On March 24, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported positive pharmacokinetic (PK), safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, minimal systemic absorption relative to oral formulations, a favorable safety profile with no serious adverse events, and encouraging reductions in symptom severity.

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In addition, HT-001 demonstrated encouraging clinical activity, with treated subjects exhibiting meaningful reductions in symptom severity and sustained response over the treatment period. These efficacy observations were consistent with the pharmacokinetic profile, suggesting that increased and sustained drug exposure may translate into improved clinical outcomes.

In the Company’s PK analysis, mean AUC₀–₂₄ increased to 80.60 h•ng/mL on Day 42 from 45.61 h•ng/mL on Day 1, representing an approximate 76.7% increase in systemic exposure. Mean Cavg increased to 3.36 ng/mL from 1.90 ng/mL (~76.8%), while mean Cmax increased to 4.56 ng/mL from 3.07 ng/mL (~48.5%), demonstrating consistent, dose-dependent increases in drug exposure.

Mean and individual concentration-time profiles showed higher overall exposure at Day 42 compared to Day 1. Semilog analysis confirmed predictable elimination kinetics and sustained plasma concentrations across the dosing interval.

Importantly, systemic exposure following topical HT-001 remained minimal relative to oral formulations. On Day 1, exposure levels were approximately 0.2% of those observed with FDA-approved oral formulations, and remained below 0.5% on Day 42 despite repeated dosing.

Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile.

Across paired evaluable subjects, the mean accumulation ratio (RA_AUCτ) was approximately 2.09x, with mean RA_Cmax of approximately 1.72x, supporting repeat-dose pharmacokinetic activity and sustained drug levels over time.

Safety and tolerability findings included:

No serious adverse events (0%)
No dose-limiting toxicities observed
No treatment discontinuations due to adverse events
"These pharmacokinetic results, combined with a favorable safety and tolerability profile, support the continued advancement of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The approximately 77% increase in systemic exposure, along with consistent accumulation and minimal systemic absorption relative to oral therapies, reinforces our dosing strategy as we advance development."

The Company believes these data support continued clinical advancement and dose optimization, with PK findings aligning with observed clinical outcomes, including meaningful reductions in symptom severity and sustained patient response.

(Press release, Hoth Therapeutics, MAR 24, 2026, View Source [SID1234663879])

On March 24, 2026 Duality Biotherapeutics, Inc. (Hong Kong Stock Exchange Code: 09606.HK, hereinafter referred to as "DualityBio" or the "Company"), a leading global clinical-stage innovative biopharmaceutical company, reported its first annual results since listing on April 15, 2025 (for the year ended December 31, 2025), providing a comprehensive update on its global clinical pipeline and corporate operations.

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Dr. John Zhu, Founder, founder and Chief Executive Officer of DualityBio, stated:

"Over the past decade, the innovative pharmaceutical industry has evolved from partial exploration to systematic development. Today, we stand at a brand-new starting point – an era that is more open, more uncertain yet more imaginative. Technological advancement is reshaping industry boundaries, global clinical and regulatory systems are gradually integrating, and innovation is no longer confined to a single region but occurs collaboratively worldwide, marking the ‘Great Voyage Era of Innovative Drugs’. In 2025, DualityBio anchored on innovation and forged ahead steadily in the ADC track. Leveraging the profound accumulation of our four core technology platforms, we drove the full-speed advancement of core assets: the enrollment of over 3,200 patients globally has verified our R&D strength and original aspiration for global layout; in-depth collaborations with partners such as BioNTech and Avenzo have continuously amplified innovation value, injecting strong momentum for long-term development.

In 2026, we will build on this momentum to accelerate the commercialization of core products, deepen pipeline iteration and technological breakthroughs, and steadily advance the A-share listing plan, responding to every expectation with a clearer growth path and more solid performance. The road to innovation is long and challenging. DualityBio will always be guided by unmet clinical needs, keep forging ahead in the journey of overcoming intractable diseases, and embark on a journey of value growth with all partners."

Financial Highlights

During the reporting period, the Company achieved total revenue of RMB1.852 billion , providing a solid financial foundation for the continuous advancement of business. R&D investment remained at a high level, with annual R&D expenses reaching RMB838 million; the adjusted loss for the year was RMB389 million (calculated by deducting the fair value change of preferred shares issued prior to the Global Offering from the loss for the year. Such fair value changes arose from the preferred shares issued in connection with previous equity financings prior to the Global Offering on April 15, 2025. From this date onward, these preferred shares ceased to exist, and there will be no further profit or loss impact of this nature in subsequent financial periods). The Company maintained a healthy cash flow position, with cash and bank balances of RMB3.325 billion as of the end of the period (comprising cash and cash equivalents, restricted cash and term deposits with initial term over three months), and achieved a net cash inflow from operating activities of RMB195 million, which has been positive for three consecutive years, providing sufficient capital support for the Company’s long-term growth, subsequent pipeline advancement, clinical research and commercialization layout.

Milestone of First-Wave Assets: Pivotal Clinical and Regulatory Progress

In 2025, DualityBio drove the accelerated global clinical progress of its ADC pipeline relying on four core technology platforms. The Company currently has 10 clinical stages self-developed ADC candidates. Global clinical trials have enrolled over 3,200 patients cumulatively, with more than 1,200 new patients enrolled in 2025 alone, of which approximately 50% are located in the U.S., EU, Australia and other regions outside China, covering 17 countries and over 300 clinical centers, fully verifying the Company’s global clinical development capabilities.

The clinical development of Trastuzumab pamirtecan (DB-1303/BNT323 or "T-
Pam") achieved a milestone breakthrough in 2025. In September 2025, the Independent Data Monitoring Committee ("IDMC") reviewed the interim data of a Phase 3 registrational trial (DYNASTY-Breast01; NCT06265428) and confirmed that the trial had achieved the primary endpoint of Progression-Free Survival ("PFS"), as evaluated by Blinded Independent Central Review ("BICR"), relative to the control arm. This trial is conducted in China to evaluate the efficacy of DB-1303/BNT323 versus T-DM1 in patients with HER2+ unresectable and/or metastatic Breast Cancer ("BC") previously treated with trastuzumab and taxane. Another Phase 3 trial of the product in China (NCT06265428) targets patients with HER2+ unresectable/metastatic breast cancer previously treated with trastuzumab and taxane, and the Biologics License Application ("BLA") has been submitted to the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA"), which is currently in the formal acceptance and review stage. A potential registrational cohort in a global Phase 1/2 trial for HER2-expressing advanced/recurrent Endometrial Cancer ("EC") has completed enrollment, and partner BioNTech plans to submit a BLA to the U.S. Food and Drug Administration ("FDA") in 2026. In addition, the global Phase 3 trial of the product (DYNASTY-Breast02; NCT06018337) completed enrollment in February 2026, targeting advanced or metastatic HR+, HER2-low breast cancer, with interim data expected to be available in 2026.

As the Company’s core ADC product targeting the B7-H3 antigen, DB-1311/BNT324 has continuously released positive clinical data in multiple solid tumor indications. In June 2025, the Company presented data from 73 heavily pretreated patients with metastatic Castration-Resistant Prostate Cancer ("mCRPC") at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting; the 6-month Radiographic Progression-Free Survival ("rPFS") rate was 67.7% (as of March 4, 2025). In February 2026, at the ASCO (Free ASCO Whitepaper) Genitourinary ("GU") Cancers Symposium, the Company further presented updated data from 146 heavily pretreated mCRPC patients, with a median rPFS of 11.3 months and a median Overall Survival ("mOS") of 22.5 months; in patients with no prior exposure to Lutetium-177 ("Lu-177"), the median rPFS reached 13.6 months; in patients who had previously received Lu-177 (with a median of 5 prior lines of therapy), the median rPFS remained 11.3 months, and the median OS was not yet reached. Safety findings were consistent with prior reports; nausea and hematologic events were the most common adverse events and were mainly Grade 1-2; in the 6 mg/kg dose group (n=110), the incidence of Grade ≥3 Treatment-Related Adverse Events ("TRAE") was 20.0%, the discontinuation rate due to TRAE was 5.5%, and no treatment-related deaths were reported. Meanwhile, the product also demonstrated considerable potential in gynecological tumors. Data presented at the European Society for Medical Oncology ("ESMO") Asia Congress in December 2025 showed that in previously treated cervical cancer patients (n=30), DB-1311/BNT324 achieved an Unconfirmed Objective Response Rate ("uORR") of 43.3%, a Confirmed Objective Response Rate ("cORR") of 33.3%, a Disease Control Rate ("DCR") of 86.7%, and a median Progression-Free Survival ("mPFS") of 7.0 months; in Platinum-Resistant Ovarian Cancer ("PROC") patients (n=12), the cORR was 58.3%, DCR was 75.0%, and mPFS was 8.2 months. The above data fully confirm the broad application potential of the product in various solid tumors. Based on the excellent preliminary data, the first global Phase 3 trial (NCT07365995) evaluating DB-1311/BNT324 compared to docetaxel in taxane-naïve mCRPC patients is planned to start in 2026, with primary endpoints of PFS and OS.

As an innovative ADC developed by the Company targeting the HER3 antigen, DB-1310 has achieved important clinical breakthroughs in both Non-Small Cell Lung Cancer ("NSCLC") and breast cancer("BC"), and obtained two Fast Track Designations from the U.S. FDA. In June 2025, the Company presented clinical data from patients with Epidermal Growth Factor Receptor mutation ("EGFRm") NSCLC at the ASCO (Free ASCO Whitepaper) Annual Meeting. As of April 11, 2025, across the 1.5 mg/kg to 6.5 mg/kg dose range in 172 subjects, DB-1310 demonstrated a manageable safety profile, with Grade ≥3 TRAE occurring in 36% of patients and a low treatment-related discontinuation rate of 3.5%; among 46 efficacy-evaluable patients, the uORR was 43.5%, cORR was 28.3%, DCR was 91.3%, mPFS was 7.03 months, and mOS was 18.89 months; in the 5 mg/kg dose group (n=16), the cORR was 37.5%, DCR was 87.5%, mPFS was 8.28 months, and mOS was not reached. In December 2025, at the San Antonio Breast Cancer Symposium ("SABCS"), the Company presented data from pretreated HR+/HER2- breast cancer patients. In patients receiving DB-1310 at doses of 5.0-5.5 mg/kg (n=18), DB-1310 achieved a uORR of 55.6%, a cORR of 50.0%, and a confirmed DCR of 94.4%, with a manageable safety profile primarily involving Grade 1-2 hematologic and gastrointestinal events, a TRAE-related discontinuation rate of 4.5%, and no new safety signals. At the regulatory level, the R&D process of DB-1310 has been accelerated: in July 2025, it received Fast Track Designation from the FDA for the treatment of adult patients with advanced, unresectable or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or L858R mutation who have progressed on or after treatment with a third-generation EGFR Tyrosine Kinase Inhibitor ("TKI") and platinum-based chemotherapy; in December 2025, it received an additional Fast Track Designation from the FDA for the treatment of adult patients with advanced/unresectable or metastatic HR-positive/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy, CDK4/6 inhibitor, with or without chemotherapy for unresectable or metastatic disease, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Deepen Global Cooperation and Unleash Strategic Synergies

DualityBio continues to advance the "Duality Flywheel Model", deepen global cooperation, and maximize the value of self-developed assets. The Company has established a robust global cooperation network, entering into multiple out-licensing and collaboration agreements with leading industry players worldwide, including core partners such as BioNTech, BeOne, Adcendo, GlaxoSmithKline ("GSK") and Avenzo, with a total transaction value exceeding US$6 billion, fully demonstrating the industry’s high recognition of the Company’s independent R&D technology platforms.

Exploration of IO2.0+ADC Combination Therapies

Next-generation IO+ADC combination therapy is a core development trend in the global biopharmaceutical industry. The "bispecific antibody + ADC" combination can not only improve the efficacy of indications already covered by bispecific antibody combined with chemotherapy but also expand the scope of indications that cannot be covered by existing therapies, making it an important development direction in the field of tumor treatment. The Company is collaborating with BioNTech to explore the combination potential of DB-1303/BNT323, DB-1311/BNT324 and DB-1305/BNT325 with pumitamig (PD-L1xVEGF bispecific antibody) to expand their frontline application in various solid tumors.

DB-1303/BNT323 in Combination with Pumitamig: In May 2025, the first patient was dosed in a global Phase 1/2 clinical trial evaluating the combination therapy in patients with HR+ or HR-, HER2-low, ultralow, or null advanced metastatic breast cancer or Triple-Negative Breast Cancer ("TNBC"), with trial data expected to be available in 2026.

DB-1311/BNT324 in Combination with Pumitamig: In May 2025, the first patient was dosed in a global Phase 1/2 clinical trial evaluating the combination therapy in patients with advanced lung cancers; in July 2025, the first patient was dosed in a global Phase 2 clinical trial evaluating DB-1311/BNT324 in combination with pumitamig or with DB-1305/BNT325 in patients with advanced solid tumors, with data from both trials expected to be available in 2026. For DB-1311, DualityBio holds an exclusive option to share the development and commercialization costs and profits and losses from the exploitation of the first DB-1311 product in the United States, in accordance with the terms set out in the agreement. As of the date of this announcement, the Company has not exercised this cost & profit/loss sharing option and retains the right to do so in the future.

DB-1305/BNT325 in Combination with Pumitamig Clinical Readout: In April 2025, the first clinical data evaluating the combination of pumitamig and DB-1305/BNT325 were presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting. Interim data from 67 patients showed that the combination therapy had a manageable safety profile with a low incidence of overlapping toxicities and early signs of anti-tumor activity in patients with PROC, NSCLC or TNBC; among evaluable PROC patients (n=13), seven achieved partial response and three had stable disease.

In addition, DualityBio has established cooperative partnerships with companies such as BeOne, Adcendo, GSK and Avenzo, leveraging complementary advantages in R&D and global commercialization to jointly drive value growth.

Next-Generation Innovation Progress: Continuously Expand Moat with Diversified Platforms and Product Pipelines

In addition to first-wave core assets, the Company has advanced the rapid development of a series of high-potential ADCs and Bispecific ADCs ("BsADCs"):

DB-2304 (BDCA2 ADC): A potential First-in-class ADC for the treatment of Systemic Lupus Erythematosus ("SLE") and Cutaneous Lupus Erythematosus ("CLE"), with the first patient dosed in the Phase 2a study. Data from a Phase 1 randomized controlled study (Clinical Trial Code: NCT06625671, Phase 1/2a study) was presented orally at the 53rd Autumn Immunology Conference ("AIC 2025"). The results showed that DB-2304 was generally safe and well-tolerated in healthy subjects, with linear Pharmacokinetics ("PK") characteristics, and could effectively bind to the target, verifying its pharmacologic mechanism.

DB-1418/AVZO-1418 (EGFR×HER3 BsADC): Partner Avenzo has announced the first patient dosed in the Phase 1 portion of a global Phase 1/2 trial in patients with advanced solid tumors. In November 2025, Avenzo announced that DB-1418/AVZO-1418 received Fast Track Designation from the FDA for the treatment of patients with unresectable, locally advanced, or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation whose disease has progressed on or after therapy with an EGFR TKI.

DB-1419 (B7-H3×PD-L1 BsADC): Currently the only B7-H3×PD-L1 BsADC under clinical development globally, a global Phase 1/2a trial is being conducted in patients with advanced/metastatic solid tumors and is currently enrolling patients.

DB-1317 (ADAM9 ADC): A next-generation ADC targeting ADAM9, a highly expressed antigen in gastrointestinal cancers, a global Phase 1a/1b trial is being conducted in patients with selected advanced/metastatic solid tumors and is currently enrolling patients.

DB-1324 (CDH17 ADC): Licensed to GSK for development outside Greater China, received IND clearance from the FDA in December 2025, and a global Phase 1/2 clinical trial is being conducted in patients with advanced/metastatic gastrointestinal tumors and is currently enrolling patients.

2026: Build on Momentum and Forge Ahead

To fully prepare for commercialization in the Chinese market, DualityBio has established a core commercial team, with senior leaders appointed in key functional areas including strategic planning, market access and commercial partner management. In January 2025, DualityBio entered into a collaboration agreement with 3SBIO Inc. (HKEX: 1530, "3SBIO"), leveraging its professional Contract Sales Organization ("CSO") capabilities to accelerate launch preparations for Trastuzumab pamirtecan, ensuring rapid and targeted access to key markets and customer segments. In the Territory (Mainland China, Hong Kong and Macau), 3SBIO will also provide related commercialization services – including market access, medical affairs, and channel management – to support the product’s commercial activities. The Company has submitted a BLA to the CDE for Trastuzumab pamirtecan (DB-1303) for the treatment of breast cancer. Globally, partner BioNTech is also actively advancing the process of submitting a BLA to the U.S. FDA for HER2-expressing endometrial cancer.

In addition to clinical execution, in line with the Company’s global development and domestic commercialization layout, on October 17, 2025, the Board of Directors of the Company resolved to propose the issuance of RMB-denominated ordinary shares to be listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange.

Looking ahead, DualityBio will always implement the strategic original aspiration of "Global Team, Global Clinical Trials, Global Market", aiming to evolve into a global leading pharmaceutical enterprise and provide therapeutic options for patients worldwide.

(Press release, DualityBio, MAR 24, 2026, View Source [SID1234663878])

On March 24, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that the Investigational New Drug (IND) application for SKB103, its self-developed novel bispecific antibody-drug conjugate with combined Tumor-Associated Antigen-targeting and Immuno-Oncology mechanisms (TAA-PD-L1 bsADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors. The approval marks SKB103 as the Company’s first TAA-PD-L1 bsADC candidate and its second bsADC program for tumor therapy to enter the clinical stage, following SKB571.

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As one of the industry leaders in the ADC field, Kelun-Biotech has established a solid competitive advantage. Currently, the Company’s self-developed TROP2 ADC and HER2 ADC have been approved for marketing, demonstrating significant clinical efficacy and competitive differentiation. Focusing on advances in oncology therapeutics, Kelun-Biotech continues to expand its innovative layout by building a diversified pipeline covering cutting-edge therapies such as RDCs and bsADCs and fully driving breakthroughs and innovations in existing cancer treatment paradigms.

SKB103 is a potential best-in-class novel bsADC developed using Kelun-Biotech’s proprietary OptiDC platform. Designed as a single molecule, it is expected to realize targeted delivery of cytotoxic payloads to tumors and modulation of tumor immune microenvironment simultaneously. In preclinical studies, SKB103 demonstrated outstanding anti-tumor activity and a favorable safety profile. The therapeutic potential of SKB103 will support its subsequent clinical development.

"The IND approval for SKB103 represents another important milestone in our bsADCs pipeline and reflects the continued clinical translation of our novel DC strategy, further solidifying our core technical advantages in the ADC field," said Dr. Michael Ge, CEO of Kelun-Biotech. "Innovation in IO and ADC is currently reshaping the global cancer treatment landscape. Leveraging our systematic and platform-based R&D capabilities and extensive ADC development experience, we will advance the development of next-generation ADC drugs like SKB103, deeply explore the global clinical value of our portfolio, and fully promote innovation in cancer therapies, opening up broader prospects for the treatment of patients worldwide and the Company’s sustainable development."

(Press release, Kelun, MAR 24, 2026, View Source [SID1234663877])

On March 24, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported that members of its commercial and medical affairs teams will attend the USCLC Annual Workshop 2026. The meeting, titled "Frontiers in Cutaneous Lymphoma: New Technologies, Therapeutics, and Future Directions," will take place on March 26, 2026, at the Hyatt Regency Denver at Colorado Convention Center.

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The United States Cutaneous Lymphoma Consortium (USCLC) Annual Workshop is widely regarded as one of the most focused scientific gatherings dedicated to cutaneous lymphomas, including cutaneous T-cell lymphoma (CTCL). The meeting brings together leading dermatologists, hematologist-oncologists, translational researchers, and academic investigators from major U.S. cancer centers who specialize in diagnosing and treating CTCL and related diseases.

This year’s workshop is expected to convene dozens of key opinion leaders and clinical investigators from leading academic institutions, with program sessions covering:

Novel molecular diagnostics and biomarkers
Radiology and digital pathology advancements
Emerging therapies for CTCL
Future clinical and research directions in cutaneous lymphoma
The workshop format emphasizes small-group discussions and direct interaction among experts, creating an environment where physicians and researchers can exchange insights about evolving treatment paradigms and clinical experience.

Citius Oncology’s team will participate in the meeting to engage with clinicians and researchers regarding the treatment landscape for CTCL and discussions regarding clinical experience with LYMPHIR (denileukin diftitox-cxdl) which Citius Oncology recently launched in the U.S.

"Our participation in the USCLC Workshop reflects our commitment to engaging directly with the leading clinicians who treat patients with cutaneous lymphoma," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "The USCLC community represents many of the foremost experts and practitioners in CTCL care, and we look forward to productive scientific discussions regarding treatment experience, patient selection, and emerging opportunities to improve outcomes."

About the USCLC Annual Workshop

The USCLC Annual Workshop is organized by the United States Cutaneous Lymphoma Consortium, a collaborative network of leading U.S. academic centers dedicated to improving research, diagnosis, and treatment of cutaneous lymphomas. The workshop serves as a platform for leading specialists to discuss cutting-edge diagnostics, emerging therapeutics, and future research directions in CTCL and related diseases.

USCLC is the only organization in America where professionals from the collaborating disciplines of dermatology, medical oncology, radiation oncology and pathology can exchange ideas and practice tips, discuss, plan and execute scientific collaborations, develop new educational tools, and help shape the research agenda in cutaneous lymphomas. USCLC was created with the express purpose of breaking communication barriers, encouraging "outside-the-box" thinking, and fostering and supporting innovative ideas regarding the treatment and research relating to cutaneous lymphomas. The key initiatives of USCLC are a national registry, a virtual tissue repository, and a clinical trials network.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, MAR 24, 2026, View Source [SID1234663876])

On March 24, 2026 Aethlon Medical, Inc. (Nasdaq: AEMD), a clinical-stage biotechnology company developing the investigational Aethlon Hemopurifier, an extracorporeal device for oncology and other indications, reported that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial AEMD-2022-06 has completed its scheduled safety review of the second cohort participant data and recommended advancing to the third and final cohort. They also stated that "no safety concerns were noted with Hemopurifier device/procedure".

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The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier’s safety, feasibility, and optimal dosing.

The DSMB, comprised of independent medical experts in nephrology and oncology- reviewed data from participants enrolled in the second cohort, in which patients received two Hemopurifier treatments over a one-week period. Based on their evaluation, the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier device or treatment have been reported.

"The DSMB’s continued positive recommendation supports the safety profile observed to date and allows us to advance into the third and final cohort of this study," said Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "We are encouraged by the gathering momentum of the trial and having a final data set and clinical study report to share with potential investors, partners and regulatory agencies".

Enrollment for Cohort 3 is now open. In this final cohort, participants will receive three Hemopurifier treatments over a one-week period further evaluating safety, feasibility and dosing parameters at the study’s three active clinical sites in Australia. This trial is designed to enroll approximately 9 to 18-patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda) or Nivolumab (Opdivo).

The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier- treated patients. In addition to safety monitoring, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (EVs) and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities.

Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for use in oncology and will continue to provide updates as the clinical trial progresses.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived EVs from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects.

The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for:

The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and
The treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications.

(Press release, Aethlon Medical, MAR 24, 2026, View Source [SID1234663875])