Cellular Biomedicine Group (CBMG) has seven preclinical CAR-T programs and two Phase I clinical trials using its CD19 CAR-T therapy in China, making it the only US-traded CAR-T company in this market. It has rights to the Dendristim lung cancer vaccine. In addition, it is adapting its osteoarthritis (OA) treatment ReJoin as an allogeneic product, AlloJoin, which will be developed in the US after an IND in 2017 or 2018.
Written by
Cellular Biomedicine Group |
A transpacific cell therapy company
|
Pharma & biotech |
QuickView
2 May 2017 |
Share price graph
Share details
Business description
Bull
Bear
Analysts
Cellular Biomedicine Group is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||
Cellular Biomedicine Group (CBMG) has seven preclinical CAR-T programs and two Phase I clinical trials using its CD19 CAR-T therapy in China, making it the only US-traded CAR-T company in this market. It has rights to the Dendristim lung cancer vaccine. In addition, it is adapting its osteoarthritis (OA) treatment ReJoin as an allogeneic product, AlloJoin, which will be developed in the US after an IND in 2017 or 2018.
Chinese CAR-T trials ongoing
The company has two ongoing Phase I studies using its CD19 CAR-T therapy for the treatment of diffuse large B-cell lymphoma (DLBCL) and adult acute lymphoblastic leukemia (ALL). None of the major CAR-T developers currently running trials in the US and Europe have initiated studies in China, positioning CBMG as an early entrant into the market. Data are expected for the trials in Q417.
AlloJoin: Off-the-shelf OA cell therapy
AlloJoin is a cell line derived from human adipose-derived mesenchymal progenitor cells. The company’s autologous version of these cells (ReJoin) previously showed improvement in cartilage growth (p=0.007) in patients with knee OA in an early clinical trial. CBMG is developing AlloJoin as an off-the-shelf version of this product and received a grant of $2.29m from the California Institute for Regenerative Medicine to support US development. The interim results from the Phase I trial (n=18) reported no serious adverse events and the most common adverse events were pain (77%) and swelling (52%). The trial is expected to be complete in Q317.
Chinese GMP cell production
One of the unique strengths of the company is its efficient manufacturing. It has three GMP-certified facilities in China, with significantly improved production costs compared to US facilities. CBMG estimates it can provide 10,000 doses of cells per year for the Chinese market (export of human cells from China is highly restricted). This capacity has recently attracted a partnership with GE Healthcare Life Science China to develop control processes for cell manufacturing.
Valuation: EV of $129m and financed through 2018
CBMG ended 2016 with $39m in cash, which we expect to provide a runway through the current CAR-T trials and the AlloJoin US trial. In our view, the EV of $129m is modest considering the company’s first mover advantage into the Chinese immune-oncology space and the tissue regeneration seen with ReJoin.
|
Consensus estimates
Source: Bloomberg |
|
Disclaimer
|
|
Disclaimer
|
Research: Healthcare
ReNeuron continues to prepare for its Phase III chronic stroke study (due to start in H217) and has indicated that it is making progress with the US/EU regulatory authorities. It intends to submit an IND in the US in Q217 and shortly after in the EU. ReNeuron also announced that it now plans to expand its ongoing Phase I/II retinitis pigmentosa (hRP cells) study to 20 patients in Phase II and commence a Phase II study in a new indication: cone-rod dystrophy (CRD). As a result, it will not continue development of CTX in critical limb ischaemia (CLI). We maintain our rNPV at £291m.