Summary of recent progress in the field of cancer (01.29)
January 29, 2018 Source: WuXi PharmaTech
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Amoy Diagnostics recently announced that the State Food and Drug Administration (CFDA) has approved its Super-ARMS® EGFR mutation assay for plasma samples on January 19 this year, using epidermal growth factor as a non-small cell lung cancer (NSCLC). Concomitant diagnosis of EGFR tyrosine kinase receptor inhibitor (TKIs) therapy. It is the first companion diagnostic kit approved by the CFDA for the detection of EGFR gene mutations in circulating tumor DNA (ctDNA) from plasma. in
For various reasons, not every patient can submit tumor tissue for molecular testing, and many patients are therefore unable to receive targeted therapy or even delay the disease. The approval of the Super-ARMS® EGFR mutation test, which only requires plasma samples, will help reduce the barriers to molecular detection and provide doctors with more information and treatment options. Since April 2017, the test has passed CE-IVD certification. The Super-ARMS® EGFR mutation assay was developed based on the globally successful detection of the ADx-ARMS® EGFR mutation, which expands the range of detectable mutations and recognizes 41 of the exons 18-21. EGFR mutations, including L858R, exon 19 deletion and T790M. NSCLC patients carrying these EGFR mutations are eligible for targeted therapy with EGFR-TKIs. The kit can detect 0.2 to 0.8% of mutant DNA in the background of 99.8 to 99.2% of normal genomic DNA.
"The development of diagnostic techniques for non-small cell lung cancer based on liquid biopsy will change the diagnostic approach for advanced patients. Techniques for isolating and detecting tumor DNA from a simple minimally invasive test can determine subsequent treatment options for doctors and The patient will be very helpful." Professor Wu Yilong, former chairman of the Chinese Society of Clinical Oncology (CSCO) and general hospital of Guangdong Province, said.
“The CFDA approves the Super-ARMS® EGFR mutation test, a liquid biopsy used for companion diagnostics, setting a new standard for treating patients with non-small cell lung cancer,†said Dr. Zheng Limou, founder and CEO of AmoyDx. “We are very happy to see that Chinese patients who would otherwise be unable to provide a sample of the organization will also have access to personalized medicine. In the future, we will continue to provide our customers with a mission of excellence in innovative products and services to improve healthcare and patient life."
2. Agenus initiates clinical trials to evaluate immunological checkpoint inhibitor combination therapy
Recently, Agenus announced that it has launched a clinical trial in December 2017 to test the efficacy of a combination therapy with the company's CTLA-4 antibody AGEN1884) and PD-1 antibody AGEN2034 in the treatment of patients with advanced solid tumors.
The introduction of immunological checkpoint inhibitors is a major breakthrough in the field of cancer treatment, but not all patients respond to them. Moreover, during the process of T cell activation, different immune checkpoint proteins regulate T cell activity at different stages. Therefore, combination therapies consisting of different immunological checkpoint inhibitors have the potential to further promote the activity of T cells, thereby enhancing the killing effect on tumor cells.
AGEN1884 and AGEN2034, developed by Agenus, are fully humanized monoclonal antibodies that block the function of CTLA-4 and PD-1. The main role of blocking the PD-1 signaling pathway is to restore the effector function of antigen-specific T cells in the tumor microenvironment, and the main role of blocking the CTLA-4 signaling pathway is to enhance the initiation of T cell activation in lymphoid organs. stage. The regulatory functions of PD-1 and CTLA-4 do not overlap, and blocking these two signaling pathways may further activate T cells. Preclinical trials have shown that the combination of AGEN1884 and AGEN2034 can increase T cell activity in both cell culture models and non-human primate models.
The purpose of this open-label clinical phase 1/2 trial is to test the safety, tolerability, pharmacokinetic profile, and biological and clinical efficacy of AGEN1884 and AGEN2034 in patients with advanced solid tumors. The optimal formulation and timing of the drug combination will be tested in a group of cervical cancer patients whose tumors relapse after receiving platinum-based chemotherapy and cannot be surgically removed.
"The rapid advancement of clinical trials of combination therapy with CTLA-4 and PD-1 antibodies is key to bringing our tumor immunotherapy to market. Moreover, we believe that these two antibodies are combined with other innovative tumor immunotherapies owned by the company. Lieutenant will play a key role," said Dr. Garo Armen, President and CEO of Agenus.
3. The overall survival rate increased by 10% , and the early data of new drugs for pancreatic cancer were positive.
ChemoCentryx recently announced patient survival data for ongoing Phase 1b clinical trials of pancreatic cancer. The study used the CCR2 inhibitor CCX872 in combination with the chemotherapy regimen FOLFIRINOX, and the overall survival rate observed in the 18th month of the study was 29%. There was a significant increase in the 18.2% survival rate compared to the FOLFIRINOX treatment trial conducted in 2011. ChemoCentryx plans to publish its specific data at the next ASCO-SITC (American Society of Clinical Oncology - Cancer Immunotherapeutics Society) workshop.
It is estimated that more than 337,000 cases of pancreatic cancer are diagnosed each year worldwide. It is estimated that there will be about 55,000 cases of pancreatic cancer in the United States in 2018. Currently, the standard treatment for pancreatic cancer is chemotherapy. In a few cases, it can be surgically removed, and the five-year survival rate is only 7%.
CCX872 is an oral, potent and selective CCR2 inhibitor. CCR2-positive cells have immunosuppressive behavior and can effectively help the tumor to evade the body's immune response to tumor cells. In many preclinical solid tumor models, inhibition of CCR2 exhibits an effect of inhibiting tumor growth.
The Phase 1b clinical trial announced this time is a multi-center open-label trial that completed patient enrollment in March 2016. All 50 patients enrolled had advanced unresectable pancreatic cancer (76% of patients with pancreatic cancer had metastasized). All patients received FOLFIRINOX (up to 12 times) plus a daily dose of CCX872 every two weeks for a total of 12 weeks. Patients with stable disease at the end of the 12-week treatment continued to receive CCX872 until disease progression. The 18-month overall survival rate data released this time is the first to report survival results since the completion of the group.
Dr. Thomas J. Schall, President and CEO of ChemoCentryx, said: "The positive results of our pancreatic cancer trial suggest that selective inhibition of CCR2 with CCX872 can improve patient survival. This may be due to blocking CCR2 maintenance in the tumor environment. Inhibiting cells. This new method stimulates a powerful anti-tumor immune response that releases the body's own potential. These data support CCX872 as a very promising new immunotherapy for this deadly cancer. Based on these encouraging results, We look forward to more opportunities to combine CCX872 with other therapies."
4. Cell therapy is sharply awarded $100 million in Series A financing
Recently, Tmunity Therapeutics, based in Philadelphia, Pennsylvania, announced the completion of a $100 million Series A financing. Investment groups involved in financing include Ping An Ventures, Parker Institute for Cancer Immunotherapy, Gilead Sciences and Be The Match BioTherapies, as well as existing investors. Tmunity is committed to the development of next-generation T-cell immunotherapy, and the company's development of therapeutics is expected to achieve optimal levels of control of T cell activation and targeting in vivo. The funds from this round of financing will be used to expand the company's business and operational structure, supporting transformational research, development and production of T cell-based innovative immunotherapy.
Tmunity was created based on an exclusive partnership and licensing agreement with the University of Pennsylvania (UPenn). Tmunity's scientific founders include five UPenn researchers led by Dr. Carl H. June, who have granted Tmunity an exclusive license to further transform and develop their research.
Tmunity is committed to integrating excellent innovations and designing T-cell therapies using multiple channels to quickly push therapies into clinical development, optimize and expand the manufacturing process, actively seek regulatory approval, and effectively deliver therapies to patients. . The company's drug development pipeline is expected to have a solid tumor CAR-T therapy will enter clinical trials in the first half of this year, a solid tumor T cell receptor (TCR) therapy will enter the clinical phase in the second half of this year . In addition, the company has five CAR-T projects and two TCR projects in pre-clinical development, and plans to submit more IND applications this year.
“Tmunity is significantly different from other startups in cell therapy in three areas: an unparalleled scientific founding team, a highly experienced management team in cell and gene therapy, and a complete system of T cell clinical transformation and mass production processes. "Accumulate," this round of investment, Dr. Zhang Jiang, founding partner of Ping An Ventures, said: "At the same time, we are also very optimistic about the industrialization prospects of Tmunity's research product line on a global scale, especially for various types of solid tumors and autoimmunity. The clinical application of sexual and infectious diseases in the Greater China region is a good synergy with our growing investment pipeline."
Reference material
[1]China FDA Grants Liquid Biopsy Approval to AmoyDx Super-ARMS EGFR Mutation Test
[2]Agenus Announces Combination Clinical Trials of its Anti-CTLA4 (AGEN1884) & Anti-PD1 (AGEN2034)
[3]Pancreatic cancer combo sees high survival rates in ChemoCentryx PhIb data
[4]Tmunity Therapeutics Raises $100 Million in Series A Financing to Advance Portfolio of Next-Generation T cell Immunotherapies to Transform the Treatment of Cancer
Original title: Summary of recent progress in the field of cancer (No. 52)
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