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Week 30 – Body Heal Thyself!

Hope everyone is doing well and is safe and healthy. We continue to move forward on several fronts, although progress never goes as fast as you would like it to go. This is mostly applicable to the business side of the company. These are two of my big concerns as a small business owner; everyone going slow at the same time keeping things in limbo and then everyone getting into gear at the same time. While you may be asking yourself why is the latter a problem since you would have multiple business opportunities (this would be a great problem to have), ramping up in multiple areas all at the same time could have its challenges. Since we are stuck on the former at the moment, it is allowing us to formulate a solid plan if the multiple opportunities present themselves. Here’s hoping for some movement!

We rely a lot on our body to take care of us. So much so, we do not even think about it until something like COVID-19 comes along and turns our world upside down. From exposure to bacteria to cold viruses, our body provides a formidable defense against the outside world to keep us healthy unless the body has never seen the “attacker” before. It is truly amazing how the body works (that’s a topic for another day). Unfortunately, people can be afflicted with different diseases such as cardiovascular and gastrointestinal disease. In these specific cases, the body does not have the ability to provide the typical type of responses that maintain a person’s health. These people will be required to take medications to make up for the body’s shortcomings (a lot of people, myself included, take medication(s) to prevent or treat different aliments). While this may seem like a simple fix, there are many issues that can occur. First, taking medication can lead to adverse complications. What I mean by this is that if you are swallowing a pill to treat your intestinal issues, the drug gets dispersed all around the body which could lead to complications. Second, patients are not always great at taking their medicine each day leading to issues related to inconsistent treatment of the disease. Lastly, drugs included into a medical device (e.g. drug-eluting stent) can sometimes affect how the device gets incorporated into the body (changes how the body heals the device). Wouldn’t it be great if a drug could be delivered over an extended period of time right at the problem area while not affecting the device delivering it?

This may seem like science-fiction but it is an area that we have been working on with our partners at Takeda over the past three years. Other groups have also explored this approach to treat diseases such as diabetes and macular degeneration, delivering specific proteins (insulin, growth factors) that the body is not producing. Our approach is similar but

slightly different. In layman’s terms, picture building a factory that makes a specific item, putting the factory into an area/neighborhood where it can help the most, provides consistent delivery of the item to the local neighborhood and allow the factory to be moved if required. We have been able to modify genes in cells that can be placed in the body that will naturally produce a drug or drugs at levels that would be beneficial for treating the patient’s affliction. We put these cells into a special electrospun chamber that prevents the body’s defenses from attacking them, permits nutrients from the body to keep those modified cells alive and allows the drug to be released at a therapeutic level from the chamber.

Our Bio-Spun™ cell chamber is being developed to serve as the factory building. Within the factory, we have infused genetically-modified cells that can produce the Takeda drug

Entyvio. Entyvio is used to treat patients with ulcerative colitis or Crohn’s disease to prevent flare-ups in the intestinal wall. During our R&D program, we developed all aspects of this technology, from the electrospun materials and how strong the resulting materials to making the prototype and evaluating Entyvio release as well as implantation into a preclinical model. On the BioSurfaces’ side, this work was led by Ms. Rayan Kassab. All of the iterations required to make this work have driven her to become an expert in making these types of devices (and likely driven her a little crazy in the process when making some very small iterations). We have been able to show that our Bio-Spun™ cell chamber can house cells that produce Entyvio (with many other options available), with drug production persisting for at least 55 days. Looking at this chamber after explantation shows the genetically modified cells protected in the middle of the device while the body’s tissue grows into the outer electrospun material. Really cool start! We have other applications to explore and more parameters to improve.

Continue to stay vigilant and keep social distancing, wear a mask where social distancing is not possible to protect yourself and those around you and frequently wash your hands. We have seen a slight increase in cases in Massachusetts, likely due to what we’ve seen with people letting their guard down. It is too easy to go backwards if we do not all pull together. Getting back to some sort of real normal depends on it. The evidence is overwhelming that masks have a positive effect on controlling the virus. Keep supporting your local businesses as they continue to work through these challenging times.



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