And also: a patent extension for Afosense and a clinical trial for Selcure and a scientific article complimenting Yes-Fate's CF101
The HBL company (Hadisit Bio) continues to promote the investment strategy in the portfolio companies: the HBL group, under the management of CEO Tami Kafir, announces that it has completed an investment in the Protab company, in which HBL holds approximately 69.54% of the share capital, to the extent of 460 thousand dollars.
Protab has signed an agreement with the NIH, the National Institute of Health in the USA, to conduct feasibility trials of the human antibody developed by Protab in mouse models for Behçet's disease, a rare autoimmune disease that causes chronic inflammation of the blood vessels and is also in talks with another senior academic institution for cooperation In connection with deciphering the mechanism of action of the antibody.
Protab develops drugs for the treatment of rheumatoid arthritis (RA), inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, as well as other autoimmune diseases. The company has a therapeutic approach based on the discoveries of Prof. Yaakov Neprestek from the Hadassah Ein Kerem Hospital, to regulate pro-inflammatory and anti-inflammatory signals by developing human antibodies. The company's leading product is a human antibody, prozumab, which shifts the balance of the inflammatory process towards an anti-inflammatory. Laprotab owns patents and patent applications in various countries around the world that protect the various sequences of Prozumab and their use in the treatment of patients with autoimmune diseases in general and in the treatment of patients with rheumatoid arthritis and inflammatory bowel diseases in particular.
Selkiur from the HBL group reports positive efficacy and safety results in the stem cell product for the treatment of retinal degeneration in the framework of preclinical trials
The Israeli company Selcure Neurosciences from the HBL group (Hadisit Bio) is preparing to start clinical trials of the company's product, the OpRegen, for the treatment of retinal degeneration with the help of human embryonic stem cells. The HBL Group and its American partner Bio Time Company report that Cell Cure Neurosciences received positive final results in a series of pre-clinical efficacy and safety trials of the OpRegen product that were performed in accordance with FDA guidelines and by leading clinical research companies (CROs).
The results of the successfully completed trials will now be used by Selkior in preparation for submitting an IND to the FDA for a Phase I/IIa trial in age-related retinal degeneration (dry-AMD) patients using the OpRegen cells developed by Selkior.
The OpRegen is a product for the treatment of retinal degeneration, which includes macular degeneration of cells located in the center of the retina of the eye and is based on pigment cells in the back of the retina of the eye (RPE).
The main cause of AMD is the death of the RPE cells that are under the retina and support it. The unique treatment developed by the Selcure company to cure the dry AMD disease, Dry-AMD, is the transplantation of pigment cells of the retina, RPE cells, produced from embryonic stem cells. The medical treatment is a procedure in which RPE cells are injected to renew and replace the degenerating RPE cells in the patient's eye and stop the progression of the disease. Currently, there is no cheap and relatively simple source for supplying RPE cells, while embryonic stem cells are a source that allows for an unlimited amount of RPE cells. Also, today there is no approved medical treatment for macular degeneration of the dry type.
"We are very satisfied with the safety results obtained in experiments on two species of animals which showed that the OpRegen cells survived after transplantation for a long period of time and did not lead to teratoma formation or any other pathology. The effectiveness of the OpRegen cells was determined on the basis of a well-known research model for retinal degeneration surgery (Royal College of Surgery), which is considered an accepted model in animal experiments and is widely used for the needs of evaluating a variety of potential cell therapies. The OpRegen cells were found to be effective for long-term treatment and preserved the animals' visual abilities, which usually degenerate over time in this disease model," said Dr. Benjamin Raubinoff, Cell Cure's Chief Scientist and Chair of Obstetrics and Gynecology and Director of the Cell Research Center Fetal stem at the Hadassah Medical Center in Jerusalem.
"In addition, the protection of the animals' vision against degeneration was dependent on the dose of OpRegen® cells administered. As another indication of the therapeutic potential, it was found that the number of photoreceptors, which are responsible for good vision in humans and which degenerate among patients with dry-AMD, is maintained, in the animal model, at a stable level and for a long period of time."
"We are very pleased with the progress Cell Cure has made in preparing for the IND submission to the FDA," said Dr. Charles, S. Irving, CEO of Cell Cure. "We are preparing for the start of the clinical trials that will allow for the first time the use of (xeno-free grade) RPE cells to treat the more severe stage of retinal degeneration."
A hepatitis C virus research laboratory was established at the Galilee Faculty of Medicine of Bar-Ilan University
It is headed by Dr. Mital Gal-Tanami, a virologist by training who recently completed her post-doctoral training at the University of Texas in which she specialized in this virus
At the Faculty of Medicine in the Galilee of Bar-Ilan University, in Safed, a virological laboratory was established that studies the hepatitis C virus (jaundice type C). It is headed by Dr. Mittal Gal-Tanami, a virologist by training. Dr. Gal-Tanami did her post-doctorate at the University of Texas, USA, in the laboratory of Prof. Stanley Lemon, on virology and the hepatitis C virus. She did her doctorate at Tel Aviv University on antibody engineering and the hepatitis C virus. Dr. Gal-Tanami's research has been published in prestigious scientific journals in Israel and around the world.
Hepatitis C virus is the main cause of chronic liver disease and primary liver cancer. More than 180 million people worldwide suffer from chronic hepatitis C. Infection with the virus is the main cause today in the western world, and in Israel in general, for a liver transplant. Today there is no vaccine against this virus, and there is not enough knowledge about the natural immunity against it and about the mechanisms by which the virus causes liver cancer. While vaccines and neutralizing antibodies can be effective in treating the disease, the development of immunological approaches to control the virus has been delayed due to the lack of suitable systems in which neutralizing antibody activity can be measured. In recent years, systems have been developed for the study of the hepatitis C virus, which allowed the development of accurate tests for antibodies that neutralize the virus, and today it is possible to investigate important questions concerning the mechanisms of neutralizing the virus by antibodies. These days, Dr. Mittal Gal's laboratory is conducting isolation tests of neutralizing antibodies unique to the laboratory, which can help in the future in the treatment of the disease or in the development of a vaccine against the virus.
The research in Dr. Gal-Tanami's laboratory is a multidisciplinary study of the hepatitis C virus, which in most cases causes chronic infection - or, in a small number of cases, a one-time infection, which the immune system manages to overcome. In Dr. Gal-Tanami's laboratory, in a unique way, they study the entire antibody repertoire of a chronic patient and of a patient who has recovered from the disease, while trying to identify and build the antibodies that are activated during infection with the virus, and cause the virus to be effectively eliminated. Therefore, the differences in antibody levels and quality between chronic patients and patients who carry the virus and the difference between the immune systems of the two types of patients are being investigated. The research in the laboratory is done with innovative technologies that help in understanding the immune response and the ability of the virus to evade it. In addition, neutralizing antibodies against the virus are developed in the laboratory using methods of antibody engineering. The research in the laboratory will in the future form a basis for the development of passive and active vaccines against the hepatitis C virus.
Another central goal of the laboratory is to understand the process of the development of liver disease caused by infection with the hepatitis C virus and its effect on the mechanisms leading to the development of liver cancer. In the laboratory, the relationship between the effect of the virus on changes in the three-dimensional structure of the DNA and the effect of these changes on the frequency and location of mutations in cancer cells is studied. In addition, the differences in the characteristics of liver cancer caused by hepatitis C virus infection compared to the characteristics of liver cancer caused by hepatitis B virus infection, both of which infect the liver and cause liver cancer, are investigated.
The goal is to enable appropriate treatment according to the cause of the cancer. Furthermore, the dynamic evolutionary balance between the immune system and the viral genome is examined in the laboratory. Another aspect of research that is carried out in the laboratory is the examination of cancer development under the influence of the virus which contributes to the motility and invasiveness of cancer cells during a metastatic process, and how the hepatitis C virus and the hepatitis B virus cause cancer metastases and by which mechanisms the process occurs. The importance of the distinction is that if the mechanisms can be discovered, it will be possible to delay the development of metastases and cancer through drugs.
The research in the laboratory is done in collaboration with researchers in the faculty, senior researchers and doctors in Israel and around the world, hospitals in Israel and in collaboration with pharmaceutical companies.
Dr. Mital Gal-Tanami says that she chose to teach and research at the Faculty of Medicine in the Galilee for Zionist reasons, to settle the Galilee and assist in its development and in view of the one-time opportunity she was given to be a part of the establishment and construction of the Faculty of Medicine and its design.
Scientific paper compliments Yes-Fate's CF101
The article states that it is desirable to develop drugs that are small molecules administered by ingestion to treat psoriasis
Yes Fate Biopharma, a biotechnological company with a pipeline of unique drugs in advanced stages of development intended for inflammatory and cancerous diseases, announces today that a scientific article entitled: "New Drugs and Treatments in Psoriasis" presents Yes Fate's drug CF101 as one of four small molecules being developed into potential drugs that are In the development phase for future treatment of psoriasis, alongside medicines from Pfizer, Celgene and Incyte.
The article is published in the scientific magazine Acta Derm Venereologica and was written by researchers at the dermatology-allergy department, Gentofte Hospital, University of Copenhagen in Denmark. To read the full article: Acta Derm Venereologica.
The article states that biological products for the treatment of psoriasis are expensive, require repeated injections and some patients experience withdrawal of the therapeutic effect. Therefore, it is desirable to develop drugs for ingestion, which are small molecules, say the authors of the article. They identify the A3 adenosine receptor (A3AR) agonist as one of four potential small molecules currently in clinical development.
The article includes a summary of Chen-Fayette's phase 2 psoriasis study and includes CF101 as one of four small molecules under development in addition to Pfizer's Tofacitinib, Celgene's Apremilast and Incyte's Ruxolitinib.
"There is a need to use small molecules as orally administered drugs to treat psoriasis, which is a chronic disease. We believe that the high safety and efficacy profile achieved in phase 2 and the interim analysis of phase 2/3, positions Yes-Fayt's CF101 as a leading drug for psoriasis," says Prof. Panina Fishman, CEO of Yesh-Fayt.
Yes-Fate's phase 2/3 psoriasis study is proceeding as planned and its results are expected to be published in the first quarter of 2015. The psoriasis drug market, which was estimated at $3.6 billion in 2010, is expected to grow to $6.7 billion in 2018, based on Global Data's forecast.
Aposense has secured a patent for its product until 2030
Aposense, a biomed company that develops molecules based on generic drugs, announced today that it has received approval from the USPTO to register an American patent that significantly expands the protection of the company's ATT-11T molecule and its new derivatives for the treatment of various types of cancer. This patent enables the extension of the protection of the molecule developed by the company also for colon cancer and other cancer indications and establishes the ability to protect the molecule for many years, until 2030.
The United States Patent and Trademark Office (United States Patent and Trademark Office) has approved Opusense's application for registration in the United States of the patent for the treatment of various types of cancer in addition to colon cancer, including ovarian, breast, lung, melanoma, lymphoma, etc.
Dr. Miri Ben Ami, CEO of Afosense, said that "the approval of the patent that expands the use of the ATT-11T molecule to treat other types of cancer is a significant milestone in the company's activities. The patent will allow Opsens to gain a substantial competitive advantage in possible entry into the development and commercialization of the molecule also for new cancer indications in the future."
This year, Afosense successfully completed the proof-of-efficacy phase in the pre-clinical development for the ATT-11T drug, after it demonstrated an advantage in effectiveness over the original drug irinotecan in pre-clinical trials carried out to date in several types of cancer: melanoma cancer, colon cancer, lung cancer and ovarian cancer .
