On April 21, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that clinical data for its first-in-class IBI363 (PD-1/IL-2α-biased bispecific fusion protein) * as well as TYVYT (sintilimab injection)** will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 to June 2, 2026, in Chicago, Illinois, U.S.

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Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "We are excited to announce that at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, we will present new PoC data of IBI363 in NSCLC, across both IO-resistant and first-line settings. With robust PoC data for IO-resistant NSCLC now in hand, we are moving IBI363 into MRCT pivotal development, an important step toward tackling a major global unmet medical need. At the same time, we are encouraged by the promising dose optimization data in first-line NSCLC, and we look forward to continued maturation of PoC full data to inform our next steps. Innovent will continue to push the boundaries of cancer care, as we are dedicated to delivering physicians and patients more innovative, effective, and life-saving treatment options."

Abstracts of IBI363(PD-1/IL-2α-biased bispecific fusion protein)

1. Presentation Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC).
Abstract Number: 8586
Session Type: Poster
Session Title: Lung Cancer/Non-Small Cell Metastatic
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Haiyan Tu, Guangdong Provincial People’s Hospital

2. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody IBI363 (TAK-928) in patients (pts) with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC): updated results from a phase I study.
Abstract Number: 2618
Session Type: Poster
Session Title: Developmental Therapeutics/Immunotherapy
Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Jianya Zhou, First Affiliated Hospital of Zhejiang University School of Medicine

3. Presentation Title: Randomized phase 3 study (MarsLight-11) evaluating IBI363 (TAK-928) versus docetaxel in patients (pts) with squamous non-small cell lung cancer (sqNSCLC) after prior chemotherapy (chemo) and immunotherapy (IO).
Abstract Number: TPS8673
Session Type: Poster
Session Title: Lung Cancer/Non-Small Cell Metastatic
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Roy S. Herbst, Yale School of Medicine

Abstracts of TYVYT(sintilimab)

1. Presentation Title: Adjuvant sintilimab plus bevacizumab following curative resection of spontaneously ruptured hepatocellular carcinoma: A prospective exploratory phase II study (CLEAR-2)
Abstract Number: TPS4254
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Yongjun Chen, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

2. Presentation Title: Neoadjuvant chemoradiotherapy with or without PD-1 blockade in pMMR/MSS low rectal cancer patients (CHOICE II): A multi-center, open-label, randomized controlled trial.
Abstract Number: 3640
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Wei Zhang, Changhai Hospital

3. Presentation Title: Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC): A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study
Abstract Number: 4148
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Jia Fan, Zhongshan Hospital, Fudan University

4. Presentation Title: CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer.
Abstract Number: TPS3680
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Yue Liu, The Second Affiliated Hospital of Zhejiang University School of Medicine.

5. Presentation Title: Long-term survival and biomarker analysis of neoadjuvant chemoradiotherapy with or without PD-1 antibody sintilimab in pMMR locally advanced rectal cancer: A randomized clinical trial.
Abstract Number: 3610
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Xiao Weiwei, Sun Yat-sen University Cancer Center

6. Presentation Title: Larynx preservation via chemotherapy-free neoadjuvant sintilimab-cetuximab-SBRT and response-adapted treatment in locally advanced laryngeal cancer: A phase II, single-arm clinical trial (The NeoVOICE study).
Abstract Number: 6095
Session Type: Poster
Session Title: Head and Neck Cancer
Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Song Ming, Sun Yat-sen University Cancer Center

7. Presentation Title: Pathological complete response and ctDNA analyses in SCIENCE: Results from a randomized, phase III trial of neoadjuvant chemotherapy plus sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy in resectable locally advanced esophageal squamous cell carcinoma.
Abstract Number: LBA4082
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Xuefeng Leng, Sichuan Cancer Hospital

8. Presentation Title: Sintilimab (PD-1 antibody) Plus Gemcitabine and Docetaxel (GT) as First-line or Later-line Therapy in Patients with Advanced Epithelioid Sarcoma: A Prospective, Multicenter, Single-arm, Phase II Clinical Study.
Abstract Number: 11574
Session Type: Poster
Session Title: Sarcoma
Session Date & Time: June 1, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Xiaowei Zhang, Fudan University Shanghai Cancer Center

9. Presentation Title: Sintilimab plus Anlotinib and Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma: A Prospective, Phase II Clinical Trial.
Abstract Number: 8050
Session Type: Poster
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Jianchun Duan, Cancer Hospital, Chinese Academy of Medical Sciences

(Press release, Innovent Biologics, APR 21, 2026, View Source [SID1234664631])

On April 21, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) reported it will present results from three clinical studies, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT, 佳泰莱), next-generation selective RET inhibitor lunbotinib fumarate (A400/EP0031, 宁泰莱[1]) and novel ADC SKB500. The abstracts for these studies will be published on the ASCO (Free ASCO Whitepaper) official website on May 21, 2026, local time.

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Detailed information on the studies selected for 2026 ASCO (Free ASCO Whitepaper) is as follows:

Title: Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus pembrolizumab (P) as first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC): Results from the randomized, controlled phase III OptiTROP-Lung05 study
Presentation Type: Oral
Abstract Number: 8506
Session Date and Time: May 29, 3:12 PM-3:24 PM CDT | Lung Cancer-Non-Small Cell Metastatic

Title: Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC)
Presentation Type: Oral
Abstract Number: 8505
Session Date and Time: May 29, 2:36 PM-2:48 PM CDT | Lung Cancer-Non-Small Cell Metastatic

Title: An open-label, first-in-human study of SKB500 in patients with locally advanced or metastatic solid tumors
Presentation Type: Rapid oral
Abstract Number: 3011
Session Date and Time: June 2, 9:57 AM-10:03 AM CDT | Molecularly Targeted Agents and Tumor Biology

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting);2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About A400/EP0031

A400/EP0031 novel next-generation selective RET inhibitor for NSCLC, medullary thyroid cancer (MTC) and other solid tumors with a high prevalence of RET alterations. The NDA of A400/EP0031 has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced or metastatic NSCLC. The Company is also conducting a Phase Ib/II clinical study in China for the treatment of RET-positive solid tumors.

In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries. In April 2024, A400/EP0031 was cleared by the Food and Drug Administration (FDA) to progress into a Phase II clinical trial (NCT05443126) which is currently recruiting in the United States, United Kingdom, Europe and United Arab Emirates, where it is being evaluated as a monotherapy and in combination with chemotherapy in RET fusion positive NSCLC.

About SKB500

SKB500, a novel, proprietary ADC developed via the OptiDC platform, is designed to leverage specific target biology through a validated target combined with a differentiated payload-linker strategy. In preclinical investigations, SKB500 demonstrated a favorable therapeutic window with robust efficacy and manageable safety profiles across multiple advanced solid tumors.

Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

(Press release, Kelun, APR 21, 2026, View Source [SID1234664630])

On April 21, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industrial chain, reported that a recent clinical case report on its self-developed novel Nectin-4 ADC (bulumtatug fuvedotin, R&D code: 9MW2821) for the treatment of cervical cancer has been published in The New England Journal of Medicine (NEJM, Impact Factor: 78.5), a leading international medical journal.

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The article, published by the team of Dr. Wang Shanbing, Director of the Oncology Center at the Second People’s Hospital of Yibin, reveals for the first time globally a rare case of hepatic "pseudoprogression" phenomenon observed in a patient with advanced cervical cancer following treatment with the novel Nectin-4 ADC (9MW2821). Pseudoprogression generally refers to a phenomenon where existing lesions temporarily enlarge or new lesions appear early in immunotherapy, without clinical deterioration, followed by subsequent stabilization or shrinkage—typically not representing true tumor progression.

This article reports the case of a patient with metastatic cervical squamous-cell carcinoma whose disease was refractory to platinum–taxane chemotherapy with no prior immunotherapy. After just two cycles of treatment with 9MW2821, the patient’s baseline metastatic lesions showed substantial regression, and serum squamous cell carcinoma (SCC) antigen levels dropped precipitously—from 37.0 ng/mL to 1.2 ng/mL (normal range ≤1.5). However, despite comprehensive improvement across multiple indicators, a CT scan unexpectedly revealed a "new hypoattenuating lesion " measuring 1.8 cm × 2.5 cm in the medial segment of the left lobe of the liver. A liver biopsy showed dense infiltration of lymphocytes, plasma cells, and neutrophils, with no evidence of granulomas, spindle cell proliferation, or viable tumor cells. The biopsy results ruled out disease progression, sarcoid-like reactions, or inflammatory pseudotumor. Given the patient’s p16-positive status (implying high HPV antigenicity) and the absence of previous immunotherapy, Dr. Wang Shanbing’s team hypothesized that the antibody-drug conjugate (ADC) targeted occult micrometastases, inducing immune-cell death and releasing damage-associated molecular patterns that triggered this robust inflammatory influx. The patient continued treatment, and subsequent imaging showed gradual resolution of the liver lesion, with no reappearance during two years of follow-up.

ADCs are hailed as "magic bullets" for precisely targeting tumors. Previously, pseudoprogression has been predominantly observed in immunotherapies such as PD‑1/PD‑L1 inhibitors, whereas its occurrence in ADC therapy for solid tumors is considered exceedingly rare. This finding by Dr. Wang Shanbing’s team carries significant implications for the clinical management of advanced cervical cancer. The article strongly emphasizes that treatment that could prolong life should not be prematurely discontinued based solely on radiographic "false impressions," providing a valuable reference for the clinical application of ADCs and safeguarding optimal therapeutic benefits for oncology patients.

9MW2821 is the world’s first Nectin-4 ADC candidate to enter Phase III clinical trials for cervical cancer. Currently, enrollment for the monotherapy Phase III trial has been completed. Interim analysis is expected to be conducted and pre-NDA to be submitted in H2 2026. The first-line combination study with toripalimab is in Phase II.

(Press release, Mabwell Biotech, APR 21, 2026, View Source [SID1234664629])

On April 21, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that four abstracts highlighting botensilimab (BOT), alone or in combination with balstilimab (BAL), have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2, 2026, in Chicago, Illinois.

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The accepted abstracts reflect continued progress of Agenus’ botensilimab and balstilimab immunotherapy program across colorectal cancer, melanoma, and translational research. They include the first presentation of Phase 2 clinical data for BOT with or without BAL in advanced cutaneous melanoma refractory or resistant to anti–PD-(L)1 therapy, with or without prior CTLA-4 inhibition, as well as a translational biomarker abstract evaluating an artificial intelligence foundation model in solid tumors and two trials-in-progress posters in colorectal cancer.

"Our presence at ASCO (Free ASCO Whitepaper) reflects strong momentum across the botensilimab and balstilimab program. From the first Phase 2 melanoma presentation to important colorectal cancer trial updates and innovative translational biomarker research, these presentations underscore our focus on delivering new immunotherapy options to patients who need them most," said Garo H. Armen, PhD, Chairman and CEO of Agenus.

Presentation Details:

Abstract Title: Botensilimab (BOT) ± balstilimab (BAL) in patients (pts) with advanced cutaneous melanoma (cMEL) refractory/resistant (R/R) to anti–PD-(L)1 ± CTLA-4: A phase 2 trial
Abstract No.: 9543
Presenter: Michael Atkins MD; Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Session Title: Poster Session – Melanoma/Skin Cancers
Location: Hall A – Posters and Exhibits
Poster Board: 259
Date/Time: May 31, 2026, 9:00 AM–12:00 PM CDT

Abstract Title: Artificial intelligence (AI) foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images
Abstract No.: 2535
Presenter: Ryan Dalton, Noetik
Session Title: Poster Session – Developmental Therapeutics—Immunotherapy
Location: Hall A – Posters and Exhibits
Poster Board: 325
Date/Time: May 30, 2026, 1:30 PM–4:30 PM CDT

Abstract Title: The CO.33/BATTMAN trial: A phase 3 randomized study of botensilimab + balstilimab versus best supportive care in chemo refractory unresectable colorectal adenocarcinoma that is not dMMR/MSI-H
Abstract No.: TPS3676
Presenter: Jonathan Loree MD; BC Cancer; Canadian Cancer Trials Group, Queen’s University
Session Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Location: Hall A – Posters and Exhibits
Poster Board: 441a
Date/Time: May 30, 2026, 9:00 AM–12:00 PM CDT

Abstract Title: Phase 2 study of adjuvant botensilimab in combination with balstilimab in patients with microsatellite-stable colorectal cancer and persistent circulating tumor DNA following surgery and chemotherapy
Abstract No.: TPS3689
Presenter: Neil Segal, MD; Memorial Sloan Kettering Cancer Center
Session Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Location: Hall A – Posters and Exhibits
Poster Board: 447b
Date/Time: May 30, 2026, 9:00 AM–12:00 PM CDT

(Press release, Agenus, APR 21, 2026, View Source [SID1234664628])

On April 21, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported that clinical imaging and dosimetry data of AKY-2519 in patients with various B7-H3 expressing solid tumors will be presented in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 – June 2, 2026, in Chicago.

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AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumors, including prostate and lung cancers. In March 2026, the U.S. Food and Drug Administration (FDA) cleared Investigational New Drug (IND) applications for Aktis to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is the second clinical-stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical trial. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors.

Details of the ASCO (Free ASCO Whitepaper) presentations on AKY-2519 are as follows:

Presentation Title: AKY-2519, a novel B7-H3–targeted radioconjugate, and its biodistribution profile in patients with mCRPC*
Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster #: 234
Abstract #: 3097
*This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging and normal tissues and tumor dosimetry analyses through sequential SPECT/CT imaging of patients with mCRPC was conducted at the Nuclear Medicine Research Infrastructure (NuMeRI), University of Pretoria and Steve Biko Academic Hospital, South Africa.

Presentation Title: First-in-human PET/CT imaging with 68Ga-AKY-2519, a B7-H3 targeted miniprotein radioconjugate, to demonstrate tumor uptake and normal tissue exposure across various advanced solid tumors**
Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster #: 235
Abstract #: 3098
**This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging in various solid tumors was conducted at the Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), Universitätsklinikum Essen (University Hospital Essen), Essen, Germany.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, APR 21, 2026, View Source [SID1234664626])