HRAS

Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

Retrieved on: 
Wednesday, March 27, 2024
Mutation, RAF, MAPK, Growth, Half-life, PD, Colorectal cancer, RAS, Patient, Neoplasm, Cancer, HRAS, DCI, Human, Binimetinib, AACR, NRAS, Safety, Cycle, Pharmacokinetics, Encorafenib, Pharmaceutical industry

CAMBRIDGE, Mass., March 27, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations.

Key Points: 
  • In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.
  • “We are pleased to have dosed the first patient in our Phase 1/2a trial for IMM-6-415, our second product candidate to enter the clinic,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation.
  • We believe the shorter half-life of IMM-6-415 could provide a potential treatment option for a broad patient population with RAS or RAF mutations.
  • The trial will include solid tumor patients with any mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria.

Kura Oncology Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
NSCLC, Leukemia, Research, AML, Pedal, QT interval, FTI, Mirati Therapeutics, Investment, Postcholecystectomy syndrome, Physician, Clinical trial, ID, HRAS, Mirati, Prognosis, Renal cell carcinoma, FLT3, Webcast, Patient, KURA, Disease, G&A, LDAC, HNSCC, Cancer, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported fourth quarter and full year 2023 financial results and provided a corporate update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $32.5 million, compared to $22.7 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $14.2 million, compared to $12.5 million for the fourth quarter of 2022.
  • ET / 1:30 p.m. PT today, February 27, 2024, to discuss the financial results for the fourth quarter and full year 2023 and to provide a corporate update.

Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

Retrieved on: 
Tuesday, December 12, 2023
Food, MAPK, IND, FDA, Colorectal cancer, Hope, ANY, Half-life, Human, Clinical trial, Cancer, HRAS, Mutation, Neoplasm, RAF, Growth, NRAS, RAS, Patient, Binimetinib, Pharmaceutical industry

CAMBRIDGE, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-6-415, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, twice-daily small molecule, in development for the treatment of advanced RAF or RAS mutant solid tumors.

Key Points: 
  • “The clearance of the IND application for IMM-6-415 is another important milestone in our efforts to create safer, more durable, and more effective treatment options for large groups of cancer patients,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation.
  • We are proud that the IMM-6-415 clinical trial will be open to an even broader group of solid tumor patients with ANY mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria.
  • In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.
  • “Furthermore, IMM-6-415 as a single agent demonstrated high sensitivity in a wide range of MAPK-driven tumor types, including models of RAS or RAF mutant disease.

Kura Oncology Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
CR, Research, Mirati Therapeutics, NSCLC, AACR, Kura, Acute myeloid leukemia, FTI, Hematology, Mirati, Conference, KMT2A, CRH, KRAS, Azacitidine, HRAS, HNSCC, Disease, ID, Marketing, Webcast, Cancer, KURA, Oncology, Venetoclax, Mixed-phenotype acute leukemia, FLT3, Safety, European Society of Gynaecological Oncology, Renal cell carcinoma, Investment, Patient, Therapy, AML, Pharmaceutical industry, Bank, Video game, Cryptocurrency

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Key Points: 
  • ET –
    SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported third quarter 2023 financial results and provided a corporate update.
  • Research and development expenses for the third quarter of 2023 were $29.3 million, compared to $25.0 million for the third quarter of 2022.
  • General and administrative expenses for the third quarter of 2023 were $13.1 million, compared to $11.6 million for the third quarter of 2022.
  • ET / 1:30 p.m. PT today, November 2, 2023, to discuss the financial results for the third quarter 2023 and to provide a corporate update.

Kura Oncology Announces First Patient Dosed in FIT-001 Trial of Next-Generation Farnesyl Transferase Inhibitor KO-2806

Retrieved on: 
Thursday, October 19, 2023
NSCLC, FTI, Therapy, Lung cancer, Protein, HRAS, Pharmacokinetics, KURA, Carcinoma, Safety, Cancer, Renal cell carcinoma, SAN, EGFR, Pharmaceutical industry

SAN DIEGO, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in the FIT-001 Phase 1 dose-escalation trial of KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI) for the treatment of advanced solid tumors.

Key Points: 
  • SAN DIEGO, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in the FIT-001 Phase 1 dose-escalation trial of KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI) for the treatment of advanced solid tumors.
  • “We’re excited to advance our next-generation FTI drug candidate into the clinical setting, underscoring our commitment and sense of urgency to develop novel therapies for cancer indications with high unmet medical needs,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.
  • “Our understanding of how to use FTIs to target farnesylated proteins has matured significantly beyond our initial strategy to target HRAS mutant tumors.
  • For more information regarding FIT-001, please visit www.clinicaltrials.gov (identifier: NCT06026410 ).

Vesica Health Announces Publication of Study Demonstrating AssureDx Meaningfully Improves Identification of Hematuria Patients at High Risk for Bladder Cancer

Retrieved on: 
Monday, October 9, 2023
OTX1, Probability, AUA, Physician, Department of Urology, University of Virginia, National Capital FreeNet, American Urological Association, TERT, Johns Hopkins University, DNA, Risk, AUC, Capital city, Microhematuria, Urology, Hematuria, Health, HEALTH, Cancer, Carcinoma, TWIST1, Alvin J. Siteman Cancer Center, HRAS, DNA methylation, European Urology, Medical school, Patient, Bladder cancer, FGFR3, Liquid biopsy, Risk assessment, Barnes-Jewish Hospital

The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology.

Key Points: 
  • The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology.
  • The study analyzed a prospectively collected cohort of 838 hematuria subjects previously tested by AssureDx.
  • Subjects were classified into the AUA risk categories for bladder cancer based on their sex, age, and type of hematuria, also known as urothelial carcinoma (UC).
  • "Publication of this pivotal study in a leading international urology journal, demonstrating AssureDx enhances the AUA Guidelines, underscores the importance of the test for risk stratification of hematuria patients and identification of those at increased risk for bladder cancer," stated Christopher Thibodeau, Chief Executive Officer of Vesica Health.

Loxo@Lilly Unveils Three New Oncology Programs at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Wednesday, October 4, 2023
NRAS, KRAS, Eli Lilly and Company, LLY, AACR, Conference, NYSE, HRAS, Pharmaceutical industry, Vaccine

INDIANAPOLIS, Oct. 4, 2023 /PRNewswire/ -- Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), today announced that preclinical data for agents targeting KRAS G12D, multiple oncogenic KRAS mutations and Nectin-4, will be presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023, in Boston.

Key Points: 
  • INDIANAPOLIS, Oct. 4, 2023 /PRNewswire/ -- Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), today announced that preclinical data for agents targeting KRAS G12D, multiple oncogenic KRAS mutations and Nectin-4, will be presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023, in Boston.
  • These programs are among the next slate of new oncology agents planned to enter clinical trials for Loxo@Lilly in 2024.
  • "These new programs represent years of focused work to create differentiated molecules against exacting target product profiles.
  • Details on poster presentations are below:
    Presentation Title: Preclinical characterization of orally bioavailable, highly potent pan-KRAS inhibitors with selectivity over HRAS and NRAS

Kura Oncology Reports Preclinical Data Showing Ability of KO-2806 to Enhance Antitumor Activity of KRASᴳ¹²ᶜ Inhibitors in Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, September 28, 2023
KRAS, Senior, CDX, HRAS, Neoplasm, Cancer, Cell proliferation, MAPK, NSCLC, Lung cancer, FTI, PDX, Patient, Translational research, SAN, KURA, Drug development, RTK, Poster, Pharmaceutical industry

SAN DIEGO, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported preclinical data supporting the development of its next-generation farnesyl transferase inhibitor (FTI) KO-2806 in combination with KRASG12C inhibitors to drive tumor regressions and durable responses in KRASG12C-mutant non-small cell lung cancer (NSCLC).

Key Points: 
  • The new findings are being presented in an oral session today at the 5th RAS-Targeted Drug Development Summit in Boston.
  • A copy of the presentation, entitled “Farnesyl Transferase Inhibitors – Evolution from Targeting HRAS to Overcoming Adaptive Resistance to Targeted Therapies,” is available in the Posters and Presentations section on Kura’s website.
  • KRASG12C inhibitors have previously been shown to activate RTK signaling, leading to ERK-RSK and/or mTOR-S6 pathway reactivation.
  • In addition, the CDX and PDX models demonstrated enhanced duration and depth of antitumor response compared to adagrasib as a single-agent therapy.

New Data Suggest Veracyte’s Afirma Molecular Testing Capabilities Can Help Advance Scientific Understanding of Thyroid Nodules and Cancer

Retrieved on: 
Tuesday, June 20, 2023
Oncology, Medical Supplies, Health, Biometrics, Health Technology, Genetics, Biotechnology, ENDO, NRAS, Thyroid nodule, Database, DNA, Malignancy, Memorial Hermann Health System, Aggression, HRAS, Cancer, Lymph, Research, RNA, Washington University in St. Louis, Thyroid, FNA, Patient, Physician, Risk, TERT, Endocrine Society, Diagnosis, GSC, Metastasis, Biopsy, Medical device, Endocrinology

(Nasdaq: VCYT) announced that new data presented at ENDO 2023, the annual meeting of The Endocrine Society, suggest the company’s Afirma molecular testing and whole-transcriptome capabilities can provide novel insights that may advance the scientific understanding of thyroid nodule biology.

Key Points: 
  • (Nasdaq: VCYT) announced that new data presented at ENDO 2023, the annual meeting of The Endocrine Society, suggest the company’s Afirma molecular testing and whole-transcriptome capabilities can provide novel insights that may advance the scientific understanding of thyroid nodule biology.
  • “These data demonstrate that our Afirma molecular testing capabilities and genomic-profile database are valuable tools that can help researchers better understand the genomic underpinnings of thyroid nodules and cancer,” said Joshua Klopper, M.D., Veracyte’s medical director of Endocrinology.
  • They assessed the signatures among known malignancies and indeterminate nodules (Bethesda III-IV) classified as suspicious for cancer by the Afirma Genomic Sequencing Classifier (GSC).
  • “Our study demonstrates that the Afirma testing platform and database can be used as a research tool to develop novel genomic research signatures that may help advance the understanding of thyroid cancer behavior,” said Dr. Golding.

Immuneering Completes Dose Escalation in the IMM-1-104 Phase 1 Clinical Trial for RAS-Mutant, Advanced Solid Tumors

Retrieved on: 
Monday, June 5, 2023
NRAS, AACR, PD, Half-life, HRAS, SRC, Cancer, American Association for Cancer Research, Mutation, Cmax, Optimus, Patient, Data, China Bio-Immunity Corporation, Toxic leukoencephalopathy, Caregiver, Safety, Pharmaceutical industry, Immune-related response criteria

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, today announced the completion of the dose-escalation portion of the Phase 1/2a study for its lead asset IMM-1-104 in patients with advanced solid tumors. The study’s Safety Review Committee (SRC) completed its evaluation and determined that doses up to and including 320 mg once daily are tolerable with no dose limiting toxicities. Enrollment in the Phase 1b expansion portion of the study will now commence and is designed to evaluate two dosing cohorts of 12 patients each at an oral dose of 240mg or 320 mg once daily. Three patients already enrolled in the study have been dosed at the 320 mg dose level.

Key Points: 
  • The study’s Safety Review Committee (SRC) completed its evaluation and determined that doses up to and including 320 mg once daily are tolerable with no dose limiting toxicities.
  • Enrollment in the Phase 1b expansion portion of the study will now commence and is designed to evaluate two dosing cohorts of 12 patients each at an oral dose of 240mg or 320 mg once daily.
  • Three patients already enrolled in the study have been dosed at the 320 mg dose level.
  • “We are very pleased to have completed the dose escalation portion of our Phase 1 study of IMM-1-104 ahead of our original timeline,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.