Entry into a Material Definitive Agreement

On May 24, 2026, Viridian Therapeutics, Inc. (the "Company") reported to have entered into a Commercial Manufacturing Services Agreement (the "Agreement") with WuXi Biologics (Hong Kong) Limited ("WuXi Biologics") pursuant to which WuXi Biologics will manufacture and supply the Company’s anticipated long-term supply requirements of veligrotug drug substance and drug product for commercial use (the "Product"), if approved. Wuxi Biologics will be a non-exclusive supplier of the Product to the Company and the Company may procure the Product from one or more alternate manufacturers of the Product.

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Under the Agreement, the Company will provide rolling forecasts of volume requirements to WuXi Biologics on a monthly basis (each, a "Forecast"). A portion of each Forecast will be considered a binding and non-cancellable commitment of the Company. The parties have agreed to volume-based pricing under the Agreement. The Product service fee will remain fixed until December 31, 2026 and thereafter may be annually adjusted based on a volume-based structure. The Company will also reimburse WuXi Biologics for certain pass-through costs.

The Agreement has an initial term of five years and will automatically renew for successive five-year periods unless either party provides notice of non-renewal at least 24 months prior to the expiration of the initial term or any renewal period. The Company may terminate the Agreement upon 30 days’ prior notice to WuXi Biologics if there is a change in applicable laws that materially and adversely impacts WuXi’s Biologics ability to perform services under the Agreement. Additionally, each party may terminate the Agreement upon an uncured material breach of the Agreement by the other party or upon the other party’s insolvency or bankruptcy.

The Agreement contains customary provisions relating to, among other things, delivery, quality, change procedures, regulatory compliance, confidentiality, dispute resolution, warranties, and indemnification.

The foregoing description of the terms of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement, a copy of which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the period ended June 30, 2026.

(Filing, Viridian Therapeutics, MAY 24, 2026, View Source [SID1234666059])

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])

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])

BriaCell Presentations Highlight Positive Clinical Data for Bria-IMT™ at ASCO 2026

On May 22, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported positive clinical data from three clinical data poster presentations and three publication-only abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2, 2026 at McCormick Place, Chicago, Illinois. The presentations will include two poster presentations featuring data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor, Bria-ABC (ClinicalTrials.gov identifier: NCT06072612), and one poster highlighting further analyses of Phase 2 data.

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"These data from the ongoing pivotal Phase 3 Bria-ABC study highlight Bria-IMT’s potential to preserve quality of life, limit toxicity, and potentially support self-administration — benefits that would be clinically meaningful for patients," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women’s Cancer Program.

"The Phase 2 study of the combination of a whole-cell vaccine with anti-PD-1 demonstrated a tolerable safety profile and the emergence of a long-term survivor cohort inclusive of the heavily pre-treated nature of these patients," stated Saranya Chumsri, M.D., principal investigator in the Phase 3 study of Bria-IMT+CPI, and Professor of Oncology at Mayo Clinic Florida. "I’m proud to do this work that brings new attention to metastatic breast cancer patients who have few or no remaining treatment options."

"Our positive clinical data across six presentations or abstracts at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting highlight the progress we are making in our clinical programs," noted William V. Williams, MD, BriaCell’s President & CEO. "These data reflect our commitment to advancing innovative therapeutic options for patients with cancer patients who need better treatments."

The details of the presentations and publish-only abstracts are listed below.

Abstract Title: Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months.
Session Type/Title: Poster Session – Breast Cancer—Metastatic
Poster Board: 222
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Clinical Data: 32 Phase 2 Bria-IMT patients were randomized to receive immune checkpoint inhibitor (CPI) in the first cycle or delayed to the second cycle. Two Bria-IMT formulations were also evaluated. Patients had median age of 61 (range 41-80) and had received median 6 prior therapies (range 2-13). Median overall survival (OS) was 13.3 vs. 7.4 months for starting CPI in cycle 1 versus cycle 2. In patients who developed an immune response as measured by delayed-type hypersensitivity (DTH) positive vs. negative, OS was 11.9 vs. 4.7 months, with 48% 12-months survival vs 0.0% 12-month survival. Patients with circulating tumor cells (CTCs) <5 vs. > 5 at baseline had median OS of 16.6 vs. 5.5 months. Median OS was 16.6 months for the formulation selected for the Phase 3 study with 52% of patients surviving at 12-months. The 12-month survival rate was 44% and the 24-month rate was 26%. There were no treatment-related discontinuations and no unexpected safety signals.

Conclusions: In heavily pretreated MBC patients, Bria-IMT demonstrated a tolerable safety profile and the emergence of a long-term survivor cohort. Durable survival rates were observed beyond 12 and 24 months. Differential survival favored the Phase 3 formulation, DTH positivity, lower baseline circulating tumor cell (CTC) levels, and early CPI sequencing. These findings support prospective validation of DTH and CTC as predictive biomarkers for effectiveness of the Bria-IMT regimen and the continued use of the Phase 3formulation in the ongoing Phase 3 study Bria-ABC.

Abstract Title: Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer.
Session Type/Title: Poster Session – Breast Cancer—Metastatic
Poster Board: 221
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Summary: Heavily pretreated MBC patients in the pivotal Bria-ABC demonstrated stable global health and key functional domains. Measurements included quality of life (QOL) and time without symptoms or toxicity (TWiST). Blinded data indicated that QOL was largely preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure. Clinical data demonstrates meaningful benefits without significant toxicity. Ongoing follow up will further characterize durability of patient-reported outcomes and clinical correlation. Data further supports decentralized care and potential home self-administration of the Bria-IMT+CPI regimen.

Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC Phase 3 trial for advanced metastatic breast cancer: An ongoing analysis.
Session Type/Title: Poster Session – Developmental Therapeutics—Immunotherapy
Poster Board: 442
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Summary: In an ongoing analysis of heavily treated MBC patients, we observed that in the entire blinded population, 65% of patients had stability/drop in Cancer-Associated Macrophage-Like cells (CAMLs) and this significantly correlated with better progression free survival (PFS). Treatment arm specific comparisons will not be unblinded until completion of the designated milestone (144 mortalities).

Publication-Only Abstract Title: Cell-based second-generation immunotherapy BC1 in metastatic breast cancer.
Summary: Dose escalation from 20M to 60M and combination with CPI showed tolerable intradermal BC1, Bria-OTS, and potential clinical benefit in refractory MBC patients. One patient received 17 cycles with 12 months of disease control. Expansion cohorts will assess HLA match, DTH, dose optimization, and combination activity. Based on very early preliminary data, BC1, Bria-OTS first generation, is a potential new option for late-stage cancer patients with minimal toxicity and potential home administration as a single agent. Clinical trial information: NCT06471673.

Publication-Only Abstract Title: Liquid biopsy to stratify metastatic breast cancer progression risk using multi-analyte cell subtyping prior to systemic therapy.
Summary: Circulating tumor cells were uncommon in metastatic breast cancer patients but correlated with very poor clinical outcomes. In parallel analysis, CAMLs were common with CAML size correlating with increasingly poorer outcomes. By combining CTC & CAML subtypes, MBC patients were more accurately stratified by risk of progression and death. Additional multivariate studies correlating treatment class and tumor response rates are ongoing.

Publication-Only Abstract Title: Monitoring PD-L1 expression in circulating cancer associated cells for prediction of clinical outcomes in metastatic breast cancer patients treated with immune checkpoint inhibitors.
Summary: In this study of MBC patients treated with programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (ICIs), tissue combined positive score (for PD-L1) did not correlate with PD-L1 expression in CTCs or tumor-macrophage fusion cells. Further, neither Combined Positive Score (CPS) nor baseline PD-L1 in CTC/ tumor-macrophage fusion cells (TMFCs) predicted clinical outcomes in ICI therapies. However, PD-L1 in CTC/TMFCs~40 days post-induction of ICI did predict better response rates. While this study suggests predictive value of monitoring PD-L1 in blood during ICI therapies, further studies are required to refine and validate these findings.

Following the presentation, copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, MAY 22, 2026, View Source [SID1234666029])

2026 ASCO | Pivotal Data of InnoCare’s Novel BCL2 Inhibitor Mesutoclax Released

On May 22, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the abstracts of two clinical studies of the Company’s novel BCL2 inhibitor mesutoclax have been published on the official website of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The study of mesutoclax for the treatment of myeloid malignancies was selected for an oral presentation at this year’s ASCO (Free ASCO Whitepaper) annual meeting, and the research on mesutoclax for B-cell malignancies was chosen for a poster presentation.

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The following data has just been released on the ASCO (Free ASCO Whitepaper) official website, with updated oral presentation data to be announced on June 2 Central Time. The data show that mesutoclax demonstrates outstanding efficacy and safety in treating various hematologic malignancies.

Oral Presentation

Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies (Abstract No.: 6506)

The study enrolled patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Mesutoclax has demonstrated favorable safety and efficacy in the treatment of both MDS and AML.

Among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including complete response (CR) in 20%, and marrow CR in 80%. The composite CR rate was 70% per IWG 2023 criteria including 30% CR even when most patients only received 1 cycle treatment.

Among the evaluable TN AML patients, 85.7% achieved composite CR (cCR, CR+CRi). Among those who achieved cCR, 86.7% were MRD (Minimal Residual Disease) negative per flow cytometry. cCR was 75% in adverse risk per 2017 ELN classification. The duration of response (DOR) rate at 3 months was 91.7%. The 6-month overall survival (OS) rate was 94.1%.

There were no dose-limiting toxicity (DLT) or tumor lysis syndrome (TLS) events in the study.

The updated research data, including findings from studies on relapsed or refractory (R/R) AML patients (including those with prior BCL2 inhibitor treatment failure), hematologic recovery, and data related to the TP53-mutated population, will be further disclosed following the oral presentation at the ASCO (Free ASCO Whitepaper) annual meeting.

Poster Presentation

Efficacy and safety of mesutoclax (ICP-248) in combination with orelabrutinib in patients with B-cell malignancies: A pooled analysis (Abstract No.: 7073)

The study enrolled patients with R/R mantle cell lymphoma (MCL), R/R marginal zone lymphoma (MZL), and TN chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The data demonstrated that mesutoclax combined with orelabrutinib exhibited favorable efficacy and safety in the treatment of these B-cell malignancies, suggesting that this all oral, chemo-free regimen has the potential to establish a novel therapeutic option for patients with B-cell non-Hodgkin lymphoma.

All treatment groups achieved an overall response rate (ORR) of 100% and a high complete response rate (CRR). Deep response was observed in patients receiving mesutoclax 125mg combined with orelabrutinib.

Among MCL and MZL patients who had at least one disease evaluation, the CRR was 100% and 50% respectively. 38.5% of patients achieved peripheral blood (PB) undetectable MRD (uMRD).

For TN CLL/SLL, 76.2% of patients had moderate or high TLS risk, and 14.3% had TP53 mutation or del (17p). In the CLL/SLL patients receiving mesutoclax 125 mg, the CRR was 38.1%, and the peripheral blood uMRD rate at 36-week was 65%. The 12-month progression-free survival (PFS) rate was 100%.

Mesutoclax in combination with orelabrutinib demonstrated a tolerable safety profile in all treatment groups. No treatment-related adverse events (TEAEs) leading to drug discontinuation or death reported. No clinical or laboratory TLS occurred.

Note:

1. IWG criteria refers to International Working Group (IWG) response criteria in myelodysplasia.

2. CRi refers to complete response with incomplete hematologic recovery.

(Press release, InnoCare Pharma, MAY 22, 2026, View Source [SID1234666028])