Event
At the ASCO conference held in early June, a recent analysis of data further supported the development of multiple Selinexor combination therapies in China, while the company announced the completion of the first patient administration of the phase I/II clinical trial of Eltanexor for patients with MDS who had failed to treat demethylation drugs.
In May, the company signed a global licensing agreement with Calithera for the development of CB-708, a small molecule inhibitor of CD73. Calithera will receive a down payment and milestone payments based on development, registration and sales progress, and will be eligible for tiered royalties in the sales revenue of the licensed products. The toxicological study of GLP (quality Management Standard for non-Clinical Research of drugs) for CB-708 has been completed.
Comment
Selinexor is the world's first approved SINE drug targeting XPO1 targets. SINE drugs are a kind of small molecular drugs that target nuclear export proteins and inhibit their transport function. Selinexor targeting XPO1 can inhibit the enucleation of tumor inhibitory factors such as p53, promote its accumulation in the nucleus, and induce apoptosis of cancer cells, thus giving play to the anti-tumor effect, which is a new anti-tumor mechanism. Selinexor introduced products for the company, currently used in the treatment of MM, DLBCL has been approved in the United States; domestic for these two indications have been submitted to NDA, is expected to be approved to market in 2022, is the first domestic SINE drug. Four treatments have been included in the latest CSCO guidelines and are expected to be extended to other indications in the future.
ATG-037 is a small molecular inhibitor of oral CD73, which can inhibit CD73 at the skin molar level and reduce the production of adenosine in the tumor microenvironment, thus enhancing the anti-tumor activity of T cells and naturally killing NK cells, which is expected to provide a new therapy for tumor therapy. Compared with CD73 antibodies and other small molecular inhibitors, ATG-037 showed stronger activity and could completely inhibit CD73.
ATG-037 showed a positive correlation between dose and activity in vitro model, and no "hook effect" was observed. It showed a large therapeutic window in the toxicological study of GLP, and no obvious side effects were observed. The company is expected to start clinical research on the drug between the end of this year and early next year.
The layout of global rights and interests or independent R & D pipeline is rich, and the products cover large and small molecular drugs. ATG-017 (small molecule inhibitor of ERK1/2), which has a global interest, is progressing smoothly in the first phase of the clinical trial in Australia. The differential ATG-101 (PD-L1/4-BB double antibody) is expected to enter the clinic in the middle of the year. ATG-018 (ATR small molecule inhibitor) and ATG-037 (CD73 small molecule inhibitor) are expected to enter the clinic at the end of this year or early next year. At present, most of the other self-developed products are in the stage of preclinical research and development, with small molecular drug targets including KRAS and macromolecular drug targets including Claudin 18.2. with rich pipeline layout and great potential for combination.
Profit forecast and investment suggestion
It is estimated that the company's revenue from 2021-2023 will be about 0.28 USD 0.59 USD 0.88 million. Due to the smooth progress of SINE drug research and development and the introduction of ATG-037, we have upgraded to a "buy" rating with a target price of HK $24.
Risk hint
The progress of R & D project, clinical and commercial expansion are not up to expectations, and the progress of product approval is not up to expectations.