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In a recent trial, nine patients whose tumors were resistant to androgen-blocking therapy continued that therapy but were also given a CD105 inhibitor called carotuximab. Forty percent of those patients experienced progression-free survival, based on radiographic imaging Investigators from Cedars-Sinai Cancer have identified an investigational therapeutic approach that could be effective against treatment-resistant prostate cancer. Results of their Phase II clinical trial, published in the peer-reviewed journal Molecular Therapy, have led to a larger, multicenter trial that will soon be underway. Cancer of the prostate, a small gland just below the bladder, is the second-leading cause of cancer-related death in men. Many prostate tumors are not aggressive and may require no or minimal treatment. Aggressive tumors are initially treated with surgery or radiation therapy. In about one-third of patients, the cancer comes back after initial treatment, said Neil Bhowmick, PhD, research scientist at Cedars-Sinai Cancer, professor of Medicine and Biomedical Sciences and senior author of the study. Those patients are usually treated with medications that suppress the actions of testosterone and other androgens -- male hormones that help prostate tumors grow. "Patients do really well until the tumor figures a way around the androgen-suppressing therapy," Bhowmick said. "One way that it can do this is to cause cells to make only part of the protein that the drug binds to, rendering the drug useless. The partial proteins are called splice variants." Through research with human cells and laboratory mice, study first author Bethany Smith, PhD, a project scientist in the Bhowmick Lab, figured out that the cancer cells were signaling to the surrounding supportive cells through a protein called CD105 to make these slice variant proteins. Investigators then conducted a trial in human patients to test a drug that they hoped would keep those partial proteins from forming by inhibiting CD105. In the trial, nine patients whose tumors were resistant to androgen-blocking therapy continued that therapy but were also given a CD105 inhibitor called carotuximab. Forty percent of those patients experienced progression-free survival, based on radiographic imaging. "Every single one of the patients in our trial was totally resistant to at least one androgen suppressor, and the normal course of action would be to simply try a different one or chemotherapy, which research has shown generally doesn't stop tumor growth for more than about three months," Bhowmick said. "Carotuximab prevented the cancer's workaround and made the tumor sensitive to androgen-suppressing therapy." Importantly, Bhowmick said, carotuximab also appears to prevent androgen receptor splice variants in the supporting cells surrounding tumors, further sensitizing the tumor to the androgen suppressor. "We found that this therapy may be able to, especially in early cancers, resensitize select patients to androgen suppression. This could allow patients to avoid or delay more toxic interventions such as cytotoxic chemotherapy," said Edwin Posadas, MD, co-director of the Experimental Therapeutics Program, medical director of the Urologic Oncology Program/Center for Uro-Oncology Research Excellence (CURE), associate professor of Medicine at Cedars-Sinai and a co-author of the study. "We also hope to find ways of predicting which patients are most likely to benefit from this approach by testing blood and tissue samples using next-generation technologies housed at Cedars-Sinai Cancer." Study co-author Sungyong You, PhD, director of the Urologic Oncology Bioinformatics Group, pinpointed three biomarkers that could help indicate which patients will respond to this investigational therapy, and the team will validate those markers in a new clinical trial. This will allow future studies to target patients most likely to be helped by this intervention, Bhowmick said. Funding: The study was supported by Department of Defense grant number W81XWH-17-1-0154 and Veterans Administration grant number I01BX001040.

Kairos Pharma, Ltd. ("Kairos"), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, today announced that it has received FDA approval to proceed with a Phase 2 clinical trial of ENV105 with apalutamide for the treatment of metastatic castration-resistant prostate cancer. The phase II trial is sponsored by Enviro Therapeutics, a wholly-owned subsidiary of Kairos Pharma. Kairos CEO John Yu, M.D. commented, "This IND acceptance establishes the first of many substantial clinical milestones that Kairos is working toward in 2022. We will roll out our Phase 2 clinical trial with the goal of verifying the benefit of our transformative technologies to reverse the normal course of drug resistance in patients with prostate cancer, lung cancer, and breast cancer." ENV105 has been demonstrated to complement standard of care androgen targeted therapy with non-steroidal anti-androgens such as XTANDI® (enzalutamide) and Zytiga® (abiraterone acetate) in limiting therapeutic resistance to these drugs in a previous Phase II trial. These encouraging results is the premise for this randomized, multi-center phase II trial enrolling 100 patients. Prostate cancer patients failing to respond to androgen targeted therapy interventions will be randomized to receive the combination of ENV105 and a third-generation androgen receptor antagonist, apalutamide or apalutamide alone. Interruption of the BMP/CD105 signaling between cancer cells and surrounding non-cancer cells with ENV105 sensitizes prostate tumors to androgen targeted therapy through a novel mechanism of action. Three academic medical centers will participate in the randomized trial including Cedars Sinai Medical Center, University of Utah, and City of Hope. Kairos Chief Scientific Officer Neil Bhowmick, Ph.D. added, "This achievement represents the next major step in testing the degree of potential clinical benefit of ENV105 for patients with androgen resistant prostate cancer." In addition to the upcoming Phase 2 trial of ENV105 with apalutamide, a Phase 1 trial of ENV105 with Tagrisso (AstraZeneca) for lung cancer is planned to start in 2022, and a Phase 1 trial of activated T cell therapy for KROS 201 in patients with glioblastoma will enter Phase 1 clinical trials in 2022. About Kairos Pharma Kairos Pharma is a clinical-stage biopharmaceutical company focused on developing a diversified pipeline of cutting-edge therapeutics for cancer patients that reverse the inhibitory effects of cancer on the immune system. The Company's unique portfolio of seven drug candidates is anchored by a new class of novel drugs that reverse drug resistance and immune resistance to cancer. The Company has made unparalleled strides through its transformative technology, strong IP, and world-class team working to make a significant impact on the most pervasive problems in cancer treatment.

Preeclampsia is a hypertensive disorder of pregnancy and affects about 5% of pregnant women globally, out of whom 0.5% to 1% develop it in the severe form. It is one of the most common complication of pregnancy and a major cause of morbidity, long-term debility, and death among both the baby and the mother. Preeclampsia generally occurs after the 20th week of pregnancy, caused by mixture of elevated blood pressure and protein in the urine (proteinuria). Severe headache, blurring vision, heartburn, and swelling of the face are the common symptoms of preeclampsia. According to a report published by the Center for Maternal and Child Enquiries in the U.K., preeclampsia was ranked as the second most common direct cause of maternal death between 2006 and 2008. In Asia and Africa, one in 10 deaths is associated with pregnancy related hypertension. However, majority of deaths caused by eclampsia or preeclampsia are preventable through proper diagnosis and effective care of the patients. Preeclampsia accounts for about 20% of total maternal deaths and is the third leading cause of maternal mortality in the U.S. Read Report Overview - The preeclampsia diagnostics market can be segmented into test type, instrument, and end-user. Based on test type, the global preeclampsia diagnostics market can be classified into biomarker and immunoassay. The immunoassay (ELISA) segment can be further divided into Elecsys PIGF/sFLT-1, and DELFIA Xpress PlGF kit2. The immunoassay test provides early and specific diagnosis of preeclampsia. The biomarker segment can be further categorized into placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble endoglin (sEng), soluble Fms-like tyrosine kinase -1(sFlt-1), pregnancy associated plasma protein-A (PAPP-A), placental protein 13(PP-13), neutrophil gelatinase-associated lipocalin (NGAL), and others. Request Brochure of Report - Based on instrument, the global preeclampsia diagnostics market can be segmented into Victor2 D Instrument, AutoDELFIA immunoassay system for prenatal screening, and others. In terms of end-user, the global preeclampsia diagnostics market can be divided into hospitals, specialty clinics, diagnostics laboratories, research centers, and others. The diagnostics laboratories segment constituted major market share in 2016. The specialty clinics segment is expected to register high growth during the forecast period. Good service provided by the specialty clinics and diagnostics laboratories, and availability of instruments are estimated to propel the market during the forecast period. Other factors that drive the global preeclampsia diagnostics market are rise in prevalence of pregnancy related hypertension and recent developments in diagnostics kits. Request for Analysis of COVID-19 Impact on Preeclampsia Diagnostics Market- Geographically, the global preeclampsia diagnostics market can be segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America is expected to account for high market share of the global preeclampsia diagnostics market, owing to the developments in diagnostic tests and increase in prevalence of pregnancy related diseases in the region. Europe accounted for major market share in 2016, owing to rise in incidence of preeclampsia in the region. Governments of countries in Europe are focused on launching awareness programs for prevention of preeclampsia, and diagnostics and treatment of women suffering from the disease. In 2012, the European Foundation for the Care of Newborn Infants (EFCNI), announced collaboration with PerkinElmer, a global leader focused on improving the health and safety of people and environment. Rise in prevalence of the disease is expected to boost the growth of the preeclampsia diagnostics market during the forecast period. The market in Asia Pacific is expected to register a high CAGR during the forecast period. Rise in demand for newer and advanced diagnostics tools, increase in research and development programs, and participation of governments in creating awareness about the disease are expected to boost the growth of the market in the region during the forecast period. Request for Custom Research - Key players in the global preeclampsia diagnostics market are Roche, DRG INSTRUMENTS GMBH, PerkinElmer Inc., Diabetomics, Inc., Siemens AG, LionsGate Technologies Inc., among others. Roche was the first company that developed immunoassay for diagnosis of preeclampsia. Growing demand for preeclampsia screening due to rise in awareness about the disease is expected to propel the global preeclampsia market during the forecast period. Pre Book Preeclampsia Diagnostics Market Report - About Us Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals. Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories. 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