On June 18, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the completion of initial patient screening in the randomized multicenter Phase II part of its Phase I/II clinical trial with TG4050, an individualized neoantigen therapeutic vaccine, as a single agent in the adjuvant treatment of HPV-negative squamous head and neck cancers (NCT04183166) (Press release, Transgene, JUN 18, 2025, View Source [SID1234653982]). TG4050, Transgene’s lead asset, is based on its proprietary myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection for individual patients.

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All patients treated with TG4050 in the Phase I part of the trial remained disease-free after a minimum of two years of follow-up, confirming clinical proof of principle. Translational data showed sustained T cell responses at 24 months in these patients. The results, which met all trial endpoints including safety, feasibility, immune activation and disease-free survival (DFS, defined as survival without recurrence or death for any cause), were presented in an oral presentation at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2025) annual meeting.

Transgene expects to complete randomization of all patients in the Phase II part by the end of 2025, following a second screening of patients conducted after surgery and adjuvant (chemo)radiotherapy. These screenings represent key steps during which patients are evaluated to determine whether they meet the eligibility criteria to participate in the clinical trial. In total, approximately 80 patients with a complete response to adjuvant therapy are anticipated to be enrolled and subsequently randomized in the Phase I/II trial. First immunogenicity data from the Phase II part of the trial are expected to be available in H2 2026, and preliminary efficacy data are expected in H2 2027.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene added: "Timely completion of first patient screening of the Phase II part of our Phase I/II trial is an important milestone for Transgene and brings us one step closer to providing a new treatment option for patients living with operable squamous head and neck cancer. With meaningful data readouts expected over the next two years, we are preparing to deliver important data for TG4050 and at the same time explore its wider potential. We are grateful to the patients, their families, investigators, and clinical staff whose commitment made this achievement possible."

Dr. Alessandro Riva, CEO of Transgene commented: "The positive results from the Phase I part of our TG4050 trial support the strong potential of our myvac platform. The successful completion of the first screening of the randomized Phase II part in less than a year and ahead of schedule underscores the investigators’ commitment to rapidly advance the development of TG4050. In the ongoing Phase II part of the trial, we have been able to scale efficiently, strengthen our manufacturing capabilities and operate with the agility needed to lead in a highly competitive and fast-moving environment.

The myvac individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. Consequently, Transgene is starting initial preparations for a new Phase I trial in a second, undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025."

On June 18, 2025 CEL-SCI Corporation (NYSE American: CVM) reported the U.S. Food and Drug Administration’s (FDA) approval of Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test (Press release, Cel-Sci, JUN 18, 2025, View Source [SID1234653997]). Merck’s application was granted the FDA’s priority review on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda’s Phase 3 KEYNOTE-689 trial.

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Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.

In contrast to the results of the KEYNOTE-689, CEL-SCI’s Phase 3 study showed that Multikine* treated patients whose tumors expressed low (Tumor Proportion Score [TPS <10]) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65], p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI’s Phase 3 study had low to zero levels of PD-L1.

"It is encouraging for CEL-SCI that Merck’s Keytruda application received the FDA’s priority review and that marketing approval was given based on a Phase 3 study’s first pre-specified interim analysis. CEL-SCI has received the FDA’s go-ahead for a confirmatory Registration Study with 212 patients based on results from the completed Multikine Phase 3 study in head and neck cancer patients. The patients in the Phase 3 study that benefited from Multikine pre-surgery treatment showed an almost 4-year median overall survival advantage over control, and pre-surgery tumor responses to Multikine predicted survival benefit. The Keytruda approval based on pre-specified interim results strongly implies that Multikine has the potential for accelerated regulatory approval based on favorable post-surgical tumor responses," stated CEL-SCI’s CEO, Geert Kersten.

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.

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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.

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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]).

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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.