The company’s GlycOBI platform is compatible with various antibodies, payloads, and linkers. Credit: MIND AND I/Shutterstock.

OBI Pharma has received clearance from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application for OBI-902 to commence a Phase I/II trial for treating individuals with advanced solid tumours.

The clinical trial is set to commence subject enrolment in the second half of this year.

The trop-2 antibody-drug conjugate (ADC), OBI-902, employs the company’s GlycOBI ADC enabling technology, offering hydrophilicity and stability.

Trop-2 is known to be highly expressed in numerous solid tumour types, including ovarian, breast, and gastric cancers.

The ADC is said to carry a topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of four, designed to target and destroy tumour cells.

With its enhanced pharmacokinetic characteristics, this site-specific glycan-conjugated ADC is claimed to have shown antitumor efficacy and a favourable safety profile in several animal models.

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OBI Pharma CEO Heidi Wang said: “The impending OBI-902-001 clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-902 in patients with advanced solid tumours. We are very excited to begin dosing patients in our Phase I/II clinical study of OBI-902 later this year.” 

Since December 2021, the company has licenced Trop-2 targeting antibody from the biotech company Biosion, securing the exclusive global rights, with the exception of China.

OBI has global commercial rights to OBI-902, except for the rights pertaining to the antibody in China.

The company noted that its GlycOBI platform is compatible with various antibodies, payloads, and linkers.

Leveraging EndoSymeOBI and HYPrOBI, the company’s enzymatic and linker technologies, respectively, the GlycOBI platform produces homogenous ADCs that are site-specific, under good manufacturing practice (GMP) conditions.

The GlycOBI conjugation process preserves the antibody structure, ensuring that the ADC maintains biophysical characteristics akin to the native antibody.

OBI’s linker technology is claimed to have enhanced the payload conjugation efficiency and minimised aggregation propensity, offering manufacturing advantages for ADC products.

Additionally, the company has further developed the ThiOBI platform to enable irreversible cysteine-based conjugation.

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