On June 11, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported updated positive clinical data from two clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia (AML) at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress.

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"We are encouraged by the sustained strength and consistency of the data from both the ALICE-2 and FRIDA trials," said Carlos Buesa, Chief Executive Officer of Oryzon Genomics. "With over 80% of patients now enrolled in ALICE-2, the favorable safety profile and strong efficacy signals of iadademstat in newly diagnosed, unfit AML patients reinforce our confidence in this combination approach, including within genomically defined adverse-risk populations such as TP53-mutated and RAS pathway–mutated AML. These results are consistent with prior findings in TP53-mutated patients in our ALICE trial, where the combination of iadademstat and azacitidine doubled median overall survival compared with historical rates. As enrollment continues, we anticipate reporting final data by year-end and advancing toward a potential registrational study in first-line AML by 2027, with a focus on adverse-risk populations."

Ana Limón, Senior Vice President of Clinical Development and Global Medical Affairs at Oryzon, added: "Historically, with azacitidine plus venetoclax, one third of first line AML patients do not respond, and the depth of response is variable, underscoring the need for novel triplet strategies, particularly for patients without targetable mutations. The maturing data from both trials continue to reinforce the strength of LSD1 inhibition as an add-on approach in AML. In addition to the high ORR and CR rates observed to date in the ALICE-2 trial, treatment with the iadademstat-azacitidine-venetoclax triplet has enabled a high proportion of patients to transition to allogeneic hematopoietic cell transplantation (HCT), potentially improving long-term survival. Overall, the safety and efficacy observed across both trials support further clinical development."

Data Summary

ALICE-2 Phase Ib clinical trial (NCT06357182) investigating iadademstat in combination with azacitidine and venetoclax in newly diagnosed AML

High rates of activity, with a 100% (18/18) overall response rate (ORR), 89% (16/18) composite complete remission (CRc) rate and 78% (14/18) complete response (CR) rate.
CRs occur early, most of them in cycle 1.
Efficacy was observed across different genomic risk groups, including TP53 and RAS pathway mutations and patients with complex karyotypes, all considered adverse risk.
Patients with TP53-mutated disease (2/2) attained CR and showed a reduction in TP53 variant allele frequency (14% to undetected and 22% to 1%, respectively).
All patients with RAS pathway mutations (3/3) achieved CR.
After a median follow-up of 8 months, median overall survival (OS) and event-free survival (EFS) were not reached; estimated 12-month OS and EFS were 79% and 71%, respectively.
9 patients successfully transitioned to allogeneic HCT, with an estimated 12-month OS of 88%.
The iadademstat-azacitidine-venetoclax combination continues to show a favorable safety profile.

FRIDA Phase Ib clinical trial (NCT05546580) investigating iadademstat in combination with gilteritinib in FLT3‑mutated relapsed/refractory AML

The poster reports data from the expansion cohort at the selected pharmacological active dose (PAD, 75 ug iadademstat); 23 patients have been enrolled at this dose, with 18 being evaluable for response.
High CRc rate of 67% (12/18) in a heavily pre-treated population.
Iadademstat plus standard of care (SoC) treatment gilteritinib demonstrated a manageable safety profile, without adding toxicity to the SoC.

About ALICE-2

ALICE-2 (NCT06357182) is a Phase Ib investigator-initiated study sponsored by Oregon Health & Science University (OHSU) in newly diagnosed AML. It is evaluating treatment with iadademstat in combination with azacitidine and venetoclax, the standard of care, in newly diagnosed unfit patients. The study’s primary endpoint is the incidence of dose-limiting toxicities (DLTs). Secondary endpoints include efficacy measurements such as composite complete remission (CRc: complete remission [CR] + CR with partial hematologic recovery [CRh] + CR with incomplete recovery [CRi]), and overall response rate (ORR: CRc + morphologic leukemia free state [MLFS] + partial remission [PR]). The trial plans to enrol 24 patients to achieve 21 evaluable patients.

About FRIDA

FRIDA (NCT05546580) is a Phase Ib clinical study sponsored by Oryzon. It is evaluating iadademstat in combination with gilteritinib for the treatment of FLT3-mutant relapsed/refractory AML. The primary endpoints are incidence of treatment emergent adverse events (TEAEs) and determination of the recommended Phase II dose (RP2D). Secondary endpoints include response rates (CR, CRh, CRi, MLFS, CRc), event-free survival (EFS), and overall survival (OS).

(Press release, Oryzon, JUN 11, 2026, View Source [SID1234666593])

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])

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 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 Anocca AB (‘Anocca’ or the ‘Company’), a clinical-stage biotechnology company developing advanced T-cell immunotherapies, reported the successful dosing of the first patients across multiple clinical sites with ANOC-001, a novel T cell receptor-modified T cell therapy (TCR-T)[1] targeting KRAS G12V mutations in an aggressive form of pancreatic cancer.

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ANOC-001 is the first product to enter Anocca’s VIDAR-1 clinical programme, which focuses on pancreatic ductal adenocarcinoma (PDAC). The therapy is designed for patients whose tumours carry a specific mutation in the KRAS gene. The product candidate has been discovered, developed and manufactured by Anocca at its in-house facilities in Sweden. ANOC-001 is the first non-viral gene-edited T cell therapy to be evaluated in Europe, with the deployment of this technology enabling scalable product development and future commercialisation.

Pancreatic cancer remains one of the deadliest cancer types, with a five-year survival rate below 10% (1). Despite recent advances there are currently no definitive treatments for patients with progressed disease (2). KRAS mutations are one of the most common cancer mutations and are implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. VIDAR-1 addresses this unmet need by engineering the immune system’s T-cells to recognise and attack cancer cells carrying the KRAS mutation.

Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: "The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products. The novel ANOC-001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets and identifies, characterises and engineers T-cell receptors. We are grateful to our team, investors and partners whose efforts and participation made this milestone possible."

Hugh Salter, Chief Scientific Officer, added: "The VIDAR-1 clinical programme is designed to evaluate multiple TCR-T product candidates targeting distinct KRAS mutations and HLA combinations [2]. ANOC-001 is the first product in this series and additional products targeting different forms of mutant KRAS will be introduced into the uniquely designed clinical programme. By using non-viral gene editing technology, we are able to scale delivery of highly precise therapies to broader patient populations. We would like to thank our clinical collaborators for their support as well as the study participants and their families."

Recruitment and manufacture are ongoing for Phase I of the multi-centre VIDAR-1 trial, which is being conducted at eight leading university hospitals across Sweden, Denmark, Germany, and The Netherlands.

(Press release, Anocca, JUN 11, 2026, View Source [SID1234666589])