Expanded potential of the polyamine analog SBP-101 (diethyl dihydroxyhomospermine) as a modulator of polyamine metabolism and cancer therapeutics

Panbela Therapeutics, Inc.

  • In vitro studies have determined that SBP-101 reducesD cell viability in a wide range of cancer cell types, with an exceptionally strong reduction in ovarian adenocarcinoma viability leading to a 42% increase in median survival in the VDID8+ mouse model of ovarian cancer

MINNEAPOLIS, June 28, 2022 (GLOBE NEWSWIRE) — Panbela Therapeutics, Inc..(Nasdaq: PBLA), a clinical-stage company developing disruptive therapies for the treatment of patients with urgent unmet medical needs, today announced the release of preclinical data from studies of SBP-101 that have demonstrated a 42% increase in median survival in a mouse model of VDID8+ ovarian cancer. Data published in the International Journal of Molecular Sciences also showed that SBP-101 delayed tumor progression and decreased overall tumor burden. SBP-101 is a proprietary polyamine analog designed to induce polyamine metabolic inhibition (PMI) by exploiting the compound’s observed high affinity for pancreatic ductal adenocarcinoma and other tumors. The company plans to launch a clinical program in ovarian cancer for SBP-101 in 2022.

“These data underscore the importance of polyamines as a therapeutic agent against cancer. These preclinical studies are fundamental to the expansion of our clinical development program. We are looking to extend SBP-101 to ovarian cancer, and later the potential for other cancers. This complements our current clinical development program with the ongoing global randomized trial (ASPIRE) of SBP-101 in first-line metastatic pancreatic cancer, and eflornithine in combination with an anti-PD-1 in pancreatic cancer. non-small cell lung (NSCLC) to begin later this year,” said Jennifer K. Simpson, PhD, MSN, CRNP, President and CEO of Panbela. “We look forward to advancing our development program for SBP-101 and eflornithine in the ovarian cancer clinic and NSCLC indications to help as many patients as possible. »

About our pipeline

The 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 colon cancer. ovary. The combined development programs have a steady cadence of catalysts with programs ranging from preclinical studies to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analog designed to induce polyamine metabolic inhibition (PMI) by exploiting the compound’s observed high affinity for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown tumor growth inhibition signals in clinical studies of US and Australian patients with metastatic pancreatic cancer, demonstrating a median overall survival (OS) of 14.6 months, which is and an objective response rate (ORR) of 48%, both of which exceed what is typically seen with standard treatment of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the standard FDA-approved chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which may be chemotherapy-related adverse events. Serious visual adverse events were assessed and patients with a history of retinopathy or at risk for retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the clinical trial currently sponsored by Panbela support the continued evaluation of SBP-101 in a randomized clinical 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 of 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% of subsequent precancerous sporadic adenomas compared to placebo. Focusing on FAP patients with lower gastrointestinal (GI) tract anatomy in the recent Phase 3 trial comparing Flynpovi to eflornithine monotherapy and sulindac monotherapy, FAP patients with lower gastrointestinal (GI) tract anatomy lower intestinal (patients with an intact colon, retained rectum, or surgical pouch), Flynpovi showed statistically significant benefit over both single agents (p ≤ 0.02) in delaying surgical events in the lower GI up to four years. The safety profile of Flynpovi did not differ significantly from that of single agents and supports the continued evaluation of Flynpovi for FAP.

RPC-1X

CPP-1X (eflornithine) is in development as a single-agent tablet or high-dose powder packet for several indications, including gastric cancer prevention, neuroblastoma treatment, and diabetes type 1 of recent appearance. Preclinical studies as well as investigator-initiated Phase 1 or Phase 2 trials suggest that the CPP-1X treatment is well tolerated and has potential activity.

About Panbela

Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapies for patients with urgent unmet medical needs. The Company’s main assets are SBP-101 and Flynpovi. Further information can be found at www.panbela.com. The common stock of Panbela Therapeutics, Inc. is listed on the Nasdaq Stock Market LLC under the symbol PBLA.

Caution Regarding Forward-Looking Statements

This press release contains “forward-looking statements”, including within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as: “believe”, “design”, “expect to’, ‘feel’, ‘intend’, ‘may’, ‘plan’, ‘intended’ and ‘will’. All statements other than statements of historical fact are statements that should be considered forward-looking statements. Forward-looking statements are neither historical facts nor guarantees of future performance. Instead, they are based solely on our current beliefs, expectations and assumptions about 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 beyond our control. Our actual results and financial condition may differ materially and adversely from forward-looking statements. Accordingly, you should not rely on any such forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those set forth in the forward-looking statements include, among others, the following: (i) our ability to obtain additional funds to execute our commercial and clinical development plans; (ii) the 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 efficacy of our product candidates: SBP-101 and eflornithine (v) our addiction to a third party for performing the registration trial of our Flynpovi product candidate; (vi) our ability to obtain regulatory approvals for our product candidates, SBP-101 and eflornithine in the United States, European Union or other international markets; (vii) market acceptance and level of future sales of our product candidates, SBP-101 and eflornithine; (viii) cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101 and eflornithine; (ix) the rate of progress in setting up reimbursement agreements with third-party payers; (x) the effect of competing technological and market developments; (xi) costs relating to the filing and prosecution of patent applications and the enforcement or defense of patent claims; and (xii) other factors as discussed in Part I, Item 1A under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, any additional risk disclosed in our Quarterly Reports on Form 10-Q and our current report. Reports on Form 8-K. Any forward-looking statements we make in this press release are based on information currently available to us and speak only from the date on which it is made. We undertake no obligation to update publicly any forward-looking statement or the reasons why actual results would differ from those anticipated in such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise.

Contact information:

Investors:
James Carbonara
R.I. Hayden
(646) 755-7412
[email protected]

Media:
Tammy Green
Panbela Therapeutics, Inc.
(952) 479-1196
[email protected]

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