MNK1 inhibitors(MAP kinase-interacting serine/threonine-protein kinase MNK1 inhibitors), MNK2 inhibitors(MAP kinase-interacting serine/threonine-protein kinase 2 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [3]

Active Indication

Non-Small Cell Lung CancerPD-L1 positive Lung CancerBreast Cancer+ [4]

Inactive Indication

Advanced breast cancerAdvanced Malignant Solid NeoplasmAdvanced Triple-Negative Breast Carcinoma+ [2]

Originator Organization

eFFECTOR Therapeutics Operations, Inc.

Active Organization

Merck Serono SA

Pfizer Inc.

eFFECTOR Therapeutics Operations, Inc.

+ [1]

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Structure

Molecular FormulaC17H21ClN6O2

InChIKeyWBGPPUUXCGKTSC-UHFFFAOYSA-N

CAS Registry1849590-02-8

Clinical Trials associated with Tomivosertib

NCT05744739 / Active, not recruitingPhase 1IIT

Phase 1 Dose Escalation Study of Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)

Phase 1 of the study will open first with a (Bayesian optimal interval BOIN) dose finding design. The starting dose of tomivosertib is 100mgdaily (doses 24 ± 2 hours apart), PO, self-administered with meals. The dose finding follows a BOIN design, with the 100mg BID dose level with a meal being the highest dose. There is one dose level below (dose level -1 = 100mg QD without a meal) that will be given if the de-escalation condition is met during dose finding. Upon completion of the phase 1 dose finding portion of the study, the recommended starting dose of tomivosertib for the subsequent combination with the other agents will be determined, as described in Section 4.3 and Section 8.0.
Tomivosertib will be dosed continuously on days 1-28 of each 28-day cycle at the dose level assigned for that cohort.

Start Date29 Sep 2023

Sponsor / Collaborator

Northwestern University

[+2]

NCT04622007 / Active, not recruitingPhase 2

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

Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC

Start Date02 Jun 2021

Sponsor / Collaborator

eFFECTOR Therapeutics Operations, Inc.

[+2]

NCT04261218 / CompletedPhase 1IIT

A Trial to Assess the Safety, Pharmacodynamic Effects, Pharmacokinetics and Efficacy of the MNK Inhibitor Tomivosertib (eFT508) in Combination With Paclitaxel, Following a Run-in Period of Tomivosertib Monotherapy, in Patients With Advanced Breast Cancer

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.
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 and at least one measurable lesion, for whom standard-of-care treatments are ineffective, not tolerated or were refused.
All patients will be initially treated with tomivosertib for 14 days (referred as the run-in period). Once treatment samples are obtained, weekly paclitaxel will be added to the treatment regimen.
Tumor assessments will be done at screening and then periodically throughout trial treatment. Patients will continue to receive trial treatment until progressive disease, as defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, intolerable trial-treatment-related toxicity, consent withdrawal, or other criteria is met (defined within the trial protocol).

Start Date25 Aug 2020

Sponsor / Collaborator

Translational Research In Oncology

[+2]

100 Clinical Results associated with Tomivosertib

100 Translational Medicine associated with Tomivosertib

100 Patents (Medical) associated with Tomivosertib

Literatures (Medical) associated with Tomivosertib

05 Sep 2024·NATURE

Remodelling of the translatome controls diet and its impact on tumorigenesis

Article

Author: Yang, Haojun ; Oses-Prieto, Juan A ; Kajimura, Shingo ; Shah, Hardik ; Burlingame, Alma L ; Lincoff, James ; Seiple, Ian ; Ruggero, Davide ; Edmondson, Quinn ; Grabe, Michael ; Zingaro, Vincenzo Andrea ; Oikawa, Satoshi ; Tom, Harrison

Fasting is associated with a range of health benefits^1-6. How fasting signals elicit changes in the proteome to establish metabolic programmes remains poorly understood. Here we show that hepatocytes selectively remodel the translatome while global translation is paradoxically downregulated during fasting^7,8. We discover that phosphorylation of eukaryotic translation initiation factor 4E (P-eIF4E) is induced during fasting. We show that P-eIF4E is responsible for controlling the translation of genes involved in lipid catabolism and the production of ketone bodies. Inhibiting P-eIF4E impairs ketogenesis in response to fasting and a ketogenic diet. P-eIF4E regulates those messenger RNAs through a specific translation regulatory element within their 5' untranslated regions (5' UTRs). Our findings reveal a new signalling property of fatty acids, which are elevated during fasting. We found that fatty acids bind and induce AMP-activated protein kinase (AMPK) kinase activity that in turn enhances the phosphorylation of MAP kinase-interacting protein kinase (MNK), the kinase that phosphorylates eIF4E. The AMPK-MNK-eIF4E axis controls ketogenesis, revealing a new lipid-mediated kinase signalling pathway that links ketogenesis to translation control. Certain types of cancer use ketone bodies as an energy source^9,10 that may rely on P-eIF4E. Our findings reveal that on a ketogenic diet, treatment with eFT508 (also known as tomivosertib; a P-eIF4E inhibitor) restrains pancreatic tumour growth. Thus, our findings unveil a new fatty acid-induced signalling pathway that activates selective translation, which underlies ketogenesis and provides a tailored diet intervention therapy for cancer.

03 Sep 2024·BRAIN

Tomivosertib reduces ectopic activity in dorsal root ganglion neurons from patients with radiculopathy

Article

Author: Price, Theodore J ; Dussor, Greg ; Li, Yan ; Cata, Juan P ; Dougherty, Patrick M ; Uhelski, Megan L ; Tatsui, Claudio E ; Mwirigi, Juliet M ; Corrales, German ; North, Robert Y ; McDonough, Kathleen E

Abstract:

Spontaneous activity in dorsal root ganglion (DRG) neurons is a key driver of neuropathic pain in patients suffering from this largely untreated disease. While many intracellular signalling mechanisms have been examined in preclinical models that drive spontaneous activity, none have been tested directly on spontaneously active human nociceptors.Using cultured DRG neurons recovered during thoracic vertebrectomy surgeries, we showed that inhibition of mitogen-activated protein kinase interacting kinase (MNK) with tomivosertib (eFT508, 25 nM) reversibly suppresses spontaneous activity in human sensory neurons that are likely nociceptors based on size and action potential characteristics associated with painful dermatomes within minutes of treatment.Tomivosertib treatment also decreased action potential amplitude and produced alterations in the magnitude of after hyperpolarizing currents, suggesting modification of Na+ and K+ channel activity as a consequence of drug treatment. Parallel to the effects on electrophysiology, eFT508 treatment led to a profound loss of eIF4E serine 209 phosphorylation in primary sensory neurons, a specific substrate of MNK, within 2 min of drug treatment. Our results create a compelling case for the future testing of MNK inhibitors in clinical trials for neuropathic pain.

01 Aug 2024·PHARMACOLOGICAL RESEARCH

ephrin-B2 promotes nociceptive plasticity and hyperalgesic priming through EphB2-MNK-eIF4E signaling in both mice and humans

Article

Author: Srikanth, Kolluru D ; Price, Theodore J ; Jain, Ashita ; Venkatesan, Rupali ; Krishnagiri, Sharada ; Yousuf, Muhammad Saad ; Dussor, Gregory ; Dalva, Matthew B ; Mei, Hao-Ruei ; Elahi, Hajira ; David, Eric T

Ephrin-B-EphB signaling can promote pain through ligand-receptor interactions between peripheral cells, like immune cells expressing ephrin-Bs, and EphB receptors expressed by DRG neurons. Previous studies have shown increased ephrin-B2 expression in peripheral tissues like synovium of rheumatoid and osteoarthritis patients, indicating the clinical significance of this signaling. The primary goal of this study was to understand how ephrin-B2 acts on mouse and human DRG neurons, which express EphB receptors, to promote pain and nociceptor plasticity. We hypothesized that ephrin-B2 would promote nociceptor plasticity and hyperalgesic priming through MNK-eIF4E signaling, a critical mechanism for nociceptive plasticity induced by growth factors, cytokines and nerve injury. Both male and female mice developed dose-dependent mechanical hypersensitivity in response to ephrin-B2, and both sexes showed hyperalgesic priming when challenged with PGE₂ injection either to the paw or the cranial dura. Acute nociceptive behaviors and hyperalgesic priming were blocked in mice lacking MNK1 (Mknk1 knockout mice) and by eFT508, a specific MNK inhibitor. Sensory neuron-specific knockout of EphB2 using Pirt-Cre demonstrated that ephrin-B2 actions require this receptor. In Ca²⁺-imaging experiments on cultured DRG neurons, ephrin-B2 treatment enhanced Ca²⁺ transients in response to PGE₂ and these effects were absent in DRG neurons from MNK1^-/- and EphB2-Pirt^Cre mice. In experiments on human DRG neurons, ephrin-B2 increased eIF4E phosphorylation and enhanced Ca²⁺ responses to PGE₂ treatment, both blocked by eFT508. We conclude that ephrin-B2 acts directly on mouse and human sensory neurons to induce nociceptor plasticity via MNK-eIF4E signaling, offering new insight into how ephrin-B signaling promotes pain.

News (Medical) associated with Tomivosertib

24 Jun 2024

·www.fiercebiotech.com

The end of eFFECTOR Therapeutics: Oncology biotech winds down after midstage fail

Part of the next steps include looking for strategic alternatives for eFFECTOR’s development programs. It’s the end of an era—eFFECTOR Therapeutics’ era to be exact. The oncology biotech has laid off staff as it plans to wind down, according to a June 24 company release. This includes eFFECTOR CEO Stephen Worland, Ph.D.; Chief Financial Officer Michael Byrnes; and Chief Medical Officer Douglas Warner, M.D., who all stopped serving in their positions at the end of last week. The company expects to spend about $600,000 by June 30 in one-time charges and cash expenditures tied to the workforce reduction, according to Securities and Exchange Commission documents. In the meantime, the board of directors has tapped Craig Jalbert to lead as eFFECTOR’s CEO, president, treasurer, secretary and sole board member. Jalbert is a principal from the accounting firm Verdolino & Lowey, P.C., and has more than three decades of experience helping companies wind down. Part of the next steps include looking for strategic alternatives for eFFECTOR’s development programs. The biotech’s lead asset is zotatifin, a selective eIF4A inhibitor being tested out in several mid-stage trials for solid tumors. In April, the company's other wholly-owned asset, tomivosertib, failed to improve progression-free survival in a phase 2b trial of patients with non-small cell lung cancer (NSCLC). Based on all the data available in the primary analysis, the company said it didn't see an obvious path forward for continuing development of the asset in frontline NSCLC. eFFECTOR also had a partnership with Big Pharma Pfizer for a preclinical asset dubbed eIF4Ei, which is also designed to tackle solid tumors. The $507 million biobucks deal was struck back in 2019 when Pfizer paid out $15 million up front in an exclusive licensing agreement to develop small-molecule inhibitors of eukaryotic initiation factor 4E (eIF4E) with eFFECTOR. The biotech was founded in 2012 based on research from the University of California, San Francisco labs of Davide Ruggero, Ph.D., and Kevan Shokat, Ph.D. eFFECTOR plans to ask to be delisted from the Nasdaq. Since announcing the planned shuttering, the biotech’s stock plummeted 77% from $1.17 per share at market close Friday to 29 cents this morning at opening.

Phase 2License out/inExecutive ChangePhase 1

20 May 2024

·www.globenewswire.com

eFFECTOR Therapeutics to Collaborate with the Dana-Farber Cancer Institute on an Investigator-Sponsored Phase 2 Clinical Trial Evaluating Zotatifin as Combination Treatment in ER+ Endometrial Cancer and in Low Grade Serous Ovarian Cancer

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today announced a collaboration to conduct an investigator-sponsored trial (IST) evaluating zotatifin in combination with abemaciclib and letrozole in patients with estrogen receptor-positive (ER+) endometrial cancer and low grade serous ovarian cancer at the Dana-Farber Cancer Institute (DFCI) under the direction of Panagiotis Konstantinopoulos, M.D., Ph.D., Director of Translational Research and attending oncologist in the Division of Gynecologic Oncology at DFCI, and an Associate Professor of Medicine at Harvard Medical School. “Endometrial cancer is the most prevalent cancer affecting the female reproductive organs in the United States,” said Dr. Konstantinopoulos. “While early detection offers hope for successful treatment, patients with recurrent or metastatic disease have limited treatment options. Recent studies of the abemaciclib and letrozole combo in ER+ endometrial cancer patients have shown promising activity, however, most patients either fail to respond or eventually develop resistance to CDK4/6 inhibition, a critical aspect of treatment. Similarly, low grade serous ovarian cancer has shown sensitivity to combined treatment with aromatase inhibitors and CDK4/6 inhibition, but responding patients eventually develop disease progression. By targeting eIF4A, which subsequently downregulates the key factors implicated in CDK4/6 inhibition resistance, we believe that integrating zotatifin with abemaciclib and letrozole treatment regimen represents a compelling strategy for combating recurrent endometrial cancer and low grade serous ovarian cancer.” Doug Warner, M.D., chief medical officer of eFFECTOR Therapeutics added, “We are thrilled to embark on this investigator-sponsored Phase 2 trial in collaboration with Dr. Konstantinopoulos and his team at the DFCI. This trial represents a significant step forward in our collective efforts to address the complexities of endometrial cancer and low grade serous ovarian cancer. By exploring the potential of zotatifin as a combination treatment and its unique mechanism of action, we aim to redefine the treatment landscape and improve outcomes for these patients. With this comprehensive approach which simultaneously targets tumor cell cycle progression while reducing estrogen levels, we hope to overcome resistance mechanisms and enhance treatment efficacy which we believe could be applied in various malignancies beyond breast and endometrial cancers. In parallel, we continue to advance development of zotatifin in ER+ metastatic breast cancer and anticipate determination of the Phase 2 dose (RP2D) of zotatifin in combination with fulvestrant and abemaciclib, in the second half of 2024.” About Zotatifin Zotatifin is a potent and sequence-selective small molecule inhibitor of the RNA helicase eIF4A that is designed to suppress the overproduction of cell cycle proteins and oncogenes, including Cyclins D and E, CDKs 4 and 6, ERα, KRAS, HER2, and other RTKs. Zotatifin is currently being evaluated in a Phase 2a expansion cohort in combination with fulvestrant and abemaciclib in ER+ breast cancer. Efficacy data presented at 2023 ASCO and SABCS showed a 26% response rate and mPFS of 7.4 months as a triplet in heavily pretreated patients. About eFFECTOR Therapeutics eFFECTOR is a clinical-stage biopharmaceutical company pioneering the development of a new class of oncology drugs referred to as STRIs. eFFECTOR’s STRI product candidates target the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK). The eIF4F complex is a central node where two of the most frequently mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways, converge to activate the translation of select mRNA into proteins that are frequent culprits in key disease-driving processes. 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. Zotatifin, eFFECTOR’s inhibitor of eIF4A, is currently being evaluated in a Phase 2a expansion cohort in combination with fulvestrant and abemaciclib in ER+ breast cancer and in Phase 2 IST in combination with abemaciclib and letrozole in ER+ endometrial cancer. Tomivosertib, eFFECTOR’s MNK inhibitor, is currently being evaluated in an investigator-sponsored trial in AML. eFFECTOR has a global collaboration with Pfizer to develop inhibitors of a third target, eIF4E. Forward-Looking StatementseFFECTOR cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the future clinical development of our product candidates, including expectations on enrollment and the timing of reporting data from ongoing clinical trials; the potential therapeutic benefits of our product candidates; and the timing and potential benefits of the IST evaluating zotatifin in combination with abemaciclib and letrozole in patients with ER+ endometrial cancer and low grade serous ovarian 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: potential delays in the commencement, enrollment and completion of clinical trials, including the IST conducted by DFCI; the success of our clinical trials and preclinical studies for our product candidates is uncertain; we are dependent on DFCI to conduct the IST trial and we may not realize any benefits from the collaboration with DFCI; our dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; and other risks described in our prior filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Investors: Christopher M. CalabreseManaging DirectorLifeSci Advisors917-680-5608ccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors617-283-2856kgardner@lifesciadvisors.com Media: Michael Fitzhugh Vice President, Chief of Media StrategyLifeSci Communicationsmfitzhugh@lifescicomms.com

Phase 2Clinical ResultPhase 1

20 May 2024

·www.biospace.com

eFFECTOR Therapeutics to Collaborate with the Dana-Farber Cancer Institute on an Investigator-Sponsored Phase 2 Clinical Trial Evaluating Zotatifin as Combination Treatment in ER+ Endometrial Cancer

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today announced a collaboration to conduct an investigator-sponsored trial (IST) evaluating zotatifin in combination with abemaciclib and letrozole in patients with estrogen receptor-positive (ER+) endometrial cancer and low grade serous ovarian cancer at the Dana-Farber Cancer Institute (DFCI) under the direction of Panagiotis Konstantinopoulos, M.D., Ph.D., Director of Translational Research and attending oncologist in the Division of Gynecologic Oncology at DFCI, and an Associate Professor of Medicine at Harvard Medical School. “Endometrial cancer is the most prevalent cancer affecting the female reproductive organs in the United States,” said Dr. Konstantinopoulos. “While early detection offers hope for successful treatment, patients with recurrent or metastatic disease have limited treatment options. Recent studies of the abemaciclib and letrozole combo in ER+ endometrial cancer patients have shown promising activity, however, most patients either fail to respond or eventually develop resistance to CDK4/6 inhibition, a critical aspect of treatment. Similarly, low grade serous ovarian cancer has shown sensitivity to combined treatment with aromatase inhibitors and CDK4/6 inhibition, but responding patients eventually develop disease progression. By targeting eIF4A, which subsequently downregulates the key factors implicated in CDK4/6 inhibition resistance, we believe that integrating zotatifin with abemaciclib and letrozole treatment regimen represents a compelling strategy for combating recurrent endometrial cancer and low grade serous ovarian cancer.” Doug Warner, M.D., chief medical officer of eFFECTOR Therapeutics added, “We are thrilled to embark on this investigator-sponsored Phase 2 trial in collaboration with Dr. Konstantinopoulos and his team at the DFCI. This trial represents a significant step forward in our collective efforts to address the complexities of endometrial cancer and low grade serous ovarian cancer. By exploring the potential of zotatifin as a combination treatment and its unique mechanism of action, we aim to redefine the treatment landscape and improve outcomes for these patients. With this comprehensive approach which simultaneously targets tumor cell cycle progression while reducing estrogen levels, we hope to overcome resistance mechanisms and enhance treatment efficacy which we believe could be applied in various malignancies beyond breast and endometrial cancers. In parallel, we continue to advance development of zotatifin in ER+ metastatic breast cancer and anticipate determination of the Phase 2 dose (RP2D) of zotatifin in combination with fulvestrant and abemaciclib, in the second half of 2024.” About Zotatifin Zotatifin is a potent and sequence-selective small molecule inhibitor of the RNA helicase eIF4A that is designed to suppress the overproduction of cell cycle proteins and oncogenes, including Cyclins D and E, CDKs 4 and 6, ERα, KRAS, HER2, and other RTKs. Zotatifin is currently being evaluated in a Phase 2a expansion cohort in combination with fulvestrant and abemaciclib in ER+ breast cancer. Efficacy data presented at 2023 ASCO and SABCS showed a 26% response rate and mPFS of 7.4 months as a triplet in heavily pretreated patients. About eFFECTOR Therapeutics eFFECTOR is a clinical-stage biopharmaceutical company pioneering the development of a new class of oncology drugs referred to as STRIs. eFFECTOR’s STRI product candidates target the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK). The eIF4F complex is a central node where two of the most frequently mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways, converge to activate the translation of select mRNA into proteins that are frequent culprits in key disease-driving processes. 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. Zotatifin, eFFECTOR’s inhibitor of eIF4A, is currently being evaluated in a Phase 2a expansion cohort in combination with fulvestrant and abemaciclib in ER+ breast cancer and in Phase 2 IST in combination with abemaciclib and letrozole in ER+ endometrial cancer. Tomivosertib, eFFECTOR’s MNK inhibitor, is currently being evaluated in an investigator-sponsored trial in AML. eFFECTOR has a global collaboration with Pfizer to develop inhibitors of a third target, eIF4E. Forward-Looking Statements eFFECTOR cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the future clinical development of our product candidates, including expectations on enrollment and the timing of reporting data from ongoing clinical trials; the potential therapeutic benefits of our product candidates; and the timing and potential benefits of the IST evaluating zotatifin in combination with abemaciclib and letrozole in patients with ER+ endometrial cancer and low grade serous ovarian 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: potential delays in the commencement, enrollment and completion of clinical trials, including the IST conducted by DFCI; the success of our clinical trials and preclinical studies for our product candidates is uncertain; we are dependent on DFCI to conduct the IST trial and we may not realize any benefits from the collaboration with DFCI; our dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; and other risks described in our prior filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Investors: Christopher M. Calabrese Managing Director LifeSci Advisors 917-680-5608 ccalabrese@lifesciadvisors.com Kevin Gardner Managing Director LifeSci Advisors 617-283-2856 kgardner@lifesciadvisors.com Media: Michael Fitzhugh Vice President, Chief of Media Strategy LifeSci Communications mfitzhugh@lifescicomms.com

Phase 2Clinical Result

100 Deals associated with Tomivosertib

External Link

KEGG	Wiki	ATC	Drug Bank
D11452	-	-	DB15219

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 2	US	eFFECTOR Therapeutics Operations, Inc.	02 Jun 2021
Non-Small Cell Lung Cancer	Phase 2	AU	eFFECTOR Therapeutics Operations, Inc.	02 Jun 2021
Non-Small Cell Lung Cancer	Phase 2	GE	eFFECTOR Therapeutics Operations, Inc.	02 Jun 2021
PD-L1 positive Lung Cancer	Phase 2	US	eFFECTOR Therapeutics Operations, Inc.	02 Jun 2021
PD-L1 positive Lung Cancer	Phase 2	AU	eFFECTOR Therapeutics Operations, Inc.	02 Jun 2021
PD-L1 positive Lung Cancer	Phase 2	GE	eFFECTOR Therapeutics Operations, Inc.	02 Jun 2021
Castration-Resistant Prostatic Cancer	Phase 2	US	eFFECTOR Therapeutics Operations, Inc.	27 Nov 2018
Solid tumor	Phase 2	US	eFFECTOR Therapeutics Operations, Inc.	25 Jul 2018
Advanced Triple-Negative Breast Carcinoma	Phase 2	US	eFFECTOR Therapeutics Operations, Inc.	21 Nov 2017
Hepatocellular Carcinoma	Phase 2	US	eFFECTOR Therapeutics Operations, Inc.	21 Nov 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03690141 (CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	16	eFT508	lhwgprqncz(yzxnbkzphb) = mqprsjbtnr rbhwwkwxwj (wcqrqazysh, azqlpfusyb - naziwelkhz)	-	21 Jun 2024
NCT04622007 (KICKSTART, Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer First line PD-L1 ≥50%	-	tomivosertib+pembrolizumab	wzgexjxjyu(txlcsqyokh) = kpaccbcynh emzgfgzpin (noojefwvdm ) Not Met View more	Negative	04 Apr 2024
				Placebo+pembrolizumab	wzgexjxjyu(txlcsqyokh) = vweptjanra emzgfgzpin (noojefwvdm ) Not Met View more
NCT04261218 (AACR2022)	Phase 1	Metastatic breast cancer	14	Tomivosertib	gfkhfvkhfu(ptqgwgbrrg) = lljodoczjs pnbvqacezl (uuiuvokwgq, +/ - 40)	-	15 Jun 2022
				Paclitaxel	amttkvmdgd(jwbkgvnaca) = oluzlmgwqm jacwvwippv (ymhurdkofy, +/ - 220)
NCT03258398 (ASCO2019) Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma Third line Microsatellite Stable (MSS)	52	avelumab+tomivosertib	xzvvwyhlhr(bwmpdgrrtn) = buajrztbqv aqvghpcnwu (mofqjzgzso ) View more	Positive	31 May 2019
				avelumab+tomivosertib	knzkeppipm(fumdbzrvjx) = ulxmohxidw rpuroyktmw (xtropzvaxn )
NCT02605083 (ASCO2017)	Phase 1	HR-positive/HER2-low Solid Tumors	28	eFT508	okjunsjmoi(cuuqjlezam) = one pt with reversible Gr3 AST/ALT elevation cujnlgzwtf (hkcxllfdbb ) View more	-	30 May 2017

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