Panbela Therapeutics, Inc. · OTC:PBLA
Panbela Therapeutics — Investor Presentation (June 2021)
23 slides from Panbela Therapeutics's investor presentation, Jun 21, 2021
Slide 1: Company Overview June 2021
S Panbela. Company Overview June 2021
Slide 2: Forward-looking statements
Certain statements in this presentation are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. Forward-looking statements are based on curr
Slide 3: Developing small molecule polyamine metabolic inhibitors
Developing small molecule polyamine metabolic inhibitors with tumor and organ-specific preferential uptake Multiple cancer types with known elevated polyamine levels represent potential targets Novel Trojan Horse polyamine metabolic inhibitor (PMI) mechanism and tolerability profile seen in early st
Slide 4: Leadership Team and Board of Directors
Collectively developed 10 FDA-approved therapies generating billions in sales Leadership Team Jennifer K. Simpson, PhD, MSN, CRNP President & CEO Susan Horvath, CPA (inactive), CMA VP of Finance & CFO Thomas X. Neenan, PhD Co-Founder, Chief Scientific Officer Suzanne Gagnon, MD, FACP Chief Medical O
Slide 5: Pancreatic cancer deaths and incidence more than doubled from 1990 to 2017
Globally, the number of deaths caused by, and incidence of, pancreatic cancer has more than doubled from 1990 to 2017
Slide 6: 70% of SBP-101 patients had CA 19-9 reductions greater than 60%
In addition to strong ORR results, 70% of SBP-101 patients presented CA 19-9 biomarker reductions of greater than 60%
Slide 7: Many tumors maintain greatly elevated levels of polyamines
Many tumors maintain greatly elevated levels of polyamines to support their rapid growth and survival Of all human tissues, the pancreas has the highest level of native spermidine creating a polyamine rich environment for proliferation Oncogenes such as MYC & RAS upregulate polyamine synthesis & inc
Slide 8: SBP-101 is a synthetic analogue of spermine
SBP-101 is a synthetic analogue of spermine being designed to exploit the self-regulating nature of polyamine metabolism SBP-101 preferentially accumulates in tumor cells and downregulates the polyamine metabolic pathway, lowering production of the natural polyamine pool and inhibiting cell prolifer
Slide 9: Polyamines and immuno-oncology agents hypothesis
Historical clinical trials using IO agents have been unsuccessful A potential hypothesis is that excess polyamines, especially spermine, insulate the tumor microenvironment from immune cells SBP-101 is a synthetic analogue of spermine, which is believed to reduce endogenous polyamine production Pote
Slide 10: Upregulated polyamine metabolism in other oncogenic mutations
Upregulated polyamine metabolism is also a phenotypic change caused by certain oncogenic mutations, creating potential for future patient stratification strategies in other cancers
Slide 11: Preclinical mouse studies of SBP-101 in pancreatic cancer
Study in mice subcutaneously implanted with human pancreatic cell line PANC-1 SBP-101 found effective in reducing pancreatic tumor growth Study in mice orthotopically implanted with human pancreatic cancer cell line L3.6pl Treatment with SBP-101 and/or Gemcitabine significantly reduced tumor volume
Slide 12: SBP-101 Demonstrates Superior and Additive Efficacy in vitro
SBP-101 Demonstrates Superior and Additive Efficacy in vitro
Slide 13: Open-label P1A/1B study design
Open-label P1A/1B study to assess safety, tolerability and PK when combined with Nab-Paclitaxel and Gemcitabine Identify P2 dose and schedule and assess preliminary efficacy of 3-drug treatment combination Primary Outcome Measure Safety, PK, Tolerability Areas of Exploration Overall Response Rate, C
Slide 14: Enrollment, vision adverse events and partial clinical hold
Enrollment completed December 2020 Some patients experienced serious vision adverse events Visual changes not seen in monotherapy study Consulted with DSMB Decided not to administer SBP-101 to ongoing patients while safety information analyzed All other trial activities continue Conferred with FDA P
Slide 15: CA 19-9 as a biomarker in pancreatic disease
Carbohydrate antigen (CA) 19-9 is a type of antigen found in the blood that is often elevated in pancreatic disease Studies have suggested that decreases in CA 19-9 levels are correlated with improved prognosis; ≥60-75% declines in CA 19-9 levels correlated with the greatest survival benefit in panc
Slide 16: MPACT study CA 19-9 decrease and survival benefit
Patients in the MPACT study (Phase III Gem+Nab) whose CA 19-9 levels decreased saw an approximate 5-month incremental median survival benefit (P=.001) compared to patients with unchanged or increased CA 19-9 levels Greatest survival benefit observed in patients with CA 19-9 decreases > 60%
Slide 17: CA 19-9 decreases in SBP-101 subjects
CA 19-9 tumor marker often released by pancreatic cancer cells 70% of subjects had a maximum CA 19-9 decrease greater than 60% 90% of subjects had a decrease in CA 19-9 levels
Slide 18: SBP-101 Well Tolerated in Combination with Gemcitabine and Nab-Paclitaxel
SBP-101 Well Tolerated in Combination with Gemcitabine and Nab-Paclitaxel 3.1x the response rate of Gemcitabine & Nab-Paclitaxel in Cohort 2 2.1x the response rate in Cohort 4 + P1B 2.1x the disease control rate of Gemcitabine & Nab-Paclitaxel in Cohort 2 1.5x the disease control rate in Cohort 4 +
Slide 19: Response rates in Cohort 4 and P1B
N = 7 across Cohort 2 (0.4 mg/kg) 71% partial response (5 of 7) 29% stable disease (2 of 7) N = 29 across Cohort 4 and P1B (0.4 mg/kg) ORR: 48% 3% Complete Response (1 of 29) (1) 45% Partial Response (13 of 29) (2) 34% stable disease (10 of 29)
Slide 20: Safety comparison with gemcitabine and nab-paclitaxel
Gemcitabine (G, Gemzar, Eli Lilly) & Nab-Paclitaxel (A, Abraxane, Celgene): Standard pancreatic cancer Rx combination Grade 3-4 neutropenia 38% Grade 3-4 thrombocytopenia 13% Grade 3-4 peripheral neuropathy 17% SBP-101 No added neutropenia, thrombocytopenia, or neuropathy Grade 3-4 hepatic enzyme el
Slide 21: Cash Balance and Capitalization as of March 31, 2021
Cash Balance and Capitalization as of March 31, 2021
Slide 22: Milestones
] Milestones 2021 > Data from phase 1 trial (1H'21) > Initiation of randomized phase 2 study (2H ‘21) > Pre-Clinical Data (2H’21) > Conference presentation (1H'21 or 2H'21)
Slide 23: SBP-101 Summary
SBP-101 Summary Unique dual-attack MOA is synergistic with other agents, potentially enhancing anti-tumor response Favorable safety & tolerability profile and subcutaneous administration in clinical studies to date ‘supports potential ease of use Encouraginginterim efficacy and tumor marker signals
Panbela Therapeutics — Investor Presentation (June 2021) on 6ix