On April 21, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION, a tumor-activated oncology delivery platform, reported two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. These presentations include the first in vivo efficacy and exposure pharmacology for the pre|CISION dual payload technology program and updated pharmacology and preclinical exposure data analyses highlighting the favorable delivery profile of AVA6103 (FAP-EXd), its second clinical candidate, which has recently entered Phase 1 development. Updates to the ongoing Phase 1 clinical trial are also being presented.

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Christina Coughlin, CEO of Avacta, commented:

"The data being presented at AACR (Free AACR Whitepaper) underline the potential of our pre|CISION technology and AVA6103 to make a considerable difference to cancer patients. These observations could significantly increase the probability of success with AVA6103, given both the ability of FAP-Exd to deliver more payload selectively to the tumor in the preclinical setting, and the success of Enhertu in the clinic. The FOCUS-01 Phase 1 clinical trial of AVA6103, now underway in the US, is designed to demonstrate the benefits of pre|CISION in unlocking the full potential of exatecan while minimizing systemic toxicity.

Furthermore, we have shown how pre|CISION delivers a therapeutically relevant combination of payloads specifically to the tumor microenvironment while reducing systemic dose-limiting toxicities, broadening its utility in the delivery of novel medicines. The dual delivery mechanism of pre|CISION shows its potential to dramatically increase the therapeutic window and reduce systemic toxicities, offering improved outcomes for patients with cancer."

Details of the Two Presentations:

AVA6103 (FAP-EXd) Preclinical and Clinical Trial in Progress Highlights (Rink, C. et al.)

This presentation includes updated preclinical data from the Company’s second clinical candidate, AVA6103, a novel FAP-activated pre|CISION peptide-drug conjugate (PDC) delivering the topoisomerase I inhibitor (TOP1i) exatecan directly to the tumor-stroma interface, as well as details of the ongoing FOCUS-01 Phase 1 trial of this agent.

The data demonstrate that AVA6103 has robust activity in multiple patient-derived xenograft (PDX) models with FAP levels ranging from very low to high, suggesting excellent antitumor effects even at the lowest levels of FAP expression in stromal cells only. This presentation also includes a data analysis comparing pre|CISION FAP-cleavable payload delivery with that of the leading marketed ADC Enhertu (an AstraZeneca/Daiichi Sankyo product).

The data analysis used a synthetic comparator arm that was generated using AI to recreate a published AstraZeneca data set[1] and compare to experimental data generated with AVA6103 in a similar experimental design using a FAP-high animal model with two drugs using similar payloads (exatecan and deruxtecan). It demonstrated three key differences in the pharmacokinetics (PK) of the payload: more rapid tumor penetration and payload release with AVA6103, tumor Cmax of more than one log higher with AVA6103, and Tumor Selectivity Index (TSI: AUCtumor / AUCplasma) three times higher with AVA6103.

AVA6103 has recently entered the clinic, with the first patient receiving treatment in the FOCUS-01 study in March. FOCUS-01 (NCT07454642) is a multicenter, open-label Phase 1 clinical trial of AVA6103 in adults with selected advanced cancers, and the initial clinical data readout from the study is anticipated later this year. Based on favorable preclinical activity and biomarker readouts from the strategic collaboration with Tempus, two indications have been added to the trial: colorectal cancer (CRC) and hormone receptor-positive breast cancer (HR+ BC)

Abstract Number and Title: Abstract #5846, AVA6103 is a FAP-enabled pre|CISION peptide-drug conjugate delivering sustained release of exatecan in the tumor microenvironment with potent antitumor activity.
Poster number and Location: 5846, Section 17, Board 15
Session: Tumor Microenvironment, Multi-specifics, and Immunomodulation

The pre|CISION dual payload technology (AVA6207) update (Juskaite, V. et al.)

This presentation includes the description of how pre|CISION delivers a therapeutically relevant combination of payloads specifically to the tumor microenvironment while reducing systemic dose-limiting toxicities, broadening its utility in the delivery of novel combinations of medicines.

The AVA6207 dual payload is designed to simultaneously release a TOP1i and a DNA Damage Repair (DDR) inhibitor by FAP cleavage, resulting in synthetic lethality in two genetic models of TOP1i resistance: tumor cells harboring either (1) ATM-deficiency or (2) loss of SLFN11. These studies demonstrate the ability of AVA6207 to overcome key mechanisms of TOP1i resistance and mediate synergistic tumor cell killing.

The first in vivo data with this novel combination mechanism are presented, with tumor and plasma pharmacokinetic studies demonstrating the robust tumor-selective release of both payloads with a highly potent TSI. In addition to the robust exposure data, antitumor efficacy is demonstrated in a patient-derived xenograft (PDX) model of HER2+ gastric cancer with low FAP expression with optimal activity of AVA6207 over the HER2-targeted TOP1i ADC (Enhertu)

Abstract Number and Title: Abstract #5656, Characterization and translational development of novel pre|CISION technology compounds delivering complementary dual payloads to the tumor microenvironment following FAP cleavage

Session: Antibody-Drug Conjugates and Linker Engineering 4
Section: Experimental and Molecular Therapeutics

(Press release, Avacta Life Sciences, APR 21, 2026, View Source [SID1234664660])

On April 21, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported the acceptance of an abstract "Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)" at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place May 29 – June 2, 2026, in Chicago, IL.

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Presentation Details:
Title: Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)
Presenting author: Shiraj Sen, MD. PhD., NEXT Oncology Dallas, TX
Session: Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Poster Board: 244


For more information on the ACESOT-1051 trial, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, APR 21, 2026, View Source [SID1234664597])

On April 21, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that ANKTIVA (nogapendekin alfa inbakicept) is now commercially available in Saudi Arabia. Initial patients have been identified for treatment across both approved bladder and lung cancer indications in the Kingdom:

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In combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease; and
In combination with an immune checkpoint inhibitor for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC), as authorized by the Saudi Food and Drug Authority (SFDA)
ANKTIVA is being distributed through ImmunityBio’s partnerships with Biopharma and Cigalah Healthcare, leading healthcare distribution companies in the Middle East, with support from the company’s wholly owned subsidiary in Saudi Arabia.

"Thanks to our strategic partnership with Biopharma and Cigalah Healthcare, and despite a fluid situation in the region, we have been able to bring this innovative cancer treatment to patients ahead of the deadline we announced in February," said Richard Adcock, President and CEO of ImmunityBio. "We continue to work with the same level of diligence and commitment to expand access to ANKTIVA for eligible patients across the Middle East and North Africa."

The Middle East and North Africa (MENA) region faces one of the most rapidly growing burdens of cancer globally, including bladder and lung cancers, underscoring the need for additional treatment options. Lung cancer today is among the most common cancers in Saudi Arabia, while the incidence of bladder cancer is elevated in several countries across the region. 1 2

"We are pleased to support the introduction of this immunotherapy to physicians and their patients in Saudi Arabia," said Tamer Eissa, General Manager, Biopharma. "We look forward to expanding access across the region."

"This milestone represents an important step in expanding access to ANKTIVA for patients in Saudi Arabia," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "We are encouraged by the growing body of clinical data and experience supporting its use across multiple indications and remain committed to working with physicians to bring this immunotherapy to appropriate patients in need around the globe."

ANKTIVA received U.S. Food and Drug Administration approval in April 2024 in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. It has subsequently received regulatory authorizations in multiple regions, including the United Kingdom (MHRA, July 2025), the European Union (European Commission, February 2026), Macau Special Administration Region of China (ISAF, March 2026), and Saudi Arabia (SFDA, January 2026); in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer.

Saudi Arabia Indication and Usage

BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:

ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.

Non-small cell lung cancer (NSCLC):

ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy).

This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.

U.S. IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, APR 21, 2026, View Source [SID1234664613])

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 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])