On August 9, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported an Issue Notification for patent US 11,098,005 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL" (Press release, Panbela Therapeutics, AUG 9, 2021, View Source [SID1234586104]). This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process for the production of our lead investigational product SBP-101, reduces the number of synthetic steps for its production from seventeen to six, and provides patent coverage to 2039.
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Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Panbela Therapeutics, commented, "We’re excited to receive this U.S. patent issuance, a landmark event for the company. This patent, covering a shorter synthesis of SBP-101, provides many benefits including: 1) the ability to manufacture product with a reduced lead time 2) quicker access to drug supply facilitating expansion into additional indications and 3) enables a scalable, efficient and cost-effective manufacturing process for future commercialization. We applaud the dedicated efforts of our valued long-term partner Syngene International Ltd. in helping us achieve this important goal."
Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International said, "We congratulate Panbela for this milestone achievement. Our partnership with them dates back to 2013 and since then we have collaborated on multiple projects. In this case, streamlining the production process of an investigational product is a core expertise in our Development Services division. If the drug is approved, a simpler production process means that commercialization will be easier and the drug will reach patients more quickly."
Dr. Simpson added, "This process developed utilizes a pharmaceutical starting material that is widely available, assuring the company of drug supply moving forward. The Company expects to continue innovation and patent portfolio building as it develops its clinical programs".
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 have been 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 provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .