Week In Review: Abbisko Out-Licenses Rights To Precision NSCLC Medicine For $188 Million

Deals and Financings

Shanghai Abbisko Therapeutics (HK: 02256) out-licensed Greater China rights to a pre-clinical EGFR-TKI candidate for NSCLC to Shanghai Allist Pharma (SHA: 688578) in a $188 million agreement. ABK3376 is a third-gen EGFR targeting drug designed to inhibit L858R activating mutation or exon 19 deletion mutation with acquired C797S mutation. Because the candidate can cross the blood-brain barrier, it is also expected to be effective against brain metastases. Allist is already commercializing Abbisko’s furmonertinib, an approved NSCLC drug in China. Allist also has a time-limited option for worldwide expansion of territorial rights for ABK3376.

Immorna, a Hangzhou company developing novel RNA therapeutic and vaccine candidates, raised $100 million in a Series A+/A++ funding to support clinical development of its portfolio. Founded in 2019, the company has built multiple RNA platforms for conventional, self-replicating and circular RNA technologies. With its advanced screening tools, Immorna has developed several RNA delivery vehicles. Immorna has a total of 11 RNA candidates that target indications in cancer immunotherapy, infectious diseases, rare genetic diseases and cosmology. The company has approval to start three clinical trials for two assets in the US.

Shenzhen’s Chipscreen Bio (SHA: 688321) acquired greater China rights to a bispecific immunotherapy from Eucure (Beijing) Biopharma, a subsidiary of Biocytogen (HK: 02315), in a $72 million agreement. YH008 is designed to activate the immune pathway in the tumor microenvironment. It is engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated immune activation outside the area. Biocytogen will receive $6 million upfront and up to $66 million in milestones, plus royalties on sales. YH008 is approved to start trials in China and the US.

Shanghai Oricell Therapeutics closed a $45 million B1 investment round to develop its portfolio of cellular immunotherapies, particularly in the US. In July 2022, the company completed a $120 million B round. Oricell plans to take OriCAR-017, a GPRC5D CAR-T therapeutic that treats relapsed and refractory multiple myeloma, to the US as the lead drug in its US expansion. The candidate is in IND enabling studies in the US and China. The B1 round was led by RTW Investments and Qatar Investment Authority, with participation from existing investors Qiming Venture Partners and C&D Emerging Industry Equity Investment.

Suzhou TandemAI, a drug discovery company, closed a $35 million Series A round to expand its platform that integrates breakthrough computational tools with wet lab biophysics, medicinal chemistry and biology. Established in 2021, TandemAI was formed with the goal of lowering the barrier to entry for drug discovery’s most advanced tools, including physics-based molecular simulation, AI and access to high-performance computing infrastructure. The company completed a $25 million Seed and pre-Series A financing in late 2021. Qiming Venture Partners led the financing, along with participation from OrbiMed, Eight Roads Ventures and F Prime Capital.

Chengdu Kelun Biotech, a subsidiary of Sichuan Kelun Pharma, will stage an IPO on the Hong Kong Exchange. Kelun develops novel biologics - especially ADCs - and small molecule drugs for oncology, autoimmune, inflammatory and metabolic indications. In 2022, Kelun out-licensed ex-China rights for some of its products to Merck (MRK)/MSD in three separate agreements with a value of up to $12 billion, a record amount. Using its proprietary platforms, Kelun Bio has built a portfolio of 33 novel candidates, including 13 assets in clinical trials. It has filed a China NDA for its anti-PD-L1 candidate as a nasopharyngeal cancer therapy.

Trials and Approvals

Shanghai Junshi Biosciences (OTCPK:SHJBF, HK: 1877; SHA: 688180) reported its anti-PCSK9 mAb met the primary Phase III endpoints in two trials that enrolled patients with primary hypercholesterolemia and mixed hyperlipidemia (see story). Dyslipidemia, the increase of low-density lipoprotein cholesterol (LDL-C), is the most important risk factor for atherosclerotic cardiovascular diseases. PCSK9 inhibitors, a new class of lipid-lowering drugs, are recommended in China and overseas guidelines for the condition. There are two imported ant-PCSK9 mAbs approved for China use - Amgen’s (AMGN) Repatha and Sanofi (SNY) and Regeneron’s (REGN) Praluent - but no domestic versions.

Shanghai’s JW Therapeutics (OTCPK:JWCTF, HK: 2126) started China trials of an autologous T-cell immunotherapy candidate that targets GPC-3 in patients with advanced hepatocellular carcinoma (see story). JWATM214 combines the high affinity and specificity of the GPC-3 mAb with added cJun protein regulation to delay T cell exhaustion. JW expects the candidate, which incorporates Eureka ARTEMIS platform for better CAR-T drugs and Lyell's T cell anti-exhaustion technology, to have a more durable response with better anti-tumor activity than the competition. JW was originally formed as a JV between Seattle's Juno Therapeutics, a cell therapy biotech, and WuXi AppTec (OTCPK:WUXIF, OTCPK:WUXAY), a China CRDMO.

Suzhou Transcenta (HK: 06628) published study results from its CLDN18.2-targeting Immuno-PET probe for non-invasive imaging in gastrointestinal tumors in the Journal of Pharmaceutical Analysis. Because CLDN18.2 expression level is correlated with drug efficacy, the level is critical for using CLDN18.2-targeted therapies. Currently, the main detection tool for CLDN18.2 protein expression is immunohistochemistry, which is invasive and requires an endoscopic biopsy. Transcenta is developing Osemitamab, a high-affinity anti-CLDN18.2 monoclonal antibody, in eight Phase I and II trials in China and the US for oncology indications.

Jiangsu Atom Bioscience reported positive results from its China Phase IIa clinical trial of the company’s lead candidate, ABP-671, a treatment for gout. ABP-671 is a small-molecule candidate that inhibits the urate transporter 1 (URAT1) protein. By reducing the reabsorption of uric acid in the kidneys, ABP-671 increases the excretion of uric acid. Atom says ABP-671 is more potent and significantly less toxic than existing drugs. The company plans to start China Phase III trials in 2023. Atom Bioscience develops small-molecule therapeutics that treat inflammatory and metabolic diseases.

Disclosure: None.

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