Morphogenesis, Inc.

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July 29, 2019 Issue



Morphogenesis, Inc. is developing a Cell and Gene Therapy focusing on a Cancer Vaccine Immunotherapy that uses the Bodyís Own Immune System to Kill Solid Tumors



Dr. Patricia Lawman, PhD

Chief Executive Officer


Morphogenesis, Inc.


Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published Ė July 29, 2019


CEOCFO: Dr. Lawman, what is the vision behind Morphogenesis, Inc? 

Dr. Lawman: When my husband and I and a group of very talented scientists from around the world founded Morphogenesis, our idea was to transform the way medicine was practiced. We felt that the body was much smarter than any kind of artificial drugs that we could come up with and we wanted to maximize the ability of cells and tissues to treat chronic disorders like diabetes and cancer. So, we set out to overcome the challenges along the way to making that happen. One challenge was being able to identify very rare cells in the body, so we developed monoclonal antibodies that recognize primitive stem cells. The next challenge was to be able to isolate a meaningful number of those cells from complex mixtures and tissues like blood, so we began working on a cell separation device to purify cells from large volumes.


CEOCFO: Why did you think the body could do better than science and medicine of the moment? 

Dr. Lawman: Take insulin production as an example. Beta islet cells respond to the levels of sugar in the blood with exquisite sensitivity and release exactly the right amount of insulin to deal with the sugar in the blood. It is difficult for a device to reach that level of sensitivity and accuracy, and there are some pretty exciting devices on the market for delivering insulin and sensing the real time sugar levels in tissues. However, the levels that these devices reach canít match beta islet cells. This is one of example of how the body can do things better than we can.


CEOCFO: What have you worked on and what are you working on today? 

Dr. Lawman: We are a cell and gene therapy company, and we have developed many technologies over the years. We are currently focusing on our cancer vaccine. This is an immunotherapy where we simply take a gene that encodes a bacterial protein that is highly immunogenic. We put this gene into a patientís tumor cells and because there is a proprietary sequence within this protein, it is actually expressed on the surface of the tumor cell where it acts like a big red flag to the immune system. What this does is draw the antigen presenting cells to the tumor cells, which now appear to be like bacteria. The antigen presenting cells then do what they do best, and that is to eat the cells that appear foreign to them. They then display all the bits and pieces of that tumor cell on their surface in a way that naÔve T-cells can now recognize the peptides they have been waiting all their lives to recognize. This recognition triggers the T-cells to activate, proliferate and start trafficking throughout the body to find that antigen on other cells. This very simple technique exposes a patientís own tumor antigens to their immune system so that it can go and kill these tumor cells wherever they are in the body, without destroying any of the healthy cells and tissue.


CEOCFO: Would this be for any type of cancer? Are there specific areas where it might work better or differently? 

Dr. Lawman: Our immunotherapy could potentially work against any type of cancer. We have tested the vaccine in laboratory models with several different cancers, where we provide the tumor cells to the mouse and grow the tumor. However, we have also worked with companion animals, dogs, cats and horses with naturally occurring disease. This is important because our pet dogs and cats live in the same environment that we do. They are exposed to the chemicals and all the environmental hazards that we are, and their bodies develop cancer in very much the same way ours do. At the same time, their immune response to those cancers can fight the cancer just like ours. Unlike mouse models, which are basically cloned animals that all have the same genetic makeup, companion animals are diverse, out bred animals of different species, another important distinction when evaluating the safety and efficacy of a therapy. Over three thousand doses of our vaccine have been delivered to pets that have developed over 40 different types of cancer.


To explain in a little bit more detail; this is a cell AND a gene therapy. It is a gene therapy, because we put this bacterial gene into a personís tumor cells. However, it is the personís tumor cells that provide the targets we are trying to get the immune system to go after. Therefore, in that sense, this is a cell and gene therapy. It can also be delivered as a cell therapy, but we are currently testing it as a direct intratumoral injection. This form of our therapy is now in human trials.


CEOCFO: Is this concept recognized? Is the medical community onboard with this concept? 

Dr. Lawman: I would say that the medical community that knows about it, is excited about it. We are a small company in Tampa, Florida, and have not gone after a lot of publicity. Our trial for melanoma is being held right now at Moffitt Cancer Center, and the physicians there are excited about it. We are in the process of starting human trials for Merkel cell carcinoma and cutaneous squamous cell carcinoma as well. These will be multi center studies. We will see when we get to the point of enrolling those sites, how excited people are. However, our therapy is not a very complex idea. You do not have to take a personís cells out, genetically engineer them, grow them up and then give them back or you do not have to take the personís tumor cells, sequence the entire genome and then try to figure out which antigens the immune system is going to see and then go synthesize those peptides and create a vaccine specifically for that person. You just directly administer the vaccine right into the personís tumor, which takes about 30 seconds.


We see this as a very economical way to treat cancer. It is not going to cost anywhere near the half million dollars companies are charging for the CAR-T cell therapies being used in the clinic now. The other thing about our therapy is that with the three thousand doses we administered to companion animal with naturally occulting cancer, we have seen very, very few side effects. However, the current immunotherapies that are being used in the clinics have a number of side effects; we see this as a distinct advantage of our approach. Most times people do not take into consideration the supportive costs to treat or manage the toxic side effects of the patientís immune reaction to these other expensive immunotherapies. Therefore, we are very excited because our gene therapy is in the form of a small circular plasmid DNA.


We are also working on an RNA version. Both plasmid DNA and RNA can be lyophilized, shipped and stored and then reconstituted. This makes the cost considerably less than a personalized cell therapy where you have to get live cells back to the patient in a timely fashion. Of course, it will be borne out by the data we derive from our human studies. That is when we expect the community to be really excited. An affordable therapy that can be directly administered into a personís tumor inside of 30 seconds in an outpatient setting should be enough to get notice, but we are most excited about the possibilities this offers to people with cancer in low to middle income countries.


CEOCFO: Why did you start with melanoma? 

Dr. Lawman: We chose melanoma for several reasons. One, we had experience with melanoma in mouse models. We also carried out a study in horses diagnosed with advanced malignant melanoma. We directly injected three tumors on each horse and calculated the effect on total tumor burden after 35 weeks. The results were impressive. We also wanted to start our human studies with something that would be easy for clinicians, both to administer and to quantify the results. We knew we would be able to see results fairly quickly and that this therapy would not preclude patients from going on to other therapies if they chose to.


CEOCFO: What, if anything, did you learn so far through the various trials that surprised you? 

Dr. Lawman: The biggest surprise to me has been that the response we saw in the human patients treated so far was much quicker than what we saw with some of the animals treated with our therapy.


CEOCFO: Do you know why? 

Dr. Lawman: We are not sure, but we will certainly do our best to find out why that is. These patients are late Stage 3 or 4 and they, for the most part, failed current standard of care, i.e. some type of checkpoint inhibitor. They may have responded originally to the checkpoint inhibitor but then stopped responding. Why do we think this is important? The immune system has to regulate itself because it is so powerful. Checkpoints are one way the immune system keeps itself in check. Whenever there has been an immune response that has activated T-cells, perhaps against a previous infection, these T-cells have to be kept in check so they donít keep going out of control. The last thing you want is for these T-cells to be running around, going haywire and secreting cytokines that will make you feel really bad and could perhaps kill you.


What the checkpoint inhibitors do is stop these checkpoints from working. The analogy is that checkpoint inhibitors release the brakes on T-cells that have already been activated. This is where the side effects come in. However, for diseases like melanoma that have a lot of mutations, and therefore a large number of antigens that the immune system can recognize, it takes the brakes off of those T-cells that are activated against those melanoma antigens. However, these T-cells that were activated can be pushed to their limit and become exhausted. Then the checkpoint inhibitors no longer have an effect because the tumor-specific T-cells are malfunctioning. What our therapy does is allow T-cells that have never been activated before to become activated, so it enlists a whole new army. In the case of our first few patients, we believe that residual checkpoint inhibitor in the patientís system may account for the quick response. Just a theory!


CEOCFO: Are you funded for the next steps? 

Dr. Lawman: Yes we are. However, we are a small biotech, so we are always going to be raising funds.


CEOCFO: What does the next year or two look like? What is the plan for Morphogenesis? 

Dr. Lawman: The plan is to continue fund raising and keep an eye out for the opportunity to hold a public offering, but certainly to carry out our clinical development strategy. We have worked very hard for the last six months to decide which cancers to go after, because, as you mentioned, this therapy is possibly efficacious against many different types of cancer. Many factors needed to be considered because we have so many options. We are moving from melanoma, as I said, into Merkel and cutaneous squamous cell cancer. Squamous cell will then lead us into head and neck cancer, because most head and neck cancers are squamous in origin, and then we will proceed to less accessible cancers like gastric and colon. That is the progression. We are doing safety studies first with our therapy alone, then combinations with check point inhibitors. We hope to start our large Phase II skin cancer basket study in the fall.


CEOCFO: How do you deal with some of the frustration in how long it takes to move through the process when you have something that potentially could make such a difference? 

Dr. Lawman: Initially, we dealt with it by going to the veterinary world so we could see results and get more immediate fulfillment. Day to day, we just keep focused on the things that we have to get accomplished and make sure we do them the best we can so that our results will benefit as many people as possible.



ďAn affordable therapy that can be directly administered into a personís tumor inside of 30 seconds in an outpatient setting should be enough to get notice, but we are most excited about the possibilities this offers to people with cancer in low to middle income countries.Ē
- Dr. Patricia Lawman, PhD


Morphogenesis, Inc.



Patricia Lawman, CEO

813-875-6600 x 102







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