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%).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reported updated Phase 1 data for its IMA203CD8 PRAME TCR T-cell therapy in gynecologic cancers and synovial sarcoma at the Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL, USA. One-time infusion of IMA203CD8 demonstrated meaningful clinical activity across different tumor types as well as manageable tolerability. The broad expression of PRAME in more than 50 cancers further supports the continued development of IMA203CD8 in multiple PRAME-positive solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The updated Phase 1 results in gynecologic cancers will be presented on May 30, 2026, during the Rapid Oral Abstract Session – Gynecologic Cancer from 8:00-9:30 am CDT by Antonia Busse, M.D., Charité Medical University Hospital, Berlin, Germany (Abstract ID 5509). Presentation slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website. Phase 1 data in synovial sarcoma will be presented on May 31, 2026, during the Rapid Oral Abstract Session – Sarcoma from 4:30-6:00 pm CDT by Dejka M. Araujo M.D., The University of Texas MD Anderson Cancer Center (Abstract ID 11516). Presentation slides will be accessible on May 31, 2026.

"These clinical data in ovarian cancer, uterine cancer and synovial sarcoma, along with previously released data in melanoma, further reinforce our aim to develop IMA203CD8 in PRAME-positive cancers beyond melanoma. PRAME is expressed in more than 50 cancers, and the compelling anti-tumor activity observed in these historically hard-to-treat indications supports its promise as a broadly applicable target," said Cedrik Britten, M.D., Ph.D., Chief Medical Officer at Immatics. "We are encouraged by the consistency of response signals observed with IMA203CD8 and remain focused on advancing IMA203CD8 in gynecologic cancers with the potential to broaden development to other indications in a tumor-agnostic approach to deliver meaningful outcomes to patients."

Next development steps:
The clinical activity observed in ovarian cancer, a tumor type generally associated with lower levels of PRAME expression, together with the observed activity across tumor types with different and distinct tumor microenvironments, supports the broad applicability of IMA203CD8 across solid tumors with differing levels of PRAME and tumor biology, starting with ovarian and uterine cancer. Updated data from the ongoing study, including durability follow-up at the RP2D, are planned for presentation in the second half of 2026. Immatics is expanding clinical evaluation of IMA203CD8 into additional PRAME-positive solid tumor indications to more fully assess its therapeutic potential.

Highlights of Immatics’ clinical data on IMA203CD8 presented at ASCO (Free ASCO Whitepaper) 2026

Gynecologic cancers:
Patient population: Heavily pretreated patient population with limited treatment options

As of March 30, 2026, 27 heavily pretreated patients with gynecologic cancers received a one-time infusion of IMA203CD8 in the ongoing Phase 1 dose escalation/dose expansion trial (NCT03686124).
The median total infused dose across seven escalating dose levels was 3.3×109 TCR T cells (range 0.5×109 – 12.5×109 TCR T cells) for ovarian carcinoma and 3.2×109 TCR T cells (range 1.3×109 – 10.1×109 TCR T cells) for uterine cancer.
All patients were heavily pretreated, including at least one prior line of platinum-based regimen. Patients with ovarian carcinoma had a median of four lines of systemic treatment (range 1-7), patients with uterine cancer had a median of two lines (range 1-3).
The efficacy-evaluable1 patient population included 26 patients, 19 of whom were treated at clinically relevant doses (≥DL4c, median 5.4 x109 TCR T cells, range 1.4 – 12.5): 17 with ovarian carcinoma and two with uterine cancer
Safety: Treatment with IMA203CD8 showed predictable and manageable tolerability

IMA203CD8 demonstrated manageable tolerability in the 27 enrolled patients.
The most frequent treatment-emergent adverse events (TEAE) were anticipated cytopenias associated with lymphodepletion.
Expected and manageable cytokine release syndrome (CRS) was mostly low-grade and was consistent with the mechanism of action (Grade 1: 44%, Grade 2: 44%, Grade 3: 7%).
Immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) were infrequently observed (any Grade: 7%, each).
No IMA203CD8-related Grade 5 events occurred.
Based on the manageable tolerability profile, the Company expects to determine the recommended Phase 2 dose (RP2D) in 2026.
Anti-tumor activity: A one-time infusion of IMA203CD8 PRAME cell therapy showed anti- tumor activity in gynecologic cancers at clinically relevant doses (≥DL4c)

Objective response rate (ORR): 63% (12/19), confirmed ORR (cORR)2: 50% (9/18)
Including two confirmed and two unconfirmed complete responses
89% (8/9) of confirmed responses were ongoing as of the data cutoff with longest ongoing response at 12 months post infusion (metabolic complete response)
Responses were observed with and without low-dose IL-2
Tumor reduction: 78% (14/18)
Disease Control Rate (DCR) at week 6: 68% (13/19)
Median duration of response (mDOR), median progression free survival (mPFS) and median overall survival (mOS) were not reached, with median follow-up times (mFU) of 3.9, 5.3 and 5.3 months, respectively

* For those patients who achieved a (c)CR with <100% changes from baseline, target lesions were lymph nodes that resolved to <10 mm. + Patient had a PR prior to CR. BOR, best overall response; (c)CR: (confirmed) complete response; (c)ORR, (confirmed) objective response rate; PD, progressive disease; (c)PR, (confirmed) partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

Synovial sarcoma:

As of the March 30, 2026 data cutoff, 12 heavily pretreated patients with synovial sarcoma, who had received a median of two prior lines of systemic therapy (range, 1-5), were treated with a one-time infusion of IMA203CD8.
The safety profile was manageable and consistent with the mechanism of action.
The most frequent TEAEs were anticipated cytopenias associated with lymphodepletion. CRS events were expected, manageable and predominantly Grade 1/2.
No IMA203CD8-related Grade 5 events were observed.
A one-time infusion of IMA203CD8 showed promising anti-tumor activity with deep and durable response in synovial sarcoma across all doses (median 1.59 × 10⁹ TCR T cells; range: 0.89–10.00 × 10⁹):

ORR: 67% (8/12), cORR: 64% (7/11)
4 ongoing responses, including 1 confirmed complete response, with longest response ongoing at ~ 3 years
Tumor reduction: 92% (11/12)
DCR at week 6: 100% (12/12)
mDOR: 14.8 months (3.7, 31.8+) at mFU of 31.0 months

About IMA203CD8 PRAME Cell Therapy
IMA203CD8 is Immatics’ PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. The co-transduction of CD8αβ alongside the PRAME TCR adds functional CD4+ T cells designed to boost anti-tumor activity. IMA203CD8 is currently being evaluated in a Phase 1 clinical trial in solid tumors expressing PRAME.

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and three combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy, IMA402 PRAME bispecific as monotherapy, in combination with immune checkpoint inhibitors, in combination with IMA401 MAGEA4/8 bispecific as well as anzu-cel in combination with Moderna’s PRAME mRNA designed to enhance cell therapy.

(Press release, Immatics, MAY 30, 2026, View Source [SID1234666246])