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Panbela Therapeutics, Inc. (NASDAQ: PBLA) is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics to address unmet medical needs in cancer treatment and prevention. Headquartered in Minneapolis, Panbela's primary assets include Ivospemin (SBP-101) and Flynpovi.
Panbela's core business revolves around advancing its drug pipeline through clinical trials. The company has made significant strides in 2023 and early 2024, particularly with its Phase III ASPIRE trial, which targets untreated metastatic pancreatic ductal adenocarcinoma. This trial has surpassed 50% enrollment, bringing it closer to its goal of enrolling approximately 600 patients by Q1 2025. The recent approval of Onivyde in the same therapeutic area for the first time in over a decade augments Panbela's optimism regarding its interim analysis and potential for providing additional treatment options.
Financially, Panbela reported a net loss of $6.5 million in 2023's fourth quarter, with general and administrative expenses decreasing to $0.9 million. Research and development expenses rose to $6.1 million, reflecting the company's robust commitment to its clinical programs. As of December 31, 2023, Panbela had $2.6 million in cash and current assets totaling $3.1 million against current liabilities of $12.3 million. The completion of a public offering in January 2024 raised approximately $9 million in gross proceeds, bolstering the company's financial standing.
Panbela collaborates with renowned institutions like Johns Hopkins University School of Medicine, enhancing its research capabilities. The company's development programs encompass various cancers, including familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer, and diabetes.
- Ivospemin (SBP-101): This proprietary polyamine analogue aims to inhibit polyamine metabolism in pancreatic ductal adenocarcinoma and other tumors. Clinical studies have shown promising results, including a median overall survival of 14.6 months and an objective response rate of 48%, outperforming standard chemotherapy regimens. Ivospemin has not exacerbated chemotherapy-related adverse events, supporting its continued evaluation in the ASPIRE trial.
- Flynpovi™: A combination of CPP-1X (eflornithine) and sulindac, Flynpovi inhibits polyamine synthesis and enhances polyamine catabolism. Phase III trials have demonstrated its efficacy in preventing precancerous sporadic adenomas and delaying surgical events in FAP patients. The safety profile of Flynpovi supports its ongoing evaluation.
- CPP-1X (Eflornithine): Developed as a single agent for indications like gastric cancer prevention and recent onset Type 1 diabetes, CPP-1X has shown potential activity and tolerability in preclinical and early-phase trials.
Panbela's common stock is listed on the OTCQB market under the symbol “PBLA”. The company remains dedicated to advancing its clinical programs and maximizing stockholder value through strategic initiatives and potential regulatory approvals.
Panbela Therapeutics (Nasdaq: PBLA) announced a conference call scheduled for May 4, 2023, at 4:30 PM ET to discuss its Q1 2023 financial results. The call will include participation details and options for a replay. Panbela's pipeline features innovative therapies targeting urgent medical needs, including Ivospemin (SBP-101), which showed promising results in metastatic pancreatic cancer, achieving a median overall survival of 14.6 months and an objective response rate of 48%. Another product, Flynpovi, has demonstrated significant effectiveness in preventing pre-cancerous adenomas in Phase 3 trials. Despite these advancements, the company acknowledges potential risks concerning funding and regulatory approvals, which may impact future performance.
Panbela Therapeutics (Nasdaq: PBLA) presented results for ivospemin (SBP-101) at the AACR conference, demonstrating its potential in treating platinum-resistant ovarian cancer.
The study, in collaboration with Johns Hopkins University, shows that SBP-101 significantly improves survival rates when combined with chemotherapy agents like doxorubicin, gemcitabine, and topotecan. The addition of SBP-101 resulted in a 265% increase in median survival compared to untreated controls. Future plans include initiating a clinical trial program in ovarian cancer.
The ongoing research highlights SBP-101's unique ability to enhance chemotherapy effectiveness and aims to address urgent medical needs for ovarian cancer patients where treatment options are limited.
Panbela Therapeutics (Nasdaq: PBLA) announced the regained North American rights to develop and commercialize Flynpovi, a combination therapy for patients with familial adenomatous polyposis (FAP), following the termination of its licensing agreement with Cancer Prevention Pharmaceuticals. This allows Panbela to lead the global trial protocol and engage with the FDA and EMA for registration approval. The new trial will focus on FAP patients with intact lower gastrointestinal anatomy, building on the successful FAP-310 trial that showed a 100% risk reduction in surgery needs. With no approved drug therapies for FAP, Panbela aims to meet this urgent medical need, utilizing its internal expertise to design a compelling registration trial, seeking global market launch.
Panbela Therapeutics (Nasdaq: PBLA) announced that an abstract about CPP-1X (Eflornithine) has been accepted for poster presentation at the upcoming Immunology of Diabetes Society (IDS) meeting from May 23-27, 2023. This study is part of a multi-site clinical trial led by Indiana University, with funding from JDRF. Panbela is providing the drug for free to researchers.
The poster presentation will focus on the inhibition of polyamine biosynthesis and its effects on β cell function in type 1 diabetes. Panbela’s product pipeline includes assets for treating several conditions, including pancreatic cancer and familial adenomatous polyposis. Notable developments include promising results for Ivospemin indicating a median overall survival of 14.6 months and an objective response rate of 48% in clinical trials.
Panbela Therapeutics (Nasdaq: PBLA) announced that its abstract on CPP-1X (DFMO or Eflornithine) has been accepted for a poster presentation at the Endocrine Society meeting from June 15-18, 2023. The research is part of a multi-site clinical trial led by Indiana University School of Medicine, funded by JDRF. Panbela is providing the drug at no cost to researchers.
The poster presentation will explore the effects of Ornithine Decarboxylase deletion on preserving β-cell health in recent-onset Type 1 diabetes patients. The company’s pipeline includes other investigational drugs like Ivospemin (SBP-101) and Flynpovi, targeting conditions such as familial adenomatous polyposis and pancreatic cancer, showing promising outcomes in clinical studies.
Panbela Therapeutics (Nasdaq: PBLA) announced a new research partnership with Johns Hopkins University School of Medicine on April 3, 2023. The collaboration aims to advance the development of ivospemin (SBP-101), focusing on its activity in ovarian cancer and other cancer types, along with potential combinations with existing therapies. This partnership will be co-led by esteemed researchers in polyamine biology. Notably, ivospemin has shown promising results with a median overall survival of 14.6 months in clinical studies. Panbela's pipeline includes ongoing trials for various cancers, positioning the company for future growth.
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