ToBeSoft "ToBeBio to Develop Additional Indications with PlatBio"

[Asia Economy Reporter Eunmo Koo] Immuno-oncology drug developer ToBeSoft is expanding the clinical indications of its new drug candidate Allostatin through combination therapies with FlatBio's targeted anticancer drugs and Green Cross Cell's immuno-oncology cell therapies.

On the 17th, ToBeSoft announced that its wholly owned subsidiary ToBeBio New Drug Research Institute (hereafter ToBeBio, 100% stake) signed a joint new drug development agreement with anticancer drug development partner FlatBio to expand the clinical indications of Allostatin and will conduct preclinical studies for new indications.

Allostatin is a novel compound created by modifying the molecular structure of Alloferon, a new drug commercialized in Russia for treating viral diseases, to enhance Alloferon's efficacy and safety. It has the effect of enhancing the cytotoxic activity of mononuclear immune cells, including NK cells (Natural Killer Cells).

Through joint research with FlatBio, ToBeBio confirmed that Allostatin, when used in combination with chemotherapy agents for pancreatic and ovarian cancers, provides additional and significant survival benefits. Clinical sample production is currently underway at Polypeptide, a European contract manufacturing organization (CMO).

Through this joint development, ToBeBio will develop combination therapies with FlatBio to expand Allostatin's indications and conduct preclinical studies. They plan to extend indications to various solid tumors, including brain cancer, through combination therapies with FlatBio's proprietary targeted anticancer drugs and Green Cross Cell's immuno-oncology cell therapies.

Sunjin Kim, CEO of FlatBio and Chief Research Advisor of ToBeBio, stated, “Generally, when developing combination therapies with already commercialized drugs, clinical design and interpretation to prove significant efficacy of the new drug candidate are challenging, often requiring separate repeated clinical trials for approval, which takes considerable time in preclinical and clinical phases. However, ToBeBio is expected to quickly generate effective data and enter clinical trials by using syngeneic models with high clinical translation probability and pathological analysis based on preclinical results.” He added, “It is also noteworthy that we adopted a strategy to start combination therapy development simultaneously from the early stages to drastically reduce trial and error,” emphasizing the significance of this joint development.

Kanghee Cho, CEO of ToBeSoft and ToBeBio, said, “We have high expectations for this preclinical study to expand indications being conducted with FlatBio, which possesses world-class new drug research and development capabilities.” He continued, “Especially, Allostatin, which has shown efficacy in pancreatic and ovarian cancers, can undergo advanced preclinical and clinical studies through strategic joint development with FlatBio, further increasing the likelihood of new drug success.” He added, “We are continuously pursuing the introduction and development of additional anticancer drug candidates,” and concluded, “As encouraging results are emerging from our partnership with FlatBio, we will further expand our strategic cooperation.”