Vaxil BioTherapeutics completed the merger of its activities with Sheldonco Ltd
Nes-Ziona, Israel – July, 2012 – Vaxil BioTherapeutics (SLDC:IT), a clinical stage biotechnology company developing therapeutic vaccines for the treatment of cancer and infectious diseases, announced today that it has completed its merger with Sheldonco Ltd (SLDC:IT), a "shell" company traded on the TASE (Tel Aviv Stock Exchange). According to the agreement, Vaxil will be acquired in its entirety by Sheldonco. The shareholders of Vaxil will receive 56% of the share capital of Sheldonco on a fully diluted bass and their holding will increase up to 74% in Sheldonco on a fully diluted bass subject to achieving two technological milestones. Throughout this transaction, Vaxil was represented by Attorney David Ben Yaish, Attorney Amit Za'arur and Attorney Eyal Gottlieb from the Law Offices of Schnitzer, Gottlieb, Samet & Co.
In addition, Vaxil has filed updates on new developments that have occurred since publication of the Mitaar (the regulatory filing relevant to the merger). The company has opened another clinical trial center for its VAXIL-001 study at Rambam Medical Center (RMC) in Haifa. In the last month, two patients have been enrolled at RMC who will be receiving the company's therapeutic vaccine ImMucin.
In addition, Vaxil has published a scientific article in the journal "Experimental and Therapeutic Medicine" where it presented results on the potential usage of the company's VaxHit technology also in the field of cancer diagnostics. The findings of this article indicate the existence of autoantibodies against a unique region known as the SP on the MUC1 antigen in blood samples of myeloma patients but not in the blood of healthy individuals. MUC1 is expressed on a wide variety of cancers, and measuring the blood levels of autoantibodies antibodies in healthy individuals against this marker's can potentially help in early detection of cancer. For the avoidance of doubt, these findings are at a preliminary stage and more research needs to be performed before solid conclusions can be made.
Vaxil was founded in 2006 by Dr Lior Carmon and Mr. Julian Levy. The company is developing therapeutic vaccines to treat both cancer and infectious diseases based on the company's novel technology, VaxHit. VaxHit is a proprietary technology combining an algorithm and reverse immunology to identify the most appropriate portion of a target antigen which can cause a strong and comprehensive immune response.
Vaxil's lead product is ImMucin, a therapeutic vaccine comprising a novel 21mer peptide sequence from the MUC1 antigen which is expressed by many different cancers. In a recent study conducted by the National Cancer Institute of USA (NCI) MUC1 was selected as one of the two leading antigens (out of 75 antigens) based on its advantages in dozens of parameters tested. The ImMucin therapeutic vaccine activates immune cells called CD4 and CD8 T-cells to attack and destroy cancer cells expressing the MUC1 marker. This enables a robust comprehensive and highly specific immune activation with minimal side effects. ImMucin is appropriate for all cancers which express the MUC1 marker. MUC1 appears in over 90% of different cancers, including solid tumors such as lung, breast, colorectal, prostate, kidney, and pancreatic as well as hematological cancers such as Leukemia, Lymphomas and Multiple Myeloma.
In September 2010 Vaxil initiated VAXIL-001, "A first in man" phase I/II study to evaluate the safety, dosing and preliminary signs of efficacy of ImMucin in patients with Multiple Myeloma, a cancer of the bone marrow. Eligible candidates are asymptomatic slowly progressing patients after a period of remission following a bone marrow transplant. The study is being carried out in two medical centers in Israel: Hadassah Medical Center in Jerusalem and Rambam Medical Center in Haifa. The trial will include up to 15 patients of which 13 have so far been treated. Each patient receives either 6 or 12 injections of ImMucin (100 or 250 micrograms) every 2 weeks along with 250 micrograms of GM-CSF.
In April 2011 the company announced the results of an interim analysis on 7 patients who had completed the treatment with ImMucin. The report's conclusions showed the following: ImMucin is safe and patients experienced no adverse effects other than minor local symptoms at the injection site which were characteristic of a vaccination. These minor side effects disappeared within 24 hours with no need for any additional medical treatment. In addition, ImMucin was able to cause a strong immune response encompassing both CD4+ and CD8+ T-cells in all patients after 2-4 injections. In addition, it also caused a strong antibody response in selected patients.
Moreover, in some of the patients there was a stabilization or reduction of disease markers as well as a reduction in the % of Plasma cells in the bone marrow one month after the end of treatment when compared to the % before treatment. Following treatment, three of the seven patients were assessed to be in a Complete Response i.e. that no signs of disease could be detected.
Vaxil develops therapeutic vaccines to treat both cancer and infectious diseases. As opposed to traditional prophylactic vaccines which protect healthy people from disease, a therapeutic vaccine deals with sick people and seeks to harness their immune system to identify and destroy cancer cells in a safe, efficient and focused manner. From the patient's perspective a therapeutic vaccine is a drug.
ImMucin which was identified using Vaxil's proprietary technology, VaxHit, teaches the patient's immune system to identify and destroy cells which display the cancer marker MUC1 which appears on over 90% of all cancers. Consequently, ImMucin has the potential to be used against a wide range of cancers. In addition, ImMucin has a number of specific characteristics which differentiate it from other therapeutic vaccines. Firstly, ImMucin can be offered to a very wide section of the population with no need for complicated and expensive personalization or prior selection based on the patient's immune system. Second, ImMucin has an ability that may enable it to cope with the tendency of the tumor to evade the immune response and develop resistance to treatment. Moreover, unlike other cancer treatments therapeutic vaccines like ImMucin are not accompanied by severe side effects.
In addition to ImMucin, Vaxil is also developing the MTbuVax- therapeutic vaccine for TB with potential for prophylactic use. MTbuVax, which was also identified using VaxHit, is currently being evaluated in animal studies. Globally, TB is one of the largest causes of mortality. According to the WHO, in 2009 9 million people worldwide were diagnosed as carrying the TB bacteria and 2 million died of it.
Although most TB cases are in developing countries, over the last few years, there has been an increase in incidence rates in the western world due to the low efficiency of the current TB vaccine (BCG), increased global travel movements, the mutation of the TB bacteria to new strains which are partially or sometimes even totally resistant to drug treatment and the strong link of TB with HIV infection.
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