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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).

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"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.

Adcendo ApS Announces FDA Fast Track Designation Granted to ADCE-D01 for the Treatment of Soft Tissue Sarcoma

On October 9, 2025 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first and best-in-class antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ADCE-D01 for the treatment of soft tissue sarcoma (STS) (Press release, ADCendo, OCT 9, 2025, View Source [SID1234656545]).

ADCE-D01 is a first-in-class ADC targeting urokinase plasminogen activator receptor-associated protein (uPARAP) conjugated to the Topoisomerase I inhibitor payload P1021. uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas. Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including STS and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific toxicity.

ADCE-D01 is currently being evaluated in the ADCElerate1 clinical trial, a first-in-human Phase I/II multicenter, open-label, dose escalation and expansion study evaluating ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS. The primary objective of the study is to evaluate the safety and tolerability of ADCE-D01. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-D01. The study is recruiting in the US (NCT06797999) and in Europe. (EUCT number: 2024-516900-41-00).

Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: "This Fast Track designation is an important recognition of the potential of our uPARAP-targeting drug candidate and marks another meaningful milestone for Adcendo. We are committed to further advancing ADCE-D01 and believe that our uPARAP-targeting approach has the potential to transform the sarcoma treatment landscape and overcome the limitations experienced with existing therapies."

Dr. Victoria Marsh, Global Head of Regulatory at Adcendo, said: "With this Fast Track designation the development of ADCE-D01 will now benefit from more frequent interactions with the FDA. Increased FDA engagement will support and expedite the future regulatory review of ADCE-D01 with the aim of making ADCE-D01 available to patients sooner".