple
myeloma cell lines. When ivospemin and CPP-1X were combined an
almost complete abolition of cell growth occurred. These results
demonstrate the anti-neoplastic potential of ivospemin and CPP-1X
and offer a compelling rationale for its clinical development as a
potentially promising treatment option for multiple myeloma.
The work reflects the company’s on-going collaboration with
researchers from The University of Texas MD Anderson Cancer Center
for the evaluation of polyamine metabolic inhibitor therapies in
combination with CAR-T cell therapies in preclinical models. The
abstract can be found in the Journal Blood Volume 142. Supplement
1, 28 November 2023, page 6589.
An earlier publication identified a metabolite panel primarily
consisting of polyamines as predictive of poor response to
anti-CD19 CAR T-cell therapy in relapsed refractory large β
cell lymphoma (LBCL) and it is known that the polyamine (PA) uptake
transport system is upregulated in LBCL and multiple myeloma (MM).
The results from the in vitro studies published in this abstract
are the first step in assessing if ivospemin and/or CPP-1X
treatment will augment CAR-T mediated cytotoxicity against multiple
myeloma cell lines. Together, this suggests the potential for a
polyamine targeted therapy in combination with CAR-T therapies.
“We are excited to have initiated the studies evaluating our
polyamine inhibitors ivospemin and CPP-1X in models of multiple
myeloma. This work demonstrates that each agent alone and in
combination with each other can decrease tumor cell growth and
induce tumor cell death. Since the literature has demonstrated the
relationship between polyamines and the immune system, this
suggests that by adding our polyamine metabolic inhibitors, such as
ivospemin and eflornithine, they may augment CAR-T cell therapy
with the potential to overcome this resistance mechanism to
potentially improve initial response rates and durability of
response,” said Jennifer K. Simpson, PhD, MSN, CRNP, President
& Chief Executive Officer of Panbela. “Polyamine modulation of
the immune system is an important focus for Panbela. With our first
clinical proof of concept of polyamine targeted therapy in
combination with a checkpoint inhibitor for patients with STK11
non-small cell lung cancer, we are excited for this research
collaboration to now evaluate the potential benefit of polyamines
in immune modulation for hematologic malignancies.”
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 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), 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.
Eflornithine (CPP-1X)CPP-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 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”.
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
Panbela Therapeutics (NASDAQ:PBLA)
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