Case Report of Mabwell’s Nectin-4 targeting ADC (9MW2821) in Cervical Cancer Published in The New England Journal of Medicine

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])

Tubulis to Present Phase I/IIa Trial Data for ADC Candidate TUB-040 in Platinum-resistant Ovarian Cancer in Rapid Oral Presentation at ASCO 2026

On April 21, 2026 Tubulis reported that an abstract covering current clinical trial data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for a rapid oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, being held May 29 – June 2, 2026, in Chicago. The presentation by Prof. Dr. Toon Van Gorp, clinical investigator of the study, will provide an update of maturing data from the ongoing dose escalation part of the ovarian cancer cohort.

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Details of the oral presentation:

Title: NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC)
Presenter: Dr. Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven, Belgium
Session Category and Title: Rapid Oral Abstract Session: Gynecologic Cancer
Session Date and Time: May 30, 2026; 08:00 – 09:30 AM CDT
Location: McCormic Place, E450a
Abstract Number: 5513

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer, lung adenocarcinoma, and endometrial cancer. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate has already demonstrated robust clinical activity with a favorable safety profile as monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC), reported at ESMO (Free ESMO Whitepaper) 2025. It is currently being further investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) in PROC and relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

(Press release, Tubulis, APR 21, 2026, View Source [SID1234664645])

Remix Therapeutics Announces Oral Presentation of First-in-Class Small Molecule MYB mRNA Degrader REM-422 Phase 1/2 ARIA Trial Results at the 2026 American Society of Clinical Oncology Annual Meeting

On April 21, 2026 Remix Therapeutics (Remix), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported the final results of the Phase 1 dose-escalation cohort of the Phase 1/2 ARIA study evaluating MYB mRNA degrader, REM-422, in patients with recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC), have been accepted for an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place on May 29 – June 2, 2026 in Chicago and online.

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The presentation will be delivered by Renata Ferrarotto, MD, from The University of Texas MD Anderson Cancer Center and will highlight results from the Phase 1 portion of the study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of REM-42 in patients with R/M ACC, a disease driven by MYB dysregulation, for which there are no approved systemic therapies.

Oral Presentation Details:

Title: Clinical Activity of REM-422, a MYB mRNA Degrader, in Recurrent/Metastatic Adenoid Cystic Carcinoma: Final Results from the Phase 1/2 Dose-Escalation Cohort
Session Type/Title: Clinical Science Symposium – Small Glands, Big Challenges: Novel Therapeutics in Salivary Gland Cancer
Presenter: Renata Ferrarotto, MD, Professor in the Department of Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center
Abstract Number: 6009
Date and Time: June 1, 2026, 8:00 AM – 9:30 AM CDT

About REM-422

REM-422 is a first-in-class, potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.

About the ARIA (A study of REM-422 In Adenoid cystic carcinoma) Clinical Trial
This Phase 1/2, open-label, non-randomized, multicenter study (NCT06118086) is investigating REM-422 in patients with recurrent, metastatic or unresectable Adenoid Cystic Carcinoma (ACC). The study includes a Dose Escalation Phase and a Dose Expansion Phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with recurrent, metastatic, or unresectable ACC. The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the REM-422 RP2D in biomarker positive patients.

About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) is a solid tumor that most commonly arises in the salivary glands characterized by frequent recurrent, perineural invasion and dysregulation of the MYB oncogene. Depending on the location of the tumor, symptoms may include numbness of the face, difficulties swallowing, changes in vision, or difficulty breathing, among others. Many therapeutic approaches, such as chemotherapy, kinase inhibitors, and immunotherapy have been studied in ACC with modest or disappointing results, and there remain no approved treatment options.

(Press release, Remix Therapeutics, APR 21, 2026, View Source [SID1234664661])

Aulos Bioscience Announces Presentation of Promising Phase 1/2 Data for Imneskibart in Melanoma at 2026 ASCO Annual Meeting

On April 21, 2026 AulosTM Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic imneskibart (AU-007), reported that new Phase 1/2 data from its ongoing study of imneskibart will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. The presentation will focus on promising results for imneskibart with and without nivolumab in checkpoint inhibitor (CPI)-refractory cutaneous melanoma. The ASCO (Free ASCO Whitepaper) Annual Meeting is being held online and in Chicago, Illinois, from May 29–June 2, 2026.

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Details of the poster presentation are as follows:

Poster Title: Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study
Abstract: 9526
Session Type/Title: Poster Session – Melanoma/Skin Cancers
Session Date and Time: Sunday, May 31, 2026, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in the Exhibit Hall at McCormick Place. An electronic version will also be available on the ASCO (Free ASCO Whitepaper) 2026 online meeting platform.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the imneskibart Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

(Press release, Aulos Bioscience, APR 21, 2026, View Source [SID1234664598])

Karyopharm’s Phase 3 SENTRY Trial in Myelofibrosis Selected for Late-Breaking Oral Presentation at ASCO 2026 Annual Meeting

On April 21, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that its late-breaking abstract was accepted for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 to June 2 in Chicago. The oral presentation will feature results from the Phase 3 SENTRY trial, a randomized, double-blind, placebo-controlled trial of 60 mg selinexor in combination with ruxolitinib in myelofibrosis.

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Presentation Details:

Title: Selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis: Phase 3 SENTRY trial

Abstract Number: LBA6500

Session Title: Oral Abstract Session – Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Presentation Time: June 2, 2026, 9:45 a.m. to 12:45 p.m. Central Time

Presenter: Dr. John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Center of Excellence for Blood Cancers and Myeloid Disorders
Late-breaking abstracts for presentations being held on June 2, 2026 will be released by ASCO (Free ASCO Whitepaper) on Tuesday, June 2, 2026 at 8:00 a.m. Eastern Time / 7:00 a.m. Central Time. A copy of the SENTRY presentation being delivered at ASCO (Free ASCO Whitepaper) on June 2, 2026 will be available following the event under "Publications and Presentations" in the Investor section of the Company’s website.

About the Phase 3 SENTRY Trial

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L. Patients were randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib.

1. Clarivate/DRG (2023)

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in myelofibrosis and endometrial cancer.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).

For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.

Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.

Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.

Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.

Serious Infection: Monitor for infection and treat promptly.

Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.

Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.

Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.

The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations

Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

(Press release, Karyopharm, APR 21, 2026, View Source [SID1234664614])