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Ono Announces ONO-4578 (EP4 antagonist) in Combination with Opdivo and Chemotherapy Met the Primary Endpoint in a Phase 2 Clinical Trial in Patients with Certain Gastric Cancer

On October 9, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported that ONO-4578, an EP4 antagonist, in combination with Opdivo, an anti–PD-1 antibody and chemotherapy which is one of the standard treatments in this setting met the primary endpoint in the Phase 2 clinical trial (ONO-4578-08 study) in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) (Press release, Ono, OCT 9, 2025, View Source [SID1234656550]).

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In the trial, ONO-4578 in combination with Opdivo and chemotherapy demonstrated a statistically significant prolongation of progression-free survival (PFS) compared with placebo in combination with Opdivo and chemotherapy. In addition, no new safety concerns were identified in the trial. Ono will publish the results at an upcoming academic meeting.

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. In this trial, 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 was observed. The primary endpoint of this trial is PFS.

About Gastric cancer

It is estimated that approximately 126,000 new cases with gastric cancer are diagnosed per year in Japan1) (approximately 968,000 cases worldwide2)) and approximately 43,000 deaths per year in Japan1) (approximately 660,000 deaths worldwide2)) resulting from gastric cancer, which 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 have been approved for the first-line treatment of HER2-negative unresectable advanced or recurrent gastric cancer as the standard treatment. However, unresectable gastric cancer remains incurable, and a new treatment option is needed for patients with gastric cancer.

About ONO-4578

ONO-4578 is a selective, oral antagonist of EP4, which is one of the prostaglandin E2 (PGE2) receptors, developed by Ono. PGE2, which is produced by cancer cells, suppresses the action of cancer immunity through EP4 receptors expressed on various immune cells3)~5). ONO-4578 is expected to exert antitumor effect by suppressing EP4-mediated effects of PGE2 and by restoring cancer immunity6). In the phase 1 clinical trial 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 profile7). Currently, Ono is conducting several clinical trials of ONO-4578, including a global phase 2 clinical trial in patients with colorectal cancer.

RefleXion Announces First Patient Treatment at Leading Freestanding Cancer Center

On October 9, 2025 RefleXion, an external-beam, theranostic oncology company, reported that Beverly Hills Cancer Center, a leading private cancer diagnostic and treatment facility, has treated its first patient with the RefleXion X1 dual-treatment modality radiotherapy platform (Press release, RefleXion, OCT 9, 2025, View Source [SID1234656549]). This milestone marks an important expansion of the X1’s clinical footprint into freestanding cancer centers, broadening patient access to both SCINTIX biology guided-radiotherapy and conventional image-guided radiotherapy (IGRT).

"We are very pleased to have begun patient treatments on the RefleXion X1 platform," said Ari Gabayan, M.D., medical director at Beverly Hills Cancer Center. "This dual-treatment platform enables us to treat all stages of solid tumor cancers in IGRT mode and to introduce a completely new therapeutic option using the autonomous guidance of SCINTIX therapy for patients with lung and bone tumors. SCINTIX technology is unlike any other radiotherapy, and we believe it represents the next frontier in precision cancer care."

With this installation, Beverly Hills Cancer Center joins a growing network of cancer centers adopting RefleXion’s X1 platform to expand their radiotherapy capabilities. In addition to delivering conventional IGRT, Beverly Hills Cancer Center is preparing to offer SCINTIX therapy for patients with lung and bone tumors. SCINTIX therapy uses real-time biological signals emitted from cancer cells to autonomously guide radiation delivery. Patients receive an injection of a small amount of a PET tracer, fludeoxyglucose F18, which the cancer cells consume. The X1 detects the signals produced by the PET tracer and dynamically directs radiation dose to active tumor cells.

"With their first patient treatment on the X1 platform, Beverly Hills Cancer Center continues their strong tradition of delivering cutting-edge cancer treatment," said Todd Powell, president and CEO of RefleXion. "This milestone underscores the scalability and adaptability of our technology, opening access to both hospital-based and freestanding centers. It also demonstrates the growing commercial potential of our platform as we move closer to establishing SCINTIX therapy as a new standard for metastatic disease."

Recently, RefleXion announced positive results from its PREMIER registry a prospective, multi-institutional study evaluating SCINTIX therapy. Findings presented at the 2025 ASTRO Annual Meeting in San Francisco, showed local control of 100 percent via follow up imaging of up to nine months post-treatment with no reported Grade 2 or higher adverse events among 31 patients. Patients were treated for lung tumors, including early-stage and metastatic disease, or for bone metastases. These data represent the first evidence of SCINTIX therapy’s clinical impact.

OPM Publishes Its 2025 Half-Yearly Report

On October 9, 2025 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported that its half-yearly financial report as of June 30, 2025 has been filed with the Financial Markets Authority (Press release, Oncodesign Precision Medicine, OCT 9, 2025, View Source [SID1234656548]).

The report includes:

The statement by the responsible person;
The management report;
The consolidated financial statements;
The various reports by the statutory auditors.
It also includes the company’s cash position. As of June 30, 2025, OPM had cash of €2.45 million. This amount does not include the €1.10 million research tax credit refund received in July 2025, nor the €0.22 million in repayable advances granted for the OncoSNIPE project.

This cash position does not take into account future revenues relating to potential future revenues, milestones and up-fronts for its products developed in existing or future partnerships, nor the amounts of public funding still to be received. Without any funding inflows in the coming weeks, OPM’s cash horizon is December 2025. However, several discussions are underway with potential partners, particularly regarding OPM-201.

The report is available (French only) on the OPM website, www.oncodesign.com, under the Investors / Regulated Information section.

Vir Biotechnology Announces First Patient Dosed in Part 3 of Phase 1 Trial of PSMA-Targeting PRO-XTEN® Dual-Masked T-Cell Engager VIR-5500 in Combination with Androgen Receptor Pathway Inhibitors for the Treatment of Metastatic Prostate Cancer

On October 9, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that the first patient has been dosed in Part 3 of the Company’s Phase 1 clinical trial evaluating VIR-5500 in combination with androgen receptor pathway inhibitors (ARPIs). VIR-5500 is an investigational PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA) and will be evaluated in participants in first-line pre-taxane metastatic castration-resistant prostate cancer (mCRPC) (Press release, Vir Biotechnology, OCT 9, 2025, View Source [SID1234656547]). VIR-5500 is the only dual-masked PSMA-targeting TCE currently in clinical trials.

"We are excited to advance our VIR-5500 Phase 1 trial with the addition of early line metastatic prostate cancer cohorts exploring combination therapy," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "Opening Part 3 of the Phase 1 trial brings the potential benefits of the universal PRO-XTEN approach to patients earlier in their cancer journey, when treatment intervention may have the greatest impact on their long-term outcomes."

The Phase 1 clinical trial is an open-label, non-randomized study designed to assess the safety, pharmacokinetics and preliminary anti-tumor activity of VIR-5500 in combination with ARPIs in participants with metastatic prostate cancer. VIR-5500 is currently being evaluated in the same Phase 1 clinical trial as a monotherapy and has demonstrated promising early anti-tumor activity and a favorable safety profile in heavily pre-treated patients with mCRPC. VIR-5500 incorporates the universal PRO-XTEN masking technology, which is designed to enable the selective activation of the TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity.

"VIR-5500 has demonstrated potential as a monotherapy with PSA reductions in heavily pre-treated patients early in dose escalation," said Mark Eisner, MD, MPH, Chief Medical Officer, Vir Biotechnology. "Building on our understanding of VIR-5500 as a monotherapy, we look forward to evaluating the potential benefit of combining the complementary mechanisms of action of VIR-5500 and ARPIs with the goal to deliver the best possible outcomes for patients."

Prostate cancer is the most diagnosed cancer in men.1 Metastatic prostate cancer encompasses disease that has spread beyond the prostate, including both hormone-sensitive and castration-resistant forms. The disease progresses quickly and is a significant burden with limited treatment options. Despite advancements, there is still a significant unmet need for efficacious, well-tolerated treatments that can extend survival and improve quality of life.

References:

1 Leslie SW, Soon-Sutton TL, Skelton WP. Prostate Cancer, available from: View Source, accessed September 2025.

About VIR-5500

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics, and preliminary efficacy of VIR-5500 in participants with metastatic castration-resistant prostate cancer (mCRPC).

VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN masking technology. The universal PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens.

ESSA Announces Completion of Arrangement with XenoTherapeutics

On October 9, 2025 ESSA Pharma Inc. (NASDAQ: EPIX) ("ESSA" or the "Company") reported the completion of XenoTherapeutics’ ("Xeno") previously announced acquisition of ESSA (the "Acquisition") (Press release, ESSA, OCT 9, 2025, View Source [SID1234656546]).

Xeno Acquisition Corp., a wholly owned subsidiary of Xeno, has acquired all of the outstanding common shares of ESSA (the "Common Shares") for approximately US$0.1242 per Common Share, plus one contingent value right ("CVR") per Common Share, which CVR represents the right to receive up to approximately US$0.14 per CVR and payable within specified periods following the close of the Acquisition. The potential CVR payment of US$0.14 per Common Share represents up to US$6.7 million in the aggregate that may be distributed to CVR holders depending on the outcome and related expenses of certain contingent liabilities.

On October 7, 2025, the Company obtained a final order from the Supreme Court of British Columbia approving the Arrangement. ESSA has requested that the Nasdaq Capital Market ("Nasdaq") file a delisting application on Form 25 to report the delisting of the Common Shares from Nasdaq. ESSA expects to terminate the registration of the Common Shares under the U.S. Securities Exchange Act of 1934, as amended, approximately 10 days after the closing of the Acquisition.

An early warning report will be filed on SEDAR+ at www.sedarplus.ca under the Company’s profile.

Advisors and Counsel

Leerink Partners LLC served as ESSA’s exclusive financial advisor in connection with the Acquisition. Blake, Cassels & Graydon, LLP and Skadden, Arps, Slate, Meagher & Flom LLP acted as ESSA’s Canadian legal counsel and U.S. legal counsel, respectively.