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Imugene Reports First Complete Response in Concurrent BTKi Cohort of azer-cel Phase 1b Trial

On June 30, 2026 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first patient data from the concurrent BTK inhibitor (BTKi) cohort of its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel).

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This Follicular Lymphoma (FL) patient, who had previously failed BTKi therapy, achieved a complete response at the Day 28 assessment.

FL is the most common indolent B-cell lymphoma and, while many patients respond to initial treatment, it remains a high unmet need with standard therapies and most patients will relapse over time.

All patients enrolled in the concurrent BTKi cohort have relapsed on or are refractory to BTKi therapy, a standard treatment across multiple B-cell malignancies. Despite the established efficacy of BTK inhibitors, a significant proportion of patients develop resistance over time and are left with limited remaining options. This cohort evaluates whether concurrent dosing of azer-cel with a BTKi may restore or enhance therapeutic activity in this setting. The global BTKi market reached approximately US$12.0 billion in 2025.

Leslie Chong, Managing Director and CEO of Imugene, said, "This initial data provides further confidence in the potential of azer-cel in patients who have exhausted standard treatment options, including BTK inhibitors. Given how widely BTKi therapies are used, we believe this combination approach could represent a meaningful development pathway for azer-cel."

To date, four patients have been dosed in the concurrent BTKi combination cohort, including the first patient with mantle cell lymphoma. Further updates will be provided as additional data becomes available, and the dataset matures.

Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy which targets CD19 to treat blood cancers. Azer-cel is derived from healthy donor T cells and ready for administration within days, without the three-to-six-week manufacturing lead time required for autologous CAR T products.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has most recently expanded into a concurrent BTKi cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. Treatment with azer-cel, lymphodepletion and IL-2 has produced meaningful clinical responses across multiple indications, including a complete response in the first evaluable patient from the BTKi combination cohort. Additionally, the safety profile is manageable and generally well tolerated.

(Press release, Imugene, JUN 30, 2026, View Source [SID1234668996])

ITM, Helmholtz Munich and the University of Münster Announce Updated Preliminary Phase 1 Data with ITM-31 in Glioblastoma Patients

On June 29, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, Helmholtz Munich and the University of Münster reported updated preliminary results from a Phase 1 clinical trial of investigational candidate, ITM-31 (177Lu-6A10-Fab), an intracavitary targeted radiotherapy, in patients with glioblastoma. These data showed a manageable safety profile, with all patients remaining alive since enrollment began in January 2024. Enrollment is now complete, and the initial six-month follow-up period for all patients is expected to be completed by the end of 2026. Preliminary data were recently presented at the Nuclear Medicine and Neuro-Oncology (NMN) Society Annual Symposium, in Vienna, Austria.

The investigator-initiated Phase 1 trial (NCT05533242) is a prospective, single-arm, multicenter, dose-escalation study evaluating the safety, tolerability, and maximum tolerated dose of ITM-31, as well as progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed glioblastoma, following surgical resection and standard radio-chemotherapy, with no or minimal residual disease. ITM-31 is designed as a maintenance therapy applied during a period of stability. The study enrolled ten patients across four clinical sites at German university hospitals in Münster, Würzburg, Essen, and Cologne.

ITM-31 is a Lutetium-177-labeled 6A10 Fab fragment targeting carbonic anhydrase XII (CA XII), a cell surface protein expressed in more than 90% of glioblastoma cases but absent in healthy brain tissue. It is administered via intracavitary injection directly into the post-surgical resection cavity, enabling targeted radiation of residual tumor cells, bypassing the blood–brain barrier. Under a licensing agreement with Helmholtz Munich, ITM holds exclusive rights to develop and commercialize ITM-31.

"By delivering ITM-31 directly into the surgical resection cavity, our goal is to achieve high targeted radiation exposure at the site of residual disease, while minimizing systemic toxicity," said Dr. Michael Müther, study investigator and neurosurgeon at the University of Münster. "Given the disease’s high rate of recurrence, strategies that address residual tumor cells locally may play an important role in improving outcomes."

"We have come a long way from validating our antibody in the first cell assays to bringing it into the clinic. It has been a wonderful experience to partner with the University of Münster and ITM for this first study, and we are hopeful that this approach may ultimately benefit patients with glioblastoma," said Prof. Reinhard Zeidler, group leader at the Institute of Structural Biology, Molecular Targets and Therapeutics Center, Helmholtz Munich, who identified and developed the CA XII-targeting 6A10 antibody fragment used in ITM-31.

Study design:

Patients with newly diagnosed glioblastoma received individualized total doses of ITM-31 in three fractions with an interval of 4 weeks between injections after completion of standard of care therapy. There were three dose-escalating cohorts.

Key preliminary findings show:

ITM-31 demonstrated a manageable safety profile across all cohorts; adverse events were predominantly reversible and manageable with standard treatment.
No Grade ≥3 hematological toxicities were observed, and dosimetry confirmed radiation exposure remained below established safety thresholds for organs at risk.
ITM-31 has demonstrated early signs of efficacy in patients with newly diagnosed glioblastoma. All enrolled patients remain alive during ongoing follow-up.

"These preliminary results support the potential of intracavitary targeted radiotherapy with ITM-31 as a novel approach for patients with glioblastoma, where outcomes remain extremely poor following standard of care treatment," said Dr. Celine Wilke, chief medical officer of ITM. "The safety profile and early signs of anti-tumor activity observed to date support continued clinical development."

Patients will continue to be followed for up to two years after initial treatment with ITM-31.

Preliminary pilot data were published in EJNMMI Research (2023), demonstrating the feasibility and safety of intracavitary administration of [177Lu]6A10-Fab fragments in patients with glioblastoma.

About Glioblastoma
Glioblastoma is the most common and aggressive primary malignant brain tumor in adults, accounting for nearly half of all gliomas and affecting more than 25,000 patients annually in Europe and over 100,000 worldwide. In the United States, approximately 12,000–14,000 new cases are diagnosed each year.

Despite standard treatment with surgery, radiation and chemotherapy, outcomes remain poor, with median overall survival of approximately 15–20 months. Recurrence mostly occurs around the original tumor site, underscoring the need for effective locoregional therapies. The blood-brain barrier further limits the impact of many systemic treatments, highlighting the need for novel therapeutic approaches.

(Press release, ITM Isotopen Technologien Munchen, JUN 29, 2026, View Source [SID1234669005])

New PROSPER Data Demonstrate Real-World Impact of Mogamulizumab on Symptoms and Health-Related Quality of Life in Mycosis Fungoides and Sézary Syndrome

On June 29, 2026 Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd (TSE: 4151), reported positive results from PROSPER, a real-world observational study of mogamulizumab in adults with mycosis fungoides (MF) or Sézary syndrome (SS). In the study, patients reported clinically meaningful improvements in skin symptoms (itch, flaking, and redness) and body temperature regulation as early as week 4, with improvements in sleep and health-related quality of life (HRQoL) starting at week 12. Improvements were sustained throughout the study period, with additional gains in HRQoL reported through week 48.

"Cutaneous T-cell lymphoma can affect far more than just the skin, impacting how patients feel and function every day," said Professor Julia Scarisbrick, Principal Investigator, Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. "These findings from the PROSPER study are encouraging because they show that in patients with MF or SS, mogamulizumab can help ease symptoms that affect everyday life, and those improvements can be long-lasting."

Mycosis fungoides and Sézary syndrome are two sub-types of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma that primarily affects the skin, presenting as patches, plaques, tumors, or reddening of the entire skin, and may be associated with severe itching. The disease may spread to lymph nodes, blood, and/or other organs in some patients.

"Clinical studies are stronger when they are shaped by the voices and lived experiences of people living with the disease," said Susan Thornton, study author and co-CEO, Cutaneous Lymphoma Foundation. "Collaboration between industry and the patient community is essential to designing studies that generate more relevant insights into symptom burden, quality of life, and the day-to-day treatment experience."

Key PROSPER Findings

The study included 73 patients with relapsed or refractory MF or SS (n=41 MF; n=32 SS). Patient-reported outcomes were collected at baseline and throughout the study using:

A CTCL-specific symptom diary assessing the severity of skin itch, pain, redness, and flaking, frequency of sleep problems, and difficulty regulating body temperature
The MF/SS-CTCL-QoL questionnaire, which measured the impact of CTCL on daily life
The Brief Fatigue Inventory (BFI), which assessed fatigue severity and its impact on daily functioning

Mean symptom scores (mean +/- standard deviation) improved from baseline to week 48 across key skin symptoms, including itch (−2.5 ±3.4), flaking (−3.1 ±3.5), redness (−3.1 ±3.5), and pain (−1.7 ±4.4). Clinically meaningful improvements in skin itch, flaking, and redness were observed as early as week 4, and improvements in pain by week 12 (i.e., exceeding the minimum important difference (MID)). These effects were sustained through week 48.

By week 48, 30% of patients reported at least a 2-point improvement in sleep, and 37% reported better body temperature regulation. Patients also showed significant, clinically meaningful improvements in disease-specific health-related quality-of-life scores (MF/SS-CTCL-QoL) beginning at week 12, with further gains through week 48. While fatigue scores changed little among patients with MF, patients with SS showed a significant improvement in total BFI scores, reaching the MID threshold at week 48.

"Studies like PROSPER show why real-world data generation matters, particularly in rare cancers like mycosis fungoides and Sézary syndrome," said Angela Williams, PhD, Global Head of Health Economics and Outcomes Research at Kyowa Kirin. "These data help broaden understanding of the lived experience of patients and care partners with mogamulizumab treatment in everyday practice, including the impact on symptoms and quality-of-life that may not be fully reflected by outcomes collected in clinical trial."

About PROSPER

The objective of the PROSPER (ClinicalTrials.gov ID NCT05455931) study is to gain insight into the experiences of patients with MF or SS receiving mogamulizumab in real-world clinical practice through the collection of patient-reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience. The study was designed with input from patients and caregivers to ensure patient-relevant outcomes were selected, and it was conducted in six countries across North America, Europe, and the Middle East, at 19 sites working with patients with MF or SS. Patients were followed for up to 50 weeks from study enrollment.

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%).

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.

(Press release, Kyowa Hakko Kirin, JUN 29, 2026, View Source [SID1234669004])

Nuvectis Pharma Announces Pricing of $100 Million Public Offering of Common Stock

On June 29, 2026 Nuvectis Pharma, Inc. (Nasdaq: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology, reported the pricing of its previously announced underwritten public offering of 5,000,000 shares of its common stock at a price of $20.00 per share, with expected gross proceeds to Nuvectis of $100 million. Nuvectis has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about July 1, 2026, subject to satisfaction of customary closing conditions.

Cantor is acting as sole book runner for the offering. H.C. Wainwright & Co., Laidlaw & Company (UK) Ltd., Lucid Capital Markets, Maxim Group LLC, Roth Capital Partners and Titan Partners, a division of American Capital Partners are acting as co-managers for the offering.

Nuvectis intends to use the net proceeds from the offering to continue to advance the development programs of NXP100, NXP200, and NXP900 or any future product candidate, hiring of additional personnel, capital expenditures, costs of operating as a public company and other general corporate purposes.

The shares of common stock described above are being offered by Nuvectis pursuant to its shelf registration statement on Form S-3 (File No. 333-293459) filed with the U.S. Securities and Exchange Commission ("SEC") on February 13, 2026 and declared effective by the SEC on February 20, 2026. The preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to these shares of common stock may also be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Nuvectis Pharma, JUN 29, 2026, View Source [SID1234669003])

Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)

On June 29, 2026 Samsung Bioepis Co., Ltd. reported that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints.

"We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development," said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. "We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patients with unmet needs."

Pembrolizumab is a humanized monoclonal antibody that acts as an immune checkpoint inhibitor by targeting and blocking the programmed cell death protein 1 (PD-1) receptor on T cells. It is used to treat various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell cancer (HNSCC).2

The randomized, double-blind, three-arm, parallel group, multicenter Phase 1 clinical trial demonstrated pharmacokinetic (PK) bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. The study assessed PK, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA NSCLC following complete resection and adjuvant platinum-based chemotherapy.3 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks up to 51 weeks, and blood samples were collected. The preliminary PK evaluation indicates that the drug exposure, measured by the Area Under the Curve (AUC), has met the predefined equivalence criteria.

The randomized, double-blind, parallel group, multicenter Phase 3 clinical trial demonstrated equivalent objective response rate (ORR) at Week 24. The study assessed efficacy, safety, PK, and immunogenicity of SB27 and Keytruda in patients with metastatic non-squamous NSCLC, followed by chemotherapy.4 555 participants were randomized to receive SB27 or Keytruda followed by pemetrexed and carboplatin5 every 3 weeks up to 48 weeks. The 90% confidence interval (CI) for the ORR ratio between SB27 and Keytruda at Week 24 was 0.737 to 1.071, which completely fell within the pre-defined equivalence margin of 0.712 to 1.405, thereby demonstrating equivalence. Safety, PK and immunogenicity profiles of SB27 were also comparable with those of Keytruda.

(Press release, Samsung Bioepis, JUN 29, 2026, View Source [SID1234669002])