On November 11, 2026 IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, reported that its Investigational New Drug (IND) application for IASO208, a CD20-targeting in vivo CAR-T therapy developed on the company’s proprietary InTelliCAR platform, has been approved by the National Medical Products Administration (NMPA) of China. This follows the implicit clearance of the IASO208 IND by the U.S. Food and Drug Administration (FDA) in September 2026. As the first lentiviral-vector-based in vivo CAR-T product from China to receive an FDA IND clearance, IASO208 will build on investigator-initiated trial (IIT) data generated in China to initiate a Phase Ib clinical study directly in the United States, targeting adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

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The approval of the China IND marks the formal entry of IASO’s InTelliCAR platform into a phase of synchronized U.S.–China clinical development, and further validates the feasibility of leveraging China’s early clinical data to support global registrational development. IASO208 is the company’s first product to obtain IND approval through China’s 30-day expedited review pathway. This not only reflects regulatory recognition of the scientific merit of IASO208, but also demonstrates that IASO has established mature, end-to-end capabilities across the full development value chain for in vivo CAR-T products—spanning chemistry, manufacturing and controls (CMC), nonclinical studies, clinical trial design, and communication with regulatory authorities.

IASO208 is currently being evaluated in an investigator-initiated, single-arm, open-label, dose-exploration study designed to assess its safety, tolerability and preliminary efficacy in patients with relapsed/refractory B-cell malignancies. In this study, patients are not required to undergo conventional apheresis or lymphodepleting conditioning and receive a single intravenous infusion of IASO208. To date, 11 patients have been dosed. Early data have demonstrated favorable tolerability and promising anti-tumor activity, laying a solid foundation for larger, more systematic clinical studies to be conducted in both China and the United States. The early results of this study have been selected for an Oral Presentation at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Abstract :#705).

Ms. Jinhua Zhang, Founder, Chairperson and Chief Executive Officer of IASO Bio，stated:"The approval of the China IND for IASO208 is another milestone for IASO’s proprietary in vivo CAR-T platform, InTelliCAR, following our receipt of FDA IND clearance. It marks a decisive step for this product—the first lentiviral-vector-based in vivo CAR-T from China to receive an FDA IND clearance—from ‘U.S. IND approval’ toward ‘synchronized U.S.–China clinical development.’ Leveraging the InTelliCAR platform, IASO has assembled a portfolio of in vivo CAR-T product candidates across hematologic malignancies, autoimmune diseases and solid tumors, with several candidates now in the IND-enabling stage. The launch of synchronized U.S.–China clinical development for IASO208 lays a critical foundation for the global expansion of the InTelliCAR platform. Looking ahead, IASO will accelerate the global clinical development of IASO208 so that this China-originated, innovative in vivo CAR-T product can reach and benefit an even broader patient population worldwide at an earlier date."

(Press release, IASO Biotherapeutics, NOV 11, 2026, View Source [SID1234674619])

On November 11, 2026 Immunofoco, in collaboration with Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai East Hospital, Tongji University, reported a novel in vivo T-cell engager (TCE) delivery strategy using CD19-targeted lentiviral vectors at the 41st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2026), held November 4–8 in Phoenix, Arizona. The approach explores the engineering of tumor cells and B cells into cellular factories capable of continuously secreting CD3×CD19 bispecific T-cell engagers (BiTEs), with the aim of enabling sustained T-cell activation and tumor elimination.

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The study was presented as a poster entitled "Engineering lymphoma cells as in situ CD3×CD19 BiTE factories via CD19-targeted lentiviral delivery enables sustained T-cell engagement and tumor elimination."

Abstract

Background

CD3×CD19 T-cell engagers (TCEs) have demonstrated significant clinical benefit in B-cell malignancies and have been successfully translated into approved therapies[1,2]. However, their clinical application remains limited by short serum half-life, the need for continuous or repeated administration, and treatment-related toxicities associated with systemic exposure[2-4]. To address these challenges, we developed a lymphoma-targeted in vivo gene delivery strategy that selectively reprograms lymphoma cells into endogenous CD3×CD19 BiTE-producing factories, enabling sustained local BiTE secretion, continuous T-cell engagement, and bystander elimination of neighboring non-transduced tumor cells.

Methods

We developed an engineered lentiviral delivery platform that contains a CD19-targeting envelope, selectively transduct CD19+ lymphoma cells to drive sustained endogenous CD3×CD19 BiTE secretion. In vitro, transduction efficiency, BiTE secretion, T-cell activation, and cytotoxicity were evaluated in Raji and Nalm6 models. In vivo efficacy was assessed in Nalm6-Luc-bearing NSG mice receiving human PBMCs, with longitudinal monitoring of tumor burden, serum BiTE levels, tumor transduction, and survival.

Results

The CD19-targeted lentiviral platform selectively transduced CD19-positive lymphoma cells, with transduction efficiencies of approximately 9–18% in Raji cells and 15–29% in Nalm6 cells 2 days after infection.

Transduced tumor cells continuously secreted functional CD3×CD19 BiTE, reaching peak concentrations of approximately 300 pg/mL in both Raji and Nalm6 cultures. Tumor-derived CD3×CD19 BiTE induced potent T-cell responses, with 50–80% proliferating T cells, 15–30% PD-1+Lag3+ T cells, over 70% lymphoma cell killing, and IFN-γ secretion exceeding 900 pg/mL. CD20-targeted BiTE showed limited activity in CD20-negative Nalm6 cells, which showed target-dependent activity.

In Nalm6-bearing NSG mice, systemic administration of the CD19-targeted BiTE virus following human PBMC infusion resulted in durable tumor clearance with bioluminescence signals remaining near baseline throughout the observation period (>58 days). In contrast, mice treated with blinatumomab (recombinant CD3×CD19 BiTE protein) plus PBMC exhibited frequent tumor relapse. PBMC alone, BiTE virus alone, and untreated controls showed rapid disease progression.

Conclusions

Tumor-targeted in vivo lentiviral delivery reprograms CD19-positive lymphoma cells into endogenous CD3×CD19 BiTE factories, enabling sustained BiTE production, continuous T-cell activation, and bystander tumor killing. This strategy achieved durable lymphoma elimination and prolonged survival with superior efficacy compared with conventional BiTE administration, supporting a promising in vivo immune engineering approach for B-cell malignancies.

Advancing Dual-Engine Cell Therapy Platforms

Immunofoco continues to advance its dual-engine technology platforms spanning autologous CAR-T and in vivo CAR-T therapies. The company is conducting research into key technologies including cell engineering, targeted in vivo lentiviral delivery, and the in situ expression of immune effector molecules. Going forward, Immunofoco will continue to advance the research and validation of these technologies, explore their potential applications across different disease areas, and build a scientific foundation for future product development and clinical translation.

(Press release, Immunofoco, NOV 11, 2026, View Source [SID1234674618])

On November 11, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported it will present new data on DecisionDx-Melanoma at the Society of Dermatology Physician Associates (SDPA) 24th Annual Fall Dermatology Conference, taking place Nov. 11-15, 2026, in Hollywood, Florida, and the 3rd European Congress on Dermato-Oncology (Dermato-Onco2026), taking place Nov. 12-13, 2026, in Rotterdam, The Netherlands.

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More precise assessment of a patient’s risk of melanoma recurrence or death can help clinicians tailor follow-up and surveillance to each patient’s individual needs. The analyses being presented evaluate DecisionDx-Melanoma, Castle’s CP+GEP test that combines an independently validated 31-gene expression profile (GEP) score with clinicopathologic (CP) factors. The studies assess the test’s ability to identify patients with thin T1a tumors at elevated risk of melanoma-specific mortality and the performance of its i31-ROR algorithm, which is designed to provide individualized five-year recurrence-risk estimates. Together, the data reinforce the value of combining tumor biology with CP factors to refine risk assessment beyond American Joint Committee on Cancer (AJCC) staging and inform more personalized, risk-aligned patient care.

"A thin melanoma may be reassuring, but these findings remind us that some of those patients still face a higher risk of dying from their disease," said study author Harrison Nguyen, M.D., MBA, MPH, board-certified dermatologist at Harrison Dermatology and Research Group in Missouri City, Texas. "The additional prognostic information provided by DecisionDx-Melanoma can help us explain to patients why we may recommend closer follow-up, even when their tumor’s traditional features appear favorable."

SDPA: Identifying Higher-Risk Patients with Thin Melanomas

Castle’s data at SDPA will be shared in a digital poster, which may be viewed directly through the official conference app.

ePoster Title: The 31-gene expression profile test identifies patients with AJCC T1a (<0.8 mm) cutaneous melanoma at increased risk of 5-year melanoma-specific mortality

First author: Harrison Nguyen, M.D., MBA, MPH, FAAD
Summary: This study evaluated 750 patients with thin T1a cutaneous melanomas (<0.8 mm), a tumor category traditionally considered low risk under AJCC staging, who were diagnosed between 2013 to 2019 and had at least five years of follow-up or died from their disease. The study linked DecisionDx-Melanoma results from patients tested in clinical care with survival outcomes recorded in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program registries. The analysis demonstrated that DecisionDx-Melanoma:

Identified higher-risk patients in approximately 1 in 8 cases: Nearly 12% of patients with T1a tumors (88 of 750) received a Class 1B/2A (increased-risk, n=59) or Class 2B (highest-risk, n=29) result, identifying a subset of patients with elevated melanoma-specific mortality risk despite having thin primary tumors.
Significantly stratified five-year melanoma-specific survival (MSS): Survival was 97.1% for patients with Class 1A (lowest-risk) results, compared with 88.1% for patients with Class 1B/2A (increased-risk) results and 86.2% for patients with Class 2B (highest-risk) results (p<0.001). Patients with higher-risk classes had similar survival rates to patients with T2b tumors (82.4%) or stage IIA melanoma (85.1%).
These findings demonstrate that patients with thin T1a melanomas can have different biological risk profiles and outcomes. DecisionDx-Melanoma can help identify those at elevated risk who may benefit from increased surveillance or more proactive management, providing additional insight into each patient’s prognosis to guide more individualized, risk-aligned care.

At SDPA, Castle will also present an ePoster titled "Clinical Utility of the 487-Gene Expression Profile Test for Atopic Dermatitis in a Private Practice Setting," featuring a case series with outcome data evaluating the use of AdvanceAD-Tx in 17 patients with moderate-to-severe atopic dermatitis (AD).

Dermato-Onco2026: Individualized Five-Year Recurrence-Risk Assessment

Castle’s data at Dermato-Onco2026 will be shared in an oral presentation as well as a digital poster, which may be viewed in the E-Poster Gallery during the conference.

Abstract Title: The i31-ROR stratifies patients with cutaneous melanoma by high and low 5-year recurrence risk to better inform management decisions

Abstract Number: 137
Session #9: Short Presentations Young Investigators
Date and Time: Friday, Nov. 13, 1:50–2:00 p.m. Central European Time
Summary: This study evaluated 1,726 patients with stage I–III cutaneous melanoma from 49 U.S. sites, representing one of Castle’s largest retrospective melanoma cohorts. All patients underwent DecisionDx-Melanoma testing between 2013 and 2018 as part of their clinical care, providing a large, real-world dataset to evaluate the test’s ability to predict patient outcomes.

The study focused on i31-ROR, one of DecisionDx-Melanoma’s integrated algorithms, which is designed to combine the test’s GEP class score with CP factors to provide an individualized five-year recurrence-risk estimate. This study suggests that DecisionDx-Melanoma can give clinicians a patient-specific risk estimate beyond the population-based risk associated with a broad staging category, helping inform how closely an individual patient should be followed.

The study demonstrated that DecisionDx-Melanoma’s i31-ROR algorithm:

Predicted five-year recurrence more accurately than AJCC staging: The i31-ROR better distinguished patients who experienced recurrence within five years from those who did not, supporting the value of individualized recurrence-risk assessment.
Distinguished patients with low and high recurrence risk: Five-year recurrence-free survival was 92.5% among patients with low-risk i31-ROR results versus 54.2% among those with high-risk results (p<0.001).
Identified significant differences in distant metastasis-free survival (DMFS) and MSS: Patients with low-risk i31-ROR results had five-year DMFS of 94.7%, compared with 68.3% for those with high-risk results (p<0.001). Five-year MSS was 98.4% for patients with low-risk results versus 81.6% for those with high-risk results (p<0.001).
These findings support the use of DecisionDx-Melanoma’s individualized five-year recurrence-risk estimates to guide risk-aligned clinical decisions, including patient follow-up and surveillance.

About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile (GEP) test designed to analyze tumor biology to deliver a personalized risk assessment for patients with stage I–III cutaneous melanoma, enhancing risk stratification beyond American Joint Committee on Cancer (AJCC) staging alone. By combining molecular insights with select clinicopathologic features, the test provides two distinct outputs: a personalized risk of sentinel lymph node (SLN) positivity and a personalized risk of recurrence and/or metastasis. This clinically actionable information is designed to help guide risk-aligned patient management decisions, including SLN biopsy consideration, follow-up intensity, imaging, and referrals.

DecisionDx-Melanoma is supported by 58 peer-reviewed publications, including prospective studies and meta-analyses, and was developed in collaboration with more than 100 leading U.S. institutions. The test has been clinically validated in more than 10,000 patient samples, ordered more than 260,000 times since launch, and has been shown to be associated with improved patient survival. Learn more at www.CastleBiosciences.com.

About AdvanceAD-Tx
AdvanceAD-Tx is a non-invasive gene expression profile (GEP) test designed to guide systemic treatment decisions for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). Using RNA expression data from lesional skin scraping samples—no biopsy required—the test evaluates 487 genes across 12 inflammatory and cutaneous biology pathways to reveal the underlying immune biology driving an individual patient’s disease. The test classifies patients into one of two molecular profiles: a Janus Kinase (JAK) Inhibitor Responder Profile or a T helper type 2 (Th2) Molecular Profile.

The prospective, clinical validation study showed that the test identifies a subset of patients with a JAK Inhibitor Responder Profile who experience significantly greater clinical benefit—including improved and faster skin clearance (EASI-90), reduced itch, fewer flares and better quality of life by three months— when treated with a JAK inhibitor therapy compared to those treated with a Th2-targeted therapy. AdvanceAD-Tx provides clinicians with objective, molecular-based insights to help personalize systemic treatment decisions and improve care for patients. Learn more at View Source

(Press release, Castle Biosciences, NOV 11, 2026, View Source [SID1234674617])

On November 11, 2026 Caris Life Sciences (Caris), a leading next-generation AI TechBio company, reported that the first patients have been enrolled in a prospective, real-world observational study evaluating Caris ChromoSeq, a Whole Genome Sequencing (WGS) assay designed to provide comprehensive genomic characterization of myeloid malignancies through a single integrated workflow. The first patients enrolled in late September 2026, marking the start of prospective evidence generation for the assay.

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The study represents a significant milestone in Caris’ effort to simplify one of the most fragmented molecular testing paradigms in oncology. Approximately 300 adult patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN) will be enrolled across multiple U.S. institutions through July 2027.

For decades, clinicians have relied on a combination of cytogenetics, fluorescence in situ hybridization (FISH) and targeted next-generation sequencing (NGS) to characterize myeloid malignancies. This multi-test approach often requires coordination across multiple laboratories and platforms, creating delays, administrative complexity, and the challenge of integrating separate test results into a single clinical interpretation.

Caris ChromoSeq leverages Whole Genome and Whole Transcriptome Sequencing to deliver high-resolution genomic profiling in a single integrated report with a turnaround time of approximately seven days. The prospective study will evaluate how this comprehensive approach performs in routine clinical practice compared with conventional testing methods across key measures including risk stratification, ease of use, and turnaround time.

"Oncology has embraced comprehensive molecular profiling, yet patients with myeloid malignancies are often still evaluated through a fragmented testing process that requires multiple assays and workflows," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "Caris ChromoSeq was developed to challenge that paradigm. This study is designed to generate the real-world evidence needed to demonstrate how a single Whole Genome Sequencing workflow can provide a more comprehensive and efficient approach to molecular characterization."

The scientific foundation for Whole Genome Sequencing in myeloid malignancies has already been established. Research published in The New England Journal of Medicine demonstrated that Whole Genome Sequencing can support diagnosis and risk stratification in patients with AML and MDS. However, despite these advances, adoption in routine clinical practice remains limited.

The Caris ChromoSeq study is intended to address the next critical question: how a Whole Genome Sequencing based workflow performs in real-world clinical settings across diverse institutions and patient populations.

The study, "An observational study to describe the performance of Caris ChromoSeq as compared to conventional cytogenetics, FISH, and NGS testing among patients receiving the Caris ChromoSeq assay for hematologic malignancies" (NCT07680868), received Institutional Review Board approval on April 23, 2026. The first patients began enrollment in late September 2026.

The start of patient enrollment follows MolDX approval of Caris ChromoSeq and marks another important milestone in Caris’ strategy to expand access to Whole Genome Sequencing while generating the prospective clinical evidence necessary to support broader adoption.

About Caris ChromoSeq
Caris ChromoSeq is a Whole Genome and Whole Transcriptome Sequencing assay designed for the comprehensive genomic characterization of myeloid malignancies, including acute myeloid leukemia, myelodysplastic syndrome and myeloproliferative neoplasms. By consolidating genomic analysis into a single integrated workflow and report, Caris ChromoSeq is designed to simplify traditionally fragmented testing approaches while delivering clinically relevant molecular insights for diagnosis, risk stratification and patient management.

(Press release, Caris Life Sciences, NOV 11, 2026, View Source [SID1234674616])

On November 11, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that Leonard Mazur, Chairman and Chief Executive Officer, will participate in the Jefferies London Healthcare Conference, taking place November 16–19, 2026, in London, United Kingdom.

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Mr. Mazur will provide an overview of the Company’s business and recent developments, including the ongoing commercialization of LYMPHIR (denileukin diftitox-cxdl) by the Company’s majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).

Conference Details:

Conference: Jefferies London Healthcare Conference
Dates: November 16–19, 2026
Location: Waldorf Hilton & ME Hotels, London, United Kingdom
Format: one-on-one meetings
One-on-one meetings with management may be scheduled by contacting a conference representative or the Company’s investor relations team.

(Press release, Citius Pharmaceuticals, NOV 11, 2026, View Source [SID1234674615])