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Zelluna ASA activates The Royal Marsden as second clinical site for ZIMA-101, expanding clinical execution capabilities

On June 29, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported that The Royal Marsden NHS Foundation Trust has been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

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The Royal Marsden is one of Europe’s leading cancer centres with a strong track record in execution of early-stage clinical trials in oncology, and Dr. Andrew Furness serves as the principal investigator at the site. The activation of this second clinical site further expands the Company’s clinical execution capabilities and patient recruitment capacity as ZIMA-101 progresses through its early stages. The site, will soon be in a position to actively identify and screen patients with suitable tumour types, characteristics (including expression of the MAGE-A4 antigen and HLA-A*02 positivity) and disease stage for potential enrolment.

The activation of The Royal Marsden follows the activation of the first clinical site, The Christie NHS Foundation Trust, where Professor Fiona Thistlethwaite serves as Chief Investigator for the study. With both sites now activated, the ZIMA-101 programme has full clinical execution capability across two of the UK’s leading cancer centres.

ZIMA-101 is a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate and the world’s first MAGE-A4-targeting TCR-NK therapy in clinical development. The study marks the first clinical evaluation of Zelluna’s proprietary TCR-NK platform.

"This is another important milestone for Zelluna as we continue to advance the execution of the ZIMA-101 study," said Namir Hassan, Chief Executive Officer of Zelluna. "The activation of The Royal Marsden expands our ability to identify and enrol eligible patients and reflects the continued progress being made across the programme. We remain focused on advancing the study with discipline and urgency and are grateful to the investigators, clinical teams and patients who are making this important work possible."

Zelluna remains on track for initial clinical data from the ZIMA-101 study to emerge from mid-2026.

(Press release, Zelluna Immunotherapy, JUN 29, 2026, View Source [SID1234668994])

Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update

On June 29, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update.

The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

"The FDA’s acceptance of our RP1 BLA resubmission marks a pivotal milestone in our mission to bring this important therapy to patients facing advanced melanoma, where the need for durable, effective treatment options remains significant," said Sushil Patel, Ph.D., CEO of Replimune. "We are working hard to ensure we can provide access to RP1 as soon as possible pending an approval. We are equally pleased by the momentum across our clinical programs including continued strong enrollment in our IGNYTE-3 trial of RP1 in advanced melanoma and our REVEAL trial of RP2 in metastatic uveal melanoma."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

• IGNYTE Trial (RP1 + Nivolumab) – 3-Year Overall Survival Analysis: In an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 annual meeting, RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients, with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9 months – including an 83.5% 3-year survival rate among responders – representing a rare and meaningful long-term benefit in a patient population with historically limited treatment options (Presentation).
• IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

• Phase 1 First-in-Human Trial (RP2) – Final Data: In an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 annual meeting, RP2 monotherapy and in combination with nivolumab demonstrated promising efficacy across multiple advanced solid tumor types, achieving a 19% objective response rate in both arms with durable responses (median duration not reached for monotherapy), while translational analyses confirmed the intended mechanism of transforming immunologically "cold" tumors into immune-inflamed environments with systemic T-cell activation, supporting advancement to a randomized Phase 2/3 trial in metastatic uveal melanoma (Presentation).
• REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027.

Financial Highlights

• Cash Position: As of March 31, 2026, cash, cash equivalents and short-term investments were $268.9 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations into the first quarter of calendar 2027, which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

• R&D Expenses: Research and development expenses were $52.3 million for the fiscal fourth quarter and $221.2 million for the fiscal year ended March 31, 2026, as compared to $54.0 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025. This year over year increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as consulting and facility-related costs. Research and development expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $16.7 million for the fiscal year ended March 31, 2026.

• S,G&A Expenses: Selling, general and administrative expenses were $21.0 million for the fiscal fourth quarter and $98.7 million for the fiscal year ended March 31, 2026, as compared to $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $15.5 million for the fiscal year ended March 31, 2026.

• Net Loss: Net loss was $73.7 million for the fiscal fourth quarter and $313.9 million for the fiscal year ended March 31, 2026, as compared to a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, JUN 29, 2026, View Source [SID1234668993])

NovaBridge Biosciences Appoints Dr. Srishti Gupta as Chief Executive Officer

On June 29, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a clinical-stage biopharmaceutical company advancing innovative medicines for areas of significant unmet need, reported the appointment of Srishti Gupta, MD MPP as Chief Executive Officer and a member of the Company’s Board of Directors, effective July 1, 2026. Xi-Yong (Sean) Fu PhD MBA will step down as Chief Executive Officer to pursue other opportunities. Dr. Fu will support the Company in an advisory capacity during the transition.

Dr. Gupta is an experienced CEO who brings more than two decades of transformative leadership across biopharmaceuticals, global health, and strategy. As CEO of NovaBridge, she will focus on advancing givastomig toward registration, expanding the ophthalmology franchise under Visara, and establishing strategic partnerships to maximize the potential of the Company’s medicines for patients and shareholders globally.

"Srishti’s perspective as both a physician and CEO makes her uniquely suited to lead NovaBridge," said Fu Wei, Chairman of the Board of NovaBridge. "Her global commercial experience and proven ability to build strategic partnerships positions NovaBridge to advance givastomig and VIS-101 toward registration, and deliver innovative medicines to patients. I am confident in her ability to create lasting value for our patients and shareholders. The Board and I are grateful to Sean Fu for his contributions to NovaBridge as our former CEO and wish him well in his future endeavors."

"Extraordinary science is being created faster than the industry’s ability to bring it to patients — and NovaBridge was built to bridge that gap," said Dr. Gupta. "We believe our competitive advantage is identifying underappreciated, differentiated assets and advancing them toward registration and global reach through the right partnerships. My immediate priority is delivering on that promise for patients and shareholders."

About Srishti Gupta, MD MPP

Dr. Srishti Gupta is a physician-executive with more than two decades of leadership experience across biopharmaceuticals, global health, and strategy.

Most recently, she served as Chief Executive Officer of Idorsia Ltd (SIX: IDIA), a Switzerland-based biopharmaceutical company. Appointed to lead the company after four years on its board of directors, she executed a full operational and financial turnaround.

Earlier in her career, Dr. Gupta spent 18 years at McKinsey & Company, where she led the firm’s Global Health Practice for more than a decade and built large-scale public-private partnerships across the United States, Europe, and emerging markets. She advised life sciences companies and governments on strategy, growth, market access, and organizational transformation, and served on the faculty of the MIT Sloan School of Management.

Dr. Gupta serves as a member of the board of Santhera Pharmaceuticals (SIX: SANN). She has previously served on the boards of directors of Invivyd, Inc. (Nasdaq: IVVD), where she chaired the Compensation Committee, and Idorsia Ltd (SIX: IDIA), where she chaired the Nominations Governance and Compensation Committee. She also serves as a member of the board of directors of Partners In Health and a Board Trustee of the International Vaccine Institute.

Dr. Gupta holds a Doctor of Medicine from Harvard Medical School; a Master of Public Policy in international development from Harvard Kennedy School; a Master of Philosophy in Natural Sciences from the University of Cambridge; and a Master of Arts in Molecular and Cellular Biology and a Bachelor of Arts in Biological Sciences, both from Harvard University.

(Press release, NovaBridge Biosciences, JUN 29, 2026, View Source [SID1234668992])

Ipsen to acquire Kartos Therapeutics, expanding hemato-oncology late-stage pipeline

On June 29, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) and Kartos Therapeutics, reported they have entered into a definitive merger agreement under which Ipsen has agreed to acquire Kartos Therapeutics. The acquisition adds navtemadlin, an investigational MDM2 inhibitor designed to restore the natural tumor-suppressing function of p53, a critical tumor-suppressor in myelofibrosis. Data show strong therapeutic potential of navtemadlin for intermediate and high-risk TP53 wild-type (wt) myelofibrosis as an add-on treatment for patients with a suboptimal response to standard of care ruxolitinib.

"This acquisition further strengthens our late-stage oncology pipeline and reflects our continued focus on bringing transformational treatments to people living with cancer," said David Loew, CEO, Ipsen. "We are excited by the potential of navtemadlin to define a new treatment paradigm for patients with myelofibrosis who have a suboptimal response to current standard of care, addressing a critical care gap and offering the potential for a new therapeutic option as early as 2028."

Current standard of care ruxolitinib improves splenomegaly and myelofibrosis-related symptoms. However, a significant proportion of patients experience a suboptimal response to ruxolitinib, resulting in treatment discontinuation. Patient outcomes after ruxolitinib discontinuation are dismal, with a median overall survival of approximately 1-2 years. Navtemadlin is currently being evaluated in the global Phase III trial POIESIS designed to enroll >600 patients across >250 sites, as an add-on therapy to standard of care ruxolitinib in patients with intermediate and high-risk TP53wt myelofibrosis who have a suboptimal response to ruxolitinib. The trial builds on earlier clinical evidence, including a Phase Ib/II trial (KRT-232-109) in which add-on navtemadlin demonstrated clinically meaningful and disease-modifying activity in myelofibrosis patients who had a suboptimal response to standard of care ruxolitinib. Data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in 2023 showed that at Week 24, in patients with a suboptimal response to ruxolitinib (n=19), 42% achieved at least a 25% reduction in spleen volume, 32% achieved at least a 35% reduction in spleen volume, and 32% achieved a total symptom score improvement of at least 50%. These data also showed potential disease modification activity of navtemadlin, as evidenced by 71% of evaluable patients (n=7) achieving a ≥20% reduction of driver variant allele frequency and 57% showing an improvement in bone marrow fibrosis by Central Review of ≥1 Grade by Week 24.

Srdan Verstovsek, MD, PhD, Chief Medical Officer of Kartos Therapeutics, commented, "As a treating clinician who cared for more than a thousand patients with myelofibrosis, I have seen first-hand the significant care gap for patients with myelofibrosis who remain symptomatic or have persistent splenomegaly despite ruxolitinib treatment. Navtemadlin has the potential to enhance the existing standard of care through an add-on approach designed to move patients with a suboptimal response into a clinical responder group by optimizing their care. We believe this innovative treatment paradigm could meaningfully improve outcomes for patients while avoiding unnecessary over-treatment of those already responding well."

"Myelofibrosis remains a serious and rare blood cancer associated with a substantial symptom burden and progressive splenomegaly that significantly impact quality of life," said John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Center of Excellence for Blood Cancers and Myeloid Disorders. "The clinical rationale for combining navtemadlin with ruxolitinib is very compelling, and the emerging data suggest the synergistic potential to deepen responses and address the underlying biology of the disease."

"The Phase III POIESIS trial has the potential to redefine how we treat patients with myelofibrosis," said Dr Pankit Vachhani, Associate Professor of Medicine and Director of Clinical Research Unit at the University of Alabama at Birmingham, and Global Principal Investigator of POIESIS. "It is the largest trial conducted in this disease and uniquely designed to reflect real-world clinical practice. The trial evaluates how adding navtemadlin can deliver more clinically meaningful and durable responses, thereby addressing a critical unmet need. I am excited by the prospect of navtemadlin delivering disease modifying benefits, ushering an era of rational combination therapies for those with suboptimal response to standard therapy, and targeting complementary disease pathways beyond JAK inhibition alone in myelofibrosis."

Transaction details
Under the terms of the agreement and plan of merger, Ipsen through a fully-owned subsidiary, will pay $450 million upfront at closing. Kartos Therapeutics shareholders are also eligible to receive additional milestone payments of up to $1.3 billion including a significant regulatory approval milestone and sales-based milestones.

This late-stage transaction is expected to be accretive to Ipsen’s core operating income from 2029, with limited dilution to 2026 full-year guidance. The transaction is anticipated to close by the end of Q3 2026, subject to fulfilment of customary closing conditions including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Advisors
Orrick Herrington & Sutcliffe LLP (DC office) is acting as legal counsel to Ipsen. Goldman Sachs & Co. LLC and PJT Partners (UK) Ltd are serving as financial advisors to KARTOS THERAPEUTICS. DLA Piper LLP (NY office) is serving as legal counsel to KARTOS THERAPEUTICS.

About navtemadlin
Navtemadlin is an investigational oral MDM2 inhibitor being developed as an add-on therapy to ruxolitinib for patients with myelofibrosis who have a suboptimal response to ruxolitinib. The Phase III POIESIS study is evaluating whether the addition of navtemadlin could improve clinical outcomes compared with ruxolitinib alone in this patient population. Early clinical data demonstrate navtemadlin has the potential to transform suboptimal responses to standard of care ruxolitinib into clinically meaningful responses in patients with intermediate and high risk TP53wt myelofibrosis, to provide both enhanced clinical outcomes and potential disease-modifying benefit.

About myelofibrosis
Myelofibrosis is a myeloproliferative neoplasm, frequently linked to alterations in the JAK/STAT pathway, in which patients develop bone marrow fibrosis due to the abnormal proliferation of hematopoietic stem cells and secretion of fibrogenic cytokines. As marrow function declines, blood production shifts to other organs, most often the spleen, leading to splenomegaly. Myelofibrosis is characterized by bone marrow failure, fibrosis, splenomegaly and a high symptom burden that can significantly affect quality of life, including fatigue, night sweats and other progressive symptoms. It also carries a risk of transformation to acute myeloid leukemia. The median age at diagnosis is approximately 67–69 years and the condition affects around 1.5 per 100,000 people in the U.S. and Europe. Approximately 75–89% of patients are intermediate- or high-risk at diagnosis and more than 95% are TP53wt. Ruxolitinib, a JAK inhibitor, is the first-line standard of care; however, it is estimated that a significant proportion of patients have an initial suboptimal response and approximately 50%-75% discontinue treatment after three years. Median overall survival is typically one to two years after treatment discontinuation, underscoring the need for new strategies that can increase the number of patients that can achieve optimal clinical outcomes.

(Press release, Ipsen, JUN 29, 2026, View Source [SID1234668991])

Genmab Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Demonstrating Statistically Significant Improvement in Progression-Free Survival

On June 29, 2026 Genmab A/S (Nasdaq: GMAB) reported topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of fixed duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, and lenalidomide, compared to standard-of-care, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of treatment. Based on topline results, the trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p value < 0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p value < 0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively. The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the previously reported safety profiles of the individual agents (epcoritamab or lenalidomide).

"These topline results add to the growing evidence supporting the versatility of epcoritamab-based combinations, including fixed-duration epcoritamab, across lines of therapy for patients with relapsed or refractory large B-cell lymphoma who received at least one prior treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "With each new combination and treatment setting, we are building on our vision for epcoritamab as a core therapy across B-cell malignancies. We look forward to engaging with regulatory authorities as we continue to advance this program."

Genmab and AbbVie will engage global regulatory authorities. Data will be submitted for presentation at a future medical meeting.

About the EPCORE DLBCL-4 Trial
EPCORE DLBCL-4 (NCT06508658) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) in combination with lenalidomide compared to chemoimmunotherapy, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including patients with diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC and B-cell /lymphoma 2 (BCL2) and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B), T-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr Virus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). Patients in the trial were previously treated with at least one line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy, and failed or relapsed after, or were not a candidate for autologous stem cell transplantation (ASCT) and ineligible for or unable to receive CAR-T since DLBCL diagnosis. The trial started on August 13, 2024, and is ongoing.

More information on this trial can be found at View Source (NCT: NCT06508658).

About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.[i],[ii] In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.[iii] DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.[iv],[v] DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,[vi]

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.[vii]

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976) and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab have not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

Please see local country prescribing information for all labeled indication and safety information.

(Press release, Genmab, JUN 29, 2026, View Source [SID1234668990])