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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.

"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.

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])

Crinetics Pharmaceuticals to Participate in Jefferies Global Healthcare Conference 2026

On May 22, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that company management will participate in the Jefferies Global Healthcare Conference, taking place June 2-4, 2026 in New York, NY.

Management will be available for 1×1 meetings with investors on Wednesday, June 3, 2026. If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

(Press release, Crinetics Pharmaceuticals, MAY 22, 2026, View Source [SID1234666027])

Pivotal Trial Data for EP0031 (A400), a Next-Generation Selective RET Inhibitor (SRI), in RET Positive Advanced NSCLC, to be Presented at ASCO 2026

On May 22, 2026 Ellipses Pharma ("Ellipses"), a global oncology drug development company with a pipeline of innovative programmes, reported that its partner, Kelun-Biotech, is presenting pivotal trial data for EP0031/A400, for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC), at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Chicago, May 29 to June 2.

Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET-fusion positive non-small cell lung cancer (NSCLC), will be presented as an oral presentation scheduled on May 29, 2026, 14:36-14:48 local time (Abstract #8505: Lung Cancer – Non-Small Cell Metastatic).

The oral presentation of these data at the prestigious ASCO (Free ASCO Whitepaper) annual meeting, represents another major milestone in the global development of EP0031/A400 as a next generation SRI.

The data were generated in Kelun-Biotech’s Phase 2 study (NCT05265091) that evaluated the efficacy and safety of EP0031/A400 90mg orally once daily (QD) in patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic, NSCLC. EP0031/A400 demonstrated robust efficacy in both cohorts and an encouraging, manageable tolerability and safety profile. In September 2025 Kelun-Biotech submitted an NDA for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) which was accepted for review by the NMPA of China.

EP0031/A400 is being developed jointly by Ellipses and Kelun-Biotech. Ellipses has been granted an exclusive licence to develop, manufacture and commercialise this agent outside Greater China and certain Asian countries under the code EP0031.

Ellipses has an ongoing Phase 1/2 trial in US, EU, UK and UAE (EP0031-101 NCT05443126). Phase 2 cohorts are currently evaluating the combination of EP0031/A400 with platinum doublet chemotherapy in patients with RET-fusion positive NSCLC that are naïve to or have previously received 1st generation SRI. Data supporting the strong preclinical rationale for this combination strategy were recently presented at the annual European Lung Cancer Congress 2026 (ESMO Open Volume 11, Suppl 3, https://www.sciencedirect.com/science/article/pii/S2059702926007490).

Professor Sir Christopher Evans, Chairman, Ellipses Pharma, commented: "We congratulate our partners Kelun-Biotech on the tremendous progress they have made with the development of EP0031/A400 in China. The presentation of these exciting data from the pivotal trial represents a significant step in the development of this agent for patients globally. Ellipses is immensely proud to be partnering with Kelun-Biotech and continues to make significant progress with the development of EP0031/A400 for patients outside Greater China."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma, commented: "Congratulations to our colleagues at Kelun-Biotech on the acceptance of these data for oral presentation at ASCO (Free ASCO Whitepaper). These data further establish the credentials of EP0031/A400 as a promising next-generation SRI. We look forward to continuing to build our data in the Ellipses trial to ensure EP0031/A400 is brought to Western patients as early as possible.’

About EP0031/A400

EP0031/A400 has broad and potent activity against the spectrum of common RET fusions and mutations, as well as RET resistance mutations that have been shown to emerge on progression on 1st gen SRIs. EP0031 has a differentiated preclinical profile compared with 1st gen SRIs with greater potency and antitumour activity in SRI naïve and SRI resistant PDX models as well as greater tissue permeability, with increased exposure in the CNS and improved survival in orthotopic models.

Data from the dose finding and optimisation cohorts, which evaluated EP0031/A400 as a monotherapy, were presented at ASCO (Free ASCO Whitepaper) in June 2025, showing promising evidence of activity, including CNS responses, in patients with advanced NSCLC that had received prior 1st generation Selective RET Inhibitor (SRI), with encouraging safety and tolerability (Journal of Clinical Oncology Volume 43, Number 16_suppl View Source).

In November 2023, Ellipses announced it had secured Orphan Drug designation for EP0031/A400 from the US Food and Drug Administration (FDA) for EP0031/A400 for the treatment of RET-fusion positive tumours.

About RET altered malignancies

Activating RET mutations and rearrangements have been identified as actionable drivers of oncogenesis in numerous tumour types and are most prevalent in non-small cell lung and thyroid cancer. It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours. After the successful development of first generation SRIs and an increasing understanding of escape mechanisms to these agents, there is an unmet need to develop new treatments that can address acquired resistance, including the development of next-generation SRIs.

(Press release, Ellipses Pharma, MAY 22, 2026, View Source [SID1234666026])