Bladder cancer

CytomX Therapeutics Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Therapy, EDT, Head, CD3, SAN, Investigational New Drug, Cancer, EGFR, Research, Biotechnology, Partnering, TCE, Epithelial cell adhesion molecule, Investment, Melanoma, FDA, Amgen, Therapeutic index, Food, Camptothecin, Gastrointestinal tract, Bladder cancer, Drug discovery, CRC, ADC, Bristol Myers Squibb, BMS, Safety, Kidney, Cytokine, Webcast, Tumor microenvironment, PDT, Patient, Workforce, IND, Trial of the century, Colorectal cancer, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today reported full year 2023 financial results and provided a business update.

Key Points: 
  • Throughout 2023, CytomX made substantial progress across all research partnerships including the commencement of programs under its new alliances with Regeneron and Moderna.
  • In 2023, CytomX remained focused on controlling costs and efficiently allocating capital towards its lead pipeline programs.
  • General and administrative expenses in the fourth quarter of 2023 were $7.8 million compared to $10.1 million in the corresponding period in 2022.
  • CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update.

Ludwig Enterprises Inc. (OTC:LUDG) Announces Patent Filing for Breakthrough in Identifying mRNA Genes Associated with Certain Cancers

Retrieved on: 
Wednesday, March 6, 2024
Breast cancer, Neoplasm, Messenger, Epigenome, OTC, Cancer, Bladder cancer, Stem cell, IRB, Breast, Biomarker, Element, Cytokine, Patent, Patient, Gene, Medicine, Thermo Fisher Scientific, Disease, Diagnosis, Machine learning, Trial of the century, Colorectal cancer, DNA, Environment, Vaccine

The Company’s mRNA for Life™ is a one-of-the-kind noninvasive at-home sceening test for genes that could be associated with cancer.

Key Points: 
  • The Company’s mRNA for Life™ is a one-of-the-kind noninvasive at-home sceening test for genes that could be associated with cancer.
  • This test allows a person to make themselves a priority and could be a signal to seek a medical examination.
  • The Company selected for measurement 48 distinct mRNA genes in stored specimens from patients afflicted with breast, bladder or colorectal cancer.
  • mRNA levels were analyzed using machine learning artificial intelligence (AI) to identify markers of genetic expression involved in separate cancers.

Corbus Pharmaceuticals Appoints Dr. Dominic Smethurst as Chief Medical Officer

Retrieved on: 
Wednesday, February 28, 2024
Therapy, AstraZeneca, CMO, CD25, Biotechnology, Roche, Neoplasm, Physician, Obesity, Amgen, Icon, Pharmaceutical medicine, Bladder cancer, Royal college, ADC, Antibody, NHS, Safety, CB1, CSPC, Patient, CD137, Faculty, Partnership, Pharmaceutical industry

NORWOOD, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today announced the appointment of Dr. Dominic Smethurst, MA MRCP, as the Company’s Chief Medical Officer (CMO).

Key Points: 
  • NORWOOD, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today announced the appointment of Dr. Dominic Smethurst, MA MRCP, as the Company’s Chief Medical Officer (CMO).
  • Additionally, Dr. Smethurst will help guide strategic development of CRB-913, the Company’s highly peripherally restricted CB1 inverse agonist for the treatment of obesity.
  • “We are pleased to welcome Dominic to the Corbus team and look forward to benefitting from his experience in developing novel oncology therapeutics including ones that specifically target Nectin-4", said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.
  • Previously, Dr. Smethurst worked as a consultant advising biopharma companies, providing guidance on clinical development strategies and licensing projects.

CG Oncology Announces First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Tuesday, February 27, 2024
FACS, PFS, Recurrence, BCG, Medical director, RFS, TURBT, Bladder cancer, Cancer, Patient, Disease, Face, Pharmaceutical industry

IRVINE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the first patient has been dosed in the PIVOT-006 Phase 3 clinical trial of cretostimogene for the treatment of patients with intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT).

Key Points: 
  • “The dosing of the first patient in our PIVOT-006 trial advances cretostimogene earlier in the treatment paradigm for NMIBC patients who face limited treatment options, frequent disease recurrence and repetitive surgery,” said Arthur Kuan, Chairman and Chief Executive Officer, CG Oncology.
  • The initial induction course is six weekly doses of cretostimogene containing 1x1012 VPs per milliliter.
  • The primary endpoint of this trial is overall RFS, with secondary endpoints including RFS at 12 and 24 months and PFS.
  • Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer.”

Lipella Pharmaceuticals to Present at PropThink Digital Investor Conference

Retrieved on: 
Tuesday, February 20, 2024
HC, Hemorrhagic cystitis, Tacrolimus, Q&A, Bladder cancer

the potential of therapies in late-stage development to replace existing, toxic standards of care.

Key Points: 
  • the potential of therapies in late-stage development to replace existing, toxic standards of care.
  • why hemorrhagic cystitis (HC) is a large, overlooked opportunity and where existing treatments stand.
  • Following the presentation, investors will have an opportunity to ask relevant questions through an interactive Q&A portal.
  • The webcast link will also be posted on the Investors section of Lipella’s company website , and archived following the event.

KaliVir Immunotherapeutics Appoints James M. Burke, M.D., as Chief Medical Officer

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Therapy, CMO, Potyvirus, Immunotherapy, Hematology, Growth, GM, AKA, Bladder cancer, Patient, Internal medicine, AAV, Lentivirus, Pharmaceutical industry

KaliVir Immunotherapeutics, Inc. , a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the appointment of industry leader James M. Burke, M.D., as Chief Medical Officer (CMO) to further advance its vision of providing patients with truly life changing cancer therapeutics by leveraging its next generation oncolytic virus platform.

Key Points: 
  • KaliVir Immunotherapeutics, Inc. , a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the appointment of industry leader James M. Burke, M.D., as Chief Medical Officer (CMO) to further advance its vision of providing patients with truly life changing cancer therapeutics by leveraging its next generation oncolytic virus platform.
  • Dr. Burke brings over 20 years of global development experience in immuno-oncology.
  • “We are thrilled to welcome Dr. Burke to our team as we bring our pipeline of multi-mechanistic oncolytic virus programs into the clinic,” said Helena Chaye, Ph.D., J.D., Chief Executive Officer of KaliVir.
  • Previously, Dr. Burke was Chief Medical Office at Sillajen, Jennerex and Turnstone Biologics.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Orbis, BMY, PFS, Progression-free survival, Confidence interval, Research, Recurrence, MD, Pneumonitis, Immunotherapy, Hematology, Kidney, Food, Cancer, Bladder cancer, HSCT, Hepatotoxicity, Checkmate, Risk, Bristol Myers Squibb, Hepatitis, Dexamethasone, Cisplatin, History, Death, Patient, Colitis, Multiple myeloma, Nephritis, Disease, Mortality, Priority review, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

Limmi appoints nationally recognized cancer researcher, Dr. Kader, to its Board of Directors

Retrieved on: 
Tuesday, March 5, 2024
Advisory board, Doctor of Philosophy, MD, Urinary diversion, Bladder cancer, FRCSC, Genomics, Risk, Patient, Big data, UC San Diego Health, Deep learning, UCSD, Prostate cancer, Pharmaceutical industry

"We're in a desperate need at this time for solutions like the one Limmi is offering.

Key Points: 
  • "We're in a desperate need at this time for solutions like the one Limmi is offering.
  • states Professor Kader , and continues, "As a surgeon scientist, I made a discovery regarding genetic risk in prostate cancer.
  • In addition to being a board-certified urologist who specializes in detecting, treating, and preventing prostate cancer, Dr. Kader is nationally recognized for his expertise in performing robot-assisted radical cystectomy and urinary diversion for patients with bladder cancer.
  • He holds several patents for genetic discoveries related to early detection of prostate cancer.

NCCN Updates Treatment Recommendations for Breast, Colorectal, Lung, and other Cancer Types Based on Emerging Evidence

Retrieved on: 
Monday, March 4, 2024
Classification, Neoplasm, MD, System, Heredity, Bladder cancer, Lung, Principle, Conference, Breast, Lung cancer, Kidney cancer, NCCN, Pathology, Patient, Virtual, National Comprehensive Cancer Network, Medicine, Poster, Research, Medical imaging

PLYMOUTH MEETING, Pa., March 4, 2024 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) is announcing several new updates to the cancer treatment practices listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). The evidence-based expert consensus recommendations are the most frequently updated guidelines for any area of medicine and are used by cancer care providers worldwide to stay up to date on innovations. Recently, the alliance of leading cancer centers published updated versions for several high-incidence cancer types, including breast, colorectal, lung, and pancreatic.

Key Points: 
  • Latest recommendations and underlying evidence will be explained at NCCN 2024 Annual Conference April 5-7.
  • PLYMOUTH MEETING, Pa., March 4, 2024 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) is announcing several new updates to the cancer treatment practices listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
  • Recently, the alliance of leading cancer centers published updated versions for several high-incidence cancer types, including breast, colorectal, lung, and pancreatic.
  • Some recent updates to the NCCN Guidelines recommendations include:
    Updates to treatment of HR-positive, early-stage breast cancer, including a new page outlining the general principles for adjuvant endocrine therapy.

DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024

Retrieved on: 
Monday, March 4, 2024
Recurrence, BCG, CMS, Physician, Bladder cancer, LDT, NMIBC, Medicare, Medicine, Patient, Diagnosis, CAP

PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.

Key Points: 
  • PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.
  • Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance.
  • Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies.
  • By securing Medicare reimbursement for Oncuria®, DiaCarta continues to facilitate access to innovative diagnostic solutions for patients and healthcare providers nationwide.