May 07, 2021
The development of a therapeutic can be thought of as series of important milestones; all the way from what we call bench to bedside. As you get closer to the “bedside” the development is centered on human clinical trials; and then eventually regulatory approval and reimbursement/pricing levels. But even these late stage milestones are hostage to the steps and successes earlier in the process. And the crucial point to understand about these early stage activities is that no matter how well a drug may perform in a trial, if an error is found in the steps leading up to the trial it will invalidate the results. You don’t get to say “we’ll do it right next time”. You do it all over again from scratch.
We are deep into these “early stage” building blocks on both our reformulation of Metformin to treat Wet AMD, and our CD56 Antibody drug conjugate to treat glioblastoma. And it never ceases to amaze me how complex and connected every step of the process is.
We have completed the expansion and testing of the initial NIH research cell bank transferred to us, which houses our fully humanized CD 56 monoclonal antibody, including confirmation with 28-day sterility testing. This is the first major step towards moving the product into GMP level manufacturing.
The metformin hydrochloride API (active pharmaceutical ingredient) we have received is already GMP quality (think super clean room level manufacturing) material. So, prior to ever receiving a shipment, we needed to already have put into place FDA review compliant plans for receiving the material with appropriate chain of custody protocols and forms to retain that GMP status as it moved around the world to get to us and as we move it around to various places to work with it. This allows us to use it for formulation development, Safety/Toxicology studies and for GMP manufacturing of our final formulation for our first in human trial.
We have also brought on to our Scientific and Clinical Advisory Board the lead inventors of both programs, Dr. Kapil Bharti at NEI and Dr. Dimiter Dimitrov now at Pitt. Soon I hope to be able to announce the Principal Investigators for the Clinical trials for both. But none of the trials can start, and indeed their results can’t count without laying the foundation first in preparation for, and then properly manufacturing the drug. So indeed, this little candle we are burning at both ends rights now throws it’s light all the way from the bench to the bedside.