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Details:
Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Lead Product(s): Eflornithine
Therapeutic Area: Oncology Product Name: Iwilfin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2024
Details:
CPP-1X-T (eflornithine) is a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes. It is approved by USFDA for the treatment of Pediatric Neuroblastoma.
Lead Product(s): Eflornithine
Therapeutic Area: Oncology Product Name: CPP-1X-T
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: US WorldMeds
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
Lead Product(s): Eflornithine
Therapeutic Area: Oncology Product Name: Iwilfin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
Lead Product(s): Eflornithine
Therapeutic Area: Oncology Product Name: Iwilfin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
DFMO (eflornithine) is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, which is investigated in combination with eflornithine in patients newly diagnosed with glioblastoma.
Lead Product(s): Eflornithine,Temozolomide
Therapeutic Area: Oncology Product Name: DFMO
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2023
Details:
Panbela has divested certain assets in its eflornithine pediatric neuroblastoma program including, CPP-1X (eflornithine), being developed for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes.
Lead Product(s): Eflornithine
Therapeutic Area: Oncology Product Name: CPP-1X
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: US WorldMeds
Deal Size: $9.5 million Upfront Cash: Undisclosed
Deal Type: Divestment July 19, 2023
Details:
The agreement is for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial is evaluating the maximum tolerated dose of CPP-1X (eflornithine).
Lead Product(s): Eflornithine,Pembrolizumab
Therapeutic Area: Oncology Product Name: CPP-1X
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Moffitt Cancer Center
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 22, 2023
Details:
CPP-1X-T (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes.
Lead Product(s): Eflornithine
Therapeutic Area: Endocrinology Product Name: CPP-1X-T
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: JDRF
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2023
Details:
Panbela has regained the North American rights to develop and commercialize Flynpovi (the combination of CPP-1X (eflornithine hydrochloride) and sulindac) in patients with FAP. The drug is withdrawn form the european market and company will conduct FAP trial for phase 3.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: One-Two Therapeutics Assets Limited
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination April 11, 2023
Details:
The collaboration is intended to expand the development of Panbela’s investigative agent SBP-101 (ivospemin), including activity in models of ovarian and other cancer types, further evaluations into MOA, and potential combination with CPP-1X and standard of care agents.
Lead Product(s): Ivospemin,Eflornithine
Therapeutic Area: Oncology Product Name: SBP-101
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johns Hopkins University School of Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 03, 2023
Details:
CPP-1X-T (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes.
Lead Product(s): Eflornithine
Therapeutic Area: Endocrinology Product Name: CPP-1X-T
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Indiana University School of Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 11, 2023
Details:
DFMO (eflornithine) is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer.
Lead Product(s): Eflornithine
Therapeutic Area: Rare Diseases and Disorders Product Name: DFMO
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Michigan State University
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 10, 2023
Details:
Flynpovi (eflornithine hydrochloride) is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2022
Details:
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. The safety profile for Flynpovi did not differ from the single agents and supports the evaluation for FAP.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Panbela Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 16, 2022
Details:
The combined entity will have an expanded pipeline addressing focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer, including Flynpovi, the lead asset.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Panbela Therapeutics
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition February 22, 2022
Details:
Enrollment of patients in Phase 3 STELLAR trial for DFMO (eflornithine hydrochloride), a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase in patients in patients with recurrent anaplastic astrocytoma.
Lead Product(s): Eflornithine,Lomustine
Therapeutic Area: Oncology Product Name: DFMO
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2022
Details:
Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer.
Lead Product(s): Eflornithine,Lomustine
Therapeutic Area: Oncology Product Name: DFMO
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
DFMO is a repurposed molecule investigated for use as an extended maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy.
Lead Product(s): Eflornithine
Therapeutic Area: Oncology Product Name: DFMO
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Norgine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 23, 2021
Details:
Patent relates to a solution of eflornithine for oral administration currently being evaluated in Orbus’ Phase 3 STELLAR study in rare brain cancer.
Lead Product(s): Eflornithine,Lomustine
Therapeutic Area: Oncology Product Name: DFMO
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2020
Details:
The expanded Series A funding will support the ongoing STELLAR study, a Phase 3 clinical trial studying eflornithine in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy.
Lead Product(s): Eflornithine,Lomustine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Longitude Capital
Deal Size: $71.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing October 22, 2020
Details:
Although the trial did not demonstrate that overall disease progression was significantly lower with CPP-1X/sul compared to eflornithine or sulindac alone, in a subgroup of patients with intact colons there was a 70% decreased risk of disease progression with CPP-1X/sul.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Genetic Disease Product Name: CPP-1X/sul
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2020
Details:
The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Genetic Disease Product Name: CPP-1X/sul
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Cancer Prevention Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration this month seeking accelerated approval for CPP-IX/sul for the same indication.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Genetic Disease Product Name: CPP-1X/sul
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
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