BlackJack3D
Offers and financing
Adlai Nortye (ANL), a Hangzhou-New Jersey-based immuno-oncology biopharmaceutical company, has completed a $97.5 million initial public offering on the NASDAQ stock exchange, comprising $57.5 million from the public offering and $40 million from a concurrent private placement (see article).). Adlai Nortye was founded in 2016 and has three candidates in clinical trials and three assets in preclinical stages. The Company’s lead drug, buparlisib, is an oral pan-PI3K inhibitor currently in a global Phase III clinical trial for the treatment of head and neck squamous cell carcinoma. Adlai Nortye’s shares were valued at $23 per ADS in the offering but are trading at $16.90, a loss of 27%.
Nanjing Triastek has closed a $20 million pre-C funding round to support the development of its 3D printing process for complex drug delivery and programmed drug release. The company’s proprietary technology, the Melt Extrusion Deposition (MED®) 3D printing process, combined with digital recipe development techniques, did it have been used to produce time-released drugs. Triastek is also developing new technologies, 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 has closed $16 million in pre-B financing to support the company’s genetically engineered stem cell products, including a lead product in trials in China for CD19-positive B-cell non-Hodgkin -Lymphoma were started. According to Qihan, QN-019a is the first IND for genetically engineered induced pluripotent stem cell-derived cell therapy approved in China. 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 that AbbVie (ABBV) will end its CD47 partnership with I-Mab and return all rights to the drug (see story). In 2020, AbbVie acquired ex-China rights to the drug, including options on two additional I-Mab candidates, in a deal worth up to $2 billion. I-Mab will retain $200 million in upfront and milestone payments to AbbVie. AbbVie said the separation was a “strategic decision,” a description that was not explained, although the company recently ended several partnerships. A year ago, AbbVie reduced the size of the I-Med partnership and stopped 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 the company’s autoimmune drug telitacicept as a treatment 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, which are involved in several autoimmune diseases. RemeGen has submitted an application for telitacicept in China for the RA indication. In 2021, telitacicept was approved in China for the treatment of systemic lupus erythematosus.
Shanghai AffaMed will begin Phase III trials in China of risuteganib (luminate®), its first-in-class injectable ophthalmic intravitreal candidate for intermediate dry age-related macular degeneration (dry AMD). Luminate® is a world-class integrin regulator that regulates multiple oxidative stress response pathways, including mitochondrial dysfunction, which contributes to intermediate dry AMD. In 2021, AffaMed acquired major China rights (including manufacturing) to the candidate from South Korea’s Hanmi Pharma in a $145 million deal. AffaMed expects AM011 to be the first product to enter Phase III development in China for dry AMD.
BioCity Biopharma, headquartered in Wuxi, China, will conduct a China Phase Ib/II trial of BC3402, a mAb targeting T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3), along with the approved anti-antibodies from AstraZeneca (AZN). -PD-L1, Imfinzi (durvalumab) (see story). The study will involve patients with advanced hepatocellular carcinoma (HCC). BioCity believes BC3402 has the potential to be a best-in-class anti-TIM-3 mAb as it binds to multiple TIM-3 epitopes with higher binding affinity than similar candidates. BioCity develops differentiated therapeutics for cancer and autoimmune diseases including chronic kidney disease.
Suzhou Gracell Biotech (GRCL) reported strong results from an ongoing investigator-initiated Phase I trial of the company’s dual CAR T-cell therapy for multiple myeloma (see article). GC012F as a first-line therapy resulted in an overall response rate (ORR) of 100% and a minimal residual disease rate (MRD) of 100% in 19 transplant-eligible patients. Participants were newly diagnosed high-risk 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 Chinese Phase III trial of ASC40 in combination with bevacizumab for the treatment of 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 reduce energy supply and disrupt the membrane phospholipid composition of tumor cells. In 2019, Ascletis acquired the China rights to ASC40 from San Francisco-based 3-V Biosciences for NASH. In a phase II study, the combination resulted in an overall response rate of 65% and a complete response rate of 20% in patients with rGBM.
Elpiscience, a Shanghai and Suzhou-based oncology immunotherapy company, has administered ES009, an anti-LILRB2 monoclonal antibody, to the first patient in an Australian Phase 1 trial. LILRB2 is an inhibitory receptor expressed on the surface of myeloid cells and contributes to immunosuppression in the tumor microenvironment. ES009 binds to an epitope on human LILRB2, blocking LILRB2 from binding to multiple ligands. This reprograms myeloid cells from an anti-inflammatory phenotype to a pro-inflammatory phenotype, allowing T cells to function. The study will include patients with advanced solid tumor cancer.
Disclosure: none.
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