Unique Stability Considerations for Lipid-Based Nanotherapeutics and Vaccines

February 14, 2023

Liposomes have served an important role in dramatically altering the biodistribution and therapeutic index of small molecule therapeutics.  More recently, lipidic nanoparticles (LNPs) have served a critical role in delivering mRNA to immune cells and provide for efficient and highly active new class of mRNA therapeutics and vaccines.  These nanotherapeutics or LNP vaccines have unique stability challenges related to the lipid excipients, electrochemical gradients used to entrap therapeutics, and high concentration of entrapped drug or mRNA encapsulated in the nanoparticle.  Our team at Akagera Medicines has worked for more than 25 years in the drug delivery and lipid nanoparticle field addressing many of these important concerns in putting multiple agents into clinical trials, and even through FDA approval.  In this webinar:

 

  1. We use the examples of liposomal formulations of irinotecan (Onivyde), docetaxel, and doxorubicin to demonstrate unique mechanisms of drug-catalyzed lipid degradation, rationale for choice of specific lipid excipients, and impact of encapsulation on the stability profile of the active drug.
  2. Another example of a liposomal formulation of a novel oxazolidinone Akagera is developing for the treatment of multidrug resistant tuberculosis (MDR-TB) or methicillin-resistant Staphylococcus aureus(MRSA) is used to demonstrate the stabilization strategy employed for protecting lipids from drug-catalyzed oxidative degradation.
  3. We also show how targeted lipid nanoparticles containing mRNA used for highly potent vaccine candidates can be optimized to protect against oxidative damage to ionizable cationic lipids, and the potential risks to condensed/entrapped mRNA.
Course summary
Course opens: 
01/23/2023
Course expires: 
02/28/2023
Event starts: 
02/14/2023 - 11:00am CST
Event ends: 
02/14/2023 - 12:00pm CST
Cost:
$0.00
Rating: 
0
Webinar
United States

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Daryl C. Drummond, Ph.D., Chief Scientific Officer, Akagera Medicines

Daryl has 30 years of experience in the research and development of liposomal and lipidic nanoparticle (LNP) based therapeutics and vaccines.  Daryl is currently the Founder, Chief Scientific Officer, and Senior Vice President of Akagera Medicines. At Akagera, he is advancing the use of sophisticated lipid-based nanotechnologies to deliver novel and highly potent anti-bacterial agents directly to innate immune cell reservoirs for mycobacterium or gram-positive bacterium and mRNA vaccines, targeting some of the world’s most challenging and neglected infectious diseases.  Daryl also joined Tidal Therapeutics in 2019 as an SAB member, and later as the Interim Head of Research and Development, prior to be acquired by Sanofi in April 2021.  At Sanofi he oversees the engineering and pharmacology of immune cell-targeted mRNA lipid nanoparticles (LNPs).  

Through June of 2019, Dr. Drummond served as the Head of Research and Senior Vice President of Discovery for Merrimack Pharmaceuticals, a public biotechnology company headquartered in Cambridge, MA, where he oversaw the discovery efforts for Merrimack’s Nanotherapeutics and Biologics-based therapeutics. Dr. Drummond received a Ph.D. degree in Biochemistry from Indiana University in 1997, with an emphasis on membrane biochemistry and biophysics, and later completed a postdoc under the renowned father of lipid-based drug delivery systems, Demetrios Papahadjopoulos at California Pacific Medical Center in 1999.  

Dr. Drummond was a principle inventor for a wide range of nanotechnology-based drugs and platform technologies, most notably Onivyde, a highly stabilized liposomal formulation of irinotecan.  He joined Merrimack in 2009 following the merger of Merrimack with Hermes Biosciences.  Overall, Dr. Drummond has more than 30 years of experience in the research and development of advanced drug delivery systems, including five unique drugs or imaging agents that have been tested in various clinical trials, an NDA and EMA approval for Onivyde, >40 issued patents or patent applications, and more than 75 peer reviewed publications. The focus of his research at Merrimack had been in developing targeted nanotherapeutics for treating a wide range of solid tumors.  He successfully developed novel platform technologies for targeting lipidic nanocarriers such as liposomes or lipid nanoparticles (LNPs) using a range of novel ligands, but most notably Fab’ or scFv antibody fragments.  He has also developed platform technologies for dramatically improving the in vivo drug retention of difficult to stabilize small molecule drugs, and for systemic delivery of nucleic acids.  Three of these nanotherapeutics were studied in clinical trials, including an ErbB2-targeted liposomal doxorubicin which was evaluated in a Phase II study in ErbB2-overexpressing breast cancers and a nanoliposomal formulation of irinotecan which was approved by both the EMA and FDA following promising results in a Phase III trial in gemcitabine-refractory pancreatic cancer.  Onivyde is currently being studied in front line pancreatic cancer in combination with oxaliplatin and 5FU and in second line small cell lung cancer by Ipsen Pharmaceuticals.  A fourth antibody targeted lipososomal drug (MM-310) was recently evaluated in a Phase I study in multiple EphA2 overexpressing solid tumors.  In addition, Dr. Drummond previously oversaw the discovery and development of more traditional biologics, such as a stabilized TRAIL-Fc fusion and a monoclonal antibody against the immuno-oncology target, TNFR2.

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