Breakthrough: Alternative Biological Pancreas for Treating Diabetes Patients

More than 500 million people worldwide suffer from diabetes. In type 1 diabetes patients, the pancreas does not function at all and consequently does not secrete insulin into the bloodstream; in type 2 diabetes patients, there is a decrease in cell sensitivity to insulin, leading to stress on the pancreas and damage to its functionality. A healthy pancreas secretes insulin into the bloodstream according to blood sugar levels. When glucose levels rise, such as after a meal, insulin secretion from the pancreas increases; whereas during fasting, its secretion decreases. For decades, the standard treatment has combined two external devices: one measures blood sugar levels, and the other injects insulin to lower the glucose levels. In recent years, these two devices have been combined and synchronized.

"Insulin pumps, however sophisticated they may be, help manage and control blood sugar levels but don't offer an inherent solution convenient for the patient," says Dr. Racheli Ofir, CEO and CTO of Betalin Therapeutics. "Our goal is to offer patients a seamless, implanted solution that frees them from the burdens of external insulin and cumbersome devices. Designed to integrate naturally into the body, it provides lasting freedom and reliability—potentially for a lifetime."

A supportive biological environment
Betalin Therapeutics, headquartered in Jerusalem, was established based on a breakthrough at the Hebrew University that capitalized on findings by Professor James Shapiro from the University of Alberta, who attempted to implant beta cells (natural insulin-secreting cells) directly into the patient's portal (liver) vein. While the procedure showed promise, Shapiro's implants failed to engraft in 70-80% of cases and generally did not sustain long-term insulin secretion in the recipients. Researchers hypothesized that the low engraftment rates were caused by lack of a suitable biological environment. Cells do not live or function in isolation but are rather always affected by their host tissue's biological environment, which provides appropriate conditions for survival and activity.

"Essentially, what we developed is an organ or platform that serves as an alternative biological pancreas, providing a microenvironment for beta cells with familiar living conditions, similar to those found in the original pancreas, enabling them to integrate and function within the body," explains Dr. Ofir. "Our experiments prove that the platform has paved the way for the harmonious integration of beta cells in the body, in a manner superior to direct implantation of cells into the liver vein."

What is the size of the alternative pancreas and what makes it a suitable replacement for the natural pancreas?
"In a simple procedure performed under local anesthesia, patients will receive several implants, each about half a centimeter in diameter and about 300 microns thick. The implants will be introduced subcutaneously into the leg or abdomen. The scaffold is derived from pig lung tissue. Since the lung is made up of alveoli, the tissue surface area is large and contains sponge-like niches that can comfortably house pancreatic islets or stem-cell derived beta cells. We remove the pig cells from the tissue but preserve its physical structure ("scaffold") and protein composition. This protocol produces an ideal tissue for maintaining functional beta cell and, as such, an excellent platform for an alternative pancreas."

Beginning human trials
Betalin Therapeutics has now reached an important milestone. The company has successfully completed mouse trials and proven the feasibility of integrating its artificial pancreas into the body. "During the trials, we implanted our artificial pancreas and showed its ability to restore glucose-induced insulin secretion to diabetic mice. We proved that the alternative pancreas responds to elevated sugar levels and secretes insulin according to the needs of the body," said Dr. Ofir.
Following the successful findings, Betalin Therapeutics has requested FDA guidelines for commencement of human trials, including safety protocols and manufacturing processes."

Who are your investors to date and what additional funding are you seeking?
"To date, private entrepreneurs have invested in the company, and we have also received significant grants from the Israeli Innovation Authority and the European Union, including a large equity investment that is difficult to attain. These investments have given us strong backing and external validation of our product."

"Additionally, we seek biotech venture capital funds and large pharmaceutical companies looking for innovative and regenerative treatments for diabetes. We bring a biological solution to resolve a bottleneck that has stymied the industry for some time – namely, the lack of effective procedures for engrafting external cells into the body. There are attempts today to develop similar products based on 3D printing, but to my knowledge, we are the only ones developing a platform based on biological tissue that is already adapted for cell growth."

"Diabetes alone is a vast market that is enough to warrant sufficient investment. But ideally, we are looking for visionary investors who understand that our platform may be suitable for treating any hormonal imbalance by implanting different types of hormone-secreting cells, for example, cells from the thyroid or adrenal glands."

Betalin's leadership and scientific advisory board
Dr. Racheli Ofir earned her doctorate and post-doctoral fellowship in cell biology at the Technion. She has held senior positions in the pharmaceutical industry for nearly 20 years, playing a leading role in developing innovative pharma products. Before joining Betalin, she worked for 15 years at Pluristem Therapeutics as VP of Research.

"Our scientific advisory board includes the world's leading scientists and experts in diabetes," she says. "For example, Professor Peter Schwartz, President of the International Diabetes Association, Professor James Shapiro, who first conceived the idea of implanting beta cells in diabetes patients, and many other distinguished researchers."

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