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])

On June 11, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that data from the Phase 1/2 SAVE trial of an all-oral regimen of Revuforj (revumenib), decitabine/cedazuridine, and venetoclax in relapsed or refractory (R/R) NPM1 mutated (NPM1m), KMT2A-rearranged (KMT2Ar), or NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) were published in the Journal of Clinical Oncology and simultaneously presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.

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Revuforj is the first and only menin inhibitor that is FDA approved for patients one year and older with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.

"The deep and durable remissions observed among patients with R/R NPM1m, KMT2Ar, or NUP98r AML who received an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax, highlight the potential for revumenib combinations to advance the standard of care treatment for menin-dependent acute leukemias," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "The SAVE data provide strong support for further studying revumenib with venetoclax and a hypomethylating agent in multiple settings, including among newly diagnosed patients who are unfit for intensive chemotherapy in the ongoing pivotal EVOLVE-2 trial and among fit patients in the RAVEN trial."

"The results observed with the all-oral SAVE regimen in heavily pretreated patients with R/R NPM1m, KMT2Ar, or NUP98r AML are very encouraging," said Ghayas C. Issa, M.D., Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center and Principal Investigator of the SAVE trial. "Notably, 88% of patients achieved a response with the majority achieving MRD negativity, 45% proceeded to a potentially curative stem cell transplant, and we observed a 14-month median overall survival. We also saw an impressive 50% CR/CRh rate and approximately 12-month median overall survival in patients with prior venetoclax exposure, a population that has historically experienced poor outcomes with a median survival of less than three months."

Summary of Key Results from the SAVE Trial in R/R NPM1m, KMT2Ar, and NUP98r AML

The publication entitled, "All-Oral Combination of Revumenib, Decitabine, and Venetoclax for Relapsed or Refractory AML (SAVE)" reports results from the R/R cohort of patients in the Phase 1/2, single-center, open-label SAVE trial. The primary endpoint of Phase 1 was the recommended Phase 2 dose of revumenib in combination therapy, which was identified as dose level 1 (the FDA-approved monotherapy dose of revumenib). The primary endpoint of Phase 2 was the composite complete remission1 (CRc) rate.

As of January 2026, 42 patients with R/R AML were enrolled in the SAVE trial, including five adolescents. 38% (16/42) had NPM1m, 40% (17/42) had KMT2Ar, and 21% (9/42) had NUP98r. The median age was 40 years (range: 12-82). Patients were heavily pretreated, with a median of two prior lines of therapy (range: 1-5); 52% (22/42) had received prior venetoclax and 33% (14/42) a prior hematopoietic stem cell transplant (HSCT).

The overall response rate (ORR) was 88% (37/42), the CRc rate was 71% (30/42), and the complete remission plus complete remission with partial hematological recovery (CR/CRh) rate was 60% (25/42) for the entire population. Response rates were similar across genotypes, including patients with NPM1m, KMT2Ar, or NUP98r. Overall, 45% (19/42) of patients proceeded to HSCT following treatment with the regimen, including 38% (6/16) of NPM1m patients, 65% (11/17) of KMT2Ar patients, and 22% (2/9) of NUP98r patients. Of the 19 patients that proceeded to HSCT, 63% (12/19) resumed revumenib after HSCT.

The rates of measurable residual disease (MRD) negativity by flow cytometry were 68% (25/37) among evaluable responders, 80% (24/30) among those with CRc, and 80% (20/25) among those with CR/CRh. Among evaluable patients with CRc, 67% (8/12) were MRD negative by NPM1 NGS (<0.01% threshold), with the vast majority of those patients (7/8) below the limit of detection of the assay (5×10-5), highlighting the depth of MRD clearance.

With a median follow-up of 22 months, the median duration of response among patients with CR/CRh was 10.5 months for the entire cohort, 10.7 months among NPM1m patients, not reached among KMT2Ar patients, and 5.9 months among NUP98r patients. The observed 1-year overall survival (OS) rate was 56% for the entire cohort, 63% among NPM1m patients, 47% among KMT2Ar patients, and 67% among NUP98r patients. Median OS after HSCT was not reached. Patients who were MRD negative by flow cytometry had a longer median duration of response (20 months vs. 2.9 months) and OS (not reached vs. 8.4 months) compared to those who were MRD positive.

Notably, clinical activity was observed among patients with prior exposure to venetoclax, a population in whom outcomes are typically poor, with a historical estimated median survival of 2.4 months. In this trial, the CR/CRh rate was 50% (11/22) in patients with venetoclax exposure versus 70% (14/20) in those without. The median OS observed was similar between the two groups (at least 12 months in both groups), based on a Kaplan-Meier estimate. This observation supports a potential biologic synergy between BCL2 inhibition and menin inhibition and the possibility that menin inhibition may restore sensitivity to BCL2 inhibition after resistance has developed.

Revumenib was generally well-tolerated in combination with decitabine/cedazuridine and venetoclax. The most common treatment-emergent adverse events (TEAEs) included elevations in aspartate aminotransferase or alanine aminotransferase (71%), nausea (52%), and vomiting (48%). The most common Grade ≥3 TEAEs were febrile neutropenia (36%), lung infection (21%), thrombocytopenia (21%), and elevations in aspartate aminotransferase or alanine aminotransferase (21%). Rates of Grade ≥3 differentiation syndrome (5%) and QTc prolongation (5%) were both low.

About Revuforj (revumenib)

Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia
Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec
SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

(Press release, Syndax, JUN 11, 2026, View Source [SID1234666574])

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])