Subjects: TRI, FDA, IMA
J INTS BIO, Novel Oral 4th Generation EGFR TKI 'JIN-A02' - Phase 1/2 IND approved by US FDA
- First patient expected in December 2022
SEOUL, South Korea, Nov. 10, 2022 /PRNewswire/ -- J INTS BIO announced on November 9th that it had received approval from the US FDA for its Phase 1/2 clinical trial of its Novel Oral 4th Generation EGFR TKI 'JIN-A02' in patients with advanced non-small cell lung cancer (NSCLC).
IND submission is currently ongoing sequentially in territories outside of USA.
'JIN-A02' is a Novel Orally administered 4th Generation EGFR TKI, which is highly selective and potent against NSCLC harboring C797S double or triple mutations, presenting in either cis or trans forms. Cis isomer is the most common and currently untreatable. 'JIN-A02' also has high blood-brain barrier penetrance with demonstrated in-vivo efficacy.
J INTS BIO is expecting the first patient to be recruited in the US before the end of the year.
About J INTS BIO
J INTS BIO is a bio company specialized in developing innovative anti-cancer and orphan drugs to realize the goal of changing lives and improving health for patients around the world. J INTS BIO's teams have prior multi-year experience in multinational pharmaceutical companies and CROs and track records in medical, regulatory affairs, drug discovery and development.
About 'JIN-A02'
'JIN-A02' is a novel orally administered 4th Generation EGFR TKI targeting C797S mutations in NSCLC. Although 1st, 2nd, and 3rd Generation EGFR TKIs have been used with some success, recurrence occurs in most patients including those on 3rd Generation TKIs such as Osimertinib. Currently, there are no approved therapies for patients who developed EGFR C797S mutations due to the use of 3rd Generation EGFR TKIs and with the high propensity of these cancers to metastasize to the brain, there is an urgent need to develop an effective drug with high blood-brain barrier permeability as well. 'JIN-A02', a novel oral EGFR TKI, which is effective against C797S double and triple mutations and have a high brain penetrance, is therefore expected to become the most promising Best-in-Class 4th-generation EGFR TKI in NSCLC patients with limited or no viable treatment options.
SOURCE J INTS BIO
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