Announcement • Apr 24

BeyondSpring Inc Reports Compelling New Data on Plinabulin Advances Both the Anticancer Efficacy and Safety of Adc Drugs

BeyondSpring Inc. reported new preclinical data at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) demonstrating that Plinabulin has the potential to enhance both the efficacy and tolerability of ADC therapy — potentially boosting anticancer responses while keeping patients on treatment long enough to benefit. Antibody-drug conjugates — a form of targeted chemotherapy that delivers cancer-killing agents directly to tumor cells, known as ADCs — have emerged as one of oncology’s most important new treatment classes. But two persistent clinical barriers limit their full potential: they do not always produce durable responses, and neutropenia (a dangerous drop in white blood cell counts) can force dose reductions or treatment delays that cut treatment short. New AACR data show that Plinabulin directly and simultaneously addresses both. The data show why the combination works. Plinabulin, when added to two approved ADCs — T-DXd (trastuzumab deruxtecan) and Dato-DXd (datopotamab deruxtecan) — produced three significant results that neither drug achieved alone: Complete tumor regressions were more frequent and animals survived significantly longer — in both two-drug (ADC+ Plinabulin) and three-drug (ADC+ Plinabulin + PD-1 inhibitor) combinations. Plinabulin reduced animal death in both two-drug and three-drug combinations. In 6 prior clinical studies, Plinabulin measurably reduced chemotherapy-induced neutropenia, the white blood cell toxicity that commonly forces ADC dose reductions or treatment delays — potentially allowing patients to remain on treatment long enough to benefit from the drug’s anticancer activity. Analysis showed that Plinabulin enhanced the body’s own cancer-fighting T-cells, significantly increasing CD8+ T cell/Treg ratio — providing a biological explanation for why the combination outperforms either drug alone. Plinabulin activates a protein called GEF-H1 that simultaneously matures immune cells (dendritic cells) to attack tumors, signals the body to replenish cancer-fighting blood cells, and disrupts the blood supply feeding tumors. These are precisely the biological pathways that ADCs do not activate — which is why the two work better together than either does alone. In BeyondSpring’s pivotal Phase 3 DUBLIN-3 study (The Lancet Respiratory Medicine, 2024), Plinabulin combined with docetaxel chemotherapy doubled two- and three-year survival rates in second- and third-line EGFR wild-type NSCLC patients — and simultaneously reduced docetaxel-limiting grade 4 neutropenia from 33% to 5%, keeping patients on therapy longer for the drug to work. The new AACR data extend that same combination logic into the ADC setting, broadening Plinabulin’s reach across the treatment landscape. BeyondSpring’s planned DUBLIN-4 program — a 442-patient FDA-aligned confirmatory Phase 3 trial building directly on the DUBLIN-3 results — is the defined next clinical step. AACR data further strengthen the scientific rationale for Plinabulin’s combination potential and point toward future ADC combination studies beyond the confirmatory program. ADCs are increasingly being tested in earlier lines of cancer treatment and in combination with immunotherapy. However, recent large Phase 3 studies — TROPION-Lung01 and EVOKE-01 — showed that ADCs failed to outperform older chemotherapy, such as docetaxel, in certain lung cancer settings, underscoring the need for an agent that can improve the efficacy and tolerability of ADC-based combinations. Plinabulin’s ability to simultaneously boost efficacy and reduce toxicity positions it as a potential backbone agent across the ADC landscape — a role no other drug currently fills. AACR data open the door to ADC combination studies as a natural next chapter in Plinabulin’s clinical development, alongside the ongoing DUBLIN-4 confirmatory program. BeyondSpring’s China operations have been a strategic engine in building the ADC partnerships that support Plinabulin’s global development. BeyondSpring’s AACR 2026 Presentation Title: Plinabulin Boosts Antitumor Efficacy of Topoisomerase Inhibitor-Based Antibody-Drug Conjugates Without or With Immune Checkpoint Inhibitor Presenters: Yingjuan June Lu, Xiaoyan He, Weiwei Cheng, Zhengyan Zhang, James Tonra, Lan Huang Session: T Cell Engagers 2 /Antibody-Drug Conjugates 1 (Immunology Track) Poster Number: 5597 Plinabulin is a late-stage Phase 3 anticancer agent and first-in-class GEF-H1 (guanine nucleotide exchange factor H1) agonist. Its multifunctional mechanism — encompassing dendritic cell maturation, tumor microenvironment modulation, anti-angiogenesis, and chemotherapy-induced neutropenia (CIN) mitigation — activates biological pathways that standard chemotherapy and ADCs do not. Over 700 cancer patients have been treated with good tolerability and durable anticancer benefit in rational combination settings. DUBLIN-3 Phase 3 results in NSCLC were published in The Lancet Respiratory Medicine in 2024. In the DUBLIN-3 Phase 3 study of 2L/3L EGFR wild-type NSCLC (Lancet Respiratory Medicine, 2024), Plinabulin plus docetaxel significantly outperformed docetaxel monotherapy (n=559, 1:1 randomization), with improvements in OS, PFS, and ORR; doubling of 2- and 3-year survival rates; and reduction of docetaxel-induced grade 4 neutropenia from 33% to 5%.

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