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SCG Announces Late-Breaking Clinical Data of SCG101 in HBV-Related Hepatocellular Carcinoma Presented at EASL 2025

On May 7, 2025 SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, reported late-breaking clinical data from its Phase 1 trial evaluating SCG101, autologous HBV-specific TCR-T cell therapy, in patients with advanced HBV-related hepatocellular carcinoma (HCC) (Press release, SCG Cell Therapy, MAY 7, 2025, View Source [SID1234652670]). These data were presented at the European Association for the Study of the Liver (EASL) Congress 2025.

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The results demonstrated that SCG101 led to sustained clearance of serum hepatitis B surface antigen (HBsAg) and HBV-DNA in heavily pre-treated patients with HBV-related HCC. Notably, 94% of patients had received prior nucleoside analogue (NA) antiviral therapy, and 72% presented with liver cirrhosis at baseline. Following a single-dose SCG101 infusion, all treated patients experienced a rapid decline in serum HBsAg, with 94% (16/17) achieving a 1.0–4.6 log₁₀ reduction within 28 days and persisting < 100 lU/mL for up to 1 year. Notably, 4 patients (23.5%) achieved HBsAg loss.

In addition to its antiviral effects, SCG101 demonstrated encouraging antitumor activity. All patients had received at least 2 prior lines of systemic cancer treatment, including immune checkpoint inhibitors. Despite this heavily pre-treated population, 8 out of 17 patients (47%) showed measurable tumour regression. At the time of data cutoff, median overall survival (OS) had not yet been reached.

SCG101 was generally well tolerated, with a good safety profile. Transient alanine aminotransferase (ALT) elevation, consistent with the cytolytic mechanism of SCG101, was observed in 94% of patients and resolved within 14 days. Other common treatment-related adverse events (TRAEs) included cytokine release syndrome (CRS), neutropenia, and thrombocytopenia—all of which were manageable and reversible.

Prof. Dr. Shunda Du, Chief of Liver Surgery Department, Peking Union Medical College Hospital, said: "The dual antiviral and antitumor effects observed with SCG101 are highly promising, especially in this heavily pre-treated patient population. The sustained HBsAg clearance and tumour response suggest that SCG101 may offer a novel immunotherapeutic option for patients with HBV-related HCC, addressing an area of significant unmet clinical need".

HBV remains a major global health burden, affecting over 250 million people worldwide. It is a leading cause of liver cancer, responsible for 50%–80% of hepatocellular carcinoma cases globally.1 Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and activation of oncogenes, thereby contributing to the development of hepatocellular carcinoma.2

SCG101 is designed to selectively target and eliminate HBV-infected hepatocytes and HCC cells by recognizing specific epitope of HBV surface antigen (HBsAg) presented via the major histocompatibility complex (MHC). By triggering both cytolytic and non-cytolytic mechanisms, SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration.

"These positive data mark an important step forward in the development of SCG101 and validate our approach of harnessing precision T cell therapy to target chronic HBV infection and HBV-related liver cancer," said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "SCG101 is the first TCR-T cell therapy to demonstrate both virologic clearance and tumour regression in HBV-related HCC patients. We are encouraged by the data, and we look forward to advancing SCG101 through further clinical development to bring this potentially curative therapy to patients in need."

About SCG101

SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG’s proprietary GianT TCR screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC). SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies.

About Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020, it was estimated that over 905,000 new cases of liver cancer were diagnosed, and more than 830,100 deaths occurred globally, making it one of the leading causes of cancer-related mortality.3 Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide.1 HCC is typically diagnosed at an advanced stage, contributing to a poor prognosis with a five-year survival rate of less than 15%.

PAQ Therapeutics Announces $39 Million Series B Financing and Initiates Phase 1 Trial to Advance Novel Approach Addressing KRAS-Driven Cancers with High Unmet Need

On May 7, 2025 PAQ Therapeutics, a biotechnology company developing best- and first-in-class KRAS degraders for patients with lethal cancers lacking effective treatment options, reported the completion of its $39 million Series B funding (Press release, PAQ Therapeutics, MAY 7, 2025, View Source [SID1234652669]). The Series B round was co-led by Bayland Capital and MRL Ventures Fund (MRLV), with participation from Johnson & Johnson Innovation – JJDC, Inc. (JJDC), LAV Fund, BioTrack Capital, and existing investor Sherpa Health Partners.

The capital raised will fund PAQ’s next stage of clinical development for the company’s lead asset PT0253, a potent and selective degrader of KRAS G12D, a known driver for a range of solid tumors. PT0253 has demonstrated best-in-class potential based on preclinical comparison to existing agents currently in clinical development targeting the same KRAS mutant. In Q1 2025, the first patient was dosed in a Phase 1 study to assess its safety and tolerability.

"The successful completion of our Series B funding and rapid enrollment of our Phase 1 trial in the US for PT0253 mark significant steps forward in our clinical development efforts," said Nan Ji, PhD, PAQ’s co-founder, President, and CEO. "The strong support from our investors validates the potential of our innovative approach. We now turn our focus to executing a robust clinical development plan while continuing to develop a differentiated pipeline of KRAS degraders."

The funds will also support the advancement of the company’s second asset through IND-enabling studies.

"PAQ represents a compelling opportunity to develop transformative therapies for oncology populations with high unmet need," said Olga Danilchanka, Partner, MRLV, the therapeutics-focused corporate venture arm of Merck & Co. "Their innovative efforts advancing the targeted protein degradation modality aligns with our commitment to backing scientifically rigorous teams that tackle pressing medical challenges. We’re confident in PAQ’s ability to unlock the full potential of KRAS degraders and are proud to support their journey toward achieving clinical impact."

"The team at PAQ is at the forefront of an innovative approach to treat some of the most underserved patient populations in oncology," said Yuexing Su, Founding Partner, Bayland Capital. "We were attracted to PAQ based on its scientific approach, preclinical data, and experienced leadership team. We believe there is tremendous potential for KRAS degraders and are excited to be part of PAQ’s next stage of growth."

PAQ Therapeutics was founded in 2020 and completed a $30M Series A financing in 2021. Over the last three years, the PAQ team gained proprietary understanding of KRAS biology, which guided medicinal chemistry to identify KRAS degraders. These programs have the potential to address key limitations of clinical-stage KRAS inhibitors, offering more effective and durable treatments.

Accuray Showcases New Long-Term Data¹ on Benefits of 5 Session Radiotherapy Treatment for Men with Prostate Cancer at ESTRO 2025

On May 7, 2025 Accuray Incorporated (NASDAQ: ARAY) reported that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company’s CyberKnife System in the treatment of prostate cancer at multiple stages of the cancer journey (Press release, Accuray, MAY 7, 2025, View Source [SID1234652668]). The studies, shared at the annual congress held in Vienna, Austria, indicate the system’s accuracy and precision enable treatment of high-risk disease, as well as recurrent prostate cancer following prostatectomy, with stereotactic body radiation therapy (SBRT), expanding access to a non-invasive, short course of care to more men.

"At this year’s ESTRO meeting important analyses of real-world evidence (RWE) underscored the benefits of our unique robotic and helical platforms, reaffirming their use as patients’ primary care option or along with other modalities such as surgery, chemotherapy or immunotherapy. Stand out studies focused on the company’s CyberKnife System for the treatment of prostate cancer, building on a robust body of clinical data supporting its use and confirming the durability and quality of life after 10 years post-treatment. We’re grateful to the clinicians who continue to evaluate our technologies and advance personalized and precise care of patients through the work that they do," said Suzanne Winter, president and CEO of Accuray.

During the meeting, Accuray hosted a symposium titled, "Integrating Advanced Techniques in Genitourinary Radiotherapy: Harmonizing Precision, Personalization, and Efficacy," attended by 350 healthcare professionals. The event featured global thought leaders who spoke on advancements in the treatment of genitourinary indications – prostate, kidney, and bladder cancers – with radiotherapy. Patient care in these areas is dynamic and evolving rapidly, with SBRT now recognized as a safe and effective alternative to conventional treatments for localized prostate cancer and evidence continuing to build for the use of SBRT in salvage prostate treatments.

CyberKnife Platform: Empowering Advances in Prostate Cancer Patient Care
A retrospective analysis titled, "Long-term outcomes and treatment efficacy in high-risk prostate cancer patients treated with stereotactic extreme hypofractionated radiotherapy," reports on 262 men over the age of 70 or with severe comorbidities who were diagnosed with either non-metastatic high-risk or very high-risk prostate cancer and received SBRT delivered with the CyberKnife System in five sessions. With a median follow-up of 39 months, investigators found that treatment with the system offers a promising option with favorable outcomes and low rates of acute and late urogenital (UG) and gastrointestinal (GI) toxicities.

"Early results from a trial on stereotactic salvage radiotherapy for macroscopic prostate bed recurrence after prostatectomy: STARR (NCT05455736)" is a prospective study evaluating the use of stereotactic salvage radiotherapy (SSRT) delivered with the CyberKnife System in five sessions. Androgen deprivation therapy was prohibited during SSRT. An early analysis of 51 patients with a median follow up of 16 months found that the CyberKnife System provides an effective and convenient option with mild toxicity for the treatment of recurrent cancer in the prostate bed following prostatectomy. The study investigators concluded, "Only mild toxicity was reported, underlining the safety of the treatment. Moreover, SSRT may be considered a convenient approach considering the shorter treatment duration if compared to standard approach."

ViVerita Therapeutics Announces Research Collaboration with Boehringer Ingelheim to Accelerate Discovery of Novel Cancer Targets

On May 7, 2025 ViVerita Therapeutics ("ViVerita"), a US-based next-generation precision oncology company, reported a strategic research collaboration with Boehringer Ingelheim aimed at accelerating the discovery and validation of novel therapeutic targets (Press release, ViVerita Therapeutics, MAY 7, 2025, View Source [SID1234652667]). Under the terms of this collaboration, ViVerita will leverage its industry-leading in vivo CRISPR-based discovery platform to evaluate a curated set of putative targets identified by Boehringer Ingelheim, assessing their functions under physiologically relevant conditions.

Cancer continues to be one of the leading challenges in medicine responsible for one in six deaths globally and treatment options for many cancers remain limited. One of the reasons is that drug discovery efforts are focusing on a limited number of known drug targets. In the collaboration with ViVerita, Boehringer Ingelheim aims to change this and pave the way to novel treatments for people living with cancer.

Cancer target identification has traditionally relied on studying cell lines grown in vitro. While this approach is widely adopted and has contributed to numerous important discoveries, it also has relevant shortcomings, primarily due to the inability of the in vitro systems to faithfully model key physiological conditions present in the tumor microenvironment. Conversely, many putative targets identified in vitro do not validate in vivo.

"The ViVerita platform uniquely combines transformative in vivo high-throughput genetic screening technologies with faithful disease models. It will empower the discovery of cancer driver pathway-specific targets that have so-far been challenging to address. It also enables high-throughput validation of putative targets discovered using other approaches under physiological conditions," said Xuewen Pan, Co-Founder, President and CEO of ViVerita Therapeutics. "We are very excited to work with Boehringer Ingelheim, a leader in innovative oncology research and drug development, to discover new therapies to benefit cancer patients."

The collaboration with ViVerita aligns with Boehringer Ingelheim’s strategy to identify and validate novel, clinically relevant drivers of tumors to develop innovative first-in-class treatment options for patients in need.

Geneseeq Unveils Groundbreaking Blood Test for Early Detection of Pancreatic Cancer

On May 7, 2025 Geneseeq Technology Inc., in collaboration with leading clinical institutions, reported it has developed a cutting-edge blood-based screening test that could transform early detection of pancreatic cancer-potentially saving by identifying the disease at more treatable stages (Press release, Geneseeq, MAY 7, 2025, View Source [SID1234652666]). Published in the Journal of Clinical Oncology (Impact Factor: 50.7), this study represents the most comprehensive assessment to date of using cell-free DNA (cfDNA) fragmentomics and artificial intelligence (AI) for early pancreatic cancer detection.

Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies, largely because it is rarely caught early and diagnosed too late for curative treatment. The five-year survival rate remains around 12%, and currently tools-such as imaging and CA19-9 blood test-often miss early-stage cases. There is currently no recommended population-wide screening method for PDAC.

The new test model from Geneseeq analyzes cfDNA fragmentomics-specific patterns of DNA fragments shed into the bloodstream by cancer cells. By applying advanced machine learning algorithm to shallow whole-genome sequencing data, the test can detect subtle genomic and epigenetic changes associated with early-stage PDAC.

Key clinical results:

Achieved 93.4% sensitivity and 95.2% specificity in the training cohort
Reached 90.91-97.3% sensitivity and 92.8-94.5% specificity in multiple validation cohorts
Demonstrated strong performance even in early-state cancers
Outperformed CA19-9, especially in individuals with normal bilirubin levels
"Our cfDNA fragmentomics model offers a practical, highly accurate, and non-invasive option for detecting pancreatic cancer early," said Dr. Hua Bao, VP of R&D at Geneseeq. "It could support earlier identification of at-risk individuals, allowing timely clinical follow-up and potentially improving outcomes."

What makes this approach especially promising is its clinical feasibility. The test uses low-coverage sequencing (as little as 0.5×), making it cost-effective and suitable for broader population screening. The test also showed high stability, even with lower DNA sequencing data, and could be used to monitor high-risk patients or suspicious pancreatic lesions. The researchers also estimated that applying this test at the population level could reduce pancreatic cancer mortality by up to 27%, by catching more cancers at a treatable stage.

Further research is underway to refine the model’s application in screening programs and to validate its effectiveness in more diverse populations. Clinicians may soon have a powerful new tool to help combat one of the hardest-to-detect cancers.