Carcinoma

Sol-Gel Reports Full-Year 2023 Financial Results and Corporate Developments

Retrieved on: 
Wednesday, March 13, 2024
Orphan drug, Growth, NESS, Nevoid basal-cell carcinoma syndrome, Disease, Patient, Research, European Medical Association, NDA, Acquisition, Prescription, EMA, Dermatology, Clinical trial, IQVIA, BCC, FDA, Sol–gel process, Carcinoma, Food, Pharmaceutical industry

On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened.

Key Points: 
  • On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened.
  • In addition, TWYNEO increased its broad commercial formulary coverage, with over 6 million additional lives covered between December 2022 and December 2023 per MMIT Analytics.
  • Based on Sol-Gel's financing and adoption of cost-saving measures during 2023, the company continues to maintain its cash runway into the second half of 2025.
  • The decrease in revenues in 2023 resulted mainly from the milestone payment from Galderma related to the FDA approval of Epsolay in 2022.

Protara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 13, 2024
NMIBC, Research, BCG, LM, Bacillus, Patient, LMS, Cancer, Investment, Therapy, Injection, POC, Carcinoma, CIS, Food, Pharmaceutical industry

As of December 31, 2023, cash, cash equivalents, and investments in marketable debt securities totaled $65.6 million.

Key Points: 
  • As of December 31, 2023, cash, cash equivalents, and investments in marketable debt securities totaled $65.6 million.
  • The fourth quarter and full year increases were primarily due to an increase in expenses related to clinical trials and non-clinical activities for TARA-002.
  • Net loss for the fourth quarter of 2023 included approximately $1.5 million of stock-based compensation expenses.
  • Net loss for the year ended December 31, 2023 included approximately $6.1 million of stock-based compensation expenses.

Corbus Pharmaceuticals Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024
MUC, Human, Biotechnology, CSPC, Drug discovery, Carcinoma, Cervical cancer, Rash, Patient, MMAE, Tumor microenvironment, Peripheral neuropathy, IND, PH1b, Insulin resistance, Investment, Investigational New Drug, Therapy, CB1, ATM, Safety, Liraglutide, CMO, FDA, PD-1, Pharmaceutical industry

We expect to dose the first patient in our US Ph1 study in March 2024.

Key Points: 
  • We expect to dose the first patient in our US Ph1 study in March 2024.
  • For CRB-601, the FDA cleared our Investigational New Drug (“IND”) application in January 2024, and we expect to dose the first patient this summer.
  • The Company presented CRB-913 pre-clinical data at Obesity Week as an oral presentation and as a late breaking poster in October 2023.
  • The Company is currently conducting IND enabling studies and expects to file an IND in the fourth quarter of 2024.

IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

Retrieved on: 
Friday, April 5, 2024
Research, FDA, Clinical Trials, Biometrics, Health, Pharmaceutical, General Health, Science, Oncology, Lung cancer, Chemoradiotherapy, CRT, Small-cell carcinoma, Radiation, AstraZeneca, Survival, NSCLC, Immunotherapy, Disease, Infection, Carcinoma, Incidence, Progression-free survival, Patient, Warning, Doctor of Philosophy, Prednisone, Adrenocorticotropic hormone, Creatinine, Prognosis, PFS, Recurrence, ACTH, Administration, Pneumonitis, SCLC, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

Presentations at EADO Highlight Potential Impact of Castle Biosciences’ DecisionDx®-Melanoma and DecisionDx®-SCC Tests on the Management of Patients with Skin Cancer

Retrieved on: 
Thursday, April 4, 2024
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Sentinel lymph node, SCC, Congress, Castle, Risk, Patient, Neoplasm, Research, NCCN, AJCC, National Comprehensive Cancer Network, Risk assessment, Lymph node, Carcinoma, Melanoma, Trial of the century, Recurrence, Metastasis, SLN, Medical imaging

Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM.

Key Points: 
  • Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM.
  • This study explored the cost-savings impact of using the DecisionDx-Melanoma test to guide risk-aligned clinical decision-making versus using the current melanoma staging standard, a patient’s AJCC stage.
  • Summary: The DecisionDx-SCC test uses a patient’s tumor biology to independently predict risk of regional or distant metastasis in patients with high-risk SCC.
  • These data demonstrate that DecisionDx-SCC improves the accuracy of risk assessment based solely on clinicopathological risk factors, leading to more appropriate risk-aligned management plans for patients with high-risk SCC.

Nucleix Demonstrates Potential of its PCR EpiCheck® Assay to Accurately Differentiate Between Small Cell Lung Cancer (SCLC) Subtypes

Retrieved on: 
Thursday, April 4, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Oncology, Diagnosis, PCR, Plasma, Carcinoma, Cancer cell, Protocol, Biomarker, DNA, Classification, University, MD Anderson Cancer Center, DNA methylation, AACR, Liquid biopsy, SCLC, Medical imaging

Nucleix , a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced data from a pilot study demonstrating the potential of a simple PCR assay based on EpiCheck® technology to accurately differentiate between small cell lung cancer (SCLC) subtypes.

Key Points: 
  • Nucleix , a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced data from a pilot study demonstrating the potential of a simple PCR assay based on EpiCheck® technology to accurately differentiate between small cell lung cancer (SCLC) subtypes.
  • The Company is presenting the data in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, April 5-10.
  • The 13-marker PCR assay developed for this pilot study stemmed from data from a recent study published in Cancer Cell demonstrating the detection of SCLC using DNA methylation in plasma samples from heavy smokers, yielding a sensitivity of 94% and specificity of 95%.
  • In the data being presented at AACR, the 13-marker PCR assay correctly classified 97% of the SCLC tissue samples in a blinded cohort.

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

Retrieved on: 
Wednesday, April 3, 2024
Legal, Biotechnology, Pharmaceutical, Public Relations, Investor Relations, Health, FDA, Communications, Professional Services, The Orange Book, Drug discovery, Carcinoma, Patent, District court, Mitomycins, Orange Book, Food, Generic drug

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).
  • Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution.
  • JELMYTO® is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology.
  • “UroGen pioneered a significant breakthrough and remains at the forefront of transforming urothelial cancer treatment,” said Liz Barrett, President and CEO, UroGen.

Zai Lab Presentations at AACR 2024 Annual Meeting to Showcase Ongoing Clinical Studies in Key Global Oncology Programs

Retrieved on: 
Tuesday, April 2, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Development, Carcinoma, Drug discovery, Patient, Neoplasm, Tumor microenvironment, CT155, DLL3, AACR, Immunity, HKEX, ADC, SCLC, Pharmaceutical industry

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that two poster presentations highlighting ongoing global clinical studies in its oncology pipeline will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10, 2024, in San Diego, California.

Key Points: 
  • Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that two poster presentations highlighting ongoing global clinical studies in its oncology pipeline will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10, 2024, in San Diego, California.
  • The global oncology programs to be showcased at AACR 2024 include a Phase 1a/1b study of ZL-1310 ( NCT06179069 ), a novel antibody-drug conjugate (ADC) within the Zai Lab pipeline that targets the Delta-like ligand 3 (DLL3), a validated therapeutic target for the treatment of small cell lung cancer (SCLC).
  • ZL-1310 is designed with a novel linker-payload platform TMALIN® which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.
  • “These ongoing global clinical studies underscore Zai Lab’s continued commitment to pursue both novel and validated cancer biology targets and advance innovative oncology therapies that can potentially reach patients around the world,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development, Zai Lab.

Bicara Therapeutics Expands Clinical Team with Appointments of Jeltje Schulten, M.D., MBA, as SVP of Clinical and Medical Affairs and Rita Dalal, MBBS, MPH, as VP of Clinical Development

Retrieved on: 
Tuesday, March 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Carcinoma, Alkermes, Erasmus University Rotterdam, Cetuximab, Patient, SVP, ImClone Systems, Biostatistics, Merck, Epidemiology, Management, University, MBA, Merck Group, Limited partnership, MPH, Therapy, International school, PPD, Eli Lilly and Company, Marketing, Avelumab, Daiichi Sankyo

“We are very pleased to welcome Jeltje and Rita to our talented team.

Key Points: 
  • “We are very pleased to welcome Jeltje and Rita to our talented team.
  • Dr. Schulten received her medical degree from Erasmus University, Rotterdam, Netherlands and her MBA from the International School of Management RSM, Rotterdam, Netherlands.
  • Dr. Rita Dalal is a trained physician with extensive and diverse clinical research experience including in solid tumor oncology.
  • Previously, Dr. Dalal held clinical research scientist positions with Merck Sharp & Dohme Corp. and Eli Lilly and Company.

Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Wednesday, March 20, 2024
Research, General Health, Pharmaceutical, Oncology, Public Relations, Investor Relations, Clinical Trials, Science, Biotechnology, Communications, Practice Management, Other Science, Health, Fulvestrant, Carcinoma, Progression-free survival, Patient, JAMA Oncology, Pharming, Biomarker, CDK, Letrozole, IND, Triple-negative breast cancer, Puma Biotechnology, Cancer, Paclitaxel, Breast cancer, Anastrozole, Tamoxifen, FDA, Food, Pharmaceutical industry

This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.

Key Points: 
  • This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.
  • Puma plans to initiate this trial in the second half of 2024.
  • Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial.
  • We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.