Panbela Therapeutics Inc (NASDAQ: PBLA) operating out of Minneapolis, Minnesota is a clinical-stage biotech developing disruptive therapeutics with a pipeline consisting of assets in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. Panbela’s lead assets are Ivospemin (SBP-101), Flynpovi as well as CPP-1X – CPP-1X (eflornithine). 

PBLA has a strong management team led by CEO and President Jennifer K Simpson, Ph.D., MSN, CRNP. Dr. Simpson joined the Company in 2020 and brings more than 12 years’ experience in pharmaceutical executive leadership, global marketing and product commercialization. Most recently Dr. Simpson was the CEO of Delcath (Nasdaq:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancer. Also on the executive management team are Susan Horvath, Elizabeth Bruckheimer, Ph.D., Ashok Chavan, Ph.D., Rachel Bragg, MPH, Tammy Groene, Anthony L. Kiorpes, Ph.D., DVM, and Michael Walker, M.D. 

Panbela lead candidate Ivospemin (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. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. 

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Flynpovi ™ – Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP. Cancer Prevention Pharmaceuticals completed the FAP-310 Phase III trial studying the efficacy and safety of the combination of eflornithine and sulindac (Flynpovi), as compared with either drug alone, in adults with FAP.

CPP-1X – CPP-1X (eflornithine) is being developed as 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. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity. 

In January of 2022, the Company announced the initiation of a new clinical trial. Referred to as ASPIRE, studying ivospemin (SBP-101) the trial is a randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, a standard pancreatic cancer treatment regimen in patients previously untreated for metastatic pancreatic cancer. The trial is being conducted globally at approximately 95 sites in the United States, Europe and Asia – Pacific. Significant progress has been made with PLBA receiving approval from the Australian Human Research Ethics Committee (HREC) to expand the ASPIRE global clinical trial to Australia. The Company also enrolled its first patient in South Korea, Europe, Australia and received approvals to open trial sites in Spain, France and Italy. 

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Currently trading at a $7.7 million market valuation PBLA os was 14,595,873 shares as of March 13, 2023. The Company has $1 million in the treasury and manageable debt of $13 million. PBLA will host a conference call on May 4, 2023, at 4:30 PM Eastern Time to discuss results for its first quarter ended March 31, 2023.   We will be updating on PBLA when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in PBLA either long or short and we have not been compensated for this article.