Die Menarini Group und Ryvu Therapeutics geben auf der ASH-Jahrestagung 2026 die ersten klinischen Daten aus der Phase-II-Studie JASPIS-01 zu Dapolsertib (MEN1703, SEL24) bei stark vorbehandelten Patienten mit rezidiviertem/refraktärem aggressivem B-Zell-Non-Hodgkin-Lymphom bekannt

Initial Phase II JASPIS-01 results showed clinical activity and a manageable safety profile for oral dapolsertib monotherapy in heavily pretreated patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Patients had received a median of four prior therapy lines; 53% had previously received CAR-T therapy and 60% bispecific CD3×CD20 antibodies. The data will be presented at ASH on December 13, 2026; dapolsertib remains investigational and is not approved by any regulatory authority.

Analysis

Investment view — modestly positive for Ryvu, not yet a clinical de-risking event. The read-through is an incremental option-value signal for RVU: an oral monotherapy showing activity in patients who have exhausted CAR-T and bispecific therapy could address a narrow, high-need salvage setting. But the release gives no response rate, response duration, cohort size, or event maturity. “Clinical activity” and manageable safety are sponsor characterizations, not enough to judge whether benefit is durable or clinically competitive. Ryvu is the only mapped listed company with direct exposure; Menarini funds development and holds global rights, so the economic value to RVU depends on license terms not supplied here. Do not infer a material near-term revenue contribution.

Catalysts and risks: The December 13 ASH poster is the next information catalyst; the key tests are response rate by prior CAR-T/bispecific exposure, duration of response, dose intensity, and discontinuations. Over 1–3 months, detailed data could support a sharper probability-of-success update. Over 6–18 months, durability and enrollment/expansion decisions matter more than an early response signal. A further limitation: these monotherapy data do not establish benefit in the separate glofitamab combination cohort or broader B-NHL populations. Failure to show durable responses, or tolerability problems at the intended dose, would reverse the positive read-through. No direct thesis follows for BNTX or EXEL from their unrelated collaborations with Ryvu.

Key Decisions for Investors

• Do not chase RVU on the announcement alone. Treat it as a watch-list catalyst, with position sizing contingent on the full ASH dataset and the company’s license economics.
• At ASH, verify cohort size and follow-up, ORR and complete responses, duration of response, outcomes specifically after CAR-T and bispecific therapy, and dose reductions/discontinuations. Without these, the efficacy signal remains difficult to value.
• A conditional RVU long is more defensible only if the poster shows responses that are durable with acceptable dose delivery and subsequent development plans are credible; reassess or exit the thesis if responses are short-lived or safety compromises dosing.
• Keep BNTX and EXEL neutral on this item: their disclosed Ryvu relationships do not establish exposure to dapolsertib or a financial read-through.