China NMPA Grants IND Clearance to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC for the Treatment of Late-Stage Solid Tumors, Including Prostate Cancer

On June 8, 2026 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported that the China National Medical Products Administration (NMPA) has cleared Adcentrx’s Investigational New Drug (IND) application for ADRX-0405. The clearance enables the company to include China-based clinical centers to its ongoing Phase 1a/1b trial (NCT06710379) evaluating ADRX-0405 in patients with late-stage solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer.

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ADRX-0405 is a potential first-in-class, next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is overexpressed in prostate cancer and certain other cancers, with limited expression in healthy tissue.

"NMPA’s clearance of the ADRX-0405 IND is another important milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "This clearance expands our ability to enroll patients in both the U.S. and China, broadening geographic representation and allowing us to generate clinical data across more diverse patient populations. This enables ADRX-0405 to address important unmet needs across multiple tumor types."

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates completing the Phase 1a portion of the trial by the fourth quarter of 2026.

About ADRX-0405

ADRX-0405 is a clinical-stage ADC targeting STEAP1. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx’s innovative i-Conjugation technology platform, a core element of its ADC design. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

I-CONJUGATION is a trademark registered in China.

(Press release, Adcentrx Therapeutics, JUN 8, 2026, View Source [SID1234666478])

BostonGene to Present High-Impact AI Models and Biomarker-Driven Frameworks at EHA2026 Congress

On June 8, 2026 BostonGene, developer of the leading AI model for tumor and immune biology, reported that six abstracts have been accepted for presentation at European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place June 11 – 14 in Stockholm, Sweden. As Europe’s premier congress for hematology, the annual EHA (Free EHA Whitepaper) meeting brings together world-leading clinicians and researchers to share medical breakthroughs in the diagnosis, treatment, and clinical management of blood disorders.

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The presentations showcase how BostonGene’s platforms integrate clinical, genomic, and immune data to uncover critical disease mechanisms. Conducted in collaboration with leading institutions, including Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, the University of Miami, and UT MD Anderson, this research demonstrates how integrated multiomics, predictive modeling, and high-dimensional blood immune system profiling can define resistance phenotypes to CAR-T therapies, identify unique immune states, and uncover deep remission pathways. These findings deliver actionable data that enable smarter patient selection, optimize frontline treatment decision-making, and enhance clinical trial design for blood cancers.

Details about the abstracts selected for presentation can be found below:

Oral presentation
Abstract: S283
Title: Integrated Multi-Omic Profiling Identifies Genomic Subtypes Associated with Differential Outcomes after CAR-T Therapy in Large B-Cell Lymphoma
Date & time: Saturday, June 13 | 18:00 – 18:15 CEST
Speaker: Silvia Escribano Serrat, MD, Memorial Sloan Kettering Cancer Center

Researchers at Memorial Sloan Kettering Cancer Center leveraged BostonGene’s multimodal computational pipeline, integrating molecular classifiers with gene signatures, to characterize mechanisms of CAR-T resistance in large B-cell lymphoma. Using the BostonGene Lymphly classifier, the BN2 subtype emerged as a high-risk group associated with significantly inferior survival and reduced response rates. Compared with existing frameworks, Lymphly provided improved stratification and clearer discrimination of outcome-relevant subgroups, underscoring the value of integrated molecular profiling for refining risk assessment following CAR-T.

Research conducted in collaboration with Memorial Sloan Kettering Cancer Center

Poster presentations

Abstract: PS2188
Title: Overlaying TP53 Loss and Aneuploidy with Distinct Diffuse Large B-Cell Lymphoma Subtypes Refines Tumor Classification and Enhances Risk Stratification
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Pavel Zemskiy, MS, BostonGene

BostonGene integrated two dimensions of genomic instability, TP53 loss‑of‑function alterations and quantitative aneuploidy, into Lymphly, a classification framework for diffuse large B‑cell lymphoma. This approach explicitly separates TP53 loss from aneuploidy, clarifying their independent and combined effects on tumor biology. By defining these mechanisms, the framework enables drug developers to anticipate and bypass resistance pathways, identify biomarker‑driven patient groups, and design trials aligned with genomic instability profiles.

Research conducted in collaboration with Center for Cancer Research

Abstract: PS1829
Title: Risk-Stratified Patient Selection in Multiple Myeloma for Frontline Treatment Decision-Making Based on a Transcriptomic Classifier
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Evgenia Alekseeva, PhD, BostonGene

BostonGene developed a transcriptomic-based risk stratification model to identify newly diagnosed multiple myeloma patients who may benefit from risk-adapted frontline treatment strategies, including aggressive regimens with bispecific T-cell engager (BiTE) and CAR T-cell therapies. This model outperformed conventional tools by isolating high-, intermediate-, and low-risk groups, while exposing high-risk cases with established resistance to proteasome inhibitors. Together, these findings define a biologically distinct high-risk state that may help prioritize patients for novel, more intensive treatment approaches earlier in the disease course.

Abstract: PS1854
Title: Peripheral Blood Immunoprofiling Defines Three Distinct Immune States Associated with Clinical and Molecular Axes in Multiple Myeloma
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Anastasia Radko, MS, BostonGene

BostonGene applied high‑dimensional flow cytometry to characterize peripheral blood immune architecture in multiple myeloma. Three coordinated immune states emerged, each aligned with cytogenetic risk, therapy exposure, and disease subtype. By defining these mechanisms, spanning T‑cell differentiation, checkpoint enrichment, and monocyte expansion, the framework enables drug developers to anticipate resistance, identify biomarker‑driven patient groups, and design trials that integrate circulating immune states into active therapeutic strategies.

Research conducted in collaboration with University of Miami

Abstract: PS2344
Title: Tazemetostat-Mediated Immune Remodeling in B-Cell Lymphomas Receiving CAR-T
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Samuel Yamshom, MD, Weill Cornell Medicine

BostonGene applied its multimodal molecular profiling platform to characterize the systemic immune remodeling driven by tazemetostat priming in patients with B-cell lymphomas receiving CART therapy. By integrating high-parameter flow cytometry, RNA sequencing, immune cell deconvolution, and functional gene signature analysis, BostonGene’s analysis revealed systemic immune remodeling associated with enhanced antigen presentation, T-cell activation, and reduced immunosuppressive signaling, validating the use of EZH2 inhibition for improved CART efficacy and durability.

Research conducted in collaboration with Weill Cornell Medicine

Abstract: PS1673
Title: Integrated Transcriptomic and Immune Profiling Identifies Determinants of Deep Remission with Ibrutinib–Venetoclax in Chronic Lymphocytic Leukemia
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Varsha Gandhi, PhD, UT MD Anderson

Leveraging BostonGene’s blood immunoprofiling platform and KassandraTM cell deconvolution, researchers at UT MD Anderson investigated the impact of ibrutinib–venetoclax combination therapy in patients with chronic lymphocytic leukemia. The findings revealed immune cell populations and gene expression patterns consistent with a common treatment resistance mechanism among patients who did not achieve remission. This study highlights BostonGene’s ability to harmonize clinical, genomic, transcriptomic, and immune data for reliable insights that drive smarter patient selection and optimized treatment decisions.

(Press release, BostonGene, JUN 8, 2026, View Source [SID1234666494])

AIM ImmunoTech Reports Positive Mid-Year Interim Clinical Progress from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

On June 8, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive progress in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).

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See: DURIPANC, 2026 Mid-Year Interim Clinical Progress Update

AIM recently announced enrollment of the final patient in the clinical trial, barring any disqualifying pre-treatment circumstances. The Company remains on track for a planned December 2026 evaluation of the clinical trial’s primary endpoint, Clinical Benefit Rate ("CBR"), defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.

DURIPANC is a follow-up to a 57-subject Named Patient Program ("NPP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life.

AIM Chief Executive Officer Thomas Equels stated: "There is a clear need for an approved treatment that is both more effective and less toxic than what is currently available to people suffering with pancreatic cancer. Despite advances in chemotherapy, survival for these patients is too often short and agonizing. The published NPP data and the DURIPANC interim results support our belief that Ampligen has the potential to meaningfully extend survival and provide late-stage pancreatic cancer patients with a higher quality of life. For example, in the NPP stratification of subjects with immune marker Neutrophil/Lymphocyte ratios less than 4.5, we saw overall median survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months – and with positive measures of quality of life. We are also diligently planning the next step in Ampligen’s development, with an eye toward a pivotal Phase 3 clinical trial evaluating the experimental drug in combination with a PD-1 inhibitor in an effort to demonstrate its value across multiple endpoints, most importantly overall survival and progression-free survival. If a Phase 3 clinical trial was able to pair significant survival results with AIM’s impressive safety and tolerability profile, then it could position AIM as a leader in pancreatic cancer research potentially translational to the patient as a standard of care."

The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.

(Press release, AIM ImmunoTech, JUN 8, 2026, View Source [SID1234666479])

Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform

On June 8, 2026 Johnson & Johnson (NYSE: JNJ) reported it has entered into a definitive agreement to acquire Firefly Bio, Inc., a biotechnology company advancing its proprietary Firelink degrader antibody conjugate (DAC) platform, for $1 billion in cash. The Firelink DAC platform for KRAS-driven tumors bolsters Johnson & Johnson’s oncology pipeline and ambition to develop targeted medicines for the most prevalent and hard-to-treat solid tumors with high unmet need1.

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Antibody therapeutics have revolutionized the treatment of cancer through continuous innovations from monoclonal antibodies, to bi-and multi-specifics, antibody drug conjugates, and other antibody-based approaches. The Firelink DAC platform is a novel, innovative approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.

"KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years," said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. "We believe the proprietary Firelink platform will overcome the limitations of current treatments and diversify our pipeline with preclinical candidates for treating multiple types of solid tumors."

Johnson & Johnson is at the forefront of oncology therapies
For more than three decades, Johnson & Johnson has advanced innovative therapies to address some of the most complex cancers and improve outcomes for patients worldwide. Firefly Bio Inc.’s capabilities in emerging modalities complement Johnson & Johnson’s existing expertise in antibody engineering and accelerates the Company’s pioneering of more effective, durable treatments.

About the agreement
Under the terms of the agreement, Johnson & Johnson will acquire Firefly Bio, Inc. for $1 billion in cash. The closing of the transaction is expected to occur later this year, subject to applicable regulatory approvals and other customary closing conditions. The accounting treatment will be communicated on or before the close of the transaction.

(Press release, Johnson & Johnson, JUN 8, 2026, View Source [SID1234666495])

Alligator Bioscience comments on Henlius update on global phase 3 trial with HLX22

On June 8, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on a recent update regarding patient recruitment in the ongoing Phase 3 clinical trial of HLX22, developed by Shanghai Henlius Biotech, Inc.

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According to communication shared by Henlius, the first patients have now been dosed in all regions participating in the global Phase 3 study of HLX22, including China, Japan, Korea, Latin America, Australia, the United States and Europe.

HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"The successful dosing of the first patients across all regions marks an important milestone, signaling the continued progress in the Phase 3 study with HLX22," said Søren Bregenholt, CEO of Alligator Bioscience. "The continued advancement also suggests sustained investigator interest in evaluating HLX22 as a potential treatment option for patients with gastric cancers."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, JUN 8, 2026, View Source [SID1234666480])