On June 3, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

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"This approval in Australia is our third marketing authorization for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "We are in the process of authorizing our first Australian treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma."

Australia has the highest rate of melanoma globally, with an estimated 17,000 new cases diagnosed each year and more than 1,500 deaths annually.1,2 Similar to the U.S. and other global markets, there is a significant need for new therapies for patients with advanced melanoma.

TGA granted approval based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, if applicable.

About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor or a BRAF inhibitor with a MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.

(Press release, Iovance Biotherapeutics, JUN 3, 2026, View Source [SID1234666426])

On June 3, 2026 Mission Bio, a leader in single-cell multiomics, jointly announces with Heidelberg University Hospital, Martin Luther University Halle-Wittenberg, the East German Study Group for Hematology and Oncology (OSHO), and the Study Alliance Leukemia (SAL) findings from a retrospective single-cell analysis of the randomized, double-blind, placebo-controlled phase II BLAST clinical trial in acute myeloid leukemia (AML). The investigator-initiated trial was sponsored by Martin Luther University Halle-Wittenberg, scientifically coordinated and led by Heidelberg University Hospital, and conducted at 29 academic centers in Germany with the active support of OSHO and SAL.

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The initial clinical trial tested whether adding the CXCR4 inhibitor Motixafortide to high-dose cytarabine consolidation could reduce the risk of relapse in 128 AML patients in first complete remission. Across the overall cohort, the clinical trial did not meet its primary endpoint, demonstrating a median relapse-free survival (RFS) of 10.3 months with Motixafortide and 11.5 months with placebo (log-rank p = 0.98). A prespecified retrospective analysis of bone marrow samples using single-cell DNA and protein profiling on the Mission Bio Tapestri platform examined whether a clinically defined subgroup might nevertheless benefit.

Among patients treated with Motixafortide, high CXCR4 expression on residual leukemic cells was associated with a significantly reduced risk of relapse (p = 0.047). In the placebo arm, the same marker was associated with significantly elevated relapse risk (p = 0.02), consistent with the established role of the CXCR4-CXCL12 axis in bone-marrow-mediated chemoresistance. A multivariable Cox model confirmed a significant treatment-by-CXCR4 interaction (p = 0.0015).

In the post-consolidation setting, residual leukemic cells are rare and embedded in a largely normal bone marrow background. Standard-of-care analysis methods cannot reliably attribute CXCR4 signal to residual leukemic cells from the normal hematopoietic cells. By linking CXCR4 protein expression to genetically defined leukemic clones at single-cell resolution, the Tapestri platform made it possible to detect this subgroup. In individual patients, genetically distinct subclones showed divergent CXCR4 dynamics over the course of treatment, illustrating the clonal heterogeneity that standard-of-care analysis methods cannot resolve.

The results suggest that CXCR4 expression, when assessed specifically on residual leukemic cells and in the context of their clonal identity, may serve as a predictive biomarker for Motixafortide therapy in AML. The team emphasized that the analysis is retrospective and hypothesis-generating, and that the findings need to be confirmed in a prospective, biomarker-stratified clinical trial before they can guide treatment decisions in routine practice. This study supports integrating functional, clonally resolved single-cell measurable residual disease (MRD) profiling, as enabled by the Tapestri platform, into the design of future AML clinical trials.

"Our analysis suggests that the same biological marker can carry very different meanings depending on the treatment context. Patients with high CXCR4 expression on residual leukemic cells are at particularly high risk of relapse, but they also appear to benefit most from CXCR4 inhibition. Reliably identifying these patients requires measuring CXCR4 directly on residual leukemic cells and linking it to their clonal architecture, which is what single-cell MRD profiling enables," said Enise Ceran, MD, first author of the study, Medical Department V, Heidelberg University Hospital.

"These results demonstrate the need for single-cell MRD approaches to functionally characterize the molecular and phenotypic landscape of residual disease, enabling the identification of biomarker-driven therapy selection to treat AML," said Carsten Müller-Tidow, MD, corresponding author and Professor of Medicine, Hematology, Oncology and Rheumatology at Heidelberg University Hospital.

"AML is not a single disease. It is a dynamic, evolving ecosystem of clones, and this analysis proves that the right drug, matched to the right patient, works. Motixafortide works powerfully in CXCR4-high patients. Tapestri is what makes that match possible," said Zivjena Vucetic, MD, PhD, Chief Medical Officer of Mission Bio.

Mission Bio added that AML’s clonal complexity means that population-level assays can obscure the biology driving relapse. The company is actively working with clinical partners to incorporate Tapestri-based biomarker screening into prospective trial protocols.

The findings will be presented as a proffered abstract at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026 in Stockholm, June 11–14, 2026. The full results have been published in Blood: Ceran E, Jaramillo S, Merbach AK, et al. Inhibition of high CXCR4 with Motixafortide and absence of single-cell MRD predict outcome after AML consolidation. Blood. 2026. doi:10.1182/blood.2025032033

(Press release, Mission Bio, JUN 3, 2026, View Source [SID1234666425])

On June 3, 2026 Terremoto Biosciences, a biotechnology company developing highly targeted, small molecule medicines, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TER-2013, the Company’s lead AKT1-selective inhibitor, in patients with locally advanced, unresectable or metastatic HR+/HER2- breast cancer harboring one or more AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease.

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Fast Track Designation is intended to facilitate the development and expedite the review of therapies for serious conditions with unmet medical need. The designation allows for more frequent interactions with the FDA regarding development plan, clinical trial design and data requirements to support potential approval. If relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review.

"The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer," said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. "We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers."

TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximizing target engagement within tumor cells. TER-2013 is being evaluated in a Phase 1 clinical trial (NCT-07109726) in patients with solid tumors harboring AKT/​PI3K/​PTEN pathway alterations.

"Our preclinical data demonstrated potent and sustained inhibition of AKT1 while sparing AKT2, AKT3 and other off-target proteins," said James Christensen, Ph.D., President, Head of Research & Development of Terremoto Biosciences. "TER-2013 was designed to selectively target AKT1 with the goal of addressing the limitations of earlier pan-AKT inhibitors. This profile is intended to maximize the coverage of the disease-driving isoform while sparing toxicities linked to AKT2 or other off-target proteins."

The dose-escalation portion of the first-in-human trial has been completed and selection of an optimal dose for POC expansion in patients with cancers harboring AKT/PI3K/PTEN pathway alterations is ongoing. The Company also plans to evaluate expansion opportunities in additional patient populations.

About TER-2013

TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximizing target engagement within tumor cells. In preclinical studies, TER-2013 demonstrated potent and sustained inhibition of AKT1, while sparing AKT2, AKT3 and other off-target proteins at efficacious doses. This selectivity enables robust tumor response and durable anti-tumor activity across multiple xenograft models harboring PIK3CA, AKT1, or PTEN genetic alterations—without AKT2-dependent hyperglycemia, or other toxicities such as rash or diarrhea, observed with earlier pan-AKT inhibitors. TER-2013 is currently being evaluated in a Phase 1 clinical trial (NCT-07109726).

(Press release, Terremoto Biosciences, JUN 3, 2026, View Source [SID1234666424])

On June 3, 2026 Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, reported a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY, "BMS"). Under the agreement, Arcus will supply casdatifan, the company’s investigational small-molecule HIF-2a inhibitor, to be evaluated as part of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 clinical trial. This trial evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BioNTech and Bristol Myers Squibb, alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC).

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As part of this clinical trial collaboration, casdatifan combinations will be added as two new arms of ROSETTA RCC-208. Each company will retain development and commercial rights to their respective assets, and the agreement is mutually non-exclusive.

"We believe casdatifan can transform the treatment paradigm in kidney cancer, and our development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every patient has the opportunity to benefit from casdatifan across each line of therapy," said Terry Rosen, Ph.D., chief executive officer of Arcus. "HIF-2a inhibition, PD-L1 and VEGF-A blockade are validated mechanisms in the treatment of kidney cancer with a strong biologic rationale for combination. This strategic collaboration with BMS is a top priority for Arcus in order to potentially deliver an additional effective TKI-free option in the first-line setting."

This collaboration is part of Arcus’s holistic development strategy that is intended to provide physicians and patients with: 1) a casdatifan-based and only HIF-2a inhibitor-inclusive TKI-sparing first-line treatment; 2) a casdatifan-based TKI-inclusive first-line regimen; 3) a second-line HIF-2a inhibitor treatment that builds on the second-line standard-of-care TKI, cabozantinib; and 4) a late-line therapy that has been clinically validated to also provide benefit in patients previously treated with a HIF-2a inhibitor-based therapy.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma; ccRCC), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones.

Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.

The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in the:

First-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); and casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing)
Second-line setting with a cohort evaluating casdatifan plus cabozantinib in immunotherapy (IO)-experienced patients (ongoing)
Late-line setting with a cohort evaluating casdatifan plus a TKI in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients (planned)
Arcus is also enrolling patients for PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate a Phase 3 study in first-line metastatic ccRCC by year-end 2026.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally.

About Pumitamig (BNT327/BMS986545)

Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. BioNTech and BMS are currently advancing pumitamig in a broad clinical trial program with more than 20 clinical trials currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications.

About Kidney Cancer

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026. ccRCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for kidney cancer is high; for patients with advanced or late-stage metastatic kidney cancer, however, the five-year survival rate is only 19%. For metastatic kidney cancer, targeted drug therapies are one of the main treatment options.

(Press release, Arcus Biosciences, JUN 3, 2026, View Source [SID1234666423])

On June 3, 2026 Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported an agreement to evaluate automated clinical manufacturing of TSC-101, TScan’s lead TCR-T therapy candidate for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), through a comprehensive technical and operational assessment of Cellares’ automated manufacturing and testing platforms.

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TSC-101 is designed to treat residual disease and prevent relapse in patients with AML and MDS undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The therapy candidate uses a gene modification approach to engineer T cells from a healthy donor into a patient-specific cell therapy product. As TScan advances TSC-101 towards a pivotal trial, which is expected to begin in the second quarter of 2026, the Company is evaluating Cellares’ automated manufacturing platform as a scalable and economical path to future commercial demand.

Under the agreement, Cellares will automate the TSC-101 manufacturing and testing processes on the Cell Shuttle, its end-to-end manufacturing platform, and the Cell Q, its automated quality control and release testing system. These closed-system, fully automated workflows are designed to reduce process variability, minimize labor intensity, and enable consistent execution across runs and geographies, delivering the manufacturing economics and reliability that large-scale commercial production requires.

"As we prepare for the initiation of our pivotal study of TSC-101 this quarter, we are increasing our efforts for commercial readiness. Establishing a scalable and cost-efficient manufacturing strategy is a critical component. Cellares’ fully automated Cell Shuttle platform represents a promising approach to automating and scaling cell therapy production, with the potential to reduce manual processes and eliminate capacity constraints," said Ray Lockard, M.B.A., Chief Manufacturing and Quality Officer of TScan Therapeutics. "Through this evaluation, we aim to determine how this technology could strengthen our long-term manufacturing network and support broader patient access, supporting our goal of delivering transformative therapies to patients as efficiently and reliably as possible."

"Patients with AML or MDS who remain at risk of relapse following transplant represent exactly the kind of underserved population that automated manufacturing was designed to reach," said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. "Bringing automation to a late-stage program like TSC-101, with its healthy donor-derived but patient-specific manufacturing model, is the kind of challenge the Cell Shuttle and Cell Q were built for, and we believe it represents the manufacturing economics any developer will need to reach a population of this scale."

The agreement adds TCR-engineered T cell therapies to Cellares’ growing portfolio of automated cell therapy modalities, which includes CAR-T cell therapies, hematopoietic stem cell programs, and autologous progenitor T cell therapies.

(Press release, TScan Therapeutics, JUN 3, 2026, View Source [SID1234666422])