On June 11, 2026 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., patient dosing has been completed in the registrational Phase 2 clinical trial for 64Cu-PSMA-I&T in Japan.

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64Cu-PSMA-I&T is a PET radiopharmaceutical targeting PSMA. 64Cu-PSMA-I&T is being assessed as a PET agent labeled with the radioisotope Copper-64. The trial is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium, aiming at advancing innovative diagnostic radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study is designed to evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T in Japanese patients newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. The results from this study, together with data from Curium’s ongoing global clinical trials, are expected to support future regulatory submission in Japan.

In parallel, Curium announced in February, a registrational clinical trial of the therapeutic counterpart, 177Lu-PSMA-I&T, is being advanced to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC), as part of a theranostic approach.

Renaud Dehareng, CEO of Curium Group commented: "Conducting these trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to patients with prostate cancer in Japan."

Patrick C. Reid, President & CEO of PeptiDream commented: "The completion of patient dosing marks an important milestone in the development of 64Cu-PSMA-I&T in Japan. This program represents a key component of our growing radiopharmaceutical pipeline and our broader theranostics strategy. We would like to thank the patients, investigators and clinical sites for their participation and support."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*1). *1: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 SOLAR RECUR and SOLAR STAGE trial – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven prostate cancer.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and 177Lu-PSMA-I&T and in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, Curium Pharma, JUN 11, 2026, View Source [SID1234666564])

On June 11, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported longer follow up data for the ongoing CaMMouflage phase 1 trial of CB-011, the Company’s off-the-shelf CAR-T cell therapy being evaluated for relapsed or refractory multiple myeloma (r/r MM). A single dose of CB-011 produced early, deep, and durable responses in a high-risk, heavily pretreated BCMA-naïve patient population. The Company also reported a case study of a patient previously treated with an approved autologous CAR-T cell therapy who achieved an early complete response after treatment with CB-011. These data are being presented during an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, taking place June 14, 2026, at 11:00am CEST, in Stockholm, Sweden.

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"Despite recent advances, only about 10% of multiple myeloma patients receive autologous CAR-T cell therapy, highlighting the urgent need for more accessible treatment options," said Binod Dhakal, MD, professor of medicine, Medical College of Wisconsin and investigator on the CaMMouflage trial. "The encouraging CB-011 clinical data demonstrate the potential of a single-dose, off-the-shelf CAR-T cell approach to deliver deep and durable responses, including MRD negativity, for heavily pretreated patients who often have limited treatment options."

CaMMouflage BCMA-naïve dose escalation data
As of the May 26, 2026, efficacy data cutoff date, 48 patients had been treated with CB-011 in the dose escalation portion of the CaMMouflage phase 1 trial. The recommended dose for expansion (RDE) is 450 million CB-011 CAR-T cells after lymphodepletion (LD) with 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days (selected LD regimen).

Twelve BCMA-naïve patients were treated with the RDE. Median follow up for this cohort is 17.7 months. Data continue to demonstrate that CB-011 drives deep, durable responses after a single dose. Details of the efficacy results for this cohort are as follows:
•92% overall response rate (ORR)
•83% complete response or stringent complete response (≥CR) rate
•91% minimal residual disease (MRD) negativity in 10/11 evaluable patients
•50% of patients in ≥CR at 15 months

As of the April 20, 2026, safety data cutoff date, CB-011 continued to show a manageable safety profile with no cases of graft-versus-host disease (GvHD), immune effector cell-associated enterocolitis, parkinsonism, or cranial nerve palsies in any patient treated with CB-011 (N=48). In all patients treated with the selected LD regimen (N=35), there was one CB-011-related death due to immune effector cell-associated hematotoxicity and three unrelated deaths due to pneumonia, respiratory syncytial virus, and respiratory acidosis, respectively. In the 12-patient BCMA-naive RDE cohort, there were no reports of grade 3 or higher (≥Gr 3) immune effector cell-associated neurotoxicity syndrome (ICANS), and one (8%) ≥Gr 3 cytokine release syndrome (CRS). Other adverse events of special interest in the RDE cohort included three (25%) ≥Gr 3 infections, one (8%) ≥Gr 3 immune effector cell-associated HLH-like syndrome, and five (42%; 5/12) ≥Gr 3 prolonged cytopenias.

CaMMouflage patient case study after prior BCMA-targeted therapy
Caribou also reported a patient case study of a 71-year-old male with r/r MM who received eight prior lines of therapy, including ciltacabtagene autoleucel, an approved autologous CAR-T cell therapy. Before entering CaMMouflage, the patient never achieved a complete response following any of his post-front-line therapies. After receiving a single dose of 450 million CB-011 CAR-T cells (the RDE), the patient achieved a CR at day 28 that was maintained at month 3 and remained ongoing as of the May 26, 2026, efficacy data cutoff date.

The safety profile for this patient was manageable, with grade 1 CRS and grade 3/4 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation. The patient had a history of intermittent ALT elevation prior to enrolling in CaMMouflage. Translational data showed robust CB-011 CAR-T cell expansion and a rapid decrease in serum free light chains that correlated with the patient achieving a CR.

"The durability and depth of response we continue to observe with CB-011 reinforce its potential as a single-dose, off-the-shelf approach that could meaningfully expand access to cellular therapies and change the treatment paradigm for patients with relapsed or refractory multiple myeloma," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "Unlike currently available off-the-shelf treatment approaches that require ongoing administration, CB-011 has demonstrated delivery of deep and durable responses following single infusions, providing patients the potential for a treatment-free period. We are encouraged by the emerging translational and clinical data from both BCMA-naïve and BCMA-exposed patients and look forward to reporting initial dose expansion data in the second half of this year."

EHA oral presentation details
Title: CB-011, an allogeneic anti-BCMA CAR-T cell therapy with immune cloaking, for patients with relapsed/refractory multiple myeloma (CaMMouflage phase 1 trial)
Presenter: Binod Dhakal, MD, professor of medicine, Medical College of Wisconsin
Date and time: Sunday, June 14, 2026, at 11:00am – 12:15pm CEST
Session: Immunotherapy in multiple myeloma
Location: Victoria Hall
Abstract number: S201

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirty-five patients were treated with a single dose of CB-011 (150 million [N=6], 300 million [N=13], 450 million [N=13], and 800 million [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The dose expansion portion of the trial is evaluating safety and efficacy of 450 million CB-011 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, JUN 11, 2026, View Source [SID1234666563])

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])

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 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient’s mismatch repair (MMR) status. MMR is a process that scans a person’s genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.

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"By providing a standardised testing option for mismatch repair status with our VENTANA MMR RxDx Panel, we are empowering clinicians to make more informed decisions and expanding access to important therapies for patients across multiple solid tumor types," said Laura Apitz, Head of Pathology Lab at Roche Diagnostics. "This milestone exemplifies our dedication to delivering high-medical-value solutions that help improve patient outcomes through precision medicine."

The VENTANA MMR RxDx Panel is now available in countries regulated by IVDR as a companion diagnostic for the following therapies and cancer types:

KEYTRUDA (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy: For the treatment of mismatch repair deficient (dMMR) tumors in certain adults with: metastatic colorectal cancer; advanced or recurrent endometrial carcinoma; unresectable or metastatic gastric, small intestine or biliary cancer.
IMFINZI (durvalumab), AstraZeneca’s anti-PD-L1 therapy: For adult patients with dMMR primary advanced or recurrent endometrial cancer.
IMFINZI + LYNPARZA (olaparib), AstraZeneca’s anti-PD-L1 therapy and PARP inhibitor: For adult patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
JEMPERLI (dostarlimab-gxly), GSK’s anti-PD-1 therapy: for dMMR patients with endometrial cancer.1
About MMR
Cancer remains the second leading cause of death worldwide, resulting in nearly 10 million deaths annually.2, 3 Identifying specific biomarkers is critical to help identify patients who are eligible for certain therapies, as dMMR serves as a vital predictive biomarker for modern immunotherapies.

MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient, cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high-prevalence dMMR tumour types include gastric, colorectal, small intestine and biliary tract cancers. Because dMMR tumours often have a high mutational burden they may respond well to immune checkpoint inhibitors (ICIs) such as PD-1 or PD-L1 inhibitors. For patients with endometrial cancer without MMR deficiency (pMMR), the addition of PARP inhibitors in maintenance to ICIs may further enhance the benefit of ICIs. PD-1 inhibitors may retain activity when combined with a tyrosine kinase inhibitor (TKI).

About the VENTANA MMR RxDx Panel
This IVDR approval for the VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market panel. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93), and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a BenchMark ULTRA instrument.

MMR proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.4,5,6 PD-1 inhibitors can be effective in cancers with MMR deficiency.4,6 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.

(Press release, Hoffmann-La Roche, JUN 11, 2026, View Source [SID1234666540])