Ally Bridge Group, a Hong Kong-New York life science investment firm, announced it has led $140 million of investments in three new medical device companies, bringing its 18-month total to more than $500 million in private life science companies (see story). ABG's latest investments are: Imperative Care (Campbell, CA) -- $85 million; Venclose Medical (Santa Clara, CA) -- $27 million; and Mavrik Dental Systems (Tel Aviv, Israel) -- $28 million. ABG believes that each of the companies has devised a new medical instrument that will improve care in its field.

KeChow Pharma, a novel drug developer located in Shanghai Zhangjiang High-Tech Park, completed a $45 million Series C round of financing (see story). The company discovers targeted small molecule drugs for cancer that have competitive advantages over existing therapies and co-develops them with partners. KeChow will use the proceeds to support development of HL-085, a novel MAP kinase 1 inhibitor already in trials for malignant melanoma and solid tumors. The round was led by Decheng Capital, with participation from Qiming Venture Partners, Sherpa Capital and Grains Valley Venture Capital.

Cellestia Biotech of Switzerland closed a $20 million Series B financing led by FC Capital of Shanghai and PPF Group of Korea (see story). The company is developing cancer treatments that are based on inhibiting gene transcription. Cellestia plans to use the proceeds to underwrite clinical development of CB-103, a first-in-class small molecule targeted therapy. The company describes CB-103 as a highly selective protein-protein interaction inhibitor that targets an oncogene transcription factor present in specific leukemias, lymphomas and solid tumors.

Metabomed, an Israeli company developing cancer therapies based on inhibiting cancer metabolism, closed a $12.5 million financing led by Yonjin Venture, a division of Shanghai's Yonjin Group (see story). Metabomed also named its first clinical candidate, a first-in-class program that inhibits AcetylCoA Short chain Synthase 2 enzyme in cancers dependent on acetate metabolism. The company has developed a platform using computational biology, genomics and metabolomics to identify small molecule targets that stop the growth of the metabolic structure supporting the cancer. To date, Metabomed has raised $30 million.

Frontage Holdings (HK: 1521), a US-China CRO, acquired a Vancouver, Canada CRO, BRI Biopharma, which provides pre-clinical and clinical services (see story). Twenty years ago, BRI was founded by Dr. David Kwok, who remains president. Frontage said the acquisition would expand its services to Canada and the west coast of the US. Earlier this year, Frontage completed a $205 million IPO on the Hong Kong exchange, including shares sold by China CRO Tigermed, which continues to own a 51% stake in Frontage after the transaction. Financial terms of the BRI acquisition were not disclosed.

San Diego's Tracon Pharma (Nasdaq: TCON) will collaborate with 3D Medicines (Beijing) and Jiangsu Alphamab Biopharma to develop envafolimab, a PD-L1, for soft tissue sarcoma in North America (see story). Tracon will be responsible for the clinical trials and commercialization of the candidate. The company believes envafolimab, which is injected subcutaneously without the need for an adjuvant, has the potential to be a best-in-class PD-L1 inhibitor. Because PD-1 and PD-L1 candidates have shown activity in soft tissue sarcoma subtypes, including undifferentiated pleomorphic sarcoma (UPS), Tracon will begin a US envafolimab trial in UPS patients next year.

Shandong Fontacea Pharma in-licensed greater China rights to a human IgG1λ anti-human IL-17A neutralizing mAb from Janssen Biotech (see story). Further details of the candidate were not disclosed, although it is known Janssen has several interleukin mAbs in development or approved for autoimmune diseases with a focus on psoriasis diseases. Fontacea, a novel drug discovery biopharma located in the Jining Hightech Zone, is developing medicines for patients with respiratory diseases, inflammatory/autoimmune diseases and cancer. The companies did not comment on the financial details of the agreement.

Trials and Approvals

AffaMed Therapeutics, a Shanghai startup formed by C-Bridge Capital, received approval of its Clinical Trial Application in China to conduct a Phase III trial of a Samsung Bioepis biosimilar to trastuzumab (see story). Trastuzumab is a Roche drug known as Herceptin that is indicated for HER2 positive breast cancer. The biosimilar, SB3, has already been approved in the US and EU, where it is marketed as Ontruzant. AffaMed was established in February of this year to bring three Samsung Bioepis biosimilars to China. The other two are biosimilars to Lucentis and Eylea.

Everest Medicines, a US-China biopharma formed by C-Bridge, was approved to start China trials of Nefecon, a novel oral formulation of the corticosteroid budesonide aimed at treating IgA Nephropathy, a chronic autoimmune kidney disease (see story). Everest in-licensed greater China rights to Nefecon from Sweden's Calliditas Therapeutics earlier this year in a $121 million agreement. In Sweden, Calliditas has completed a successful Phase IIb trial of Nefecon in patients with inflammatory kidney disease. Everest paid $15 million upfront; the China trial approval triggers a $5 million milestone payment to Calliditas.

TransThera Biosciences, a Nanjing biotech, was granted approval to start a US trial of its novel small molecule inhibitor of phosphodiesterase 9 (PDE 9) to treat chronic heart failure (see story). The company says TT-00920 is a novel, highly potent and selective PDE9 inhibitor. By inhibiting PDE9, TransThera believes TT-00920 restores the cardio-protective mechanism that is dysfunctional in heart failure. In preclinical tests, it improved cardiac function and reversed the ventricular remodeling of heart failure. Founded in 2016, TransThera develops novel therapeutics for cancer, cardiovascular and inflammatory diseases.

InxMed (Shanghai) was approved to start a China Phase I clinical trial of its proprietary focal adhesion kinase (FAK) inhibitor in patients with locally advanced or metastatic gastric cancer (see story). Earlier this year, InxMed was given permission to start a US trial of IN10018 as a treatment for melanoma. Formed in 2018, InxMed develops combination therapies based on disease biology. So far, the company has raised "tens of millions of dollars" in a Series A funding, built R&D and clinical teams in Shanghai, Beijing, the US and Australia, and formed partnerships with well-known multinationals including Roche. 

BeiGene (Nasdaq: BGNE; HKEX: 06160), a Beijing-Boston oncology company, reported Brukinsa™ (zanubrutinib) failed to meet its primary endpoints as a treatment for Waldenström’s macroglobulinemia (WM) (see story). In a Phase III trial, Brukinsa was compared to another BTK inhibitor, Imbruvica (ibrutinib) an AbbVie-Janssen drug. BeiGene said Brukinsa was more effective than Imbruvica, especially in the Very Good Partial Response metric, but the improvement was not statistically significant. Brukinsa's safety and tolerability profile was also better than Imbruvica's, the company said. In November, Brukinsa was approved in the US to treat mantle cell lymphoma (MCL), its first approval.