Week In Review: Novartis In $1 Billion Deal For DTx Pharma

Deals and Financings

Novartis (NVS) signed a $1 billion agreement to acquire DTx Pharma, a preclinical San-Diego company developing siRNA therapies for neuroscience indications (see story). DTx was invested and incubated by Viva BioInnovator, a San Diego-China CRO/incubator that develops biotech start-ups in China and the US. The incubator is an arm of Shanghai’s Viva Biotech (OTCPK:VBIZF), which offers full-service CRO/CDMO services. DTx’s lead program is a preclinical siRNA aimed at Charcot-Marie-Tooth Disease Type 1A (CMT1A). DTx Pharma shareholders will receive $500 million upfront and up to $500 million in milestones.

Sichuan Kelun-Biotech (HK: 6990) completed a $174 million IPO on the Hong Kong Exchange last week, pricing the offering at HK$66 per share, the middle of the proposed range. The IPO valued the company at $775 million. In 2022, Kelun-Bio made a name for itself by signing three ADC deals with Merck (MRK) with total worth up to $12 billion, a record amount. The company develops novel biologics – it claims long-standing expertise in ADCs – along with small molecule drugs for oncology, autoimmune, inflammatory and metabolic indications. Kelun-Bio is a subsidiary of Sichuan Kelun Pharma.

Zhuhai Biotheus formed a far-reaching research/license collaboration with BioNTech SE (BNTX), the German COVID mRNA vaccine company that is now developing novel therapies for cancer and other diseases (see story). Biotheus will grant BioNTech global options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody for cancer indications. The company will also grant BioNTech licenses to existing panels of VHH binders for multiple targets and options for new VHH binders against BioNTech chosen targets. In exchange, BioNTech will make an upfront payment and, following option exercise, Biotheus will be eligible for milestones and single digit royalties.

CASI Pharmaceuticals (CASI), a China in-licensing company with operations in Beijing and Maryland, has acquired global rights to a novel VCP/p97 inhibitor from Cleave Therapeutics (see story). CB-5339, which has completed a US Phase I trial in acute myeloid leukemia and myelodysplastic patients, is an oral small molecule valosin-containing protein (VCP)/p97 inhibitor, designed to disrupt protein homeostasis, DNA damage response and other cellular stress pathways. CASI will assume all responsibility for Cleave’s US IND for CB-5339 along with global intellectual property rights. Cleave also announced it is selling its preclinical assets to Eikon Therapeutics.

Suzhou GeneQuantum granted a non-exclusive license for its novel bioconjugation technology to InxMed, a Shanghai clinical-stage biotech. InxMed will have use of Gene-Quantum’s technologies in site-specific glycan conjugation, stable linker small molecule technology and intelligent continuous conjugation production. GeneQuantum will receive an upfront payment plus it will be eligible for milestone payments and royalties on sales. Established in 2018, InxMed develops innovative therapies targeting the stroma microenvironment along with solid tumor resistance and metastasis, especially resistance to PD-1/PD-L1 drugs. Specific details of the agreement were not disclosed.

Trials and Approvals

Shanghai Fosun Kite Biotechnology was approved to launch Yikaida®, its CAR-T product, as a second-line therapy in China for adult large B-cell lymphoma (r/r LBCL). Patients must have failed first-line immunochemotherapy or relapsed within 12 months. Previously, Yikaida, the first CAR-T product available in China as a second-line rr/LBCL therapy, was approved as a third-line treatment. In 2017, Fosun formed a JV with LA’s Kite Pharma to develop Kite’s CAR-T immuno-oncology drug for China in a $95 million agreement that included $20 million for China development costs.

Nanjing Triastek reported its first-in-human trial of a 3D printed oral medication for ulcerative colitis met its goal of delivering the medication only to its intended target, the colon. Triastek encased the active drug with a shell to prevent premature delivery, and then it added a time-release mechanism to the active drug, extending its treatment. The US trial enrolled patients with moderate to severe ulcerative colitis (UC). Triastek believes T21 may avoid the safety issues of previous oral medications, which release some active ingredient early in the gastrointestinal tract.

Hangzhou HighField Biopharma, a clinical-stage immuno-oncology company employing immunoliposomes to treat cancer, has launched a China Phase Ib/II trial of HF1K16 for recurrent and refractory glioma. HF1K16 is a drug encapsulated immune-modulating liposome containing all-trans retinoic acid (ATRA), a small molecule metabolite of vitamin A. HighField develops next-gen drug-encapsulated immune-modulating liposomes and cancer-targeted immunoliposomes that promise to be less toxic and more effective than existing immune-oncology drugs. The liposome constructs are also more efficient, potentially lowering costs, the company says.

Shanghai Antengene (HK: 6995) has dosed the first patient in a US Phase I combination trial of its small molecule ERK1/2 inhibitor (ATG-017) and nivolumab, a Bristol Myers Squibb (BMY) PD-1 inhibitor marketed as Opdivo. The trial will enroll patients with advanced solid tumors. ATG-017 is an oral selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor. In preclinical studies, Antengene found that combining its ERK1/2 inhibitor with an immune checkpoint inhibitor produced improved efficacy in preclinical ICI-resistant in vivo murine models.

Hangzhou Qihan Biotech has been approved to start China trials of QN-019a for CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma, the first IND approved in China for a gene-edited iPSC-derived cell therapy. Qihan uses multiplexable genome editing technology to modify human Induced Pluripotent Stem Cells (iPSCs) and differentiate them into a natural killer (NK) cell therapy product that targets CD19-positive B-cell lymphoma. Qihan uses its multiplexable genome editing technologies to create cell therapies and advance organ transplantation. Its goal is to deliver off-the-shelf cell therapies with long-term efficacy.

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