Paul Frohna

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Dr. Paul Frohna is Chief Medical Officer at Endeavor Biomedicines, Inc., and has spent his 20-yr career in the biotechnology industry focused on translational medicine and clinical development of novel therapeutics for neurodegenerative diseases, immuno-oncology, autoimmune diseases, and regenerative medicine. He is a member of the Board of Directors for Accure Therapeutics and the National Multiple Sclerosis Society, and the Scientific Ad Board of IAMA Therapeutics.

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715 ICT01 plus low dose SC IL-2 produces a robust anti-tumor immune activation in advanced cancer patients (EVICTION-2 Study)

Regular and Young Investigator Award Abstracts

$Research paper thumbnail of 822O Activation of γ9δ2 T cells by ICT01 as a novel immunotherapeutic approach for relapsed/refractory hematologic cancers (EVICTION trial)$

822O Activation of γ9δ2 T cells by ICT01 as a novel immunotherapeutic approach for relapsed/refractory hematologic cancers (EVICTION trial)

Annals of Oncology

The challenge of genetic diversity in clinical trials: Is precision medicine up to the challenge?

Translational Medicine, Sep 24, 2013

Comparison of a Bayesian Program with Three Microcomputer Programs for Predicting Gentamicin Concentrations

Therapeutic Drug Monitoring, Sep 1, 1988

A recently developed Bayesian regression program was compared with three other aminoglycoside pha... more A recently developed Bayesian regression program was compared with three other aminoglycoside pharmacokinetic dosing programs available for clinical use. From 30 adult patients, 152 measured serum gentamicin concentrations (SGC) were evaluated retrospectively (78 peak and 74 trough). Predictive performance was compared for each method by using the first peak and trough SGC pair to predict subsequent serum concentrations, making a total of 92 predictions (48 peak and 44 trough). The two Bayesian programs (Brater and Koup) were further evaluated using only one initial peak or trough SGC to make the same predictions. Mean predicted error (ME), mean absolute error (MAE), and root mean squared error (RMSE) were calculated for each method. Prediction bias and precision were compared statistically, between each method, by calculating the 95% confidence intervals for the delta ME and delta MAE, respectively. No statistically significant differences were found in the MAEs among any of the methods for predicting peak SGCs, with the exception of the Brater program, using a single trough SGC, which was statistically less precise (less than 0.05). There were few statistically significant differences in the MAEs for trough SGCs; however, Koup&#39;s Bayesian program using a single trough concentration yielded statistically more precise predictions than the other methods. The ME was found to differ significantly (p less than 0.05) among estimates for peak and trough SGCs provided by some of the predictive methods.(ABSTRACT TRUNCATED AT 250 WORDS)

Results From a First‐in‐Human Study of BNZ‐1, a Selective Multicytokine Inhibitor Targeting Members of the Common Gamma (γc) Family of Cytokines

The Journal of Clinical Pharmacology, Aug 29, 2019

Pathologic roles of interleukin (IL)-2, IL-9, and IL-15, have been implicated in multiple T-cell ... more Pathologic roles of interleukin (IL)-2, IL-9, and IL-15, have been implicated in multiple T-cell malignancies and autoimmune diseases. BNZ-1 is a selective and simultaneous inhibitor of IL-2, IL-9, and IL-15, which targets the common gamma chain signaling receptor subunit. In this first-inhuman study, 18 healthy adults (n = 3/cohort) received an intravenous dose of 0.2, 0.4, 0.8, 1.6, 3.2, or 6.4 mg/kg infused over ࣘ5 minutes on day 1 and were followed for 30 days for safety and pharmacokinetic/pharmacodynamic sample collection. No dose-limiting toxicities, infusion reactions, or serious or severe treatment-emergent adverse events were observed. Headache was the only treatment-emergent adverse event in >1 subject (n = 3). Peak and total BNZ-1 exposure was generally dose proportional, with a terminal elimination half-life of ß5 days. Pharmacodynamic effects of BNZ-1 on regulatory T cells (Tregs, IL-2), natural killer (NK) cells (IL-15) and CD8 central memory T cells (Tcm, IL-15) were measured by flow cytometry and used to demonstrate target engagement. For Tregs, 0.2 mg/kg was an inactive dose, while a maximum ß50% to 60% decrease from baseline was observed on day 4 after doses of 0.4 to 1.6 mg/kg, and higher doses produced an 80% to 93% decrease from baseline on day 15. Similar pharmacodynamic trends were observed for natural killer cells and CD8 Tcm, although decreases in CD8 Tcm were more prolonged. These subpopulations returned to/toward baseline by day 31. T cells (total, CD4, and CD8), B cells, and monocytes were unchanged throughout. These preliminary results suggest that BNZ-1 safely and selectively inhibits IL-2 and IL-15, which results in robust, reversible immunomodulation.

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