ImPact Biotech Presents Updated Data from Phase 1 Trial of Padeliporfin VTP in LA-PDAC and Phase 3 ENLIGHTED Trial in LG-UTUC at ASCO 2026

On May 30, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated data from the ongoing Phase 1 trial of Padeliporfin VTP treatment in patients with unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) and from ENLIGHTED, the Company’s ongoing Phase 3 study in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29-June 2, 2026, in Chicago, IL.

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"Today’s presentations underscore the continued clinical progress across both our expanding development efforts in LA-PDAC and our pivotal Phase 3 ENLIGHTED study in LG-UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The updated early Phase 1 results in LA-PDAC, including successful resection outcomes observed to date, are encouraging and support initial validation of our VTP platform and its potential broader application in difficult-to-treat solid tumors. Given the substantial unmet need and large addressable patient population in LA-PDAC, we believe Padeliporfin VTP may offer a differentiated therapeutic option with the potential to convert these patients to surgically resectable candidates."

"In parallel, updated data from the ENLIGHTED trial continue to demonstrate compelling complete response rates, encouraging durability, and a favorable tolerability profile, reinforcing Padeliporfin VTP’s potential to offer a clinically meaningful, organ-sparing treatment option for patients with low-grade UTUC," continued Dr. Morag. "We look forward to pursuing strategic opportunities for the potential commercialization of Padeliporfin VTP in LG-UTUC, while advancing clinical development in both indications."

Key updated results from the Phase 1 study of Padeliporfin VTP in LA-PDAC:

The Phase 1 LA-PDAC trial is a three part dose-escalation and expansion study evaluating Padeliporfin VTP in patients with vascular encasement deeming them ineligible for surgical resection. As of April 24, 2026, the data cut-off for the poster presentation at ASCO (Free ASCO Whitepaper), seven patients had completed treatment across the 200 mW/cm and the 400 mW/cm dose levels without clinically significant dose-limiting toxicities (DLTs) and were evaluable for potential surgery.

Efficacy Profile:

5 of the 7 (71%) patients underwent successful surgery following Padeliporfin VTP treatment, including 4 of the 7 patients (57%) with R0 margins.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with no complications observed related to arterial injury, thrombosis, ischemia, or significant VTP-related morbidity.

Early clinical observations of Padeliporfin in LA-PDAC support advancement of the program, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates. Subject to future discussions with the U.S. Food and Drug Administration (FDA), the Company believes this program may have potential to move directly into a registrational study.

Key updated results from the Phase 3 ENLIGHTED study of Padeliporfin VTP:

The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. As of April 20, 2026, the data cut-off for the poster presentation at ASCO (Free ASCO Whitepaper), Padeliporfin VTP demonstrated a consistent efficacy profile with 50 of the 72 (70%) response-evaluable patients achieving a CR at the end of Primary Response Evaluation (PRE). 18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, reaching a current median duration of response in the treated area of 23.9 months based on available follow-up. Padeliporfin VTP treatment was well-tolerated and has demonstrated a consistent and acceptable safety profile to date.

ImPact has completed enrollment in ENLIGHTED with topline data expected in 2026. Following positive ongoing discussions with the FDA, including a recent Type C meeting which confirmed the proposed registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer, the Company is on track to submit an NDA in low-grade UTUC in 2027. ImPact is pursuing strategic partnering opportunities to support the commercialization of this program.

ASCO Presentation Details:

Poster Title: Phase I Light-Dose Escalation Study in Locally Advanced Pancreatic Ductal Adenocarcinoma: Intra-Arterial (IA) Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Nadine Abi-Jaoudeh, M.D., Professor of Clinical Radiology, University of California Irvine
Poster Number: 236a
Session Title: Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: Saturday, May 30, 2026 at 9:00 AM CT

Poster Title: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP): The ENLIGHTED Phase 3 Trial
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: 115a
Session Title: Genitourinary Cancer: Kidney and Bladder

Session Date & Time: Sunday, May 31, 2026 at 9:00 AM CT

(Press release, ImPact Biotech, MAY 30, 2026, View Source [SID1234666289])

Precigen Presents New Long-Term Durability Data for PAPZIMEOS, Recently Granted Seven-Year Market Exclusivity, Demonstrating Complete Responses Beyond 4 Years

On May 30, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported updated long-term follow-up data from the pivotal study of PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Updated durability of response data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago in a presentation titled, "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial."

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PAPZIMEOS was granted full approval by the United States Food and Drug Administration (FDA) and was subsequently granted seven-year market exclusivity, further strengthening its position as the first and only approved therapy for the treatment of adults with RRP.

Key data highlights from the ASCO (Free ASCO Whitepaper) presentation include:

15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses as of the April 30, 2026 data cutoff (see Figure 1);
Patients did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during this follow-up period;
All complete responders had at least 36 months of follow-up, with a median follow-up of 36 months (range: 36 to 51 months) and a mean follow-up of 40 months;
5 complete responders have ongoing responses beyond 4 years;
Median duration of complete response has not yet been reached; and
No new safety events were observed during long-term follow-up.
FIGURE 1: Ongoing Durability of Complete Response

"The presentation at ASCO (Free ASCO Whitepaper) marks an important maturation of the PAPZIMEOS pivotal study data, with all complete responders now followed for at least 36 months, 83% with ongoing response, including 5 patients who are surgery-free beyond 4 years," said Helen Sabzevari, PhD, President and CEO of Precigen. "For adults living with RRP, durability matters. These results continue to show that PAPZIMEOS provides sustained complete responses, reinforcing its role as the new standard of care for a disease historically managed through repeated surgeries."

About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients’ work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP.

Indication and Important Safety Information

What is PAPZIMEOS?
PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults.

What is the most important information I should know about PAPZIMEOS?
Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you’re feeling okay.

Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction:

Difficulty breathing
Widespread rash
Facial swelling
Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms:

Shortness of breath
Chest pain
Leg swelling
Persistent abdominal pain
Severe or persistent headaches
Blurred vision
What should I know before taking PAPZIMEOS?
Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including:

If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby.
If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS.
What are the most common side effects of PAPZIMEOS?
The most common side effects include:

Pain, redness, or swelling where the shot was given
Feeling tired
Chills
Fever
Muscle aches
Nausea (feeling sick)
Headache
Increased heart rate
Diarrhea
Vomiting
Sweating a lot
These are not all of the possible side effects of PAPZIMEOS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777).

Please see full Prescribing Information.

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube.

Trademarks
Precigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

(Press release, Precigen, MAY 30, 2026, View Source [SID1234666257])

Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC Published in The Lancet

On May 30, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) reported that the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱) in combination with pembrolizumab (KEYTRUDA[1], MSD’s anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), have been published in the prestigious international medical journal The Lancet (IF=88.5)[2]. The co-senior authors are: Professor Caicun Zhou from Shanghai East Hospital, Tongji University; and Dr. Junyou Ge, Director of the National Engineering Research Centre of Targeted Biologics. The co‑first authors are: Professor Anwen Xiong from Shanghai East Hospital, Tongji University; Professor Wenxiu Yao from Sichuan Cancer Hospital; Professor Wei Zheng from Shengjing Hospital, China Medical University; Professor Yan Yu from Harbin Medical University Cancer Hospital; Professor Peng Chen from Tianjin Medical University Cancer Institute and Hospital; Professor Hua Zhong from Shanghai Chest Hospital; and Dr. Junyou Ge, Director of the National Engineering Research Centre of Targeted Biologics. The study findings were also selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell).

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OptiTROP-Lung05 is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of sac-TMT in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with locally advanced or metastatic PD-L1 TPS≥1% NSCLC.

The interim analysis results show that compared with pembrolizumab monotherapy, the combination of sac-TMT and pembrolizumab significantly prolongs progression-free survival (PFS) and reduces the risk of disease progression or death, with a hazard ratio (HR) of 0.35. Consistent PFS benefits were observed across all prespecified subgroups, including by PD-L1 expression level and histological type, with PFS HRs of 0.47 and 0.28 for the PD-L1 TPS ≥50% and 1–49% subgroups, respectively, and PFS HRs of 0.28 and 0.44 for the non-squamous and squamous subgroups, respectively. A positive trend in overall survival (OS) was also observed, with an HR of 0.55. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone, and no new safety signals identified.

This is the first Phase III trial of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in the first line treatment of NSCLC, and for the first time demonstrate that "ADC+IO" combination of sac-TMT plus pembrolizumab has the potential to achieve survival benefit as first‑line therapy for NSCLC. The publication of these findings in The Lancet further signifies that the clinical and academic value of this combination therapy has received internationally recognized validation.

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 triple‑negative breast cancer (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 epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy 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 National Medical Products Administration (NMPA).

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. 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.

(Press release, Kelun, MAY 30, 2026, View Source [SID1234666274])

ENZAMET Trial Shows Veracyte’s Decipher Prostate Test Identifies Which Patients Benefit from Adding Chemotherapy in Metastatic Prostate Cancer

On May 30, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported results from the ENZAMET trial presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. The analysis demonstrates that the Decipher Prostate test identifies which men with metastatic prostate cancer benefit from adding the chemotherapy docetaxel to standard hormonal therapy (ADT plus enzalutamide), known as triplet therapy, and who can safely avoid it, providing the first Level 1B 1 evidence for a genomic test guiding this decision. Complementary data presented at the meeting also reinforce Decipher Prostate’s clinical utility in high-risk localized disease.

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Approximately 334,000 men are diagnosed with prostate cancer annually in the United States, including about 30,000 who present with metastatic disease at diagnosis.2, 3 While recent treatment advances have improved outcomes, clinicians still lack precision tools to guide chemotherapy decisions in this setting.

"For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer," said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator, South Australian Immunogenomics Cancer Institute, Adelaide University. "Decipher Prostate identifies which patients benefit from treatment intensification, and which can be safely spared chemotherapy, giving clinicians an actionable, evidence-based answer."

The ENZAMET findings build on prior validation in the STAMPEDE and CHAARTED trials, where Decipher Prostate identified patients most likely to benefit from adding docetaxel to ADT alone. ENZAMET advances that evidence with the first demonstration that the test predicts chemotherapy benefit when added to doublet therapy (ADT plus an ARPI).

Metastatic Disease: Identifying Which Men Benefit from Chemotherapy

The ENZAMET trial is an international, randomized Phase III study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Researchers performed a pre-specified biomarker analysis using the Decipher Prostate test in 634 patients to assess whether the test could predict benefit from adding chemotherapy to standard hormonal therapy with a median follow-up of 5.6 years.

Results showed:

Improved outcomes guided by Decipher Prostate: Patients with higher Decipher scores (>0.85) and high-volume disease who received triplet therapy had clinically meaningful better survival compared to those on standard hormonal therapy alone.
Patients can be spared from chemotherapy: Patients with lower Decipher scores showed no benefit from adding chemotherapy, suggesting it may be safely avoided.
Practice-changing evidence: The treatment-by-biomarker interaction was statistically significant (p=0.043), providing Level 1B evidence for the test’s predictive value.
Overcoming aggressive disease: Patients with higher Decipher scores who received triplet therapy had more aggressive disease features, yet achieved comparable survival to lower-risk patients on doublet therapy, suggesting chemotherapy offset the poor prognostic effects of aggressive disease biology.
Localized Disease: Identifying Which High-Risk Patients Need Treatment Intensification

Complementing the ENZAMET findings, a combined analysis of four mature NRG/RTOG trials presented at ASCO (Free ASCO Whitepaper) 2026 adds to Decipher Prostate’s growing body of evidence into high-risk localized prostate cancer.

Key findings include:

Improved prognostic accuracy: Decipher Prostate significantly improved prognostic accuracy for survival outcomes compared to clinical variables alone.
Refined risk classification: Combining NCCN clinical risk classification with Decipher Prostate reclassified approximately 1 in 4 patients.
Expanded population for treatment intensification: Results also show many more clinically high-risk patients may benefit from intensification with ARPI.
"Decipher Prostate is the most validated transcriptomic test across the full prostate cancer continuum – from active surveillance through metastatic disease," said Elai Davicioni, Ph.D., Veracyte’s Medical Director, Urology. "For clinicians, that means a clearer answer at every decision point. For patients, it means greater confidence that their treatment is guided by the biology of their disease, and not guesswork."

(Press release, Veracyte, MAY 30, 2026, View Source [SID1234666241])

Whitehawk Therapeutics Presents Real‑World Analysis Confirming SEZ6 as a Highly Expressed, Clinically Relevant Target for SCLC and Other Neuroendocrine Tumors at ASCO 2026

On May 30, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported the presentation of a real world analysis supporting the therapeutic potential of targeting seizure related homolog protein 6 (SEZ6) with a next-generation ADC for the treatment of neuroendocrine tumors, including small cell lung cancer (SCLC). These data will be presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29-June 2, 2026, in Chicago, Illinois.

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SEZ6 is a cell surface transmembrane protein involved in neuronal development that is primarily expressed in central nervous system (CNS) tissues. A large-scale RNA analysis demonstrated that SEZ6 is highly expressed across SCLC and other tumors of neuroendocrine origin. In SCLC, expression exceeds other approved and emerging ADC targets. SEZ6 expression is positively correlated with DLL3, indicating the potential for combination approaches with DLL3-targeted therapies. Together, these data support its potential as a clinically meaningful ADC target and reinforce the rationale for clinical development of HWK-206.

"SEZ6 demonstrates a compelling expression profile across SCLC and other neuroendocrine malignancies. In SCLC, it has levels of expression that are consistently high across disease stages and metastatic settings," said Afshin Dowlati, MD, University Hospitals Seidman Cancer Center and Case Western Reserve University. "The magnitude of SEZ6 expression relative to other therapeutic targets, along with its enrichment in neuroendocrine‑high SCLC subtypes, supports its potential as an ADC target."

Key Findings Include:

SEZ6 is highly expressed in SCLC and other tumors of neuroendocrine origin.
Expression exceeds other established and emerging ADC targets.
SCLC – SEZ6 expression was at least 3-fold higher than HER2, B7-H3, DLL3, PD-L1 and PD-1.
Prostate neuroendocrine carcinoma – SEZ6 expression was 2- to 6-fold higher than B7-H3, DLL3 and TROP2.
Among SCLC molecular subtypes, SEZ6 expression is highest in SCLC-A and SCLC-N, which accounts for ~90% of subtypes and are characterized by high expression of neuroendocrine transcription factors.
Expression is high across SCLC disease stages and metastatic status, supporting potential relevance across treatment settings.
Correlative expression in DLL3 supports combination strategies.
HWK-206 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve binding and internalization of the ADC. In preclinical models, HWK-206 has demonstrated the potential to outperform other single epitope ADCs in development. An Investigational New Drug application to evaluate HWK-206 in SCLC and neuroendocrine tumors is expected to be submitted in mid-2026, with a Phase 1 start planned in Q3 2026.

"This real-world characterization of SEZ6 expression across small cell lung cancer and other neuroendocrine tumors reinforce our conviction in SEZ6 as a clinically meaningful target for ADC development," said Margaret Dugan, MD, Chief Medical Officer of Whitehawk Therapeutics. "These findings add to the body of evidence supporting our biparatopic SEZ6-directed ADC, HWK-206, and its potential to have a meaningful impact on patients with SCLC and neuroendocrine tumors."

Poster Presentation Details:

Title: Real-world characterization of SEZ6, a transmembrane protein expressed in various solid tumors
Poster: 219
Abstract: 3082
Presenter: Afshin Dowlati, MD, University Hospitals Seidman Cancer Center and Case Western Reserve University
Date & Time: May 30th, 2026, 1:30 – 4:30 PM CDT

The analysis was conducted as part of a previously announced collaboration between Whitehawk and Tempus AI. The posters will be accessible on the Presentations page of the Investors & News section of the Company’s website at www.whitehawktx.com.

(Press release, Whitehawk Therapeutics, MAY 30, 2026, View Source [SID1234666275])