ivospemin (SBP-101) / Panbela Therap - LARVOL DELTA

Effect of Ivospemin and Difluoromethylornithine Polyamine Inhibitors on Viability of Myeloma Cell Lines (ASH 2023) - "The polyamine inhibitors,Ivospemin and DFMO, exhibited a marked anti-proliferative effect in the four human MM cell lines studied when used alone or in combination. These results confirm the anti-neoplastic potential of SBP-101 and DFMO and offer a compelling rationale for its clinical development as a potentially promising treatment option for multiple myeloma. Fig."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • ANXA5

Ivospemin and doxorubicin cooperatively modulate polyamine metabolism and the tumor immune microenvironment to improve survival in a murine ovarian cancer model (AACR 2025) - "We have also shown that ivospemin increases the efficacy of gemcitabine and topotecan in vivo by delaying tumor onset and reducing overall tumor burden...Cytokine analysis was performed on supernatant from cultured ascites cells to evaluate immune cell activity. Recognizing the non-representative mutational status of the VDID8+ model as a limitation, we are currently evaluating the combination of ivospemin and doxorubicin in genetically defined murine models that better recapitulate human high-grade serous ovarian carcinomas."

Preclinical • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • PTPRC • SAT1

Panbela Provides Business Update and Reports Q3 2024 Financial Results (GlobeNewswire) - "...'The third quarter marked another period of significant advancement for Panbela, and momentum has continued into Q4, highlighted by a transformative $12.0 million strategic financing from Nant Capital....Our Phase III ASPIRE trial continues to progress, and the previously noted lower event rate continues to suggest potential improved survival outcomes for patients, with interim analysis still on track for Q1 2025'."

Financing • P3 data • Pancreatic Ductal Adenocarcinoma

Rapidly progressive central retinal pigmented epithelium atrophy after Ivospemin (SBP-101) treatment for pancreatic adenocarcinoma. (PubMed, Am J Ophthalmol Case Rep) - "One year before, she started administration of SBP-101 combined with nab-paclitaxel and gemcitabine to treat her malignancy...In the suspect of a cancer associated retinopathy (CAR), the patient underwent bilateral injection of intravitreal slow-releasing dexamethasone, with poor clinical outcomes...No treatment was possible. In conclusion, ophthalmologists should be aware of the existence of a sight-threatening side effect of SPB-101 administration, since we highlighted a massive bilateral RPE atrophy rapidly developing after the second drug injection."

Journal • Ocular Melanoma • Oncology • Ophthalmology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Retinal Disorders

Panbela Provides Business Update and Reports Q2 2024 Financial Results (GlobeNewswire) - "Provided revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests the potential for improved survival outcomes for patients in the trial."

P2/3 data • Pancreatic Ductal Adenocarcinoma

The Polyamine Analogue Ivospemin Increases Chemotherapeutic Efficacy in Murine Ovarian Cancer. (PubMed, Biomedicines) - "The polyamine analogue ivospemin, also known as SBP-101, has shown efficacy in slowing pancreatic and ovarian tumor progression in vitro and in vivo and has demonstrated encouraging results in early pancreatic cancer clinical trials...We treated four ovarian adenocarcinoma cell lines in vitro and found that each was sensitive to ivospemin regardless of cisplatin sensitivity...Using the VDID8+ murine ovarian cancer model, we found that the addition of ivospemin to either topotecan or gemcitabine increased median survival over untreated animals alone, delayed tumor progression, and decreased the overall tumor burden. Our results indicate that the combination of ivospemin and chemotherapy is a worthwhile treatment option to further explore clinically in ovarian cancer."

Journal • Preclinical • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial Modification (GlobeNewswire) - "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....Rapid enrollment positions Panbela to remain on path to complete enrollment in Q1 2025, earlier than initially anticipated....The company looks forward to the interim survival analysis in early 2025..."

DSMB • P2/3 data • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Therapeutics Announces Interim Data Analysis for ASPIRE Trial Pushed to Q1 2025 (GlobeNewswire) - "Panbela Therapeutics, Inc...announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as Q1 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 early indications from the ASPIRE trial support this belief, and we remain committed to advancing this important study and look forward to sharing the interim results in March 2025'."

P2/3 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Announces Poster Presentation at American Association for Cancer Research (GlobeNewswire) - "Panbela Therapeutics, Inc...today 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....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."

Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Ivospemin/doxorubicin combination modulates polyamine metabolism to improve survival in murine ovarian cancer models (AACR 2024) - "Ivospemin treatment reduces cell viability in ovarian adenocarcinoma cell lines and increases the toxicity of doxorubicin regardless of cisplatin sensitivity...Recognizing the non-representative mutational status of the VDID8+ model as a limitation, we are currently evaluating the combination of ivospemin and doxorubicin in genetically defined murine models that better recapitulate human high-grade serous ovarian carcinomas. Ongoing studies will determine influences on the tumor microenvironment and will mechanistically evaluate the cooperativity of ivospemin and doxorubicin on pathways outside of polyamine metabolism."

Preclinical • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • SAT1

Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results (GlobeNewswire) - "Significantly, our Phase III ASPIRE trial for untreated metastatic pancreatic ductal adenocarcinoma exceeded 50% enrollment and we anticipate full enrollment of approximately 600 patients to be completed by the first quarter of 2025."

Enrollment status • Pancreatic Ductal Adenocarcinoma

ASPIRE: Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer (clinicaltrials.gov) - P2/3 | N=600 | Recruiting | Sponsor: Panbela Therapeutics, Inc. | N=150 ➔ 600 | Trial completion date: May 2024 ➔ Jan 2027 | Trial primary completion date: May 2024 ➔ Aug 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Acceptance of Ivospemin (SBP-101) Abstract for Poster Presentation at American Association for Cancer Research (AACR) (GlobeNewswire) - "Panbela Therapeutics...announced that an abstract for SBP-101, a proprietary polyamine analogue, has been accepted for poster presentation at the American Association for Cancer Research (AACR), which will be held April 5-10, 2024. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine."

Preclinical • Ovarian Cancer

Panbela Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated Momentum (GlobeNewswire) - "Panbela Therapeutics, Inc...today announced it has reached 50% enrollment for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma...'As we have reached the near full complement of sites open and enrolling, we have seen a steady cadence of enrollment, expecting full enrollment to be completed by Q1 2025. We are looking forward to the interim data analysis based on overall survival in mid-2024.'....In the global ASPIRE trial, there are approximately 90 sites up and running throughout the United States, Europe, Australia, and South Korea."

Enrollment status • P2/3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Announces 2nd Independent Safety Review of the ASPIRE Registration Clinical Trial: Recommended Continuation with no Trial Modification (GlobeNewswire) - "Panbela Therapeutics, Inc...announces that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients which included 214 patients in the trial. The DSMB has recommended that the study continue without modification. The ASPIRE Trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma."

DSMB • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Announces Publication of Abstract Titled: Evaluation of Myeloma Cell Lines Viability Following Administration of SBP-101 and DFMO Polyamine Inhibitors (GlobeNewswire) - "Panbela Therapeutics...announces the publication of preclinical data from studies of ivospemin (also known as SBP-101) and eflornithine (also known as CPP-1X or DFMO) research in multiple myeloma (cell lines). Data published in the November supplemental issue of the Journal Blood investigated the effects of polyamine inhibition by ivospemin and CPP-1X on myeloma cell lines growth and viability in vitro. Results showed that ivospemin and CPP-1X treatment significantly decreased cell proliferation and induced apoptosis in a panel of multiple myeloma cell lines. When ivospemin and CPP-1X were combined an almost complete abolition of cell growth occurred. These results demonstrate the anti-neoplastic potential of ivospemin and CPP-1X and offer a compelling rationale for its clinical development as a potentially promising treatment option for multiple myeloma."

Preclinical • Multiple Myeloma

Panbela Announces Validation of European Patent in UK, Italy, Germany, France, and Spain for Claims of a Novel Process for the Production of SBP-101 (GlobeNewswire) - "Panbela Therapeutics, Inc...today announced validation for the European patent 2019213664 titled 'METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL' in the United Kingdom, Italy, Germany, France, and Spain. This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101, a lead investigational product. The patent is valid until 2039."

Patent • Oncology • Solid Tumor

Acceptance of Polyamine Inhibitor CAR-T Combination Abstract for Online Publication (GlobeNewswire) - "Panbela Therapeutics, Inc...today announced that an abstract about SBP-101 and CPP-1X (also known as DFMO or Eflornithine) research in multiple myeloma (cell lines), has been accepted for an online publication on the American Society of Hematology (ASH) meeting site in the November supplemental issue of the journal Blood."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

. @mnoel3232 presenting data on SBP-101 in #pancreaticcancer and his upcoming IIT in the neoadjuvant setting #pancsm #DAVABermudaGI @RueschCenter

Panbela Announces Issuance of New Patent in China for Claims of a Novel Process for the Production of SBP-101 (GlobeNewswire) - "...announced an Issue Notification for the Chinese patent 201980010826.7 titled 'METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL'. This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101 (ivospemin), a lead investigational product. The patent is valid until 2039."

Patent • Oncology • Solid Tumor

Panbela Announces Issuance of New Patent in Europe for Claims of a Novel Process for the Production of SBP-101 (GlobeNewswire) - "Panbela Therapeutics, Inc...announced an Issue Notification for the European patent 2019213664 titled 'METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL'. This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101, a lead investigational product. The patent is valid until 2039 and is undergoing individual country validations."

Patent • Oncology • Solid Tumor

Panbela Opens Enrollment in UK and Germany for Aspire Trial in Pancreatic Cancer, All Countries/Regions in the Aspire Trial are Now Open and Actively Enrolling (GlobeNewswire) - "Panbela Therapeutics, Inc...announced it has opened enrollment in the UK and Germany for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer....'Next up, we are focused on having all sites open for enrollment within the next couple months, and then towards the interim data analysis in early 2024'. There are approximately 95 sites planned for throughout the United States, Europe, Australia, and South Korea, in the global Aspire trial."

Enrollment open • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Announces Issuance of New Patent in Australia Patent is for Claims of a Novel Process for the Production of SBP-101 (GlobeNewswire) - "Panbela Therapeutics...announced an Issue Notification for the Australian patent 2019213664 titled 'METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL'. This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101, a lead investigational product. The patent is valid until 2039."

Patent • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Announces Preliminary Safety Analysis for ASPIRE Trial (GlobeNewswire) - "Panbela Therapeutics, Inc...announces that the independent Data Safety Monitoring Board (DSMB) of the Phase III ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients in the trial. The DSMB has recommended that the study continue without modification. The ASPIRE Trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma....'With a focus on enrollment and completing site initiations, we are looking forward to the interim analysis in early 2024'."

DSMB • P2/3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Panbela Announces Sponsored Research Agreement to Evaluate Polyamine Metabolic Inhibitor Therapy in Combination with CAR-T Cell Therapy (GlobeNewswire) - "Panbela Therapeutics, Inc...announced it has entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in combination with CAR-T cell therapies in preclinical models. The initial goal of these studies will be to ascertain if eflornithine and/or ivospemin treatment will augment CAR-T mediated cytotoxicity against CD19+ large B-cell lymphoma (LBCL) cell lines."

Licensing / partnership • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology