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Our R&D team is developing biologically-active bone grafts that contain an osteoinductive factor (OIF), a bone-forming protein similar to rhBMP-2. The OIF expressed in E.coli and purified is produced using our GMP certified process.
The biocompatible β-tricalcium phosphate (β-TCP) is an ideal osteoconductive carrier for the OIF. The OIF/TCP bone graft can work in a wide array of applications, including spinal fusion, fracture fixation, and oral and maxillofacial surgery, and other surgical procedures that require bone grafting.
The osteoinductive bone graft has demonstrated its clinical efficacy equivalent to the autograft. BioGend is excited to offer in future the OIF/TCP bone graft matching to the autograft gold standard at an affordable cost.
There are two formulations under development.
BiG-001 OIF/ß-TCP (in granular form)
Indication: open tibial fracture, non-union
BiG-006 OIF/ß-TCP (in block form) in combination with cage
Indication: lumbar interbody fusion
BiG-001, a combination product of OIF and β-TCP granules, is designed to treat a tibial fracture. BiG-006 uses the TCP block as a carrier for the OIF and is used with a lumbar interbody cage to achieve spinal fusion. The β-TCP, a good bone void filler, is porous, bioresorbable, and osteoconductive.
During surgery, the freeze-dried OIF protein is reconstituted in a sterile buffer solution and drip soaked into the porous TCP scaffold before being applied to the fracture site or combined with an interbody cage for lumbar spinal fusion.
The clinical efficacy and the safety of these two osteoinductive bone grafts have been demonstrated in the rabbit tibial fracture fixation model and the sheep spinal fusion model. The OIF stimulated the formation of new bone accelerating fracture healing and bone fusion. The human clinical trials to verify the safety and efficacy of BiG-001 and BiG-006 is underway.
- Good safety profile and biocompatibility
- Global right
- GMP-grade OIF. High-quality
- ß-TCP is commercially available in Taiwan, US, Europe and China
- The clinical trial for the treatment of open tibial fracture was approved by the USFDA in 2021Q1 and Taiwan FDA in 2021Q2.
- The phase II trial for long bone non-union had finished patient enrollment in Japan (conducted by affiliated company in Japan).
- Submission for an Investigational Device Exemption (IDE) application to the USFDA for a lumbar spinal fusion trial is planned in Q1 2023.
Investigational New Drug (IND)
- Osteopharma (the licensor of the OIF) was granted to conduct a nonunion clinical study by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in 2019Q3.
-Product Preparation and Mechanism of Action-
Before bone grafting, first, the OIF solution is prepared by mixing the freeze-dried protein with a sterile buffer solution. The OIF solution and the β-TCP bioceramics material are carefully combined and left to air dry. After this, the OIF/TCP bone graft is transferred to fill the bone defect. The OIF starts slowly releasing from the bioceramics interacting with nearby bone marrow-derived mesenchymal stem cells (MSCs) and stimulating new bone formation.
Manufacturing of OIF complies with the PIC/GMP principle to ensure the consistency of high-quality products. The preclinical testing data which have demonstrated the safety and efficacy of the OIF/TCP include the following. OIF has highly potent bone regenerative capabilities.
- OIF shows a high potency in new bone regeneration capabilities.
- OIF has a short half-life and can be fast cleared from the body, lowering systemic exposure and safety concerns.
- Both OIF and TCP contain no serum of animal origin.
Iliac crest bone graft (ICBG); demineralized bone matrix (DBM); bone allografts
1. OIF showed a higher bone-forming capability at a lower dosage in an animal study compared to the name brand BMP-2 bone graft.
2. The GMP manufacturing process ensures OIF quality consistency from batch to batch as compared to DBM and other allograft bone.
3. OIF has no concern about disease transmission, unlike allografts. Synthetic TCP scaffold completely eliminates the concern of bovine spongiform encephalopathy (BSE) associated with bovine collagen materials. The OIF/TCP bone graft alleviates pain and additional surgical cost when harvesting the autologous bone.