Heligenics IDs new interferon beta variants that might help in MS

Heligenics has discovered a number of variations in the interferon beta 1 (IFNB1) gene that may markedly improve the effectiveness of medications containing the interferon beta protein — a protein widely used in the treatment of multiple sclerosis (MS).

The discovery was made using the biotechnology company’s GigaAssay drug development platform, which allows it to perform a rapid assessment of all genetic variants in a target gene. The platform also allows Heligenics scientists to test the functional impact of the protein resulting from each variant in live human cells.

This comprehensive analysis of the IFNB1 gene identified 70 genetic sequences that result in biobetters — versions of existing biological therapies with significantly improved efficacy. It also led to the identification of 1,300 sequences leading to improved biosimilars of interferon beta medications. Biosimilars are medications similar to already approved biologic therapies that are generally sold at a reduced cost.

In addition, according to the company, data from the analysis may help identify which patients are more likely to respond to a given interferon beta-based therapy, both in the real-world clinical setting and in clinical trials testing novel interferon compounds.

“With the identification of over 70 biobetter and 1,300 biosimilar sequences, Heligenics is poised to transform drug development IFN, and other, biologic drugs. These interferon beta variants hold immense promise in improving the first-line therapy for multiple sclerosis,” Martin Schiller, PhD, Heligenics’s CEO, said in a company press release.

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Heligenics is now searching for pharmaceutical companies interested in developing and commercializing the identified interferon biobetters. The company also is looking for partners to collaborate on projects aimed at the development of new biological medications.

“Until now, no one has delivered a technology to functionally assess every possible mutation in a gene,” said Jerome Rotter, MD, distinguished professor of pediatrics and human genetics at UCLA and a Heligenics board member.

“I believe that Heligenics is poised to dramatically advance both the therapeutic and diagnostic landscapes,” Rotter said, adding, “IFN beta is just the beginning.”

Until now, no one has delivered a technology to functionally assess every possible mutation in a gene.

MS is caused by the immune system mistakenly attacking healthy parts of the brain and spinal cord, leading to progressive nerve damage and death that results in a range of symptoms.

Interferon-based medications, such as Avonex (interferon beta-1a) or Betaseron (interferon beta-1b), are a type of MS disease-modifying therapy designed to prevent the excessive inflammation that contributes to the neurodegenerative condition.

Yet, not all patients respond to these medications, and interferon-based therapies are generally seen as low-efficacy drugs, with only moderate impact on disease activity and progression.

In an attempt to find better sequences of the interferon beta protein, researchers at Heligenics now scanned about 5,000 genetic variants of the IFNB1 gene and studied how the resulting proteins impacted cells.

Using this technology, new protein sequences similar to or outperforming an existing biological therapy can be identified. This includes proteins that last longer in the body, have a stronger biological activity, or show greater efficacy.

While new therapies that outperform the approved drugs have to go through the normal regulatory processes, biosimilars — which are generally similar to an approved therapy — have several advantages over classic therapy development. Among them typically are faster approval, lower regulatory risk, and instituted markets with insurance reimbursement.

Further, approved biosimilars usually are sold at a lower price than the original biological therapy.

This innovation, according to Heligenics, is “cutting-edge.” It means that high content screening — the analysis of thousands of compounds tested simultaneously, historically used for small molecules — can now be applied to biological therapies such as interferons. The company hopes new partnerships with pharmaceutical companies will allow it to advance its products to market.