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SEED Therapeutics Highlights Clinical Advancement and Broad Oncology Potential of ST-01156, an RBM39 Molecular Glue Degrader in First-in-Human in Phase 1 Studies, at ASCO 2026

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])

BeyondSpring Presents the Latest Update of a Phase 2 Study Demonstrating Durable Clinical Benefit of Pembrolizumab Plus Plinabulin/Docetaxel in Metastatic NSCLC After Progression on First-Line Immune Checkpoint Inhibitor Therapy at ASCO 2026

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.

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])

Disc Medicine Presents Updated Positive Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 2, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported updated data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. In this updated data set, treatment with DISC-0974 shows substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.

"We are excited to have solidified and strengthened the magnitude, durability, and consistency of responses as we have enrolled more patients and extended follow-up," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "The activity observed both with and without background JAK inhibitor therapy, together with improvements in transfusion burden and fatigue, continues to support the potential for DISC-0974 to serve a broad population of patients living with MF-associated anemia, an area where substantial unmet need remains."

This ongoing Phase 2 open-label study had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=31), transfusion dependent with low transfusion burden (TD Low, n=11) and transfusion dependent with high transfusion burden (TD High, n=8)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=25) and not receiving JAK inhibitor therapy (n=25). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. The updated results demonstrated:

Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response)
64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response)
50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)
56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and 72% achieved an overall response, with similar response rates regardless of which specific JAK inhibitor the patient received
Dosing with DISC-0974 was associated with improvements in patient-reported outcomes:
Clinically significant improvements in FACIT-Fatigue scores in nTD and TD Low participants that were correlated with hemoglobin change
MPN-SAF TSS50 at EOS was achieved by 50% of nTD and TD low major responders
DISC-0974 was generally well-tolerated. Diarrhea, not considered serious, was the only adverse event (AE) that was reported as related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.

Additional data from the RALLY-MF study is to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year.

DISC-0974 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide

(Press release, Disc Medicine, JUN 2, 2026, View Source [SID1234666398])

Cardiff Oncology Announces Presentation of Positive Results from its Randomized, Controlled Phase 2 Trial of Onvansertib in First-Line RAS-Mutated mCRC at the 2026 ASCO Annual Meeting

On June 2, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.

"RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers," said Dr. Lenz. "With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients."

Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026):
In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:

Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm.
Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively.
Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.

Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.

Safety/Tolerability:
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.

"We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC," said Mani Mohindru, PhD, President and Chief Executive Officer. "The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months."

The ASCO (Free ASCO Whitepaper) presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation.

Conference Call and Webcast
The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the "Events" page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded.

CRDF-004 Trial Design
The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

(Press release, Cardiff Oncology, JUN 2, 2026, View Source [SID1234666397])

KORTUC Launches Global Cervical Cancer Study, Expanding Pipeline to Second Indication

On June 2, 2026 KORTUC Inc, a global oncology biotech company, reported that it has launched enrollment into its Phase 1/2 clinical study evaluating KRC-01, a proprietary intratumoral radiosensitizer, in patients with locally advanced cervical cancer. The study examines the impact of Kortuc’s compound in low-oxygen (hypoxic) tumors, which generally do not respond to therapeutic radiation doses. The announcement comes after its trial protocol was reviewed by the U.S. Food and Drug Administration and a $20 million funding round, led by Midas Capital.

Cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases and 342,000 deaths in 2020. About 90 percent of new cases and deaths occur in low- and middle-income countries.

Hypoxia – low oxygen levels – inside a cancer cell undermines the efficacy of radiation therapy by making cells more resistant. KRC-01 has shown significant promise in creating a more oxygen-rich environment to improve radiotherapy efficacy. Led by the University of California San Diego, the trial will examine whether adding KRC-01 to standard treatment (chemotherapy combined with radiation) can improve overall survival. A total of 70 patients will be enrolled, with planned expansion to the United Kingdom and India.

"Radiation therapy is a proven curative treatment of cervical cancer," said Kazuyuki Matsuda, CEO of Kortuc. "But the unfortunate reality is about half of cervical cancer patients are unresponsive to this treatment due to hypoxic tumors. Our technology exists today, and it can lead to tangible positive impact on patients’ lives."

KRC-01 is based on a well-understood mechanism of action. Hydrogen peroxide (H₂O₂), a simple and well-known compound with an established safety profile, serves as the active ingredient in the KRC-01 radiosensitizer. As the only agent known to inactivate antioxidative enzymes within tumors, it increases tumor oxygenation and reduces hypoxia, thereby enhancing sensitivity to radiation therapy. Sodium hyaluronate delays the decomposition of H₂O₂, maintaining elevated oxygen partial pressure within the tumor for up to 48 hours following intratumoral injection of KRC-01.

Preliminary results and studies have shown that the newly oxygenated environment makes cancer cells more susceptible to radiation therapy.

The phase 1/2 clinical trial is designed to move efficiently from safety testing to early evaluation of effectiveness.

Phase 1 will include 10 patients and focus on determining the safest and most appropriate dosing schedule for KRC-01 when used alongside standard chemoradiotherapy. KRC-01 will be injected directly into the tumor shortly before radiation treatment.

Phase 2 will enroll 60 additional patients and compare standard treatment alone with standard treatment plus KRC-01. This phase will explore whether KRC-01 may help extend overall survival.
All participants will receive the current standard of care for locally advanced cervical cancer, which includes radiation therapy combined with weekly chemotherapy, followed by brachytherapy (internal radiation).

In addition to cervical cancer, Kortuc is studying the use of its technology for other solid tumor indications, including breast cancer.

(Press release, KORTUC, JUN 2, 2026, View Source [SID1234666396])