On June 4, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported 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 (G+A) in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 4-8, 2021 (Press release, Panbela Therapeutics, JUN 4, 2021, View Source [SID1234583760]).

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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. Optimal dosing regimens were explored and the signals of efficacy reported support 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 poster 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 look forward to initiating a randomized phase 2 study in metastatic PDA mid-year."

In the response-evaluable subjects in cohort 4 + Phase 1b (N=29), 11 had treatment with SBP-101 interrupted to evaluate retinal toxicity; this may impact final efficacy results. In cohort 2 (N=7) the objective response rate (ORR) was 71%, and the disease control rate (DCR) was 100% by RECIST criteria (stable disease (SD) or better for ≥ 16 weeks). Median progression free survival (PFS) in cohort 2 was 5.63 months and median overall survival (OS) was 10.3 months compared with ORR of 48%, DCR of 70%, PFS of 5.2 months and median OS, not yet reached, in cohort 4 + 1b.

SBP-101 was well-tolerated when administered at doses and schedules tested in combination with G+A in subjects with previously untreated metastatic pancreatic adenocarcinoma. 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 15 subjects (5 attributed to SBP-101 and 10 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, six subjects experienced serious vision adverse events (3 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. All future studies will exclude patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included.

The company continues to plan for the initiation of a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, in the middle of this year and releasing preclinical data across tumors outside of pancreatic cancer by year-end.

Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source After presenting at ASCO (Free ASCO Whitepaper), the poster will be available on the company’s website at the end of day on June 8, 2021.

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 events are being 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 generally provides potential support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source