Chemistry and formulation
Analytical methods, stability studies, and formulation insights can inform both compositions, with their suitability evaluated for each candidate.
Developing novel metallodrugs
at the atomic level
We translate the metallomics research into proprietary platforms, establish their scientific and development foundations for strategic partnerships, and advance lead candidates toward commercialization.
OUR PLATFORMS:
FIRST FOCUS & LEAD PROGRAMS
Interconnected broader platforms. Lead programs with defined starting point.
Our first focus is zinc as an essential element for the functioning of over 3,000 proteins and the related cellular pathways. This enables us test our hypothesis for both, isotopically modified and isotopically natural zinc.
FIRST ISM FOCUS
64Zn(L-Asp)2
Zinc-64 atoms enriched >99%
Non-radioactive isotope
KLS-1
LEAD ISM PROGRAMAn enriched, intravenous zinc metallodrug candidate
- Clinical stage
- Phase 1/2 NCT06506643
- Development priority
- Treatment of adult patients with solid tumors and lymphocytic leukemia
- Licensable
- Seeking partners to develop select neurological and metabolic applications
Currently in clinical trials. Initial safety has been established in humans. The human efficacy for intended therapeutic uses is subject to future investigations. Preclinical studies completed for select neurological and metabolic indications.
FIRST N2Rx FOCUS
Zn(L-Asp)2
Isotopically natural formulation
Bioactive zinc speciation
KLS-4
LEAD N2Rx PROGRAMIsotopically-natural intravenous zinc chelate metallodrug
- Preclinical stage
- Preparing for seeking regulatory alignment
- Development priority
- Treatment of clinically significant hypozincemia in adults unable to achieve zinc repletion by oral, enteral, or standard parenteral-nutrition routes.
- Licensable
- Seeking manufacturing and distribution partners
Currently preparing for initial clinical trials. Safety and efficacy for intended uses have not been established in humans.
MUTUALLY SYNERGISTIC DEVELOPMENT
Each program informs the other
Shared knowledge can strengthen both programs—from the next experiment to the next product decision. Their development is connected through three complementary areas.
Comparative biology
Matched studies can help distinguish the contribution of isotope enrichment from the effects of zinc, ligand, formulation, dose, and exposure.
Development strategy
Findings from either program can sharpen biomarker selection, indication priorities, and study design, guiding product differentiation and intellectual-property development.
OUR MASTER PLATFORMS
Each platform validates its core technology through the lead programs while simultaneously building a sustainable pipeline of follow-on products that benefit from accumulated platform optimization and clinical data. Thus, each platform can have broader potential while its lead candidate provides a defined starting point.
Isotope-Selective
Modulation™
Cold isotope enrichment as a therapeutic modality
ISM™ explores whether selected, enriched stable isotopes can produce biologically meaningful effects within metal-dependent pathways, and whether those effects can be translated into medicines.Lead Candidate: KLS-1 Program
KLS-1 is an isotope-targeting strategy that applies the biology-related kinetic and equilibrium isotope effects and coordination chemistry to test whether disease-specific isotopic fractionation creates a druggable vulnerability and superior efficacy.
Zinc Pulse Therapies
From nutrient metal
to differentiated therapeutics
Zinc pulse therapeutic platforms explore whether brief, controlled increases in zinc exposure can modulate zinc-dependent processes to treat diseases characterized by disrupted zinc biology.Lead candidate: KLS-4 Program
KLS-4 is a staged development strategy in which it is first commercialized as an orphan hypozincemia drug, and is sequentially translated into a multi-indication differentiated therapeutic through adapting disease-specific changes in zinc biology, dose/exposure control, and efficacy validation.
PRODUCT DEVELOPMENT
Published research provides the scientific foundation. Metallomix builds on that publicly available knowledge by developing defined compositions, formulations, and therapeutic approaches, evaluating their biological effects, and pursuing intellectual property protection for differentiated innovations. This work establishes proprietary platforms and lead candidates for further development, licensing, and commercialization.
Identify
Identify actionable insights from metallomics research and define development opportunities around disease-relevant, metal-dependent biology.
Design
Develop candidate compositions, isotopic profiles, formulations, and exposure strategies around a testable biological rationale.
Compare
Evaluate candidates using relevant models and matched comparisons to distinguish the contributions of chemistry, isotopic composition, formulation, and exposure.
Protect
Pursue intellectual property protection for differentiated compositions, formulations, methods, and therapeutic applications.
Advance
Establish lead candidates and development plans, and build partnerships for licensing, further development, and commercialization.
PLATFORM EXPANSION
Future candidates will follow a clear biological rationale, suitable isotope chemistry and biology, and testable/reproducible evidence. Progress in one program does not validate every metal or disease application.
THE BIOLOGICAL FOUNDATION
A key functional layer of human biology
Chronic diseases can involve persistent disruptions in cellular metal availability, with consequences for energy metabolism, immune signaling and tissue function. An unmet need remains for the therapies that modulate these processes in the relevant cells and tissues, with controlled exposure and measurable biological effects.
The metallome is intricately connected to other “omes”, influencing and being influenced by them through essential metal ion regulation. It is critical for protein synthesis, charge balance, DNA integrity and repair, and the structure, signaling and stem-cell function of tissues.
We see the metallome modulation as a next-generation modality for targeted chronic disease therapies: acting on a shared functional layer that connects multiple disease-relevant pathways. With this vision in mind, Metallomix investigates defined metal compositions and selected stable isotopes to translate this approach into medicines, guided by mechanistic research, biomarkers and clinical evidence.
Learn more
View full-size imageTHE METALLOME
The term "metallome" refers to metals and metal-species in biological systems, including metal ions and metalloproteins. Understanding the metallome means understanding how these species are distributed, regulated, and used by the body in health and disease.
THE THERAPEUTIC OPPORTUNITY
Disrupted metal homeostasis can cause disease or contribute to its progression. We investigate where this biology may reveal opportunities to develop new medicines. Our special focus is on cellular metal deficiencies and isotopic fractionation.
Scientific background [1–48]WE SHARE
IP Licensing
Metallomix retains selected innovations for its own pipeline and seeks to license other significant innovations to nutraceutical and pharmaceutical companies to establish strategic partnerships for development and commercialization.
Partner with usIP STRATEGY
Our intellectual-property strategy is intended to encompass bioactive compositions, pharmaceutical formulations, delivery approaches, dose and exposure regimens, and therapeutic uses, supporting development across multiple products and future candidates.
Ways to partner
Work with us to translate the metallomics science into proprietary drugs, defined product candidates, and commercial opportunities. Collaborations can begin with intellectual property, a platform capability, a specific application, or an established development program.
IP Licensing
License selected intellectual property to support the development and commercialization of differentiated compositions, formulations, and therapeutic applications.
Platform Collaboration
Collaborate on the scientific and technical foundations of our platforms, including candidate design, formulation, analytical methods, and comparative biological evaluation.
Application Development
Develop a defined application of a selected platform technology around an unmet medical need, target population, or product opportunity.
Program Partnerships
Participate in advancing a lead candidate by contributing development, manufacturing, regulatory, financing, or commercialization capabilities.
Metallomix focuses on platform creation, scientific direction, intellectual property strategy, and partnership formation. Dedicated program companies and partners can lead candidate-specific development, manufacturing, regulatory activities, and commercialization. The allocation of rights and responsibilities is defined for each program and partnership.
UNMET MEDICAL NEEDS
Following the biology.
Building the evidence.
The metallome connects to biological processes across many diseases. Our aim is to develop therapies where a defined metal-dependent mechanism can be measured and meaningfully changed.
We define unmet medical need by identifying gaps in treatment effectiveness, tolerability, and access for specific patient populations. We prioritize opportunities where metal-dependent biology offers a testable route to better outcomes and aligns with industry objectives: differentiated products, feasible development, integration with standard-of-care therapies, protectable intellectual property, and a credible path to partnership and commercialization.
Immune regulation
Metal availability helps shape host defense, inflammatory response, and immune-cell function.
Cell growth and survival
Metal-dependent enzymes and regulatory proteins connect to proliferation, DNA maintenance, and cell-death pathways.
Energy and metabolism
Metal cofactors participate in energy production, metabolic reactions, and cellular signaling.
Neuronal function
Metal homeostasis intersects with neuronal signaling, protein function, and oxidative stress.
Bone marrow function
Metal homeostasis supports hematopoietic stem-cell function and the production and maturation of blood cells in the bone marrow.
SCIENCE & EVIDENCE
From hypothesis
to evidence
Metallomix connects the established metal biology to specific, testable claims, and transparent development milestones.
Metallome biology
The metallome’s role in health and disease is well established in the scientific literature. Metallomix builds on this foundation to explore new ways to translate metal biology into better medicines.
Read the scientific backgroundPublished investigations
Review the studies behind Metallomix’s initial research. Learn more about isotopic signatures and fractionation in diseases. Find science-backed information in support of our scientific stance.
Explore publicationsFollow our progress
Keep abreast of Metallomix’s progress, from scientific research to product development. Connect with us on LinkedIn for company news, development milestones, and partnering updates.
Follow us on LinkedInFREQUENTLY ASKED QUESTIONS
What does isotope-selective modulation mean?
It is Metallomix’s research approach to investigating selected stable-isotope compositions as a variable in pharmaceutical design. A proposed isotope-dependent effect must be demonstrated experimentally and then evaluated for clinical relevance.
How does ISM relate to conventional metal chemistry?
Isotopic composition is investigated alongside chemical form, ligand, formulation, dose, and exposure. It is also investigated for kinetic and equilibrium isotope effects on pharmacokinetics, pharmacodynamics, and isotopic signatures in the context of disease-modifying and therapeutic effects. Matched comparisons are needed to determine whether an observed effect is attributable to isotopic composition.
Does the platform cover every essential metal?
The metallome is the broader biological context. It does not imply an active program for each essential metal. Some elements have only one stable isotope, and each development opportunity needs its own chemical feasibility, mechanistic rationale, and evidence.
Are all diseases caused by metallome disruption?
No. Some disorders are directly caused by defects in metal handling. In complex diseases, altered metal homeostasis may be a contributor, consequence, or marker. Therapeutic relevance and causality need to be established in the specific disease context.
How can I invest in Metallomix?
Thank you for your interest in Metallomix. At this time, Metallomix is not accepting direct investment in the parent company. We welcome investment in our subsidiaries developing KLS-1 and KLS-4. Please visit Isotozin.bio and ZnA.bio to learn more about these opportunities.
PARTNER WITH US
Let’s start
a conversation
Metallomix develops pharmaceutical and nutraceutical platforms to address unmet medical needs by investigating metal biology of the underlying diseases.
Metallomix Inc.175 SW 7-th Street
Suite 1702
Miami, Florida 33130
Fax: (305) 204-5531
Selected scientific background and program sources
* Publications by Metallomix team members.
- Zoroddu et al. The essential metals for humans: a brief overview. Journal of Inorganic Biochemistry, 2019.
- Waldron et al. Metalloproteins and metal sensing. Nature, 2009.
- Intracellular Bioinorganic Chemistry and Cross Talk Among Different -Omics, 2016.
- Metallomix program information and ClinicalTrials.gov study NCT06506643.
- An essential role for the Zn2+ transporter ZIP7 in B cell development. Nature Immunology, 2019.
- SLC30A9: an evolutionarily conserved mitochondrial zinc transporter essential for mammalian early embryonic development. 2024.
- Costa MI et al. Zinc: From Biological Functions to Therapeutic Potential. International Journal of Molecular Sciences, 2023.
- Dhawan DK et al. Zinc: a promising agent in dietary chemoprevention of cancer. Indian Journal of Medical Research, 2010.
- Wang J et al. Zinc dysregulation in cancers and its potential as a therapeutic target. Cancer Biology & Medicine, 2020.
- * Perez JA et al. Phase 1 First-in-Human Dose Escalation and Dose Expansion Study of KLS-1 (64Zinc Aspartate) in Patients With Cancer and Neurodegenerative Diseases. Cureus, 2022.
- Kapała A et al. Cross-sectional observational study: Investigation of zinc concentration in white patients with cancer. Nutrition, 2024.
- Addeo R et al. Zinc Supplementation in Head and Neck Cancer: Prevention of Chemo-Radio-Induced Complications and an Opportunity for Treatment. Oncology, 2024.
- Woyciehowsky M et al. Systematic characterization of zinc in a series of breast cancer cell lines reveals significant changes in zinc homeostasis. bioRxiv (preprint), 2025.
- Narayan S et al. Zinc dampens antitumor immunity by promoting Foxp3+ regulatory T cells. Frontiers in Immunology, 2024.
- Yang et al. Zinc Ion-Induced Immune Responses in Antitumor Immunotherapy. CCS Chemistry, 2024.
- Kocdor H et al. Zinc supplementation induces apoptosis and enhances antitumor efficacy of docetaxel in non-small-cell lung cancer. Drug Design, Development and Therapy, 2015.
- Tea I et al. Stable Isotope Abundance and Fractionation in Human Diseases. Metabolites, 2021.
- Schilling K et al. Zinc stable isotopes in urine as diagnostic for cancer of secretory organs. Metallomics, 2021.
- Hastuti AAMB et al. Cu and Zn isotope ratio variations in plasma for survival prediction in hematological malignancy cases. Scientific Reports, 2020.
- Costello LC et al. Cytotoxic/tumor suppressor role of zinc for the treatment of cancer: an enigma and an opportunity. Expert Review of Anticancer Therapy, 2012.
- Bendellaa M et al. Roles of zinc in cancers: From altered metabolism to therapeutic applications. International Journal of Cancer, 2024.
- Paredes E et al. Impact of uranium uptake on isotopic fractionation and endogenous element homeostasis in human neuron-like cells. Scientific Reports, 2018.
- Renshaw PF. A diffusional contribution to lithium isotope effects. Biological Psychiatry, 1987.
- Schilling K et al. Investigations on Zinc Isotope Fractionation in Breast Cancer Tissue Using in vitro Cell Culture Uptake-Efflux Experiments. Frontiers in Medicine, 2021.
- Zhang et al. Isotope effect of 13C‑enriched testosterone on human cells. World Academy of Sciences Journal, 2022.
- Karolinska Institutet. Ultralight ultrafast enzymes: Isotopes more powerful than previously thought. Phys.org, 2023 (research news).
- * Novak P et al. In Vitro Anticancer Activity of the Light Stable Zinc Isotope (64Zn) Compounds. Anticancer Research, 2022.
- Cheng Y et al. Aberrance of Zinc Metalloenzymes-Induced Human Diseases and Its Potential Mechanisms. Nutrients, 2021.
- Qu YY et al. Pan-Cancer Analysis of the Solute Carrier Family 39 Genes in Relation to Oncogenic, Immune Infiltrating, and Therapeutic Targets. Frontiers in Genetics, 2021.
- Acevedo S et al. Emerging Perspectives in Zinc Transporter Research in Prostate Cancer: An Updated Review. Nutrients, 2024.
- Ekinci İB et al. Ionophore Toxicity in Animals: A Review of Clinical and Molecular Aspects. International Journal of Molecular Sciences, 2023.
- Guillin O et al. Zinc Uptake by HIV-1 Viral Particles: An Isotopic Study. International Journal of Molecular Sciences, 2023.
- Jacob C et al. Control of zinc transfer between thionein, metallothionein, and zinc proteins. Proceedings of the National Academy of Sciences, 1998.
- Kimura T et al. The Functions of Metallothionein and ZIP and ZnT Transporters: An Overview and Perspective. International Journal of Molecular Sciences, 2016.
- Baltaci AK et al. Zinc Metabolism and Metallothioneins. Biological Trace Element Research, 2018.
- Krężel A et al. The Functions of Metamorphic Metallothioneins in Zinc and Copper Metabolism. International Journal of Molecular Sciences, 2017.
- Palmiter RD. Protection against zinc toxicity by metallothionein and zinc transporter 1. Proceedings of the National Academy of Sciences, 2004.
- * Temnik et al. Isotopically modified 64zinc diaspartate renders antimetastatic effect on melanoma in vitro and in vivo. Research manuscript, 2025.
- Tang W et al. Efficacy of zinc carnosine in the treatment of colorectal cancer and its potential in combination with immunotherapy in vivo. Aging, 2022.
- Hassan A et al. Ultrastructural analysis of zinc oxide nanospheres enhances anti-tumor efficacy against Hepatoma. Frontiers in Oncology, 2022.
- * Temnik M et al. Therapeutic potential of zinc 64Zn aspartate for obesity management: impact on oxidative stress, lipid metabolism, pancreas and liver in high-calorie diet model. Frontiers in Pharmacology, 2025.
- * Temnik M et al. Intravenous 64Zn-aspartate mitigates neuroinflammation and motor dysfunction in an LPS-induced Parkinson's Disease Rat Model. Journal of Neuroimmune Pharmacology, 2025.
- * Temnik M et al. Anti-inflammatory effects of 64Zn-aspartate is accompanied by cognitive improvements in rats with Aβ1-40-induced alzheimer disease. Scientific Reports, 2025.
- Costello LC et al. Zinc: The Wonder Drug for the Treatment of Carcinomas. Acta Scientific Cancer Biology, 2020.
- Wyrich M et al. Induction of metallothionein expression by supplementation of zinc induces resistance against platinum-based treatment in malignant pleural mesothelioma. Translational Cancer Research, 2023.
- Tsushima R et al. High-Dose Zinc Supplementation Therapy Does Not Improve Survival Rates in Severe Trauma Patients: A Single-Center Retrospective Observational Study. Nutrients, 2026.
- Arriaga JM et al. Metallothionein 1G and zinc sensitize human colorectal cancer cells to chemotherapy. Molecular Cancer Therapeutics, 2014.
- Hennigar SR et al. Metallothionein and Zinc Transporter Expression in Circulating Human Blood Cells as Biomarkers of Zinc Status: a Systematic Review. Advances in Nutrition, 2016.