Recent Articles in Trials & Approvals

Suzhou Gracell Biotech posted strong results from an ongoing Phase I investigator-initiated trial of the company’s dual targeting CAR-T cell therapy for multiple myeloma. GC012F produced a 100% overall response rate (ORR) and a 100% minimal residual disease (MRD) rate as a first-line therapy in 19 transplant-eligible patients. The enrollees were high-risk, newly diagnosed multiple myeloma (NDMM) patients. GC012F, Gracell’s lead drug, is a dual CD19 and B-cell maturation antigen (BCMA) candidate that also benefits from the company’s autologous FasTCAR technology, which requires only 24 hours of manufacturing time. More details....

Stock Symbol: (NSDQ: GRCL)

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Hangzhou Ascletis Pharma has enrolled the first 120 patients in the China Phase III trial of ASC40 combined with bevacizumab to treat recurrent glioblastoma. ASC40 is an oral, selective small molecule inhibitor of fatty acid synthase, an enzyme that regulates de novo lipogenesis. ASC40 is expected to decrease energy supply and disturb the membrane phospholipid composition of tumor cells. In 2019, Ascletis acquired China rights to ASC40 from San Francisco's 3-V Biosciences for NASH. In a Phase II trial, the combination produced an overall response rate of 65% with a 20% complete response rate in patients with rGBM. More details....

Stock Symbol: (HK: 1672)

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Elpiscience, a Shanghai-Suzhou oncology immunotherapy company, has dosed the first patient in an Australian Phase trial of ES009, an anti-LILRB2 monoclonal antibody. LILRB2 is an inhibitory receptor expressed on the surface of myeloid cells that contributes to immune suppression in the tumor microenvironment. ES009 binds to an epitope on human LILRB2, blocking LILRB2 binding to multiple ligands. This reprograms myeloid cells from an anti-inflammatory phenotype into a pro-inflammatory phenotype, allowing T cells to function. The trial is enrolling patients with advanced solid tumor cancers. More details....

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Shanghai Asieris Pharma reported positive Phase III results from its photodynamic drug-device combination product as a non-surgical therapy for cervical high-grade squamous intraepithelial lesions (HSIL). APL-1702 (Cevira®) is a drug-containing device with a photosensitizer that activates the active ingredients via a specific wavelength of light. APL-1702 could become the first non-vaccine product approved globally to treat cervical HSIL. Asieris, which focuses on novel treatments for genitourinary tumors, in-licensed global rights to Cevira® from Photocure of Oslo in an agreement worth up to $73 million. More details.... 

Stock Symbols: (SHA: 688176) (OSE: PHO)

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Shanghai AffaMed Therapeutics has treated the first patient in a China Phase III registrational study that will test the efficacy and safety of Dextenza as a therapy for ocular inflammation and pain following ophthalmic surgery. Dextenza is an 0.4 mg dexamethasone ophthalmic insert. In 2020, AffaMed acquired China rights to Dextenza from Ocular Therapeutix, a Bedford MA company, in a two-drug, $103 million deal. Dextenza is already approved for use in the US following cataract surgery. AffaMed in-licenses China/Asian rights to novel products for ophthalmologic, neurological and psychiatric disorders. More details....

Stock Symbol: (NSDQ: OCUL)

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