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Kyowa Kirin to Present New Complementary Evidence Further Defining Clinical Utility of Mogamulizumab in Cutaneous T-Cell Lymphoma at 2026 WCCL

On June 10, 2026 Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd (TSE: 4151), reported new data further defining the potential of mogamulizumab in the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome, two subtypes of cutaneous T-cell lymphoma, will be featured at the World Congress of Cutaneous Lymphomas (WCCL) in Montréal, Canada.

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Drawing on complementary evidence streams, including patient-reported outcomes, comparative-effectiveness estimates, molecular biomarker signals, and real-world utilization, these analyses collectively provide a more complete understanding of the therapeutic profile and potential of mogamulizumab.

"The research being presented at WCCL reflects our continued commitment to generating evidence beyond initial clinical trials for mogamulizumab in patients with relapsed or refractory mycosis fungoides and Sézary syndrome," said Daniela van Eickels, MD, PhD, MPH, Chief Medical Officer, Kyowa Kirin North America. "In these difficult-to-treat blood cancers, innovative clinical research and real-world data generation is essential to advancing and informing treatment strategies. We look forward to sharing our findings and exchanging ideas with the expert community."

WCCL Presentations:

Improved symptoms and health-related quality of life in patients with mycosis fungoides and Sézary syndrome treated with mogamulizumab in the PROSPER study
Oral Presentation; Scientific Session 8A
Friday, June 26, 3:30-4:30 PM ET

Outcomes in relapsed/refractory mycosis fungoides or Sézary syndrome from the MAVORIC trial mogamulizumab arm versus a real-world Australian cohort receiving vorinostat
(Collaborative Study)
Oral Presentation; Scientific Session 3B
Thursday, June 25, 2:30-3:30 PM ET

Overall survival in patients with mycosis fungoides or Sézary syndrome in Denmark: comparative effectiveness of mogamulizumab versus standard of care
Oral Presentation; Scientific Session 3B
Thursday, June 25, 2:30-3:30 PM ET

Targeted sequencing in patients with relapsed/refractory mycosis fungoides mogamulizumab or Sézary syndrome treated with mogamulizumab in the MOGA-2MG-Q4W clinical trial
Oral Presentation; Scientific Session 4B
Thursday, June 25, 3:40-5:20 PM ET

Mogamulizumab treatment for mycosis fungoides in clinical practice in France: data from the ongoing multicentric prospective observational PROMED study
Exhibit Hall Poster Session
Thursday-Saturday, June 25-27

U.S. POTELIGEO (mogamulizumab-kpkc) Indication
POTELIGEO injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

(Press release, Kyowa Hakko Kirin, JUN 10, 2026, View Source [SID1234666557])

MAIA Biotechnology Activates and Opens Enrollment at Second U.S. Clinical Site for International Phase 2 THIO-101 Expansion Trial

On June 10, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that it has activated the second U.S. clinical site in its Phase 2 THIO-101 expansion trial at Central Alabama Research in Homewood, Alabama. The expansion part of THIO-101 evaluates MAIA’s lead investigational therapy, ateganosine, a dual-action molecule incorporating telomere targeting and immunogenicity, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC) in patients who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy.

Parts A and B of the Phase 2 THIO-101 Phase 2 trial provided key inputs for MAIA’s market strategy by identifying optimal dosing for a well-defined patient population. The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. The additional data from the trial’s expansion may further support an accelerated approval filing with the FDA.

"Adding our second U.S. site reflects strong execution of our clinical strategy and continued momentum in the expansion of the THIO-101 trial," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "Broadening our site footprint enables more efficient patient enrollment as we advance the program under the FDA Fast Track designation and work toward upcoming interim data milestones."

David J. Mooney, M.D., oncology physician at Central Alabama Research and principal investigator for THIO-101 in Alabama commented, "We look forward to bringing ateganosine treatment to our cancer center. There’s a large regional patient pool across the Southeast, including underserved and rural populations, that can greatly benefit from a novel therapy in this hard-to-treat NSCLC setting with very limited treatment options."

In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, JUN 10, 2026, View Source [SID1234666556])

VERAXA Biotech to Debut as a Publicly Traded Company Pioneering Next-Generation Cancer Therapies on June 11, 2026

On June 10, 2026 VERAXA Biotech AG, an emerging leader in designing novel cancer therapies, reported that its previously announced business combination ("Business Combination") with Voyager Acquisition Corp. (NASDAQ: VACH, "Voyager"), a special purpose acquisition company sponsored by Cantor Fitzgerald & Co., Voyager Acquisition Sponsor Holdco LLC, and Odeon Capital Group LLC, was closed successfully (the "Closing"). Pursuant to the Closing, VERAXA Biotech AG and Voyager merged with and into VERAXA Biotech Holding AG, which will change its name to VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"). The shareholders of Voyager approved the transaction on March 12, 2026. The transaction had been previously approved by VERAXA’s shareholders on February 27, 2026. Tomorrow, on June 11, 2026, VERAXA will commence trading its shares under the symbol "VRXA" and its warrants under the symbol "VRXAW" on the Nasdaq Capital Market.

VERAXA is developing a new generation of bispecific TCEs and ADCs aimed at increasing patient benefit through enlarging the therapeutic window and maximizing safety and efficacy. Central to VERAXA’s strategy is the use of its proprietary technology platform BiTAC (Bi-targeted Tumor-Associated Cytotoxicity), which enables the creation of conditionally activated, AND-gated therapeutic strategies that precisely target cancer cells while leaving healthy cells intact. This highly specific dual-antigen approach targets tumor cells with precision and makes it possible to target solid tumors with non-exclusive cancer markers. VERAXA is currently advancing a pipeline of development programs with a focus on solid tumors, which are predominantly sourced from its BiTAC platform. VERAXA’s BiTAC platform also enables the company to contribute value to developments in complementary therapeutic sectors such as radioimmunoconjugates (RICs) and antibody-oligonucleotide conjugates (AOCs).

Initial data from VERAXA’s most advanced BiTAC program were presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, CA, USA. VERAXA’s BiTAC-TCE candidate performed as intended in vitro and in vivo, attacking cancer cells featuring both target molecules while sparing cells expressing just one of these targets. Data demonstrated a superior safety profile and matching efficacy compared to a more traditional TCE, pointing to the possibility of a significantly improved therapeutic index. The Company’s posters are available on the VERAXA website at www.veraxa.com.

Proceeds from the financings will provide VERAXA with the ability to advance its pipeline of BiTAC-TCE and BiTAC-ADC programs toward clinical development and through initial value inflection points. The financings are comprised of a senior secured note in the principal amount of $27.5 million and a securities purchase agreement of up to $50 million.

"Entering this next chapter as a public company with significant momentum is a transformational milestone for VERAXA," said Christoph Antz, Ph.D. Chief Executive Officer of VERAXA. "We are grateful for the support received to date from current and new shareholders as the completion of our business combination better positions us to deliver meaningful value to patients with cancer. From here, we look to fully unlocking the transformative therapeutic potential of our BiTAC-TCE and BiTAC-ADC programs and establish our BiTAC platform as a launch pad for a multitude of innovative cancer therapies."

"VERAXA combines strong technology, excellent science, and an experienced management team – the ideal foundation for sustainable success on an international scale," added Oliver R. Baumann, Chairman of the VERAXA Board and CEO of Xlife Sciences AG. "Bringing our first portfolio company onto the NASDAQ market and setting VERAXA up for the accelerated growth of its pipeline and organization is a significant milestone for VERAXA and for Xlife Sciences at the same time."

"New technologies are poised to unlock significant value in two of the most vibrant subsectors in cancer medicine in recent years – bispecific T-cell engagers and ADCs," said Warren Hosseinion, M.D., Chairman of the Voyager Board of Directors prior to the Closing of the Business Combination and a current member of the VERAXA Board of Directors. "In VERAXA, we have found a unique opportunity to fulfill Voyager’s mission of scaling a transformational approach in the healthcare industry toward clinical readiness and market approval."

About the Business Combination

On April 22, 2025, VERAXA entered into a definitive business combination agreement (the "Business Combination Agreement") with Voyager Acquisition Corp., a Cayman Islands exempted company and special purpose acquisition company targeting the healthcare sector (NASDAQ: VACH, "Voyager"). Upon closing of the Business Combination, the combined company is expected to become a publicly traded company listed on NASDAQ trading under the symbol "VRXA".

The description of the Business Combination contained herein is only a high-level summary and is qualified in its entirety by reference to the underlying documents filed with the Securities and Exchange Commission (the "SEC"). A more detailed description of the terms of the transaction has been provided in a proxy statement/prospectus filed with the SEC by Voyager on February 19, 2026.

(Press release, Veraxa Biotech, JUN 10, 2026, View Source [SID1234666555])

BostonGene to Feature Next-Generation AI Foundation Models for Precision Immuno-Oncology at the 22nd Annual RadMed Symposium

On June 10, 2026 BostonGene, leading developer of AI models for tumor and immune biology, reported its participation at the 22nd Annual Industry/Academia Precision Oncology & RadMed Symposium. At this premier event, global leaders in life sciences will explore the latest innovations in AI, immuno-oncology, molecular imaging, and targeted therapies. The symposium will be held on Thursday, June 11, 2026, at The Alexandria at Torrey Pines Conference Center in San Diego, California.

Presentation details:

Title: Beyond Multiomics: Leveraging AI Foundation Models to Decode the Tumor-Immune Interface
Date & time: Thursday, June 11 | 1:25 PM PST
Speaker: Michael F. Goldberg, PhD, VP of R&D, BostonGene
The presentation will showcase how BostonGene utilizes advanced AI architecture and foundation models to integrate multimodal oncology and immunology data spanning molecular, tissue, cellular, and patient levels to deliver deep biological insights and accelerate drug development. Trained on extensive data points across multiple indications, this model generates high-dimensional embeddings that significantly improve the prediction of immunotherapy response and toxicity profiles.

Dr. Goldberg will highlight how AI-based analysis of minimally invasive peripheral blood immune profiling can support clinical development. The presentation will include key findings from a large-scale clinical collaborative study, demonstrating how the platform predicts patient response and toxicity, mitigates overfitting, and unlocks rare biological signals to guide patient stratification.

To learn more or to schedule a meeting with BostonGene during the event, please contact Hannah Oman at [email protected]. For additional details, visit the 22nd Annual Industry/Academia Precision Oncology & RadMed Symposium website.

(Press release, BostonGene, JUN 10, 2026, View Source [SID1234666554])

Laverock Therapeutics Reports Key Oncology Research Milestones

On June 10, 2026 Laverock Therapeutics (‘Laverock’), a biotechnology company developing disease-responsive advanced therapies through its unique, programmable gene control technology, reported key in-vivo functional milestones across its T-cell and macrophage oncology programmes for solid tumour indications. The data support lead programme selection and progression towards the clinic.

Laverock’s platform technology enables programmable, tunable and multiplex gene control for both endogenous targets and for transgenically expressed payloads. In its T-cell programme (LVK201), the platform is designed to improve CAR-T cell anti-tumour activity without compromising safety. The latest data from ovarian cancer models, presented at the American Society of Cell and Gene Therapy (ASCGT) Annual Meeting in May, demonstrate that the Company’s technology can improve solid tumour control by targeting three distinct immunomodulatory pathways simultaneously. Previous studies have also shown that, because the technology harnesses T-cell activation dynamics to act only when needed, safety can be significantly improved compared with alternative approaches.

These findings inform development of Laverock’s lead programme whilst also providing broader validation of the platform, establishing a foundation for future tailored therapies across a range of solid tumour types. To realise this Laverock will apply AI and single-cell analytical approaches backed by recently announced grant funding.

In its macrophage programme (LVK301), Laverock’s platform technology is used to control macrophage cell phenotype and regulate the delivery of an immunomodulatory payload. The Company has shown that these engineered cells can both control tumour growth, and convert the ‘cold’, immunosuppressive solid tumour microenvironment to a ‘hot’ state, enabling the body’s immune system to attack the tumour. These findings provide strong validation of Laverock’s macrophage programme for oncology and open the way to applying myeloid biology to address additional disease classes.

Laverock is now engaged with a range of partner organisations, defining non-clinical and clinical strategy, to provide a de-risked route to early clinical validation.

David Venables, Laverock Therapeutics CEO, said: "These key data points from our oncology programmes highlight the capabilities and strength of our platform technology, and provide a clear route to lead programme selection and progression into non-clinical studies. Solid tumours remain an area of huge unmet need for cancer patients, and we look forward to moving our differentiated therapies towards the clinic."

(Press release, Laverock Therapeutics, JUN 10, 2026, View Source [SID1234666553])