OSE Immunotherapeutics Reports Positive Topline Results of TEDOVA Phase 2 Trial with Tedopi® in Recurrent Ovarian Cancer

On May 22, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, reported the release of the abstract selected for an oral presentation at the upcoming ASCO (Free ASCO Whitepaper) 2026Annual Meeting, unveiling topline results from the TEDOVA/GINECO-OV244b/ENGOT-ov58 academic, international, Phase 2 trial sponsored by ARCAGY-GINECO and evaluating Tedopi (OSE2101), with or without pembrolizumab, as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer (PSOC).

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Alexandra Leary, MD, PhD, Deputy Head of the Department of Medical Oncology at Gustave Roussy (Paris, France), oncologist specialising in gynaecological cancers, Chair of the GINECO group and Lead Investigator of the TEDOVA Phase 2 clinical trial of Tedopi, commented: "Ovarian cancer (OC) patients treated with platinum sensitive relapse post bevacizumab and PARP-inhibitors represent an unmet medical need with a progression free survival (PFS) of less than 3 months post platinum-based chemotherapy. In this difficult to treat setting, the combination of OSE2101 and pembrolizumab as maintenance significantly improved PFS. TEDOVA brings the 1st proof of concept for a vaccine strategy in OC, and actually the 1st positive trial in platinum sensitive OC in years!"

The TEDOVA Phase 2 trial enrolled 185 patients with PSOC who have progressed after or were ineligible for PARP inhibitors and bevacizumab. Patients with complete response, partial response, or stable disease after platinum-based therapy were randomized (1:1:2) to receive maintenance treatment with either best supportive care (control arm A), Tedopi monotherapy (arm B), or Tedopi in combination with pembrolizumab (arm C). The primary endpoint was progression-free survival (PFS) comparing Arm C vs Arm A. (NCT04713514)

The primary endpoint was met and results showed a statistically significant improvement in PFS for the combination of Tedopi and pembrolizumab compared to best supportive care (median PFS: 4.1 months vs 2.8 months; HR=0.53; p<0.001). When comparing the two investigational arms, the addition of pembrolizumab to Tedopi resulted in a 28% reduction in the risk of progression or death (HR=0.72, p=0.074).

The combination with pembrolizumab to Tedopi was associated with an increased incidence of adverse events, including immune-related events, consistent with the mechanism of action of immunotherapy.

These results will be presented on May 30, 2026, at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago by Lead Investigator Alexandra Leary, MD, PhD.

In addition, OSE will be hosting a KOL webcast on June 10, 2026, to discuss how Tedopi could benefit patients affected by multiple oncology indications with key opinion leaders Stephen Liu, MD (MedStar Georgetown University Hospital), Benjamin Besse, MD (Gustave Roussy Institute, Paris) and Alexandra Leary, MD, PhD (Gustave Roussy Institute, Paris).

Marc Le Bozec, Chief Executive Officer, commented: "Thanks to the collaboration with ARCAGY-GINECO, these results provide further clinical evidence supporting the potential of Tedopi in difficult-to-treat cancers such as ovarian cancer. The data highlight both the clinical activity of Tedopi as monotherapy and its strong synergy in combination with anti-PD-1 therapy in heavily pretreated patients. These findings reinforce our strategy to advance Tedopi in Phase 3 development in non-small cell lung cancer, as well as in combination approaches through investigator-sponsored trials in ovarian, pancreatic, and lung cancers in collaboration with leading academic groups, with data expected through 2026."

KOL Webcast on Wednesday, June 10, 2026
6pm CET / noon ET

Live in English with optional French subtitles
Link to Webcast: http://bit.ly/4tMxhzG

(Press release, OSE Immunotherapeutics, MAY 22, 2026, View Source [SID1234666030])

Veracyte to Host Investor Call on June 1, 2026 to Discuss ASCO Findings

On May 22, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that it will host a conference call and webcast on Monday, June 1, 2026 at 8:30 a.m. ET to discuss data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests that will be presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. This includes results from the OPTIMA and ENZAMET trials.

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Professor Iain Macpherson, one of the principal investigators of OPTIMA, Professor of Breast Oncology at the University of Glasgow and Honorary Consultant Medical Oncologist at the Beatson West of Scotland Cancer Centre, will join for the discussion.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source A webcast replay will be available following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-ins can be accessed by registering via this link.

(Press release, Veracyte, MAY 22, 2026, View Source [SID1234666015])

STORM Therapeutics to Present Promising Phase 1 Sarcoma Data Demonstrating Activity of First‑in‑Class METTL3 Inhibitor STC‑15 at ASCO 2026

On May 22, 2026 STORM Therapeutics Ltd. (STORM), the clinical stage company targeting RNA modifications to reprogram cells and develop novel cancer therapies, reported that a subset analysis of sarcoma patients enrolled in the Phase 1 dose escalation study of its lead candidate, STC-15, will be presented at the 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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The presentation, titled ‘A Subset Analysis of Clinical Activity and Pharmacodynamic Biomarkers in Patients with Sarcomas in the Phase 1 Dose Escalation Study of STC-15, a METTL3 Inhibitor’, will report clinical activity alongside pharmacodynamic (PD) and epitranscriptomic findings from sarcoma patients treated with STC-15, a first-in-class, oral small-molecule inhibitor of the RNA methyltransferase METTL3.

The Phase 1 study enrolled 42 patients with advanced malignancies across five dose‑escalation cohorts ranging from 60 mg to 200 mg and evaluated both daily and three‑times‑weekly oral dosing regimens. Thirteen patients in the study had sarcomas and had received a mean of three prior lines of therapy.

Encouraging clinical activity in the sarcoma subset includes:

Evidence of clinical activity consistent with a differentiation‑driven mechanism of action, with disease control observed across multiple sarcoma subtypes
Disease control rate (DCR) of 54% at 12 weeks, including one confirmed partial response, and a median progression‑free survival of 6 months
Robust target engagement, demonstrated by an average >50% reduction in m6A (methylated adenosine) marks on mRNA within 24 hours of dosing across dose cohorts
Quantitative m6A and transcriptomic analyses providing supportive evidence of downstream effects on gene transcription, including RNA transcript changes associated with STC‑15 treatment
In patients who derived clinical benefit, decreased enrichment of genes associated with developmental pathways, consistent with modulation of biological processes linked to cancer stemness and aberrant differentiation, central to sarcoma pathology
Taken together, these data provide PD and transcriptional evidence linking METTL3 inhibition to modulation of gene expression pathways relevant to sarcoma biology, supporting the proposed mechanism of action of STC‑15.

Justin Moser, Associate Clinical Investigator at HonorHealth Research Institute and Associate Research Professor at Arizona State University John Shufeldt School of Medicine, said: "STC‑15 represents a novel, first-in-class approach to treating sarcoma by targeting RNA methylation to disrupt malignant progression. Early clinical activity, supported by biomarker evidence of target engagement and transcriptional modulation, supports further evaluation in this devastating disease with high mortality and limited treatment options."

Jerry McMahon, Chief Executive Officer of STORM Therapeutics, commented: "These data from the Phase 1 sarcoma subset provide encouraging early clinical and molecular evidence supporting STC‑15’s differentiation‑focused mechanism of action. Importantly, we observed a connection between target engagement, downstream transcriptional effects and signals of clinical benefit. For heavily pretreated sarcoma patients with limited treatment options, these results support our ongoing Phase 2 trial and highlight STC-15’s potential to transcriptionally reprogram tumor cells."

STC-15 represents a novel therapeutic approach in sarcoma by targeting RNA methylation to modulate aberrant epitranscriptomic programs that are central to sarcoma biology. In this Phase 1 sarcoma subset, STC-15 demonstrated robust target engagement with substantial reductions in m6A marks accompanied by downstream transcriptional changes. In patients who derived clinical benefit, these changes were associated with decreased enrichment of genes linked to developmental pathways that lead to cancer cell proliferation, mutation and spread.

These findings support the continued clinical evaluation of STC-15 in an ongoing Phase 2 study in selected sarcoma populations, assessing safety, pharmacokinetics, efficacy and exploratory biomarkers. STC-15 is also available to cancer patients under an Expanded Access Program.

Details of the poster presentation are as follows:

Poster Title: A Subset Analysis of Clinical Activity and Pharmacodynamic Biomarkers in Patients with Sarcomas in the Phase 1 Dose Escalation Study of STC-15, a METTL3 Inhibitor
Presenter: Justin C Moser, Associate Clinical Investigator at HonorHealth Research Institute, Scottsdale, AZ
Authors: Justin C Moser1, Jordi Rodon Ahnert2, Kyriakos P. Papadopoulos3, Yaara Ofir- Rosenfeld4, Josefin-Beate Holz4, Melinda Snyder4, Marguerite Hutchinson4, Kristen McCaleb4, Sean Uryu4, Ayush Raman5, Ananya Anmangandla5, Samantha M Carlisle6, Audrey Delgarno6, Laura Hover6, Ian Hoskins6, Gudrun Stengel5, Eric Martin4
Session Type/Title: Poster Session – Sarcoma
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Location: Hall A – Posters and Exhibits
Abstract Number: 11548
Poster Board: 338

(Press release, STORM Therapeutics, MAY 22, 2026, View Source [SID1234666031])

Azer-cel Demonstrates Promising Response Rates in CAR T naïve cohort in ASCO 2026 abstract

On May 22, 2026 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported data from its azer-cel Phase 1b abstract, now published on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website following the lifting of the conference embargo.

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The abstract, titled "Safety and efficacy of Azer-cel, an allogeneic CD19 CAR T for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia not previously exposed to autologous CAR T therapy" reports data from the CAR T-naïve cohort of the ongoing Phase 1b basket study across multiple malignancies.

At the time of the abstract data cut, nineteen patients with relapsed or refractory blood cancers received azer-cel in combination with low-dose IL-2; 16 patients were evaluable for response following their first disease assessment at Day 28. Patients had a median age of 59 years (range 56–73) and included diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), follicular lymphoma (FL) and Waldenström macroglobulinemia (WM). Several patients had received multiple prior therapies, including bispecific antibodies and autologous stem cell transplant.

Among the 16 evaluable patients, the overall response rate (ORR) was 81% (13/16). Responses were observed across multiple lymphoma and leukemia subtypes, including:
• DLBCL: 60% response rate (1 CR [CR], 2 partial responses [PRs])
• MZL: 100% response rate (3 CRs, 1 PR)
• CLL: 100% response rate (3 PRs)
• PCNSL: 50% response rate (1 PR)
• FL: 100% response rate (1 CR)
• WM: 100% response rate (1 PR)

Imugene will present updated data during their oral presentation at ASCO (Free ASCO Whitepaper) on 29May 2026 at 1:00pm. These promising response rates and the broader maturing data package from the basket study informs future clinical development, ensuring we target the specific indications where azer-cel can deliver the strongest clinical impact.

Dr John Byon MD PhD, Chief Medical Officer, commented "Our ASCO (Free ASCO Whitepaper) 2026 abstract supports our clinical strategy and highlights the potential of our off-the-shelf allogeneic CAR-T platform. The response rates seen in this CAR-T naïve patient group, particularly in these heavily pre-treated patients across multiple blood cancer types, are very encouraging. We look forward to presenting the updated dataset during our oral presentation at ASCO (Free ASCO Whitepaper) next week."

Leslie Chong, Managing Director and CEO of Imugene, said "We are excited to showcase these highly encouraging results during our oral presentation at ASCO (Free ASCO Whitepaper) next week. This represents an important milestone for Imugene and further increases the Company’s visibility to an international audience, including leading cancer experts, potential pharmaceutical partners and global investors."

The full abstract is available at asco.org/abstracts (Abstract #7012; DOI:
10.1200/JCO.2026.44.16_suppl.7012).

Dr Supriya Gupta, University of Minnesota will present the data in person at the Rapid Oral Abstract Session — Hematologic Malignancies: Lymphoma and Chronic Lymphocytic Leukemia, on 29 May 2026 at 1:00 PM CDT at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago. The final presentation will be made available at imugene.com/investors/conferencepresentations following the session.

BTKi Combination Cohort

Imugene has recently opened cohort 3 in the Phase 1b protocol to evaluate azer-cel in combination with a Bruton Tyrosine Kinase inhibitor (BTKi) and added Mantle Cell Lymphoma (MCL) as an indication. The combination arm will enrol patients who previously failed BTKi therapy. BTKis are an established standard of care therapy across multiple B-cell malignancies including CLL, MCL, MZL and WM. The global BTKi market reached approximately US$12.0 billion in 2025.

About Dr John Byon MD PhD, Chief Medical Officer

Dr Byon is an accomplished physician-scientist with extensive experience in clinical development and cancer immunotherapy, particularly in CAR-T cell therapy. Prior to Imugene, Dr Byon served as Vice President, Clinical Development, Hematology at Fate Therapeutics, overseeing a portfolio of CAR-NK and CAR-T therapies for hematologic malignancies including acute myeloid leukemia and multiple myeloma. His career also spans leadership roles at Lyell Immunopharma, Juno Therapeutics, and Genentech. Dr Byon holds a Doctor of Medicine and Doctor of Philosophy from Tulane University and a Bachelor of Science from the Massachusetts Institute of Technology.

(Press release, Imugene, MAY 22, 2026, View Source [SID1234665952])

Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors

On May 22, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, reported translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.

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"These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens," said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. "This further underscores Oncolytics’ continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers."

"KRAS-mutant tumors remain among the most challenging to treat with immunotherapy," said Jared Kelly, Chief Executive Officer of Oncolytics. "These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed."

Abstract: Influence of pelareorep on mutant KRAS-specific blood TIL clonal expansion.
Author: Richard Trauger, PhD
Date: May 30, 2026, 1:30-4:30 p.m. Central Time
Abstract Number: 2664
Poster Board Number: 454

Translational analyses from the Phase 1/2 GOBLET study in advanced pancreatic cancer and the AWARE-1 window-of-opportunity study in early-stage breast cancer illustrate a multi‑step immune activation process following treatment with pelareorep. Results demonstrate that pelareorep induces an antiviral immune response within the tumor via double-stranded RNA signaling, leading to expansion of virus‑specific T cells and subsequent activation of tumor‑specific T cells associated with tumor regression.

In pancreatic cancer, serial blood analyses demonstrated expansion of anti‑viral T cells by ELISPOT and clonal expansion of tumor‑specific T cells after one cycle of therapy. Notably, the expansion of pre‑existing tumor‑infiltrating lymphocyte ("TIL") clones in blood correlated with reductions in tumor volume in pancreatic cancer. T‑cell receptor sequencing with antigen specificity assessment confirmed expansion of mutant KRAS-specific T‑cell clones, supporting a model in which pelareorep engages both innate and adaptive immunity and may help drive tumor‑directed immune responses in difficult‑to‑treat, KRAS‑driven disease.

In serial breast tumor biopsies, gene expression profiling demonstrated significant increases in antiviral and immune gene expression, consistent with activation of toll‑like receptor 3 (TLR3), alongside induction of CXCL13, a chemokine linked to the formation of tertiary lymphoid structures (TLS). TLS formation in the tumor microenvironment was further supported by imaging mass cytometry following treatment. Across studies, evidence of the expansion of TILs was observed in the tumor and the blood.

A copy of the ASCO (Free ASCO Whitepaper) presentation will be available on the Media page of the Oncolytics’ website following the conclusion of the meeting.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

Pelareorep in combination with atezolizumab (Tecentriq), gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH ("AIO") emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.

(Press release, Oncolytics Biotech, MAY 22, 2026, View Source [SID1234666016])