On June 18, 2025 FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging solutions, reported that use of its AFP-L3 and DCP in vitro diagnostic tests is being evaluated in the National Liver Cancer Screening Trial (known as TRACER), a study funded by the National Cancer Institute, part of the National Institute of Health (Press release, Fujifilm, JUN 18, 2025, View Source [SID1234653998]). The multi-center study compares liver cancer screening strategies in patients with cirrhosis or chronic hepatitis B.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Hepatocellular cancer (HCC) is the third leading cause of cancer-related mortality worldwide and the most rapidly growing cause of cancer deaths in the U.S.1 HCC mortality continues to escalate due to the increased prevalence of chronic liver diseases, inadequate diagnostic precision in the early stages of disease, and historical lack of effective systemic therapies for late-stage HCC. Surveillance of high-risk patients is typically conducted via liver ultrasound in combination with serum alpha-fetoprotein (AFP) serum testing. However, ultrasound sensitivity can be compromised by the severity and underlying cause of liver disease, and serum AFP levels can be affected by hepatic inflammation, patient characteristics, and hereditary and other non-hepatic disorders,2 among other factors, compromising early-stage HCC diagnostic accuracy.

The use of serum biomarkers such as AFP-L3 and des-gamma-carboxyprothrombin (DCP) in surveillance can significantly improve early diagnosis capabilities, and the GALAD score3 – derived from Gender, Age, AFP-L3, AFP and DCP – has shown promise as a more accurate model for screening and early detection of HCC in at-risk patients in recent studies, including the HCC Early Detection Strategy (HEDS) Study conducted through the EDRN (View Source). FUJIFILM Healthcare Americas Corporation In Vitro Diagnostics division offers FDA-cleared AFP-L3 and DCP biomarker tests that are utilized as an aid in HCC risk assessment in conjunction with other laboratory findings, imaging studies, and clinical assessment.

The GALAD model continues to be studied in the TRACER study. The Phase IV prospective validation study, which began enrollment in January 2024 and is being conducted in the U.S., will enroll 5,500 at-risk patients across 15 sites that will be randomly assigned semi-annual screening with ultrasound ± AFP arm (the standard of care) or semi-annual screening via the GALAD model. Patients will be actively recruited over a 3-year period, with assessment of the data at year 5.5; the primary aim is a reduction in the proportion of late-stage HCC diagnosis. The TRACER study will measure secondary outcomes of interest including psychological and financial harms utilizing validated patient surveys.

"We are pleased that the TRACER study is evaluating the use of Fujifilm’s biomarker tests as a potential way to improve effectiveness in HCC screening in at-risk patients," said Henry (Hidetoshi) Izawa, president and chief executive officer, FUJIFILM Healthcare Americas Corporation. "HCC is often diagnosed at an advanced stage, with limited treatment options. Our hope is that this study will further underscore the benefits of HCC-specific blood tests in the detection of early-stage HCC, and patients will benefit from earlier diagnosis and treatment options."

The use of the Fujifilm’s biomarkers in the GALAD model is a novel concept and for research use only.
TRACER is supported by a grant within the Early Detection Research Network, a program of the National Cancer Institute, National Institutes of Health.

On June 18, 2025 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that it has entered into securities purchase agreements with certain healthcare-focused and institutional investors to purchase (i) 2,465,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 12,325,000 shares of its common stock (the "Common Warrants") at a purchase price of $3.25 per share and associated Common Warrants in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptevo Therapeutics, JUN 18, 2025, View Source [SID1234653984]). Each share of common stock is being offered together with five Common Warrants, each to purchase one share of common stock. The Common Warrants will have an exercise price of $3.25 per share, are exercisable upon stockholder approval, and will expire five years following the date of stockholder approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering is expected to close on or about June 20, 2025, subject to customary closing conditions. Roth Capital Partners is acting as placement agent for the offering. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $8 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-288061), that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 18, 2025. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected]. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On June 18, 2025 Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK) reported the first US patient has started treatment in the ongoing Phase 1 trial (SIM0500-101, NCT06375044) at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM) (Press release, Jiangsu Simcere Pharmaceutical Company, JUN 18, 2025, View Source [SID1234653985]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SIM0500 (formerly SCR-8572) is a humanized trispecific antibody targeting GPRC5D, BCMA and CD3, developed using Simcere Zaiming’s proprietary T-cell engager polyspecific antibody platform. [1] "In the last few years, BCMA and GPRC5D-targeted therapies have demonstrated significant promise in treating RRMM and have been anticipated as the cornerstones of the next chapter in the pursuit of curing myeloma. SIM0500 is the natural evolution of combining these targets with the aim to optimize outcomes in the RRMM," said Dr. Joshua Richter, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of Multiple Myeloma at the Blavatnik Family Chelsea Medical Center at Mount Sinai, and Principal Investigator.

"SIM0500 is designed to bind to two tumor antigens, GPRC5D and BCMA. It has shown strong T-cell cytotoxicity against multiple myeloma cells in preclinical studies," said Prof. Shaji Kumar, M.D. "I look forward to participating in the Phase 1 study of SIM0500 to evaluate the safety and efficacy of this potentially transformative therapy in patients with RRMM."

"We are quite pleased with the safety and encouraging efficacy results generated to-date in the ongoing dose escalation and look forward to the extension of the SIM0500 Phase 1 trial to the US. This marks an important step forward in Simcere Zaiming’s continued commitment to advance new oncology treatments and elevate the standard of care for patients with RRMM," said Yongyu Wang, M.D., Chief Medical Officer, Simcere Zaiming.

SIM0500 is being developed in partnership with AbbVie.

About SIM0500

SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in existing multiple myeloma treatments. In April 2024, the FDA awarded SIM0500 a Fast Track designation. In January 2025, Simcere Zaiming entered into an agreement with AbbVie granting AbbVie an option to license SIM0500.

SIM0500 is an investigational agent that has not been approved by the FDA or any other regulatory authority.

About SIM0500-101 Phase 1 study

SIM0500 is currently being investigated in a phase 1 clinical trial both in US and in China. Preliminary data suggested a good safety profile, desired pharmacokinetic profile of SIM0500 with encouraging efficacy.

On June 18, 2025 Cebiotex reported that the clinical trial to evaluate the safety, pharmacokinetics and efficacy of CEB-01 in locally resectable abdominal tumours of children has been green lighted by the regulatory authorities (Press release, Cebiotex, JUN 18, 2025, View Source [SID1234653973]). This is a basket trial designed for pediatric patients under 18 years of age diagnosed with de novo or recurrent soft tissue sarcoma, neuroblastoma, or other rare tumors such as Wilms’ tumor or germ cell tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Why it matters
It marks the first time that the potent active substance SN-38 is being evaluated in these patients as a local chemotherapy, with the goal of controlling tumor recurrence and addressing an unmet medical need. This step brings us closer to delivering new therapeutic options to children with rare cancers.

Thank You
This milestone reflects the commitment to developing innovative surgical treatments for children of our team and collaborators in Hospital Sant Joan de Déu Barcelona, i4KIDS I i4KIDS-EUROPE and Ship2B Ventures.

On June 18, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL’s registrational PATHFINDER 2 study (Press release, Grail, JUN 18, 2025, View Source [SID1234653986]). PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the previously published PATHFINDER study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening. In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER.

In PATHFINDER, Galleri demonstrated a positive predictive value (PPV), or likelihood that a positive Galleri test was confirmed to be cancer, of 43%; specificity of 99.5%; and 88% cancer signal origin (CSO) accuracy. Data from evaluable PATHFINDER 2 participants with 12 months of follow-up showed a substantially higher PPV than that observed in the PATHFINDER study. CSO accuracy and specificity were consistent with that observed in the PATHFINDER study.

There were no serious safety concerns reported in PATHFINDER 2.

"We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial’s prevalent screening round," said Josh Ofman, MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward. We look forward to sharing the detailed PATHFINDER 2 data at a medical congress later this year."

PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026.

Detailed results from the PATHFINDER 2 study will be submitted for presentation at a leading international oncology meeting before the end of the year.

About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes (PRO) over several time points, including an assessment of participants’ anxiety and satisfaction with the MCED test.