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 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA’s review of a pre-specified interim safety report of the first three patients treated in the trial. The Company intends to recommence patient recruitment immediately, on the back of tremendous clinical interest in continuing the trial.

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As previously announced on May 11, 2026, interim results at the cutoff date of May 3, 2026 from the first three patients, treated between December 2025 and March 2026 at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, demonstrated 100% local disease control, a 67% complete response rate as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and only one associated grade 3 serious adverse event (SAE), with no unanticipated associated SAEs observed. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure.

This clearance to continue the trial is the latest in a series of successful regulatory submissions to the FDA over more than four years with respect to exploring the use of Alpha DaRT in treating recurrent GBM. In October 2021, the Company was awarded Breakthrough Device Designation by the FDA for Alpha DaRT in recurrent glioblastoma, and in October 2024, the Company was accepted into the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, a highly selective program designed to expedite patient access to highly promising medical devices by providing coveted access to FDA expertise and guidance throughout the device development process.

In parallel with the FDA’s clearance to advance enrollment, Alpha Tau has received FDA authorization for two additional leading U.S. academic cancer centers to join the REGAIN trial as participating sites. The addition of these centers increases the geographic reach of the REGAIN trial, with the aim to broaden access for patients across the United States, and to bring additional multidisciplinary neuro-oncology expertise to the program.

Uzi Sofer, CEO of Alpha Tau, commented, "Glioblastoma is one of the most devastating diagnoses in oncology and is a core strategic indication for the Company. Since the fantastic interim results we released last month from our first three recurrent GBM treatments, clinicians have been overwhelmingly demanding that we keep treating patients as quickly as possible. This clearance, combined with the expansion to additional leading U.S. centers, hopefully brings us meaningfully closer to making Alpha DaRT a real option for these patients."

"I’m very gratified by the FDA’s review of the initial safety assessment and by its clearance to advance to full patient enrollment. What stands out in the early interim data from our first three patients is not just the magnitude of the responses, but their consistency," said Dr. Robert Den, Chief Medical Officer of Alpha Tau. "In recurrent GBM, where objective response rates with most systemic therapies rarely reach double digits, seeing two patients achieve complete disappearance of all enhancing tumor lesions on serial MRI scans as of the cutoff date, while the third showed meaningful tumor volume reduction, is a clinically significant and encouraging pattern. The adverse event profile was manageable: one grade 3 SAE, fully resolved, with no unanticipated toxicities. This is the kind of consistent, interpretable signal that gives us confidence as we advance to the next set of patients."

About the REGAIN Study

The REGAIN study is a prospective, open-label, single-arm interventional study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma. The clinical trial is expected to enroll up to ten U.S. patients with recurrent GBM not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at View Source

(Press release, Alpha Tau Medical, JUN 11, 2026, View Source [SID1234666561])

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 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 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that vispa-cel, its off-the-shelf CD19-targeted CAR-T cell therapy, produced durable long-term responses in patients enrolled in the ANTLER phase 1 clinical trial for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL), with the potential to bring the benefit of cell therapy to patients who lack curative options. The results are being presented during an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting on June 12, 2026, at 5:15pm CEST, in Stockholm, Sweden.

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"Vispa-cel is uniquely positioned as the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line LBCL," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "The long-term efficacy and safety outcomes we continue to observe reinforce the potential of vispa-cel, as a readily available CAR-T cell therapy, to overcome many of the logistical and access barriers that prevent the majority of second-line patients from receiving therapies with curative intent."

ANTLER phase 1 efficacy and safety data
As of the March 6, 2026, data cutoff date, 27 second-line (2L) large B cell lymphoma (LBCL) patients had received a single dose of 80 million optimized vispa-cel CAR-T cells, defined as cells from a donor younger than 30 years old and with at least 2 matched HLA alleles between patient and donor. This pivotal optimized vispa-cel subgroup best represents the treatment regimen and patient population for the planned ANTLER-3 phase 3 clinical trial.

Efficacy data from the pivotal optimized vispa-cel subgroup included:
•82% overall response rate (ORR)
•67% complete response (CR) rate
•17.1 months median progression-free survival (PFS)

Vispa-cel continues to demonstrate a generally well-tolerated safety profile. In the pivotal optimized vispa-cel subgroup (N=27), there were no reports of graft-versus-host disease (GvHD) or grade 3 or higher (≥Gr 3) immune effector cell-associated neurotoxicity syndrome (ICANS), and there was one (4%) ≥Gr 3 cytokine release syndrome (CRS). Other adverse events of special interest included six (22%) ≥Gr 3 infections, five (21%; 5/24) ≥Gr 3 prolonged cytopenias, and one (4%) ≥Gr 3 immune effector cell-associated HLH-like syndrome (IEC-HS). In the pivotal optimized vispa-cel subgroup, one vispa-cel-related death occurred due to IEC-HS and one possibly-related death occurred due to progressive multifocal leukoencephalopathy.

"These data demonstrate that vispa-cel’s durable responses may have similar curative potential as we see with approved autologous CAR-T cell therapies. As an allogeneic CAR-T cell therapy, vispa-cel could provide a much-needed treatment option for those patients who cannot receive autologous CAR-T cell therapy as second or later line of therapy," said presenting author, Stephen J. Schuster, MD, Louis-Dreyfus professor of CLL and lymphoma and director of lymphoma program and lymphoma translational research at the Abramson Cancer Center, University of Pennsylvania. "Many patients don’t receive auto CAR-T cell therapy due to rapid disease progression, low blood T cell counts, or lack of access to these specialized therapies. Vispa-cel is well positioned to address these challenges as a readily available, off-the-shelf therapy that can be administered in the community setting."

As previously disclosed, Caribou has reached alignment with the FDA on the design of ANTLER-3, a randomized, controlled pivotal phase 3 clinical trial expected to enroll approximately 250 CD19-naïve 2L LBCL patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the need for urgent therapy. Patients in the investigational arm will receive a single dose of 80 million optimized vispa-cel CAR-T cells following lymphodepletion. Patients in the comparator arm will be treated with an investigator’s choice of standard-of-care regimen: polatuzumab vedotin (Pola), bendamustine (B), and rituximab (R) (Pola-BR); R, gemcitabine, and oxaliplatin (R-GemOx); Pola-R-GemOx (Pola-RGO); or tafasitamab and lenalidomide. Crossover to the vispa-cel arm is permitted after progressive disease. The primary endpoint is progression-free survival (PFS). The study is expected to be conducted at approximately 75 clinical trial sites globally, including academic and sophisticated community centers in the United States.

EHA oral presentation details
Title: Vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, in patients with relapsed/refractory B cell non-Hodgkin lymphoma (ANTLER phase 1 clinical trial)
Presenter: Stephen J. Schuster, MD, Robert and Margarita Louis-Dreyfus professor of chronic lymphocytic leukemia and lymphoma; department of medicine, hematology-oncology division; director, lymphoma program and lymphoma translational research; Abramson Cancer Center, University of Pennsylvania
Date and time: Friday, June 12, 2026, at 5:15 – 6:30pm CEST
Session: Prospective lymphoma trials
Location: Nobel Hall
Abstract number: S236

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. As of a March 6, 2026, data cutoff date, 85 patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40, 80, or 120 million CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Eighty million CAR-T cells was selected as the recommended phase 2 dose (RP2D). Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Six patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, JUN 11, 2026, View Source [SID1234666562])