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Week in Review: US FDA Rejects Innovent/Lilly PD-1 NDA Based on China-only Trial Subjects

publication date: Feb 12, 2022
author/source: Richard Daverman, PhD

US FDA Says Innovent/Lilly PD-1 Based on China-Only Trials 

As predicted, a US FDA oncology advisory panel rejected the NDA submitted by Innovent (HK: 01801) and Lilly (NYSE: LLY) for their partnered anti-PD-1 antibody (see story). Before the panel met, Lilly tried to influence the panel to approve the drug, sintilimab (Tyvyt), by announcing it would offer the drug at a wholesale price 40% lower than the US competition. The last-minute strategy didn't work: the panel voted 14-1 against approval. Yesterday, it seemed the problem was the Phase III trial, which included only people with China genomes. But there were other issues as well.  

Deals and Financings 

Lepu Biopharma (HK: 2157) of Beijing has begun taking orders for its $115 million Hong Kong IPO (see story). The company has built a portfolio of oncology candidates that include eight products at clinical-stage, three in pre-clinical development and three combination therapies. It considers its PD-1 antibody a backbone of its development portfolio and has filed NDAs in China for two candidates. Because recent China life science IPOs have not held their value in post-IPO trading, the Lepu IPO will measure the appetite of investors for new biopharma offerings in 2022.  

Hangzhou's Huadong Medicine (SHZ: 000963) acquired Asia Pacific (ex-Japan) rights to a bi-functional immunotherapy from Akso Biopharma of Menlo Park, CA in a $75 million agreement (see story). Akso's AB002, a pre-clinical stage candidate, includes a DEEP-engineered soluble PD-1 decoy receptor that traps PD-L2 and PD-L1 and an IL-15 agonist to activate natural killer cells. Huadong will be responsible for development in Asia, but the two companies will form a Joint Research Committee to oversee IND-enabling work. Huadong Medicine develops products for oncology, immunology, nephrology and diabetes indications.  

Beijing EdiGene and Neukio Biotherapeutics of Shanghai will collaborate to develop next-gen allogenic induced pluripotent stem cell (iPSC) and natural killer cell (NK Cell) CAR therapies (see story). EdiGene will use its high-throughput genome editing screening platform to discover candidates for novel targets, while Neukio will contribute its NK Cell expertise. Formed last year, Neukio completed a $40 million Angel round led by Lilly Asia Ventures. Neukio will develop the cell therapies for specific undisclosed indications. It will make payments to EdiGene upon reaching clinical development milestones and pay royalties on sales.  

Trials and Approvals 

Suzhou CStone Pharma (HK: 2616) was approved to market Tibsovo® (ivosidenib tablets) in China for adult patients with relapsed/refractory acute myeloid leukemia who have a susceptible IDH1 mutation (see story). About 75 thousand new cases of leukemia are diagnosed each year in China, 59% of whom are AML patients including up to 10% with IDH1 mutations. Tibsovo is an oral targeted IDH1 inhibitor that offers a new precision medicine for the condition. In a China bridging study, Tibsovo® produced a complete response in 37% of these patients. The approval is CStone's fourth in China.  

Shanghai Everest Medicines (HK: 1952) was approved to launch Trodelvy® (sacituzumab govitecan) in Singapore to treat triple-negative breast cancer (see story). It is Edison's first marketing approval. Trodelvy, a TROP-2 antibody conjugate, is approved as a third-line treatment for adult patients with unresectable advanced or metastatic triple-negative breast cancer. In 2019, Everest acquired Greater China rights to Trodelvy from Immunomedics (now part of Gilead) in an agreement worth up to $835 million. Edison expects additional Trodelvy approvals from China and other southeast Asian countries later this year.  

Ascletis (HK: 1672), a Hangzhou pharma, announced the US FDA has approved the company's IND for its self-developed oral PD-L1 small molecule inhibitor (see story). ASC61 will be tested as a therapy for advanced solid tumors. Ascletis said that ASC61, an oral drug, will be easier to administer than injectable PD-1/PD-L1 antibodies. The approval was Ascletis' second US IND approval in 2022 following envafolimab, a possible cure for chronic hepatitis B. Ascletis started with a focus on anti-viral drugs with an emphasis on hepatitis C and has expanded into oncology.  

CANbridge Pharma (HK: 1228) of Beijing reported positive data from a Singapore Phase I trial of its long-acting anti-C5 complement recombinant human mAb (see story). CAN106 is a novel, long-acting mAb designed to neutralize C5, a key component of the complement system. In patients with paroxysmal nocturnal hemoglobinuria (PNH), division of C5 can cause cell lysis of red blood cells. The Phase I trial showed CAN106 to be well-tolerated while lowering levels of free C5 by 99%. CANbridge, a rare disease and oncology company, has also been approved to start CAN106 trials in China for PNH.  

Shanghai Antengene (HK: 6996) was approved to start an Australian Phase I trial of ATG-037, an oral small molecule CD73 inhibitor, in patients with advanced or metastatic solid tumors (see story). As a primary objective, the study will evaluate the safety and tolerability of ATG-037 as a monotherapy and in combination with an immune checkpoint inhibitor. It will also determine the appropriate dose for Phase II studies and assess preliminary efficacy. CD73 is a target because it generates adenosine, which suppresses the immune system in the tumor microenvironment. The trial is a first-in-human study of the candidate.  

COVID-19 Vaccine News 

Shanghai Zerun Bio (SHZ: 300142) announced an additional $8 million grant from CEPI to conduct trials of its COVID-19 multi-variant vaccine candidate (see story). CEPI, the Coalition for Epidemic Preparedness Innovations, formed a collaboration with Zerun that includes access to finished vaccines, which will be distributed by COVAX. The latest grant brings CEPI's total support of Zerun's COVID vaccines to $25 million. Zerun will conduct a Phase I/II trial of its prototype and multi-variant vaccine candidates in Mali to assess their safety and immunogenicity. Zerun is a subsidiary of Walvax Bio. 

Disclosure: none.











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