Multiple Modalities

Modalities

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-Anabella Villalobos

Multiple

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At Home

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I am very passionate about solving problems in neuroscience. I think this is what really gets me in every day. This is why I wake up thinking that I am going to make a difference in people's lives.

“Many companies will focus on small molecules or monoclonal antibodies exclusively, but few have the balanced portfolio of modalities that we have here," Anabella says. For patients with conditions like Alzheimer's disease or spinal muscular atrophy, this mix of modalities means that they could one day have access to an entire range of treatments tailored to their specific disease. “One drug might get them better results, or maybe it turns out to complement another," Anabella explains. “Or maybe they pick a treatment not only because it's effective, but also because it's the easiest approach for them." Some, for example, might prefer having to take a daily pill, while others might not mind a monthly infusion or be fine with a quarterly injection. “By developing a suite of offerings, we can give them that choice," she says. As Anabella and her R&D colleagues look to the future, they hope to expand on their modality approach with new products designed to advance patient care. Cell therapy, for example, is a rapidly evolving field that many scientists believe could revolutionize how neurological diseases are treated. In the coming years, even more modalities may emerge with greater promise.

Biotherapeutic and Medicinal Sciences (BTMS) at Biogen

Biotherapeutic and Medicinal Sciences (BTMS) at Biogen,

Biotherapeutic and Medicinal Sciences (BTMS)

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“The best option for any patient is the option that works for them in a safe manner."

-Anabella Villalobos

A pill, an injection, an infusion. These are some of the things many of us think of when we hear the terms medicines or treatments. Some of them can be kept at home in the medicine cabinet or the fridge, while others are only available at the doctor's office or specialty centers. Beyond how a treatment enters your body, drug developers are reaching into an expanding toolbox of modalities that allows them to address any facet of a disease. With the advent of new technologies that target disease-causing proteins, DNA or RNA, scientists have the potential to single out and correct problem areas within our biology. With this backdrop of possibilities, Anabella Villalobos, Ph.D., head of Biotherapeutics and Medicinal Sciences (BTMS) at Biogen, and her team are finding ways to give options to people living with neurological diseases. Each person might respond differently to an identical treatment for a particular disease. The big challenge for those in drug discovery is how to develop solutions for all—therapies that fit patients according to their needs. For Anabella, that question is the driving force for everything she does at work every day. In addition, she says, it's at the heart of Biogen R&D, which takes a “multiple-modality approach" to advancing drug candidates for neurological diseases. The benefits of a multiple-modality approach are twofold according to Anabella. “The most important element of any therapy is that it has to be efficacious," she explains. The human brain, she notes, is the most important part of our body and is protected by multiple layers, including the blood-brain barrier that keeps out pathogens and toxins that may be in our blood. But it can also keep potential treatments from reaching their target. In addition, the sheer complexity of the brain, with a variety of passages leading in and out, means that there is no single approach or technology that could work for every neurological disease. “We are all here because we want to work on potential treatments for people with neurological diseases,” Anabella says. “And we don’t want to limit ourselves by focusing on a single method – we want to identify the target and the best way to modulate it so that we can get treatments to those who need them.” But it’s also about giving people treatment options, she says. “The best way for us to do that is by investigating multiple methods of treatment that target these diseases using different techniques."

Modalities are important in neuroscience because they define the types of targets we can aim for and how treatments are administered, Anabella says. “I believe that at Biogen we're uniquely positioned from a modality point of view. It doesn't matter to us what modality we use—we're always going to pursue the best one for each target."

Main Modalities

Behind the medicine cabinet The multiple modality approach

At home

In the fridge

In the medicine cabinet

At the doctor's office

How are we pursuing modalities?

Take multiple sclerosis for example, patients have the option of taking medicine via injection or a pill. When each of these medicines was developed, scientists used the modality that was most likely to be effective in patients. This is often how development of new medicines happens: scientists start by finding the drug that works best using the modality that will reach the target. The next step is to consider ways to use other modalities to provide a similar or greater effect while offering options and convenience.

Biogen has capabilities in four main drug modalities: small molecule therapeutics, protein therapeutics (for example, monoclonal antibodies), antisense oligonucleotide technologies and gene therapy. “Each of these modalities gives you access to the central nervous system and brain in different ways and to different extents." By having solutions within each one, Anabella says, “it allows you to attack any given disease from multiple directions."

ASOs are synthetic single strands of DNA or RNA that bind to specific molecules of RNA to interfere with target gene expression, Anabella notes. These are injected into the spine, where they can directly reach the brain, making ASOs a valuable tool in treating neurodegenerative diseases. BIIB080, for example, is an investigational ASO therapy that could help patients with Alzheimer's disease by lowering levels of a protein in the brain that scientists have linked to neurodegeneration.

Antisense Oligonucleotides (ASOs)

injected directly into the central nervous system

Researchers target the root cause of a disease by focusing on the underlying genetic problem. “We are at early stages," Anabella says, “but it's also incredibly exciting. With gene therapy, you're really looking at ways to potentially administer a treatment once and cure a disease forever."

Gene Therapy

a one-time injection

Protein therapeutics, also called “biologics" are made in part or entirely from components of living organisms. “They offer the convenience of intravenous or subcutaneous systemic administration, typically with a once-a-month dosing regimen," Anabella says. Biogen is currently developing biologics, including monoclonal antibodies, for diseases like Alzheimer’s disease, multiple sclerosis and lupus.

Protein Therapeutics

administered through a vein or injection

Small-molecule therapeutics typically include pills that patients take orally, she explains. Unlike other modalities, they can readily distribute into cells and tissues like the brain, and because they're extremely easy to administer, they're usually associated with high patient compliance. Biogen is currently developing small-molecule treatments for patients with diseases like multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and depression

Small Molecules

often given by pill

A “suite" of offerings

“If there's a modality that we believe can help us deliver on our mission, we're going to pursue it and do everything we can to bring it to those patients who can use it."

- Anabella Villalobos

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Protein therapeutics, also called “biologics" are made in part or entirely from components of living organisms. “They offer the convenience of intravenous or subcutaneous systemic administration, typically with a once-a-month dosing regimen," Villalobos says. Biogen is currently developing biologics, also known as monoclonal antibodies for diseases like Alzheimer’s disease and lupus

Protein Therapeutics

administered through a vein or injection

Small molecule therapeutics typically include pills that patients take orally, she explains. Unlike other modalities, they readily distribute into cells and tissues, and because they're extremely easy to administer, they're usually associated with high patient compliance. Biogen is currently developing small molecule treatments for patients with diseases like multiple sclerosis and depression

Small Molecules

often given by pill

Researchers target the root cause of a disease by focusing on the underlying genetic problem. “That's much further away," Villalobos says, “but it's also incredibly exciting. With gene therapy, you're really looking at ways to potentially cure a disease forever."

Gene Therapy

a one time injection

Head of Biotherapeutics and Medicinal Sciences (BTMS) at Biogen

Learn more about Biogen’s Multiple Modality approach.