2017 European biotechnology company 8 major clinical failure cases
December 19, 2017 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];For the biotech industry, 2016 is a tough year, so 2017 is also seen as a year to reverse industry pressure. Although there have been some improvements this year, there are still some industry obstacles that have to be faced.
In the bio-pharmaceutical industry in 2017, the results of the first few months of the first few months were remarkable. In the first four months, the FDA approved a total of 14 new drugs. Compared with the same period of 2016, it has been significantly improved. It is necessary to know that it was approved in 2016. 22 new drugs. The good news is that biotech companies' stocks are still in the best year of the year, but this does not hide the "disappointment" in the drug development field.
The business model of big pharmaceutical companies is still “a messâ€: even if big pharmaceutical companies invest heavily in research and development, this does not prevent biotech companies from being at the forefront of innovation. Big pharmaceutical companies will strive to achieve a return on investment after huge investment in R&D, and according to EvaluatePharma, their return on investment to 2020 will likely be zero.
In addition, a study by King's College London and the London School of Economics raised concerns about the clinical trial process and results. The study found that 57% of cancer drugs did not improve survival and quality of life, and only 35% improved overall survival, which should be the main goal of an innovative anticancer drug.
Christmas and 2018 are coming, and it is a time to summarize the development of the industry throughout the year. The following are the major clinical failures of European biotech companies in 2017:
1. CureVac 's prostate cancer drug candidate failed to reach the main research endpoint
CureVac, the German biotech newcomer, did not start well in 2017. In January, the company's prostate cancer therapeutic vaccine CV9104 failed to reach the primary end point in clinical phase 2 trials. CureVac is a biologic disease prevention and treatment company. The pharmaceutical company, its main candidate mRNA therapy drug CV9104, only reached the secondary study endpoint and did not significantly improve the overall survival of the patient.
CureVac no longer sees mRNA as an independent treatment, and company CEO Ingmar Hoerr remains optimistic about the future: “The experience we have gained in the past suggests that mRNA therapy itself is not enough for treatment, you have to break tolerance, You must make it more immunogenic." In fact, mRNA therapy can be combined with immunological checkpoint inhibitors, and Moderna and BioNTech are conducting research evaluations in this area.
2. Innate Pharma immunological checkpoint inhibitor clinical phase 2 trial failed
In February 2017, French innate's immune checkpoint drug lirilumab failed to reach the primary study end point in clinical phase 2 trials evaluating acute myeloid leukemia. In 2011, BMS obtained a license from Innate for anti-KIR monoclonal antibody lirilumab, with a transaction value of 400 million euros. Although lirilumab is undergoing clinical research evaluations in the treatment of six other cancer types, the company's stock has fallen by nearly 25% with the failure of this phase 2 trial.
The failure of this trial has forced Innate to focus on the treatment of BIS's another listed immune checkpoint inhibitor, nivolumab (Opdivo), in combination with lirilumab.
3. Patient death in Actelion clinical trial
Actelion was acquired by Johnson & Johnson and should be a huge booster for Johnson & Johnson. In fact, the company's pulmonary hypertension drug uptravi was due to the death of 5 patients, and the EMA is reviewing accordingly. The price of Uptravi is as high as 150,000 euros and is an important asset of Actelion. The potential of this drug is also one of the reasons why Johnson & Johnson spent 30 billion euros to acquire Actelion.
Since then, a clinical phase 3 trial of Actelion's main drug candidate, Opsumit, has not been successful, and clinical outcomes have not surpassed placebo treatment. Despite this, the drug received 780 million euros in revenue in 2016. The failure of these trials apparently did not allow Johnson & Johnson to retreat, and Johnson & Johnson added another 2 billion euros in the subsequent acquisition offer.
4. Cerenis Therapeutics Heart Drug Phase 2 Trial Failure
In March, the French company Cerenis evaluated that the clinical phase 2 trial of the drug CER-001 failed to reach the primary end point. The drug is mainly for the treatment of acute coronary syndrome, which is characterized by a decrease in blood flow to the heart. To prevent the heart from working properly or causing death.
The trial was the second clinical phase 2 trial of CER-001, which in 2014 has shown no reduction in atherosclerotic plaque in patients. However, the company has not given up on the hope of CER-001, and is currently conducting a clinical phase III study for the treatment of high-density lipoprotein genetic defects.
5. CHMP does not recommend approval of mastinib
In May, the European Union's Pharmaceutical Products Committee (CHMP) failed to give positive advice on the approval of the French AB Science company masitinib, which is used for the treatment of rare hereditary diseases such as systemic mastocytosis. It is characterized by abnormal proliferation of mast cells, which can affect many systems around the body, most commonly the skin, but it also affects the bone marrow, liver and spleen.
CHMP's opinion is based on the results of the review of the macitinib clinical trial site, the clinical trial failed to meet the GCP specification requirements, and serious flaws occurred during the trial. More importantly, the agency is not satisfied with the statistical analysis of the main analysis of the study.
6. Onxeo 's liver cancer nanoparticle therapy failed to succeed
In September, the Nanoparticle formulation Livatag (adriamycin nanoparticles) of Onxeo, France, failed to improve the prognosis of patients with hepatocellular carcinoma compared with other existing treatments. The results that the Institute hopes to see are that livatag can significantly improve patient survival compared to other anticancer therapies, including oxaliplatin, gemcitabine, and tyrosine kinase inhibitors.
By encapsulating chemotherapeutic drugs such as doxorubicin into nanoparticles, it is expected to overcome the resistance of tumor cells by introducing them into cells.
7. DBV Technology peanut allergy treatment drug clinical phase 3 failure
The viaskin patch developed by DBV Technology in France can non-invasively treat children with peanut allergy. However, in October the company said that the drug candidate failed to reach the primary endpoint. After 12 months of treatment, 35% of children had a relief from DBV treatment, corresponding to a 14% response rate in the placebo group. Although this was a significant difference, the placebo performance was better than expected.
This forced the company to re-examine its own allergy immunotherapy product line. However, DBV Technologies is communicating with the FDA to continue the following study, after the FDA has granted viaskin breakthrough therapy and fast-track identification. Now, we are looking forward to the results of the second clinical trial of the drug in children between the ages of 1-3.
8. Auris 's sudden deafness treatment failed
The sudden deafness treatment of Auris Medical in Switzerland failed to reach the end point of the study, leading the company to terminate the trial early. Compared with placebo treatment, the candidate drug AM-111 did not significantly improve the hearing level of patients with severe or severe severe deafness after 28 days of treatment.
Auris has started discussing the possibility of drug approval, and the company believes that the results of the study depend on the research design rather than the drug itself. If the drug is successfully approved, it will not be the first product to seek a market but does not show a clear effect.
Five of the above eight companies are French biotech companies. This does not include Cellectis. One of the company's CAR-T therapy clinical phase 1 trials killed one patient, causing the FDA to make a decision to suspend the trial. This number may make France a bit worried, because the industry performance in the country has been very good so far.
It is worth mentioning that Merck's immune checkpoint inhibitors, including avelumab, failed to show superiority to chemotherapy in phase III trials of gastric cancer. Last month, Imcorecore's TCR immunotherapy IMCgp100 in the UK's clinical phase 1 trial for the treatment of metastatic uveal melanoma did not meet the company's psychological expectations.
The clinical trial results of these companies may not be so dazzling, but they are all doing their own efforts for human health. I sincerely hope that these companies will be able to go better in the clinical road in the coming year. (Sina Pharmaceutical Compilation / David)
Article, image reference source: Grab the Tissues: Here are the 8 Biggest European Biotech Clinical Failures of 2017
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