BlackJack3D
Deals and Financings
Adlai Nortye (ANL), a Hangzhou-New Jersey immunoncology biopharma, completed a $97.5 million IPO on the NASDAQ exchange, consisting of $57.5 million from the public offering and $40 million in a concurrent private placement (see story). Founded in 2016, Adlai Nortye has three candidates in clinical trials and three pre-clinical stage assets. The company’s lead drug, buparlisib, is an oral pan-PI3K inhibitor currently in a global Phase III clinical trial for head and neck squamous cell carcinoma. Adlai Nortye’s shares were priced at $23 per ADS in the offering, but they are trading at $16.90, a loss of 27%.
Nanjing Triastek closed a $20 million Pre-C financing round to support development of its 3D printing process for complex drug delivery and programmed release medications. The company’s proprietary technology, the Melt Extrusion Deposition (MED®) 3D printing process, combined with digital formulation development techniques, have been put to use to create timed release drugs. Triastek is also developing new technology including Semi-Solid Extrusion, Micro-Injection Molding, and Micro-Droplet Jetting to deliver and develop oral peptides, gastric retention and high potency products. The round was led by Guoxin Investment.
Hangzhou Qihan Biotech closed a $16 million pre-B funding to support the company’s gene-edited stem cell products, including a lead product that has started China trials for CD19-positive B-cell non-Hodgkin lymphoma. Qihan says QN-019a is the first IND approved in China for a gene-edited Induced Pluripotent Stem Cells-derived cell therapy. The company uses multiplexable genome editing technology to modify iPSCs and differentiate them into a natural killer cell therapy product. The pre-B round was led by Zhejiang Industrial Fund. In 2021, Qihan raised $67 million in an A+ round.
Shanghai’s I-Mab (IMAB) announced AbbVie (ABBV) will end its CD47 partnership with I-Mab, returning all rights for the drug (see story). In 2020, AbbVie acquired ex-China rights to the drug in a deal worth up to $2 billion, including options on two other I-Mab candidates. I-Mab will keep $200 million in AbbVie upfront and milestone payments. AbbVie said the breakup was a “strategic decision,” a description that wasn’t explained, though the company has ended several partnerships recently. One year ago, AbbVie reduced the scope of the I-Med partnership, stopping two Phase Ib trials of lemzoparlimab.
Trials and Approvals
Yantai RemeGen (OTCPK:REGMF, HK: 9995, SHA: 688331) reported positive results from a Phase III trial of Telitacicept, the company’s autoimmune drug, as a therapy for rheumatoid arthritis (see story). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-cell lymphocyte stimulator and a proliferation inducing ligand (APRIL). The combination has been shown to reduce B-cell mediated autoimmune responses implicated in several autoimmune diseases. RemeGen has filed a Telitacicept NDA in China for the RA indication. In 2021, Telitacicept was approved in China to treat systemic lupus erythematosus.
Shanghai AffaMed will begin China Phase III trials of Risuteganib (luminate®), its first-in-class injectable ophthalmic intravitreal candidate for intermediate dry age-related macular degeneration (Dry AMD). Luminate® is a first-in-class integrin regulator that regulates multiple pathways of oxidative stress response, including mitochondrial dysfunction, which contributes to intermediate Dry AMD. In 2021, AffaMed acquired greater China rights (including manufacturing) to the candidate from South Korea’s Hanmi Pharma in a $145 million agreement. AffaMed believes AM011 will be the first product in China to start Phase III development for Dry AMD.
BioCity Biopharma, headquartered in Wuxi, China, will conduct a China Phase Ib/II trial of its BC3402, a mAb targeting the T cell immunoglobulin and mucin domain-containing protein 3 (TIM-3), together with AstraZeneca’s (AZN) approved anti-PD-L1, Imfinzi (durvalumab) (see story). The trial will enroll patients with advanced hepatocellular carcinoma (HCC). BioCity believes BC3402 has the potential to be a best-in-class anti-TIM-3 mAb because it binds to multiple TIM-3 epitopes with a higher binding affinity than similar candidates. BioCity develops differentiated therapeutics for cancer and autoimmune disorders including chronic kidney diseases.
Suzhou Gracell Biotech (GRCL) posted strong results from an ongoing Phase I investigator-initiated trial of the company’s dual targeting CAR-T cell therapy for multiple myeloma (see story). 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.
Hangzhou Ascletis Pharma (OTCPK:ASCLF, HK: 1672) has enrolled the first 120 patients in the China Phase III trial of ASC40 combined with bevacizumab to treat recurrent glioblastoma (see story). 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.
Elpiscience, a Shanghai-Suzhou oncology immunotherapy company, has dosed the first patient in an Australian Phase 1 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.
Disclosure: none.
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