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.

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"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])

FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer

On April 20, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026.

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If approved, these indications would expand the use of KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as the first perioperative treatments for patients with MIBC regardless of cisplatin eligibility and build on the previously approved indications of the combination for the treatment of patients with MIBC who are ineligible for cisplatin-based chemotherapy.

"Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Even with curative-intent surgery and chemotherapy, patients still experience disease progression or limited survival. These data add to the growing body of evidence demonstrating that KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, have the potential to reshape how we approach treatment for these patients and improve outcomes for people facing this aggressive disease."

The sBLAs are based on data from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas, which were presented at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium. The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings.

KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA plus Padcev is also approved in the U.S. for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. KEYTRUDA as a monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

KEYTRUDA plus Padcev has now demonstrated an overall survival (OS) benefit across three Phase 3 trials in bladder cancer. In addition to KEYNOTE-B15, these trials include previously announced positive results from KEYNOTE-905 for the treatment of patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy and positive results from KEYNOTE-A39 for the treatment of adult patients with la/mUC. Three additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic disease. Two of these studies are in MIBC including KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676 (NCT03711032).

KEYNOTE-B15 is one of six Phase 3 studies of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an OS benefit. It was also the 15th positive pivotal trial for a KEYTRUDA-based regimen in earlier-stage cancers.

About KEYNOTE-B15/EV-304

KEYNOTE-B15, also known as EV-304, is an open-label, randomized Phase 3 trial (ClinicalTrials.gov, NCT04700124) evaluating perioperative KEYTRUDA in combination with Padcev and surgery (radical cystectomy and pelvic lymph node dissection) versus neoadjuvant chemotherapy (gemcitabine plus cisplatin) and surgery in patients with MIBC who are cisplatin-eligible. The trial enrolled 808 patients who were randomized to receive either:

Four cycles (each cycle length is 21 days) of neoadjuvant KEYTRUDA intravenous (IV) infusion plus enfortumab vedotin IV infusion, followed by surgery, followed by 13 cycles of adjuvant KEYTRUDA IV infusion plus five cycles of enfortumab vedotin IV infusion, or;
Four cycles (each cycle is 21 days) of standard of care neoadjuvant chemotherapy followed by surgery.
The primary endpoint is event-free survival (EFS), defined as the time from randomization to the first occurrence of the following events: radiographic disease progression precluding radical cystectomy and pelvic lymph node dissection, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review or death due to any cause. The key secondary endpoints are OS and pathologic complete response rate.

About bladder cancer

In 2022, bladder cancer changed the lives of more than 600,000 people around the world. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence.

(Press release, Merck & Co, APR 20, 2026, View Source [SID1234664543])

Rznomics Reports Interim Clinical Data for RZ-001 in Hepatocellular Carcinoma at AACR 2026 Demonstrating Encouraging Efficacy and Favorable Safety Profile

On April 20, 2026 Rznomics reported that it presented interim clinical data from its ongoing study of RZ-001, an RNA editing-based investigational anticancer therapy, in patients with hepatocellular carcinoma (HCC) during an oral presentation at the AACR (Free AACR Whitepaper) 2026 (American Association for Cancer Research Annual Meeting), held on April 19, 2026, in San Diego, California.

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The presentation was delivered by Professor Yoon-Jun Kim of the Department of Gastroenterology at Seoul National University Hospital.

The study includes patients with HCC who are refractory to or ineligible for transarterial chemoembolization (TACE) and have not received prior systemic therapy.

According to the data presented, combination treatment of RZ-001 with atezolizumab and bevacizumab demonstrated an objective response rate (ORR) of 38.5% (confirmed) and 46.2% (unconfirmed) based on RECIST v1.1 criteria.

Under mRECIST criteria, the ORR reached 61.5%, with a complete response (CR) rate of 23%, suggesting deep tumor responses. Given that mRECIST reflects tumor necrosis, these findings may indicate meaningful therapeutic impact in HCC.

At interim analysis, responses are typically categorized as "confirmed" or "unconfirmed." Confirmed responses are those validated through subsequent assessments, while unconfirmed responses represent initial observations. In this study, patients classified as having "unconfirmed PR" under RECIST criteria had achieved an initial tumor size reduction of at least 30%.

In terms of safety, a total of five Grade 3 or higher adverse events were reported as related to combination agents, including hypertension (2 cases), proteinuria, hyperglycemia, and gastrointestinal bleeding. Notably, no Grade 3 or higher adverse events were attributed to RZ-001.

The company believes these results demonstrate a favorable safety profile for RZ-001, with no treatment-related safety concerns identified to date, along with encouraging signals of antitumor activity in terms of both response depth and overall response rate in combination with standard immunotherapy.

"This oral presentation at AACR (Free AACR Whitepaper) represents an important milestone for our lead program RZ-001," said Seong-Wook Lee, Chief Executive Officer of Rznomics. "We are encouraged by the early efficacy and safety signals observed, and we believe these data support the potential of RZ-001 as a novel therapeutic approach for HCC."

He added, "Beyond the RZ-001 program, these findings could further support the clinical applicability of our RNA trans-splicing ribozyme platform technology."

Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma (HCC) is the most common type of primary liver cancer, accounting for the vast majority of liver cancer cases worldwide. It originates in the hepatocytes, the main cells of the liver, and is often associated with chronic liver diseases such as cirrhosis or viral hepatitis (B or C). HCC is known for its aggressive nature and high recurrence rates, presenting a significant global health challenge. Because it is often diagnosed at advanced stages, there is a critical unmet medical need for innovative therapies that can provide deeper and more durable responses than current systemic treatments.

Transarterial Chemoembolization (TACE)

Transarterial Chemoembolization (TACE) is a minimally invasive, localized procedure frequently used to treat patients with intermediate-stage liver cancer. The procedure involves delivering a concentrated dose of chemotherapy directly to the tumor through the hepatic artery, while simultaneously blocking (embolizing) the blood vessels that supply the tumor with oxygen and nutrients. While TACE can be effective for localized control, patients are considered "TACE refractory" when the tumor continues to progress or recurs despite multiple sessions, at which point systemic therapy is typically required.

RECIST v1.1 (Response Evaluation Criteria in Solid Tumors)

RECIST v1.1 is the standardized international guideline used to evaluate how solid tumors respond to treatment based on anatomical changes in tumor size. It primarily focuses on the sum of the longest diameters of target lesions, where a significant reduction in physical dimensions is categorized as a "response." While it remains the gold standard for most oncology trials, it mainly tracks physical shrinkage and may not fully capture the immediate biological impact of therapies that induce cell death without an immediate change in the overall tumor mass.

mRECIST (modified RECIST)

mRECIST is a specialized assessment tool developed specifically for Hepatocellular Carcinoma (HCC) to provide a more accurate evaluation of therapeutic efficacy. Unlike traditional criteria that measure the total size of a tumor, mRECIST focuses on the "viable" or living portion by measuring arterial enhancement—the area with active blood flow as seen on imaging. This is particularly critical in HCC because effective targeted or local treatments often cause internal tumor necrosis (cell death). In such cases, the tumor’s overall size may remain the same even though the cancer cells are dead, a successful response that mRECIST is uniquely designed to capture.

(Press release, Rznomics, APR 20, 2026, View Source [SID1234664560])

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.

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"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])

Ascentage Pharma to Present Four Promising Preclinical Studies Demonstrating the Potential of Combination Therapies at American Association for Cancer Research (AACR) 2026 Annual Meeting

On April 19, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that it will present four preclinical studies in poster format at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting, held April 17 to 22, 2026 in San Diego, CA, USA.

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These posters feature three of the Company’s drug candidates, Olverembatinib (HQP1351), a novel BCR-ABL inhibitor; APG-2449, a FAK/ALK/ROS1 triple tyrosine kinase inhibitor; and APG-5918, a PRC2/EED inhibitor.

Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, said, "These preclinical findings reflect our continued commitment to advancing innovative therapies across multiple cancer types. The four studies demonstrate the breadth and versatility of our pipeline, exploring the therapeutic potential of our key assets in combination with other approved treatment options in both hematologic malignancies and solid tumors.

Notably, the research examines Olverembatinib’s potential beyond its approved use in China for chronic myeloid leukemia (CML), exploring new applications in areas such as endometrial carcinoma and mantle cell lymphoma, including combination approaches with BTK inhibitors. In addition, our evaluation of APG-2449 in BRAF-mutant tumors, and APG-5918 in small-cell lung cancer, underscores our strategic focus on addressing resistance mechanisms and exploring combination strategies.

These preclinical investigations are designed to inform our clinical development strategies and complement our ongoing global registrational trials as we bring new treatment options to patients with significant unmet medical needs."

Detailed data presented at AACR (Free AACR Whitepaper) 2026 Annual Meeting are summarized below:

(Abstract #4583)

Multitarget kinase inhibitor Olverembatinib (HQP1351) is efficacious and synergizes with chemotherapy in preclinical models of endometrial carcinoma (EC)

Background:

EC is the most common gynecologic malignancy in developed countries, with an incidence that is steadily increasing globally. Patients with advanced-stage, high-risk non-endometrioid EC subtypes or recurrent disease have a poor prognosis and limited treatment options.
Olverembatinib is a tyrosine kinase inhibitor approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with CML. It targets multiple kinases, including VEGFR1–3, FGFR1–4, Src family kinases, RAF, KIT, RET, and PDGFR.
Drug sensitivity screening of 883 human cancer cell lines using the PRISM (Profiling Relative Inhibition Simultaneously in Mixtures) platform showed that EC is one of the tumor types most sensitive to Olverembatinib. This study further explored the antitumor effects of Olverembatinib alone or in combination with standard-of-care chemotherapy in preclinical EC models.

Summary:

In a broad range of preclinical in vitro and in vivo EC models, Olverembatinib was efficacious and synergized with chemotherapy agents to promote antitumor effects.
Mechanistically, Olverembatinib combined with chemotherapy suppressed FGFR2, PI3K/AKT, and MEK/ERK signaling pathways, induced DNA damage, and resulted in enhanced cell apoptosis.
These findings support future clinical evaluation of Olverembatinib and its combination with other approved treatment options in EC.

(Abstract #5875)

Multikinase inhibitor Olverembatinib (HQP1351) is efficacious and synergizes with BTK inhibitor acalabrutinib in mantle cell lymphoma (MCL) preclinical models

Background:

MCL is a rare, aggressive type of non-Hodgkin lymphoma. Although BTK inhibitors have transformed MCL treatment, response to monotherapy is limited, and efforts are underway to develop combination therapies.
Olverembatinib, an investigational multikinase inhibitor (approved in China for CML), inhibits Src-family kinases (e.g., Lyn, Fyn, YES1) and BTK, which are essential for B-cell receptor (BCR) signaling and B-cell proliferation, differentiation, and activation.
Hypothesizing that dual inhibition of Lyn and BTK pathways could enhance antitumor effects, this study evaluated Olverembatinib in combination with acalabrutinib in preclinical MCL models and explored potential mechanisms of action.

Summary:

Olverembatinib potently inhibited MCL cell proliferation both in vitro and in vivo and showed synergistic effects when combined with acalabrutinib. The combination significantly promoted apoptosis and induced G0/G1 cell cycle arrest.
Mechanistically, Olverembatinib inhibited phosphorylation of Lyn and its downstream BTK, while the combination further downregulated NF-kB activity.
These data provide a scientific rationale for further clinical evaluation of this novel combination therapy in patients with MCL.

(Abstract #1858)

FAK inhibition by APG-2449 enhances the antitumor activity of MAPK pathway blockade in BRAF V600E-mutant tumor models

Background:

BRAF mutations occur in approximately 4% to 8% of all cancers, most frequently in colorectal cancer (CRC), melanoma, and non-small-cell lung cancer. The V600E mutation is the most common and functionally activating form, leading to constitutive activation of the mitogen activated protein kinase (MAPK) signaling cascade.
Combined BRAF and MAPK kinase (MEK) inhibition has shown substantial clinical benefit in BRAF V600Emutant melanoma and CRC. However, resistance frequently develops through feedback reactivation of extracellular signal-regulated kinase (ERK) or compensatory activation of the phosphoinositide-3 kinase (PI3K)-AKT signaling pathway.
Recent evidence indicates that focal adhesion kinase (FAK) signaling is also adaptively reactivated upon MAPK inhibition, contributing to therapeutic resistance.
This study evaluated the effects of APG-2449, a potent and selective multi-kinase inhibitor that also targets FAK, on the antitumor activities of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib in BRAF V600E-mutant CRC and melanoma preclinical models.

Summary:

The results showed selective sensitivity of BRAF V600E-mutant cancer cell lines to APG-2449.
APG-2449 suppresses compensatory signaling activation induced by MAPK pathway blockade and synergistically enhances the antitumor activity of dabrafenib + trametinib in preclinical models.
These results warrant clinical development of APG-2449 for patients with melanoma or CRC harboring the BRAF V600E mutation.

(Abstract #4500)

Embryonic ectoderm development (EED) inhibitor APG-5918 synergizes with topoisomerase I inhibitors in preclinical small-cell lung cancer (SCLC) models through epigenetic priming of chemosensitivity

Background:

Although SCLC initially responds to platinum-based chemotherapy, it rapidly develops resistance, resulting in a poor prognosis.
PRC2-mediated epigenetic silencing represses Schlafen 11 (SLFN11), a biomarker of sensitivity to DNA-damaging therapies, thereby contributing to treatment resistance.
EZH2, the catalytic subunit of PRC2, promotes chemoresistance in part through SLFN11 repression. EED, another core PRC2 component, stabilizes the complex and maintains its methyltransferase activity, making it an attractive therapeutic target in SCLC.
Topoisomerase I inhibitors, such as topotecan and irinotecan, are used in relapsed SCLC; however, their efficacy is limited when SLFN11 is epigenetically suppressed.
APG-5918 is a selective and investigational EED inhibitor that disrupts PRC2 function. This study evaluated the antitumor activity of APG-5918 in combination with topoisomerase I inhibitors in preclinical SCLC models.

Summary:

In preclinical SCLC models, combination treatment with APG-5918 and topoisomerase I inhibitors synergistically inhibited cell proliferation and induced apoptosis.
In vivo, APG-5918 combined with irinotecan demonstrated synergistic antitumor activity in the NCI-H446 SCLC cell-derived xenograft (CDX) model without significant body-weight loss, indicating favorable tolerability.
Mechanistically, APG-5918 reduced the repressive histone mark H3K27me3, indicating on-target inhibition of PRC2 activity. Consistent with this effect, APG-5918 treatment increased SLFN11 and p21 expression. Notably, treatment with topotecan or SN-38 increased H3K27me3 levels, whereas APG-5918 reduced this effect. Combination treatment further decreased expression of PRC2 core components, suppressed cell-cycle progression, and enhanced DNA damage and apoptotic signaling, supporting a synergistic proapoptotic effect.
The findings support clinical investigation of APG-5918 in combination with DNA-damaging agents as a promising therapeutic strategy for SCLC.

(Press release, Ascentage Pharma, APR 19, 2026, View Source [SID1234664528])