Dizal Presents Positive NSCLC Data for Fourth-Generation EGFR TKI DZD6008 and Golidocitinib in Combination with Anti-PD-1 at ASCO 2026

On May 30, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, reported the presentations of two studies in non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. One study evaluated DZD6008, an investigational fourth-generation EGFR TKI, in pre-treated NSCLC patients with EGFR C797X mutations following progression on third-generation EGFR TKI treatment. The results were featured in an oral presentation. The other study reported results for golidocitinib, a JAK1-selective inhibitor, combined with an anti-PD-1 antibody as a first-line treatment for PD-L1-positive, advanced NSCLC without driver mutations.

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DZD6008: A Fourth-Generation EGFR TKI Overcomes Resistance Following Third-Generation EGFR TKI Failure

The latest findings showed that DZD6008 demonstrated strong and durable anti-tumor activity in patients relapsed from third-generation EGFR TKI with a favorable safety profile.

The majority of patients (82.1%) had tumor shrinkage following DZD6008 treatment. Higher response rate is expected with longer treatment.
Tumor response is durable, with 6 months progression free survival (PFS) rates at 70.6% and 61.8%, respectively for 40 mg and 60 mg cohorts. The median duration of response (DoR) was not reached.
Excellent blood-brain barrier (BBB) penetration was observed, including strong intracranial anti-tumor activity among patients with baseline brain metastasis.
DZD6008 demonstrated a favorable safety profile with high selectivity for wild-type EGFR, resulting in minimal adverse effects.
Patients with EGFR-mutant NSCLC whose disease progresses on or after third-generation EGFR TKI treatment often acquire resistance mutations, among which EGFR C797X is one of the most frequently reported. DZD6008 is a fourth-generation EGFR TKI designed with full BBB penetration and high selectivity over wild-type EGFR. Preclinical and clinical data support its potent activities against single, double and triple EGFR mutations (L858R/19del, T790M, C797X).

Golidocitinib: A JAK1 Inhibitor Combined with Anti-PD-1 Demonstrates Durable Clinical Benefit

Among 47 enrolled treatment-naïve patients with advanced NSCLC, golidocitinib plus sintilimab following chemo-immunotherapy demonstrated encouraging and durable anti-tumor efficacy, particularly in those with high PD-L1 expression. Profound improvement of irAE was noticed.

Dr. Xiaolin Zhang, CEO of Dizal, said: "Main reasons for patients relapsed from 3rd generation EGFR TKI treatment include acquired resistance mutations and CNS metastasis. DZD6008 was designed to address these clinical issues. The data presented confirmed that DZD6008 met our design criteria and has the potential to provide an oral safe treatment option for these patients. We are very excited by the clinical data. We look forward to collaborating with investigators worldwide to accelerate its clinical development globally."

About Golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About DZD6008

DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

(Press release, Dizal Pharma, MAY 30, 2026, View Source [SID1234666273])

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])

Orion Pharma announces first results from Phase 1/2 TEADES trial with TEAD inhibitor ODM-212 in patients with advanced solid tumours

On May 30, 2026 Orion Pharma reported first Phase 1 results from the ongoing Phase 1/2 multi-site, open-label, first-in-human TEADES trial evaluating the safety, tolerability and preliminary efficacy of ODM-212, a small molecule oral pan-TEAD inhibitor in patients with advanced solid tumours. According to the results, ODM-212 was well tolerated. Dose limiting toxicities (DLT) were not reported and the maximum tolerated dose (MTD) was not reached. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 7.9% of patients. Other common TRAE’s were increased lipase (15.8%) and nausea (10.5%).

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Treatment responses by RECIST 1.1 were observed across multiple doses (overall response rate1, ORR 15.6%), predominantly in patients with mesothelioma (ORR 27.8%, disease control rate2, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The new data were presented during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, United States, from May 29-June 2, 2026.

"We are encouraged by the safety profile and early signs of clinical activity observed with ODM-212, particularly in mesothelioma and EHE, where treatment options remain limited", said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion Pharma. "These results support continued clinical development of ODM-212 both as a monotherapy and in combination settings."

Phase 2 of the TEADES trial is ongoing. The trial will enroll up to 300 patients with malignant pleural mesothelioma (MPM), EHE or other solid tumours with dysfunction in Hippo pathway, and who have progressed despite available standard treatments and with limited further treatment options. Another ongoing Phase 1/2 trial TEADCO is evaluating ODM-212 in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer.

About the TEADES study
The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction in Hippo pathway. The trial will include patients who have progressed despite available standard treatments and with limited further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, MAY 30, 2026, View Source [SID1234666256])

Molecular Partners Holds Presentations at ASCO and SNMMI 2026 on DLL3-Targeting Radio-DARPin MP0712, Now Dosing Patients in Phase 1

On May 30, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported it will hold trial-in-progress poster presentations on the Phase 1/2a study of its lead targeted alpha radiotherapy candidate MP0712 at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. ASCO (Free ASCO Whitepaper) takes place May 29-June 2 in Chicago, and SNMMI May 30-June 2 in Los Angeles.

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MP0712 is a 212Pb-based Radio-DARPin Therapy (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3) for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. DLL3 is a highly relevant target for radiopharmaceutical therapy due to its abundant expression in tumors of patients with SCLC (present in >85% of tumors) and other aggressive neuroendocrine tumors, while expression in healthy tissues is low. MP0712 is being co-developed with Molecular Partners’ strategic partner Orano Med, a pioneer in targeted alpha therapy.

The US multicenter Phase 1/2a study of MP0712 (ClinicalTrials.gov: NCT07278479) is actively recruiting patients with dosing ongoing in the first cohort. The Phase 1/2a study objectives are to assess safety and determine a recommended Phase 2 dose for MP0712. Molecular Partners expects to share initial clinical data from this study in 2026.

Molecular Partners and the team of Dr. Mike Sathekge at the Nuclear Medicine Research Institute (NuMeRI) in South Africa presented first patient imaging and dosimetry data on MP0712 at the 8th Theranostics World Congress (TWC) in January 2026.

The data, generated with MP0712 carrying the diagnostic isotope 203Pb as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa, showed specific uptake in tumor lesions and are supportive of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb.

Details of the presentations:

ASCO 2026

[212Pb] Pb-MP0712 in patients with small cell lung cancer and other Delta-like ligand 3-expressing solid tumors: A phase 1/2a study to assess safety, tolerability, and efficacy

Abstract/Publication Number: TPS3176
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster Board: 302b
Location: Hall A – Posters and Exhibits
Date and Time: 30 May 2026, 1:30–4:30 pm local time

SNMMI 2026

A phase 1/2a study to assess safety, tolerability, and efficacy of [212Pb] Pb-MP0712 in patients with small cell lung cancer (SCLC) and other Delta-like ligand 3 (DLL3)-expressing solid tumors

Abstract/Publication Number: 261055
Poster Session: POP08: Oncology: Discovery & Translational (Preclinical & Phase 0/1 human studies)
Poster Screen: 51
Location: Science Pavilion–South Hall GHJK
Date and Time: 2 June 2026, 11:30am-12:15pm local time (Meet-the-Author Session [MTA] 11)

The posters will be made available on Molecular Partners’ website after the presentations.

About Radio-DARPins

Molecular Partners develops targeted alpha therapeutics leveraging its Radio-DARPins as isotope-agnostic vectors with the potential to unlock a broad range of cancer targets and indications. Molecular Partners designs its Radio-DARPin candidates matching disease and target biology with vector and isotope properties to address unmet medical needs. Building on the DARPins’ unique properties, Molecular Partners has developed a proprietary Radio-DARPin platform for precise delivery of potent radioactive payloads to tumor lesions. Molecular Partners’ Radio-DARPins address historic limitations of radioligand therapy, such as kidney accumulation and suboptimal tumor uptake, through optimized half-life extension and surface engineering approaches, while preserving the advantages of the small protein format.

(Press release, Molecular Partners, MAY 30, 2026, View Source [SID1234666255])

Salubris Biotherapeutics Announces Updated Phase 1/2 Data for JK06, a 5T4-Targeted Antibody Drug Conjugate, at the 2026 American Society of Clinical Oncology Annual Meeting

On May 30, 2026 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported updated data from the Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC) and breast cancer. The data are being presented 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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"We are proud to have treated 173 patients across our Phase 1/2 study. These updated results are a meaningful step forward for JK06, with particularly compelling efficacy observed in squamous NSCLC, an area of significant unmet medical need. Among response-evaluable squamous NSCLC patients treated at 4.5 mg/kg, JK06 demonstrated a 50% ORR, and overall, we observed a 35% ORR and 94% DCR for 17 response-evaluable squamous NSCLC patients enrolled to date," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics. "These results, together with a consistently favorable safety profile and durable activity across multiple subtypes of NSCLC and breast cancer, reinforce 4.5 mg/kg as a promising dose for continued evaluation and support our plans to advance JK06 into additional monotherapy expansions and as a potential combination therapy."

The ongoing Phase 1/2, open-label study (NCT06667960) includes dose escalation (1.5 to 8.0 mg/kg) and multiple tumor-specific expansion cohorts in NSCLC, breast cancer, and a basket of other 5T4-expressing tumors. JK06 is administered intravenously once every three weeks (Q3W), with responses assessed per RECIST 1.1. As of May 12, 2026, 173 patients have been treated with JK06, including 42 patients in dose escalation and 131 patients in expansion cohorts. Of the 131 patients treated in the cohort expansion, 64 were NSCLC patients, 44 were breast cancer patients, and 23 were enrolled in the basket cohort.

Key Efficacy Findings:

NSCLC

Across all response-evaluable squamous NSCLC patients, JK06 achieved a confirmed ORR of 35% (6 of 17), including 50% (5 of 10) at 4.5 mg/kg, and a DCR of 94% (16 of 17).
Across all response-evaluable EGFR-mutant NSCLC patients, JK06 achieved a confirmed ORR of 43% (3 of 7) and a DCR of 86% (6 of 7).

Breast Cancer

Across all response-evaluable hormone receptor-positive (HR+) breast cancer patients, JK06 achieved a confirmed ORR of 30% (3 of 10) and a DCR of 60% (6 of 10).
Across all response-evaluable triple-negative breast cancer (TNBC) patients, JK06 achieved a confirmed ORR of 25% (4 of 16) and a DCR of 69% (11 of 16).
Six of seven breast cancer responders had received prior ADC therapy, including two with multiple prior ADCs.

Other Tumor Types

One confirmed partial response was observed among two response-evaluable endometrial cancer patients, representing the fifth tumor type to demonstrate a response with JK06 following NSCLC, breast, gastric and cervical cancers.

Key Safety Findings in Expansion Cohorts (n=131):

JK06 at doses ≤ 5.2 mg/kg was generally well-tolerated, with TRAEs that were predominantly low grade and manageable.
The most frequently observed TRAEs (≥ 5% overall) were alopecia (15%), asthenia (15%), dry eye (10%), fatigue (10%), and nausea (10%).
No Grade 4 or Grade 5 TRAEs were reported.
Grade 3 TRAEs were uncommon and consisted of keratitis (n=2, 2%), and one case each of fatigue (1%), gait disturbance (1%), and neuralgia (1%).
Two patients out of 131 (2%) required dose reduction, both due to peripheral neuropathy, and three patients out of 131 (2%) discontinued JK06 (one each due to fatigue, gait disturbance, and pneumonitis).

Details of the ASCO (Free ASCO Whitepaper) presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), In Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Omar Saavedra, M.D., New Experimental Therapeutics (NEXT) Oncology, Hospital Universitario Quironsalud, Barcelona, Spain
Abstract #: 552322
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date/Time: May 30, 2026 | 1:30 – 4:30 CDT

About JK06

JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of solid tumors, including non-small cell lung cancer (NSCLC), breast, gastric, and genitourinary cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and enhanced internalization resulting from the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has demonstrated the potential for robust efficacy and a favorable safety profile.

(Press release, Salubris Biotherapeutics, MAY 30, 2026, View Source [SID1234666253])