공시 • Oct 30
Nant Capital Engages in Discussions with Panbela Therapeutics On October 29, 2024, Nant Capital, LLC announced that it has been and may continue to be in contact with members of Panbela Therapeutics, Inc.’s management, the Company’s board of directors, other significant shareholders, and others regarding alternatives that the Company could employ to maximize shareholder value. 공시 • Jun 24
Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial Modification Panbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended study continuation without modification, marking the third consecutive positive safety review. The safety database now includes 395 patients, compared to 214 patients on November 29, 2023. Key Takeaways: The DSMB's recommendation to proceed without modification affirms support for ivospemin’s safety profile. The safety database has expanded to 395 patients, providing a robust foundation for evaluating ivospemin's safety. The lower-than-expected event rate suggests the potential for prolonged survival among ASPIRE trial participants. Rapid enrollment positions Panbela to remain on path to complete enrollment in First Quarter 2025, earlier than initially anticipated. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin, and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years, with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9-month survival benefit compared to the approval of gemcitabine and nab-paclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela remains committed to advancing the ASPIRE trial and evaluating ivospemin's potential to improve outcomes for patients with mPDAC. Despite recent advancements in treatment, the median overall survival for patients with mPDAC remains less than 12 months. The company looks forward to the interim survival analysis in early 2025, which will provide important insights into ivospemin's potential to address this significant unmet medical need. 공시 • Apr 27
Panbela Therapeutics, Inc. Announces Nasdaq Files A Form 25 Notification of Removal from Listing On April 25, 2024, The Nasdaq Stock Market LLC (Nasdaq") filed a Form 25 Notification of Removal from Listing indicating that the delisting will become effective ten days after the Form 25 was filed. As a result, Panbela Therapeutics, Inc. no longer intends to file its own Form 25. The Company has applied to list its common stock on the US Equity Listings Tier II of the Chicago Board of Options Exchange (CBOE"). No assurances can be given that the application will be approved or that a trading market will develop on the CBOE. In the interim, the Company intends to maintain the existing eligibility for quotation of its common stock on the OTCQB under its current symbol, PBLA". 공시 • Apr 24
Panbela Therapeutics, Inc. Announces Interim Data Analysis for its Ongoing ASPIRE Trial Pushed to First Quarter of 2025 Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as first quarter of 2025. This delay in the projected date for analysis comes as a result of the trial's current event rate, which is lower than initially anticipated, indicating that patients have lived longer than expected. The ASPIRE trial, which is evaluating the efficacy and safety of Panbela's lead product candidate, ivospemin (SBP-101), in combination with gemcitabine and nab-paclitaxel (Abraxane) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), requires 33% of the total expected events to occur before the interim analysis can be conducted. As of the latest assessment, less than half of the required events for the interim analysis have occurred. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9 month survival benefit compared to the approval of gemcitabine and nab-paclitaxel which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate. 공시 • Apr 20
Panbela Announces Poster Presentation At American Association for Cancer Research Panbela Therapeutics, Inc. announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine. The poster highlights the efficacy of SBP-101 in combination with doxorubicin which is used to treat platinum-resistant ovarian cancer. Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increase polyamine catabolism and decrease overall cell survival in vitro. Utilizing the immunocompetent VDID8+ murine ovarian cancer model (ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin), the combination of SBP-101 and doxorubicin was evaluated significantly increased median mouse survival time. Cotreatment also results in delayed ascites formation and decreased overall tumor burden. The combination treatment cooperatively decreases overall ascitic polyamine content.Immunodeficient NSG mice injected with VDID8+ ovarian cancer cells do not receive a survival benefit from ivospemin, doxorubicin, or a combination treatment, indicating that an intact immune system is required for the efficacy of this therapy. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators as well as with immune modulators. 