On June 11, 2026 Arima Genomics, Inc., a cancer diagnostics company bringing DNA sequence and structure together to advance cancer therapy selection, reported new data to be presented at the Association for Molecular Pathology (AMP) 2026 Europe Congress, taking place June 15–17, 2026, in Tallinn, Estonia.

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The new findings demonstrate that Arima’s Hi-C sequencing-based approach, available clinically through the Aventa Lymphoma test, identified clinically relevant lymphoma rearrangements missed by high-coverage whole genome sequencing (WGS), including rearrangements involving key lymphoma-associated genes such as MYC, BCL2, BCL6, CCND1, and IRF4. The presentation builds on previously presented data showing Hi-C sequencing can overcome limitations of fluorescence in situ hybridization, or FISH, by enabling genome-wide detection of diagnostic, prognostic, and therapeutic biomarkers from FFPE lymphoma specimens.

In the WGS comparison study, 25 FFPE lymphoma specimens containing 37 clinically relevant structural variants previously identified by Hi-C sequencing and validated by orthogonal methods were analyzed using high-coverage WGS. Despite average raw sequencing coverage of 180×, with a range of 132× to 238×, many rearrangements remained undetected by two different WGS analysis pipelines. The DRAGEN Somatic Pipeline identified 19 of 37 rearrangements, representing just 51% recall when compared to Hi-C sequencing, while Sentieon TNscope showed improved but still incomplete detection, with performance particularly limited for immunoglobulin-associated rearrangements.

WGS detection was lower for rearrangements involving immunoglobulin partners than for non-immunoglobulin rearrangements. DRAGEN detected seven of 16 (44%) immunoglobulin-associated rearrangements and 12 of 21 (57%) non-immunoglobulin rearrangements, while Sentieon TNscope detected eight of 16 (50%) and 15 of 21 (71%), respectively. Key lymphoma-associated genes were also missed across both pipelines: BCL6 was missed in three of 11 cases (27%) by Sentieon and four of 11 cases (36%) by DRAGEN; MYC was missed in four of eight cases (50%) by both algorithms; and BCL2 was missed in two of six cases (33%) by both algorithms.

"Rearrangements are central to lymphoma diagnosis and classification, but they remain challenging to detect reliably with methods that were not designed to directly capture genome structure," said Anthony Schmitt, PhD, Senior Vice President, Science, Arima Genomics. "These data show that even deep whole genome sequencing can miss a substantial fraction of clinically relevant rearrangements in FFPE lymphoma specimens. By providing a more direct view of genome structure, Hi-C sequencing enables high-resolution detection of rearrangements that are critical for accurate lymphoma workup. Together with prior data showing advantages over FISH, these findings support Hi-C as a powerful approach for comprehensive rearrangement detection in routine lymphoma biopsies."

Arima will also present additional data demonstrating Hi-C sequencing shows superior performance to FISH. These data further support the use of Hi-C sequencing as a genome-wide approach to detect guideline-recommended and emerging cytogenomic biomarkers in lymphoma.

Presentation Details

Title: Hi-C FFPE Sequencing Outperforms High-Coverage WGS for Detection of Diagnostic Fusions and Rearrangements in Lymphoma

Oral Presentation:
Abstract Presentation Session 3 – Hematopathology: Wednesday, 17 June 2026, 13:00–14:00 EEST
Poster Session 2:
Poster Number H-04: Wednesday, 17 June 2026, 9:00–9:45 EEST
Title: Hi-C FFPE Sequencing for Detection of Fusions and Rearrangements that are Diagnostic, Prognostic, and Therapeutic Biomarkers in Lymphoma

Poster Session 2:
Poster Number H-10: Wednesday, 17 June 2026, 9:00–9:45 EEST

(Press release, Arima Genomics, JUN 11, 2026, View Source [SID1234666590])

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])

On June 11, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported new research findings at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (EHA2026), June 11-14, in Stockholm, Sweden. Shared in two poster presentations, the data demonstrated encouraging safety and efficacy results in both adult and pediatric patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (R/R T-ALL/LBL), a disease with limited treatment options and poor prognosis.

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Patients with R/R T-ALL/LBL face substantial treatment challenges due to paucity and limited efficacy of available therapies. Findings presented at EHA (Free EHA Whitepaper)2026 highlight the value of CTD402 as an "off-the-shelf", point-of-care-ready CAR-T cell therapy for heavily pretreated pediatric and adult patients.

TENACITY-01 A Global Study of CTD402, Allogeneic Anti-CD7 CAR T-Cell, In Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL)

In a second poster presentation delivered by Dr. Lori Muffly of Stanford Medicine, preliminary data from TENACITY-01, a global Phase 1b/2 study of CTD402, was featured. As of June 8th, 2026, seven patients with R/R T-ALL/LBL received CTD402 at the recommended phase 2 dose following standard lymphodepletion chemotherapy. The therapy demonstrated an overall response rate of 85.7% (6/7 patients) and an overall complete remission (CRc = CR + CRi) rate of 71.4% (5/7 patients), with 80% (4/5) achieving MRD-negative status.

The safety profile has been manageable, with low-grade (<=G2) cytokine release syndrome observed in 86% of patients and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome observed in 29% of patients. Notably, no cases of immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were reported. CTD402 demonstrated robust pharmacokinetics with peak expansion at Day 10 and persistence beyond 28 days in 60% of patients. One highlighted case involved a heavily pretreated patient with 90% bone marrow blasts and extensive extramedullary disease who achieved complete remission with incomplete hematologic recovery and successfully transitioned to allogeneic hematopoietic stem cell transplant, continuing in remission thereafter.

"These results from TENACITY-01 validate our earlier CTD402 findings in a global setting," said Lori Muffly, MD, MS, of Stanford Medicine. "We’re now seeing consistent efficacy with an 85.7% overall response rate and high rates of MRD-negative remissions, reinforcing the potential of this off-the-shelf therapy for patients with very limited treatment options."

CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T ALL/LBL

In a poster presentation delivered by Dr. Xian Zhang of Hebei Yanda Ludaopei Hospital, researchers analyzed pooled safety and efficacy data from multiple Phase 1/2 studies, conducted across five academic centers in China, evaluating CTD402 in 15 adolescent and pediatric patients with a median age of 15 years (range 10-17). Despite treating a challenging patient population who had received a median of two prior lines of therapy (range 1-5), with 26.7% having primary refractory disease, 60% with extramedullary disease, and 60% with high-risk molecular features, the therapy demonstrated an impressive 80% complete remission rate (12/15 patients), with 83.3% of responders (10/12) achieving MRD-negative status.

The safety profile was favorable, with 66.7% experiencing predominantly mild Grade 1-2 CRS and notably no neurotoxicity or severe infections observed. CAR-T cells persisted for at least 28 days in 66.7% of patients, with some showing persistence up to 90-180 days, and at a median follow-up of 21.94 months, median overall survival was not reached in patients who received consolidative allogeneic transplant, compared with 4.8 months in non-transplant patients (p=0.026), highlighting the potential benefit of post-CAR-T consolidation strategies.

"These encouraging results from our pediatric cohort underscore CTD402’s potential to transform care for patients with R/R T-ALL/LBL," said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. "The combination of strong efficacy—with 80% of pediatric patients achieving complete remission—and a favorable safety profile, alongside CTD402’s immediate availability as an off-the-shelf therapy, demonstrates the potential to address a critical unmet need in this patient population."

Abstracts are currently available to the public at: View Source!*menu=6*browseby=3*sortby=2*ce_id=2934.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, JUN 11, 2026, View Source [SID1234666591])

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 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the publication of a peer-reviewed case study from researchers at Moffitt Cancer Center was recently published in Radiology Case Reports.

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The case study highlights potential optimization of the TAMP procedure with RenovoCath to deliver intra-arterial gemcitabine (a commonly used chemotherapy) directly near a tumor (rather than traditional systemic IV administration) in a patient with locally advanced pancreatic cancer (LAPC). Importantly, PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment, suggesting that PET may improve monitoring of therapeutic response following treatment delivered via TAMP.

The case study, titled "Trans-arterial gemcitabine micro perfusion of locally advanced pancreatic cancer enabled by coil plus glue embolization of a pancreaticoduodenal branch," was authored by Bela Kis, MD, PhD, and his colleagues at Moffitt Cancer Center and published in Radiology Case Reports. This is the first reported case in which physicians successfully embolized, or sealed off, a small branching artery using tiny coils and surgical glue to better optimize isolation of flow with TAMP-mediated gemcitabine delivered with RenovoCath during the same procedure.

The case study describes treatment of an 82-year-old patient with unresectable LAPC who underwent targeted intra-arterial gemcitabine treatment using TAMP following stereotactic body radiation therapy. During the procedure, physicians identified a pancreaticoduodenal artery (PDA) side branch that prevented optimal vessel isolation required for TAMP’s approach to pressure-mediated drug-delivery. Investigators subsequently performed coil plus glue embolization of the side branch, successfully enabling localized gemcitabine delivery via TAMP in the same procedural setting. The patient tolerated all 8 TAMP procedures (twice per month) without complications. Post eighth treatment at the 4-month follow-up, CT scans revealed stable disease (no change in tumor size) relative to scans performed prior to the first TAMP treatment, whereas PET-CT revealed a 52% reduction in tumor metabolic activity at the site of treatment.

"LAPC is already difficult-to-treat, and a pancreaticoduodenal artery (PDA) side branch adds another challenge to targeted therapy," said Bela Kis, MD, PhD, Moffitt Cancer Center and the first author of the case study. "TAMP uses RenovoCath, an innovative dual-balloon occlusion catheter designed to deliver therapy directly near tumors while reducing systemic exposure. The technology creates localized intra-arterial pressure that drives therapeutic agents across the vessel wall near the tumor."

Dr. Kis added, "We were encouraged by this case because the patient completed all eight RenovoCath-enabled TAMP treatments without complications. At the four-month follow-up, PET-CT imaging showed stable disease, while metabolic imaging indicated a positive treatment response, including a 52% reduction in fluorodeoxyglucose (FDG) activity at the treatment site."

"These findings further strengthen the growing body of peer-reviewed evidence supporting the procedural flexibility and targeted delivery capabilities of our TAMP therapy platform enabled by RenovoCath," said Ramtin Agah, MD, RenovoRx’s Chief Medical Officer, Executive Chairman, and Founder. "They also show how physicians may be able to address anatomical challenges to optimize targeted intra-arterial therapy, potentially increasing the therapeutic benefit of localized treatment options for patients with difficult-to-treat cancers."

Publication Details

Title: Trans-arterial gemcitabine micro perfusion of locally advanced pancreatic cancer enabled by coil plus glue embolization of a pancreaticoduodenal branch
Journal: Radiology Case Reports
DOI: View Source
Lead Author: Dr. Bela Kis, MD, PhD
Institution: Moffitt Cancer Center, Tampa, FL

About RenovoCath
Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, JUN 11, 2026, View Source [SID1234666592])