On April 28, 2025 PredxBio, a pioneer in AI-powered spatial biomarker discovery, reported a strategic collaboration with Hamamatsu Photonics K.K., a global leader in imaging technologies (Press release, Hamamatsu Photonics KK, APR 28, 2025, View Source [SID1234652266]). The partnership unites Hamamatsu’s advanced MoxiePlex multiplex immunofluorescence imaging system with PredxBio’s SpaceIQ spatial analytics platform to deliver an integrated workflow tailored to basic and translational research tailored to immuno-oncology.

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Launched in late 2024, Hamamatsu’s MoxiePlex is a research use only platform that captures up to 10 fluorescent markers simultaneously, enabling precise spatial mapping of proteins on cancer and immune cells within the tumor microenvironment. Designed to support the complex needs of spatial proteomics research while maintaining workflow simplicity, MoxiePlex may in the future be developed for clinical applications, especially in areas like immunotherapy response profiling.

"This partnership reflects a shared vision to unlock the true potential of spatial proteomics through innovation and accessibility," said James Butler, VP of Marketing at Hamamatsu Corporation (the US subsidiary of Hamamatsu Photonics). "With MoxiePlex and SpaceIQ combined, we’re delivering a solution that meets the demands of advanced cancer research today, while paving the way for future development of clinical integrations."

By combining the high-resolution imaging capabilities of MoxiePlex with the explainable, multi-modal analytics of SpaceIQ, the joint offering creates a streamlined, plug-and-play ecosystem. Researchers can move from image capture to actionable insights—such as spatial immune cell profiling, pathway activation analysis, and biomarker stratification—with unprecedented speed, clarity, and scalability.

"We’re excited to partner with Hamamatsu to bridge the gap between image generation and spatial intelligence," said Dr. Dusty Majumdar, CEO of PredxBio. "Our joint solution makes it possible to explore not only what proteins are expressed, but where and how they drive disease biology—empowering researchers and drug developers with insights that matter."

PredxBio and Hamamatsu are jointly committed to simplifying spatial workflows while enhancing biological resolution. The integration supports spatially resolved proteomic data in support of translational research, biomarker validation, and clinical trial optimization.

On April 28, 2025 SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for disorders of the central nervous system (CNS) and cancer, presented late-breaking research at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago (Press release, SK Life Science, APR 28, 2025, View Source [SID1234652265]). The research identified novel orally bioavailable p300-selective degraders that have therapeutic potential for difficult-to-treat prostate cancer and multiple cancers where the protein CBP is mutated or missing.

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"What is extremely promising about our research is that we have shown that selective p300 degraders are highly effective in rapidly shutting down tumor growth in hard-to-treat cancers while also reducing toxicity due to their precise targeting," said Ryan Kruger, Ph.D., Chief Scientific Officer at SK Life Science Labs. "This study offers great hope for the development of safer drug therapies that could effectively treat some of the most challenging types of cancers for patients who currently have few good treatment options."

The p300 protein is implicated in oncogenic processes that drive a variety of solid cancers. Targeted p300 degraders demonstrate superb selectivity and potency, inhibiting tumor cell growth across several indications including castrate-resistant prostate cancer and cancers where the related protein, CBP, is missing or mutated. Once daily oral administration of these potent p300-selective degraders in tumor-bearing mice results in rapid degradation of p300 and a significant reduction in tumor growth.

"There are two primary advantages of using a heterobifunctional degrader to target p300. First, using the power of ternary complex formation, we are for the first time able to generate molecules that can target p300 over CBP with exquisite selectivity. Second, p300 degraders eliminate this critical protein required for cancer cells instead of just suppressing its activity as other molecules in development do," continued Dr. Kruger. "This discovery underscores the potential for safer and more effective oncology therapies for some of the most difficult-to-treat cancers."

On April 28, 2025 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported initial results demonstrating the ability of its MRD test to predict recurrence in early-stage non-small cell lung cancer, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 25-30, 2025 (Press release, Adela, APR 28, 2025, View Source [SID1234652264]).

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Adela’s MRD test is a blood-only, tissue-free approach for detecting recurrence prior to clinical exam and imaging, eliminating the need for tumor tissue samples and enabling broader access to MRD testing. A blood-only approach is especially important in lung cancer, where nearly 40% of patients do not have sufficient tumor tissue for tissue-informed MRD tests.1

The ability of Adela’s test to quantify cfDNA cancer signal and predict recurrence was evaluated in 136 samples from 24 patients diagnosed with stage I-II non-small cell lung cancer treated at New York University Langone Medical Center. Blood draws occurred prior to surgery, after surgery and at intervals before recurrence or last clinical follow-up. Adela’s test demonstrated the ability to identify recurrences up to 35.9 months before standard of care clinical exam and imaging, with a mean lead time of 16.6 months. Significant differences in recurrence-free survival (RFS) were observed when patients were stratified by MRD positivity (hazard ratio of 3.58, P=0.038).

"We are greatly encouraged by these results which highlight the ability of Adela’s tissue-free MRD test to detect recurrence in lung cancer well in advance of standard of care," said Dr. Anne-Renee Hartman, Chief Medical Officer of Adela. "Adela’s MRD test has been clinically validated for head & neck cancer. These results further validate the strong performance of Adela’s genome-wide methylome enrichment platform and demonstrate its applicability across multiple cancer types."

Adela’s MRD test based on its genome-wide methylome enrichment platform is currently available to biopharmaceutical companies and other investigators for Research Use Only (RUO), including for biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head & neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making.

Presentation Details

Abstract #: 3249: The Development of a Tissue-Agnostic Genome-Wide Methylome Enrichment Assay for Lung Cancer

Harvey I. Pass2

Monday Apr 28, 2025 2:00 PM – 5:00 PM

Poster Section 29, Poster Board Number: 14

On April 28, 2025 Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering novel, targeted, small molecule cancer therapeutics, reported new preclinical data on its first-in-class oral DHX9 inhibitor, ATX-559, and its potentially best-in-class KIF18A inhibitor, ATX-295, in poster and oral presentations, respectively, at the AACR (Free AACR Whitepaper) Annual Meeting 2025 taking place April 25-30 in Chicago, Illinois (Press release, Accent Therapeutics, APR 28, 2025, View Source [SID1234652263]). ATX-559 and ATX-295 are currently under investigation in Phase 1/2 clinical trials.

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"Our presentations at the AACR (Free AACR Whitepaper) annual meeting showcase the outputs of Accent’s precision oncology approach to drug development, with strong foundational data that inform our current and future clinical development plans for our lead programs, ATX-559 and ATX-295," said Serena Silver, Ph.D., Chief Scientific Officer of Accent Therapeutics. "These preclinical data reinforce our assets’ therapeutic potential across several cancer indications with high unmet need."

The company’s poster presentation includes preclinical data supporting continued clinical evaluation of ATX-559, a first-in-class potent, selective, and orally bioavailable small-molecule inhibitor of DHX9. Results within characterize the compound’s activity in cancer cell lines with genomic instability and elevated replication stress spanning several indications, including dMMR/MSI-H colorectal cancer and BRCA-altered triple negative breast cancer, and in subtypes of lung, gastric, ovarian, and prostate cancers. ATX-559 was shown to be well tolerated in vivo, leading to robust and dose dependent tumor growth inhibition and regression in BRCA deficient breast cancer and dMMR/MSI-H cell- and patient-derived xenograft models.

ATX-559 is currently under investigation in a first-in-human, Phase 1/2, open-label, dose-escalation and expansion study, with a focus on advanced or metastatic patients with BRCA-1 and/or BRCA-2-deficient breast cancer or MSI-H and/or dMMR solid tumors (NCT06625515). Additional undisclosed solid tumor indications undergoing replicative stress and representing significant patient populations may be explored either in parallel or in subsequent studies.

For Accent’s second lead program, preclinical data included in the company’s oral presentation demonstrates sensitivity to KIF18A inhibition across several solid tumor indications with high chromosomal instability, signaling significant opportunity for patient impact by leveraging KIF18A as a selective oncology target. Results further characterize ATX-295 as a potent and selective KIF18A inhibitor capable of inducing mitotic arrest, cell death, and anti-tumor activity in cancer models with high chromosomal instability. Studies in relevant cellular and xenograft models exhibiting whole genome doubling confirm selective anti-cancer activity, providing rationale for whole genome doubling as a predictive biomarker of ATX-295 sensitivity in ovarian and triple negative breast cancer.

Accent recently initiated clinical evaluation of ATX-295 in a first-in-human Phase 1/2 open-label, dose-escalation and expansion study designed to evaluate the molecule’s safety, tolerability, and preliminary efficacy in patients with locally advanced or metastatic solid tumors, including high-grade serious ovarian cancer (NCT06799065).

Details for the presentations are as follows:

Presentation Title: Activity of the Novel KIF18A Inhibitor, ATX-295, is Enriched in Whole Genome Doubled Ovarian Cancer Pre-Clinical Models

Abstract Number: 3784
Session Type: Minisymposium
Session Title: Novel Antitumor Agents
Session Date and Time: Monday, April 28, 2:30 pm – 4:30 pm CT
Location: Room S103 – McCormick Place South (Level 1)
Presenter: Maureen Lynes, Ph.D.
Poster Title: ATX-559, a First in Class DHX9 Inhibitor, and Targeted Therapeutic for Molecularly Defined Tumors with Genomic Instability and Replicative Stress

Abstract Number: 1758
Session Title: Novel Antitumor Agents 1
Session Date and Time: Monday, April 28, 9:00 am – 12:00 pm CT
Location: Poster Section 22
Poster Board Number: 10
Presenter: Jennifer Castro
About ATX-559
ATX-559 is a first-in-class potent and selective inhibitor of DHX9, a novel and previously undrugged RNA and DNA/RNA helicase, shown to play a critical role in tumors with high levels of replication stress (including breast, ovarian, colorectal, endometrial, gastric, and others), representing large patient populations with significant unmet medical need. DHX9 has been reported to play important roles in replication, transcription, translation, RNA splicing, RNA processing, and maintenance of genomic stability, making it a compelling novel oncology target. In addition to exploiting key tumor vulnerabilities in DNA repair deficient backgrounds (e.g., BRCA) and hyper-mutated states (e.g., MSI-H/dMMR), Accent is exploring the sensitivity of other tumor types to DHX9 inhibition, and the potential to combine DHX9 inhibitors with other cancer treatments to maximize its full potential for helping patients. Accent retains full worldwide rights to ATX-559, currently being evaluated in a Phase 1/2 clinical trial (NCT06625515), and the DHX9 program.

About ATX-295
Accent’s second lead program is a potential best-in-class inhibitor for KIF18A which may address a large patient population across several cancer indications, including ovarian and triple negative breast cancer (TNBC). KIF18A is a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability, but not in healthy cells. KIF18A inhibitor treatment results in rapid cell death for cancers with an abnormal number of chromosomes (aneuploid) in vitro and in vivo, while cells with normal numbers of chromosomes (euploid) are unaffected. Accent retains full worldwide rights to ATX-295, which is currently being evaluated in a Phase 1/2 clinical trial (NCT06799065), and the KIF18A program.

On April 28, 2025 Privo Technologies, Inc., a clinical-stage biopharmaceutical company pioneering nanotechnology-based cancer therapies, reported the activation of multiple premier clinical sites across the United States for its ongoing CLN-004 trial (Press release, Privo Technologies, APR 28, 2025, View Source [SID1234652262]). This Phase 2/3, open-label, two-arm study is evaluating the safety and efficacy of two of Privo’s lead assets—PRV111 and PRV211—in patients with head and neck squamous cell carcinoma (HNSCC).

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The trial is now actively recruiting at the following esteemed institutions:

University of Chicago Medicine (Chicago, IL)

City of Hope (Los Angeles, CA)

Miami Cancer Institute (Miami, FL)

Cleveland Clinic (Cleveland, OH)
Additional leading cancer centers are in the process of being activated and will be announced in the coming weeks.

"We are honored to collaborate with some of the nation’s leading head and neck oncology experts at these top-tier institutions," said Dr. Manijeh Goldberg, CEO of Privo Technologies. "Their participation underscores the potential impact of our novel therapies in transforming the treatment landscape for patients with HNSCC."

About the CLN-004 Trial

The CLN-004 study comprises two distinct arms:

Arm 1: Evaluates PRV111, a nanoengineered, self-adhesive patch designed for the topical delivery of cisplatin directly to the tumor site. This arm targets patients with carcinoma in situ (CIS) and high-grade dysplasia of the oral cavity, aiming to improve local control and potentially reduce the extent of surgical intervention.

Arm 2: Assesses PRV211, an intraoperative chemotherapy system intended for application into the resected tumor bed during surgery. This approach seeks to eliminate residual microscopic disease and reduce the risk of tumor recurrence in patients with stages T1-T4 HNSCC.
Both PRV111 and PRV211 are part of Privo’s proprietary PRV platform, which utilizes nanotechnology to enhance the locoregional delivery of chemotherapeutic agents, aiming to maximize therapeutic efficacy while minimizing systemic toxicity.