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Juncell Therapeutics’ GC101 TIL Therapy Achieves Primary Endpoint in the Pivotal Phase II Trial for PD-1 Antibody Failed Advanced Melanoma

On June 3, 2026 Shanghai Juncell therapeutics, reported a Late-Breaking Abstract (LBA) oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Professor Lu Si from Peking University Cancer Hospital presented the results of a Pivotal Phase 2 clinical study (MIZAR-003) conducted in China evaluating the efficacy and safety of GC101 TIL therapy (Nolgileucel), developed by Shanghai Juncell Therapeutics Co., Ltd. for PD-1 antibody failed patients with advanced melanoma. Comparing with the control group who received chemotherapy, GC101 TIL therapy demonstrated statistically significant and clinically meaningful efficacy improvement, potentially to benefit patients with advanced melanoma who failed PD-1 antibody.

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Addressing the Unmet Need in the Treatment of Advanced Melanoma

Unlike cutaneous melanoma which is predominant in Western population, melanoma in East Asia is primarily composed of acral melanoma and mucosal melanoma. The differences in subtypes result in distinct patient outcomes. For instance, the objective response rate (ORR) and duration of response (DoR) of PD-1 antibody as the first treatment setting for advanced melanoma in China are only around 1/3 of those in Western population.

Conventional TIL therapies can offer deep and durable clinical benefits, but the requirements of high-intensity lymphodepletion chemotherapy and high-dose IL-2 administrations may lead to severe adverse events and even mortality.

The MIZAR-003 study selected for this ASCO (Free ASCO Whitepaper) LBA is an open-label, randomized, active-controlled, multicenter pivotal Phase II clinical trial. Initiated in December 2024 and led by Professor Jun Guo of Peking University Cancer Hospital. The trial was conducted across 25 leading cancer centers in China. The study aims to evaluate the efficacy and safety of GC101 in patients with advanced melanoma who have failed prior PD-1 antibody therapy, with the primary endpoint being progression-free survival (PFS).

Juncell’s GC101 TIL Therapy Demonstrates Exceptional Efficacy

All enrolled patients in MIZAR-003 had advanced melanoma that failed prior PD-1 antibody therapy. The median number of prior systemic therapy lines was 2, acral and mucosal melanoma accounted for 81.8% of patients, the median sum of the diameters (SOD) of target lesions was 68.4 mm, 89.9% of patients had distant metastasis, with more than half of the patients having metastases involving ≥ 3 organs. Among these, 66.7% had metastases to vital organs including the liver, lungs, and bones. After randomization, baseline characteristics were balanced between the GC101 treatment group and the control group.

As the first registrational randomized controlled trial (RCT) of a TIL therapy in late-line melanoma globally, MIZAR-003 met its primary endpoint, achieving clinical trial success. According to the data presented, the median progression-free survival (PFS) in the GC101 treatment group was 4.3 months, which was significantly superior to 1.6 months in the chemotherapy control group (HR=0.43，95% CI 0.26~0.68，P=0.0002), representing a 57% reduction in the risk of progression or death. Overall survival (OS) data are not yet mature but have shown a clear trend of benefit.

The ORR in the GC101 treatment group was 42.0%, representing a substantial improvement over the 6.1% observed in the control group. Moreover, some patients in the treatment group converted from long-term partial response (PR) to complete response (CR), demonstrating excellent efficacy.

Juncell’s GC101 TIL Therapy Exhibits Favorable Safety Profile

Unlike conventional TIL therapy which requires high-intensity lymphodepletion chemotherapy and high-dose IL-2 administration, GC101 TIL therapy adopts an innovative regimen featuring low-intensity preconditioning and no IL-2 administration, thereby reducing related adverse events.

In terms of safety profile, compared with conventional TIL therapies, adverse events following GC101 treatment were substantially lower in both incidence and grade, with shorter duration. The median duration was 8 days.

(Press release, Juncell Therapeutics, JUN 3, 2026, View Source;juncell-therapeutics-gc101-til-therapy-achieves-primary-endpoint-in-the-pivotal-phase-ii-trial-for-pd-1-antibody-failed-advanced-melanoma-302790931.html [SID1234666414])

Sapu Nano Expands International Development of Sapu003 and Appoints Global Clinical Trials (GCT) as Lead CRO for Phase 1b Program

On June 3, 2026 Sapu Nano and Oncotelic Therapeutics (OTCQB:OTLC) reported the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization supporting international execution of Study SP-03-B101.

The announcement follows recent regulatory approvals supporting the study expansion and CRO transition and represents an important milestone in the evolution of the Sapu003 clinical program from its initial Australian clinical footprint toward a broader multinational clinical program.

GCT was selected following a competitive evaluation process that assessed international oncology expertise, regulatory capabilities, operational execution, clinical quality systems, and global logistics infrastructure. Following its appointment, GCT successfully completed key regulatory submissions ahead of schedule and has initiated clinical operations, regulatory coordination, site activation activities, investigational product logistics, and study management functions.

The appointment supports the expansion of the SP-03-B101 study beyond Australia into Europe and represents an important step in establishing the clinical, operational, and regulatory infrastructure necessary to support future multinational Phase 3 development. By building an international clinical network early in development, Sapu Nano aims to position Sapu003 for efficient advancement into global registrational studies following successful completion of ongoing clinical evaluation.

SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors.

"Sapu003 has progressed from concept through formulation development, manufacturing, regulatory approval, and clinical evaluation in a remarkably short period of time," said Dr. Vuong Trieu, Chief Executive Officer. "The expansion of the program beyond Australia and the appointment of GCT provide the international infrastructure necessary to support continued clinical development. We believe these milestones position Sapu003 for broader global evaluation and future registrational studies while expanding access for patients with advanced cancers."

Sapu003 is a proprietary intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform technology. The program is designed to address limitations associated with oral everolimus administration, including variable absorption, food effects, and first-pass metabolism, while providing more predictable systemic drug exposure through intravenous delivery.

The Company expects the expanded international footprint and integrated clinical operations platform established through GCT to support continued enrollment, future site expansion, and long-term global development objectives for the Sapu003 program.About Deciparticle

Deciparticle is Oncotelic’s proprietary nanomedicine platform designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The platform utilizes amphiphilic polymer architectures intended to improve aqueous compatibility, stability, manufacturability, and translational flexibility across multiple therapeutic classes.

(Press release, Sapu Bioscience, JUN 3, 2026, View Source [SID1234666413])

Actinium Presents New ATNM-400 Data in KRAS and EGFR Mutant Models at SNMMI 2026 Supporting a Mutation-Agnostic Opportunity In Non-Small Cell Lung Cancer

On June 3, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, on June 2, 2026, reported new preclinical data on ATNM-400 in non-small cell lung cancer (NSCLC) at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in Los Angeles, California.

The new KRAS-mutant data, together with a growing body of EGFR-mutant data, demonstrate ATNM-400’s activity across the two major mutation driver classes in NSCLC and support a distinct strategic opportunity. ATNM-400 can be developed as a potential mutation-agnostic backbone for the broader NSCLC market, alone or in combination with standard-of-care therapies, rather than as another mutation-specific drug for a narrow subset.

NSCLC accounts for roughly 85% of the more than two million lung cancer cases diagnosed globally each year, a market more than twice the size of prostate cancer. It is also highly heterogeneous: no single mutation dominates, so treatments are fragmented across mutation-specific therapies such as EGFR, KRAS, BRAF, ALK and others, each marketed by different companies, each addressing only a molecular subset, and each ultimately limited by acquired resistance. ATNM-400, Actinium’s first-in-class Actinium-225 (Ac-225) antibody radioconjugate, is designed to break out of that single-mutation paradigm. Rather than blocking a specific mutant protein, it delivers a high-linear-energy-transfer alpha-particle payload that induces dense, irreversible double-strand DNA breaks and tumor-cell death independent of a tumor’s driver mutation or signaling pathway, the mechanistic basis of its mutation-agnostic activity.

ATNM-400’s target antigen, from previously published immunohistochemistry studies, is present in approximately 98% of NSCLC tumors and highly expressed in approximately 70% of those tumors. It is conserved across EGFR-, KRAS-, and other driver-defined subgroups, and further increased in tumors that have become resistant to EGFR, KRAS, and immune-checkpoint therapies. In new KRAS-mutant studies presented at SNMMI, sotorasib (active ingredient in LUMAKRAS/Amgen) and adagrasib (active ingredient in KRAZATI/BMS) increased ATNM-400’s target up to 3.5- and 3.8-fold, respectively, and adding ATNM-400 deepened tumor-cell killing beyond either inhibitor alone. These results demonstrate the same target-expression increasing, synergy-enabling biology shown previously with the EGFR inhibitor osimertinib, which produced tumor growth inhibition of 107% when combined with ATNM-400.

These combination benefits also broaden ATNM-400’s commercial opportunity. The franchises it could enhance are substantial; the KRAS inhibitor class in NSCLC is projected to exceed $5 billion in peak sales, and the EGFR-mutant segment has peak sales estimates over $15 billion, led by osimertinib (active ingredient in TAGRISSO/AZ), which generated $7.3 billion in 2025. This positions ATNM-400 to participate in these established markets by enhancing the standard of care, while also reaching the broader NSCLC population beyond any single mutation.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Today’s data further strengthen our conviction that ATNM-400 represents a fundamentally different approach to treating NSCLC solid tumors. While most targeted therapies are designed for a single mutation-defined patient population, ATNM-400 combines the mutation-independent cell-killing power of Actinium-225 with a target that is broadly expressed across tumors and becomes even more abundant as resistance emerges. The consistency of activity we have now demonstrated across both EGFR- and KRAS-driven NSCLC supports our vision for ATNM-400 as a potential mutation-agnostic backbone therapy that can be used alone or in combination across large patient populations. We believe this opportunity could extend beyond lung cancer and may position ATNM-400 as a foundational therapy across multiple solid tumor indications."

Highlights from the SNMMI 2026 Poster Presentation

Poster Titled: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer Models

New data demonstrated ATNM-400’s potential as a mutation-agnostic antibody radioconjugate therapy for NSCLC:

Across a panel of four lung cancer cell lines spanning EGFR- and KRAS-driver mutations, ATNM-400 bound and was internalized specifically by the three target-positive lines (NCI-H1975, NCI-H358 and Calu-3) but not by the target-negative line (A549), confirming that its activity is driven by target expression rather than by any particular mutation.

In a KRAS G12C model (NCI-H358), PET imaging of radiolabeled ATNM-400 showed the drug concentrating in the tumor with low uptake in healthy tissue, visually confirming that it reaches its target in a living animal and delivers its alpha payload where intended while largely sparing normal organs.

In a KRAS G13D model (Calu-3), a single dose of ATNM-400 drove tumor regression (124% and 135% inhibition at two dose levels), indicating marked antitumor potencywith full body-weight recovery. Deep responses from one dose with a clean tolerability profile point to a wide therapeutic window and dosing flexibility, favorable attributes for clinical translation.

Treatment with both approved KRAS inhibitors (sotorasib and adagrasib) raised ATNM-400’s target expression dose-dependently—up to roughly 3.5- to 3.8-fold—reaching statistical significance at every dose (p < 0.0001). The effect occurred with both agents, indicating a class-wide consequence of KRAS G12C inhibition that builds a rationale for combining ATNM-400 with these therapies.
Post both KRAS drugs ATMN400 expression increases

ATNM-400 plus sotorasib or adagrasib decreased cancer-cell viability beyond either inhibitor alone. The data demonstrate that ATNM-400 has development potential not only as a monotherapy but also in combination with these leading KRAS therapies and possibly the entire KRAS-mutant class.

In an EGFR-mutant model (NCI-H1975), ATNM-400 monotherapy achieved 75% tumor growth inhibition versus 40% for osimertinib; combined with osimertinib it reached 107% inhibition with complete cures in 100% of mice. Osimertinib raised target expression, providing a clear rationale for the combination.

Actinium Pharmaceuticals Oral Presentation at SNMMI 2026 Highlights ATNM-400 Overcoming Resistance to All Three Approved Androgen Receptor Inhibitors and Offers Flexible, Well-Tolerated Dosing in Prostate Cancer Models

On June 3, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, on June 2, 2026, reported new data on ATNM-400 in prostate cancer at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting taking place in Los Angeles, California.

Androgen receptor pathway inhibitors (ARPIs) such as enzalutamide (Xtandi, Astellas/Pfizer), apalutamide (Erleada, Johnson & Johnson), and darolutamide (Nubeqa, Bayer) are foundational to advanced prostate cancer care, but virtually all patients eventually develop resistance and progress -with up to 50,0001 patients per year exhausting ARPI therapy- creating a large and recurring unmet need. ATNM-400, Actinium’s first-in-class Actinium-225 antibody radioconjugate, targets a non-PSMA antigen linked to aggressive prostate cancer biology and delivers a high-energy alpha-particle payload that kills tumor cells through a mechanism independent of PSMA expression and androgen receptor signaling. In preclinical head-to-head studies, this PSMA-independent mechanism allowed ATNM-400 to match or exceed PSMA-targeted radioligand therapies, including 177Lu-PSMA-617 (active ingredient of Pluvicto, Novartis) and 225Ac-PSMA-617, across PSMA-high, PSMA-low, and PSMA-negative models.

The new data presented at SNMMI 2026 address three key questions: whether ATNM-400 can overcome ARPI resistance in the mCRPC setting, whether it works as both a single agent and in combination, and how its dosing and safety profile support translation to patients. The data answer each: ATNM-400 remained potent against cells and tumors resistant to all three approved ARPIs, achieved 94% tumor growth inhibition as a single agent and durable complete responses in combination, and maintained a consistent, clean safety profile across both single-bolus and repeat-dose regimens.

Prostate cancer is one of oncology’s largest commercial opportunities: androgen receptor pathway inhibitors generate more than $12 billion in annual sales in 2025 and Pluvicto (177Lu-PSMA-617) reached $2.0 billion in 2025, yet up to 50,0001 patients exhaust ARPI therapy each year and roughly 30% of mCRPC patients are ineligible for PSMA-directed therapy. Because ATNM-400 acts independently of both androgen receptor signaling and PSMA, it is positioned to serve the full mCRPC continuum, from patients who have failed ARPIs to the PSMA-low and PSMA-negative populations with no approved targeted radiotherapy today. Actinium estimates this represents a combined opportunity of more than 100,000 patients annually, addressable as a monotherapy or in combination with existing standards of care.

Sandesh Seth, Actinium’s Chairman and CEO, said, "ARPI resistance is a central problem in advanced prostate cancer as once these drugs stop working there are few good options left. The new data are compelling as ATNM-400 stayed potent in cells and tumors resistant to all three approved ARPIs, outperformed apalutamide and darolutamide on its own similar to previous data with enzalutamide, and produced durable complete responses when combined with them. Equally important for development, ATNM-400 worked across single-dose and repeat-dose regimens with a consistent, clean safety profile, giving us real flexibility as we move toward the clinic. We believe these findings position ATNM-400 as a differentiated option for patients who have run out of ARPI choices. The same resistance-targeting biology underlies the compelling activity we have reported in non-small cell lung cancer and breast cancer, positioning ATNM-400 as a potential pan-tumor backbone for large, resistance-driven patient populations, alone or in combination. We look forward to sharing additional data across these programs in the coming months as we advance ATNM-400 toward the clinic."

Highlights from the SNMMI 2026 Poster Presentation

Poster Titled: ATNM-400: A First-in-Class Non-PSMA Actinium-225 Antibody Radioconjugate Demonstrates Superior Efficacy to PSMA-617 Radioligands and ARPIs With Favorable Safety Profile in Prostate Cancer Models

New data presented at SNMMI 2026 highlight several findings central to ATNM-400’s development in prostate cancer:

In a low-PSMA, moderate-target tumor model (22Rv1), a single bolus dose of ATNM-400 (40 or 30 µCi/kg) delivered superior tumor control versus fractionated dosing, and a repeat 30 µCi/kg regimen sustained tumor control and survival through day 60 with all regimens outperforming 177Lu-PSMA-617 and showing minimal deviation from vehicle in blood, liver, and kidney safety markers. Flexible, well-tolerated dosing gives clinicians multiple ways to balance efficacy and safety and points to a wide therapeutic window.

ATNM-400 produced potent, dose-dependent killing of prostate cancer cells that are resistant to enzalutamide, apalutamide, and darolutamide, driving cell viability toward zero after each ARPI had failed, while the ARPIs alone left the resistant cells largely intact. Demonstrating activity specifically after ARPI failure addresses the most common point of progression in advanced prostate cancer and supports ATNM-400 as a treatment option for patients with few alternatives.

As monotherapy in an ARPI-resistant tumor model (22Rv1), ATNM-400 achieved 94% tumor growth inhibition versus just 32% for apalutamide and 5% for darolutamide, roughly three- to eighteen-fold greater tumor control than the ARPIs themselves. Working on its own in tumors that no longer respond to standard ARPIs positions ATNM-400 as a potential stand-alone therapy after resistance, not only an add-on.

In combination with either apalutamide or darolutamide in the same ARPI-resistant model, ATNM-400 delivered durable tumor control at 107% tumor growth inhibition, with complete responses in at least 57% of mice (4/7 and 5/7). Turning resistant tumors into complete responses by pairing ATNM-400 with the very drugs that had failed supports a combination strategy that could extend the commercial and clinical value of approved ARPIs.

In a high-PSMA, high-target tumor model (C4-2), ATNM-400 matched or exceeded both PSMA-targeted radioligands-comparable to 225Ac-PSMA-617 and superior to 177Lu-PSMA-617-while being given at roughly one-thousandth the administered radioactivity of 177Lu-PSMA-617 (40 µCi/kg versus 40 mCi/kg), with durable survival and favorable tolerability. Because ATNM-400 acts independently of PSMA, this activity carries across PSMA-high, PSMA-low, and PSMA-negative models, reaching the PSMA-variable patients that PSMA-directed radioligand therapy serve least well. Moreover as the ATNM-400 target is not expressed in the salivary glands xerostomia, a limitation of PSMA directed therapies and especially PSMA-Ac-225 based agents, is not expected.

(Press release, Actinium Pharmaceuticals, JUN 3, 2026, View Source [SID1234666411])

Medicenna’s MDNA11 Potential in Earlier Line Melanoma Setting Highlighted in Presentation of the NEO-CYT trial at ASCO 2026

On June 3, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines targeting cancer and autoimmune disease, reported that its long-acting, "beta-enhanced not-alpha" IL-2 Superkine, MDNA11, was featured in a poster presentation describing the investigator-sponsored NEO-CYT trial at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), held in Chicago from 28th May to 2nd June.

Surgery has long been the first course of action in treating locally advanced melanoma. Recently, the landmark NADINA clinical trial (comprised of 2 pre-operative cycles of ipilimumab plus nivolumab) completely flipped the conventional treatment paradigm on its head by proving that giving combination immunotherapy before surgery is significantly more effective than the previous post-surgery standard, setting a new gold standard of care. However even with this regimen, 41% of patients did not achieve a Major Pathologic Response (< 10% of viable tumor). In view of the promising single agent activity of MDNA11 in patients with metastatic melanoma, the hypothesis of the NEO-CYT trial is to demonstrate if patient outcomes can be further enhanced over the gold-standard of care by introducing MDNA11 in combination with nivolumab +/- ipilimumab.

"NEO-CYT provides an important opportunity to evaluate MDNA11, a potentially best-in-class IL-2 superagonist, in a frontline neoadjuvant setting where immune activation may be especially impactful," said Fahar Merchant, Ph.D., President and Chief Executive Officer of Medicenna. " If the tumor is still present at the time of the treatment, the immune cells ‘see’ more of the cancer cells. This allows the most potent anti-tumor immune cells to expand and attack the tumor and can remain active in the body for many years, preventing the tumors from recurring. Importantly, this trial complements our ongoing ABILITY-1 study, which has already demonstrated durable disease control in more advanced stages of melanoma. The ABILITY-1 trial is also advancing MDNA11 into earlier lines of therapy through expansion cohorts in 2L/3L melanoma, endometrial cancer, colorectal cancer, lung cancer and tumor agnostic biomarker driven cancers. We look forward to sharing updates on the ABILITY-1 trial and the NEO-CYT study during the second half of 2026."

NEO-CYT is a randomized, multicenter Phase 1b trial evaluating MDNA11 in combination with nivolumab, with or without ipilimumab, as neoadjuvant therapy in patients with high-risk, surgically resectable Stage IIIB/C/D cutaneous melanoma. The study is sponsored by Fondazione Melanoma Onlus and led by Professor Paolo A. Ascierto of the Istituto Nazionale Tumori Fondazione "G. Pascale" in Naples, Italy.

The trial represents an important expansion of MDNA11’s clinical development into an earlier-line, curative-intent melanoma setting. Neoadjuvant immunotherapy, administered before surgery while the tumor and its immune microenvironment remain intact, has emerged as a promising strategy to generate deeper anti-tumor immune responses and improve long-term outcomes for patients with high-risk resectable melanoma. However, a meaningful proportion of patients still do not achieve a major pathologic response with checkpoint-based neoadjuvant therapy, underscoring the need for novel immune-activating approaches that may improve depth and durability of response.

The NEO-CYT poster at ASCO (Free ASCO Whitepaper) highlighted the scientific rationale for combining MDNA11 with checkpoint inhibitors in the neoadjuvant setting. Prior clinical and translational research has shown that lack of response to neoadjuvant checkpoint therapy may be associated with an immunologically "cold" tumor microenvironment, including IL-2–related immune features. MDNA11 was designed to selectively engage the IL-2 receptor beta pathway, promoting expansion and activation of CD8+ T cells and NK cells that are central to anti-tumor immunity, while minimizing stimulation of immunosuppressive regulatory T cells.

The study is expected to enroll up to 80 patients across four treatment arms. The control arm will comprise of patients treated with the current gold-standard, ipilimumab plus nivolumab, while investigational arms will evaluate MDNA11 in combination with nivolumab alone, MDNA11 in combination with ipilimumab plus nivolumab, and an optional arm adding tocilizumab to MDNA11 plus ipilimumab and nivolumab following Steering Committee safety review.

The primary efficacy endpoint is Major Pathologic Response at surgery, defined as 10% or less viable tumor in the treated tumor bed. Co-primary safety endpoints include the incidence, severity and duration of treatment-related adverse events, with particular focus on immune-related adverse events.

MDNA11 is also being evaluated in Medicenna’s ongoing Phase 1/2 ABILITY-1 study, where it has demonstrated immune activation, including expansion of CD8+ T cells and NK cells, as well as single-agent clinical activity and a manageable safety profile in patients with advanced solid tumors. Together, NEO-CYT and ABILITY-1 are intended to inform Medicenna’s broader development strategy for MDNA11 across multiple treatment settings, including earlier-line melanoma populations where patients may have more intact immune systems and greater potential to benefit from immunotherapy.

Clinical updates from MDNA11 studies are anticipated in the second half of 2026.

About High-Risk Stage III Surgically Resectable Melanoma

Melanoma is the fifth most common cancer in the United States and the most lethal form of skin cancer. Stage III melanoma refers to disease that has spread beyond the primary tumor to regional lymph nodes or nearby tissue, but not to distant organs. In high-risk Stage III melanoma, patients face a significant risk of recurrence even after complete surgical removal, underscoring the need for effective systemic treatment strategies. Neoadjuvant immunotherapy, administered before surgery while the tumor and its immune microenvironment remain intact, has emerged as a promising approach to improve pathologic responses and long-term outcomes in this setting.

About MDNA11

MDNA11 is a long-acting, ‘beta-enhanced not-alpha’ IL-2 Superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (CD8+ T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 Superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) profile and pharmacological activity of MDNA11 due to albumin’s natural propensity to accumulate in highly vascularized sites, in particular tumor and tumor draining lymph nodes. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both monotherapy and in combination with pembrolizumab.

About Fondazione Melanoma Onlus

Fondazione Melanoma Onlus is a non-profit organization based in Naples, Italy, that supports and promotes melanoma research, education, and clinical trials. It is known for organizing international conferences like the Melanoma Bridge, which bring together clinicians and researchers to discuss advancements in melanoma treatment and its related fields. The foundation also sponsors scientific awards for outstanding achievements in melanoma research.

(Press release, Medicenna Therapeutics, JUN 3, 2026, View Source [SID1234666410])