Drug Delivery & Formulation

The Drug Delivery, Reformulation and Repurpose (D2-R2) program uses the 505(b)(2) pathway to develop improved medicines in niche markets where commercial gaps or clinical opportunities exist. Our in-house formulation experts customize the core delivery technologies to satisfy the unmet medical needs. Drug repurposing is another strategy for clinical development of our product candidates either independently or in collaboration with pharma partners to expand our product pipeline.

FOCUS AREA 1: Bone Marrow Drug Delivery

Zymeron developed a peptide-based drug delivery platform that shows rapid and efficient delivery of a broad range of small molecules to the bone marrow. This targeted delivery and stimuli-triggered release technology improved the drug availability by many folds compared to systemic administration e.g. iv injection. The platform is a plug and play system enabling rapid and flexible incorporation of any new molecules; in addition, the release of drug payload to the marrow microenvironment can be regulated to achieve desired drug concentration and duration of effect.

Bone marrow is the primary hematopoietic organ, which is involved in multiple malignant diseases including acute and chronic leukemia, multiple myeloma, myelodysplastic syndromes, and bone metastases from solid tumors. On the other hand, high dose and frequency of chemotherapeutics lead to severe side effects including myelosuppression or myelotoxicity, which is often the dose-limiting factor for cancer treatment.

Zymeron is actively seeking collaborators and joint pharma or biotech partners to expand the bone marrow drug delivery pipeline with new or existing molecules.

Success 1 – Molecularly Targeted Therapy to Treat Myelotoxicity. 

Myelotoxicity is a very common treatment-related adverse effect for patients receiving systemic chemotherapy, and patients receiving radiotherapy directed to body regions rich in bone marrow and hematopoiesis activity. Myelotoxicity is the most common dose-limiting toxicity in cancer treatment with cytotoxic agents, and often leads to dose reduction, dose delay or discontinuation of treatment, limiting the therapeutic effect.

Zymeron develops prophylactic drug for the prevention of radiotherapy-induced myelosuppression, chemotherapy-induced myelosuppression, and hematopoietic acute radiation syndrome (ARS). The drug provides broad spectrum protection for multi-lineages of the hematopoietic stem cells to prevent neutropenia, anemia and thrombocytopenia. Radiation-induced myelosuppression and chemotherapy-induced myelosuppression represent multi-billion dollar markets; however current healthcare solutions are for post-treatment management and there is no cancer-agnostic preventive medicine that protects the hematopoietic stem cells from chemo or radio-toxicity and maximizes cancer treatment efficiency and eliminates or reduces their toxicity to bone marrow.

Focus Area 2: Long Acting Drug Implants

Zymeron develops long-lasting implant technology that is capable of sustaining the release of small molecule drugs from two weeks to twelve months. The implants have precisely engineered shell thickness, pore size and pore volume that modulate the release kinetics of the active molecules from the drug core. The subdermal implants are physiological depots loaded with new or existing small molecule therapeutics to offer sustained effects to patients. The biggest advantages of long-releasing drug implants over oral or parenteral drugs include improved medication adherence, circumventing first-pass inactivation by the liver, reducing GI tract irritation, providing steady absorption and constant drug levels in circulation, lowering adverse effects via avoiding high plasma drug levels, and reduced logistic burdens for travelers and field workers. Current long-lasting implant programs include: preventive malaria therapeutics to control the spreading of infectious agents at the point of mosquito-to-human transmission. Our unique implant device has the following advantages and benefits.

  • Reservoir-based, slow release implants
  • Pre-programmed drug release rates (duration of release)
  • Zero-order, constant release rates help reach steady states rapidly
  • Bioresorbable implant materials
  • Injected through syringe needles or inserted via an incision
  • Active drug loading greater than 90% permitting higher drug dose and longer duration of effect
  • Compatible with hydrophobic and hydrophilic drugs
  • Cylinder-shaped, matchstick-sized solid implants

Cumulative Drug Release

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Daily Drug Release

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Focus Area 3: Adjuvant-Vaccine Platform

Zymeron develops a revolutionary immunogen-adjuvant codelivery platform to bring next generation capability to prevent and control viral infections and to deliver a step-change in vaccine performance. Our vaccine product development efforts target primarily acquired immunodeficiency disorders. The adjuvanted nanoparticle delivery technology is a plug and paly system ready to incorporate any recombinant protein expressed with common tags. The one step preparation of the final vaccine formulation from a qualified recombinant antigen accelerates the preclinical development process, save time and reduce costs.

  • Nanoparticle delivery of molecular adjuvants
  • Nanoparticle-based biomimetic antigen display
  • Staged immunogen-adjuvant release technology

Zymeron’s internal vaccine program includes adjuvanted gp140 trimer nanoparticles for HIV vaccine. Zymeron seeks collaborators to build upon the adjuvanted nanoparticle system and develop better antigen vaccines.