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Other Disclosures4588Oncolys BioPharma Inc.Pharmaceuticals

Notice regarding the submission of a clinical trial notification for the oncolytic virus OBP-301 in a new indication

Oncolys BioPharma submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase 1b/2a clinical trial of oncolytic virus OBP-301 in patients with lower rectal cancer and anal cancer. Dosing is planned to begin during the fiscal year ending December 2026.

Worth reading
67In focus
Scored from 4 of 6 sections
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Neutral
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Wording
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Announced details

Oncolytic virus OBP-301
Applicable field (uses covered by this announcement)

Lower rectal cancer and anal cancer. Patients eligible for preoperative chemoradiotherapy.

Launch dateDosing in the trial is planned to begin during the fiscal year ending December 2026.
Relationship between the counterparty and the company
Oncolys BioPharma Inc.4588
Relationship with the Company

Recipient of the clinical trial notification for OBP-301. Capital, personnel, and business relationships are Not disclosed.

CounterpartyPharmaceuticals and Medical Devices Agency (PMDA), an independent administrative agency

Pharmaceuticals and Medical Devices Agency. Other information on its location, representative, business activities, capital, and year of establishment is Not disclosed.

Impact on Business Performance

The impact on financial results for the fiscal year ending December 2026 is expected to be immaterial. Following approval as a regenerative medical product with esophageal cancer as the initial indication and inclusion in the NHI drug price list, the company plans to begin sales of OBP-301 during the fiscal year ending December 2026 as scheduled.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredOncolytic virus OBP-301
CounterpartyPharmaceuticals and Medical Devices Agency (PMDA), an independent administrative agency
Counterparty overviewPharmaceuticals and Medical Devices Agency. Other information on its location, representative, business activities, capital, and year of establishment is Not disclosed.
Relationship with the CompanyRecipient of the clinical trial notification for OBP-301. Capital, personnel, and business relationships are Not disclosed.
Launch dateDosing in the trial is planned to begin during the fiscal year ending December 2026.
Applicable areaLower rectal cancer and anal cancer. Patients eligible for preoperative chemoradiotherapy.
Impact on Business PerformanceThe impact on financial results for the fiscal year ending December 2026 is expected to be immaterial. Following approval as a regenerative medical product with esophageal cancer as the initial indication and inclusion in the NHI drug price list, the company plans to begin sales of OBP-301 during the fiscal year ending December 2026 as scheduled.
Items this document does not state (11)
Contract ValueOffering priceContract 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.

The trial will evaluate the efficacy and safety of combining preoperative chemoradiotherapy with OBP-301. In addition, because the decline in quality of life resulting from colostomy associated with resection is well known, the company decided to develop OBP-301 in this new indication under the development concept of treating cancer without surgery.

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Notice regarding the submission of a clinical trial notification for the oncolytic virus OBP-301 in a new indication | Oncolys BioPharma Inc. (4588) timely disclosure | Komori