A Successful 2022 for Our Team, and the Advancement of OxyBridge
Dear Friends and Supporters,
As we begin the new year, I would like to share the significant progress we have made during 2022. As you know, VirTech Bio is developing a novel human derived hemoglobin-based oxygen carrier (HBOC), OxyBridgeTM, for use in vivo when blood is not an option and ex vivo to improve the viability of organs for transplant. Here are some highlights:
Established Manufacturing Advantage. One of the unique features of OxyBridge is the ability to utilize a Contract Manufacturing Organization (CMO) to produce the product vs. the expensive custom-build plants required for previous generations of HBOCs. After extensive market research, FujiFilm Diosynth Biotechnologies (FujiFilm) was selected as the CMO for OxyBridge. This was incorporated into the original application for non-dilutive funding to the US Army through the Medical Technology Enterprise Consortium (MTEC), which has now awarded $10 M to VirTech.
As with most businesses and individuals, COVID-19 created challenges for VirTech Bio’s operations, although with a unique effect. As a leading contract drug manufacturer, FujiFilm was selected by Operation Warp Speed as a key supplier in the COVID vaccine production effort. This initially consumed FujiFilm’s manufacturing capacity including equipment and personnel but by March 2022 it regained capacity and we were able to sign the Statement of Work with FujiFilm to proceed with technology transfer and process development.
FujiFilm has now produced 3 batches at low-volume scale to develop the processes and achieved the major goal of reducing endotoxin levels to well below the specified maximum. Additional process development batches are planned this month to meet the other product specifications, with a planned transition to larger volume engineering batches three months later that will be usable for stability studies and certain IND-enabling GLP animal studies. We currently anticipate having GMP runs at the end of 3rd Quarter 2023.
OxyBridge Advancement. A number of studies have been conducted on OxyBridge this year. We have been able to show that the larger molecular size of OxyBridge reduces extravasation and thus nearly eliminates the effect on blood pressure seen with other HBOCs. Another study showed improved survival in a rat trauma model when OxyBridge was added to plasma vs using plasma alone. In a small pilot study for the transplant application, early indications are that OxyBridge performed as well as actual blood in a warmed swine liver study, with the potential additional benefit that OxyBridge could be used in cooled organs which is not possible with blood. An in vitro study showed that OxyBridge does not activate complement or platelets, nor cause red cell rouleaux formation, addressing potential safety issues reported with some other polymerized hemoglobins.
VirTech Bio Team. In March 2022, I was asked to serve as the CEO of VirTech Bio. In addition, Matias Vidal and Martha Farmer are serving as Executive Chairman and Executive Vice President along with Phil Farabaugh as COO. (Joe Tucker, who was CEO of VirTech for the prior three years, became CEO in September 2021 of a NASDAQ company, Enveric Biosciences.) In August 2022, Shawn Bengtson, who is serving as Quality Management consultant to VTB, and I were privileged to tour a number of high-level centers in Brazil and Argentina with Matias. There are major opportunities for collaboration, pre-clinical studies, and clinical trials at several of those sites.
Funding. On the funding front, the non-dilutive funding from the DoD requires that VTB provide $1.9 M in cost share, requiring us to raise funds to complete that work. We have spoken with a number of organizations including blood suppliers who are projected to utilize their networks to distribute OxyBridge for in vivo applications. In addition, we presented at two venture conferences resulting in several leads we are pursuing. Fundraising will be a key activity for 2023 with a goal of raising $5 M to take us through 2024 when we expect to complete the first-in-human studies and advance the ex vivo application. I have held early discussions with the DoD on advanced development funding and have been told that they consider OxyBridge to be the most advanced oxygen carrier product in development. Selection as a Program of Record would provide significant funding to support later stage clinical trials leading to FDA approval.
Major Patent Approval. I am pleased to announce that the first of our pending patents issued: Patent 11,504,417, Blood Substitutes Comprising Hemoglobin and Methods of Making. Additional patents are pending, and several foreign patent applications are pending as well.
Communications. This year, it became apparent that we need to exit the “stealth mode” we have been operating under and become more visible to the investment and medical community as well as public. To that end, we have engaged the services of Steve Cousineau with RedThread and developed a new brand approach and theme, “It’s About Time.” Our website (VirTechBio.com) is updated, we have a new theme for our presentations, issued a Press Release that was well received, and are working on additional campaigns.
Thank you for all the support and I welcome your input as we seek to meet this critical medical need. Please contact me at [email protected] or 304-839-2690 if you have any questions.
Sincerely,
Dallas C. Hack MD MPH
CEO