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Other Disclosures4978ReproCELL IncorporatedMaterials and Chemicals

Notice of Completion of PMDA Face-to-Face Consultation on the Clinical Trial Plan for GPC-1 CAR-T Therapy

The Company has completed face-to-face consultation with PMDA concerning GPC-1 CAR-T therapy for recurrent esophageal squamous cell carcinoma and finalized the clinical trial implementation plan based on the discussions. The trial is scheduled to be conducted at Kyoto University Hospital, after which the Company will proceed with preparations to submit the clinical trial notification.

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Announced details

GPC-1 CAR-T therapy
Applicable field (uses covered by this announcement)

Recurrent esophageal squamous cell carcinoma; GPC-1-positive recurrent and refractory solid tumors

Relationship between the counterparty and the company
ReproCELL Incorporated4978
Relationship with the Company

The Company receives face-to-face consultation from PMDA concerning the clinical trial plan. The project was selected for an AMED open call program and receives support from AMED. The clinical trial is scheduled to be conducted at Kyoto University Hospital. Capital and personnel relationships are Not disclosed.

CounterpartyPharmaceuticals and Medical Devices Agency (PMDA)Japan Agency for Medical Research and Development (AMED)Next-Generation Medicine and iPS Cell Therapy Research Center (Ki-CONNECT), Kyoto University Hospital

PMDA is an incorporated administrative agency, and AMED is a national research and development agency. The planned trial site is the Next-Generation Medicine and iPS Cell Therapy Research Center (Ki-CONNECT), Kyoto University Hospital. Other information on location, representative, capital and year of establishment is Not disclosed.

Impact on Business Performance

The impact on consolidated results for the current fiscal year is expected to be immaterial.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredGPC-1 CAR-T therapy
CounterpartyPharmaceuticals and Medical Devices Agency (PMDA), Japan Agency for Medical Research and Development (AMED), Next-Generation Medicine and iPS Cell Therapy Research Center (Ki-CONNECT), Kyoto University Hospital
Counterparty overviewPMDA is an incorporated administrative agency, and AMED is a national research and development agency. The planned trial site is the Next-Generation Medicine and iPS Cell Therapy Research Center (Ki-CONNECT), Kyoto University Hospital. Other information on location, representative, capital and year of establishment is Not disclosed.
Relationship with the CompanyThe Company receives face-to-face consultation from PMDA concerning the clinical trial plan. The project was selected for an AMED open call program and receives support from AMED. The clinical trial is scheduled to be conducted at Kyoto University Hospital. Capital and personnel relationships are Not disclosed.
Applicable areaRecurrent esophageal squamous cell carcinoma; GPC-1-positive recurrent and refractory solid tumors
Impact on Business PerformanceThe impact on consolidated results for the current fiscal year is expected to be immaterial.
Items this document does not state (12)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration 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.

Based on the discussions held during the face-to-face consultation with PMDA.

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Notice of Completion of PMDA Face-to-Face Consultation on the Clinical Trial Plan for GPC-1 CAR-T Therapy | ReproCELL Incorporated (4978) timely disclosure | Komori