On June 1, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported the results of the phase 2 clinical study (ONO-4578-08 study) of the EP4 antagonist ONO-4578 in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer). The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting.

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In this study, patients received ONO-4578 in combination with the anti–PD-1 antibody nivolumab (OPDIVO) and chemotherapy or placebo in combination with OPDIVO and chemotherapy. The ONO-4578 group demonstrated a statistically significant improvement of PFS compared to the placebo with a median PFS of 9.0 months in the ONO-4578 group and 6.9 months in the placebo group (HR, 0.67; 90% CI, 0.48–0.92; P = 0.040). The ONO-4578 group also showed improvements in overall survival (OS) and objective response rate (ORR). Median OS was not reached in the ONO-4578 combination group and 12.7 months in the placebo combination group (HR, 0.60; 95% CI, 0.37–0.96). ORR was 62.0% and 48.7%, respectively (odds ratio, 1.72; 95% CI, 0.98–3.00).

Clinical benefit was more pronounced in patients with PD-L1 CPS ≥1. In this subgroup, the median PFS was 9.9 months in the ONO-4578 combination group versus 5.7 months in the placebo combination group (HR, 0.52; 95% CI, 0.34–0.79), median OS was not reached versus 12.7 months (HR, 0.44; 95% CI, 0.26–0.77), and ORR was 70.9% versus 50.9% (odds ratio, 2.36; 95% CI, 1.22–4.54), respectively. No new safety signals were identified. These results suggest that ONO-4578 may provide additional clinical benefit when added to standard therapy with an anti–PD-1 antibody and chemotherapy in this previously untreated patient population.

Based on these findings, Ono and its affiliate company, Deciphera, plan to initiate a pivotal phase 3 clinical study.

About ONO-4578-08 study

ONO-4578-08 study is a multicenter, randomized phase 2 clinical trial conducted in Japan, South Korea, and Taiwan in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer. ONO-4578 in combination with OPDIVO and chemotherapy (S-1 + oxaliplatin or capecitabine + oxaliplatin) was compared with placebo in combination with OPDIVO and chemotherapy. Patients received 40 mg of ONO-4578 once daily and 360 mg of OPDIVO every 3 weeks in combination with chemotherapy until disease progression or unacceptable toxicity occurred. The primary endpoint was PFS.

About Gastric cancer

Approximately 126,000 new cases of gastric cancer are diagnosed annually in Japan1 and 968,000 worldwide,2 with approximately 43,000 deaths in Japan1 and 660,000 worldwide.2 Gastric cancer is the third most common type of cancer following colorectal cancer and lung cancer in Japan. Combination therapies with anti–PD-1 antibody and chemotherapy is a standard first-line treatment for HER2-negative unresectable advanced or recurrent gastric cancer. However, gastric cancer remains incurable, and a new treatment option is needed.

About ONO-4578

ONO-4578 is a selective, oral antagonist of EP4, a receptor for prostaglandin E2 (PGE2), developed by Ono. PGE2, produced by cancer cells, suppresses the action of cancer immunity through EP4 receptors expressed on various immune cells.3-5 ONO-4578 is designed to exert antitumor effect by suppressing EP4-mediated effect of PGE2 and by restoring cancer immunity.6 In a phase 1 clinical study in patients with unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) after the third- or later-line treatment, a combination therapy with ONO-4578 and OPDIVO showed antitumor effect and a manageable safety profile.7 Currently, Ono is conducting several clinical studies of ONO-4578, including a global phase 2 clinical study in patients with colorectal cancer.

(Press release, Ono, JUN 1, 2026, View Source [SID1234666341])

On June 1, 2026 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with established laboratory services and therapeutic development businesses, reported it presented updated data in the Head and Neck Cancer Track during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting Rapid Oral Abstract Session, scheduled from 4:30 p.m. to 6:00 p.m. CDT in Hall D1 at McCormick Place in Chicago.

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The abstract, entitled "FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020," will present updated preliminary data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study is evaluating the efficacy of two dosing regimens and characterizing the pharmacokinetics, safety, and tolerability of FID-007 in combination with cetuximab in patients whose disease progressed following PD-1 based immune checkpoint inhibitor therapy. As of the April 16, 2026, data cutoff, FID-007 demonstrated meaningful clinical activity and a manageable safety profile in combination with cetuximab in this target patient population.

The presentation slides with updated data will be available on Fulgent’s investor relations website at the conclusion of the presentation on June 1, 2026.

Dr. Guilherme Rabinowits, one of the study’s Principal Investigators and a Senior Member in the Department of Head and Neck-Endocrine Oncology at Moffitt Cancer Center, said: "Patients with R/M HNSCC who progress after anti PD-1 based therapy lack an established, best second-line standard of care. In this setting, preliminary data showed encouraging clinical activity and a manageable safety profile for FID-007 in combination with cetuximab. The objective response rate was 61.9%, median progression-free survival was 6.7 months, median duration of response was 7.4 months, and one-year overall survival was 63.4%. Additionally, this combination showed activity in both human papilloma virus-related and -unrelated head and neck squamous cell carcinoma." A Phase 3 study is planned.

(Press release, Fulgent Genetics, JUN 1, 2026, View Source [SID1234666340])

On June 1, 2026 MEDSIR, a leading international oncology research company, reported the final results of the ZZ‑FIRST study during an oral session at the ASCO (Free ASCO Whitepaper) 2026 scientific congress, held in Chicago. This study evaluates a therapeutic intensification strategy in patients with advanced prostate cancer. Previously, the study demonstrated relevant treatment response results in more than 70% of cases, reflected by a decrease in PSA (prostate‑specific antigen) levels, a biomarker used in the blood monitoring of prostate cancer.

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ZZ-FIRST: a new therapeutic strategy

In the ZZ‑FIRST study, a phase II, multicenter, randomized trial, 54 patients from eight centers across Spain were enrolled. Specifically, the trial included patients with high‑volume metastatic hormone‑sensitive prostate cancer (mHSPC), meaning a high tumor burden at diagnosis and typically a poorer prognosis.

For these patients, current treatment is based on androgen deprivation therapy, usually in combination with next‑generation hormonal treatments such as enzalutamide. Since many prostate cancer cells depend on male hormones for growth (androgens such as testosterone), these therapies aim to block these hormonal signals by reducing testosterone levels and inhibiting their downstream effectors. However, over time, some tumors develop resistance and continue to grow despite hormonal blockade, becoming hormone‑resistant.

In this context, the ZZ‑FIRST study evaluates the feasibility of intensifying initial treatment with enzalutamide by combining it with talazoparib (a PARP inhibitor, a protein involved in DNA repair) from earlier stages of the disease. By administering both drugs together while the disease is still hormone‑sensitive, the goal is to increase the accumulated DNA damage in tumor cells and promote their destruction before mechanisms of resistance to hormonal therapy emerge.

The results presented at ASCO (Free ASCO Whitepaper) show that patients treated with the experimental combination achieved a radiographic progression‑free survival of 45.3 months, compared with 31.1 months in those treated with enzalutamide alone. This endpoint measures the time from treatment initiation until tumor progression is detected by imaging tests. In addition, patients receiving the combination also showed a longer time to PSA progression and to the development of resistance to hormonal therapy.

In addition, adaptive tumor mechanisms were investigated before initiating therapy and during the first weeks of treatment with enzalutamide, providing key information to better understand how resistance develops. The ZZ‑FIRST results indicate that the combination of hormonal therapy with PARP inhibitors may particularly benefit patients whose tumors present certain mutation profiles in DNA repair genes. "Although patients with metastatic disease initially respond to hormonal therapy, the tumor eventually adapts and grows again. Therefore, it is essential to investigate the biological mechanisms that allow the tumor to develop resistance to hormonal treatment and to identify new therapeutic strategies capable of delaying or preventing this process," explained Dr. Joaquín Mateo, principal investigator of the study, oncologist at Vall d’Hebron University Hospital and Head of the Prostate Cancer Group at the Vall d’Hebron Institute of Oncology (VHIO), who presented the results at ASCO (Free ASCO Whitepaper).

ZZ‑FIRST has received external funding from Pfizer S.L., the Spanish Association Against Cancer (AECC), and the United States Department of Defense (DoD). The drugs used in the study were provided by Pfizer S.L. (talazoparib) and Astellas Pharma Europe Ltd. (enzalutamide).

ADELA and CADILLAC: MEDSIR presence at the ASCO (Free ASCO Whitepaper) congress

In addition to the presentation of the ZZ‑FIRST study, MEDSIR also presented the design of other studies during the congress.

On the one hand, the company presented, in collaboration with the Menarini Group, the design of the ADELA study, an international phase III trial evaluating the selective estrogen receptor degrader (SERD) elacestrant combined with everolimus versus elacestrant monotherapy. The study includes patients with ER+/HER2‑ tumors who developed an ESR1 gene mutation after progression on prior endocrine therapy and CDK4/6 inhibitors. The trial is being implemented in more than 100 hospitals across nine countries, including Spain, Austria, the Czech Republic, Greece, the United Kingdom, France, Italy, Germany, and Brazil.

On the other hand, the CADILLAC study is also noteworthy. This is an international phase II trial evaluating the efficacy and safety of combining the SERD camizestrant with the CDK4/6 inhibitor ribociclib in patients with advanced HR+/HER2‑ breast cancer who have stopped responding to standard treatments. The study, currently ongoing at centers in Spain, Germany, and China, includes 150 patients whose data will be compared with historical records from more than 150 patients receiving conventional therapy.

(Press release, MedSIR, JUN 1, 2026, View Source [SID1234666339])

On June 1, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a patent covering key aspects of Anixa’s ovarian cancer vaccine technology.

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The allowed patent, exclusively licensed from Cleveland Clinic, includes methods of administering an immunogenic composition comprising a nucleic acid encoding the anti-Müllerian hormone receptor 2 (AMHR2) polypeptide to elicit an AMHR2-specific immune response to prevent or treat ovarian cancer.

Anixa’s ovarian cancer vaccine, being developed in a collaboration between Cleveland Clinic and the National Cancer Institute (NCI), represents a novel approach to preventing and treating ovarian cancer, particularly among high-risk populations such as those carrying BRCA mutations or with a family history of the disease.

The Canadian Notice of Allowance expands the international scope of Anixa’s intellectual property portfolio around its ovarian cancer vaccine technology and complements the Company’s existing patent protection in the United States. In July 2025, Anixa announced the issuance of U.S. Patent Number 12,357,593 covering key aspects of its ovarian cancer vaccine technology, including broad claims related to methods of eliciting an immune response targeting AMHR2.

"This Canadian Notice of Allowance further strengthens the international patent protection around our ovarian cancer vaccine program and supports the novelty of our AMHR2-targeted immunoprevention approach," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Together with our U.S. patent protection for ovarian cancer vaccine technology and our separate intellectual property portfolio for breast cancer vaccine technology, this allowance supports our strategy of building a broad cancer vaccine platform based on retired-protein targets. Our breast cancer vaccine recently completed a Phase 1 clinical trial, funded by a grant from the U.S. Department of Defense and conducted in collaboration with Cleveland Clinic, in which all primary endpoints were met."

Anixa’s ovarian cancer vaccine is based on immunizing against AMHR2, a protein expressed in normal ovaries prior to menopause and also aberrantly expressed in certain types of ovarian cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, is designed to train the immune system to recognize and target cells associated with ovarian cancer while seeking to avoid harm to normal tissue.

By expanding its patent protection in Canada, Anixa is continuing to build a broader international intellectual property position around its cancer vaccine technologies. The Company believes this intellectual property foundation is important as it evaluates future clinical, regulatory and strategic development opportunities for its vaccine programs.

(Press release, Anixa Biosciences, JUN 1, 2026, View Source [SID1234666338])

On June 1, 2026 Minghui Pharmaceutical ("Minghui"), a late-stage clinical biopharmaceutical company focused on developing innovative therapies for oncology and autoimmune diseases, reported updated clinical data from its Phase I/II study evaluating MHB088C (QLC5508) in heavily treated patients with metastatic castration-resistant prostate cancer (mCRPC). The results were presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Poster title:

Safety and efficacy of QLC5508 (MHB088C) in heavily-treated patients with metastatic castration-resistant prostate cancer: Updated data from a phase 1/2 trial

Poster session:

Genitourinary Cancer—Prostate, Testicular, and Penile

The updated findings demonstrated encouraging anti-tumor activity and durable disease control in heavily pretreated mCRPC patients, including patients previously treated with androgen receptor pathway inhibitors (ARPIs) and taxane-based chemotherapy.

As of the data cutoff date of November 30, 2025, 59 patients had been enrolled in the study. The patient population represented a heavily pretreated setting:

74.6% received three or more prior lines of therapy
84.7% had prior taxanes exposure
28.8% received three or more prior lines of second-generation ARPIs
16.9% had received two or more prior lines of taxanes
Clinical Activity

MHB088C demonstrated durable anti-tumor activity.
The median rPFS was not reached (95% confidence interval [CI], 13.1-not evaluable [NE]), with a 12-month rPFS rate of 71.7% (95% CI, 52.6%-84.3%).
Among 40 patients treated at the 2.0 mg/kg Q2W dose, median rPFS was also not reached (95% CI, 13.1-NE), with a 12-month rPFS rate of 78.6% (95% CI, 50.7%-91.8%).
Safety Profile

MHB088C demonstrated a manageable safety profile, consistent with prior clinical data
Most common Grade ≥3 treatment-emergent adverse events (TEAEs):
Neutrophil count decreased (25.4%)
Anemia (23.7%)
White blood cell count decreased (20.3%)
"These updated data presented at ASCO (Free ASCO Whitepaper) further reinforce the potential of MHB088C as a differentiated therapeutic option for patients with metastatic castration-resistant prostate cancer, particularly those with limited treatment alternatives after multiple prior therapies," said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "We are encouraged by the durable clinical benefit observed with MHB088C, including prolonged disease control in this heavily pretreated patient population, together with its manageable safety profile. These findings further strengthen our confidence in the potential of MHB088C to address significant unmet needs for patients with metastatic castration-resistant prostate cancer, and we look forward to advancing the program through its next stage of development."

About MHB088C

MHB088C is an investigational B7-H3-targeted antibody-drug conjugate (ADC) developed using Minghui’s proprietary SuperTopoi platform.

Under an exclusive licensing and collaboration agreement, Qilu Pharmaceutical holds rights for the development, manufacturing, and commercialization of MHB088C in Greater China. Minghui retains China-based combination study rights with MHB039A and global rights outside Greater China.

In Greater China, Qilu is advancing the clinical development of MHB088C across multiple indications. The program has received three Breakthrough Therapy Designations and is currently being evaluated in two Phase 3 studies in second-line small cell lung cancer (SCLC) and second-line esophageal squamous cell carcinoma (ESCC).

Minghui is advancing additional clinical development strategies for MHB088C. Ongoing studies in China include a Phase I/II trial evaluating MHB088C in combination with MHB039A, Minghui’s investigational PD-1/VEGF bispecific antibody, in patients with advanced solid tumors, including first-line SCLC expansion cohorts.

(Press release, Minghui Pharmaceutical, JUN 1, 2026, View Source [SID1234666337])