Deals and Financings

VectorBuilder, a CDMO based in Chicago, announced plans to build a $500 million gene delivery manufacturing and research campus in Guangzhou (see story). When finished, the site will include 30 production suites designed to manufacture lentivirus, plasmids, messenger RNA, adeno-associated virus, cell lines and other types of viral and non-viral vectors. VectorBuilder says it offers gene therapy delivery services so biopharmas can focus on their candidates instead of developing their own vectors. The new Guangzhou campus, which will take four years to complete, is part of a global expansion. 

Shanghai Ji Xing Pharma in-licensed Greater China rights for two eye-drop far-sightedness therapies from San Diego’s Lenz Therapeutics in a $110 million pact (see story). Lenz’s two therapies are based on aceclidine, a small molecule acetylcholine receptor agonist that causes pupil contraction (miosis), creating a pinhole effect that improves near vision. Ji Xing is backed by New York’s RTW Investments, which invested $10 million in Lenz. Ji Xing will pay $15 million upfront and up to $95 million in milestones, plus royalties. Lenz plans to start US Phase III trials of the two presbyopia therapies in H2 of 2020. 

AnPac Bio-Medical, a Shanghai-Philadelphia company focused on early cancer screening and detection, raised $15 million from Hunan Weitou Technology (see story). Weitou will make five payments of $3 million each over the next 30 months. AnPac Bio offers many cancer screening and detection tests, including its own Cancer Differentiation Analysis (CDA), The company’s CDA technology combines an assessment of existing biomarkers with an analysis of biophysical properties and cellular proteins to provide early signals of serious health conditions and cancer.  

Trials and Approvals

Germany’s Bayer (XE: BAYN) announced China approval of Vitrakvi™ (larotrectinib), a precision medicine for adult and pediatric patients who have advanced solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion (see story). Larotrectinib is a first-in-class, highly selective TRK inhibitor. In clinical trials, larotrectinib demonstrated efficacy in more than 20 different solid tumors including lung, thyroid and colorectal cancers. It was also effective in salivary gland cancer and soft tissue sarcomas. According to Bayer, Vitrakvi is the first therapy in China with a tumor-agnostic indication. 

Beijing’s BeiGene (NSDQ: BGNE; HK: 06160; SHA: 688235) reported China approved the launch of its PD-1 antibody as a second line treatment for esophageal squamous cell carcinoma, the eighth China approval for tislelizumab (see story). In early 2021, BeiGene out-licensed global tislelizumab rights (ex-China) to Novartis in a $2.2 billion deal. Tislelizumab is designed to minimize binding to FcγR on macrophages. In pre-clinical studies, this binding lowers the anti-tumor activity of PD-1 antibodies by activating macrophage-mediated killing of T effector cells. 

BeiGene announced its BTK inhibitor showed a better overall response rate than ibrutinib in a Phase III trial for leukemia (see story). BeiGene said Brukinsa produced an ORR of 80.4% versus 72.9% for ibrutinib. The ALPINE trail enrolled 652 patients who were followed for a median 24.2 months in a multination trial. The next read of ALPINE data will be the final analysis for progression free survival. Brukinsa is already approved for three indications in the US: mantle cell lymphoma, Waldenström’s macroglobulinemia and marginal zone lymphoma. 

Shanghai AffaMed and VistaGen (NSDQ: VTGN), a South San Francisco company, have filed an IND to conduct a China Phase III trial of their partnered therapy for adults with acute social anxiety disorder (SAD) (see story). PH94B is an odorless, as-needed, fast-acting (15 minutes) neuroactive pherine nasal spray with a novel mechanism of action. PALISADE Global is designed to evaluate the efficacy, safety and tolerability of VistaGen’s PH94B in China and other ex-US markets. The two companies plan to expand the Phase III trial into Canada, Mexico and South Korea. 

InventisBio of Shanghai reported promising early data from two trials of its oral KRAS G12C inhibitor, D-1553 (see story). In a Phase I international trial in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation, D-1553 produced an objective response rate of 19% and disease control rate of 86%. In a larger 59 patient study, D-1553 achieved an ORR of 40% and a DCR of 90% among NSCLC patients with a KRAS G12C mutation. In 2020, InventisBio completed a $147 million series D financing led by GL Ventures, a Hillhouse affiliate. 

Shanghai Junshi Bio (HK: 1877; SHA: 688180) was granted US Orphan Drug Designation for toripalimab, its PD-1 inhibitor, to treat small cell lung cancer (see story). Immunotherapies have not been particularly effective in SCLC because the disease has low expression of PD-L1 and low levels of tumor infiltrating immune cells. Junshi believes that toripalimab is effective in low PD-1 cancers. Toripalimab is in a US Phase III trial as a first line therapy for extensive stage SCLC. In 2021, Junshi partnered US-Canada rights for toripalimab with Coherus BioSciences of Redwood City, CA in a $1.1 billion agreement. 

Suzhou CStone Pharma (HK: 2616) released preclinical data on a tri-specific antibody-based molecule that targets PD-L1, 4-1BB and human serum albumin (see story). It described the molecule, CS2006/NM21-1480, as a broadly acting next-gen anti-PD-1/PD-L1 cancer immunotherapy that will serve as a novel backbone for tumor-specific combination therapies. By targeting the immune co-stimulatory receptor 4-1BB, the molecule is expected to bind and activate T cells only when binding PD-L1 on the surface of tumor cells. CStone has started Phase I trials of the candidate in the US, Taiwan and China. 

<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">var switchTo5x=true;</script><script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script><script type="text/javascript">stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'});</script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="http://www.chinabiotoday.com/articles/20150311" size="small"></g:plusone> <br /><br />