Receptor tyrosine kinase

Comanche Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for CBP-4888, an siRNA Investigational Therapy for the Treatment of Preeclampsia

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Thursday, March 30, 2023
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CONCORD, Mass., March 30, 2023 /PRNewswire/ -- Comanche Biopharma Corp., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for Comanche's novel, siRNA therapy to treat preeclampsia.

Key Points: 
  • CONCORD, Mass., March 30, 2023 /PRNewswire/ -- Comanche Biopharma Corp., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for Comanche's novel, siRNA therapy to treat preeclampsia.
  • Preeclampsia is a prevalent hypertensive disorder of pregnancy for which there is no existing therapy that can modify disease progression.
  • "The FDA's clearance of CBP-4888 allows us to take another major step toward developing a treatment for preeclampsia," said Scott Johnson, M.D., Co-Founder and CEO of Comanche Biopharma.
  • Comanche is committed to lowering the risks of pregnancy and prematurity worldwide by safely sustaining natural pregnancy.

Mirati Therapeutics Announces Update for the Phase 3 SAPPHIRE Study

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Friday, December 2, 2022
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SAN DIEGO, Dec. 2, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that based on the results of an interim analysis on overall survival, the registrational Phase 3 study evaluating sitravatinib in combination with nivolumab (OPDIVO®)1 in patients with second or third line non-squamous non-small cell lung cancer (NSQ-NSCLC) who have acquired resistance to prior therapy with chemotherapy and immune checkpoint inhibitor therapy (SAPPHIRE) will continue to the study's final analysis. The final analysis is expected to be reached in mid-2023.

Key Points: 
  • "We remain committed to developing our portfolio of oncology candidates and advancing our lung cancer strategy to positively impact the lives of patients with cancer.
  • Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12Dinhibitor, MRTX1719, an investigational PRMT5 inhibitor, and other oncology discovery programs.
  • For more information about Mirati Therapeutics, Inc., visit us at Mirati.com or follow us on Twitter and LinkedIn .
  • This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati").

eFFECTOR Therapeutics Completes Enrollment in Second of Three Cohorts of Phase 1b Clinical Trial of Zotatifin for the Treatment of COVID-19

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Wednesday, October 26, 2022
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eFFECTOR anticipates opening enrollment in the third cohort by the end of 2022, and expects to report topline data for all three cohorts in the first half of 2023.

Key Points: 
  • eFFECTOR anticipates opening enrollment in the third cohort by the end of 2022, and expects to report topline data for all three cohorts in the first half of 2023.
  • Zotatifin is an investigational host-directed antiviral, meaning that it acts on a human protein that the SARS-CoV-2 virus hijacks to synthesize new viruses.
  • As such, zotatifin may have a higher barrier to viral mutational escape than therapies that target components of the virus itself.
  • eFFECTOR cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

eFFECTOR Therapeutics Doses First Patient in Second Cohort of Phase 1b Clinical Trial of Zotatifin for the Treatment of COVID-19

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Wednesday, September 14, 2022
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SAN DIEGO and REDWOOD CITY, Calif., Sept. 14, 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 announced it has dosed the first patient in the second cohort of its Phase 1b clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. The study is a double-blind, randomized, placebo-controlled trial evaluating the safety and antiviral activity of a single dose of zotatifin and is being conducted in collaboration with the Quantitative Biosciences Institute (QBI) at the University of California, San Francisco, under a $5 million cooperative agreement sponsored by the Defense Advanced Research Projects Agency.

Key Points: 
  • Dose escalation to the second cohort comes after the positive recommendation of the independent data safety monitoring board upon review of safety data from the first dose cohort.
  • The completed cohort also included the first subjects dosed with a sub-cutaneous formulation of zotatifin and preliminary analysis demonstrated equivalent plasma drug levels compared to IV delivery.
  • Achieving equivalent drug levels when zotatifin was delivered by the sub-cutaneous route provides an opportunity for convenient dosing in both the COVID and cancer settings.
  • As such, zotatifin may have a higher barrier to viral mutational escape than therapies that target components of the virus itself.

Erasca Presents Promising Preliminary Phase 1/1b Monotherapy Data for ERAS-007 ERK and ERAS-601 SHP2 Inhibitors Supporting Ongoing and Future Combination Trials

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Wednesday, September 7, 2022
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SAN DIEGO, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced promising preliminary Phase 1/1b monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in BRAF-driven and RAS/MAPK-altered solid tumors.

Key Points: 
  • We anticipate initiating a dose escalation trial for ERAS-007 in combination with ERAS-601 in the first half of 2023.
  • HERKULES-3 is a Phase 1b/2 master protocol for ERAS-007 in combination with various agents in patients with gastrointestinal cancers.
  • HERKULES-1 is a Phase 1b/2 clinical trial that will include evaluation of ERAS-601 in combination with ERAS-007 in advanced solid tumors.
  • HERKULES-2 is a Phase 1b/2 master protocol that includes evaluation of ERAS-601 in combination with various agents in patients with NSCLC.

Erasca to Host R&D Day with KOL Dr. David Hong on Lead Clinical Programs ERAS-007 and ERAS-601 in Advanced Solid Tumors

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Wednesday, August 24, 2022
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SAN DIEGO, Aug. 24, 2022 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced that it will host a research and development day, with a focus on the company’s ERAS-007 ERK1/2 inhibitor and ERAS-601 SHP2 inhibitor in advanced solid tumors, on Wednesday, September 7, 2022, at 4:30 PM Eastern Time.

Key Points: 
  • Erasca, who will present preliminary clinical data and future directions for its lead clinical candidates with best-in-class potential, ERAS-007 and ERAS-601, for the treatment of advanced solid tumors with RAS/MAPK pathway alterations.
  • David S. Hong, M.D., serves as deputy chair in the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center in Houston, Texas.
  • Dr. Hong earned his medical degree from Albert Einstein College of Medicine in 1999, following his undergraduate studies in oncology at Yale University.
  • FLAGSHP-1 is a Phase 1/1b dose escalation trial evaluating ERAS-601 as a monotherapy in advanced solid tumors and in combination in triple wildtype CRC and HPV-negative advanced HNSCC.

Erasca and MD Anderson Announce Strategic Research and Development Collaboration in RAS/MAPK-Driven Cancers

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Tuesday, August 23, 2022
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SAN DIEGO and HOUSTON, Aug. 23, 2022 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, and The University of Texas MD Anderson Cancer Center (MD Anderson), today announced a strategic research and development collaboration to evaluate multiple agents from Erasca’s pipeline targeting the RAS/MAPK pathway as either single-agent or combination therapies.

Key Points: 
  • Our strategic collaboration with MD Anderson broadens the evaluation of ERAS-007 and ERAS-601 and explores additional therapeutic opportunities across our pipeline, said Jonathan E. Lim, M.D., Erascas chairman, CEO, and co-founder.
  • The RAS/MAPK pathway is one of cancers most frequently altered pathways, affecting more than 5 million new patients with cancer annually worldwide.
  • The alliance will build on Erascas existing collaborations with MD Anderson investigators Scott Kopetz, M.D., Ph.D. , professor of Gastrointestinal Medical Oncology , and David S. Hong, M.D.
  • MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Erasca Announces Clinical Trial Collaboration and Supply Agreement with Eli Lilly and Company to Evaluate ERAS-601 and Cetuximab Combination

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Monday, July 18, 2022
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SAN DIEGO, July 18, 2022 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced that it has entered into a clinical trial collaboration and supply agreement (CTCSA) with Eli Lilly and Company for Lilly’s anti-EGFR antibody cetuximab (ERBITUX®).

Key Points: 
  • Erasca is the sponsor of the trial, and Lilly is supplying cetuximab at no cost.
  • Erasca previously signed CTCSAs with Lilly and Pfizer, respectively, to evaluate cetuximab and encorafenib (BRAFTOVI) in combination with Erascas ERK1/2 inhibitor, ERAS-007, as part of Erascas HERKULES-3 Phase 1b/2 trial.
  • We are pleased to enter another clinical trial collaboration with Lilly to explore cetuximab in combination with ERAS-601, our SHP2 inhibitor, in EGFR-driven cancers that are highly dependent on RAS/MAPK signaling, said Jonathan E. Lim, M.D., Erascas chairman, CEO, and co-founder.
  • ERBITUX is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist Market Insights 2022: Coverage of 15 Companies and Respective Pipeline Drugs - ResearchAndMarkets.com

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Wednesday, June 29, 2022
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This Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist - Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist pipeline landscape.

Key Points: 
  • This Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist - Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence R&D Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist.
  • Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist: Therapeutic Assessment
    This segment of the report provides insights about the Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • The companies which have their Fibroblast Growth Factor Receptor 4 (FGFR4) Antagonist drug candidates in the most advanced stage, i.e Phase III include, Helsinn.

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

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Sunday, June 5, 2022
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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 treatment was generally well tolerated, resulted in suppression of multiple oncogenic drivers and demonstrated initial signals of clinical activity.

Key Points: 
  • As of the cutoff date of March 4, 2022, interim results showed that zotatifin was generally well tolerated.
  • In the 25 patients who received the recommended Phase 2 dose, none exhibited zotatifin-related Grade 3, 4 or 5 TEAEs.
  • In Part 2 of the trial, early signals of clinical activity were observed in two patients with breast cancer.
  • Coupled with the initial signals of activity, these early results are encouraging for further development of zotatifin, especially in ER+ breast cancer.