The engineered micro pancreas from Israel that will try to improve the quality of life of diabetics

Betalin Therapeutics is developing an engineered micropancreas (EMP) designed to improve the quality of life of millions of people with diabetes.

Betalin Therapeutics is developing an engineered micropancreas (EMP) designed to improve the quality of life of millions of people with diabetes. Betalin Therapeutics licensed the EMP technology developed at the Hebrew University of Jerusalem by Prof. Eduardo Mitrani in an exclusive agreement in 2015. The Hebrew University continues to cooperate with the company to support research and development.

Based on in vitro test results and preliminary in vivo results, Betalin Therapeutics recently submitted a pre-IND (Investigational New Drug) application to the Food and Drug Administration (FDA). Following the positive response from the FDA, Betalin Therapeutics is now preparing the pre-IND meeting on its way to submitting the IND.

Betalin Therapeutics is currently raising funding to optimize the treatment in animal models, submit the IND application to the FDA and proceed with clinical trials. Betalin Therapeutics was recently awarded a competitive matching grant from the Office of the Chief Scientist, doubling the impact of investments made at this stage.

Nikolay Konicher, CEO of Beta Linn and Avi Treves, the company's vice president for R&D, discussed the matter with the Hidan website.

Konicher explains: "Beta Lin deals in a field called cellular therapy - using cells to cure a disease and not just manage it as is the case today with insulin and drugs. The idea is to take cells that know how to produce insulin, as a response to an increase in the sugar level, and inject it into the body. Beta cells, or more precisely islets of such cells found in the pancreas (called islets of Langerhans)."
"We are not the only ones. There are quite a few companies that do this, Leno's idea is to take Langerhantz islets from a donor and transplant them into the patient's body. Companies have developed the ability to implant cells that will sense an increase in the sugar level and secrete insulin. There are even FDA approvals, but this is very problematic because most of the cells die, to such a degree that islets from three donors have to be taken for one patient. Their problem is the lack of a biological constant."
What is a biological constant?
All the cells in the body come into contact with a supporting tissue - some kind of structure (matrix-like) that surrounds the cells. This tissue supports not only mechanically but also functionally. When cells without supporting tissue are injected, they will not function and live as long as they could if they had such supporting tissue. This is where our technology, invented by Prof. Mitrani, comes into play. We were able to produce a support tissue on which we seed the Langerhantz cells, or beta cells, and create a micro-pancreas, a real organ with all the supporting tissue - a scaffold."
"The idea is to insert the same micropancreas under the patient's skin, not in surgery but under local anesthesia in outpatient clinics, without the need for hospitalization, compared to the current situation. It is about lowering the costs of surgery and hospitalization. Once the implant enters the body, the patient no longer needs to measure the amount of glucose and inject insulin because the cells will do it by themselves because that is their nature."
"It is true that it is an artificial pancreas, but it consists of only biological materials. We make it from pig lungs, there are companies developing a synthetic scaffold, but it will never give the same results as a biological scaffold.

There is no fear of rejection of the implant?
"We implanted the artificial pancreases in mice, and they were completely inert. We found no rejection after three months. Even the pathologist we sent the samples to was amazed by the result. We put them into mice with cells from pigs, yet so far we haven't gotten any immune response. This suggests that our scapula may be providing protection to the cells inside. We have ideas on how to deal with postponement problems and if necessary we will use additional solutions. The emphasis is that we are trying to turn the problem into a local rejection prevention problem and not a systemic one as it is today."
"So far we have conducted experiments on mice and we have seen that the cells live much longer. If you take Langerhantz islets in a petri dish, they will live 10-5 days. In our experiments, they lived inside the mice for at least three months and produced insulin at a high level." Conicer concludes.

And Treves adds: "We have already completed the pre-clinical phase. The company completes the regulatory instructions for a complete clinical file with production processes, quality control and more. We have a product that can already be frozen and sent all over the world and there to produce the final product with the cells loaded on it. We produce the skeleton - the carrier, a three-dimensional scaffold with a very large surface area inside which cells or islets can be inserted and then it will function as a micropancreas."
"The ability to freeze the product allows us to collaborate with the centers that already perform pancreatic cell transplants. And when they hear about our product, it immediately adds value to what they have. Indeed, today we are in three of the best centers in the world for a clinical trial: in Germany, China and the USA and we are also looking at the possibility in the UK. "

Who are the patients who will participate in the experiment?

Treves: "The participants in the experiment will be those whose pancreatic function is zero, mainly type 1 diabetes or type 2 diabetes in an advanced state. We are now in the phase of raising funds for the clinical trials phase. We demonstrated capability, we finished the development, we are now starting the work for the clinical phase and of course it costs a lot of money. Our team has people who can turn the cellular product into a finished product for clinical use. Our consultant, Nobel laureate Sidney Altman, came to Israel specifically to discuss the product's capabilities with us. Altman himself is a diabetic who injects himself with insulin twice a day. He is enthusiastic about the technology and the possibility of bringing it to the clinic as quickly as possible."

According to Treves, diabetes treatment is just one demonstration of the use of technology, but it is a much broader platform: "Our technology is a platform. You can load different types of cells on it. All types of cells that secrete hormones, enzymes and more, which are missing in the body, and there are some of these in clinical trials. We come with the complementary product, so our product will be used very widely in the future. We are currently focusing on diabetes in order to reach a clinical trial and with God's help we will bring the solution to this serious disease."
"Biological drugs have been around for about twenty years and today there are drugs for many diseases that are suitable for healing with biological drugs and immunotherapy, healing with the help of cells, on the other hand, is more complex, it started with bone marrow transplants, and now it continues for other clinical uses - for heart diseases, for neuronal diseases and also for immunotherapy - cells of the immune system."
"Cell healing is the next wave after biological drugs, and its realizations are beginning to be seen today. There are still very few cell healing methods approved for use but there is a very long pipeline. We are in exactly this field - technology that enables cellular healing."
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More of the topic in Hayadan:

• Three researchers who studied how cells sense oxygen levels have won the 2019 Nobel Prize in Medicine
• An innovative method of introducing genes into cells
• Pancreatic cell transplantation for type I diabetes patients