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Principal Investigator: Cesar Torres Luna
Organization: LYNTHERA CORPORATION
Fiscal Year: 2024
Award: $55,000
Funding agency: National Institute on Drug Abuse
PROJECT SUMMARY
The proposed I-Corps project is based on a predicate SBIR Phase I award for the development of a long-lasting,
sustained release of NLX product using a novel system of a pH/temperature-sensitive hydrogel embedded with
NLX-encapsulated solid lipid nanoparticles (SLNs), employed in an in-situ gelling, subcutaneous injectable
formulation (1R43DA058477-01A1). The specific aims of this project are:
Aim 1: Formulation and characterization of anionic NLX-loaded SLNs dispersed in a cationic temperature
sensitive tri-block copolymer hydrogel system.
Aim 2: Evaluating the in vivo efficacy of the hydrogel system in a fentanyl-induced rat model of opioid overdose.
In vivo studies under Milestone 2 aim to demonstrate that SLNs-loaded hydrogels can prevent fentanyl-induced
respiratory depression and antinociception for up to 48 h following a single subcutaneous injection.
The I-Corps team will be composed of Mr. Jeff Yang as the C-level Corporate Officer, Dr. Roman Domszy and
Dr. Barry Rhein as the Industry Experts, and Dr. Cesar Torres Luna as the Technical Lead. Mr. Yang is the CEO
of Lynthera and has significant healthcare experience, including extensive fundraising relationships with
healthcare investors (VC funds, family offices, private equity) through his previous career as a healthcare-
focused investment banker and private equity investor. Dr. Domszy is the R&D managing director of Lynthera
and has more than 20 years of experience in the development of nanocomposite materials for industrial and
biomedical applications. Dr. Domszy has served as the principal investigator on several NIH-funded SBIR grants
and is part of the senior/key personnel of the current SBIR. Mr. Barry Rhein is part of Lynthera's Scientific
Advisory Board and currently provides the company with his extensive industry expertise with respect to
commercialization and manufacturing of pharmaceutical products. Dr. Domszy and Mr. Rhein will be splitting
responsibilities for the Industry Expert role of the team to best meet the needs of this role and its time-intensive
requirements. Dr. Torres Luna is a research scientist at Lynthera and the Principal Investigator of the current
SBIR project. Dr. Torres Luna has a broad background in drug delivery, nanomedicine, polymer science,
nanotechnology, formulation development, and soft materials characterization.
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