Danyelza (naxitamab-gqgk) / SERB Pharmaceuticals, Takeda, SciClone, Nobelpharma, INPHARMUS - LARVOL DELTA

Ganglioside Profiling Uncovers Distinct Patterns in High-Risk Neuroblastoma. (PubMed, Int J Mol Sci) - "Profile C was found only in cell lines of the mesenchymal subtype. These findings support further investigation of GG composition and associated enzyme expression as potential biomarkers for risk stratification and treatment response in NBL."

Biomarker • Journal • Neuroblastoma • Oncology • Solid Tumor • B4GALNT1

Dinutuximab Beta Versus Naxitamab in the Treatment of Relapsed/Refractory Neuroblastoma in Patients with Stable Disease, Minor Response or Partial Response and Disease in Bone or Bone Marrow: Systematic Review and Matching-Adjusted Indirect Comparison. (PubMed, Cancers (Basel)) - "Sensitivity analyses and unadjusted comparisons supported the results. In the indirect comparison, dinutuximab beta significantly extended PFS and increased ORR compared to naxitamab."

Journal • Neuroblastoma • Oncology • Solid Tumor • CSF2 • IL2 • MYCN

Quadruple Immunotherapy for Neuroblastoma (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Hong Kong Children's Hospital | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

Navigating Naxitamab: Equipping Interdisciplinary Teams for Success (APHON 2025) - No abstract available

SERB Pharmaceuticals Completes Acquisition of Y-mAbs Therapeutics (GlobeNewswire) - "'The acquisition strengthens our Rare Oncology portfolio with the addition of Danyelza (naxitamab-gqgk) and brings deep oncology expertise that will help us to expand our partnerships with the US oncology community and to advance treatments for rare and hard-to-treat cancers.'"

M&A • Neuroblastoma • Osteosarcoma

Naxitamab-combination Therapy for the Treatment of Patients With Refractory and/or Relapsed High-risk Neuroblastoma. (PubMed, J Pediatr Hematol Oncol) - "In this case series, 4 patients were treated with the anti-GD2 monoclonal antibody naxitamab and granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with cyclophosphamide and topotecan between August 2021 and December 2022. This combined chemoimmunotherapy regimen was well tolerated in these heavily pretreated patients with R/R HR neuroblastoma who had few treatment options and overall poor prognoses."

Journal • Neuroblastoma • Oncology • Solid Tumor • CSF2

Affinity Affects the Functional Potency of Anti-GD2 Antibodies by Target-Mediated Drug Disposition. (PubMed, Cancers (Basel)) - "DB has a higher ADCC potency over NAXI at clinically relevant concentrations, attributed to stronger TMDD effects of NAXI compared to DB."

Journal • Neuroblastoma • Oncology • Solid Tumor

Y-mAbs Reports Second Quarter 2025 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Total revenues for the quarter ended June 30, 2025 were $19.5 million, which was a 14% decrease from the $22.8 million of total revenues for the quarter ended June 30, 2024, driven by a $2.9 million decrease in Ex-U.S. DANYELZA net product revenues and a $0.9 million decrease in U.S. DANYELZA net product revenues, partially offset by a $0.5 million increase related to license revenue recognized in the three months ended June 30, 2025....Total revenues for the six months ended June 30, 2025 were $40.4 million, which was a 5% decrease from the $42.7 million of total revenues for the six months ended June 30, 2024, driven by a $6.1 million decrease in U.S DANYELZA net product revenues, partially offset by a $3.8 million increase in Ex-U.S. DANYELZA net product revenues."

Sales • Neuroblastoma

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=93 | Recruiting | Sponsor: Giselle Sholler | Trial completion date: Sep 2035 ➔ Sep 2036 | Trial primary completion date: Sep 2028 ➔ Sep 2029

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

SERB Pharmaceuticals Agrees to Acquire Y-mAbs Therapeutics (GlobeNewswire) - "SERB Pharmaceuticals...and Y-mAbs Therapeutics...announced that they have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead commercial oncology asset, DANYELZA (naxitamab-gqgk), in an all-cash transaction, representing an equity value for Y-mAbs of approximately $412 million. Under the terms of the merger agreement, SERB will commence an all-cash tender offer to purchase all outstanding shares of Y-mAbs common stock. Holders of Y-mAbs common stock would receive $8.60 per share in cash, representing a premium of approximately 105% to Y-mAbs’ closing share price on August 4, 2025, the last full trading day prior to the transaction announcement. The transaction was unanimously approved by the Y-mAbs Board of Directors....The transaction is expected to close by the fourth quarter of 2025."

M&A • Neuroblastoma

The Psychological Experience of Caregivers of Children With Neuroblastoma Undergoing Naxitamab Treatment: A Qualitative Study in China. (PubMed, Child Care Health Dev) - "Caregivers of children undergoing naxitamab treatment for NB encounter diverse psychological challenges throughout different stages. It is crucial for clinical medical professionals to provide tailored psychological support to both children and their families during various stages of treatment."

Journal • CNS Disorders • Depression • Mood Disorders • Neuroblastoma • Oncology • Psychiatry • Solid Tumor

Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma (clinicaltrials.gov) - P1 | N=85 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jul 2025 | Trial primary completion date: Jan 2026 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=93 | Recruiting | Sponsor: Giselle Sholler | Trial completion date: Sep 2033 ➔ Sep 2035 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Real-life Use of IV Naxitamab for Children With Relapsed/Refractory Neuroblastoma. (PubMed, J Pediatr Hematol Oncol) - "Between November 2021 and July 2023, 102 Naxitamab infusions were administered at Shaare Zedek Hospital with ketamine as the only analgesic drug during Naxitamab infusion. Thus, its use is feasible in multiple clinical settings. Significant infusion-related AEs after the completion of the 3rd treatment cycle are rare."

Journal • Neuroblastoma • Oncology • Pain • Solid Tumor

Rapid COJEC without myeloablative therapy for high-risk neuroblastoma. (PubMed, Int J Cancer) - "Group 1 patients had resection of primary tumors and received 1-2 cycles of HR-NB regimens (cyclophosphamide-topotecan ± vincristine), local radiotherapy, and naxitamab + GM-CSF; 9 also received anti-NB vaccine...Group 2 patients received second-line therapy post-COJEC, including high-dose cyclophosphamide + topotecan ± vincristine or cyclophosphamide + doxorubicin + vincristine. Treatment after all chemotherapy included naxitamab + GM-CSF ± irinotecan-temozolomide...Six developed PD (four are again in complete remission and two died of NB). Avoiding MAT after rapid COJEC does not appear to adversely affect outcome compared to rapid COJEC + MAT."

Journal • Endocrine Cancer • Hematological Malignancies • Myelodysplastic Syndrome • Neuroblastoma • Oncology • Solid Tumor • Thyroid Gland Carcinoma • CSF2

High-risk neuroblastoma in Mexico: from multimodal treatment to immunotherapy. Regarding the first case treated with naxitamab. (PubMed, Front Oncol) - "Despite their high costs, the demonstrated benefits should outweigh the disadvantages, justifying efforts to make them accessible to all patient populations. Future studies in LMICs including Mexico and Latin America, must focus on optimizing dosing strategies to minimize adverse effects and improve both survival outcomes and the quality of life for patients receiving immunotherapy."

Journal • Review • CNS Disorders • Critical care • Dermatology • Hypotension • Immunology • Neuroblastoma • Oncology • Ophthalmology • Pediatrics • Pruritus • Solid Tumor • Urticaria • Ventriculomegaly

A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=59 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Steven DuBois, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Neuroblastoma • Oncology • Solid Tumor

111In/225Ac-Naxitamab: Theranostic anti-GD2 antibody in the management of Osteosarcoma - in-vitro evaluation (SNMMI 2025) - "The radiolabeling yield of 111In-Naxitamab was 99%; therefore, no further purification was needed. The specific activity was 27.75 MBq/nmol. The radiolabeling yield for 225Ac-Naxitamab was 30-40%, and after purification with a PD-10 column, radiochemical purity was 99%."

Preclinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

111In/225Ac-Naxitamab: Theranostic anti-GD2 antibody in the management of Osteosarcoma - in-vitro evaluation (SNMMI 2025) - "The radiolabeling yield of 111In-Naxitamab was 99%; therefore, no further purification was needed. The specific activity was 27.75 MBq/nmol. The radiolabeling yield for 225Ac-Naxitamab was 30-40%, and after purification with a PD-10 column, radiochemical purity was 99%."

Preclinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Pulmonary Toxicity Associated With Concurrent Lorlatinib and Anti-GD2 Monoclonal Antibody Therapy in Patients With Neuroblastoma. (PubMed, Pediatr Blood Cancer) - "Concurrent use of lorlatinib with anti-GD2 mAbs may be associated with severe pulmonary toxicities. Temporarily withholding lorlatinib during immunotherapy appeared to mitigate this risk."

Adverse events • Journal • Cough • Neuroblastoma • Oncology • Respiratory Diseases • Solid Tumor • ALK

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Steven DuBois, MD

New P1 trial • Neuroblastoma • Oncology • Solid Tumor

A novel therapeutic strategy for osteosarcoma using anti-GD2 ADC and EZH2 inhibitor. (PubMed, Biomark Res) - "We constructed an ADC by conjugating naxitamab to mertansine (DM1) via an SMCC linker. Tazemetostat upregulates GD2 expression, enhancing the ADC's efficacy. This dual-approach strategy demonstrates the potential of integrating epigenetic modulation with targeted drug delivery, offering a promising path for improving outcomes in hard-to-treat cancers."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sun Yat-sen University | N=30 ➔ 120 | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Pediatrics • Solid Tumor