On June 11, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that the first patient has been dosed in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic cancer patients. Atebimetinib is a novel MEK inhibitor with a pulsatile mechanism designed to target RAS, RAF, and other MAPK pathway-driven cancers with greater durability and tolerability than traditional chronic inhibitors.

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"Pancreatic cancer remains a challenging malignancy to treat," said Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center, and the lead principal investigator of the MAPKeeper 301 study. "There is an urgent need for new first-line treatment options that can improve treatment outcomes by augmenting survival and improving quality of life. The MAPKeeper 301 trial evaluating atebimetinib with standard of care therapy represents an exciting step toward addressing that need."

The global MAPKeeper 301 trial (NCT07562152) is evaluating the safety and efficacy of atebimetinib + mGnP in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received no prior systemic anti-cancer therapy. Patients are being randomized to receive either atebimetinib + mGnP, or standard GnP treatment alone. The primary endpoint is overall survival (OS) of patients in the atebimetinib + mGnP arm versus patients in the GnP arm. Key secondary endpoints include progression free survival (PFS), overall response rate (ORR), disease control rate (DCR), safety and tolerability, and quality of life.

"The dosing of the first patient in our pivotal Phase 3 trial is a significant milestone for Immuneering and, more importantly, patients with pancreatic cancer and their families," said Ben Zeskind, PhD, CEO of Immuneering. "Global interest in MAPKeeper-301 has been overwhelming, largely driven by our highly encouraging survival and tolerability data presented earlier this year. We look forward to initiating more sites and dosing more patients as expeditiously as possible with topline data from the pivotal trial expected in mid-2028."

More information about the MAPKeeper 301 trial can be found at www.clinicaltrials.gov, identifier NCT07562152 or the MAPKeeper 301 clinical trial microsite at View Source

About Pancreatic Ductal Adenocarcinoma (PDAC)
According to the National Health Institute, PDAC is the most common and highly lethal form of pancreatic cancer with nearly 68,000 new cases estimated for 2026 in the U.S. alone. Often diagnosed too late, PDAC currently carries a poor prognosis with a five-year survival rate of approximately 13%. Atebimetinib targets MEK in the MAPK pathway, from which 90% of PDAC cases grow and thrive, and is designed to shrink tumors durably with less resistance, optimize tolerability and counteract cachexia, enabling patients to live longer, stay strong and thrive.

(Press release, Immuneering, JUN 11, 2026, View Source [SID1234666594])

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 12, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for an additional indication as maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer.

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"There is no established standard treatment for maintenance therapy following definitive chemoradiotherapy for locally advanced esophageal cancer. In the SKYSCRAPER-07 study, Tecentriq monotherapy indicated a trend toward improvement in overall survival and progression-free survival compared with placebo. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients as a new therapeutic option as soon as possible," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the global Phase III clinical study (SKYSCRAPER-07/ YO42137)1 in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study is a randomized, double-blind, multicenter trial comparing the efficacy and safety of maintenance therapy with Tecentriq in combination with tiragolumab (development discontinued) or Tecentriq monotherapy versus placebo. Based on the results from the first 2 and second interim analyses, it was confirmed that the Tecentriq monotherapy arm continued to show clinical benefit in the primary endpoint of overall survival (OS) and the secondary endpoint of investigator-assessed progression-free survival (PFS). The results of the second interim analysis are planned to be presented at an upcoming medical congress. The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

About the SKYSCRAPER-07 (YO42137) study1
SKYSCRAPER-07 is a global Phase III randomized, double-blind, multicenter study in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study evaluated the efficacy and safety of Tecentriq plus tiragolumab or Tecentriq monotherapy compared with placebo. Development of the Tecentriq plus tiragolumab combination was discontinued as no clinical benefit was observed in the primary PFS analysis and the first interim OS analysis (cutoff: February 18, 2025)2.

About maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer3
Esophageal cancer has an incidence rate in Japan (2021) of 34.7 per 100,000 population for men and 7.7 per 100,000 population for women. The number of deaths from esophageal cancer in 2024 was 10,638, and the 5-year relative survival rate (2009–2011) was 41.5%.
In Japan, squamous cell carcinoma is the most common histologic type. In unresectable, locally advanced esophageal squamous cell carcinoma, there is no clearly established standard treatment for patients without disease progression after definitive chemoradiotherapy, and new treatment options are needed.

About Tecentriq4
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JUN 11, 2026, View Source;category= [SID1234666579])

On June 11, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported initial clinical data from its ongoing first-in-human Phase 1/1b trial of BH-30236 in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndrome (HR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden. BH-30236 is an intentionally designed novel, orally bioavailable, macrocyclic CDC-like kinase (CLK) inhibitor that modulates aberrant alternative mRNA splicing, a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors.

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"The preliminary anti-leukemic activity observed with BH-30236 in R/R AML and HR-MDS, both as a monotherapy and in combination with venetoclax, is very encouraging," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "In addition to the reassuring tolerability profile, we have seen provocative responses in patients after progression on prior venetoclax-based therapy, a population with few treatment options. In the ongoing study of BH-30236, we will further characterize the effect of this novel mechanism in myeloid malignancies, both as a monotherapy and in synergy with venetoclax to maximize the potential of this promising program."

"We intentionally designed BH-30236 to target CLK, which is upstream of multiple resistance pathways, not by addressing one resistance mechanism after it develops, but by suppressing the splicing machinery that enables resistance to begin," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "We believe these data further validate our approach of leveraging a deep understanding of disease and protein dynamics and applying our structure-based rational drug design expertise to identify specific structural liabilities that limit existing therapies or approaches and design novel chemical scaffolds to directly address these limitations."

Presentation Highlights:

As of the data cutoff date of April 10, 2026, 30 patients received BH-30236 monotherapy at doses ranging from 5 to 120 mg on a continuous daily administration schedule (QD), and 18 patients received BH-30236 at doses ranging from 20 to 90 mg QD in combination with venetoclax
BH-30236 was generally well tolerated as both a monotherapy and in combination with venetoclax, with most treatment-related adverse events being low-grade and manageable, with one dose limiting toxicity of Grade 3 diarrhea at the 120 mg QD monotherapy dose level
Dose escalation showed predictable pharmacokinetics without drug accumulation, and no significant drug-drug interactions were observed with venetoclax
With efficacy follow-up through May 20, 2026, preliminary anti-leukemic activity was observed in patients with R/R AML and HR-MDS when treated with BH-30236 as a monotherapy or in combination with venetoclax, including in patients previously relapsed or refractory to venetoclax-based therapy:
In the monotherapy cohort, 28.6% (n=6) of evaluable patients achieved at least a 50% reduction in bone marrow blast counts, including one HR-MDS patient treated at 60 mg with ongoing blast count reduction with treatment ongoing for more than a year
In the combination cohort, 87% (n=13) of patients had prior venetoclax exposure and 53% (n=8) of evaluable patients experienced at least a 50% blast reduction, including one patient refractory to all prior therapy including venetoclax, who achieved a minimal residual disease (MRD)-negative complete remission

About R/R AML and HR-MDS
AML is the most common acute leukemia in adults, with approximately 21,000 new diagnoses annually in the United States, with as many as 75% of those being patients resistant to or relapsing on first-line venetoclax therapy. Approximately 14,000 patients are diagnosed with HR-MDS annually in the United States. There is no currently approved targeted therapy for the venetoclax-resistant and refractory segment of AML patients without targetable genetic alterations. Patients with HR-MDS closely mirror AML in clinical course, frontline treatment, and unmet need in the relapsed and refractory setting.

About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 is was intentionally designed to potently inhibit CLK, leading to modulation of aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives relapsed or refractory (R/R) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine.

BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BH-30236 for the treatment of AML.

(Press release, BlossomHill Therapeutics, JUN 11, 2026, View Source [SID1234666595])

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])