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Deals and Financings
Shanghai Abbisko Therapeutics has sold greater China commercialization rights for pimicotinib, a small molecule CSF-1R inhibitor, to Germany’s Merck (OTCPK:MKGAF) in a $605 million deal, including $70 million upfront (see story). Abbisko is currently conducting a global Phase III trial of pimicotinib in patients with tenosynovial giant cell tumor (TGCT), a benign tumor that can provoke painful joint swelling and stiffness. Merck will pay an additional upfront fee if it decides to exercise an option for global rights to pimicotinib. Merck also has the option to co-progress pimicotinib in additional indications.
Xtalpi, a China-US AI drug discovery company, has filed for a Hong Kong IPO. The company’s quantum physics-based, AI-powered, and robotics-driven platform offers a complete suite of services for companies seeking small molecule or biologics discovery. Xtalpi claims to be the largest AI discovery company based on funds raised: since its 2015 start, it has raised $780 million in venture capital, including a $400 million Series D round in 2021 that valued the company at $2 billion. Boston is the company’s headquarters for BD, though its discovery operations are in Shenzhen, Shanghai and Beijing.
Aspen Pharmacare (OTCPK:APNHF) of South Africa will extend its China operations by acquiring Sandoz’s (OTC:SDZNY) China business for $100 million plus $20 million in revenue milestones for the portfolio (see story). In return, Aspen will sell European rights to four anesthetic products to Sandoz for $60 million plus $10 million if sales face targets. After the agreement closes, Aspen will have rights to Sandostatin, Aclasta and Voriconazole plus a pipeline of products that will be available in China in the medium term. Aspen expects the China products will add $60 million to its revenues, while it will lose $15 million from its European sales.
Adcentrx Therapeutics, a San Diego-Shanghai ADC biotech, added $13 million to the Series A+ funding announced earlier this year, bringing the total to $51 million for the round. The company’s direct drug is an ADC targeting Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. ADRX-0706 is currently being tested in a US Phase Ia/b clinical trial. Adcentrx said the additional funds will extend its runway into 2025 and expedite development of the company’s portfolio. The Series A+ extension included participation from Quan Capital and Partners Investment.
AbelZeta Pharma, a Maryland-Shanghai CAR-T company, will co-progress C-CAR031 in China with AstraZeneca (AZN) (see story). C-CAR031 is an autologous, armored GPC3-targeting CAR-T therapy aimed at treating hepatocellular carcinoma (HCC). The candidate was designed by AstraZeneca and is manufactured by AbelZeta in China. AbleZeta was previously known as CBMG, but it has sold its portfolio of stem cell drugs that is now developing a portfolio of 10 CAR-T candidates. When CBMG changed its focus to CAR-T, Janssen announced a $250 million upfront deal for a CAR-T and AstraZeneca invested $120 million in the company.
Suzhou Innovent Biologics (OTCPK:IVBIY, HK: 01801) will extend its partnership with Synaffix, a Lonza company (SIX:LONN), using the company’s technology to progress at least one antibody-drug conjugate (‘ADC’) candidate. In 2021, Innovent employed Synaffix’s ADC technologies to progress IBI343, a CLDN18.2 ADC, which is now in a Phase 1 trial. Innovent will be responsible for all development for the new ADC candidates, while Synaffix is eligible to acquire an upfront payment plus potential milestones and royalties on commercial sales for each licensed target. Details were not disclosed. Earlier this year, Lonza paid 100 million euros to acquire Synaffix, an Amsterdam company.
Company News
Trading in WuXi Biologics (OTCPK:WXXWY, HK: 2289) was stopped Monday after its shares dropped 24% to HK$33.15 following the company’s investor presentation that predicted lower revenues and profits for 2023’s second half. The company said it would not face a 30% target for 2023 revenue growth. Its new development agreements are lower by 40 projects, causing a drop of US$300 million, while delays in regulatory approvals will lower manufacturing revenues by US$100 million. Longer term, the CRDMO expects its revenues from Research projects will flatten out, while most of its growth will come from Development and Manufacturing services.
Trials and Approvals
280Bio has treated the first patient with TEB-17231, a small molecule inhibitor of RAS signaling being tested in solid tumor cancers with KRAS, NRS and HRAS alterations. 280Bio, a precision oncology company located in South San Francisco, is a wholly owned subsidiary of Shanghai Yingli Pharma. In preclinical trials, TEB-17231 showed potent inhibition of tumor cell proliferation, demonstrating activity with different KRAS, NRAS and HRAS alterations, including tumors that have become resistant to KRAS G12C inhibitors. TEB-17231 is being developed in collaboration with The University of Texas MD Anderson Cancer Center.
Jiangsu Ractigen Therapeutics filed an IND in Australia to start clinical trials of its direct small acting RNA (saRNA) product in patients with non-muscle-invasive bladder cancer who did not answer to Bacillus Calmette-Guérin therapy. RAG-01 targets and activates the tumor suppressor gene p21. The Phase Ⅰ, open-label, multi-center investigate will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of RAG-01, which is Ractigen’s first clinical stage product and the first saRNA candidate from a Chinese company to start trials.
Singapore’s CytoMed (GDTC) announced plans to conduct Investigator Initiated Trials in China of its allogeneic gamma delta T cells as therapies for solid tumor cancers. The company will work together with CytoMed China, a Hong Kong company that (despite its name) is owned by third parties, to conduct the trials in Chongqing, loaning the company $1 million over three years to manage the evaluate. If the trials are successful, CytoMed will acquire the China operation. CytoMed was spun out from Singapore’s A*STAR to progress cell therapies based on gamma delta T cells and gamma delta Natural Killer T cells in-licensed from A*STAR.
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