Infectious Disease Focused Zalgen Labs Opens New
HQ in Frederick, Eyes Clinical Trial for
Lassa Fever Therapeutic
Zalgen Labs is beginning 2022 with new digs in Frederick, Maryland and plans to file an investigational New Drug Application with the U.S. Food and Drug Administration for its developmental Lassa fever therapeutic, Arevirumab.
Zalgen Labs, which until late December been housed at the Germantown Innovation Center for the past eight years, is focused on developing diagnostics and therapeutics for infectious emerging viral threats that have become endemic in the far corners of the world, including diseases such as Lassa fever, Ebola and other hemorrhagic diseases.
While those diseases are typically isolated from the consciousness of the western world, they are a present and ongoing issue in West Africa. Zalgen Labs is developing countermeasures to prevent these viruses from becoming global concerns that could result in a pandemic. Luis Branco, managing director and co-founder of Zalgen Labs, warned that those seemingly isolated viral threats can easily reach U.S. shores through something as simple as an infected individual boarding an airplane. In fact, in 2014, the first cases of Ebola were diagnosed in the United States after passengers arrived on an airplane.
Branco pointed to a 2021 paper that zeroed in on the potential viral concerns that could threaten the globe. At the top of the list was Lassa fever, which is primarily spread by rats in parts of West Africa. Lassa is estimated to infect 100,000 to 300,000 people each year. Of those, approximately 5,000 people die. Due to a lack of proper surveillance, however, the numbers could actually be higher. According to the U.S. Centers for Disease Control and Prevention, approximately 10-16% of patients who are admitted to hospitals in Sierra Leone and Liberia have Lassa fever. This increases the risk of person-to-person transmission as well as the potential for social and economic disruption. There are no approved therapeutics for the virus yet.
Beyond West Africa, the disease has been found in other parts of the continent, as well as parts of Germany and the United States. It’s with that understanding, coupled with the ongoing COVID-19 pandemic, that has fueled Zalgen and its mission of pandemic preparedness.
And that is what Zalgen hopes to prevent with its diagnostic and therapeutic tools.
“Twenty-four hours is all it takes for the world to be caught off guard,” Branco said.
The company developed the first rapid diagnostic test for Lassa fever, which is currently being used in Africa. Also, the company is supplying antibody testing kits to the Coalition for Epidemic Preparedness Innovations (CEPI) for the largest ever Lassa fever study in West Africa. Coupled with that is Zalgen’s preclinical therapeutic asset, Arevirumab-3, a first-in-class immunotherapeutic for prophylaxis and post-exposure treatment of Lassa fever. Branco said that Zalgen plans to file its IND for Arevirumab-3 sometime this year, but does not have a specific timeline. In addition to Areviruman-3, Zalgen is also developing bi-specific antibodies against Lassa. That work is currently in preclinical development.
“The Lassa therapeutic remains our top priority,” Branco said.
The first part of the clinical study will assess the safety of Arevirumab-3. After that, the study will move abroad to Africa where the virus is currently a threat. Ahead of that potential portion of the trial, Branco said Zalgen has been working with organizations in Africa to lay the groundwork to test the medication in a clinical setting.
“When we’re ready to go, the brick and mortar will be there,” he said.
As the company moves forward with its clinical plans, Branco noted that raising finances to support the clinical program will be necessary. Infectious diseases such as Lassa have not traditionally drawn the attention of wealthy venture capitalists, but he hopes to partner with philanthropic organizations and other groups that will provide the necessary support.
With the clinical study, Zalgen could be in a position to expand operations, especially in Maryland, Branco said. Much of that would likely be contract base due to Zalgen’s smaller size, he added.
As Zalgen moves forward with its plans, the company will continue to make itself at home in its new 6.500 square foot facility in Frederick. Branco said the company intended to find new space a few years ago, but COVID-19 slowed the search for new real estate down. However, after working with Scheer Partners, they were able to settle into their new facility.
“The place is great. It has allowed us to integrate everything into one space,” Branco said.
Not only does the facility in Frederick provide Zalgen with more elbow room, the new location also places the company in the heart of an innovation center of more than 80 biotech companies. Branco said this will boost opportunities for collaboration, which is highly important when it comes to battling infectious diseases.
“As we’ve seen over the past two years during the COVID-19 pandemic, sharing information and ideas is critical to advancing the knowledge and tools necessary to improve public health,” Branco said.
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