On June 17, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported the presentation of results from its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel (Press release, Lutris Pharma, JUN 17, 2025, View Source [SID1234653961]). The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for use by patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The clinical data will be released in an oral presentation during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, being held July 2-5 in Barcelona, Spain.

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Presentation Details:

Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies
Presenting Author: Dr. Ofer Purim, Head of Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, Israel
Abstract Number: 50
Session Title: Proffered Paper Session
Session Date: Friday July 4, 2025
Session Time: 5:30 – 5:40 pm CET
Session Location: Madrid Room
About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

On June 17, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported that preparations for the commercial launch of LYMPHIR, an FDA-approved immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), are nearing completion (Press release, Citius Oncology, JUN 17, 2025, View Source [SID1234653960]). The Company believes it is now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization, with all major launch-enabling activities underway. Final preparations are in process for a U.S. launch of LYMPHIR in the second half of 2025.

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"We’ve made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we’ve built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community," added Mazur.

Manufacturing and Supply Chain Readiness

Citius Oncology has completed commercial-scale manufacturing of LYMPHIR, with packaged and labeled inventory now held at a leading global Contract Development and Manufacturing Organization (CDMO). Sufficient inventory has been manufactured, with a product shelf life of 60 months, to meet projected demand for 12 to 18 months post-launch.

Citius Oncology has executed one and is finalizing other distribution services agreements with multiple top-tier global pharmaceutical logistics partners to support broad access and timely delivery across the United States. These agreements are intended to provide access for CTCL patients so that they may be treated at both major cancer centers and within the community setting.

KOL Engagement

As part of its extensive market research efforts, our team has engaged U.S. Key Opinion Leaders (KOLs) in CTCL and participated in a series of medical congresses and community forums to build awareness and gather insight. Our engagement with the Cutaneous Lymphoma Foundation and similar organizations continues to shape LYMPHIR’s patient-centered commercial approach.

A recent Advisory Board convened at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, composed of leading CTCL experts, provided us with information that informed both launch strategy and refinement of target patient profiles.

Early interest from the clinical community is evident, with 70 institutional oncology centers already signed up via the LYMPHIR website (www.lymphirhcp.com).

Commercial & Marketing Activities

The commercial team has developed a targeted launch strategy that leverages a proprietary generative AI model to efficiently and effectively target key accounts. These efforts are designed to amplify the expertise of the commercial organization so that they may have more meaningful interactions with providers, ultimately reaching CTCL patients who would benefit from LYMPHIR more expeditiously.

A comprehensive suite of marketing and educational materials has been developed to support LYMPHIR’s introduction. These tools are tailored to providers, patients, and caregivers and include clinical guides, dosing protocols, and disease awareness content.

Market Access Update

LYMPHIR’s inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, assignment of a permanent J-code under HCPCS, and Citius Oncology’s continued engagement with payors, positions the product for efficient reimbursement and coverage at launch.

Financing and Strategic Partnerships

The successful capital raise recently completed by Citius Pharma assists with final preparations for LYMPHIR’s commercialization, supporting the planned launch of LYMPHIR in the second half of 2025. Concurrently, the Company is actively engaged in strategic partnership discussions, guided by its financial advisor, to expand LYMPHIR’s market reach and evaluate potential future development opportunities.

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 of tumor cells and immunosuppressive regulatory T-cells (T-regs) and is internalized. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. This action leads to direct tumoricidal effects as well as a transient depletion of T-regs to enhance overall antitumor activity.

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 Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA in August 2024.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

INDICATION

LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: CAPILLARY LEAK SYNDROME

Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome.

As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred.

Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.

Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.

Visual Impairment

LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment.

Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.

Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.

Infusion-Related Reactions

LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management.

Hepatotoxicity

LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.

ADVERSE REACTIONS

The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Lactation

Risk Summary
No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.

Females and Males of Reproductive Potential

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.

Contraception

Females
Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

Infertility

Males
Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.

Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not been established.

Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Oncology, Inc. 1-844-459-6744.

Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.

On June 17, 2025 The Lung Cancer Research Foundation (LCRF) reported a new research collaboration with Boehringer Ingelheim creating two funding mechanisms designed to address HER2 mutations in lung cancer: a new Team Science Award and an Early Career Investigator Award (Press release, Boehringer Ingelheim, JUN 17, 2025, View Source [SID1234653959]).

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Lung cancer is responsible for more deaths worldwide than any other cancer, accounting for an estimated 130,180 deaths annually in the United States alone.1 In the last 10 to 15 years, accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma have been possible in part due to advances in molecular profiling of tumors. Many of these targeted therapies are directed against oncogenic drivers.

The HER family of tyrosine kinases include HER1 (epidermal growth factor receptor [EGFR] or ERBB1), HER2 (HER2/neu or ERBB2), HER3, and HER4. EGFR mutations were one of the first oncogenic drivers that were successfully targeted with the use of tyrosine kinase inhibitors. Despite substantial progress in this area, available treatments are generally not curative, and resistance invariably develops. HER2 mutations have also been identified as potential oncogenic drivers in lung cancer and occur in up to 4% of NSCLC.2,3 In the past two decades, several clinical trials have investigated the use of anti-HER2 therapies in lung cancer but led to disappointing results. On August 11, 2022, the Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.4 This was a positive step forward for patients with NSCLC whose tumors harbor these mutations. Most recently there are orally administered tyrosine kinase inhibitors of HER2 that have demonstrated promising results in the treatment of HER2-mutant NSCLC.

Immunotherapeutic strategies have not been successful in the treatment of lung cancers with EGFR or HER2 mutations. It is of vital importance that there is a better understanding of the biology of HER2-mutated lung cancer as well as the mechanism of tumor response and resistance. Moreover, given that therapeutic options available to date are not curative, there is a need for novel approaches to treat HER2-mutant lung cancers. Boehringer Ingelheim and LCRF share the belief that a team approach to solving complex issues has the greatest likelihood to have near-term impact for patients, and funding early career investigators maintains the research continuum needed for scientific discovery that leads to breakthroughs.

"We believe that supporting scientists to pursue their curiosity is key to driving meaningful progress and innovation—and that collaboration is essential to bringing groundbreaking treatments to patients," said Bjoern Rueter, U.S. Vice President, Clinical Development and Medical Affairs. "We are excited to join forces with Lung Cancer Research Foundation as we embark on a new era for cancer research and create the Team Science and Early Career Investigator awards."

"Delivering impact to patients is what drives LCRF’s research program," says Dr. Antoinette Wozniak, Chief Scientific Officer for LCRF. "Research collaborations like this will accelerate the pace of scientific discovery moving forward. Our shared commitment to improving outcomes for people living with lung cancer continues to provide hope."

The LCRF|Boehringer Ingelheim Team Science Award on Innovative Approaches Toward the Treatment of HER2-Driven Lung Cancer award, is a $1.5 million, three-year award to a team of researchers whose proposals have a program of closely integrated projects focused on the science behind HER2 mutations as oncogenic drivers of malignancy and/or the development of novel therapeutic approaches for patients with tumors harboring HER2 mutations.

The LCRF|Boehringer Ingelheim Early Career Investigator’s Award on Innovative Approaches Toward the Treatment of HER2-Driven Lung Cancer is expected to total $750,000 for up to three, two-year awards of $250,000 each, focused on HER2 mutations.

Submissions to the Request for Proposals will be reviewed through a two-step process: Letters of Intent will be accepted until midnight on July 29, 2025; if selected, projects will then be chosen to submit full proposals. All applications will be subject to a rigorous review by LCRF’s Scientific Advisory Board. More details about the Request for Proposal, along with eligibility, requirements, and deadlines can be found at LCRF.org/FundingOpportunities.

On June 17, 2025 Orion Corporation and Glykos Finland Oy reported that they have extended their research collaboration and licensing agreement for the development of next-generation antibody-drug conjugates (ADCs) (Press release, Orion, JUN 17, 2025, View Source [SID1234653956]).

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Under the extended agreement, Orion gains access to Glykos’ proprietary ADC technologies with the potential to expand into three additional programs in the future, in addition to the three ADC programs outlined in the previous agreement. Orion will be responsible for the target selection, research, development, and commercialization of up to three next-generation ADCs, with a focus on solid tumors.

The financial terms of the extended agreement for the three new ADC projects are the same as in the original agreement for the first three projects. Glykos is entitled to milestone payments related to the development of the ADCs and product sales. Glykos is also entitled to receive royalties from the commercial sales generated by the three ADC programs.

"This successful collaboration with Glykos allows us to continue leveraging their advanced ADC technology and underscores our commitment to developing new treatment options for cancer patients," said Professor Outi Vaarala, Executive Vice President, Innovative Medicines and Research & Development at Orion.

"The extension of our agreement with Orion highlights the potential of our ADC technology. We are excited to expand our collaboration with Orion, whose expertise in cancer therapies and strong clinical development capabilities are crucial for bringing new, effective treatments to cancer patients," said Juhani Saarinen, CEO of Glykos.

On June 17, 2025 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing first-of-its-kind targeted therapies for primary and metastatic breast cancer, reported the peer-reviewed publication in PLOS-One of their dose optimization in-vivo study results of ZetaMast (Zeta-MBC-005) (Press release, Zetagen Therapeutics, JUN 17, 2025, View Source [SID1234653955]).

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Zetagen identified two concentrations of ZetaMast (Zeta-MBC-005) which demonstrated superior effectiveness, reduction in tumor burden, and increased survival rate over control Doxorubicin.

"Patients with disseminated metastatic breast cancer involving the liver, face a poor prognosis and new approaches are urgently needed., stated Debasish Tripathy, MD, Professor and Chairman, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX "Although some therapies have been designed for direct administration for liver metastases, they have not demonstrated efficacy in significantly improving survival. ZetaMast is an innovative therapeutic approach that has demonstrated systemic biological effects potentially extending beyond liver metastases in preclinical models, offering promising potential to enhance outcomes in this setting."

ZetaMast (Zeta-MBC-005) Increased Survival in a Mouse Xenograft Liver Metastases Model. The 4T1, TNBC cell line, tagged with luc2 luciferase (4T1-luc2), was implanted directly into the liver of BALB/c mice. Seven days after tumor inoculation, mice were treated with various concentrations via a single administration of ZetaMast (Zeta-MBC-005) (30-, 60-, 120-, 180-, 240-, or 480-μg) in combination with 5-mg/kg doxorubicin. Mice in the Control group received 5 mg/kg of doxorubicin and the ZetaMast (Zeta-MBC-005) carrier without Zetagen’s small molecule, administered every72-hours.

ZetaMast (Zeta-MBC-005) has the ability to deliver Zetagen’s small molecules intratumorally as well as other therapies, avoiding off-target side effects.

"Effective locoregional therapies are likely the key to reducing breast cancer mortality for patients with disseminated metastatic disease and increasing 5-year survival above 31%. If treatments like ZetaMast (Zeta-MBC-005) can be given when and where needed, increasing the duration of overall tumor control, which may be enough to tip the balance towards a favorable impact on survival.," stated Bryan S. Margulies, MS, Ph.D., CSO of Zetagen.

To view the ZetaMAST (Zeta-MBC-005) dose optimization study results go to View Source

About ZetaMAST (Zeta-MBC-005)
ZetaMast (Zeta-MBC-005) is a proprietary drug eluting carrier designed for locoregional administration, controlled release of two small molecules in the treatment of multifocal, unresectable, liver metastases from breast cancer with the potential to increase survival rates.

The USPTO has granted Zetagen a "Composition of Matter" patent for ZetaMast (Zeta-MBC-005), and Zetagen has also submitted a filing to the FDA for Orphan Drug Designation.

Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase Ib clinical trial set to commence early 2026.