Identification. 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. PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL. Compensation included. "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 . 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 study will evaluate the safety and antitumor activity of tomivosertib versus placebo in subjects . 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 . . eFFECTOR's lead product candidate, tomivosertib, is a MNK inhibitor currently being . Pending positive results from the KICKSTART Phase 2b clinical trial, the company plans to advance tomivosertib into Phase 3 registration trials. A Phase III Clinical Trial for Test Use and Document Creation Only. NCT04261218. 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. This trial is sponsored by a grant from the Defense Advanced Research Projects Agenda (DARPA) and is being . 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. This study will evaluate the safety and antitumor activity of tomivosertib versus placebo in subjects . About UC Irvine Clinical Trials. 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%. Kickstart is a double-blind, randomized, multi-center Phase 2b clinical trial. The researchers also found that Tomivosertib synergistically enhances the anti-leukemic effects of Venetoclax against AML cells in vitro. Tomivosertib is now in phase 2 clinical trials. - Any illness, medical condition, organ system dysfunction, or social situation, . 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. Background. If results from the KICKSTART trial are clinically . A Randomized Double-Blind Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-(L) . The leading candidate, tomivosertib, is the subject of two Phase 2 studies featuring two . . 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. Tomivosertib (formerly eFT 508) is a highly selective, orally available, small molecule inhibitor of MNK1 and MNK2, . eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulators (STRs) for the treatment of cancer, today announced publication in the peer reviewed journal Nature Medicine of preclinical research demonstrating that tomivosertib (eFT508), the company's oral, selective, small molecule inhibitor of MNK1/2, selectively inhibits expression of the programed-death . 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. Lung Cancer Studies . 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 . Ph2 Tomivosertib+Anti-PD-L1 NSCLC. The company's research program currently has two novel drug candidates undergoing clinical trials. "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 . SAN DIEGO, July 27, 2018 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 anti-PD-1 or anti . 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. Clinical trial of BAY 1143269 as a combination therapy with docetaxel in NSCLC was terminated due to project prioritization. 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 . Finally, we demonstrate that the in vitro functional and mechanism observations are translatable to in vivo gastric cancer model in mice. It is scheduled to be annotated soon. Tomivosertib (eFT508) treatment leads to a dose-dependent reduction in eIF4E phosphorylation at serine 209 (IC50=2-16 nM) in tumor cell lines. Principal Investigator 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. 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 . 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. Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Tomivosertib. Generic Name. This Phase 2 Open-label Study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in Patients with advanced CR. DB15219. Home . Nave mice were trained for 1 trial, and then 2 baseline trials were conducted and scores for both trials were averaged. Tomivosertib (eFT508) also dramatically downregulates PD-L1 protein abundance. 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 . 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 . The success of tomivosertib reflects the powerful advantages of FBDD in rapid identification of selective lead compounds, and provided important guidance for medicinal chemists to carry out FBDD. 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 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 . 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). It potentially results in decreased tumor cell proliferation and tumor growth. eFFECTOR is supplying . 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; that together control tumor growth, survival and immune evasion. Tomivosertib (eFT508): eFFECTOR's wholly-owned, highly selective MNK inhibitor designed to enhance anti-tumor activity by stimulating activation, . 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 : Our trial will determine if the potent MNK inhibitor, tomivosertib, controls tumor growth either directly or by enhancing anti-tumor immunity. 3112 Background: Despite the broad activity of checkpoint inhibitors across tumor types, primary or secondary resistance after initial response represents a major challenge. Zotatifin Update Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure. 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 . Tomivosertib (eFT508) is a potent, highly selective, and orally active MNK1 and MNK2 inhibitor, with IC50s of 1-2 nM against both isoforms. 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) 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 . It is one of the first two Mnk inhibitors that entered clinical trials, and has displayed momentous activity against several solid and hematological cancers. Annapolis, MD. 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 . The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. 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 . 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 . Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy. Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Status: Enrolling Updated: 12/31/1969 Anne Arundel Medical Center. Multiple Myeloma. A Phase 1b/2 Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination With . Phase: III. 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 . 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 . Our study provides pre-clinical evidence to initialize clinical trials for gastric cancer using tomivosertib in combination with chemotherapy. eFFECTOR's lead product candidate, tomivosertib, is a MNK . The researchers also found that Tomivosertib synergistically enhances the anti-leukemic effects of Venetoclax against AML cells in vitro. "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 . This drug entry is a stub and has not been fully annotated. 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) The first patient was dosed in the phase 2b KICKSTART clinical trial from eFFECTOR Therapeutics, Inc. in early June. 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. The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. We are currently investigating zotatifin in ongoing clinical trials for solid tumors and as a potential host . 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. 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 . 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 . Tomivosertib Completed Phase 2 Trials for Castration Resistant Prostate Cancer Treatment. Each entry includes links to find associated clinical trials. Pending positive results from the KICKSTART Phase 2b clinical trial, the company plans to advance tomivosertib into Phase 3 registration trials. Our lead product candidate, tomivosertib, is an oral small molecule inhibitor of MNK. eIF4E is a component of the eIF4F . 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 . 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 . The present compilation provides a succinct review of the current state of development of pyridone-aminal-derived Mnk . 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 . The time until each animal fell was recorded for each trial. mi. The trial (NCT03690141), currently recruiting participants, will evaluate the safety, tolerability and antitumor activity of . . Tomivosertib (eFT-508) For research use only. 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 . The time until each animal fell was recorded for each trial. 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. This trial; Search. 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. A clinical trial for an investigational respiratory syncytial virus (RSV) vaccine combined with an approved flu vaccine for older adults. 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. Tomivosertib (eFT-508) inhibits eIF4E phosphorylation and dramatically downregulates PD-L1 protein abundance. 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), . Back to Tomivosertib. : EFT508-0011. Status: Enrolling . Sasikumar et al. Tomivosertib (eFT-508) is a potent and selective MNK1/2 inhibitor with IC50s of 2.4 nM and 1 nM, respectively. - Concurrent participation in another therapeutic clinical trial. Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART) NCT04622007. Tomivosertib (eFT508): eFFECTOR's wholly-owned, highly selective MNK inhibitor designed to enhance anti-tumor immune activity by stimulating activation, . 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 (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) is one of the molecules with such scaffold. One cohort will enroll patients with PD-L1 1% NSCLC who have . In addition, Dr. Patel will serve as a consultant to eFFECTOR through September 30, 2022. Nave mice were trained for 1 trial, and then 2 baseline trials were conducted and scores for both trials were averaged. including clinical trial and manufacturing delays; our ability to access the LPC facility is subject to certain conditions; our . 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.. These results prompted the advancement of CA-170 to human clinical trials. 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. . 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 . . 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), . Tomivosertib is under investigation in clinical trial NCT03318562 (A PD Study of Oral eFT508 in Subjects With Advanced TNBC and HCC). DrugBank Accession Number. The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance . The randomized trial will treat patients who have non-small cell lung cancer (NSCLC) with a combination of tomivosertib and Keytruda (pembrolizumab). Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART) . 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. Current Clinical Trials; EFT508-0011; Navigation. Protocol No. 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 Each entry includes links to find associated clinical trials. "We observed in our phase 2a trial of tomivosertib in combination with . Tomivosertib (formerly eFT 508) is a highly selective, orally available, small molecule inhibitor of MNK1 and MNK2, . describe the identification and characterization of CA-170, a small molecule inhibitor of PD-L1 and VISTA. 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; SAN DIEGO, CA, USA I July 27, 2018 I 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 anti-PD-1 . eFFECTOR is supplying . . from . We thank Jiangsu HengRui Medicine Co., China, for kindly providing the anti-PD-1 antibody camrelizumab. Tomivosertib. 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 .