Alteogen "ALT-B4 Partner Enters Global Phase 3 Clinical Trial"

[Asia Economy Reporter Myunghwan Lee] Alteogen announced on the 14th that the global Phase 3 clinical trial of its partner company using the hyaluronidase 'ALT-B4' has begun.

ALT-B4 is a hyaluronidase developed by Alteogen in 2018 as an SC formulation modification platform. To date, it has signed partnerships with a total of four global companies. Alteogen explained that this clinical trial is related to an anticancer antibody therapy being conducted by one of the top 10 global pharmaceutical companies, with which it signed a contract worth 4.7 trillion KRW in 2020.

Alteogen expects that entering Phase 3 clinical trials will serve as an opportunity to enhance the technical validation and credibility of ALT-B4. Since this clinical trial is at the product approval stage conducted by a world-renowned pharmaceutical company, it signifies recognition of its necessity and effectiveness.

An Alteogen official stated, "Many prospective partner companies of ALT-B4 have increased their enthusiasm as the clinical stages progressed, and entering Phase 3 will further strengthen this." He added, "We will continue to cooperate with Osong Advanced Medical Industry Promotion Foundation (KBIO) for the production of ALT-B4 and prepare for commercialization by obtaining Process Performance Qualification (PPQ) certification in contract manufacturing (CMO), striving for the first commercialization and future platform expansion."

Currently, SC formulation modification using hyaluronidase is being devised not only for previously used monoclonal antibody therapies (mAb) but also for bispecific antibody therapies and fusion proteins. Alteogen explained that in the future, the application areas are expected to expand to include small molecule therapeutics and antibody-drug conjugate (ADC) therapies.

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