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Other Disclosures4521KAKEN PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Announcement of the Results of the “KP-483” Nonclinical and Phase I Trials —Presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting—

Results from nonclinical studies and a domestic Phase I trial of “KP-483,” an anticancer drug candidate under development by Kaken Pharmaceutical, were presented at ASCO 2026. In the Phase I trial, no dose-limiting toxicities were observed in 19 patients, and evaluable efficacy included stable disease (SD) in 4 patients and a partial response (PR) in 1 patient.

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Direction
Mixed performance
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Scale
19
Example
Wording
Conditional
How definitive the wording is.

Announced details

KP-483
Applicable field (uses covered by this announcement)

Treatment of solid tumors

Launch date29 May–2 June 2026 (the period of ASCO 2026; presentation completed)
What the company reported numerically
Quantitative Effects

No dose-limiting toxicities in the Phase I trial (19 patients); T1/2 of 7.9–12.8 hours; best overall assessment of SD in 4 patients and PR in 1 patient. Antitumor effects were confirmed in nonclinical studies with monotherapy and in combination with an immune checkpoint inhibitor (ICI).

Usage history

19 patients in the domestic Phase I trial (number of patients enrolled in the trial)

Relationship between the counterparty and the company
KAKEN PHARMACEUTICAL CO.,LTD.4521
Relationship with the Company

Kaken Pharmaceutical presented the results of its nonclinical studies and domestic Phase I trial of KP-483 at this conference.

CounterpartyAmerican Society of Clinical Oncology (ASCO)

A conference at which clinical research results on solid tumors and other cancers are presented. The 2026 conference was held in Chicago, United States.

Registration number and expiry date

jRCT2031220311 (registration number for the domestic Phase I trial)

Location (as indicated in this announcement)

Kaken Pharmaceutical headquarters: Bunkyo-ku, Tokyo

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

American Society of Clinical Oncology (ASCO) 2026、Abstract No.2659

Announced details
ItemDetails
Names of Products / Services CoveredKP-483
CounterpartyAmerican Society of Clinical Oncology (ASCO)
Counterparty overviewA conference at which clinical research results on solid tumors and other cancers are presented. The 2026 conference was held in Chicago, United States.
Relationship with the CompanyKaken Pharmaceutical presented the results of its nonclinical studies and domestic Phase I trial of KP-483 at this conference.
Launch date29 May–2 June 2026 (the period of ASCO 2026; presentation completed)
Applicable areaTreatment of solid tumors
Registration number and expiry datejRCT2031220311 (registration number for the domestic Phase I trial)
LocationKaken Pharmaceutical headquarters: Bunkyo-ku, Tokyo
Quantitative EffectsNo dose-limiting toxicities in the Phase I trial (19 patients); T1/2 of 7.9–12.8 hours; best overall assessment of SD in 4 patients and PR in 1 patient. Antitumor effects were confirmed in nonclinical studies with monotherapy and in combination with an immune checkpoint inhibitor (ICI).
Usage history19 patients in the domestic Phase I trial (number of patients enrolled in the trial)
SourceAmerican Society of Clinical Oncology (ASCO) 2026、Abstract No.2659
Items this document does not state (7)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyLocation scaleImpact on Business Performance

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 results were presented at ASCO 2026. The trial was conducted to assess the safety, preliminary pharmacokinetics and efficacy of once-daily oral administration of KP-483.

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Announcement of the Results of the “KP-483” Nonclinical and Phase I Trials —Presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting— | KAKEN PHARMACEUTICAL CO.,LTD. (4521) timely disclosure | Komori