Tanabe Research Labs Announce FDA Acceptance of IND Application for TR1801-ADC

TRL announced the U.S. Food and Drug administration (FDA) accepted the company's first Investigational New Drug (IND) application to initiate a phase I trial for its Antibody Drug Conjugate TR1801-ADC (MT- 8633) in patients with cMet positive solid tumors.

"We are excited to be able to move TR1801-ADC into the clinic," said Roland Newman, TRL's Chief Scientific Officer. "TR1801-ADC is an extremely potent ADC that combines a non-agonizing anti-c-Met antibody developed at TRL, with a pyrrolobenzodiazepine dimer (PBD) toxin, and has demonstrated potent dose dependent anti-tumor activity against Met positive tumors in preclinical models."

The PBDs were developed by TRL's collaborative partner MedImmune, the global biologics research and development arm of AstraZeneca, via its proprietary Spirogen technology and licensed to TRL. PBDs are of an order of magnitude more potent than other warheads currently used with other ADCs, and in the case of TR1801-ADC are linked to the antibody via a site-specific conjugation site.

cMet, also referred to as the hepatic growth factor receptor (HGFR), is a validated target expressed on a variety of tumor types including colorectal, NSCLC, gastric, esophageal, pancreatic, bile duct and many other cancers.

"Patients will be selected based on c-Met expression levels using a histological screening system (IHC) to determine their eligibility. Patients that have either cMet gene amplification or are non-gene amplified will both be eligible for the trial as long as they meet the IHC expression cutoff requirement," said Gary Woodnutt, TRL's VP of Development.

"The acceptance of this IND by the FDA is an important milestone for TRL," said CEO and President Naoki Sakurai, "as it validates our research efforts and represents the first ADC product in a rich future pipeline. This achievement is a result of hard work by our dedicated employees and is the first drug in TRL's mission of creating therapies with a meaningful clinical benefit for patients."

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