Technology name
Last update: Dec 2024SAFA (anti-Serum Albumin Fab Associated) platform technology
Developer(s)
Sponsor(s)
Type of technology
Fusion of a therapeutic protein with a human antibody engineered to bind albumin.
Administration route
Intravenous
Development state and regulatory approval
APB-A1 (anti-CD40L agent)
Phase I
Not provided
Description
SAFA (anti-Serum Albumin Fab-Associated) is a novel technology that modifies antiserum albumin Fab fragments to create long-acting therapeutic proteins. This modified fab can be fused with antibody fragments and/or recombinant proteins. These fused constructs, termed SAFAbodies, exhibit high affinity binding to natural serum proteins. At the cellular level, these SAFAbodies bind to neonatal Fc Receptor (FcRn) to avoid degradation. This FcRn binding mechanism results in the prolonged action of the SAFA formulation i.e., prolonged half-life and targeted site of action.
Developer(s)
AprilBio
AprilBio is a South Korean biopharmaceutical company that is based at Gangwon University, developing specialized biologics and antibody drugs for rare diseases, oncology, autoimmune and inflammatory diseases. Their focus areas include rare diseases, oncology, autoimmune and inflammatory diseases.
Technology highlight
1) Prolonged Half-Life 2) Targeted Site of Action 3) No chemical conjugated with PEG or any other polymer 4) Flexibility in choosing protein expression system 6) Less immunogenic side effects due to no/low Fc gamma receptor (FcgR) interaction.
Illustration(s)
Technology main components
1) Genetically Modified Albumin Fusion protein 2) API 3) FcRN4 4) Excipients such as fillers, antiagglutinating agents, lubricating agents, wetting agents, flavoring agents, emulsifiers, and preservatives are added based on the API.
Not provided
Safety, Efficacy and Evidence Summary
Preclinical animal studies show that the 4-week repeated dose toxicity revealed no abnormal toxicological symptoms.
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APIs compatibility profile
Therapeutic proteins such as Monoclonal Antibodies, Interleukins, CD-40, Granulocyte Colony-Stimulating Factor (G-CSF) analogues, Human Growth Hormone (HGH), IFN-β (Interferon Beta), checkpoint inhibitors, Follicle-Stimulating Hormone (FSH) analogues, and GLP-2 (Glucagon-Like Peptide-2) are targeted
Not provided
Not provided
75-90 wt%
1 single API :
Not provided
Scale-up and manufacturing prospects
Not provided
Not provided
The manufacturing process of the SAFA formulation involves the following key steps: • Generation of SL33X-API Fusion Constructs: This step is performed using polymerase chain reaction (PCR) amplification followed by cloning techniques to produce the desired constructs. • Preparation of Soluble Fab Fragments and SL33X-API Fusion Proteins: Soluble Fab fragments and fusion proteins are synthesized and purified as part of the formulation process. Note: The complete manufacturing process for the finalized product remains undisclosed.
• Differential scanning calorimeter (DSC) • Enzyme-linked immunosorbent assay (ELISA) • In vitro bioactivity assay • UV Spectrometer (Bio-Rad) • Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis (SDS-PAGE) and Western Blot analyses (using Coomassie Blue staining)
Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
No delivery device
Additional features
- Room temperature storage
- At least 1 year shelf life
- Other(s)
Drug release from the protein fragments at intercellular level
The antigen-binding fragment (Fab) of the API specifically binds to albumin, enhancing protein binding and thereby extending the API’s half-life (~19 days), volume of distribution at steady state (Vss), and systemic clearance (CL). The prolonged release mechanism involves FcRn-mediated recycling of the Fab-albumin complex at the cellular level, resulting in the slow, sustained release of the API from the complex.
SAFA injections are administered via subcutaneous route of administration using a standard 21-gauge needle or even thinner depending on the formulation characteristics.
The shelf life of the SAFA is approximately one year, with a serum stability of the SAFA-coordinated complex lasting 16 days.
Room temperature storage is possible.
Therapeutic area(s)
- Other(s) : "Male infertility, Endocrine disorders, Auto-inflammatory disease , Still's disease and Obesity"
- Oncology
- Treatment
Potential associated API(s)
- Interleukins
- Cytokines agonists
- Interleukins
- Glucagon-like peptide-1 (GLP-1) analogues (GLP-1)
- APB-R6 (TSHR analog)
- APB-R2 (FSHR analog)
- APB-A1 (anti-CD40L agent)
Use of technology
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
Weekly, Monthly
Targeted user groups
- Adults
- Older Adults
- All
Unspecified
Unspecified
Unspecified
Not provided
Interleukins
IL-18 inhibitor
Phase I
Auto-inflammatory diseases and Still's disease
Not provided
Not provided
Not provided
Cytokines agonists
Anticancerous agent
Pre-clinical
Not provided
Solid Tumors
Not provided
Not provided
Not provided
Interleukins
IL-2R inhibitor
Pre-clinical
Not provided
Autoimmune diseases
Not provided
Not provided
Not provided
Glucagon-like peptide-1 (GLP-1) analogues (GLP-1)
GLP-1R agonist (antiobesity agent)
Pre-clinical
Not provided
Obesity
Not provided
Not provided
Not provided
APB-R6 (TSHR analog)
Anterior Pituitary Hormone receptor analogues
Pre-clinical
Not provided
Endocrine Disorders
Not provided
Not provided
Not provided
APB-R2 (FSHR analog)
Anterior Pituitary Hormone Receptor analogues
Pre-clinical
Not provided
Male Infertility
Not provided
Not provided
Not provided
APB-A1 (anti-CD40L agent)
Immunosuppressants
Phase I
Autoimmune diseases, such as amyotrophic lateral sclerosis, systemic lupus erythematosus, Sjögren’s syndrome or organ transplantation
Not provided
Every 2 to 4 weeks
Not provided
Fusion protein comprising two anti-CD40L single-chain variable fragment (scFv) linked to an anti-serum albumin Fab for use in treatment of thyroid eye disease (TED)
The present disclosure relates to methods of treatment of thyroid eye disease (TED) by administering a fusion protein, such as a fusion protein as defined herein, to subjects in need thereof. The disclosure provides treatment of pathophysiological parameters of TED, including both systemic and local pathophysiological parameters, whereby the disease is efficiently treated.
WO2025114319
Compound, MoT
APRILBIO CO.; LTD H. LUNDBECK A/S
Not provided
November 27, 2044
Not yet entered in national phase, deadline for entry 28.05.2026
Recombinant fusion protein comprising an interleukin-2 mutein (IL-2m) and an antigen binding fragment (Fab) that binds to serum albumin.
Provided are recombinant fusion proteins and compositions and uses thereof, the recombinant fusion protein including an interleukin-2 mutein and an antigen-binding fragment to serum albumin. The recombinant fusion protein has the advantage of a relatively long administration cycle due to an increased in vivo half-life and can be effectively used for the treatment of various immune diseases and inflammatory neurological diseases including inflammatory bowel disease, systemic lupus erythematosus, etc., due to selective activity of the recombinant fusion protein on regulatory T cells.
WO2024084432
Compound
AprilBio Co., Ltd.
Not provided
October 19, 2043
Pending: AU, BR, CA, CN, EA, EP, IN, JP, KR, US
Recombinant fusion protein comprising a human follicle stimulating hormone (hFSH) and an antigen binding fragment (Fab) that binds to serum albumin.
The present application relates to a fusion protein including a follicle stimulating hormone and an antigen-binding fragment to serum albumin and a use thereof. Accordingly, a recombinant fusion protein, which includes an antigen-binding fragment that binds to serum albumin and a human follicle stimulating hormone linked to the antigen-binding fragment, and a long-acting human follicle stimulating hormone formulation including the recombinant fusion protein as an active ingredient are provided.
WO2024075050
Compound
AprilBio Co., Ltd.
Not provided
October 4, 2043
Pending: AU, BR, CA, CN, EA, EP, IN, JP, KR, US
Recombinant fusion protein comprising an interleukin- 18-binding protein (IL-18BP) and an antigen binding fragment (Fab) against serum albumin.
Provided are recombinant fusion proteins comprising an interleukin- 18-binding protein and an antigen binding fragment against serum albumin and uses thereof. The recombinant fusion proteins have an improved administration cycle due to an increase in the half-life in the body. Further, the recombinant fusion proteins have low immunogenicity and do not cause side effects in vivo, and therefore, can be effectively used for the treatment of various cancers and immune diseases and conditions.
WO2022070112
Compound
AprilBio Co., Ltd.
Not provided
September 29, 2041
Pending: AU, BR, CA, CN, EA, EP, IN, JP, KR, US
Recombinant protein comprising feline granulocyte colony-stimulating factor (fGCSF) and an antigen binding fragment (Fab) against serum albumin.
The present disclosure relates to recombinant proteins comprising a feline granulocyte colony-stimulating factor and an antigen binding fragment that binds to serum albumin, nucleic acid molecules encoding the recombinant proteins, vectors, cells, and uses thereof. Provided are compositions for treating feline panleukopenia.
WO2021205401
Compound
AprilBio Co., Ltd.
Not provided
April 9, 2041
Pending: EP, US
Multispecific antibody wherein the antigen binding fragment (Fab) is a serum albumin Fab
The present disclosure provides multispecific antibodies having increased in vivo sustainability, the multispecific antibodies comprising one or more bioactive effector moieties (anti-CD40 mentioned) linked to either or both of an N-terminal and a C-terminal of an antigen binding fragment Fab that binds to human serum albumin.
WO2021149015
Compound
AprilBio Co., Ltd.
Not provided
January 23, 2041
Granted: EA (AM, AZ, BY, KG, KZ, RU, TJ, TM), US Pending: AE, AU, BH, CA, CL, CN, CO, CR, DO, DZ, EC, EG, EP, GE, GT, HN, ID, IL, IR, JO, JP, KR, KW, MX, MY, NI, NZ, PA, PH, QA, SA, SG, SV, TH, UA, ZA Not in force: BR, MA, ME, TN
Antigen binding fragment (Fab) to a serum albumin (SA), and fusion construct of an antigen binding fragment (Fab) and a bioactive effector moiety
The present invention relates to antigen-binding fragment (Fab) and a Fab-effector fusion protein or (poly)peptide comprising thereof. The Fab of the present invention specifically binds to serum albumin and thereby has extended in vivo half-life. The Fab of the present invention is characterized by not having cysteine residues that are responsible for the interchain disulfide bond in CH1 domain and CκL domain as well. The Fab-effector fusion protein or (poly)peptide of the present invention can be produced in periplasm of E. coli with high yield, and has increased in vivo half-life. Further, the present invention provides E. coli strain which produces various kinds of Fab-effector fusion proteins or (poly)peptides, pharmaceutical composition comprising the fab-effector fusion proteins.
WO2015030539
Compound
Aprilbio Co Ltd
Not provided
August 29, 2034
Granted: AU, CA, CN, CO, EP (BE, CH, DE, DK, ES, FR, GB, IE, IT, LI, LU, NL, PL, TR), IN, JP, KR, MX, PH, RU, UA, US Pending: BR, VN, HK, TH
