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Palleon Pharmaceuticals Presents First-in-Class B7-H3 Targeted Sialidase at the 2026 AACR Annual Meeting

On April 20, 2026 Palleon Pharmaceuticals reported preclinical data and announced the initiation of a human clinical trial for E-688/HLX316, a first-in-class B7-H3 targeted sialidase, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting "New Drugs on the Horizon" session. The presentation, titled "E-688/HLX316: A First-in-Class B7-H3 Targeted Sialidase for Boosting Innate and Adaptive Anti-Tumor Immunity" introduces the first ever tumor-targeted enzymatic desialylation agent to enter the clinic.

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Tumor hypersialylation — the upregulation of sialic acid-containing glycans on the surface of cancer cells — activates several sialic acid-dependent immune regulatory pathways that suppress anti-tumor immunity. This axis of immune evasion is present across the majority of solid tumors and correlates with poor clinical outcomes in dozens of published studies. Conventional antibodies and small molecules cannot effectively disrupt this redundant glycan-mediated immunosuppression. Palleon’s engineered human sialidase overcomes this challenge by enzymatically removing sialic acid from the tumor surface, broadly neutralizing sialic acid-mediated immune suppression.

Palleon’s first-generation sialidase, E-602, established human proof-of-mechanism and a favorable tolerability profile in a previous clinical trial and is now in Phase 2 development in autoimmunity. This early clinical experience helped define the additional design requirements needed for the oncology clinical setting: durable tumor-localized desialylation and direct tumor cell killing. E-688/HLX316 was engineered to satisfy both conditions, and preclinical data confirm that it extends tumor surface desialylation to more than seven days in vivo and outperforms anti-PD-1 as a single agent in humanized tumor models, enhancing both innate and adaptive anti-tumor immunity.

"Tumor hypersialylation is now an addressable axis of immune evasion that is independent of PD-1/L1 biology," said Jim Broderick, M.D., CEO and Founder of Palleon Pharmaceuticals. "Our first-generation clinical experience identified the attributes of an effective oncology sialidase and informed the design of E-688/HLX316. The preclinical package confirms the approach works as intended."

E-688/HLX316 is being evaluated in a first-in-human monotherapy trial in platinum-resistant ovarian cancer in China led by Palleon’s strategic collaborator Henlius. Palleon’s clinical roadmap includes a systematic expansion into other large cancer populations characterized by high B7-H3 expression and hypersialylation, including lung and prostate cancer.

(Press release, Palleon Pharmaceuticals, APR 20, 2026, View Source [SID1234664578])

Samsung Bioepis Presents Nonclinical Data for its First Novel Antibody-Drug Conjugate Candidate SBE303 at AACR 2026

On April 20, 2026 Samsung Bioepis Co., Ltd. reported that the company has presented a nonclinical characterization of its first novel antibody-drug conjugate (ADC) candidate SBE303 in a poster presentation at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22, 2026, in San Diego.

"The results we’ve shared reinforce the strong potential of SBE303 as a next-generation ADC and our commitment to innovation beyond biosimilars," said Donghoon Shin, Executive Vice President and Clinical Sciences Division Leader at Samsung Bioepis. "The nonclinical results show encouraging efficacy, safety, tolerability and a promising ability to work in combination with existing immuno-oncology therapies. Importantly, it demonstrates that our engineered antibody is designed to significantly improve target-mediated internalization. We look forward to continuing the clinical development of SBE303 and advancing our broader mission to bring innovative treatments to patients in need."

SBE303 is Samsung Bioepis’s first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.1 Currently available Nectin-4 targeting ADCs are often limited by narrow therapeutic index (TI) and dose-limiting toxicities. SBE303 is engineered to improve the therapeutic window by combining a highly specific anti-Nectin-4 antibody conjugated with a potent novel topoisomerase I inhibitor via a proprietary linker. For nonclinical characterization of SBE303, a comprehensive set of pharmacology, pharmacokinetics, and toxicology studies was performed to evaluate the underlying mechanism, preclinical efficacy and safety, as well as its potential form combination therapy with anti-PD-1 blockade to support clinical development. SBE303 treatment resulted in robust anti-tumor activity with a differentiated tolerability profile, supporting an improved TI. Notably, the highest non severely toxic dose (HNSTD) was estimated to be 40 mg/kg and no intestinal lung disease (ILD) findings were observed at doses ≥40 mg/kg in repeat-dose toxicity studies. Based on the promising data, SBE303 is currently under Phase I clinical development (NCT07524348).

Poster presentation details:

– Title: Nonclinical characterization of SBE303: A Nectin-4 targeted antibody-drug conjugate (ADC) with novel topoisomerase 1 inhibitor shows a favorable safety margin
– Authors: Ji Yeon Kim, Sungwoo Hyung, Hyun-Ji Choi, Songhyun Lim, Jae Hee Lee, Seokuee Kim, Donghyun Kim, So-Shin Ahn, Donghoon Shin
– Abstract number: 1815
– Presentation Date & Time: Monday, April 20, 2026, 09:00 a.m. CET

The abstract is available on the AACR (Free AACR Whitepaper) 2026 website.

(Press release, Samsung Bioepis, APR 20, 2026, View Source [SID1234664577])

Takara Bio USA, Inc. Validates New Class of Spatial Technology with Benchmark Study for Cancer Research

On April 20, 2026 Takara Bio USA, Inc., a wholly owned subsidiary of Takara Bio Inc. ("Takara Bio"), reported data from a benchmark study comparing key performance metrics of its Trekker FX technology against conventional spatial methods. This study was conducted using formalin-fixed paraffin-embedded (FFPE) tissue samples from human lung squamous cell carcinoma. This study is the first in a planned series of independent studies to validate the advantages of Trekker FX technology over other existing spatial transcriptomics products. Takara Bio USA will present a poster on the findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference, taking place this week in San Diego.

"This benchmark study demonstrates that Trekker FX enables higher resolution, easier scalability, and deeper unbiased spatial characterization and insights than other methods," said Andrew Farmer, PhD, CSO of Takara Bio USA. "By combining true single-cell spatial mapping with broad molecular detection, the Trekker approach represents an entirely new class of spatial technology that complements existing single-cell sequencing workflows and expands what researchers can reveal in a cell’s native tissue environment."

In this benchmark study, Trekker FX delivered improved whole-transcriptome detection through its unique donation-based spatial tagging approach, which maintains single-cell NGS sensitivity. This results in Trekker FX being able to identify key subpopulations relevant in tumor biology (i.e., Tregs, plasmacytoid dendritic cells, lymphatic endothelial cells, and others). Trekker FX also identified 3X more statistically significant ligand-receptor interactions to better uncover how cells communicate within the tumor microenvironment.

The benchmark study was conducted by Takara Bio Genome Analysis Center in Japan, leveraging its world-class service capabilities and expertise across various spatial products and solutions. As a global leader in biotech research and development, Takara Bio offers a wide range of services that help scientists around the world push their research to new frontiers with a comprehensive array of technologies. Takara Bio USA, a subsidiary of Takara Bio Inc., published this study as the first in a new benchmarking series. This technology is now being further explored by top independent researchers, reflecting strong external validation beyond Takara Bio.

AACR poster presentation details

Title: Cross-platform comparison of spatial transcriptomics technologies in an FFPE lung squamous cell carcinoma sample
Abstract: View Source!/21436/presentation/10770
Session date and time: April 21, 2026, from 9:00 am–12:00 pm PST
Presenter: Bryan Bell, PhD
Location: Section 31
Poster board number: 17
Presentation number: 4960

(Press release, Takara Bio, APR 20, 2026, View Source [SID1234664576])

Dana-Farber Cancer Institute Study Demonstrates Predictive Value of Ignite Proteomics’ RPPA Platform for T-DXd (Enhertu®) Therapy in Metastatic Breast Cancer Patients

On April 20, 2026 Aditxt, Inc. (Nasdaq: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, reported that its precision oncology subsidiary, Ignite Proteomics, LLC ("Ignite" or "Ignite Proteomics"), has been featured in a peer-reviewed study published online ahead of print in npj Precision Oncology, a Nature journal. The study, led by investigators at Dana-Farber Cancer Institute, evaluated outcomes among patients with metastatic breast cancer treated with trastuzumab deruxtecan (T-DXd, marketed as Enhertu by AstraZeneca and Daiichi Sankyo) and assessed multiple quantitative HER2-related assays for their association with treatment outcomes.

While conventional HER2 immunohistochemistry (IHC) showed some association with outcomes in the broader patient population, the study found that quantitative HER2-related assays provided more granular predictive information in several matched biomarker sub-cohorts. In those sub-cohorts, traditional IHC classification often showed limited predictive value compared with quantitative approaches. Ignite’s Reverse Phase Protein Array (RPPA) platform, the only commercially available multiplex assay in the study, was one of the quantitative methods that demonstrated meaningful predictive value for patient outcomes.

T-DXd is an approved treatment option for a broad population of patients with metastatic breast cancer, yet there is currently no reliable way to predict which patients will respond.

"According to several studies, approximately 40% of cancers do not respond to the FDA approved therapy at front line in a metastatic setting," said Jeff Busch, Chief Executive Officer of Ignite Proteomics. In oncology, published research and institutional analyses have shown that approved therapies often fail to benefit a substantial portion of the patients who receive them. A 2017 study published in the BMJ reported that 57% of cancer drug indications approved by the European Medicines Agency entered the market without evidence of improved survival or quality-of-life benefit. MIT researchers have noted that targeted tyrosine kinase inhibitors typically work for only 40% to 80% of patients expected to respond. Johns Hopkins has reported that only 15% to 20% of patients achieve durable results with immunotherapy.

Ignite’s RPPA platform measures multiple protein biomarkers, including pathway activation and payload-relevant markers, from a single tumor sample. In the Dana-Farber study, Ignite’s platform was the only commercially available multiplex assay evaluated and demonstrated predictive value in matched biomarker cohorts where conventional HER2 IHC showed limitations. Notably, the study found that TOPO1 expression, the target of T-DXd’s cytotoxic payload, was detectable by Ignite’s platform in certain HER2-negative patients, highlighting the potential value of measuring tumor biology beyond HER2 expression alone. Ignite’s assay is CLIA-certified, CAP-accredited, listed on the Medicare Clinical Laboratory Fee Schedule under AMA CPT code PLA 0249U, and orderable today on standard biopsy tissue.

"Cancer therapy has made extraordinary progress, but oncology still has a treatment-selection problem," added Busch. "Too many patients receive therapies without enough information about whether those therapies are likely to work for their tumor biology. That is not an indictment of the drugs. These are powerful therapies. The issue is that cancer is complex, and single-marker testing often does not capture the functional biology that drives response or resistance. Ignite’s RPPA platform was built to address that gap by measuring multiple proteins, pathway activation, and payload-relevant biology from the same tumor sample. In this study, one of the world’s leading breast cancer research teams evaluated our platform alongside standard testing, and our platform demonstrated predictive value where conventional testing had limitations. That is the opportunity: better data, better treatment selection, and fewer patients receiving therapies that were never likely to help them."

"This publication represents an important milestone for our subsidiary Ignite and reflects the strength of Aditxt’s model of advancing and scaling impactful health innovations," said Amro Albanna, Co-Founder and Chief Executive Officer of Aditxt. "Peer-reviewed clinical evidence from one of the world’s leading cancer research institutions is key to accelerating the commercialization of this platform and expanding access to it for millions of patients making treatment decisions without clear guidance on what will work. Our goal is to help ensure that more patients receive the right therapy at the right time, with the potential to improve outcomes and make a meaningful difference in people’s lives."

The full study is available open access at: View Source

(Press release, Dana-Farber Cancer Institute, APR 20, 2026, View Source [SID1234664575])

Following Oral Presentation of Phase I Data at AACR 2026, Debiopharm Announces FDA Fast Track Designation for Lunresertib in Combination With Zedoresertib for Genomic-Defined Platinum-Resistant Ovarian Cancer

On April 20, 2026 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of its PKMYT1 inhibitor, lunresertib (Debio2513), and its WEE1 inhibitor, zedoresertib (Debio 0123).

The designation is for the treatment of adult patients with CCNE1 amplified, or a deleterious mutation in either FBXW7 or PPP2R1A, platinum-resistant/refractory ovarian cancer.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and fill an unmet medical need. Programs granted Fast Track designation benefit from more frequent communication with the FDA and, if relevant criteria are met, may be eligible for Priority Review and Accelerated Approval of a New Drug Application (NDA).

Momentum Following AACR (Free AACR Whitepaper) Oral Presentation

This regulatory milestone follows the first clinical data disclosure from the MYTHIC Study (NCT04855656), a Phase I trial evaluating the lunresertib and zedoresertib combination in patients with advanced solid tumors harboring these specific genomic alterations. The data were featured yesterday in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting by Dr. Timothy A. Yap, Medical Oncologist and Physician-Scientist at The University of Texas MD Anderson Cancer Center, and Principal Investigator of the MYTHIC study.

"The FDA’s decision to grant Fast Track designation for this combination therapy validates our synthetic lethality approach to treating high-unmet-need cancers," said Esteban Rodrigo Imedio, Executive Medical Director, Oncology, Debiopharm. "Coming immediately after Dr. Yap’s presentation of the MYTHIC data at AACR (Free AACR Whitepaper), this designation highlights the potential of combining lunresertib and zedoresertib to provide a meaningful new clinical option for patients with biomarker-selected ovarian cancer who have exhausted platinum-based therapies."

Addressing Unmet Need in Ovarian Cancer

Platinum-resistant or refractory ovarian cancer remains one of the most challenging malignancies to treat, with limited effective options for patients whose tumors have developed resistance. By targeting the DNA Damage Response (DDR) pathway through the dual inhibition of PKMYT1 and WEE1, the lunresertib/zedoresertib combination aims to exploit specific genomic vulnerabilities (CCNE1, FBXW7, or PPP2R1A) to induce tumor cell death.

ABOUT DNA DAMAGE REPAIR (DDR)

When cells have damaged DNA, they must undergo a repair process known as DDR to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, ultimately activating a programmed cell death process. DDR inhibitors such as zedoresertib (Debio 0123), Debiopharm’s WEE1 inhibitor, are currently being investigated in clinical and preclinical studies.

ABOUT PKMYT1 INHIBITION

Lunresertib (Debio2513) is a first-in-class, oral PKMYT1 inhibitor designed to exploit specific genetic vulnerabilities in solid tumors, such as CCNE1 amplification. By targeting PKMYT1, the drug induces synthetic lethality, preventing cancer cells from repairing DNA damage and forcing them into programmed cell death. As the most advanced PKMYT1 inhibitor in clinical development, lunresertib has shown encouraging proof-of-concept results both as monotherapy and in combination therapies within the ongoing MYTHIC trial.

(Press release, Debiopharm, APR 20, 2026, View Source [SID1234664574])