Paronychia

Black Diamond Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, August 11, 2023
Diamond, FGFR, MAP, Myenteric plexus, DNA, AACR, Central nervous system, PRS, GBM, Diarrhea, RECIST, Clinical trial, Cancer, MAPK, Black Diamond, BRAF, Mutation, TKI, G&A, Toxicity, Appetite, Lung cancer, Paronychia, CNS, Rash, Glioblastoma, II, M26 Modular Accessory Shotgun System, Development, State Administrative Expenses, RAS, Patient, Investment, EGFR, Stomatitis, Administration, Drug discovery, Nausea, Neoplasm, Poster, R, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, ORR, Food, Safety, Fatigue, RAF, Medical imaging, Pharmaceutical industry, Security (finance), Life insurance, NSCLC

and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • and NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
  • Black Diamond initiated a Phase 1 clinical trial for BDTX-4933 in select indications for patients harboring all-class BRAF or RAS mutations in the second quarter of 2023.
  • Net cash used in operations was $14.4 million for the second quarter of 2023 compared to $18.1 million for the second quarter of 2022.
  • Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents and investments.

Black Diamond Therapeutics Announces Initial Dose Escalation Data Demonstrating Anti-Tumor Activity of BDTX-1535 in Non-Small Cell Lung Cancer Patients Across Multiple EGFR Mutation Families

Retrieved on: 
Tuesday, June 27, 2023
Diamond, PK, DNA, Radiation, Central nervous system, PRS, GBM, Diarrhea, Half-life, Progression-free survival, RECIST, Pharmacokinetics, Black Diamond, Mutation, TKI, Toxicity, Appetite, Lung cancer, Paronychia, CNS, Associate, Glioblastoma, Rash, M26 Modular Accessory Shotgun System, Patient, Stomatitis, EGFR, Memorial Sloan Kettering Cancer Center, Cancer, Webcast, Nausea, Neoplasm, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, Metastasis, Safety, Fatigue, Disease, Medical imaging, Pharmaceutical industry, NSCLC

BDTX-1535 is an investigational fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor being developed for the treatment of non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM).

Key Points: 
  • BDTX-1535 is an investigational fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor being developed for the treatment of non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM).
  • The new data from the dose escalation portion of the Phase 1 study demonstrated clinical proof of activity of BDTX-1535 in NSCLC patients harboring both acquired resistance and intrinsic driver EGFR mutations.
  • “These initial safety and clinical activity data support the continued development of BDTX-1535 as a potential first and best-in-class treatment option for osimertinib-resistant NSCLC patients.
  • ET to discuss the initial results from the Phase 1 dose escalation study of BDTX-1535 in patients with NSCLC.

Lutris Pharma Presents Data From a Real-World Analysis of Skin Toxicity From EGFR Inhibitors - an Unmet Challenge, at the 2023 American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 17, 2023
Database, Arthritis, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Trinity, IQVIA, Xeroderma, Telangiectasia, Department of Medicine – University of Pamplona, Clinical trial, Medicine, State university system, Cancer, American Academy, Toxicity, Skin condition, Paronychia, Bangladesh Technical Education Board, TEL, Trichomegaly, State University of New York Upstate Medical University, Patient, AAD, EGFR, American Academy of Dermatology, Hyperpigmentation, Human musculoskeletal system, Poster, FDA, Rash, NIH, Skin, Pharmaceutical industry, Lutris

The analysis was supported, in part, by Lutris Pharma and the intramural research program of the National Institutes of Health (NIH).

Key Points: 
  • The analysis was supported, in part, by Lutris Pharma and the intramural research program of the National Institutes of Health (NIH).
  • While such patients are commonly treated prophylactically with antibiotics, there is insufficient evidence to support its practice, leading to a significant unmet medical need."
  • EGFR inhibitors are approved for the treatment of multiple epithelial tumors and can be either biologics or small molecules.
  • The poster will be available after the event on the "Events and Presentations" section of Lutris' website at: https://www.lutris-pharma.com/events-and-presentations/

Lutris Pharma Presents Data From a Real-World Analysis of Skin Toxicity From EGFR Inhibitors - an Unmet Challenge, at the 2023 American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 17, 2023
Database, Arthritis, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Trinity, IQVIA, Xeroderma, Telangiectasia, Department of Medicine – University of Pamplona, Clinical trial, Medicine, State university system, Cancer, American Academy, Toxicity, Skin condition, Paronychia, Bangladesh Technical Education Board, TEL, Trichomegaly, State University of New York Upstate Medical University, Patient, AAD, EGFR, American Academy of Dermatology, Hyperpigmentation, Human musculoskeletal system, Poster, FDA, Rash, NIH, Skin, Pharmaceutical industry, Lutris

The analysis was supported, in part, by Lutris Pharma and the intramural research program of the National Institutes of Health (NIH).

Key Points: 
  • The analysis was supported, in part, by Lutris Pharma and the intramural research program of the National Institutes of Health (NIH).
  • While such patients are commonly treated prophylactically with antibiotics, there is insufficient evidence to support its practice, leading to a significant unmet medical need."
  • EGFR inhibitors are approved for the treatment of multiple epithelial tumors and can be either biologics or small molecules.
  • The poster will be available after the event on the "Events and Presentations" section of Lutris' website at: https://www.lutris-pharma.com/events-and-presentations/

Takeda’s EXKIVITY® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

Retrieved on: 
Wednesday, January 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Disease, NSCLC, Dor, IRC, Cancer, Paronychia, PFS, Lung cancer, National Medical Products Administration, Head, Rash, Patient, Prevalence, Appetite, EGFR, Research, NMPA, ORR, Trae tha Truth, TAK, Diarrhea, Progression-free survival, Pharmaceutical industry, Takeda

EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China.

Key Points: 
  • EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China.
  • EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA’s Breakthrough Therapy program.
  • Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
  • The most common treatment-related adverse reactions (TRAEs) were diarrhea (92%), rash (46%), paronychia (38%) and decreased appetite (37%).

Cullinan Oncology to Present Updated Data Demonstrating the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive Non-Small Cell Lung Cancer at the 2022 ASCO Annual Meeting

Retrieved on: 
Tuesday, May 31, 2022
Rash, Immunotherapy, Nausea, Neoplasm, Annual general meeting, Nasdaq, TKI, Abstract, Patient, RECIST, Society, CGEM, American Society of Clinical Oncology, BID, NSCLC, DOR, PFS, Paronychia, Anemia, ASCO, Large-cell lung carcinoma, EGFR, Cancer, Diarrhea, Fatigue, GLOBE, Pharmaceutical industry

CAMBRIDGE, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for patients with cancer, today announced positive updated clinical research highlighting the therapeutic potential of CLN-081 in patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation positive non-small cell lung cancer (NSCLC). Findings will be presented on Friday, June 3 at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation during the “Lung Cancer – Non-Small Cell Metastatic” session from 4:12- 4:24 p.m. CT (Abstract #9007). CLN-081 is being evaluated in an ongoing Phase 1/2a clinical trial in patients with NSCLC whose tumors harbor EGFR exon 20 insertion mutations that have progressed on or after prior therapy.

Key Points: 
  • Of the 39 patients in the 100 mg BID dose group:
    16 (41%) had a confirmed partial response.
  • We believe CLN-081 has the potential to be a best-in-class treatment option for patients with NSCLC whose tumors harbor EGFR exon 20 insertion mutations with persisting unmet need.
  • Cullinan Oncology will also present data on CLN-619 (Anti-MICA/MICB Antibody) in a poster presentation during the Developmental Therapeutics Immunotherapy Poster Session (Abstract #TPS2688).
  • Cullinan Oncology, Inc. (NASDAQ: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer.

Spectrum Pharmaceuticals Presents Positive Data for Poziotinib in First-line NSCLC Patients with HER2 Exon 20 Insertion Mutations

Retrieved on: 
Monday, March 7, 2022
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Genetics, Clinical Trials, Private Securities Litigation Reform Act, NDA, Progression-free survival, PFS, TKI, File, Toxicity, BID, Patient, DCR, Paronychia, Dor, Spectrum Pharmaceuticals, Cohort, Security (finance), Safety, Oncology, Annual report, EGFR, U.S. Securities and Exchange Commission, FDA, RECIST, Congress, Stomatitis, Exon, ORR, SEC, SPPI, European Society for Medical Oncology, Rash, ESMO, Mutation, 8-K, Medication, Diarrhea, HER2, Lung cancer, NSCLC, Incidence, Nasdaq, Pharmaceutical industry, Spectrum, the ZENITH20 Clinical Trial, the ZENITH20 Clinical Trial, THE ZENITH20 CLINICAL TRIAL

This data is from 70 first-line patients with non-small lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16 mg daily, given as 16 mg once daily (48 patients) or 8 mg twice daily (22 patients) of oral poziotinib.

Key Points: 
  • This data is from 70 first-line patients with non-small lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16 mg daily, given as 16 mg once daily (48 patients) or 8 mg twice daily (22 patients) of oral poziotinib.
  • Cohort 4 from our ZENITH 20 study demonstrated positive results for treatment nave lung cancer patients harboring HER2 Exon 20 insertion mutations.
  • Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLC patients with exon 20 mutations, Cohort 3 (EGFR) in first-line patients and Cohort 4 (HER2) in first-line NSCLC patients with exon 20 mutations have completed patient enrollment.
  • Cohort 5 includes previously treated or treatment-nave NSCLC patients with EGFR or HER2 exon 20 insertion mutations.

Spectrum Pharmaceuticals Presents Late Breaker Oral Presentation of Poziotinib Data in First-Line NSCLC Patients with HER2 Exon 20 Insertion Mutations at ESMO Congress 2021

Retrieved on: 
Saturday, September 18, 2021
Research, Public Relations, Investor Relations, Clinical Trials, Communications, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Forward-looking statement, Nasdaq, SPPI, RECIST, Oncology, Paronychia, Erasmus, HER2, Stomatitis, Cohort, Annual report, Congress, Security (finance), U.S. Securities and Exchange Commission, FDA, Spectrum Pharmaceuticals, Patient, 8-K, European Society for Medical Oncology, Medication, Toxicity, NSCLC, Mutation, ORR, Dor, Large-cell lung carcinoma, Rash, Licensed practical nurse, Exon, Quality control, DCR, BID, Safety, ESMO, EGFR, Progression-free survival, AE, SEC, PFS, Diarrhea, Pharmaceutical industry, the ZENITH20 Clinical Trial, THE ZENITH20 CLINICAL TRIAL

This data is from 48 first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16mg of oral poziotinib once daily.

Key Points: 
  • This data is from 48 first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16mg of oral poziotinib once daily.
  • There currently is no specific approved treatment for NSCLC patients with HER2 exon 20 insertion mutations.
  • Cohort 4 of the ZENITH20 clinical trial is enrolling treatment-nave NSCLC patients with HER2 exon 20 insertion mutations.
  • Poziotinib demonstrated clinically meaningful anti-tumor activity in newly diagnosed NSCLC patients with HER2 exon 20 mutations with 16mg QD dosing.

Veloce BioPharma Announces Positive Phase 2b Study Results for VBP-926 (Topical Povidone-Iodine in a Novel Non-Aqueous Vehicle) in Subjects with Chemotherapy-Associated Paronychia

Retrieved on: 
Wednesday, October 3, 2018
Medicine, Clinical medicine, Cancer treatments, Antineoplastic drugs, Nails, Paronychia, Tuberculosis, Chemotherapy

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia.

Key Points: 
  • The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia.
  • Results from the study showed that VBP-926 (2%) met the primary efficacy endpoint of grade-improvement on the Paronychia Severity Grading Scale.
  • Consistent with previously reported case series results, VBP-926 was well-tolerated at both doses and provided both morphological resolution and symptomatic relief in affected nails.
  • Veloce BioPharma, LLC is a privately held clinical-stage pharmaceutical company focused on the development of topical therapeutics for unmet needs in dermatology and ophthalmology.

Veloce BioPharma Announces Positive Phase 2b Study Results for VBP-926 (Topical Povidone-Iodine in a Novel Non-Aqueous Vehicle) in Subjects with Chemotherapy-Associated Paronychia

Retrieved on: 
Wednesday, October 3, 2018
Medicine, Clinical medicine, Cancer treatments, Antineoplastic drugs, Nails, Paronychia, Tuberculosis, Chemotherapy

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia.

Key Points: 
  • The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia.
  • Results from the study showed that VBP-926 (2%) met the primary efficacy endpoint of grade-improvement on the Paronychia Severity Grading Scale.
  • Consistent with previously reported case series results, VBP-926 was well-tolerated at both doses and provided both morphological resolution and symptomatic relief in affected nails.
  • Veloce BioPharma, LLC is a privately held clinical-stage pharmaceutical company focused on the development of topical therapeutics for unmet needs in dermatology and ophthalmology.