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Other Disclosures4594BrightPath Biotherapeutics Co.,Ltd.Pharmaceuticals

Notice of the Submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for BP2202

BrightPath Biotherapeutics Co., Ltd. submitted an IND application to the FDA for BP2202, an iPS cell-derived BCMA CAR-NKT cell therapy, to begin a Phase I clinical trial in the United States. The application has been submitted, but the start of the clinical trial and FDA approval have not yet been reported.

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Announced details

BP2202 (iPS cell-derived BCMA CAR-NKT cell therapy)
Applicable field (uses covered by this announcement)

Phase I clinical trial for multiple myeloma

Relationship between the counterparty and the company
BrightPath Biotherapeutics Co.,Ltd.4594
Relationship with the Company

The Company submitted an IND application to the FDA.

CounterpartyU.S. Food and Drug Administration (FDA)

The U.S. government agency responsible for food and drug administration. Other information, including its location, representative, capital, and year of establishment, is Not disclosed.

Award/certification name

Orphan Drug Designation

Awarding / certifying body

U.S. Food and Drug Administration (FDA)

Impact on Business Performance

No impact on results for the fiscal year ending March 2027

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredBP2202 (iPS cell-derived BCMA CAR-NKT cell therapy)
CounterpartyU.S. Food and Drug Administration (FDA)
Counterparty overviewThe U.S. government agency responsible for food and drug administration. Other information, including its location, representative, capital, and year of establishment, is Not disclosed.
Relationship with the CompanyThe Company submitted an IND application to the FDA.
Applicable areaPhase I clinical trial for multiple myeloma
Award/certification nameOrphan Drug Designation
Awarding / certifying bodyU.S. Food and Drug Administration (FDA)
Impact on Business PerformanceNo impact on results for the fiscal year ending March 2027
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historySource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The IND application was submitted to the FDA as part of the process for beginning a Phase I clinical trial of BP2202 in the United States.

How to read this page

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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice of the Submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for BP2202 | BrightPath Biotherapeutics Co.,Ltd. (4594) timely disclosure | Komori