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Pipeline

Novel biologic treatments made possible with plant-based production

Our RP3 platform is equipped to meet the demands of medicine. That’s why our focus lies on developing therapeutics for high-demand indications with significant unmet need.

A need for better mAb manufacturing

Monoclonal antibodies (mAbs) have expansive applications across diverse therapeutic areas, including infectious disease, oncology, and autoimmune disorders. The versatility and specificity of mAbs make them powerful tools for effective treatments, and their application dramatically increases year to year.

However, despite the therapeutic promise of mAbs, manufacturing limitations endure, including scale-up challenges with mammalian cell cultures and lengthy production timelines. Traditional mAb manufacturing also hurts the planet. High water usage and waste from unused cell culture yield environmental concerns.

We created a plant-based protein production process that has the potential to overcome the challenges of traditional
biologic manufacturing.

SCALABLE

Our easily scalable plant-growth process enables rapid adaptation to changing production requirements.

FAST

Our advanced platform has the ability to produce mAbs more rapidly than CHO-based systems. We produce high-quality good manufacturing practice (GMP) material in just 8 weeks, compared with a 4- to 6-month timeline with mammalian cells.

VERSATILE

We can easily switch between different products and programs as needed. All we need is a sequence.

SUSTAINABLE

Our vertical grow towers save on space, water, and energy consumption.

PROVEN

We harness our integrated expertise in plant expression and medicine to make plant-based biologics possible for clinical use. To date, our clinical trials have demonstrated the safety and efficacy of our plant-based materials.

A robust portfolio of mAbs and vaccines

mAbs
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Antifungal [anti-b glucan] (KB14A)
Aspergillosis & Candida
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Immuno-Oncology (KB17A)
HLA-G
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Immuno-Oncology (KB16A)
LILRB2
DISCOVERY
IND ENABLING
PHASE I
PHASE II
EBOLA Therapeutic (ZMAPP)
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Acute Flaccid Myelitis Therapeutic (KB13A)
Enterovirus D68
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Non-Hormonal Contraceptive (KB15A)
HC4 Antibody
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Vaccines
COVID-19 (KB20V)
DISCOVERY
IND ENABLING
PHASE I
PHASE II
Seasonal QIV (KB19V)
DISCOVERY
IND ENABLING
PHASE I
PHASE II
H7 Pandemic Flu (KB18V)
DISCOVERY
IND ENABLING
PHASE I
PHASE II

mAbs

ANtifungal

Our lead candidate is designed to treat aspergillosis and candidiasis—two of the world’s most common and drug-resistant fungal infections. As a novel antifungal with first-in-class potential, our mAb targets beta 1,3 glucan, a component of the fungal cell wall. It demonstrated a promising outlook with an improved safety profile and fewer side effects relative to the current standard of care.

We are currently exploring other clinical applications for our antifungal, including its potential use in prophylaxis.

IMMUNOTHERAPY

We are actively developing monoclonal antibodies that can be used in immuno-oncology settings. Our immune-focused mAbs are primarily targeting LILRB2 and HLA-G. Our initial positive in vivo data has encouraged us to expand our approach to include new I-O targets. We also leverage the rapid production capabilities of RP3 to adopt a fast-follower approach.

EBOLA THERAPEUTIC

We responded to the needs of the Ebola pandemic by producing ZMapp, a trivalent mAb cocktail. ZMapp was tested under a US IND, culminating in a randomized, controlled study containing 71 patients who received three doses of 50 mg/kg ZMapp or placebo. The Ebola pandemic ended prior to the study enrolling the necessary number of patients to achieve statistical significance, however; the safety profile of ZMapp proved promising.

The trial was pivotal in providing a clinical model for testing therapeutics in response to a pathogen outbreak. Additionally, the trial further showcased the promising potential of our RP3 platform in producing mAbs that could be promptly deployed to protect against virulent emerging infectious disease threats.

ACUTE FLACCID MYELITIS THERAPEUTIC (E228)

EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68), is an intravenous therapeutic for the treatment of acute flaccid myelitis (AFM). AFM is a rare and severe neurological disease associated with EV-D68 infection, which manifests primarily in pediatric patients. There are currently no approved treatment interventions or methods of prevention for AFM.

Currently, a Phase 1 study is planned to evaluate the safety and pharmacokinetics of EV68-228-N following intravenous administration in normal healthy adult volunteers.

NON-HORMONAL CONTRACEPTIVE (HC4 ANTIBODY)

Our lead candidate is a hormone free contraceptive mAb. This is a first-in-class contraceptive targeting CD52g in sperm. We completed a Phase I trial for its on-demand contraceptive film in eight healthy adult women, demonstrating efficacy and safety for both female participants and their male sexual partners.

Currently, we are beginning a Phase I randomized, double blind, placebo-controlled safety, and PK study, followed by a Phase 2a multicenter single blinded, PK, dose finding study. In addition, improved formulation development is in discovery stage for an optimal immediate and controlled extended-release device.

Vaccines

Our COVID and flu vaccine candidates have demonstrated the potential of RP3 to produce safe and effective prophylactic vaccines suited for future pandemic response and preparedness.

As we grow our antifungal and immunotherapy programs, we are actively seeking partnerships with industry leaders to advance our other clinical candidates.

KBio Inc is a wholly owned subsidiary of KBio Holdings Limited, a BAT Group company.

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