On April 22, 2025 Oncotelic Therapeutics, Inc. (OTCQB:OTLC), a biotechnology company focused on nanomedicine and RNA-based therapeutics, reported that its Chairman and CEO, Dr. Vuong Trieu, will deliver a keynote presentation at the 21st Annual Congress of International Drug Discovery Science & Technology (IDDST-Europe), scheduled for June 18-20, 2025, in Stockholm, Sweden (Press release, Oncotelic, APR 22, 2025, View Source [SID1234652020]).

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Dr. Trieu’s presentation, titled " Deciparticles: Novel Sub-20 nm Nanoparticles for Advanced Drug Delivery" will highlight the groundbreaking Deciparticles platform developed by Oncotelic Therapeutics and Sapu Nano. Deciparticles are a novel class of sub-20 nm nanoparticles specifically engineered to overcome challenges associated with delivering insoluble drugs to solid tumors. Deciparticles platform is able to formulate more than 90% of all water insoluble drugs tested – including the taxanes,

The presentation will outline key findings demonstrating that Deciparticles significantly improve tumor penetration and achieve superior antitumor efficacy compared to conventional formulations. A central feature of this innovation is the integration of biomarker-driven strategies, leveraging DNA methylation signatures and gene-expression profiles predictive of patient survival, potentially enabling personalized therapeutic interventions. Oncotelic’s lead candidate, Sapu-001, has shown promising preclinical results, demonstrating a higher maximum-tolerated dose and reduced toxicity relative to existing therapies.

Dr. Trieu emphasized, "With Deciparticles, we’ve entered a new era of targeted drug delivery-leveraging sub-20 nm nanoparticles combined with epigenetic biomarkers to significantly enhance treatment outcomes for patients. We anticipate Phase 1 clinical trials for Sapu-001 later this year."

Presentation Details:

Event: IDDST-Europe 2025 Conference
Date: June 19, 2025, at 10:30 CET
Speaker: Vuong Trieu, Ph.D., Chairman & CEO, Oncotelic Therapeutics
Title: " Deciparticles: Novel Sub-20 nm Nanoparticles for Advanced Drug Delivery"

On April 22, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its global first-in-class PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy, has demonstrated strongly positive results in the Phase III clinical trial (AK112-306/HARMONi-6) for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) (Press release, Akeso Biopharma, APR 22, 2025, View Source [SID1234652021]). The Independent Data Monitoring Committee (IDMC) declared that the study had met its primary endpoint of progression-free survival (PFS) at the first pre-specified interim analysis. The results of HARMONi-6 study are both statistically significant and clinically meaningful.

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Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year.

Data from the HARMONi-6 study show that, in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS)
The ivonescimab combination showed clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative populations
The trial enrolled a total of 532 patients, approximately 63% of whom had centrally located squamous cell carcinoma, a distribution consistent with real-world patient populations
Ivonescimab demonstrated a favorable safety profile, with no new safety signals identified. The incidence of treatment related serious adverse events and the incidence of bleeding events of grade 3 or higher were comparable to those of the control group
The HARMONi-6 study is ivonescimab’s third Phase III clinical trial with positive results in lung cancer, highlighting that treatment with ivonescimab can overcome the limitations of bevacizumab in treating squamous-NSCLC.

The HARMONi-6 study is also ivonescimab’s second Phase III clinical trial with positive results in lung cancer in head-to-head comparisons vs. PD-1 inhibitors, further establishing ivonescimab as a comprehensive treatment option for both first-line and later-line NSCLC. This result further positions ivonescimab to improve upon and replace the current standard of care for the treatment of NSCLC. The study was conducted at 66 clinical research centers across China.

Professor Lu Shun, Director of Shanghai lung cancer, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine and principal investigator of the AK112-306 / HARMONi-6 study, commented:

"It is a great honor for us to witness ivonescimab once again successfully challenge the optimal standard of care. This breakthrough not only advances the treatment of non-small cell lung cancer but also marks a significant milestone in global oncology immunotherapy."

"The interim analysis results from the HARMONi-6 study show that ivonescimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) compared to tislelizumab with chemotherapy. In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group. This highlights its potential to overcome the limitations of bevacizumab in treating squamous non-small cell lung cancer, ultimately enhancing the clinical benefits of immunotherapy for NSCLC. With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma."

Professor Lu added,

"Ivonescimab has gained widespread recognition for treating EGFR-TKI-resistant, advanced nsq-NSCLC since its approval in China nearly a year ago. The HARMONi-2 study showed strong positive results for PD-L1-positive squamous and non-squamous NSCLC in first-line treatment. Additionally, the recent HARMONi-6 study demonstrated significant positive outcomes in first-line squamous NSCLC, further confirming ivonescimab’s exceptional efficacy in both squamous and non-squamous cancers. This positions ivonescimab as a new standard of care for the treatment of these types of cancer. I am confident and excited about its potential in global Phase III trials and its ability to positively reshape the global oncology landscape with a Chinese solution."

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso, said:

"Today, we are incredibly excited to announce the third significant positive result for ivonescimab in a Phase III study. PD-1 combined with chemotherapy remains the global standard of care for first-line treatment of NSCLC. Ivonescimab has once again demonstrated its breakthrough clinical value and market competitiveness as a next-generation cancer therapy through compelling clinical data. We sincerely thank all the investigators, participants, and patients who have contributed to this clinical study."

Dr. Xia continued,

"Beyond its demonstrated superior efficacy and safety in non-small cell lung cancer, ivonescimab is currently being tested in multiple Phase II and III trials across other cancer types, establishing a clear leadership in both improving patients’ lives and addressing critical unmet need across multiple cancer types. The success of the HARMONi-6 study validates our very high confidence in continuing to integrate global resources and advancing ivonescimab’s role as a next-gen immunotherapy. We look forward to working with our partner Summit on expanding global access to ivonescimab. We are impressed by and also appreciative of their progress in developing ivonescimab in the US, Europe, and Japan. We are committed to improving the standard of care, changing treatment approaches, and offering safer, more unwaveringly effective solutions for patients worldwide."

On April 22, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that it will present new data highlighting the latest real-world evidence with the Galleri multi-cancer early detection (MCED) test and additional data from GRAIL’s circulating tumor DNA (ctDNA)-based targeted methylation platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, April 25-30, 2025 (Press release, Grail, APR 22, 2025, View Source [SID1234652022]).

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"GRAIL has an extensive evidence program that is setting the standard for multi-cancer early detection development that includes a large real-world dataset demonstrating Galleri test performance and implementation," said Josh Ofman, MD, MSHS, President of GRAIL. "The real-world findings being presented at AACR (Free AACR Whitepaper) support those observed in our previous clinical studies, highlighting the test’s ability to screen for deadly cancers that do not have recommended screening tests. Additional data presented will underscore the potential of GRAIL’s ctDNA-based targeted methylation assay for quantifying abnormal promoter methylation, which is a known hallmark of cancer and has shown potential utility as a biomarker in precision oncology."

Data Presentations

Title: Real-world data and clinical experience from over 100,000 multi-cancer early detection tests
Abstract Number: 7202
Session Title: Targeted Therapies and Combinations 4
Date/Time: April 30, 2025, 9 am-12 pm
Location: Poster section 35

The latest data from a real-world study of more than 100,000 participants with the Galleri test, consistent with previously reported large-scale clinical data, affirming the MCED test can reliably detect a cancer signal across a wide range of cancer types, including cancers without recommended screening, with a high Cancer Signal of Origin prediction accuracy to help guide diagnostic evaluations.
Title: Estimated Post-Test Probabilities of Cancers For Individuals Receiving Multi-Cancer Early Detection (MCED) Tests
Abstract Number: 7132
Session Title: Immune Monitoring / Clinical Correlates
Date/Time: April 30, 2025, 9 am-12 pm
Location: Poster section 31

This modeling analysis shows that individuals receiving a no cancer signal detected MCED test result have a reduced risk of cancer diagnosis for one year post-blood draw; this risk increases as screening interval goes beyond one year, highlighting the importance of annual screening with the MCED test.
Title: Promoter Methylation as a Cancer Biomarker: Insights From ctDNA-Based Targeted Methylation Data
Abstract Number: 1943
Session Title: Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2
Date/Time: April 28, 2025, 9 am-12 pm
Location: Poster section 28

Leveraging insights from the Circulating Cell-free Genome Atlas (CCGA) study, this early proof-of-concept study underscores the potential of GRAIL’s ctDNA-based targeted methylation assay for detecting clinically informative promoter methylation signals in a plasma sample.
Title: Assessment of Cancer Subtypes Across Multiple Cancer Types Using a Circulating Tumor DNA (ctDNA)-Based Targeted Methylation Assay
Abstract Number: 1947
Session Title: Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2
Date/Time: April 28, 2025, 9 am-12 pm
Location: Poster section 28

Based on this proof-of-concept study, GRAIL’s ctDNA-based targeted methylation assay enables subtyping across cancers using a single blood draw, without the need for invasive tissue biopsy.

On April 21, 2025 Axcynsis Therapeutics that is at the forefront of developing cutting-edge Antibody Drug Conjugate (ADC) therapies, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Axcynsis Therapeutics, APR 21, 2025, View Source [SID1234651989]). This meeting will be held in Chicago from April 25th to 30th 2025.

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The company will present the following two assets:

AT65474 is a highly selective anti-CLDN6 ADC with a proprietary payload
Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 4

Session Date and Time: April 30, 2025, 9:00 AM to 12:00 PM (Local Time)

Location: Poster Section 16

Poster Board Number: 7

Published Abstract Number: 6741

CLDN6 is a membrane-bound oncofetal protein and a promising target for cancers such as ovarian and testicular cancer. AT65474 is an antibody drug conjugate (ADC) candidate composed of a highly selective humanized anti-CLDN6 antibody conjugated to a proprietary payload, namely TCS132, with a drug-to-antibody (DAR) ratio of 4. The antibody is engineered to incorporate AxcynCYSTM technology for site-specific conjugation which can reproducibly achieve high DAR4 ratios of greater than 97% by HIC analysis.

The payload, TCS132, is derived from an FDA approved drug and when compared to the parent drug, demonstrates increased potency with broad sub-nanomolar activities across a wide range of cancer cell lines including those resistant to paclitaxel, DM1, MMAE and DXd. Additionally, TCS132 was chemically optimized for better PK properties and demonstrates a much-improved safety profile despite its increased potency over the parent drug.

AT2604 is a highly efficacious ADC targeting alkaline phosphatases ALPP and ALPPL2​
Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 4

Session Date and Time: April 30, 2025, 9:00 AM to 12:00 PM (Local Time)

Location: Poster Section 16

Poster Board Number: 17

Published Abstract Number: 6751

Placental alkaline phosphatases, ALPP and ALPPL2, are highly homologous, membrane-bound proteins involved in fetal development. Despite having limited expression in normal tissues, they are highly differentiated in multiple tumor cells making them ideal targets for antibody drug conjugate (ADC) development.

AT2604 is an ADC incorporating an anti-ALPP/ALPPL2 antibody conjugated to monomethyl auristatin E (MMAE) with high DAR 4 homogeneity; and displays strong tumor growth inhibition at low doses in CDX models of gastric and pancreatic cancer. In patient-derived xenograft models of gastric cancer with moderate- and low-antigen expression, AT2604 achieves near-complete tumor regression at 3 and 6 mg/kg (QWx3), respectively. A preliminary toxicity assessment in non-human primates concluded a well-tolerated dose of 10 mg/kg (Q3Wx3) without exhibiting any non-reversible adverse effects and good plasma stability; implying that AT2604 possesses an improved safety profile over other vedotin-based ADCs.

On April 21, 2025 BostonGene, a leader in AI-driven molecular and immune profiling that accelerates drug development and personalizes patient care, reported that four abstracts have been selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, held from April 25 – 30, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, APR 21, 2025, View Source [SID1234652005]). BostonGene will be exhibiting at booth #2452.

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Ferran Prat, PhD, JD, BostonGene’s Chief Commercial Officer, will also speak at the AACR (Free AACR Whitepaper) educational session, Academic Entrepreneurship: Getting Your Discovery to Patients on April 26 from 8:00 AM – 9:30 AM. The session will address key topics such as understanding intellectual property rights and patents, raising capital and developing commercialization pathways. By bridging these knowledge gaps, the session seeks to empower researchers to move innovations from the laboratory to patient care.

BostonGene is also proud to partner with the American Cancer Society to host the BrightEdge Entrepreneurs (BEE) Dinner at AACR (Free AACR Whitepaper) 2025, held on April 28 in Chicago. The event will spotlight eight innovative cancer-focused startups from the BEE Program, which empowers underrepresented scientific entrepreneurs with mentorship, investor access and early-stage funding.

In collaboration with leading academic institutions, BostonGene will present new research that highlights the power of its AI-enabled, integrated multiomic platform to drive precision oncology. By leveraging comprehensive genomic, transcriptomic and immune system profiling, the platform enables high-resolution tumor characterization, molecular subtyping, and immune landscape reconstruction—delivering clinical and mechanistic insights to optimize drug trials and clinical care. From refining transcriptional subtypes in small cell lung cancer and predicting treatment response in triple-negative breast cancer to improving germline variant interpretation and advancing biomarker detection in pan-cancer analyses, these studies demonstrate the platform’s utility in both clinical care and translational research. In addition, the studies also highlight its role in accelerating biomarker-informed drug development.

Details of BostonGene’s poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting are below:

Abstract number: 1101
Title: A novel machine learning classifier for SCLC transcriptional subtypes
Date and time: Sunday, April 27 | 2:00 PM – 5:00 PM
Presenter: Carl Gay, MD, PhD, MD Anderson Cancer Center

In this study, BostonGene applied gradient-boosting machine learning models to refine the small cell lung cancer (SCLC) subtypes developed by Gay et al. (The University of Texas MD Anderson Cancer Center). The model demonstrated high performance metrics during validation, reinforcing its potential clinical impact.

Research done in collaboration with MD Anderson Cancer Center

Abstract number: 5308
Title: Pan-cancer analysis of TRIM37 copy-number and development of fit-for-screening in situ hybridization tools
Date and time: Sunday, April 27 | 2:00 PM – 5:00 PM
Presenter: J.D. Schonhoft, PhD, Repare Therapeutics

BostonGene’s WES platform was used to examine the copy numbers and RNA levels of TRIM37 across over 12,000 adult solid tumor samples. Newly developed DNA- and RNA-based in situ hybridization (ISH) approaches uncovered high TRIM37 expression in many patients, underscoring the need for sensitive ISH methods for examining clinical biomarkers.

Research done in collaboration with Repare Therapeutics

Abstract number: 2036
Title: Transcriptomic immune signatures and reconstructed immune cell types associated with pathological complete response to neoadjuvant chemotherapy in triple-negative breast cancer
Date and time: Monday, April 28 | 9:00 AM – 12:00 PM
Presenter: Tomohiro Oshino, MD, Hokkaido University Hospital

BostonGene’s tumor microenvironment (TME) subtyping and cell deconvolution were used for TME reconstruction in triple-negative breast cancer (TNBC). The findings revealed patients with immune-enriched TME were more likely to achieve a pathological complete response following neoadjuvant chemotherapy, underscoring the potential of TME-based analytical tools to predict treatment response in TNBC.

Research done in collaboration with Hokkaido University Hospital

Abstract number: 5047
Title: Enhancing germline variant calling: Adjustment with tumor samples to filter low-confidence variants from clonal hematopoiesis
Date and time: Tuesday, April 29 | 9:00 AM – 12:00 PM
Presenter: Artur Baisangurov, MS, BostonGene

Leveraging whole-exome sequencing (WES) analysis for 2,078 cancer patients, BostonGene developed a filtering method to improve the accuracy of germline reports. This novel approach identified artifacts caused by molecular and biological variations to streamline quality control of genetic reports for cancer patients.

The abstracts will be published in an online-only Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research.