Week In Review: Legend Partners DLL3 CAR-T Candidate With Novartis In $1.2 Billion Deal

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Deals and Financings
Legend Biotech (LEGN), a New Jersey-Nanjing CAR-T biotech, partnered its DLL3 (delta-like ligand 3) CAR-T candidates to Novartis (NVS) in a $1.2 billion agreement, with $100 million offered upfront (see story). Legend will start a US trial of LB2102 in patients with extensive stage small cell lung cancer and large cell neuroendocrine carcinoma.Novartis will own worldwide rights to develop, manufacture, and commercialize the DLL3 group of cell therapies, and it may use its T-Charge platform to manufacture the candidates. In 2017, Legend, then a Genscript subsidiary headquartered in Nanjing, stunned the world when its BCMA CAR-T produced a better than 90% response in pretreated multiple myeloma patients. WuXi XDC, an ADC/bioconjugate CRDMO, staged a very successful $520 million IPO in Hong Kong, rising 39% in its first trading session and challenging the notion that the IPO market is hopelessly closed to China biopharmas (see story). It didn’t hurt the IPO that ADCs/bioconjugates are the current center of interest for novel biopharma development globally.Now 10 years old, WuXi XDC started off its life as part of WuXi Biologics, a CRDMO for biologic drug development, which was in turn started by WuXi AppTec, a CRO that made China drug development globally respectable. WuXi XDC has a market capitalization of $4.2 billion.Shanghai SciClone Pharma acquired China rights to an oral cancer therapy for metastatic breast cancer (mBC) that was developed by Menarini Group of Florence, Italy (see story). The drug, Orserdu (elacestrant), is a select estrogen receptor degrader (SERD) aimed at treating for postmenopausal women and adult men with advanced ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.About 70% of breast cancer patients are ER+, HER2-, and up to 40% of them have tumors with ESR1 mutations, which develop following endocrine therapy and cause resistance to standard endocrine therapy. Earlier this year, Menarini was approved to launch Orserdu in the US and EU. Guangzhou AnchorDx formed a long-term collaboration with California’s DiaCarta, a precision molecular diagnostics company, to develop and commercialize molecular diagnostic products for global markets (see story). Both companies will contribute their proprietary technologies for DNA methylation and mutation detection to the effort.AnchorDx develops novel oncology and infectious disease tests. By collaborating with DiaCarta, AnchorDx expects to accelerate development of its early cancer screening programs and to build a wider product pipeline. Boston’s Nona Biosciences, an antibody discovery CMO, will integrate GeneQuantum’s novel bioconjugate discovery platforms to advance discovery of next-generation bioconjugates (see story). GeneQuantum, a Suzhou biotech, claims to be a pioneer in using enzymatic site-specific conjugation technology to develop ADC drugs.The company has developed the iLDC (intelligent Ligase-dependent Conjugation) and iGDC (intelligent Glycotransferase-dependent conjugation) platforms, which will be combined with Nona Biosciences’ Harbour Mice platform. Nona Biosciences is a wholly-owned subsidiary of HBM Holdings that offers integrated antibody discovery services from discovery to preclinical testing. 

Trials and Approvals
Beijing Avistone Biotechnology was conditionally approved to launch vebreltinib, a novel small molecule therapy for MET exon 14 skipping non-small cell lung cancer (NSCLC) in China (see story). Avistone in-licensed the drug from Apollomics (APLM) of Foster City, CA, which has filed for US approval of the candidate.Vebreltinib is a small molecule, selective c-Met inhibitor that activates the HGF/c-Met axis, a pathway involved in tumor growth, proliferation, and resistance to targeted therapies. About 3% to 4% of all NSCLC patients have MET exon 14 skipping mutations. Pittsburgh’s Viatris (VTRS) and Theravance of Dublin (TBPH) reported positive results from a China Phase III trial of their partnered maintenance therapy for COPD (see story). Yupelri (revefenacin) is a once-daily nebulized long-acting muscarinic antagonist (LAMA). It works by inhibiting the M3 receptor on smooth muscle, causing bronchodilation.The Phase III placebo-controlled trial showed a statistically significant increase in trough FEV1 (forced expiratory volume in one second) versus placebo, meeting the primary efficacy endpoint. A low FEV1 suggests a breathing obstruction. Viatris has operations in Shanghai in addition to those in the US and India. South Korea’s AriBio has expanded a Phase III trial of its early Alzheimer’s disease therapy into the EU, UK, Korea, and China (see story). AR1001 (mirodenafil dihydrochloride) was originally developed as an erectile dysfunction therapy targeting phosphodiesterase 5. Similar to other PDE5 therapies, it has shown efficacy for AD, though the results have been spotty for the entire PDE5 class.AriBio says AR1001 is 10-fold more potent at inhibiting PDE5 and better at entering the brain than approved PDE5 inhibitors, including sildenafil. The Phase III study is a double-blind, randomized, placebo-controlled trial with efficacy/safety endpoints after 52 weeks of treatment in early-stage AD patients. Suzhou Gritgen Therapeutics reported its novel gene therapy for Hemophilia A (HA) posted 100% effective results in the first 12 weeks following treatment (see story). The Investigator Initiated Trial enrolled 12 patients with severe HA whose endogenous factor VIII (FVIII) activity was lower than 1%. All patients were treated with a single dose of GS1191 by mid-May.Currently, all patients enrolled in the high dose group have normal FVIII activities with no bleeding episodes observed. Gritgen has begun its own China Phase I trial of GS1191 in patients with severe HA. ChromX Health of Guangzhou will collaborate with Germany’s Boehringer Ingelheim to advance research on interstitial lung disease and to develop early diagnostic and intervention devices (see story). ChromX is developing a breath-analyzing device that detects microminiature volatile organic compounds that serve as biomarkers for lung disease screening and diagnosis.Boehringer Ingelheim has a novel drug candidate for idiopathic pulmonary fibrosis in a Phase III clinical trial. Interstitial lung disease (ILD) is an umbrella term used for a large group of diseases that cause fibrosis of the lungs, which can cause breathing difficulties and death.More By This Author:Week In Review: Eccogen Out-Licenses GLP-1 Agonist To AstraZeneca In $2 Billion DealWeek In Review: Hengrui Out-Licenses Next-Gen PARP1 To Merck KGaA For $1.7 BillionWeek In Review: Hansoh Sells Ex-China ADC Rights To GSK In $1.6 Billion Deal


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