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HUTCHMED Highlights Data to be Presented at AACR Annual Meeting 2026

On April 8, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place on April 17-22, 2026 in San Diego, California.

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Preclinical data for HMPL-A580, a first-in-class PI3K/PIKK-EGFR Antibody-Targeted Therapy Conjugate ("ATTC") will be presented. The payload of HMPL-A580 potently inhibited PI3K and PIKK family kinases, with IC50 ranging around 1 to 10 nM. Eurofins profiling across 418 kinases revealed the payload has excellent selectivity. By conjugating this potent payload with an anti-EGFR antibody via a cleavable linker, the ATTC compound HMPL-A580 demonstrated robust anti-tumor effect. Upon binding to EGFR-expression cancer cell line, HMPL-A580 underwent rapid internalization, lysosomal trafficking, payload release, and PAM and PIKK signaling inhibition to induce tumor cell apoptosis. In a 38-human solid tumor cell line panel, HMPL-A580 potently inhibited EGFR-expression tumor cell proliferation. The tumor cells harboring EGFR high expression, EGFR mut or PAM alterations were more sensitive to HMPL-A580. HMPL-A580 showed a strong bystander effect when EGFR-negative cells co-cultured with EGFR-expression cells. In human tumor xenograft models in mice, HMPL-A580, administered intravenously at 1~10 mg/kg once weekly for two weeks, demonstrated a dose / exposure-dependent anti-tumor activity in multiple EGFR-expression models, which is associated with much stronger target inhibition and suppression of downstream functions than antibody and payload alone treatment. The preliminary results demonstrated that HMPL-A580 was stable in human, monkey, rat and mouse plasma, and showed favorable PK property in cynomolgus monkeys.

Updated results from a multicenter, single-arm Phase Ib/II trial of surufatinib plus sintilimab and capecitabine in previously treated metastatic small bowel adenocarcinoma and appendiceal carcinoma, as well as results from a exploratory Phase II study of surufatinib combined with gemcitabine and nab-paclitaxel ("AG") for the treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma patients following AG induction therapy will also be presented.

Details of the presentations are as follows:

Abstract title Presenter / Lead author Presentation details
SPONSORED STUDIES
Discovery of HMPL-A580, a first-in-class antibody-targeted therapy conjugate (ATTC) of a novel PI3K/PIKK inhibitor payload linked to an anti-EGFR antibody Yu Cai, HUTCHMED, Shanghai, China 4549
Poster Session (PO.ET01.03)
Tuesday, April 21, 2026

INVESTIGATOR-INITIATED STUDIES
Updated multicenter phase Ib/II analysis of surufatinib plus sintilimab and capecitabine in previously treated metastatic small bowel adenocarcinoma and appendiceal carcinoma Xiaoyu Xie, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China CT160
Poster Session (PO.CT01.05)
Monday, April 20, 2026
Sequential treatment with surufatinib combined with gemcitabine and nab-paclitaxel (AG) or AG alone as first-line therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC) after 6 weeks of AG induction therapy: A two-cohort, exploratory phase II study Jin Xu, Fudan University Shanghai Cancer Center, Shanghai, China CT146
Poster Session (PO.CT01.05)
Monday, April 20, 2026

About the ATTC Platform and HMPL-A580

HUTCHMED’s ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based Antibody Drug Conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

The first family of ATTCs are based on a novel payload that targets the PI3K/AKT/mTOR ("PAM") pathway, a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant challenges, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery. Preclinical data from the first ATTC candidate based on this potent novel PI3K/PIKK inhibitor payload, HMPL-A251, was presented at AACR (Free AACR Whitepaper)-NCI-EORTC in October 2025.

HMPL-A580 is the second ATTC candidate based on this novel payload. It is a first-in-class ATTC comprising a highly selective and potent PI3K/PIKK small-molecule inhibitor payload linked to an anti-EGFR antibody via a cleavable linker. EGFR is highly expressed in multiple types of solid tumors and is well recognized as a driving force in tumorigenesis and disease progression. By conjugating this highly novel PI3K/PIKK payload to an anti-EGFR antibody, HMPL-A580 is designed to deliver targeted pathway inhibition directly into EGFR-expressing tumor cells, thereby potentially overcoming the systemic toxicity and narrow therapeutic index historically associated with PI3K/PIKK inhibitors. This approach aims to achieve deeper and more durable target inhibition while improving the overall tolerability profile.

HUTCHMED has demonstrated how its partnerships leverage the expertise of multinational pharmaceutical companies to accelerate bringing novel medicines to address large unmet needs around the world, and plans to apply this strategy to its ATTC technology this year.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA. HUTCHMED currently retains all rights to surufatinib worldwide.

(Press release, Hutchison China MediTech, APR 8, 2026, View Source [SID1234664255])

Hemispherian Initiates Phase 1/2a Clinical Trial of GLIX1 in Glioblastoma

On April 8, 2026 Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported the initiation of a first-in-human Phase 1/2a clinical trial of GLIX1 in patients with recurrent and progressive glioblastoma (GBM) and other high-grade gliomas (NCT07464925). The study is being conducted in collaboration with BioLineRx Ltd. (NASDAQ/TASE: BLRX).

GLIX1 is an orally available, first-in-class small molecule designed to activate TET2 and drive tumor-selective DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors.

Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. Despite existing therapies, GBM remains one of the most aggressive and treatment-resistant cancers.

In extensive preclinical studies, including orthotopic in vivo GBM models, GLIX1 demonstrated:

Potent anti-tumor activity
Robust blood-brain barrier penetration
Favorable safety profile in toxicology studies
The trial will be conducted across three leading academic centers. The first site to initiate patient enrollment is NYU Langone Health, led by Dr. Alexandra Miller. Additional sites include Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Grogan.

"The initiation of this Phase 1/2a study marks a defining milestone for Hemispherian and represents the culmination of years of dedicated research and development work by our team and our collaboration partner, BioLineRx. GLIX1 has a compelling preclinical profile and a truly differentiated mechanism of action, and we look forward to bringing this innovative therapy to patients who urgently need new treatment options. We are proud to be advancing this program alongside world-leading glioblastoma investigators and anticipate initial data readout in the first half of 2027," said Zeno Albisser, Chief Executive Officer of Hemispherian AS.

"GLIX1 is built on a fundamentally new understanding of how to exploit DNA repair vulnerabilities in cancer. The strength and consistency of the preclinical data give us confidence as we now transition this mechanism into the clinic," remarks Adam Robertson, Chief Scientific Officer at Hemispherian.

Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center at the Perlmutter Cancer Center, NYU Langone Health, stated:

"I am pleased to be the first investigator able to enroll patients into this critical study, which brings new hope to patients who are in desperate need of innovative and novel treatment options."

Dr. Roger Stupp, Medical Director of the Malnati Brain Tumor Institute at Northwestern University in Chicago and lead investigator of the study, added:

"GLIX1 is a promising innovative molecule with impressive pre-clinical data, and I could not be more excited to participate in this study. The protocol will rigorously assess the safety of an agent with an entirely novel mechanism of action, with the potential to ultimately integrate well and synergize with the current treatments. We urgently need breakthrough innovations for our patients suffering from glioblastoma, one of the most aggressive and difficult malignancies to treat."

Clinical Trial Design (NCT07464925)

The Phase 1 portion of the study will enroll up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish the maximum tolerated dose (MTD) and/or a recommended dose based on safety, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary efficacy. Data from Phase 1 are anticipated in the first half of 2027.

The Phase 2a expansion is expected to include multiple patient cohorts, including newly diagnosed and recurrent GBM, as well as additional tumor types. Combination approaches, including with PARP inhibitors, will also be evaluated. These cohorts are designed to generate early efficacy signals, inform dose optimization, and support subsequent clinical development.

(Press release, Hemispherian, APR 8, 2026, View Source [SID1234664254])

Sidewinder Therapeutics Announces $137 Million Series B Financing to Advance Precision Bispecific ADCs into Clinical Development for Cancer

On April 8, 2026 Sidewinder Therapeutics, a biopharmaceutical company pioneering the development of next-generation bispecific ADCs (antibody-drug conjugates) for the treatment of cancer, reported the closing of an oversubscribed $137 million Series B financing. The round was co-led by Frazier Life Sciences and Novartis Venture Fund, with participation from the sole Series A investor OrbiMed as well as new investors including Life Sciences at Goldman Sachs Alternatives, DCVC Bio, Samsara BioCapital, Longwood Fund, Astellas Venture Management and Alexandria Venture Investments. Concurrent with the financing, Daniel Estes, Ph.D., from Frazier Life Sciences, Michal Silverberg from Novartis Venture Fund, Josh Richardson, M.D., from Life Sciences at Goldman Sachs Alternatives and John Hamer, Ph.D., from DCVC Bio were named to the Board of Directors.

"We are pleased to receive the support of this exceptional group of investors and their shared enthusiasm in advancing Sidewinder’s mission to develop next-generation bispecific ADCs for difficult to treat cancers," said Eric Murphy, Ph.D., Co-Founder and CEO of Sidewinder Therapeutics. "The ADC field is at an inflection point driven by technological breakthroughs enabling next-generation bispecific ADCs, and Sidewinder is eager to lead this wave of innovation and advance promising therapies for patients with cancer."

Sidewinder’s mission focuses on developing bispecific ADCs designed to target receptor co-complexes that are highly expressed on certain solid tumors. The pipeline features bispecific antibodies engineered from internally discovered antibody sequences and finely tuned to target tumor-specific co-complexes consisting of an oncogenic driver receptor and an internalizing receptor. Precise targeting of these co-complexes enhances both tumor cell specificity and internalization, thereby improving the delivery of drugs to cancer cells while avoiding normal cells. Sidewinder’s programs are designed to address oncology indications that have limited treatment options and affect substantial patient populations such as squamous cell carcinomas in lung and head and neck cancers as well as gastrointestinal cancers including colorectal cancer. The company expects to advance its lead program into clinical development in 2027.

"Founded on compelling science and a differentiated approach, Sidewinder’s novel bispecific ADC pipeline has the potential to address key hurdles limiting safety and efficacy for this class of therapeutics," said Daniel Estes, Ph.D., General Partner at Frazier Life Sciences. "We believe that Sidewinder Therapeutics will significantly advance the ADC space and is well positioned to transform the treatment paradigm for cancer patients."

(Press release, Sidewinder Therapeutics, APR 8, 2026, View Source [SID1234664253])

Pilatus Biosciences to Present New Data Highlighting Sex-Specific Efficacy of CD36-Targeting Antibody in Colorectal Cancer at AACR 2026

On April 8, 2026 Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for cancer and immune-related diseases, reported it will present new preclinical data as a poster session at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22 in San Diego, California.

The poster presentation highlights a sex-specific therapeutic effect of its lead antibody, PLT012, in colorectal cancer (CRC), a finding that could inform more precise treatment strategies for a historically difficult-to-treat patient population.

Colorectal cancer remains the second leading cause of cancer-related deaths globally, with the majority of patients classified as mismatch repair-proficient (pMMR), a subtype that shows limited response to current standard therapies, including immune checkpoint inhibitors and anti-VEGF agents. The data presented at AACR (Free AACR Whitepaper) highlight CD36, a fatty acid transporter implicated in tumor metabolism and immune suppression, as a promising and differentiated therapeutic target in this setting.

In preclinical orthotopic models of pMMR CRC, PLT012, a humanized IgG4 antibody targeting CD36, demonstrated significant tumor growth inhibition in both male and female subjects. Notably, the therapeutic effect was more pronounced in female models, a difference that correlated with higher CD36 expression levels observed in female tumors. Additional analyses showed that CD36 was enriched in cancer-associated fibroblasts (CAFs), with a female-biased distribution, suggesting a potential mechanistic basis for the observed sex-specific response.

"These findings provide compelling evidence that CD36 plays a central role in shaping the tumor microenvironment in colorectal cancer, particularly in ways that may differ by sex," said Jingying Zhou, Assistant Professor, School of Biomedical Sciences, Faculty of Medicine, The Chinese University of Hong Kong. "The ability to target metabolic pathways like lipid uptake represents an important and emerging strategy in oncology, and the observed enrichment of CD36 in tumor-associated stroma further underscores its relevance as a therapeutic target."

PLT012 is designed to inhibit CD36-mediated lipid uptake, modulating tumor metabolism and reversing immunosuppressive features of the tumor microenvironment. The antibody has demonstrated activity in liver cancer models and a favorable safety profile in non-human primates, supporting its continued advancement. Given its distinct mechanism, PLT012 has the potential to function both as a monotherapy and as a sensitizing agent in combination with immune checkpoint inhibitors, with the ability to reprogram metabolically constrained tumors and convert immunologically "cold" tumors into more responsive states, addressing a key limitation of current therapies.

"The data presented at AACR (Free AACR Whitepaper) reinforce our conviction that CD36 is a highly actionable target in cancer biology," said Raven Lin, CEO & Founder, Pilatus Biosciences. "What is particularly exciting is the potential to incorporate sex as a biological variable in treatment selection, enabling more tailored, effective therapies for patients with pMMR colorectal cancer, where patients urgently need new therapies."

These findings significantly broaden the therapeutic scope of PLT012, demonstrating activity beyond tumor-associated immune cells to encompass the critical tumor-associated stromal population. By simultaneously targeting the immune and stromal compartments of the microenvironment, PLT012 is designed to overcome key barriers of tumor progression and may have utility both as a monotherapy and in combination with existing therapies, to improve outcomes in underserved CRC populations.

PLT102 is currently in an ongoing Phase 1 clinical trial (NCT07337525) in patients with advanced solid tumors, including colorectal cancer. The study is designed to assess safety, pharmacokinetics, and early clinical evidence of target engagement and biological activity in CD36-driven tumors. Translational endpoints include the evaluation of CD36 expression, stromal composition, and immune cell reprogramming, with the goal of establishing a biomarker framework to guide patient selection and combination strategies in future trials. PLT102 has received both FDA Fast Track and Orphan Drug Designation.

AACR 2026 Poster Presentation Details:

Title: A Sex-Specific Role of CD36 Targeting Therapy in Colorectal Cancer
Date/Time: Tuesday, April 21, 2026, 9:00 am – 12:00 pm PT
Poster Number: 4351

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing antitumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, APR 8, 2026, View Source [SID1234664252])

TAE Life Sciences Announces Breakthrough BNCT Research Demonstrating Durable Tumor Control and Systemic Immune Effects

On April 8, 2026 TAE Life Sciences (TLS), a leader in Boron Neutron Capture Therapy (BNCT), reported the publication of new research in ACS Pharmacology & Translational Science (an ACS journal), demonstrating that its next-generation boron delivery platform may enable both enhanced tumor control and systemic immune activation.

The study introduces a novel class of proprietary BPA-based dipeptides designed to overcome key limitations of conventional BPA (boronophenylalanine) for BNCT, particularly solubility and dosing constraints. By enabling substantially higher boron delivery to tumors, these compounds significantly improved therapeutic outcomes across multiple preclinical models.

The dipeptides achieved 12- to 77-fold higher solubility than standard BPA, allowing for increased dosing within clinically relevant administration parameters. In vivo, this translated into complete and durable tumor regressions, including 100% complete response rates (5/5) in a human head and neck cancer xenograft model using dipeptides, i.e. 10B l-BPA-BPA.

Beyond local tumor control, the study demonstrates that BNCT can activate a systemic anti-tumor immune response in mouse models. The mice that achieved complete responses were able to reject tumor rechallenge, indicating the development of durable immune memory. Additionally, suppression of untreated tumors in contralateral sites demonstrates an abscopal effect, supporting the potential for BNCT to function as an in situ tumor vaccine in the clinic.

These findings position BNCT as a dual-mechanism modality, combining highly localized, high-linear energy transfer radiation with immune activation. This profile may create meaningful opportunities for combination strategies with immune checkpoint inhibitors, targeted therapies, and other systemic treatments, particularly in tumors with limited treatment options or resistance to conventional therapies.

"Our studies highlight the potential for BNCT to evolve into a platform that not only delivers precise tumor-targeted radiation, but also engages the immune system to enhance tumor control," said Kendall Morrison, Chief Scientific Officer, at TAE Life Sciences. "These findings support the continued advancement of BNCT across clinical pathways with the goal of expanding treatment options for patients."

TAE Life Sciences is the only company with an integrated BNCT platform that combines its Alphabeam accelerator-based neutron system with a pipeline of proprietary boron drug candidates. The company is actively exploring strategic collaborations to further evaluate BNCT in combination settings and expand its clinical applications.

The full study is available in ACS Pharmacology & Translational Science (DOI: 10.1021/acsptsci.5c00613).

(Press release, TAE Life Sciences, APR 8, 2026, View Source [SID1234664251])