Japanese drug maker Takeda (TAK) - Get Report is planning to use an old therapy technology for a new disease, Covid-19. The company is developing a plasma-derived therapy, dubbed TAK-888, that would be similar to plasma-based treatments previously used on other severe acute viral infections, including during the Ebola crisis, that is based on technology believed to date back as far as the flu of 1918. Takeda is one of several companies -- including several U.S. ones -- racing for a treatment for the disease.
By concentrating the virus-specific antibodies from plasma collected from people who have already recovered from Covid-19, the disease caused by the newly discovered coronavirus, TAK-888 could be used to treat severely ill patients and -- possibly -- help their at-risk health care workers develop immunity.
The therapy would essentially “transfer” the antibodies to the ill patients, potentially helping their immune systems fight off the infection and boost their chance of recovery, according to Takeda. The company plans to initially make the therapy at its manufacturing facility in Georgia. TheStreet asked about the development of TAX-888 by email with Julie Kim, president of Takeda’s plasma-derived therapies business.
TheStreet: What is the current status of TAK-888?
Kim: We initiated the TAK-888 program in mid-February and have been moving very quickly. We have had productive conversations with regulatory bodies and health systems in a number of countries and anticipate being able to file an investigational new drug application in four to six weeks and, if effective, have the therapy available to patients in nine to 18 months.
TheStreet: So, this therapy relies on the plasma of people who have recovered from Covid-19 and have developed antibodies to the virus. How does this work logistically? Does it mean you need to actually seek out recovered patients for plasma donations, and then does that limit the amount of therapy that can be produced?
Kim: Takeda has a long history of developing plasma-derived therapies and, as part of that, collecting plasma in order to manufacture our current portfolio of immune globulins. We are actively working to identify the most efficient, effective and safe ways to collect plasma from individuals who have fully recovered from Covid-19, which includes working with regulatory bodies and health care systems in numerous countries around the world.
We have already initiated plasma collection in Austria and are close to implementing a unique protocol in the U.S. It is important to note that the precise patient population for treatment would be determined during the regulatory process. We anticipate that hyperimmune globulin would be most likely used for the treatment of high-risk patients with confirmed Covid-19 disease in a hospital.
Hyperimmune globulin may also be considered for the prevention of infection – passive immunity – in health care workers at high risk of infection.
TheStreet: And this is kind of a well-established therapy, right, using antibodies from others who have recovered. It was used during the Ebola crisis and it dates back many decades, right?
Kim: Hyperimmune is not a new concept and has been used multiple times in similar circumstances. For example, in response to the 2009 H1N1 influenza pandemic, Takeda successfully produced a hyperimmune globulin to address a pandemic virus. If TAK-888 is successful, we anticipate that hyperimmune globulin would be most likely used for the treatment of high-risk patients with confirmed Covid-19 disease in a hospital. It would be one option for treatment, and that’s why it’s important that there are multiple treatments and vaccines being pursued (by other companies).
TheStreet: It seems that there's been some concern around potential for reinfection of patients or, perhaps more likely, that tests are not sensitive enough to detect small levels of virus that then cause a "rebound" of disease. Would this affect the ability of this type of therapy to work, do you think?
Kim: Part of what we will be testing during the clinical study is the appropriate dose for effectively neutralizing the virus load in patients.
TheStreet: Could you talk about how the therapy would eliminate risks such as unwittingly spreading infections or other pathogens transmitted by blood?
Kim: In view of the strict screening procedures for plasma donors and the established processes for viral inactivation and removal during manufacturing of plasma-derived therapies, Takeda does not expect that the SARS-CoV-2, or any other pathogen, is a concern for the safety margins of our plasma-derived therapies. .... This is also one of the reasons why a hyperimmune (therapy) is better than just using plasma from fully recovered Covid-19 patients.
TheStreet: Is there anything you would like to add?
Kim: We believe that multiple therapeutic options to tackle the virus and outbreak of disease are needed, including vaccines and other treatments for when people are infected with SARS-CoV-2, and we welcome all initiatives in the best interests of public health.
A plasma-derived therapy approach offers some unique benefits. One of the benefits of a plasma-derived immune globulin therapy is that Intravenous immunoglobulin has an established safety profile based upon years of clinical evidence. The clinical development can, therefore, go straight to testing of efficacy, whereas for new molecules, an evaluation of clinical safety may be required first. In addition, a plasma-derived polyclonal immune globulin therapy can bind multiple epitopes on the virus, including the ones that have been shown to be effective in clearing the infection from the recovered donor, whereas a monoclonal approach covers one single epitope has an established safety profile based upon years of clinical evidence. The clinical development can, therefore, go straight to testing of efficacy, whereas for new molecules, an evaluation of clinical safety may be required first. In addition, a plasma-derived polyclonal immune globulin therapy can bind multiple epitopes on the virus, including the ones that have been shown to be effective in clearing the infection from the recovered donor, whereas a monoclonal approach covers one single epitope.