Week In Review: Suzhou Duality Out-Licenses Two ADCs To BioNTech In $1.7 Billion Deal

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Deals and Financings

Duality Biologics (Suzhou) out-licensed global rights (ex-China) for two ADC candidates to BioNTech (BNTX), Pfizer’s partner, for one of the two original COVID-19 vaccines in a deal worth $170 million upfront and up to $1.5 billion in milestone payments (see story). The agreement includes Duality’s lead candidate, DB-1303, a topoisomerase-1 inhibitor-based ADC directed against HER2, currently in a Phase II clinical trial.

BioNTech will also acquire Duality’s second topoisomerase-1 inhibitor-based ADC candidate, DB-1311. Duality Bio will be eligible to receive single-digit to double-digit tiered royalties on sales for both assets. 

Pierre Fabre, a French pharma-cosmetic company, acquired rights from Boston’s Scorpion Therapeutics for two next-gen EGFR inhibitors that it intends to develop in the EU and China (see story). Pierre Fabre will make $65 million in upfront and near-term payments and up to $553 million in milestones, plus royalties.

Scorpion says the two candidates are highly-selective mutant EGFR inhibitors aimed at treating NSCLC. Scorpion will retain commercialization rights to STX-721 and STX-241 in the US, Canada, and Japan, while Pierre Fabre will own the rights for all other territories. 

Trials and Approvals

Shanghai Mabwell was approved to launch a denosumab biosimilar in China for osteoporosis in postmenopausal women at high risk of fracture (see story). Mailishu, which was developed by Mabwell’s subsidiary T-mab, was shown to reduce the risk of vertebral, non-vertebral, and hip fractures.

Denosumab is a humanized mAb that inhibits the activator of nuclear factor kappa-B ligand (RANKL) to prevent development of osteoclasts, the cells that break down bone. The originator drug, Amgen’s (AMGN) Prolia/Xgeva was approved in the US in 2010, recording $5.6 billion in global revenues last year. 

Shanghai HutchMed (HCM) has completed the rolling submission of a US NDA for its lead drug, fruzuintinib, an oral VEGFR-1, -2 and -3 inhibitor, for patients with refractory metastatic colorectal cancer (see story). A global Phase III trial showed fruquintinib increased overall and progression free survival endpoints compared to best supporting care, while improving tolerability because of its increased kinase selectivity.

Fruquintinib was launched in China five years ago with the name Elunate. In January of this year, HutchMed out-licensed ex-China rights for the drug to Takeda in a deal worth $1.1 billion.

Shanghai Nuance Pharma has dosed the first patient in a China Phase III trial of a nebulized drug for COPD (see story). Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that offers both bronchodilator and anti-inflammatory effects. 

Two years ago, Nuance acquired greater China rights to the treatment from Verona Pharma (VRNA) of London in a $219 million agreement. In late 2022, Verona reported ensifentrine met its primary and key secondary endpoints in a US Phase III trial. The China trial is a placebo-controlled clinical study that will test ensifentrine for 24 weeks. 

Shanghai Mabwell reported its Nectin-4 targeted site-specific ADC candidate posted demonstrated promising clinical results in a China Phase II trial that enrolled patients with solid tumor cancers (see story). The company said preliminary data show positive efficacy with a good safety profile.

Developed with site specific conjugate technology, 9MW2821 is China's first Nectin-4 targeted ADC to start clinical trials. In preliminary data, the candidate produced an ORR of 50% and DCT of 100% in urothelial and cervical carcinoma patients, two of the more than ten solid tumor cancers targeted by the Nectin-4 ADC. 

Biosion USA was given the green light to begin a US Phase II trial of its lead asset, BSI-045B, an anti-TSLP mAb, to treat atopic dermatitis, severe asthma, and other eosinophilic and Th2 immune-related diseases (see story). Biosion Inc., the parent company, is located in Nanjing and Delaware.

In a Phase I trial, BSI-045B showed it could become a first-in-class treatment for AD based on its single dose activity in AD patients. Biosion out-licensed China rights for BSI-045B to CTTQ, a Sino Biopharm (SBHMY) subsidiary, that is currently in a China Phase II trial for severe asthma. 

Suzhou Evopoint Biosciences will start a China Phase Ib/II trial of its selective EZH2 inhibitor in combination with Merck/MSD’s anti-PD-1 drug Keytruda® in patients with advanced solid tumors (see story). According to Evopoint, the EZH2 inhibitor has shown efficacy for lymphoma, but the company wants to also evaluate the EZH2-Keytruda combo in solid tumor cancers as well.

XNW5004 is a highly selective small molecule inhibitor of EZH2 that Evopoint believes has potential be a best-in-class EZH2 drug. Evopoint will conduct the combination trial while Merck/MSD will supply Keytruda. 

Lynk Pharmaceuticals of Hangzhou said a China Phase I trial of its third-gen, intestinal-restricted JAK inhibitor showed the candidate has good safety, tolerability, and pharmacokinetics (see story). LNK01003 is an oral small molecule JAK inhibitor aimed at ulcerative colitis and related diseases.

Its mechanism concentrates exposure of the drug in the gastrointestinal tract, which is expected to avoid systemic immunosuppression and reduce side effects. At the same time, Lynk says its candidate delivers increased amounts of the drug to gastrointestinal tissues, increasing the inhibitory effect on multiple inflammatory cytokines that cause IBD. 

Beijing InnoCare Pharma has dosed the first subject in a China Phase I trial of its novel targeted protein degrader ICP-490 to treat multiple myeloma and non-Hodgkin's lymphoma (see story).

ICP-490, a CRBM Modulator, was developed by InnoCare’s molecular glue platform, and it is expected to cause anti-tumor effects in various multiple myeloma and diffuse large B cell lymphoma cancers. Because it enhances ADCC activity, ICP-490 is also expected to be a good combination therapy with InnoCare’s other candidates, especially the CD19 inhibitor tafasitamab.

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