On May 30, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

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"The overall survival analysis from IGNYTE shows that nearly half of all treated patients in the study were alive at three years, including 83.5% of responders to RP1 plus nivolumab," said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer of Replimune. "This represents a durable benefit that is rarely seen in anti-PD-1-failed melanoma, a setting with historically limited treatment options."

Key findings are detailed below.

Oral Presentation: A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial; Date/Time: May 30, 2026, 5:30 PM CDT; Location: E451; Abstract: 9518; Presenter: Michael Wong, MD, PhD

RP1 (vusolimogene oderparepvec) plus nivolumab achieved a median overall survival (mOS) of 32.9 months in patients with anti–PD-1–failed advanced melanoma, a population with limited treatment options.
At 3 years, 47.8% of all treated patients remained alive, rising to 83.5% among responders, underscoring the depth and durability of the treatment’s benefit.
The objective response rate (ORR) was 33.6%, with a median duration of response (DOR) of 24.8 months; 44.8% of responders maintained their response at 3 years.
Meaningful survival benefit was observed across all key patient subgroups, including those with varying disease stage, PD-L1 expression status, prior anti–CTLA-4 therapy, and primary or secondary anti–PD-1 resistance.
The combination continued to demonstrate a favorable and manageable safety profile over long-term follow-up, with predominantly Grade 1–2 constitutional side effects, no Grade 5 events, and no new safety signals identified.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, MAY 30, 2026, View Source [SID1234666250])

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])

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])

On May 30, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported encouraging Health-Related Quality of Life (HRQoL) data from its Phase 3 COMPETE trial in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The data showed favorable and durable quality of life outcomes for patients receiving non-carrier-added (n.c.a.) ¹⁷⁷Lu-edotreotide (also known as ITM-11 or ¹⁷⁷Lu-edotreotide) compared to everolimus, a systemic standard of care treatment.

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The data were presented by Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from May 29 – June 2, 2026 in Chicago, Illinois.

"For patients with GEP-NETs, treatment decisions are not only about preventing disease progression, but also about preserving daily functioning and quality of life," said Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain. "The COMPETE data suggest more favorable patient-reported outcomes with ¹⁷⁷Lu-edotreotide compared with everolimus, including a longer median time to deterioration in quality of life. Together with the previously reported efficacy results, these findings add important patient-centered evidence to inform treatment discussions."

The quality of life analyses included 309 patients (¹⁷⁷Lu-edotreotide, n=207; everolimus, n=102). More than 85% of patients completed the two validated EORTC QLQ questionnaires1 throughout the study: the 30-item QLQ-C30 and the 21-item QLQ-GI.NET21. Both surveys use standardized 0-100 scales to assess overall health, physical and social functioning, and GEP-NET symptom burden. Patients completed questionnaires at baseline, monthly in year one, and every three months thereafter.

Key QoL Findings:

On average, patients on the ¹⁷⁷Lu-edotreotide arm maintained their quality of life (score change: +0.9) while patients in the everolimus arm experienced a meaningful decline in quality of life (score change: -9.9)
Patients on ¹⁷⁷Lu-edotreotide experienced a longer period of time before their quality of life began to decline: a median of 10.3 months vs. 2.3 months for everolimus
A meaningful overall improvement in quality of life was reported by 43.5% of patients on ¹⁷⁷Lu-edotreotide vs. 30.4% of those on everolimus
Among those who improved, median duration of improvement was 22.0 months vs. 10.2 months, respectively
"These additional COMPETE results provide important insights into quality of life during treatment with ¹⁷⁷Lu-edotreotide, and further add to the clinical data generated to date," said Dr. Celine Wilke, chief medical officer of ITM. "Balancing treatment benefit, risk and personal preference to improve overall patient health remains a top priority for ITM, alongside delivering meaningful clinical outcomes through targeted radiopharmaceuticals."

¹⁷⁷Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated ¹⁷⁷Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with ¹⁷⁷Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. ¹⁷⁷Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, MAY 30, 2026, View Source [SID1234666288])

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])