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])

On June 10, 2026 MonTa Biosciences reported that the first patient has been dosed in Madrid at The START Center for Cancer Research FJD in our Phase 1b clinical study evaluating MBS8, our second-generation TLR7 agonist, in combination with checkpoint inhibitor therapy for patients with advanced cutaneous melanoma who have developed resistance to immunotherapy.

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For these patients, options for treatment are poor and we see this as an indication where we can really make a difference.
While checkpoint inhibitors have transformed outcomes in melanoma, many patients who initially respond eventually see their disease return. Once resistance develops, treatment options become limited and the path toward long-term disease control becomes far more difficult.

We have not taken the easiest path to make these decisions moving into cutaneous melanoma with secondary resistance to immunotherapy . With a new drug being tested in patients you are exploring new territory and the decisions you make are critical to the outcome. It is extremely important to understand how the drug works in patients, before deciding what patients you see benefit from the treatment. Based on the data generated to date, we believe this is a scientifically compelling setting in which to evaluate MBS8. Our hypothesis is that activating innate immunity may help restore anti-tumor immune responses and potentially restore sensitivity to checkpoint therapy.

(Press release, MonTa Biosciences, JUN 10, 2026, View Source [SID1234668755])

On June 10, 2026 RadioMedix, Inc., a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and cancer therapy, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s GALLIUM GA 68 GOZETOTIDE INJECTION, also known as Ga 68 PSMA-11, a prostate-specific membrane antigen (PSMA)-targeted diagnostic radiopharmaceutical for positron emission tomography (PET) imaging in patients with prostate cancer. In connection with the approval, RadioMedix also completed an FDA inspection of its manufacturing site known as The SPICA Center located north of Houston, TX with no Form 483 observations.

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Ga-68 PSMA-11 is a radioactive diagnostic agent that targets PSMA, a protein commonly expressed in prostate cancer. The approval expands RadioMedix’s precision nuclear medicine portfolio and supports the Company’s continued work to advance diagnostic radiopharmaceuticals for patients and physicians.

"FDA approval of our Ga68 PSMA-11 Abbreviated New Drug Application (ANDA) represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost effective and high-quality radiopharmaceuticals for patients," said Ebrahim S. Delpassand, M.D., Founder and Chief Executive Officer of RadioMedix. "We are also proud to have completed the FDA inspection with no Form 483 observations, which reflects the rigor of our quality systems, manufacturing capabilities, and teamwide commitment to regulatory excellence. As the radiopharmaceutical field continues to grow, quality, consistency, and regulatory readiness will be essential to ensuring these technologies can reliably reach patients."

The SPICA Center consist of a 27,500 sq. ft. radiopharmaceutical manufacturing facility, multiple clean rooms, fully equipped quality control suites, a strong quality assurance backbone, and 21 CFR 211 compliance supporting the development and production of targeted diagnostic and therapeutic radiopharmaceuticals for internal programs and external partners.

Connie Chang, Head of Quality at RadioMedix, added, "Successfully completing the FDA inspection with no Form 483 observations reflects more than a single milestone — it represents RadioMedix’s enduring commitment to a strong quality culture across the organization. This achievement is the result of sustained senior management support, cross-functional collaboration, and a company-wide dedication to quality, compliance, and continuous improvement. At RadioMedix, quality is not only a regulatory requirement, but a core value that guides our operations, strengthens our manufacturing and quality systems, and ultimately supports the reliable delivery of safe and high-quality radiopharmaceuticals to patients."

About Ga-68 PSMA-11 Injection
Ga-68 PSMA-11 Injection is a radioactive diagnostic agent for PET imaging of PSMA-positive lesions in patients with prostate cancer.

Important Safety Information
Please see safety information for GALLIUM GA 68 GOZETOTIDE INJECTION at View Source

(Press release, RadioMedix, JUN 10, 2026, View Source [SID1234666560])