Komori
Disclosure4570Immuno-Biological Laboratories Co.,Ltd.Pharmaceuticals

Notice Regarding the Status and Schedule of Anti-HIV Antibody Development

The company reported that a nonclinical toxicity study using monkeys is progressing smoothly for the anti-HIV antibody. It also presented plans to begin establishing a master cell bank during the current fiscal year, start manufacturing the investigational drug during the 46th fiscal year, and submit a clinical trial notification to the PMDA.

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Decision and Details

Development status and future plans for the anti-HIV antibody for which a patent application has been filed

ImplementationPlans to begin establishing a master cell bank for antibody-producing cells during the current fiscal year, and to begin manufacturing the investigational drug and submit a clinical trial notification to the PMDA during the 46th fiscal year
Going forwardThe company plans to begin establishing a master cell bank for antibody-producing cells during the current fiscal year, and to begin manufacturing the investigational drug and submit a clinical trial notification to the PMDA during the 46th fiscal year. If any matters requiring disclosure arise in the future, the company will promptly notify the public.
Quantity / scaleA 4-week repeated-dose toxicity study and a 4-week recovery study using monkeys
Reason

CURED is advancing development with support from AMED, and the nonclinical toxicity study has encountered no issues to date and is progressing smoothly in all respects

Impact on Business Performance

No impact on the company's consolidated financial results for the fiscal year ending March 2027 is expected

Decision and Details
ItemDetails
Matter CoveredDevelopment status and future plans for the anti-HIV antibody for which a patent application has been filed
Implementation DatePlans to begin establishing a master cell bank for antibody-producing cells during the current fiscal year, and to begin manufacturing the investigational drug and submit a clinical trial notification to the PMDA during the 46th fiscal year
Quantity / scaleA 4-week repeated-dose toxicity study and a 4-week recovery study using monkeys
Impact on Business PerformanceNo impact on the company's consolidated financial results for the fiscal year ending March 2027 is expected
ReasonCURED is advancing development with support from AMED, and the nonclinical toxicity study has encountered no issues to date and is progressing smoothly in all respects
Future plansThe company plans to begin establishing a master cell bank for antibody-producing cells during the current fiscal year, and to begin manufacturing the investigational drug and submit a clinical trial notification to the PMDA during the 46th fiscal year. If any matters requiring disclosure arise in the future, the company will promptly notify the public.
Items this document does not state (6)
Decision-Making BodyDecision DatePeriod CoveredAmountGoverning RuleRelated previous disclosures

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.

CURED is advancing development with support from AMED. It explained that the nonclinical toxicity study has encountered no issues to date and is progressing smoothly in all respects.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
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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 Regarding the Status and Schedule of Anti-HIV Antibody Development | Immuno-Biological Laboratories Co.,Ltd. (4570) timely disclosure | Komori