Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

3/24/22 18-ppl P1, open-label, single center, dose escalation study to evaluate the safety and pharmacokinetic profile of mAb AZD5396 and mAb AZD8076 following delivery of optimized dMAb AZD5396 and dMAb AZD8076 with Hylenex® recombinant, administered by intramuscular injection (IM) followed immediately by electroporation (EP) using the CELLECTRA® 2000 with Side Port needle device, in a 2-dose regimen (Days 0 and 3) in healthy adults.
The hypothesis is that the administration of dMAb AZD5396 and dMAb AZD8076 will be safe and associated with expression of mAb AZD5396 and mAb AZD8076 in serum.
https://clinicaltrials.gov/ct2/show/NCT05293249?term=Dmabs&draw=2&rank=1
3/1/22, 10-K, pg 112: Ino, Wistar Institute, AstraZeneca, the University of Pennsylvania, and Indiana University received a $37.6M grant from DARPA to leverage AstraZeneca's CV monoclonal antibody and INOVIO's dMAb®. In 2020, the Company received a $10.7M sub-grant through Wistar, which was amended in 2021 to $13.5 million, for the preclinical development and translational studies of dMAbs as countermeasures for COVID-19, with funding through September 2022. The sub-grant also includes an option for an additional $6M in funding through September 2024, of which $3.3M has been exercised as of December 31, 2021.

Estimated Study Start Date :
May 2022
Estimated Study Completion Date :
May 2023

Sponsors and Collaborators
Pablo Tebas
The Wistar Institute
Inovio Pharmaceuticals
AstraZeneca
DoD

Recombinant monoclonal antibodies, which represent the largest segment of pharmaceutical markets today with more than $100 billion in sales, are designed to enhance the immune system's ability to regulate cell functions. However, the technology has some limitations, including long and costly laboratory development and large-scale production, limited duration of in vivo potency, and a pharmacokinetic profile that can result in toxicity. INOVIO's dMAb technology offers a disruptive and differentiated solution to the challenges and limitations associated with conventional recombinant monoclonal antibody-based treatments. The company can encode the DNA sequence for a specific monoclonal antibody in a DNA plasmid and deliver the plasmid directly into cells of the body using the company's proprietary smart device called CELLECTRA®. This specific DNA medicine serves as a genetic blueprint that instruct the patient's body to build its own highly specific antibodies in vivo.