On June 12, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for an additional indication as maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer.

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"There is no established standard treatment for maintenance therapy following definitive chemoradiotherapy for locally advanced esophageal cancer. In the SKYSCRAPER-07 study, Tecentriq monotherapy indicated a trend toward improvement in overall survival and progression-free survival compared with placebo. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients as a new therapeutic option as soon as possible," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the global Phase III clinical study (SKYSCRAPER-07/ YO42137)1 in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study is a randomized, double-blind, multicenter trial comparing the efficacy and safety of maintenance therapy with Tecentriq in combination with tiragolumab (development discontinued) or Tecentriq monotherapy versus placebo. Based on the results from the first 2 and second interim analyses, it was confirmed that the Tecentriq monotherapy arm continued to show clinical benefit in the primary endpoint of overall survival (OS) and the secondary endpoint of investigator-assessed progression-free survival (PFS). The results of the second interim analysis are planned to be presented at an upcoming medical congress. The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

About the SKYSCRAPER-07 (YO42137) study1
SKYSCRAPER-07 is a global Phase III randomized, double-blind, multicenter study in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study evaluated the efficacy and safety of Tecentriq plus tiragolumab or Tecentriq monotherapy compared with placebo. Development of the Tecentriq plus tiragolumab combination was discontinued as no clinical benefit was observed in the primary PFS analysis and the first interim OS analysis (cutoff: February 18, 2025)2.

About maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer3
Esophageal cancer has an incidence rate in Japan (2021) of 34.7 per 100,000 population for men and 7.7 per 100,000 population for women. The number of deaths from esophageal cancer in 2024 was 10,638, and the 5-year relative survival rate (2009–2011) was 41.5%.
In Japan, squamous cell carcinoma is the most common histologic type. In unresectable, locally advanced esophageal squamous cell carcinoma, there is no clearly established standard treatment for patients without disease progression after definitive chemoradiotherapy, and new treatment options are needed.

About Tecentriq4
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JUN 11, 2026, View Source;category= [SID1234666579])

On June 11, 2026 Kyntra Bio (Nasdaq: KYNB) reported additional data from the Phase 3 MATTERHORN trial showing improvements in transfusion independence in patients with anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) treated with roxadustat will be presented as a poster at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026, taking place June 11-14, 2026 in Stockholm, Sweden.

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"In addition to roxadustat demonstrating clinically meaningful efficacy in patients with lower-risk MDS and high transfusion burden, improvements in transfusion independence in both RS+ and RS- disease were also observed in this post-hoc analysis, which is an important finding given the limited effectiveness of currently available treatment options for patients with RS- disease," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "These findings underscore the potential of roxadustat to elevate the standard of care for patients with lower-risk MDS who are in need of additional treatment options. We are finalizing the protocol for the pivotal Phase 3 trial, which we expect to initiate in the second half of 2026, with the aim to build upon and confirm these findings in patients with lower-risk MDS and high transfusion burden, including both RS+ and RS- disease."

"Through this novel MOA, stabilizing HIF1-⍺, thereby normalizing erythroid precursor development and improving hemoglobin production, these findings highlight the potential for roxadustat to address a significant unmet need, providing a convenient, well-tolerated and effective treatment option for anemia in patients with LR-MDS independent of RS histology," said Amer Zeidan, MD, Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center. "This post-hoc analysis from the MATTERHORN trial shows clinically meaningful RBC transfusion independence among high transfusion burden patients, as well as clear evidence of hemoglobin increase among patients who received roxadustat compared to placebo. I am excited to be able to share this data with the MDS community at the EHA (Free EHA Whitepaper) meeting and believe they provide strong rationale for the planned randomized Phase 3 trial in anemic patients with LR-MDS and high RBC transfusion burden," concluded Dr. Zeidan, who is also the global principal investigator of the planned randomized Phase 3 trial.

As previously disclosed, the initial analysis with all of the patients who participated in the Phase 3 MATTERHORN trial showed that more patients receiving roxadustat achieved transfusion independence vs. placebo (48% vs. 33%; p=0.22). The presentation highlights data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS- patients. In RS- patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for ≥8 weeks over 28 weeks in 48% of patients vs. 28% for placebo.

The presentation at EHA (Free EHA Whitepaper) also provides additional details on the subgroup of patients (n=37) who met the criteria of HTB (≥ 4 units pRBCs per 8-week period for 2 consecutive 8-week periods) per IWG-2018, where roxadustat achieved clinically meaningful efficacy in patients with LR-MDS and HTB with higher rates of ≥8-, 12-, 16-week RBC TI vs placebo. TEAEs were generally lower grade and managed medically with no new safety signals.

The poster presentation, titled "Roxadustat improves transfusion independence in LR-MDS patients with anemia and high transfusion burden and in ring sideroblast positive and negative disease: post-hoc analysis of MATTERHORN study" is scheduled for the poster session taking place on June 12, 2026 at 18:45 CEST.

The pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA.

About Myelodysplastic Syndromes Anemia
Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S., thereof 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, Kyntra Bio, JUN 11, 2026, View Source [SID1234666578])

On June 11, 2026 Genmab A/S (Nasdaq: GMAB) reported new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), which showed that epcoritamab + R2 delivered consistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score). These results were presented during an oral presentation (abstract S229) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress held in Stockholm, Sweden, June 11 -14, 2026.

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"The EPCORE FL-1 trial, bolstered by this subgroup analysis, established fixed-duration epcoritamab in combination with R2 for relapsed or refractory follicular lymphoma," said Benoit Tessoulin, M.D., Ph.D., Nantes University School of Medicine & University Hospital. "It delivers consistent efficacy and a manageable safety profile, regardless of comorbidity burden."

The EPCORE FL-1 trial randomized a total of 481 patients, with 243 receiving epcoritamab + R2 and 238 receiving R2 alone. The subgroup analysis of the Phase 3 EPCORE FL-1 trial was performed to assess the benefit and tolerability of epcoritamab + R2 across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared with standard of care R2.

The data demonstrated that progression-free survival (PFS) benefits continued to favor epcoritamab + R2, with hazard ratios (HR) consistently below 0.3 across FLIPI 0–2 (0.18 [0.10–0.33]) and FLIPI 3–5 (0.25 [0.15–0.42]), POD24 (HR 0.22 [95% CI 0.13–0.37]), and non-Hodgkin lymphoma 5 (NHL-5) subgroups (low: HR 0.27 [0.17–0.42]; H+I, high and intermediate: HR 0.14 [0.06–0.29]), indicating a substantially reduced risk of disease progression or death.

Additionally, overall response rates (ORR) were higher with the combination of epcoritamab and R² compared to R² alone across different FLIPI risk groups. For patients with FLIPI scores of 0–2, the ORR was 96.5% with the combination versus 84.8% for R2 alone. In patients with FLIPI scores of 3–5, the ORR was 93.0% with the combination compared to 72.6% with R2 alone. Moreover, complete response rates (CRR) were consistently higher with epcoritamab and R² across all analyzed subgroups. In patients with lower FLIPI scores (0–2), the CRR was 86.6% with the combination, compared to 62.1% for R2 alone. Among those with higher FLIPI scores (3–5), the CRR was 77.0% for the combination versus 35.4% for R² alone. Similar improvements in CRR were noted among non-POD24 patients (85.5% vs. 57.6%) and across various patient fitness categories, including NHL-5 low-risk patients (81.3% vs. 50.3%) and H+I patients (85.7% vs. 49.0%).

The safety profile of epcoritamab + R2 was manageable across all patient subgroups and consistent with that observed in the overall trial population, with no new safety signals identified. Although adverse events such as neutropenia and infections were more frequent among patients receiving lower lenalidomide doses, the consistent and sustained efficacy of epcoritamab + R2 compared with R² alone was maintained in this subgroup. These findings are consistent with standard clinical practice, in which lenalidomide dose reductions are routinely implemented to manage adverse events while preserving treatment benefit in combination with epcoritamab.

"The EPCORE FL-1 subgroup analysis demonstrated consistent and deep responses with a manageable safety profile across all patient characteristics, including varying risk profiles and lenalidomide dosing schedule, which validate the potential of the combination therapy," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "These data strongly reinforce our belief that epcoritamab, combined with rituximab and lenalidomide, is poised to transform the treatment paradigm, offering a highly effective and broadly accessible option for relapsed or refractory follicular lymphoma."

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR).

More information on this trial can be found at www.clinicaltrials.gov/.

About Follicular Lymphoma (FL)
Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases.i FL is considered incurable.ii Patients often relapse, and with each relapse the remission and time to next treatment shorten.iii Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.iii,iv

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, JUN 11, 2026, View Source [SID1234666577])

On June 11, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported encouraging long-term results from the Phase 1/2 KOMET-007 single-arm trial (NCT05735184) evaluating ziftomenib in combination with intensive chemotherapy, 7+3, in newly diagnosed NPM1-m or KMT2A-r AML. These results will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress.

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These data compare favorably to historical standard-of-care data with 7+3 alone:

NPM1-m Patients KOMET-0071 Historical 7+3 Benchmark
CR

Age ≤ 65 years
Age > 65 years

91% (31/34)
100% (15/15)

88%2
56%2
CRc 96% 56-89%2,3,4
CR MRD- (bone marrow) 56% 44%5
12-month OS rate 94% ~ 70-80% in younger fit patients3,4,5
~ 45-55% in patients > 65 years old2,6

1KOMET-007 (N=49) at 600 mg ziftomenib; MRD neg < 10-4; 2Lachowiez et al., Blood Adv. 2020; 4(7): 1311–1320; 3Hernández-Sánchez et al., Leukemia. 2026; 40(2): 418-428; 4Othus et al. Leukemia. 2019; 33(2):371-378; 5Othman et al., Blood. 2024; 144(7):714-728, including Supplemental Material; 6Recher et al., Leukemia. 2022; 36(4): 913-922.

Overall Survival (OS) for NPM1-m Patient Subset in Single-Arm KOMET-007 Trial: Median OS Not Reached

Kura Oncology

KOMZIFTI (ziftomenib) is approved by the U.S. Food and Drug Administration (FDA) as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The use of ziftomenib in combination with 7+3 is investigational and has not been approved by any health authority.

"The updated results from the KOMET-007 trial provide important evidence supporting the safety and clinical activity of adding ziftomenib to intensive chemotherapy for patients with newly diagnosed NPM1-m and KMT2A-r AML," said Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies at Yale Cancer Center and Professor of Medicine at Yale School of Medicine, and the lead investigator for the registrational KOMET-017 program. "Across nearly 100 patients treated to date, composite remission rates reaching 90-96%, high rates of MRD negativity and encouraging durability are especially meaningful in a disease where depth of response can inform long-term treatment decisions. The 12-month survival estimate of 94% for the NPM1-m patient cohort is particularly impressive. Based on the results observed to date, this regimen could represent a transformative therapeutic approach and may allow some patients to avoid allogeneic hematopoietic cell transplantation, a procedure that carries a significant risk of mortality and morbidity. We will continue to follow patients to assess long-term safety and clinical activity, including outcomes for those who do not undergo transplantation, and these results continue to strongly support the registrational Phase 3 KOMET-017 trials."

As of the data cut-off on April 10, 2026:

High remission rates across both molecular subtypes

96% CRc and 98% ORR in NPM1-m AML, 90% CRc and 92% ORR in KMT2A-r AML
Deep molecular responses, including marrow central MRD assessment

Local CRc MRD-negativity rates were 85% in NPM1-m AML and 82% in KMT2A-r AML
In NPM1-m AML, marrow central MRD negativity (10-4, NGS) among CRc responders was 79% (31/39) at the <0.1% threshold and 56% (22/39) at the <0.01% threshold, with all CRc responders who achieved central MRD negativity doing so by Cycle 2
Durable responses and encouraging durability with extended follow-up

After median follow-up of nearly 18 months (range 1.0-23.5) in NPM1-m AML and 11.0 months (range 0.9-21.9) in KMT2A-r AML, median duration of complete response was not reached for the NPM1-m AML cohort and was 12 months for the KMT2A-r AML cohort
Median OS was not reached, with median follow-up of 17.6 months in NPM1-m and 11.0 in KMT2A-r, respectively
NPM1-m: 94% OS rate at 12 months (range 1.0-23.5)
KMT2A-r: 71% OS rate at 12 months (range 0.9-21.9)
The majority of patients remained alive and continued on study at time of data cut-off:
NPM1-m: 90% (44/49)
KMT2A-r: 62% (31/50)
Consistent and manageable safety profile

Ziftomenib 600 mg once-daily plus 7+3 was generally well tolerated, with no new or unexpected safety signals observed with longer follow-up
Low rates of ziftomenib-related cytopenias and minimal additive myelosuppression were observed with this combination
Ziftomenib 600 mg once-daily did not delay neutrophil or platelet count recovery
No Grade 4 differentiation syndrome or QTc prolongation events were reported
Four patients (4%) experienced Grade 3 differentiation syndrome; all cases successfully resolved with protocol-specified mitigation and three continued on ziftomenib treatment
Three patients (3%) experienced Grade 3 investigator-assessed QTc prolongation (all three on azole antifungals, fluoroquinolones, or other medications at time of assessment; one with ongoing hypokalemia and hypomagnesemia); none were assessed as ziftomenib-related and all QTc events successfully resolved with all patients continuing on ziftomenib treatment
60-day mortality rate of 2% (1/49) in NPM1-m patients
"KOMET-007 has meaningfully strengthened the scientific and clinical foundation for KOMET-017 after ziftomenib was successfully integrated into intensive frontline therapy resulting in high remission rates, deep molecular clearance, encouraging durability and a favorable tolerability profile," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data increase our confidence in the ongoing registrational program and support the potential for ziftomenib to serve as a foundational menin inhibitor backbone in frontline AML. Importantly, as more patients in clinical trials receive ziftomenib earlier in the treatment course and remain on therapy for longer periods, we believe there may be an opportunity to extend the benefit of menin inhibition beyond induction and deepen its impact across the AML treatment continuum."

"These data strongly support the continued study of ziftomenib as part of a frontline regime in newly diagnosed AML," said Yoshifumi Torii, Ph.D., Chief Medical Officer of Kyowa Kirin. "We view the high remission rates, along with deep MRD negativity and encouraging durability, as particularly meaningful. Despite advances in treatment, AML remains associated with a high risk of relapse, underscoring the continued need for improved long-term treatment strategies. These results suggest that ziftomenib, when combined with standard therapy, has the potential to advance the current treatment paradigm. We look forward to further evaluating its clinical value through the ongoing Phase 3 KOMET-017 trial."

The companies plan to publish these data in a peer-reviewed publication in the second half of 2026.

Copies of the presentation will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies and Professor of Medicine at Yale School of Medicine, and the lead investigator for the registrational KOMET-017 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

Abbreviations
7+3 (cytarabine plus daunorubicin), AML (acute myeloid leukemia), CR (complete response), CRc (composite complete remission), KMT2A-r (KMT2A-rearranged), MRD (measurable residual disease), NGS (next-generation sequencing), NPM1-m (NPM1-mutant), ORR (objective response rate), OS (overall survival), QTc (corrected QT interval)

(Press release, Kura Oncology, JUN 11, 2026, View Source [SID1234666576])

On June 11, 2026 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that clinical and translational results from VCN-01’s Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) were recently published on-line first in the journal Clinical Cancer Research. The article, titled "Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy", can be read here.

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"We are very excited to see Clinical Cancer Research share the VCN-01 results in immunotherapy-refractory metastatic HNSCC patients with the broad oncology community," said Ricard Mesia (Catalan Institute of Oncology, ICO), expert on HNSCC and coordinating investigator in this study. "The trial demonstrates the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab. Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results from the study all support the VCN-01 stroma-degrading mode-of-action, being investigated to enhance tumor penetration by VCN-01 and coadministered therapies and enable/enhance an anti-tumor immune response. There are very few treatment options available to immunotherapy-refractory metastatic HNSCC patients, and the clinically impactful findings from this report encourage further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies."

Data summary – VCN-01 Phase 1 clinical trial (NCT03799744) in metastatic, immunotherapy-refractory Head & Neck Squamous Cell Carcinoma (HNSCC)

The trial enrolled 20 adult patients with refractory or metastatic HNSCC, whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors. Six patients were enrolled into the concomitant Arm I LD of the study and were administered IV low dose VCN-01 (3.3E12 virus particles; LD) four hours prior to a fixed IV dose of durvalumab (1500 mg/q4w). Eight patients were enrolled into the sequential Arm II LD of the study, receiving low dose IV VCN-01 14 days prior to IV durvalumab administration. An additional six patients were entered into Arm II HD, receiving high dose IV VCN-01 (1.0E13 virus particles; HD) 14 days prior to IV durvalumab administration.

Median progression-free survival (PFS) was 1.6 months in Arm I LD, 3.7 months in Arm II LD, and 2.1 months in Arm II HD.
Median overall survival (OS) was 10.3 months in Arm I LD, 15.5 months in Arm II LD, and 17.3 months in Arm II HD.
Circulating levels of the stroma-degrading hyaluronidase enzyme PH20 (expressed during selective VCN-01 intratumoral replication) increased significantly after VCN-01 administration in all tested patients, peaking on day 3-8 for most patients and detectable until day 28 in 11 of 12 patients.
Similarly, VCN-01 viral genome levels detected in patient blood exhibited an initial peak immediately following administration and a secondary peak on day 3-8, consistent with continued viral replication in tumors followed by a return of virus to circulation.
Upregulation of CD8 and IDO was observed in tumor biopsy samples, consistent with increased tumor infiltration by activated cytotoxic T cells – historically associated with increased HNSCC patient survival. Diminished levels of FoxP3, CD25, and CTLA4 were also observed, consistent with a reduction in tumor Tregs and inhibition of tumor immunosuppression.
Tumor biopsies revealed upregulation of PD-1 and PD-L1 in most patients following VCN-01 administration that correlated with patient survival, suggesting that immune system activity and heightened PD-L1 expression in tumors contributed to the improved outcomes from VCN-01 and durvalumab combination.

(Press release, Theriva Biologics, JUN 11, 2026, View Source [SID1234666575])