Treatment of lung cancer

EQRx Announces Acceptance of Marketing Authorization Application by the European Medicines Agency for Aumolertinib in EGFR-Mutated Non-small Cell Lung Cancer

Retrieved on: 
Friday, December 2, 2022
National Medical Products Administration, NSCLC, Safety, European Medicines Agency, Journal, Gefitinib, NMPA, Progression-free survival, Large-cell lung carcinoma, EGFR, Cancer, Annual report, American Journal of Clinical Oncology, EMA, MD, Patient, Social media, Health care, MAA, TKI, Lung cancer, Treatment of lung cancer, FAQ, Pharmaceutical industry, Greater China

The European Medicines Agency engages with 27 member states to ensure that the needs and concerns of a wide range of patients, including approximately 60,000 European patients who may be diagnosed with EGFR-mutated non-small cell lung cancer annually, are represented.

Key Points: 
  • The European Medicines Agency engages with 27 member states to ensure that the needs and concerns of a wide range of patients, including approximately 60,000 European patients who may be diagnosed with EGFR-mutated non-small cell lung cancer annually, are represented.
  • The MAA is primarily supported by data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC.
  • 3
    This is EQRxs second submission to a regulatory agency for aumolertinib.
  • Aumolertinibs MAA for use in EGFR-mutated non-small cell lung cancer is currently under review by the UKs Medicines and Healthcare products Regulatory Agency.

Qualigen Therapeutics, Inc. Announces 1-for-10 Reverse Stock Split

Retrieved on: 
Tuesday, November 22, 2022
AML, Cancer, Acute myeloid leukemia, Therapy, RAS, Exercise, Protein, Annual general meeting, CUSIP, Equiniti, Treatment of lung cancer, Prostate cancer, Fastpacking, G4S, FDA, Pharmaceutical industry, Security (finance)

CARLSBAD, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN Qualigen Therapeutics, Inc.), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces that its board of directors (the “Board”) has approved a 1-for-10 reverse stock split of the Company’s common stock. The reverse stock split will become effective at 12:01 am ET on November 23, 2022 and begin trading on a split-adjusted basis at the market open on November 23, 2022 with the new CUSIP number 74754R 202.

Key Points: 
  • The Company is implementing the reverse stock split to enable it to regain compliance with the Nasdaq $1.00 minimum bid price requirement.
  • As a result of the reverse stock split, every 10 shares of the Companys common stock issued and outstanding will be automatically reclassified into one share of common stock.
  • The reverse stock split will affect all stockholders uniformly and will not affect any stockholder's ownership percentage of Company shares, with the exception of those stockholders receiving cash in lieu of fractional shares.
  • Equiniti Trust Company (Equiniti) is acting as the exchange agent and transfer agent for the reverse stock split.

ImmunityBio to Participate in 34th Annual Piper Sandler Healthcare Conference

Retrieved on: 
Thursday, November 17, 2022
COVID-19, Infectious Diseases, Public Relations, Investor Relations, Clinical Trials, Communications, Biometrics, Biotechnology, General Health, Pharmaceutical, Health, Immunotherapy, FDA, BCG, GMP, HIV, Clinical trial, NMIBC, Infection, Severe acute respiratory syndrome coronavirus 2, Cancer, BLA, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, COVID-19, Treatment of lung cancer, CIS, Food, Vaccine, Pharmaceutical industry, ImmunityBio

ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases.

Key Points: 
  • ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases.
  • These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
  • ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.
  • ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

NEJM Evidence Publishes Results for ImmunityBio’s QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer

Retrieved on: 
Thursday, November 10, 2022
FDA, Infectious Diseases, Health, Clinical Trials, Oncology, Review, Private Securities Litigation Reform Act, Cancer, Forward-looking statement, Pembrolizumab, NEJM, Vaccine, Treatment of lung cancer, BCG, Severe acute respiratory syndrome coronavirus 2, Pancreatic cancer, Cystectomy, Food, Immunotherapy, CR, Breakthrough therapy, Incidence, Population, CRS, BLA, COVID-19, DFS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SEC, Medicine, Fast Track, TURBT, Patient, U.S. Securities and Exchange Commission, Infection, CIS, Large-cell lung carcinoma, Probability, Disease, NAI, Clinical trial, Maintenance, NK, GMP, Immune system, Progression-free survival, Nominal interest rate, HIV, FDA, Trial of the century, Pharmaceutical industry, ImmunityBio, NMIBC, FDA, Infectious Diseases, Health, Clinical Trials, Oncology

NEJM Evidence has published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease.

Key Points: 
  • NEJM Evidence has published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease.
  • Patients with intermediate or high-risk NMIBC typically receive a treatment of transurethral resection of the bladder tumor (TURBT) followed by BCG intravesical instillation.
  • However, cancer will recur in 30% to 40% of patients with NMIBC despite adequate treatment with BCG.
  • Moreover, even among those in whom a complete response is achieved with BCG, up to 50% see their cancer return.

G1 Therapeutics Announces Investigator Initiated Study of Trilaciclib and Lurbinectedin in Patients with Extensive Stage Small Cell Lung Cancer

Retrieved on: 
Wednesday, October 26, 2022
Lung, MDSC, PARK, Survival, Bladder cancer, Company, University, G1 Therapeutics, Lurbinectedin, G1, SCLC, Private Securities Litigation Reform Act, Treatment of lung cancer, Diagnosis, Nasdaq, Progression-free survival, Lung cancer, Cancer, U.S. Securities and Exchange Commission, Forward-looking statement, Patient, Trilaciclib, ISS, HIV disease progression rates, Division, Research Triangle Park, G-CSF, Breast, PFS, Risk, Quality of life, GLOBE, NSCLC, Platinum, Twitter, Therapy, Bone marrow, ORR, UNC Lineberger Comprehensive Cancer Center, Squamous cell carcinoma, Survival rate, RESEARCH, Pharmaceutical industry, Medical imaging

RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc.(Nasdaq: GTHX ), a commercial-stage oncology company, today announced that it is supporting a Phase 2 investigator initiated study (ISS) of trilaciclib and lurbinectedin in patients with extensive stage small cell lung cancer (ES-SCLC).

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc.(Nasdaq: GTHX ), a commercial-stage oncology company, today announced that it is supporting a Phase 2 investigator initiated study (ISS) of trilaciclib and lurbinectedin in patients with extensive stage small cell lung cancer (ES-SCLC).
  • Patients will receive trilaciclib and lurbinectedin on day one of each 21-day cycle until discontinuation or disease progression.
  • The primary endpoint is the rate of grade 4 neutropenia in any cycle when trilaciclib is administered prior to lurbinectedin in subjects with extensive stage small cell lung cancer (ES-SCLC).
  • In the United States, about 29,000 cases of small cell lung cancer (SCLC) are diagnosed each year.

ImmunityBio to Participate in the Jefferies London Healthcare Conference

Retrieved on: 
Thursday, October 27, 2022
Biotechnology, Pharmaceutical, AIDS, Oncology, Health, COVID-19, Infectious Diseases, Clinical Trials, Review, BCG, Infection, Private Securities Litigation Reform Act, BLA, Cancer, NMIBC, Forward-looking statement, Disease, COVID-19, Clinical trial, FDA, GMP, U.S. Securities and Exchange Commission, Treatment of lung cancer, Vaccine, CIS, Severe acute respiratory syndrome coronavirus 2, SEC, HIV, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Immunotherapy, Therapy, Pharmaceutical industry, ImmunityBio

ImmunityBio is a clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases.

Key Points: 
  • ImmunityBio is a clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases.
  • These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
  • ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.
  • ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

Lyell Immunopharma Announces FDA Clearance of its IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors

Retrieved on: 
Thursday, October 6, 2022
SAN, TIL, U.S. Securities and Exchange Commission, GSK, IND, Neoplasm, Diagnosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Security (finance), CRC, Nasdaq, Colorectal cancer, Melanoma, Cancer, Technology, NY-ESO-1, Food, EPI, Goal, Private Securities Litigation Reform Act, Company, NSCLC, Lung cancer, MD, Doctor of Philosophy, Board, Safety, Toxic shock syndrome, GLOBE, Maintenance, Board of directors, Forward-looking statement, Large intestine, Treatment of lung cancer, Survival rate, Failure, TILS, FDA, COVID-19, Biomarker, Lyell McEwin Hospital, Large-cell lung carcinoma, Pharmaceutical industry, Medical imaging, Lyell

LYL845 is an investigational tumor infiltrating lymphocyte (TIL) therapy enhanced with Lyells Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.

Key Points: 
  • LYL845 is an investigational tumor infiltrating lymphocyte (TIL) therapy enhanced with Lyells Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.
  • LYL845 is Lyells first TIL product candidate and second wholly owned product candidate to receive IND clearance within the past year.
  • LYL845 is an autologous tumor infiltrating lymphocyte (TIL) product candidate enhanced with Epi-R reprogramming technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and select solid tumors.
  • Lyell is a clinical-stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors.

Calithera Receives FDA Fast Track Designation for Sapanisertib for the Treatment of NRF2-mutated Squamous Lung Cancer

Retrieved on: 
Monday, October 3, 2022
Cancer, GLOBE, Adult, Neoplasm, RECIST, Review, Survival, Nasdaq, Disease, Private Securities Litigation Reform Act, FDA, Failure, Treatment of lung cancer, Mutation, NFE2L2, Risk, Lung cancer, Progression-free survival, ORR, U.S. Securities and Exchange Commission, Safety, Communication, SAN, CALA, Security (finance), Patient, Fast Track, Marketing, Population, PFS, Pharmaceutical industry, Medical imaging, NRF2

While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer.

Key Points: 
  • While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer.
  • This Fast Track designation allows for a variety of benefits, including the possibility of priority review of sapanisertib as we seek to provide a first-in-class treatment option that may help address the major unmet need in this patient population."
  • NRF2 mutations are found across multiple solid tumor types, with these mutations occurring in approximately 15% of sqNSCLC patients.
  • Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations.

Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations

Retrieved on: 
Friday, September 30, 2022
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In keeping with this goal, the Phase 1 portion of the clinical trial is designed to enroll solid tumor patients with evidence of any RAS mutation.

Key Points: 
  • In keeping with this goal, the Phase 1 portion of the clinical trial is designed to enroll solid tumor patients with evidence of any RAS mutation.
  • We believe this will be the first all-comers RAS clinical trial conducted to date.
  • This decision from the FDA is a critical achievement, as we are dedicated to developing better treatment options for patients with RAS mutated solid tumors.
  • The Phase 1/2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-cancer activity of IMM-1-104 for the treatment of advanced RAS mutant solid tumors.

LUNGevity Grants Three Career Development Awards to Accelerate Lung Cancer Research

Retrieved on: 
Tuesday, September 27, 2022
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WASHINGTON, Sept. 27, 2022 /PRNewswire/ -- LUNGevity Foundation, the nation's leading lung cancer-focused nonprofit organization, announced the recipients of their 2022 Career Development Awards today. 

Key Points: 
  • LUNGevity's Career Development Awards (CDA), now in their 11th consecutive year, support a cohort of future research leaders who will keep the pipeline of lung cancer research energized with new ideas and novel approaches.
  • "By funding these early career researchers, LUNGevity helps to retain promising scientists in the lung cancer space.
  • LUNGevity is the only lung cancer organization with a programmatic focus on early detection and a strong Career Development Award Program.
  • LUNGevity Foundation is the nation's leading lung cancer organization focused on improving outcomes for people with lung cancer.