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.

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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.

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.

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"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."

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.

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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.

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.

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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.

On May 7, 2025 Hyundai Bioscience reported the results of its Penetrium combination preclinical studies at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago (Press release, Hyundai Bioscience, MAY 7, 2025, View Source [SID1234652665]).

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The studies established that the repeated failures of immunotherapy and antibody treatments in cold tumors are not primarily caused by genetic resistance, as traditionally believed, but by pseudo-resistance**—a physical failure of infiltration resulting from extracellular matrix (ECM) stiffening. For the first time, Penetrium has been shown to structurally overcome this barrier.

Correcting 80 Years of Misconception: The Real Problem Is Not Genetic Mutations—It’s Pseudo-Resistance

For decades, the dominant theory behind cancer treatment failure centered around genetic mutations.

However, Hyundai Bioscience’s latest findings show that the actual obstacle lies in stiffened ECM that prevents immune cells and antibodies from reaching the tumor core.

Penetrium remodels the ECM, restoring infiltration pathways and enabling effective drug and immune cell access—providing a fundamental solution to the cold tumor problem.

Penetrium + Immunotherapy: Exceptional Results in Triple-Negative Breast Cancer (TNBC) Models

① In a TNBC mouse model, Penetrium combined with anti-PD-1 therapy led to:

A 48.3% reduction in tumor burden compared to anti-PD-1 monotherapy,
Complete elimination of metastasis observed in the combination group, which remained present in the monotherapy group.
Significantly, necrosis was induced within 3 days of Penetrium administration, and necrotic areas continued to grow with repeated dosing**—a trend not observed in the control group.

② Penetrium + Antibody Therapy: Complete Suppression of Lung Metastasis in a Metastatic Lung Cancer Model

In a metastatic lung cancer model:

Bevacizumab monotherapy showed only 33% metastasis suppression,
The Penetrium combination group recorded 0% lung metastasis at 100 mg/kg dosage.
Additionally, a marked decrease in MMP-9 and VEGF expression confirmed ECM normalization and the restoration of drug penetration routes at the molecular level.

③ Penetrium + Chemotherapy: Overcoming the Limitations of Paclitaxel

Paclitaxel monotherapy was found to paradoxically promote lung metastasis.

However, when combined with Penetrium, metastatic lesion areas were reduced by over 70–80% compared to controls.

Furthermore, suppression of MMP-9 and restoration of E-cadherin demonstrated that Penetrium not only enhances chemotherapy efficacy but also structurally blocks metastasis—without additional toxicity.

Validated in Naturally Occurring Canine Mammary Cancer Model: Stronger Responses Observed in Metastatic Tumors

In a naturally occurring canine mammary cancer model:

The Penetrium + POLYTAXEL combination reduced primary tumor volume by up to 38.7%, compared to 21.1% with monotherapy,
Metastatic lymph node lesions showed up to 78.99% tumor volume reduction.
Notably, metastatic lesions responded more strongly than primary tumors, challenging the long-standing notion that metastatic cancer is untreatable.

Proven Safety and Clinical Readiness

Penetrium was administered at less than 9% of the NOAEL dose established in a 13-week GLP-compliant toxicity study.

Its safety has also been verified in humans during a Phase 2 COVID-19 trial using the same API, niclosamide.

These results confirm Penetrium is fully prepared for human clinical application.

Official Statement from Dr. Soo-Jung Kim, Head of Research

"Penetrium is the world’s first platform to structurally solve the infiltration failure that has caused repeated failure of immunotherapy and antibody therapy in cold tumors.

Our combination study with immunotherapy exceeded expectations, and Hyundai Bioscience will soon initiate clinical trials of Penetrium combinations for both TNBC and metastatic lung cancer."

— Dr. Soo-Jung Kim, Head of Research, Hyundai Bioscience

Clinical Expansion Underway

Hyundai Bioscience is currently:

Conducting a Phase 1 trial for prostate cancer in South Korea,
Preparing an investigator-initiated trial for acute myeloid leukemia (AML) in France.
Penetrium: Launching a Tumor-Agnostic Cancer Treatment Platform

Penetrium ECM Remodeling Therapy is evolving into a tumor-agnostic universal cancer treatment platform with applicability not only to TNBC and metastatic lung cancer, but also to pancreatic, gallbladder, ovarian cancers, and hematological malignancies such as AML.

This breakthrough research is the first to structurally resolve infiltration failure in cold tumors, while also proving that metastatic cancers can be effectively treated**—a historic achievement in oncology.