Cellivery Signs Joint Development Agreement with Daiichi Sankyo... "Applying TSDT to Gene Interference Therapeutics"

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 20th that it has signed a joint development agreement to apply its 'pharmacological substance in vivo delivery technology TSDT' to the gene interference therapeutic antisense oligonucleotide (ASO) of Daiichi-Sankyo, a global pharmaceutical company.

Daiichi-Sankyo is a global pharmaceutical company operating in over 60 countries worldwide, achieving sales of $8.5 billion as of 2018. It is the second largest pharmaceutical company in Japan after Takeda, which has expanded its size by acquiring Ranbaxy, India's largest generic pharmaceutical company, and Plexxikon, a U.S. pharmaceutical company with new drug pipelines and platform technologies, for $4.6 billion and $800 million respectively.

Gene interference ASO therapeutics regulate the expression of specific genes. They can be applied to treat various difficult and intractable diseases such as cancer, diabetes, and Parkinson's disease. Recently, Spinraza, a gene interference ASO substance that can treat spinal muscular atrophy (SMA), a representative rare disease, was first approved by the U.S. FDA in 2016, and recorded sales of $1.7 billion within two years of its launch, making it a promising new drug field.

A company official explained, "The specific gene interference ASO therapeutic that Cellivery and Daiichi-Sankyo have agreed to jointly develop is expected to have a very large impact upon successful development due to the market characteristics where no treatment currently exists," adding, "This was a consensus reached at the negotiation table of the JPM Conference where Sankyo and Cellivery finalized the contract."

Due to the unique mechanism of ASO, which penetrates the cell membrane to interfere with gene expression inside the nucleus, cell-to-cell transfer is essential, but there is currently no technology that can completely overcome this hurdle. The company explained that the contract was signed with the expectation that Cellivery's TSDT platform technology is a groundbreaking new technology that can solve the problem of delivery into cells in vivo.

Jung Min-yong, Head of Business Development at Cellivery, said, "If the experiments proceed successfully, it could lead not only to the current ASO but also to a non-exclusive licensing agreement for the TSDT platform technology itself," adding, "It will lead to continuous contracts applying Cellivery's TSDT platform technology to various pharmacological substances including nucleic acid-based new drugs such as ASO, as well as recombinant proteins, peptides, and antibody therapeutics."

Meanwhile, Cellivery emphasized that in addition to Takeda, the global top 3 pharmaceutical companies, and Daiichi-Sankyo with whom it has signed contracts so far, it is also in joint development and technology licensing negotiations with several other multinational global pharmaceutical companies that possess multiple new drug candidates. The development of the ataxia candidate substance (recombinant protein) jointly developed by Cellivery and Takeda is currently in the final milestone phase 3 of the contract. The efficacy of the new drug candidate is being simultaneously evaluated in disease animal models at research institutes in Korea and Japan of both companies. Furthermore, after signing the final verification test contract last October for a candidate substance (pancreatic cancer and lung cancer-specific antibody therapeutic) from a global top 3 pharmaceutical company whose name cannot be disclosed, rapid verification tests of the cell and tissue permeability and efficacy of the aMTD-antibody new drug are currently underway, the company emphasized.

Joa Dae-woong, CEO of Cellivery, said, "With this contract, our TSDT platform technology can greatly contribute to many innovative new drug substances that have high potential for success but struggle to be developed as new drugs due to insufficient delivery deep into biological tissues and cells," adding, "Based on Cellivery's performance in its first year since listing, we expect that as time goes by, more cumulative collaboration contracts with global pharmaceutical companies will follow."

He added, "Currently, multiple academic papers are in the final stages of review in top 1% prestigious international scientific journals, and once these papers are published, global big pharma companies will evaluate our company's technology more significantly," emphasizing, "Therefore, within the limits of our research and development capabilities, we are doing our best to maintain, develop, and expand cooperative systems with global pharmaceutical companies, ultimately aiming to achieve major technology licensing."

This content was produced with the assistance of AI translation services.