Panbela Announces Acceptance of Abstract for Poster Presentation at American Society of Clinical Oncology Annual Meeting

Rhea-AI Summary

Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced that an abstract for its product candidate SBP-101 has been accepted for a poster presentation at the ASCO Annual Meeting from June 4-8, 2021. The presentation will focus on SBP-101's potential efficacy as a first-line treatment for metastatic pancreatic ductal adenocarcinoma in combination with standard therapies. While the initial studies indicate promising signals of efficacy, safety concerns remain, as the FDA has issued a partial clinical hold due to serious adverse events requiring further evaluation.

Positive

• SBP-101 shows signals of efficacy in clinical studies for treating metastatic pancreatic ductal adenocarcinoma.
• The product has not exacerbated common chemotherapy-related adverse events like bone marrow suppression.

Negative

• The FDA has placed SBP-101 under a partial clinical hold due to serious visual adverse events.
• Continued development is contingent on resolving the FDA's concerns and providing a complete response.

MINNEAPOLIS, April 06, 2021 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today announced that an abstract for SBP-101, a proprietary polyamine analogue, has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held virtually from June 4-8, 2021.

Details of the presentation are as follows:
Poster Presentation

• Title: SBP-101, a polyamine metabolic inhibitor, administered in combination with gemcitabine and nab-paclitaxel, shows signals of efficacy as first-line treatment for subjects with metastatic pancreatic ductal adenocarcinoma.
   
• Session Name: Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Additional meeting information can be found on the ASCO website at https://meetings.asco.org/am/attend. After presenting at ASCO, the poster will be available on the Company's website.

About SBP-101

SBP-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 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. 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. Recently observed serious visual adverse evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold.  For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03412799 .

About Panbela

Panbela 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 and in treating other types of cancer. 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 Statements

This 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: “believes,” “expect,” “intend,” “may,” and “plan.” Examples of forward-looking statements include statements we make regarding the timing and content of the poster presentation. 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; (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 
IR@panbela.com

FAQ

What is the significance of SBP-101 for PBLA?

SBP-101 is a proprietary compound that may offer new treatment options for patients with metastatic pancreatic ductal adenocarcinoma.

When will the results of the SBP-101 presentation be available?

The results will be presented during the ASCO meeting from June 4-8, 2021, and will subsequently be accessible on the company's website.

What is the FDA's current status on SBP-101?

The FDA has issued a partial clinical hold on SBP-101 due to the evaluation of serious adverse events.

What are the next steps for PBLA regarding SBP-101?

Panbela Therapeutics must submit a complete response to the FDA before resuming development of SBP-101.