The multinational wants to license the product to face the last phase of clinical trial.
The clinical results of the vaccine Alzheimer’s of Grifols presented Ten days ago They were an important step for the company. The test showed that the candidate ABvac40 has a safe profile, a robust immune response and showed potential cognitive benefits. With these data, the multinational blood products company plans to license the product to another company to address the development of the last phase of research in patients.
The director of operations of the pharmaceutical company, Víctor Grifols Deu, acknowledged on Thursday in a meeting with analysts that the company wants to give up the product. “We are very open to reaching some type of licensing agreement,” said the manager, a member of the fourth generation of the founding family. “Today, Grifols’ status with this vaccine is that we are looking for some kind of partnership“, he concluded.
Reduce investments and risks
With this decision, the multinational would be trying to distribute the important investments and risk of the clinical trial. A phase III study costs tens of millions and could take several years before providing conclusive results. The licensing agreement would allow the company to remain linked to the project without excessively mortgaging its investment capacity in R&D in other projects to diversify.
The vaccine is a product from biotechnology Araclon Biotech. Grifols acquired 51% of the Aragonese company in 2012 and, since then, has been increasing its participation as the company has needed resources to finance its research.
Test results
ABvac40 is designed to target the C-terminus of AB40, which plays a role in cerebral amyloid angiopathy (CAA), a highly prevalent condition. Previous vaccines targeting this therapeutic target failed because they presented harmful effects, such as meningoencephalitis.
The results presented ten days ago showed above all good safety data, in addition to eliciting a robust immune response against the AB40 peptide. Grifols highlighted that, although the trial did not have the necessary power to determine therapeutic efficacy, ABvac40 showed up to a 38% reduction in disease progression, as reflected by the Mini-Mental State Examination (MMSE) score. Other neuropsychological tests, such as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) or the Trial Performance Test (TMT), showed favorable results in ABvac40 compared to the placebo group.
Amber, waiting
In addition to the vaccine, Grifols has Ambar, a treatment for the same disease that has passed phase III. Grifols Deu explained that the ASFA, the American Apheresis Society, has included this therapy in its medical guide, but he pointed out that it is still early to make it profitable. “We are on standby. We have conversations with regulatory agencies to see opportunities on how to proceed“, said.
When the data from the latest studies was presented in 2019, some analysts estimated the Ambar market at €5 billion. “We are trying to understand the possibilities in relation to the inclusion of the protocol in the ASFA guide,” Grifols Deu insisted.
2023-11-03 23:16:00
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