On June 2, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported updated efficacy and safety data from the investigator-initiated Phase 2 303 Study evaluating pembrolizumab plus Plinabulin and docetaxel in patients with metastatic non-small cell lung cancer ("NSCLC") after progression on first-line immune checkpoint inhibitor ("ICI") therapy, either alone or in combination with chemotherapy. The data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting by Dr. Mengzhao Wang and Dr. Yan Xu, principal investigators from Peking Union Hospital.

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First-in-class small molecule agent Plinabulin is a brain-penetrant, uniquely reversible tubulin binder with immunomodulatory properties that promote dendritic cell maturation, M1 polarization and anti-tumor T-cell responses. As a GEF-H1 agonist, Plinabulin is designed to strengthen the cancer-immunity cycle, support immune activation, and help address chemotherapy-induced neutropenia, providing a potential differentiated approach in the post-ICI treatment setting.

The open-label Phase 2 study enrolled 47 patients with metastatic NSCLC who had progressed following prior ICI therapy, including 6 patients previously treated with ICI alone and 41 patients previously treated with ICI plus platinum-doublet chemotherapy. All patients had secondary resistance, defined as prior ICI treatment with progression-free survival of at least six months. Pembrolizumab (200 mg), Plinabulin (30 mg/m2) and docetaxel (75 mg/m2) were all dosed intravenously on day 1 of a 21-day cycle.

As of the February 28, 2026 data cutoff, the median follow-up was 28.8 months. Three patients remained on treatment, and 24 patients remained alive in survival follow-up. Among the 47 enrolled patients, the median age was 67 years; 80.9% were male and 19.1% were female; 72.3% were current or former smokers; and histology included 63.8% non-squamous and 36.2% squamous NSCLC. The key results at the database lock are summarized below.

Median Progression-Free Survival (PFS): 7.0 months — compared favorably with historical docetaxel data in similar post-ICI patient populations, including TROPION-Lung01 and EVOKE-01, which reported median PFS of 3.7 months and 3.9 months, respectively
Median Duration of Response (DoR): 9.3 months – indicating durable response
Disease Control Rate (DCR: PR + SD > 4 months): 79.5% — indicating clinical benefit in the majority of patients who progressed on prior PD-1/L1 inhibitor-based therapy
Confirmed Objective Response Rate (ORR): 18.2% — compared favorably with historical 5-12% ORR for docetaxel, demonstrating anti-tumor activity in metastatic NSCLC patients with secondary resistance to prior ICI
12-Month Overall Survival (OS) Rate: 78.1%; 24-Month OS Rate: 58.0%, with median OS not reached — compared favorably with historical docetaxel data in similar patient populations, including TROPION-Lung01 and EVOKE-01, which reported median OS of 11.8 months and 9.8 months, respectively
The combination demonstrated a generally manageable safety profile. 53.2% of patients experienced grade 3 or higher treatment-related adverse events, including hypertension in 17.0%, gastrointestinal disorders in 14.9%, neutrophil decrease in 17.0%, decreased white blood cell count in 6.4%, and febrile neutropenia in 2.1%
"These updates continue to support Plinabulin’s potential to address one of the most significant unmet needs in lung cancer: treatment options for patients whose disease has progressed after ICI therapy," said Dr. Mengzhao Wang, principal investigator from Peking Union Hospital in China. "With 24-month OS rate of 58%, together with 80% of disease control and encouraging immune activation and hematologic benefit, we believe Plinabulin may offer a differentiated approach to re-sensitizing tumors to immunotherapy with durable long-term benefit while improving the therapeutic profile of docetaxel-based regimens."

BeyondSpring’s ASCO (Free ASCO Whitepaper) 2026 Presentation

Title: A Phase 2 Study of Plinabulin (Plin)/Docetaxel (Doc) plus Pembrolizumab (Pemb) in Metastatic NSCLC (mNSCLC) After Acquired Resistance (AR) to Anti-PD-1/L1 Alone or in Chemotherapy Combination: Efficacy and Immunophenotyping
Presenter/Authors: Yan Xu, Minjiang Chen, Xiaoxing Gao, Huiyu Huang, Yue Chang, Xiaoyan Liu, Wei Zhong, Jing Zhao, RuiLi Pan, Taisheng Li, Mengzhao Wang
Session: Lung Cancer – Non-Small Cell Metastatic (Track)
Abstract Number: 8567

(Press release, BeyondSpring Pharmaceuticals, JUN 2, 2026, View Source [SID1234666399])

On June 2, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia," "Kazia Therapeutics" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, reported the appointment of James Levine as Chief Financial Officer, effective June 1, 2026. Mr. Levine brings more than two decades of experience across investment banking, executive and financial leadership at publicly traded biotech companies.

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"James has built an impressive career leading financial strategy, strategic transactions and major pharmaceutical collaborations, following an extensive career in investment banking," said Dr. John Friend, CEO, Kazia Therapeutics. "As we advance paxalisib and progress our pipeline, James’ expertise will be central to helping us capitalize on that momentum and continue building long-term value for patients and shareholders."

Most recently, Mr. Levine served as Chief Financial Officer of Cardiff Oncology, a clinical-stage oncology company developing a PLK1 inhibitor therapy for solid tumors. Prior to Cardiff Oncology, Mr. Levine served as CFO of Cidara Therapeutics, an antifungal and antiviral biotech company, where he led the financial structuring of a $568 million licensing collaboration with Mundipharma and a $780 million global partnership with Janssen Pharmaceuticals (Johnson & Johnson). He also served as CEO of Verenium Corporation, an industrial biotech company, where he executed major asset sales for total proceeds of approximately $200 million, as well as Sapphire Energy, a human nutrition-focused biotech.

Earlier in his career, Mr. Levine spent 12 years at Goldman Sachs & Co. as a Managing Director advising pharmaceutical and biotech clients across the U.S. and Europe on financings, mergers and acquisitions and strategic transactions, including landmark deals such as the Glaxo Wellcome and SmithKline Beecham merger. Mr. Levine holds a Master of Business Administration degree from The Wharton School at the University of Pennsylvania.

"I am very excited to be joining Kazia as the Company advances paxalisib across multiple indications and builds out a promising pipeline targeting novel mechanisms of treatment resistance," added Mr. Levine. "I look forward to working closely with the management team to help translate Kazia’s scientific progress into strategic and financial outcomes as we approach what we expect to be a period of meaningful clinical and strategic milestones for the Company."

(Press release, Kazia Therapeutics, JUN 2, 2026, View Source [SID1234666368])

On June 2, 2026 AvenCell Therapeutics, a clinical-stage cell therapy company developing switchable CAR-T therapies for cancer, reported that data from the completed Phase 1a portion of the RevSTAR-123 study, evaluating AvenCell’s investigational switchable allogeneic CAR-T candidate (AVC-201) in patients with CD123-positive relapsed/refractory (r/r) or minimal residual disease (MRD) positive acute myeloid leukemia (AML), will be presented in a late-breaking oral presentation in the plenary session at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, taking place June 11-14 in Stockholm, Sweden. The study is registered at ClinicalTrials.gov as NCT05949125.

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EHA 2026 Abstract Details

Abstract number

EHA-7241

Title

First-in-class Switchable Allogeneic CAR-T therapy for
CD123+ AML – Results from the Phase Ia RevSTAR-
123 (AVC-201-01) Study

Topic

Gene therapy, cellular immunotherapy and vaccination
– Clinical

Presenter

Martin Wermke, University Hospital Carl Gustav Carus
Dresden

Presentation details

Plenary Abstracts Session on Saturday, June 13, 12:00
– 13:30 CEST

(Press release, AvenCell Therapeutics, JUN 2, 2026, View Source [SID1234666384])

On June 2, 2026 SEED Therapeutics, Inc. ("SEED"), a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders, reported the presentation of a trial-in-progress poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting highlighting the first-in-human Phase 1 study of ST-01156, SEED’s oral, selective RBM39 molecular glue degrader. The presentation underscores SEED’s transition from platform validation to clinical execution, with ST-01156 advancing across multiple RBM39-dependent cancers, with development informed by mechanism-based preclinical data and real-time pharmacokinetic and pharmacodynamic assessments.

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ST-01156 is designed to degrade RNA-binding motif protein 39 (RBM39), a regulator of RNA splicing programs that govern oncogenes essential for tumor survival. The ASCO (Free ASCO Whitepaper) poster outlines the scientific rationale, Phase 1 dose-escalation design, and planned expansion strategy for ST-01156which is currently being evaluated in a first-in-human Phase 1 dose-escalation study (NCT07197554) in patients with advanced solid malignancies.

Highlights At A Glance

Clinical-stage lead asset: ST-01156 is currently being evaluated in an open-label Phase 1 study in patients with advanced solid malignancies.
Oral, brain-penetrant molecular glue degrader: ST-01156 was rationally optimized for selective RBM39 degradation, potency, metabolic stability, and drug-like properties.
Integrated biomarker and dose-selection strategy: The study incorporates real-time RBM39 target engagement in peripheral blood mononuclear cells (PBMCs), together with safety and pharmacokinetics, to support recommended Phase 2 dose (RP2D) selection.
Broad oncology expansion potential: Planned expansion cohorts include Ewing sarcoma, advanced hepatocellular carcinoma, KRAS-mutant cancers, and other RBM39-dependent tumors, including biliary tract carcinoma, endometrial carcinoma, and DNA damage repair–aberrant cancers.
Preclinical proof-of-concept across multiple models: SEED has demonstrated preclinical antitumor activity in response to RBM39 degradation, including tumor regression, with complete regression observed in Ewing sarcoma, neuroblastoma, and KRAS-mutant colorectal cancer models.

Together, these findings support SEED’s strategy to advance ST-01156 from dose escalation into patient-enriched expansion cohorts where emerging RBM39 biology informs indication selection and clinical proof-of-concept.

Scientific Rationale and ASCO (Free ASCO Whitepaper) Poster Takeaways

RBM39 is an RNA-binding protein that regulates cancer-relevant RNA splicing programs, including pathways involved in tumor proliferation, survival, DNA damage response, and oncogenic fusion proteins. ST-01156 is designed to act as a molecular glue degrader by recruiting RBM39 to DCAF15, an E3 ligase adapter, leading to RBM39 degradation through the ubiquitin-proteasome system. By eliminating RBM39, ST-01156 has the potential to disrupt multiple cancer-driving pathways that are difficult to address with conventional targeted therapies.

The ASCO (Free ASCO Whitepaper) poster highlights preclinical and clinical-development findings supporting SEED’s strategy:

Ewing sarcoma rationale: ST-01156 demonstrated tumor regression in an A673 Ewing sarcoma xenograft model, with complete regression at higher dose levels. Separately, treatment with ST-00937, a non-deuterated precursor of ST-01156, showed complete elimination of RBM39 and the EWS-FLI1 fusion protein in tumor lysates.
Neuroblastoma and KRAS-mutant cancer activity: ST-01156 produced complete tumor regression in an SH-SY5Y neuroblastoma xenograft model, while ST-00937 demonstrated complete regression in an HCT-116 KRAS G13D-mutant colorectal cancer xenograft model.
Mechanism-based expansion strategy: The clinical development plan includes expansion cohorts in Ewing sarcoma, advanced hepatocellular carcinoma, KRAS-mutant cancers, and other RBM39-dependent tumors, including biliary tract carcinoma, endometrial carcinoma, and tumors with DNA damage repair aberrations.
Integrated dose-selection approach: The Phase 1 study is designed to determine the optimal dose and recommended Phase 2 dose using safety, pharmacokinetic, and pharmacodynamic data, including real-time measurement of RBM39 target engagement in PBMCs.

"ST-01156 is designed to address a biologically important and difficult-to-drug target through selective RBM39 degradation. The ASCO (Free ASCO Whitepaper) presentation highlights a disciplined clinical strategy that integrates safety, pharmacokinetics, and real-time target engagement to guide dose selection and expansion into cancers with strong mechanistic rationale. We believe this approach positions ST-01156 to generate early meaningful clinical proof-of-concept across multiple RBM39-dependent tumor types," said Dr. James Tonra, PhD, President, and Chief Scientific Officer of SEED.

"The advancement of ST-01156 into first-in-human clinical evaluation is an important milestone for SEED and a validation of our RITE3 technology. Our goal is not only to discover molecular glues, but to rationally design degraders with clear target biology, translational biomarkers, and a defined clinical development path. ST-01156 reflects that strategy and represents a meaningful step toward unlocking disease drivers that have historically been considered undruggable," said Dr. Lan Huang, PhD, Co-Founder, Chairman, and Chief Executive Officer of SEED.

Clinical Development Status

ST-01156 is being evaluated in an ongoing, open-label Phase 1 multiple ascending dose (MAD) study in patients with advanced solid malignancies. The study is designed to enroll approximately 30 to 50 patients, with ST-01156 administered orally once daily for five days every seven days, with the option to adapt to a continuous once-daily schedule based on emerging data.

The primary objectives are to characterize safety and tolerability and determine the optimal dose and recommended Phase 2 dose. Secondary objectives include pharmacokinetics, RBM39 target engagement in PBMCs, and preliminary antitumor activity. Per protocol, SEED plans to evaluate ST-01156 in mechanism-based back-fill cohorts within this MAD study, including Ewing sarcoma, advanced hepatocellular carcinoma, KRAS-mutant cancers, and other RBM39-dependent tumors. Data from these cohorts are intended to inform the design of the protocol’s subsequent Phase 1 expansion phase.

ASCO 2026 Poster Presentation Details:

Title: First-in-Human Clinical Evaluation of ST-01156, an Optimized and Selective Degrader of RNA-Binding Motif 39 (RBM39): A Phase 1 Study in Advanced Solid Malignancies with a Focus on RBM39-Dependent Cancers
Presenter/Authors: Eric K. Rowinsky, Gregory M. Cote, George D. Demetri, Robert G. Maki, Suzanne George, Daneng Li, Alain C. Mita, Monica M. Mita, Jordi Rodon Ahnert, Dan Lu, Dong Liu, Lan Huang, James Tonra
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract Number: TPS3164

(Press release, Seed Therapeutics, JUN 2, 2026, View Source [SID1234666400])

On June 2, 2026 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported the publication in Blood of updated results from the relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia (NPM1-m AML) cohort of KOMET-007, a Phase 1a/b trial evaluating ziftomenib in combination with venetoclax and azacitidine (ven/aza). The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety profile in adults with R/R NPM1-m AML.

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KOMZIFTI (ziftomenib) is approved by the U.S. Food and Drug Administration as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib in combination with ven/aza is investigational and has not been approved by the FDA.

"This analysis provides a more mature evaluation of ziftomenib in combination with venetoclax and azacitidine in patients with NPM1-mutated AML," said Eunice S. Wang, M.D., Chief of Leukemia, Roswell Park Comprehensive Cancer Center, and co-first senior author of the publication. "In the relapsed/refractory setting, outcomes with venetoclax-based regimens in patients with NPM1-mutant AML remain suboptimal, highlighting the substantial need for more effective therapies. These KOMET-007 results are notable for the depth and durability of response observed with the investigational three-drug combination. The favorable safety profile also supports the continued evaluation of this combination in a setting where better treatment options are urgently needed."

"As combination approaches become increasingly important in this setting, the data highlighted in this publication strengthen the case for ziftomenib as a backbone in NPM1-mutant AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Ziftomenib combined with ven/aza demonstrated deep molecular responses, durable remissions, and a generally manageable safety profile in R/R NPM1-m AML. These findings support our ongoing efforts to evaluate ziftomenib-based combinations across the treatment continuum, including in randomized studies designed to define the potential of ziftomenib in newly diagnosed disease."

KOMET-007 Results in R/R NPM1-m AML

The data include 64 response-evaluable patients with R/R NPM1-m AML from the ongoing KOMET-007 Phase 1a/b trial (NCT05735184), 27 of whom were treated in phase 1a dose escalation and 37 of whom were treated in phase 1b expansion, as of the January 16, 2026 data cutoff date. Patients had received 1 to 8 prior lines of therapy (median of 1), and 37 patients (55%) had prior venetoclax exposure.

Robust clinical activity was observed in patients with R/R NPM1-m AML across all ziftomenib dose levels, with nearly two-thirds of all patients experiencing clinically meaningful, deep, and durable responses. In addition, rapid responses were observed, with a median time to composite complete remission (CRc) of 3.9 weeks.

Venetoclax-Naïve Population (600 mg ziftomenib)

70% CRc rate (16/23) with 75% (9/12) central measurable residual disease (MRD) negativity (<0.01% threshold), demonstrating deep molecular responses
87% objective response rate (ORR) (20/23)
Median duration of CRc response of 9.2 months (95% CI, 5.8-NE)
Median overall survival (OS) not reached after median follow-up of 10.7 months (N=25)
Venetoclax-Experienced Population (600 mg ziftomenib)

24% CRc rate (6/25) with 50% (3/6) central MRD negativity (<0.01% threshold)
48% ORR (12/25)
Median duration of CRc response of 8.6 months (95% CI, 1.6-NE)
Median OS of 7.4 months after median follow-up of 9.9 months (N=26)
Safety in Both Populations at All Dose Levels (N=67)

The triplet combination was well tolerated, with a safety profile consistent with that reported for ven/aza alone
Low rates of differentiation syndrome (3%, 2/67) observed with the protocol-specified staggered dosing schedule of ven/aza before menin inhibition; both events resolved with protocol-specified mitigation
One case of ziftomenib-related QTc; the event resolved without dose interruption or dose change
Median time to neutrophil and platelet recovery were similar to ven-based regimens alone, supporting feasibility in combination regimens
"For people living with relapsed or refractory NPM1-mutated AML, the need for new treatment regimens remains significant," said Yoshifumi Torii, Ph.D., Chief Medical Officer of Kyowa Kirin. "These published findings in the journal Blood add to our understanding of ziftomenib in combination with venetoclax and azacitidine and reinforce our shared commitment with Kura Oncology to advancing this program with urgency and rigor for patients who may benefit."

The ongoing KOMET-007 Phase 1a/1b trial (NCT05735184) is evaluating ziftomenib in combination with ven/aza in multiple cohorts of newly diagnosed chemotherapy-ineligible AML and relapsed/refractory AML. The trial is also evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-r) AML, as well as ziftomenib combined with quizartinib plus 7+3 intensive chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1-m co-mutations.

Kura and Kyowa Kirin are continuing to evaluate ziftomenib across multiple combination regimens and treatment settings, including in the ongoing pivotal KOMET-017 Phase 3 trials in newly diagnosed NPM1-m and KMT2A-r AML.

(Press release, Kura Oncology, JUN 2, 2026, View Source [SID1234666369])