Trastuzumab

Bolt Biotherapeutics Enrolls First Patient in Phase 2 Clinical Study Evaluating BDC-1001 in Patients with HER2-Positive Breast Cancer Previously Treated with Enhertu®

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Martedì, Dicembre 5, 2023
ISAC, Neoplasm, Immunotherapy, HER2, Breast cancer, Trastuzumab, Roche, FC, Data, City, Research, Therapy, Publication, Pharmacokinetics, Clinical trial, Society, Bolt, MBC, Poster, Oncology, Pertuzumab, Patient, Safety, Assistant professor, Vaccine

The trial will treat patients with HER2-positive metastatic breast cancer previously treated with trastuzumab deruxtecan (Enhertu®).

Key Points: 
  • The trial will treat patients with HER2-positive metastatic breast cancer previously treated with trastuzumab deruxtecan (Enhertu®).
  • “Patients with HER2-positive breast cancer who progress after Enhertu have few therapeutic options,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics.
  • “BDC-1001 has a unique mechanism of action compared to available agents, mobilizing the patient’s immune system to fight cancer.
  • Title: Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 +/- pertuzumab in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan.

ALX Oncology Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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Lunedì, Novembre 13, 2023
Paclitaxel, Trastuzumab, SAN, Spacecraft, Investment, Exercise, Administration, Insurance, Patient, Research and development, PD-1, GAAP, ORR, RAINBOW, CD47, Cancer, Pons, Stomach, News, Pharmaceutical industry, Life insurance

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • ALX Oncology achieved a significant corporate development milestone during the third quarter with the realignment of the Company’s leadership team.
  • Third Quarter 2023 Financial Results:
    Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of September 30, 2023, were $196.4 million.
  • A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

Genentech’s Kadcyla Is the First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment

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Venerdì, Dicembre 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ROG, Risk, Disease, Trastuzumab emtansine, Rated R, Recurrence, OS, Roche, EBC, Death, Pharmaceutical industry, Trastuzumab, Genentech

Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.

Key Points: 
  • Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.
  • “With these new data, Kadcyla is the first targeted therapy to demonstrate a significant survival benefit in people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment."
  • Approximately one in five people with breast cancer will be HER2-positive, a particularly aggressive form of the disease.
  • Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane.

BostonGene to Present at the 2023 San Antonio Breast Cancer Symposium

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Mercoledì, Dicembre 6, 2023
Technology, Women, Genetics, Health Technology, Biotechnology, Health, Consumer, Artificial Intelligence, Oncology, NST, Classification, Breast cancer, Trastuzumab, Research, ILC, Patient, Tumor microenvironment, Abstract, MD, Medical imaging

BostonGene , a leading provider of AI-driven, molecular and immune profiling solutions, today announced that two abstracts have been accepted for poster presentations for the 2023 San Antonio Breast Cancer Symposium (SABCS), which will be held December 5 - 9, 2023, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

Key Points: 
  • BostonGene , a leading provider of AI-driven, molecular and immune profiling solutions, today announced that two abstracts have been accepted for poster presentations for the 2023 San Antonio Breast Cancer Symposium (SABCS), which will be held December 5 - 9, 2023, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
  • "We are excited to present our research at the 2023 San Antonio Breast Cancer Symposium, showcasing our commitment to improving breast cancer treatment through innovative molecular profiling.
  • By developing novel approaches to transcriptomic classification, we aim to revolutionize the way we understand and treat breast cancer," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.
  • For more information, please visit the 2023 San Antonio Breast Cancer Symposium website .

TUKYSA® (tucatinib) in Combination with Antibody-Drug Conjugate ado-Trastuzumab Emtansine Improves Progression-Free Survival in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer

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Mercoledì, Dicembre 6, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Capecitabine, Trastuzumab, Senior, Food, Progression-free survival, RECIST, National Comprehensive Cancer Network, Tablet, Breast cancer, Brain, Taxane, Patient, Research and development, PFS, Corr, Division, FDA, Hematology, University, Development, HR, Tucatinib, HER2, Inc., Confidence interval, News, Professor, HIV disease progression rates, Medical imaging, Medicinal plants, Seagen

Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®).

Key Points: 
  • Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®).
  • The combination showed a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint, in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer who had been previously treated with trastuzumab and a taxane, compared to those who received placebo plus ado-trastuzumab emtansine.
  • Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals were observed for the combination.
  • Please see Important Safety Information at the end of this news release for TUKYSA (tucatinib) tablets.

Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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Martedì, Novembre 14, 2023
Biotechnology, FDA, Medical Devices, Health, Oncology, MSD, HNSCC, PD-L1, Trastuzumab, NYSE, Cervical cancer, Head, Incidence, Patient, Triple-negative breast cancer, Agilent Technologies, Stomach cancer, Stomach, Pembrolizumab, Lung cancer, PD-1, Adenocarcinoma, Partnership, ESCC, Cancer, Merck & Co., Physician, CPS, GEJ, TNBC, NSCLC, Pharmaceutical industry, Vaccine, Merck

Agilent Technologies Inc. (NYSE: A) today announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.

Key Points: 
  • Agilent Technologies Inc. (NYSE: A) today announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
  • PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic that can identify gastric or GEJ adenocarcinoma patients suitable for treatment with KEYTRUDA in combination with chemotherapy and trastuzumab plus fluoropyrimidine.
  • This marks the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval.
  • PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer

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Venerdì, Dicembre 8, 2023
Trastuzumab, Research, Progression-free survival, RECIST, Fulvestrant, Breast cancer, Jazz Pharmaceuticals, Patient, PFS, Part, Corr, DOR, MBC, DCR, Pertuzumab, HER2, Cancer, Vall d'Hebron University Hospital, BS 5839 Part 1, Metastasis, HR, Pharmaceutical industry, Medical imaging, MD

DUBLIN, Dec. 8, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • DUBLIN, Dec. 8, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • Patients treated with the combination regimen received a median of four prior systemic regimens in the metastatic setting (range, 1-12).
  • Recommended doses of the zanidatamab plus palbociclib and fulvestrant combination therapy were determined in Part 1 of the study.
  • Patients treated with the combination regimen achieved a cORR of 35% and DCR of 91%.

Anixa Biosciences to Host Conference Call This Evening to Discuss Positive New Data from Ongoing Phase 1 Study of Breast Cancer Vaccine

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Mercoledì, Dicembre 6, 2023
Woman, Associate, Trastuzumab, FACP, Radiation, Therapy, National Cancer Institute, Emory University, Conference call, Breast cancer, NCI, Cleveland Clinic, Medicine, McGill University, FRCPC, MBBS, Conference, Harvard Medical School, Cancer, Outline of health sciences, Immunotherapy, Minda, Warren Alpert Foundation Prize, Communications satellite, Pharmaceutical industry, MD, Paclitaxel

SAN JOSE, Calif., Dec. 6, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, will publicly release new data this evening from the ongoing Phase 1 clinical trial of its breast cancer vaccine, which was presented for the first time today at the 2023 San Antonio Breast Cancer Symposium ("SABCS"). All interested parties are invited to join an upcoming conference call today at 6:30 pm ET to discuss the data.

Key Points: 
  • All interested parties are invited to join an upcoming conference call today at 6:30 pm ET to discuss the data.
  • Anixa is pleased to invite all interested parties to participate in a conference call today at 6:30 p.m.
  • Jennifer Davis: Ms. Davis is a nurse, wife, mother of three, and Triple Negative Breast Cancer survivor.
  • Dr. Shepard is best known as the inventor of the life-saving breast cancer drug Herceptin® (trastuzumab).

Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

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Mercoledì, Novembre 8, 2023
Food, Multiple myeloma, CXCR2, Enrollment, B-cell lymphoma, Lupus, SITC, Cetuximab, Annual general meeting, Rituximab, SLE, CAR, Hyperbaric treatment schedules, GAAP, Graft-versus-host disease, Safety, Cancer, Therapy, Ono Pharmaceutical, Investment, Patient, IPSC, Society for Immunotherapy of Cancer, Chronic lymphocytic leukemia, Research, Immunotherapy, TRAC, CD16, NK, Clinical trial, Multiplexing, BCL, Acute leukemia, CRS, Cell, FDA, Trastuzumab, IND, ONO, ADR, HER2, Neoplasm, Protocol, Lupus Research Alliance, Destiny, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, Tumor microenvironment, BCMA, Vaccine, Pharmaceutical industry, Autoimmunity

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • FT522 is the Company’s off-the-shelf, multiplexed-engineered natural killer (NK) cell product candidate that incorporates five synthetic controls of cell function.
  • In addition, as of September 30, 2023, cash receivables from the Company’s collaboration with ONO were $1.5 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of September 30, 2023.
  • ET to review financial and operating results for the quarter ended September 30, 2023.

Kexing Biopharm Attended CPHI Worldwide 2023

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Martedì, Novembre 7, 2023
Adalimumab, Autoimmunity, Exhibition, Neoplasm, Patient, Marketing, Infliximab, Fine chemical, Tourism, Trastuzumab, Bevacizumab

SHENZHEN, China, Nov. 7, 2023 /PRNewswire/ -- Recently, CPHI Worldwide 2023 was successfully held in Barcelona, Spain.

Key Points: 
  • SHENZHEN, China, Nov. 7, 2023 /PRNewswire/ -- Recently, CPHI Worldwide 2023 was successfully held in Barcelona, Spain.
  • Although Kexing Biopharm specially booked a large booth including independent conference rooms for this exhibition, the seats were still packed with customers who came in an endless stream, and the scene was extremely popular.
  • Many overseas customers expressed great interest in several high-end drugs shown by Kexing Biopharm, and actively explored joint development of overseas business with the company.
  • The participating team of Kexing Biopharm exchanged experiences and discussed with industry leaders, aiming to explore the future development of the industry.