CalepiBio's Carbon Quantum Dots (CQDs) platform distinguishes cancer cells from healthy cells—delivering chemotherapy agents and other oncology therapies where they're needed while sparing healthy tissue.
To expand the therapeutic index of cancer medicines by enabling smarter, more selective drug delivery through Carbon Quantum Dots technology.
CalepiBio's CQDs platform is the first drug carrier shown to selectively enter cancer cells via the LAT1 transporter — delivering chemotherapy agent and other cancer therapy agents where they'd be needed, while sparing healthy tissues. In preclinical models, CQDs-delivered topotecan produced complete tumor regression with a small fraction toxicity than the drug alone.
Via a 505(b)(2) pathway built on an approved drug.
Three high-mortality solid tumor indications to start.
Mechanism and efficacy independently peer-reviewed.
Most chemotherapy drugs kill cancer cells — and the healthy ones too. Patients face a brutal trade-off between efficacy and toxicity.
Standard cytotoxics damage bone marrow, GI, hair, and immune cells. Dose-limiting toxicity caps how much a drug can do.
Up to 60% of patients require dose reductions or treatment delays — compromising tumor response.
Nausea, fatigue, neuropathy, and immunosuppression drive treatment dropout and poor adherence.
Enters cancer cells via the overexpressed LAT1 transporter; healthy cells are ignored.
Loads existing aromatic chemotherapy drugs — topotecan, doxorubicin, and others.
Facile synthesis, scalable, and lower COGS than liposomal carriers.
Nontoxic in preclinical studies; chemically stable more than 90 days at room temperature.
Tumor cells overexpress the LAT1 transporter to fuel rapid growth. Healthy cells express it at far lower levels.
Engineered surface groups make CQDs look like large neutral amino acids. LAT1 actively pulls them in.
The chemotherapeutic payload is released selectively where it needs to act. Healthy tissues are spared.
CQDs exploit a metabolic vulnerability shared by virtually every solid tumor — not just one antigen.
LAT1 mRNA upregulated in cancer vs. normal tissue across 20+ tumor types tested so far.
LAT1 protein elevated at the plasma membrane in cancer — the active uptake site for CQDs.
SCLC, ovarian, cervical, gastric, breast, bladder, renal, melanoma, glioblastoma, prostate & more.
Our edge: true molecular targeting via LAT1 — not passive accumulation, like other nanoparticle carriers.
| Approach | Selectivity | Manufacturing cost |
|---|---|---|
| Free drug | Low | Low |
| Liposomal carrier | Moderate | High |
| Polymeric nanoparticle | Moderate | Moderate |
| CalepiBio CQDs | High (LAT1-mediated) | Moderate |
Topotecan is FDA-approved. By reformulating with the CQDs carrier, we leverage existing safety and efficacy data — compressing the time and capital needed to reach market. The primary goal is to match human PK/PD with the approved drug.
Reference existing topotecan data; only nanocarrier-specific tox and safety data required.
SCLC indication qualifies as a serious condition with unmet need; priority review possible (6 months vs. 10).
Early FDA alignment on CMC and clinical design de-risks the program before IND filing.
Calepi Bio is building a Carbon Quantum Dot (CQD) platform to transform the delivery of cancer therapies. Our first programs focus on improving the safety and efficacy of approved oncology drugs, providing a practical path to validate the platform. As the platform advances, it is designed to support future combination therapies and novel therapeutics, expanding the potential of targeted drug delivery for cancer treatment.
| Strategy | Lead assets | Pathway | First IND | |
|---|---|---|---|---|
| 1 | Non-covalent loading of approved chemo and targeted drugs with aromatic moieties | Validated with first product in vivo; expandable across multiple chemotherapy agents | 505(b)(2) | 2027 |
| 2 | Combination therapies built on 1st-gen drugs for synergistic efficacy | Future combination therapies | 505(b)(2) | 2029 |
| 3 | Covalent-bonded CQDs-drug new molecular entities (NMEs) | Future novel therapeutics | 505(b)(1) | 2030+ |
CAPTURE FULL VALUE ON LEAD ASSET
Develop topotecan-CQDs through Phase 1 (human PK/PD). Out-license post-Phase 1, or continue to NDA.
CO-DEVELOP 2ND-/3RD-GEN DRUGS
License combinations to oncology pharma. Upfront plus milestones plus tiered royalties.
CQDs CARRIER FOR PARTNER DRUGS
License the carrier to pharma partners with aromatic drugs. Per-program milestones and royalties — a recurring, high-margin revenue stream.
Our multidisciplinary leadership team combines decades of experience in pharmaceutical R&D, oncology, diagnostics, CMC, regulatory strategy, and commercialization. With leadership experience spanning global biopharmaceutical and medical technology companies—including Pfizer, Roche, Merck, Halozyme, and other leading organizations—we are advancing breakthrough science into transformative cancer therapies.
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