Orgenesis to Acquire Tamir Biotechnology's Assets for $19 Million

Orgenesis Inc. (ORGS) reported that it has signed a deal with Tamir Biotechnology Inc., under which the former will acquire the assets of the latter, including its broad spectrum antiviral platform ranpirnase. The deal is cash- and stock-based and is expected to be worth nearly $19 million. Orgenesis plans to merge ranpirnase with its co-developed Bioxome technology for improving payload delivery direct to the cells.

Combined with ranpirnase, Bioxomes have showed the ability to fuse with cell membranes and delivering an intracellular cargo, mimicking the working of natural exosomes. Bioxomes, when loaded with predesignated genetic material, proteins, signaling molecules and drugs, copy the natural membrane fusion capacities of exosomes. This feature may help in providing more efficient antiviral results.

TamirBio is a clinical-stage company focusing on developing treatments for viruses and other pathological conditions. Its lead asset, ranpirnase, is a ribonuclease and belongs to a superfamily of enzymes which may catalyze the degradation of RNA. It may also mediate in different essential biological activities, such as the regulation of cell proliferation, differentiation, maturation and death. According to Orgenesis, this feature makes it suitable for treating viral and autoimmune diseases which require therapies with anti-proliferative and apoptotic properties.

TamirBio has used these properties for developing topical ranpirnase for treating human papillomavirus, a leading cause of genital warts. The drug candidate has been evaluated in Phase I/II clinical trial for genital warts, and the results demonstrated clear clinical effects. The company plans to hold additional clinical trials. Orgenesis CEO Vered Caplan said, In independent third-party testing, ranpirnase has shown anti-viral activity in multiple viruses. Additionally, over 1,000 patients have been dosed with ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase demonstrated a strong safety and tolerability profile that should help accelerate the approval pathway. TamirBio claims that the drug candidate has shown preclinical antiviral activity in such viral diseases as HPV, HIV, Ebola, and SARS.

Orgenesis also provided updates about its operating activities and reported that its research & development labs are still working. In February, the company sold its subsidiary Masthercell Global Inc. to Catalent Pharma Solutions for nearly $127 million. Masthercell was a contract development manufacturing organization. Orgenesiss CGT Biotech Platform mainly consists of three core components, which are POCare Therapeutics, POCare Technologies, and POCare Network. The CGT Biotech Platform aims to decentralize the CGT supply chain.

The company also recently entered into a new joint venture with Revatis. The partnership will work towards providing autologous cell therapies with exosomes and other cellular products obtained from muscle-derived mesenchymal stem cells. The task of making the stem cells will be entrusted to Revatis, which will use its minimally invasive muscle biopsy technique and isolator technology for this purpose. Orgenesis will be responsible for providing clinical and regulatory expertise and access to its point-of-care (PoC) technology. This POCare platform provides access to a global network of hospitals and research institutes which may be used for carrying out clinical trials for developing life-saving therapies.

Teladoc Health Inc. (TDOC) stock showed solid gains as the ongoing pandemic has put a spotlight on telemedicines. The company has seen a surge in the download of its app BetterHelp, which has a virtual behavioral health offering. According to a research note released by Bank of America Global Research, the app had the download volume of nearly 1000 per day in March, which has now surged to over 1800 per day.

While telemedicine has been around for quite some time, the current scenario has led to mass acceptance of this virtual practice. Due to strict restrictions on movement and the unprecedented burden on healthcare services, telemedicine has proved to be a boon for people with non-critical ailments. Under the 1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, the scope of telehealth facilities has been widened to include coverage for office, hospital and other visits equipped with telehealth facilities in the United States and at patients residences.

The Teladoc platform was recently deployed by Tower Health for offering virtual health care for patients suffering from different ailments. Each visit was provided at $45 and is available 24 hours a day, 7 days a week. Apart from COVID 19, some of the other prominent health issues addressed by the platform are flu symptoms, respiratory infection and rashes. Dr. Lewis Levy, chief medical officer of Teladoc, said, There is no doubt that we are seeing positive momentum and that awareness has increased. Telemedicine is now a household term.

It is estimated that the global telehealth market is expected to register 16.9 percent CAGR during the 2020-2025 forecast period. It will likely be worth $55.6 billion by 2025, up from current valuation of $25.4 billion in 2020. The low-risk and high-efficiency nature of these services are making them very popular now.

Pluristem Therapeutics Inc. (PSTI) reported that it has treated its first patient suffering from complications arising from the novel coronavirus. The patient was treated under the FDA Single Patient Expanded Access Program, and PLX cell therapy was used for this purpose. The company is now looking to initiate a multinational clinical trial at the earliest possible.

Pluristem further said that the patient was in critical condition with respiratory failure due to acute respiratory distress syndrome. The patient was in an intensive care unit with mechanical ventilation for three weeks. Single Patient Expanded Access Program is also known as a compassionate use program and is a part of the US Coronavirus Treatment Acceleration Program. The program is mainly aimed at accelerating the development of new therapies for dealing with this disease.

Pluristem focuses on using PLX cell treatment regimen. These cells are available off the shelf and may be manufactured in bulk quantities. Pluristem CEO and President Yaky Yanay said, We are receiving many inquiries and requests for treatment from healthcare providers and families worldwide. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries. PLX cells are allogeneic mesenchymal-like cells and demonstrate immunomodulatory properties.

Pluristem Therapeutics is mainly invested in developing regenerative medicines and placenta-based cell therapy products. The company has solid development pipeline and has several products in late-stage clinical trials. PLX cell drug candidates are expected to work by releasing different therapeutic proteins in response to radiation damage, inflammation, muscle trauma and ischemia. Pluristem also owns and manages a GMP certified research and manufacturing facility.

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Orgenesis Acquiring Tamir, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha