MINNEAPOLIS, April 12, 2022 (GLOBE NEWSWIRE) — Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical-stage biopharmaceutical company developing disruptive therapies for the treatment of cancer patients, announces a poster presentation highlighting results of SBP-101 as well as a modulator of polyamine metabolism in ovarian cancer at the American Association for Cancer Research (AACR), April 8-13, 2022. The work reflects the company’s ongoing collaboration with the Johns Hopkins University School of Medicine.
“Treatment of VDID8+ ovarian cancer injected C57Bl/6 mice with SBP-101 was observed to significantly prolong survival and reduce overall tumor burden,” said Jennifer K. Simpson, PhD, MSN , CRNP, President and CEO of Panbela. “We are grateful to our collaborators at Johns Hopkins University School of Medicine, who are at the forefront of cancer research. These data support our efforts to launch an ovarian cancer program this year. Additionally, we are excited to review these results on an R&D Call scheduled for May 3 at 9:00 a.m. EST.
“The results suggest that SBP-101 may play a role in the clinical management of ovarian cancer,” said Dr. Simpson, “We look forward to continuing our studies in ovarian and other cancers.” cancers, in order to develop effective treatments for cancer patients with unmet medical needs.”
The poster highlights the role of the natural polyamines, putrescine, spermidine and spermine, essential for cell growth and proliferation. As such, many cancers are dependent on high levels of polyamines that are maintained by dysregulated polyamine metabolism. Polyamine metabolism is therefore a promising target for cancer therapy, and modulation of polyamine metabolism has been attempted with many enzyme inhibitors and polyamine analogs. SBP-101 (diethyl dihydroxyhomospermine) is a novel spermine analog that has been shown to be effective in slowing pancreatic tumor progression both in vitro and in vivo.
This study determined the effect of SBP-101 treatment on polyamine metabolism in a variety of cancer cell types in vitro, including lung, ovary, prostate, pancreas, and breast. In addition, the activity of four enzymes involved in the polyamine pathway after treatment with SBP-101 or the well-characterized spermine analogue, BENSpm (N1,N11-bisethylnorspermine) was assessed. These results indicate that SBP-101 likely exerts its effects primarily through decreased polyamine biosynthesis with minor upregulation of catabolism, unlike the structurally similar BENSpm where increased polyamine catabolism is the predominant response.
The efficacy of SBP-101 using the VDID8+ murine ovarian cancer model (ID8+ C57B1/6 ovarian cells overexpressing both VEGF and defensin) was evaluated. Mice were treated with SBP-101 at 24 mg/kg or 6 mg/kg MWF alternately. Both doses of SBP-101 produced a statistically significant prolongation of survival (24 mg/kg p=0.0049, 6 mg/kg p=0.0042). There was no significant difference in response between the two doses of SBP-101. Prolonged survival was correlated with a delay in ascites production, the indication of tumor burden in this model. Moreover, when SBP-101-treated mice succumbed to the disease, their overall tumor burden was lower than that of control mice.
The poster concludes that treatment of C57Bl/6 mice injected with VDID8+ ovarian cancer with SBP-101 significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other modulators of polyamine metabolism as well as immune modulators.
The details of the presentation are as follows:
Title: The potential of the spermine analogue SBP-101 (diethyl dihydroxyhomospermine) as a modulator of polyamine metabolism in ovarian cancer Session category: Experimental and molecular therapeutics Session title: Therapeutic agents at small molecules Abstract #: 5488
Additional information about the meeting is available on the AACR website: Summaryyous | 2022 AACR Annual Meeting | April 8-13, 2022 | New Orleans
About the 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 12.0 months which is not not yet definitive, and an objective response rate (ORR) of 48%, both exceeding what is typically seen with gemcitabine + nab-paclitaxel standard of care suggesting potential complementary activity with the standard, state-approved chemotherapy regimen. FDA. 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 current clinical trial 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 .
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapies for patients with urgent unmet medical needs. The Company’s initial product candidate, SBP-101, is intended 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, ovarian cancer and exploring the potential for efficacy of SBP-101 in combination with other agents in other indications of cancer. 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”, “can”, “plan”, “intended”, and “will”. historical facts 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 funding to complete clinical trials; (ii) the progress and success of our Phase 1 clinical trial; (iii) the impact of the current COVID-19 pandemic on our ability to perform monitoring and reporting in our current clinical trial and to procure the active ingredient; (iv) our ability to demonstrate the safety and efficacy of our SBP-101 product candidate (v) our ability to obtain regulatory approvals for our SBP-101 product candidate in the United States, European Union or other other international markets; (vi) the market acceptance and level of future sales of our product candidate SBP-101; (vii) 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 setting up reimbursement agreements with third-party payers; (ix) the effect of competing technological and market developments; (x) costs relating to the filing and prosecution of patent applications and the enforcement or defense of patent claims; and (xi) 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 statement we make 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 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.
Investors: James Carbonara Hayden IR (646) 755-7412 [email protected]
Media: Tammy Groene Panbela Therapeutics, Inc. (952) 479-1196 [email protected]