Monoclonal antibodies

Japan's Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin New Drug Application

Friday, May 14, 2021 - 1:00am

In the United States, Astellas and Seagen co-promote enfortumab vedotin under the brand name PADCEV (enfortumab vedotin-ejfv).

Key Points: 
  • In the United States, Astellas and Seagen co-promote enfortumab vedotin under the brand name PADCEV (enfortumab vedotin-ejfv).
  • Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.
  • EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors [abstract].
  • Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models.

Prometheus Biosciences Reports First Quarter 2021 Financial Results and Provides a Corporate Update

Thursday, May 13, 2021 - 9:01pm

In IBD specifically, this cytokine has been implicated to contribute to non-response to anti-TNF therapies\nStrengthened leadership and Board of Directors.

Key Points: 
  • In IBD specifically, this cytokine has been implicated to contribute to non-response to anti-TNF therapies\nStrengthened leadership and Board of Directors.
  • As of March 31, 2021, Prometheus Biosciences had cash and cash equivalents of $311.2 million, compared to $54.2 million at the end of 2020.
  • Research and development expenses were $7.8\xc2\xa0million for the three months ended March 31, 2021 compared to $4.3\xc2\xa0million for the three months ended March 31, 2020.
  • The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved.

Bristol Myers Squibb Presents New Research at ASCO and EHA 2021 Featuring Novel Approaches and Demonstrating Significant Progress to Improve Survival in Cancer and Blood Disorders

Wednesday, May 12, 2021 - 4:43pm

In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

Key Points: 
  • In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).
  • In patients receiving OPDIVO monotherapy in Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients.
  • Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
  • In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients.

Progenity Receives Funding from Crohn’s & Colitis Foundation IBD Ventures Fund to Develop Drug Delivery System for IBD

Tuesday, May 11, 2021 - 12:30pm

The DDS could improve efficacy of treatment through increased localized drug concentration, while potentially minimizing harmful side effects associated with systemic drug delivery.

Key Points: 
  • The DDS could improve efficacy of treatment through increased localized drug concentration, while potentially minimizing harmful side effects associated with systemic drug delivery.
  • Progenity\xe2\x80\x99s lead candidates include PGN-001, a high-concentration formulation of adalimumab, and PGN-600, a high concentration, solubilized formulation of tofacitinib.
  • During 2020, less than 5% of applicants received funding, demonstrating the selectivity of the program.\n\xe2\x80\x9cWe are proud to have been chosen by the Crohn\xe2\x80\x99s & Colitis Foundation to receive funding through their IBD Ventures program.
  • The Foundation's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life for the millions of Americans living with IBD.

Galera Reports First Quarter 2021 Financial Results and Recent Accomplishments

Tuesday, May 11, 2021 - 12:00pm

\xe2\x80\x9cWe recently reported updated data from our placebo-controlled Phase 1/2 pilot trial, in which a near doubling of median overall survival was observed in patients with pancreatic cancer.

Key Points: 
  • \xe2\x80\x9cWe recently reported updated data from our placebo-controlled Phase 1/2 pilot trial, in which a near doubling of median overall survival was observed in patients with pancreatic cancer.
  • Building on the positive results from this trial, we anticipate initiating a Phase 2b trial in the first half of 2021 in patients with LAPC, with overall survival as the primary endpoint.
  • The Company expects to report topline data in the first half of 2022.\nResearch and development expenses were $12.4 million in the first quarter of 2021, compared to $14.3 million for the same period in 2020.
  • Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC.

Global Inflammatory Bowel Disease (Crohn's Disease, Ulcerative Colitis) Market Analysis, 2016-2020 & 2021-2026 by Disease Indication, Drug Class, Distribution Channel - ResearchAndMarkets.com

Monday, May 10, 2021 - 1:58pm

Global Inflammatory Bowel Disease Market: An Analysis\n5.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Disease Indication\n6.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Drug Class\n7.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Distribution Channel\n8.

Key Points: 
  • Global Inflammatory Bowel Disease Market: An Analysis\n5.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Disease Indication\n6.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Drug Class\n7.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Distribution Channel\n8.
  • Global Inflammatory Bowel Disease Market: Regional Analysis\n8.1 Competitive Scenario of Global Inflammatory Bowel Disease Market: By Region\n9.
  • North America Inflammatory Bowel Disease Market: An Analysis (2016-2026)\n9.1 North America Inflammatory Bowel Disease Market: Size and Forecast (2016-2026), By Value\n9.4 Market Segmentation By Drug Class (TNF Inhibitors, Aminosalicylates, Integrin Antagonists and Others.
  • )\n9.6 North America Inflammatory Bowel Disease Market: Country Analysis\n9.7 Market Opportunity Chart of North America Inflammatory Bowel Disease Market - By Country, By Value (Year-2026)\n9.9 United States Inflammatory Bowel Disease Market: Size and Forecast (2016-2026), By Value\n9.11 United States Inflammatory Bowel Disease Market - Segmentation By Disease Indication, Drug Class, Distribution Channel.\n9.12 Canada Inflammatory Bowel Disease Market: Size and Forecast (2016-2026), By Value\n9.13 Canada Inflammatory Bowel Disease Market - Segmentation By Disease Indication, Drug Class and Distribution Channel.\n10.

Immutep Operational Update

Friday, May 7, 2021 - 1:00pm

Currently the trial has reached approximately 72% of events, indicating 72% of total patients with this late-stage cancer had been followed through until death.

Key Points: 
  • Currently the trial has reached approximately 72% of events, indicating 72% of total patients with this late-stage cancer had been followed through until death.
  • Currently, 27 patients of a total of 36 patients have received the first treatment.
  • Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.
  • Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.

IMFINZI and tremelimumab With Chemotherapy Demonstrated Overall Survival Benefit in POSEIDON Trial for 1st-line Stage IV Non-small Cell Lung Cancer

Friday, May 7, 2021 - 12:00pm

b"POSEIDON was a Phase III trial of AstraZeneca\xe2\x80\x99s IMFINZI\xc2\xae (durvalumab) plus platinum-based chemotherapy or IMFINZI, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).\nPositive high-level results from the final analysis of POSEIDON showed the combination of IMFINZI, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone.

Key Points: 
  • b"POSEIDON was a Phase III trial of AstraZeneca\xe2\x80\x99s IMFINZI\xc2\xae (durvalumab) plus platinum-based chemotherapy or IMFINZI, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).\nPositive high-level results from the final analysis of POSEIDON showed the combination of IMFINZI, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone.
  • This immunotherapy combination also demonstrated a statistically significant improvement in progression-free survival (PFS) versus chemotherapy alone, as previously reported in October 2019 .
  • As both PFS endpoints were met for IMFINZI plus chemotherapy and IMFINZI, tremelimumab and chemotherapy, the prespecified statistical analysis plan allowed for independent OS testing for the IMFINZI plus tremelimumab and chemotherapy arm.
  • Real-world first-line treatment and overall survival in non-small cell lung cancer without known EGFR mutations or ALK rearrangements in US community oncology setting.

Tiziana Life Sciences Interview to Air on Bloomberg Television U.S. on the RedChip Money Report

Friday, May 7, 2021 - 7:00am

In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

Key Points: 
  • In addition to Milciclib, the Company is also developing Foralumab for liver diseases.
  • Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world.
  • Words such as \'anticipates,\' \'expects,\' \'intends,\' \'plans,\' \'believes,\' \'seeks,\' \'estimates,\' and similar expressions are intended to identify forward-looking statements.
  • The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made.

Asieris and BeiGene Enter into Clinical Collaboration to Evaluate Combinations of APL-1202 and Tislelizumab

Thursday, May 6, 2021 - 1:30pm

It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC.

Key Points: 
  • It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.
  • We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA(zanubrutinib) inthe United StatesandChina, and anti-PD-1 antibody tislelizumab inChina.
  • The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management.