The study drug, tomivosertib, works by inhibiting the activity of proteins in a pathway that allow tumor cells to grow and go unnoticed by your immune system. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial . Annapolis, MD. Title Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-L1 Therapy in Subjects With Non-Small Cell Lung Cancer as First-Line Therapy or When Progressing on Single-Agent First-Line Anti-PD-L1 Therapy. Tomivosertib (formerly eFT 508) is a highly selective, orally available, small molecule inhibitor of MNK1 and MNK2, . This Phase 2, open-label study will evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of Tomivosertib (eFT-508) in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on therapy or have undergone 12 weeks of anti-PD-1/anti-PD-L1 therapy with no . Our trial will determine if the potent MNK inhibitor, tomivosertib, controls tumor growth either directly or by enhancing anti-tumor immunity. A Phase 2 clinical trial evaluating eFFECTOR Therapeutics' investigational therapy tomivosertib (eFT508), for men with advanced castrate-resistant prostate cancer (CRPC) who failed to respond to androgen receptor signaling (ARS) inhibitors, has begun dosing patients.. KICKSTART is a randomized, double-blind, placebo-controlled clinical trial assessing the efficacy and safety of tomivosertib in combination with pembrolizumab, a U.S. Food and Drug Administration (FDA)-approved PD-1 inhibitor, as frontline combination therapy or as an extension of frontline therapy at the first radiographic progression of . The time until each animal fell was recorded for each trial. Previously received investigational product in a clinical trial within 30 days or within 5 elimination half-lives (whichever is longer) prior to the start of Tomivosertib (eFT-508), or is planning to take part in another clinical trial while participating in this study; Pending positive results from the KICKSTART Phase 2b clinical trial, the company plans to advance tomivosertib into Phase 3 registration trials. Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure. Finally, we demonstrate that the in vitro functional and mechanism observations are translatable to in vivo gastric cancer model in mice. Tomivosertib (eFT-508) is a potent and selective MNK1/2 inhibitor with IC50s of 2.4 nM and 1 nM, respectively. The researchers also found that Tomivosertib synergistically enhances the anti-leukemic effects of Venetoclax against AML cells in vitro. This trial; Search. It is scheduled to be annotated soon. Tomivosertib is now in phase 2 clinical trials. This study will evaluate the safety and antitumor activity of tomivosertib versus placebo in subjects . The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 with any breast cancer (BC) subtype . Tomivosertib (10 mg/kg i.p ~50 L) or vehicle was then injected, and 1 h later all mice were tested twice more, and their scores were averaged. "2021 was a momentous year for eFFECTOR, as we advanced both our clinical stage assets, tomivosertib and zotatifin, into Phase 2 trials and raised additional capital with our debut as a public . Ph2 Tomivosertib+Anti-PD-L1 NSCLC. 01 Apr 2021 Phase-II clinical trials in Non-small cell lung cancer (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease, Inoperable/Unresectable) in USA (PO) (NCT04622007) Our study provides pre-clinical evidence to initialize clinical trials for gastric cancer using tomivosertib in combination with chemotherapy. In addition, Dr. Patel will serve as a consultant to eFFECTOR through September 30, 2022. Home . This trial is sponsored by a grant from the Defense Advanced Research Projects Agenda (DARPA) and is being . The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. . Clinical trial of BAY 1143269 as a combination therapy with docetaxel in NSCLC was terminated due to project prioritization. Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART) NCT04622007. If results from the KICKSTART trial are clinically and statistically significant, the company plans to explore the potential for accelerated approval with the FDA. Tomivosertib, also known as eFT-508, is a potent, highly selective and orally bioavailable MNK1 and MNK2 inhibitor that is currently under investigation in Phase 1/2 clinical trials for the treatment of patients with advanced solid tumors and lymphomas . eFFECTOR Therapeutics Reports Positive Interim Results in Zotatifin (eFT226) Phase 1/2 Clinical Trial at ASCO 2022 Showing Safety and Tolerability, and Initial Signals of Clinical Activity . Tomivosertib (eFT508) is one of the molecules with such scaffold. Principal Investigator Compensation included. Status: Enrolling Updated: 12/31/1969 Anne Arundel Medical Center. A Phase 1b/2 Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination With . eFFECTOR Therapeutics Reports Positive Interim Results in Zotatifin (eFT226) Phase 1/2 Clinical Trial at ASCO 2022 Showing Safety and Tolerability, and Initial Signals of Clinical Activity Previously received investigational product in a clinical trial within 30 days or within 5 elimination half-lives (whichever is longer) prior to the start of Tomivosertib (eFT-508), or is planning to take part in another clinical trial while participating in this study; It is one of the first two Mnk inhibitors that entered clinical trials, and has displayed momentous activity against several solid and hematological cancers. Tomivosertib (10 mg/kg i.p ~50 L) or vehicle was then injected, and 1 h later all mice were tested twice more, and their scores were averaged. Tomivosertib (eFT508): eFFECTOR's wholly-owned, highly selective MNK inhibitor designed to enhance anti-tumor immune activity by stimulating activation, . Identification. Kickstart is a double-blind, randomized, multi-center Phase 2b clinical trial. Tomivosertib (eFT508) is a potent, highly selective, and orally active MNK1 and MNK2 inhibitor, with IC50s of 1-2 nM against both isoforms. Tomivosertib. eFFECTOR's lead product candidate, tomivosertib, is a MNK . The time until each animal fell was recorded for each trial. Tomivosertib (eFT508): eFFECTOR's wholly-owned, highly selective MNK inhibitor designed to enhance anti-tumor activity by stimulating activation, . This is a multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype. . eFFECTOR's lead product candidate, tomivosertib, is a MNK inhibitor currently being . . A clinical trial for an investigational respiratory syncytial virus (RSV) vaccine combined with an approved flu vaccine for older adults. Researchers in this study believe that Tomivosertib, a highly selective MNK1/2 inhibitor (currently undergoing clinical trials for the treatment of patients with advanced solid tumors and lymphomas), . SAN DIEGO, July 27, 2018 (GLOBE NEWSWIRE) eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulators (STRs) for the treatment of cancer, today announced that it has dosed the first patient in a Phase 2 clinical trial of eFT508 (tomivosertib), the company's oral, small molecule inhibitor of MNK1/2, added on to patients already receiving an FDA-approved . The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance . - Any illness, medical condition, organ system dysfunction, or social situation, . The first patient was dosed in the phase 2b KICKSTART clinical trial from eFFECTOR Therapeutics, Inc. in early June. Tomivosertib, an inhibitor of MNK 1/2, works at multiple points in the cancer immunity cycle, and has demonstrated efficacy in a Phase 2 clinical trial in patients who progressed on checkpoint . including clinical trial and manufacturing delays; our ability to access the LPC facility is subject to certain conditions; our . Tomivosertib (formerly eFT 508) is a highly selective, orally available, small molecule inhibitor of MNK1 and MNK2, . This study will evaluate the safety and antitumor activity of tomivosertib versus placebo in subjects . One cohort will enroll patients with PD-L1 1% NSCLC who have . Background. eFFECTOR Therapeutics Reports Positive Interim Results in Zotatifin (eFT226) Phase 1/2 Clinical Trial at ASCO 2022 Showing Safety and Tolerability, and Initial Signals of Clinical Activity This is a multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype. Dr. Sikorski, who played a similar role for eFFECTOR in 2020, has a deep knowledge of the company's STRI development programs and will lead clinical development of both tomivosertib and zotatifin. "The TNBC trial will expand the current tomivosertib Phase 2 clinical trial program, allowing eFFECTOR to explore a combination with KEYTRUDA for an indication in which neither drug is yet approved," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR."Based on preclinical studies showing tomivosertib has substantial immunomodulatory activity and synergizes with . Sasikumar et al. Tomivosertib (T), a potent and highly selective inhibitor of the immunosuppressive kinases MNK-1 and 2, blocks expression of checkpoint proteins PD-1, PD-L1, and LAG-3 as well as immunosuppressive cytokines IL-6 and IL-8 . These results prompted the advancement of CA-170 to human clinical trials. SAN DIEGO, July 16, 2021 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulation inhibitors ("STRIs") for the treatment of cancer, announced today the publication of data highlighting the role of eukaryotic translation initiation factor 4E ("eIF4E"), in the peer-reviewed journal Cell Reports. 3112 Background: Despite the broad activity of checkpoint inhibitors across tumor types, primary or secondary resistance after initial response represents a major challenge. Zotatifin is a potent and sequence-selective small molecule inhibitor of eIF4A that is designed to supress expression of a network of cancer driving proteins, including Cyclins D and E, CDKs 2, 4 and 6 and select RTKs as well as KRAS. An upcoming Phase 2 trial will evaluate a combination of the immunotherapies Keytruda (pembrolizumab) and tomivosertib (eFT508) as a treatment for triple-negative breast cancer patients whose disease has spread to other regions, or metastasized.. As part of a new collaboration between eFFECTOR Therapeutics and Merck (known as MSD outside the U.S. and Canada), the trial will test the . The goals of the trial include not only routine monitoring for clinical benefit and toxicity but also to employ techniques not previously used in clinical trials to understand the details of drug action in Zotatifin Update This Phase 2 Open-label Study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in Patients with advanced CR. Nave mice were trained for 1 trial, and then 2 baseline trials were conducted and scores for both trials were averaged. Tomivosertib is under investigation in clinical trial NCT03318562 (A PD Study of Oral eFT508 in Subjects With Advanced TNBC and HCC). About UC Irvine Clinical Trials. Each of eFFECTOR's product candidates is designed to act on a single protein that drives the expression of a network of functionally related proteins, including oncoproteins and immunosuppressive proteins in T cells, that together control tumor growth, survival and immune evasion. 01 Apr 2021 Phase-II clinical trials in Non-small cell lung cancer (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease, Inoperable/Unresectable) in USA (PO) (NCT04622007) from . This drug entry is a stub and has not been fully annotated. Lung Cancer Studies . Drugs; NCT03690141: An Open-label Study Examining the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC) Tomivosertib (DB15219) Interested in using DrugBank in a commercial product . we may use our capital resources sooner than expected and they may be insufficient to allow clinical trial readouts; regulatory developments in the United States and foreign countries . The company's research program currently has two novel drug candidates undergoing clinical trials. DrugBank Accession Number. . SAN DIEGO and REDWOOD CITY, Calif., June 05, 2022 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors ("STRIs") for the treatment of cancer, today reported positive interim results of the company's ongoing Phase 1/2 clinical trial of eIF4A inhibitor zotatifin in patients with solid tumors that showed . It potentially results in decreased tumor cell proliferation and tumor growth. An upcoming Phase 2 trial will evaluate a combination of the immunotherapies Keytruda (pembrolizumab) and tomivosertib (eFT508) as a treatment for triple-negative breast cancer patients whose disease has spread to other regions, or metastasized.. As part of a new collaboration between eFFECTOR Therapeutics and Merck (known as MSD outside the U.S. and Canada), the trial will test the . We are currently investigating zotatifin in ongoing clinical trials for solid tumors and as a potential host . NCT04261218. In December 2021, Biotheus Inc. announced that its proprietary anti-PD-L1/TGF- bifunctional therapeutic, named PM8001, has been approved by the USFDA (United States Food and Drug Administration . If results from the KICKSTART trial are clinically . Protocol No. Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy. This work was supported by the National Nature Science Foundation of China (grants 81872462 and 81972772) and the Clinical Trial Supporting Foundation of Tianjin Medical University Cancer Institute & Hospital (grant C1707). Pending positive results from the KICKSTART Phase 2b clinical trial, the company plans to advance tomivosertib into Phase 3 registration trials. Tomivosertib (eFT-508) inhibits eIF4E phosphorylation and dramatically downregulates PD-L1 protein abundance. Each entry includes links to find associated clinical trials. Tomivosertib (eFT508) also dramatically downregulates PD-L1 protein abundance. DB15219. Tomivosertib is being evaluated in KICKSTART, eFFECTOR's randomized, double-blind, placebo-controlled Phase 2b study in non-small cell lung cancer ("NSCLC") in combination with pembrolizumab. Tomivosertib is also currently being evaluated in two additional Phase 2 combination trials with checkpoint inhibitors targeting PD-1 or PD-L1, including a trial (NCT03258398) in patients with . eFFECTOR is supplying . . Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Multiple Myeloma. "We observed in our phase 2a trial of tomivosertib in combination with . Enrollment in SU2C Breast Cancer Trial continues: Tomivosertib is being evaluated in an ongoing Phase 2a clinical trial in patients with metastatic breast cancer in combination with paclitaxel chemotherapy in a study led by Professor Nahum Sonenberg Ph.D., Gilman Cheney Chair in Biochemistry at McGill University. . The trial (NCT03690141), currently recruiting participants, will evaluate the safety, tolerability and antitumor activity of . Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial . We thank Jiangsu HengRui Medicine Co., China, for kindly providing the anti-PD-1 antibody camrelizumab. that together control tumor growth, survival and immune evasion. Tomivosertib (eFT508): eFFECTOR's wholly-owned, highly selective MNK inhibitor designed to enhance anti-tumor immune activity by stimulating activation, delaying exhaustion, and prolonging the memory of T cells. This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging . Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART) . The randomized trial will treat patients who have non-small cell lung cancer (NSCLC) with a combination of tomivosertib and Keytruda (pembrolizumab). The researchers also found that Tomivosertib synergistically enhances the anti-leukemic effects of Venetoclax against AML cells in vitro. Tomivosertib (eFT508) treatment leads to a dose-dependent reduction in eIF4E phosphorylation at serine 209 (IC50=2-16 nM) in tumor cell lines. mi. A Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-(L)1 Therapy in Subjects With NSCLC as First Line Therapy or When Progressing on Single-Agent First-Line Anti PD (L)1 Therapy: Actual Study Start Date : June 2, 2021: Estimated Primary Completion Date : March 15, 2024: Estimated Study Completion Date : Tomivosertib (eFT-508) For research use only. Tomivosertib (eFT508) is a novel small-molecule inhibitor of MNK that delays T cell exhaustion/dysfunction and is being developed in combination with pembrolizumab in 1L NSCLC patients with PD-L1 1%. eIF4E is a component of the eIF4F . A Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-(L)1 Therapy in Subjects With Non-Small Cell Lung Cancer as First Line . The study drug, tomivosertib, works by inhibiting the activity of proteins in a pathway that allow tumor cells to grow and go unnoticed by your immune system. In addition, zotatifin is being evaluated in a Phase 1b clinical trial as an antiviral agent in patients with mild to moderate COVID-19 infections. The present compilation provides a succinct review of the current state of development of pyridone-aminal-derived Mnk .
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