On June 24, 2021 IN3BIO Research Limited reported that the company has received the Clinical Trial Application approval from the Bulgarian Drug Agency and Ethical Committee to initiate a Phase I/II clinical trial of its colorectal cancer vaccine in Bulgaria (Press release, In3Bio, JUN 24, 2021, View Source [SID1234584345]).

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IN3BIO will trial its innovative anti-EGF vaccine IN01, in combination with small molecule inhibitors (SMIs) in patients suffering from KRAS or NRAS (Cohort A) or BRAF (Cohort B) mutated colorectal cancer.

Erik D’Hondt, CEO of IN3BIO said "We are delighted to have reached this significant regulatory step to conduct our clinical trial in Bulgaria. This first approval will lead to patients being enrolled rapidly in centres in Bulgaria, then in clinical centres in other EU and non-EU countries".

About IN01

IN01 vaccine is a proprietary biologic fusion molecule designed and developed by IN3BIO. It is administered after mixing with an adjuvant Montanide ISA 51 VG ST to produce an extemporaneous water in oil emulsion (W/O) known to enhance the immune response of therapeutic vaccines.

The vaccination of IN01 produces anti-EGF antibodies which capture EGF and prevent it from binding to its target, i.e. EGF-receptor on cell surface. This prevents proliferation of tumour cells affected by EGF mediated pathways.

IN01 is manufactured in a contracted certified GMP facility in the EU. Extensive testing as a single molecule or in combination with SMIs showed no adverse effect in several pre-clinical studies.