Caelum and Alexion Announce Upcoming Data Presentations at the 62nd American Society of Hematology Annual Meeting and Exposition – Business Wire
Posted: November 4, 2020 at 11:59 am
BORDENTOWN, N.J. & BOSTON--(BUSINESS WIRE)--Caelum Biosciences and Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that two abstracts on CAEL-101, a first-in-class amyloid fibril targeted therapy, have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually from December 5 to 8, 2020. New data, from Cleveland Clinic, will be presented on the safety, efficacy and tolerability of CAEL-101 in combination with standard-of-care therapy in AL amyloidosis from the Phase 2 open-label dose escalation study that suggest early evidence of organ response. Data, from Caelum, that further demonstrate the safety and tolerability of CAEL-101 and support the selection of the 1000 mg/m2 dose for the Phase 3 study will also be presented.
The accepted abstracts are listed below and are now available on the ASH website:
Oral Presentation
Safety, Tolerability and Efficacy of CAEL-101 in AL Amyloidosis Patients Treated on a Phase 2, Open-Label, Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients with AL Amyloidosis. Abstract #729. An oral symposium presentation is scheduled for December 7, 2020, 2:45 p.m. PST.
ePoster Presentation
CAEL-101 is Well-Tolerated in AL Amyloidosis Patients Receiving Concomitant Cyclophosphamide-Bortezomib-Dexamethasone (CyborD): A Phase 2 Dose-Finding Study (NCT04304144), Abstract #2277 poster presentation, poster session II, December 6, 2020, 7:00 a.m. - 3:30 p.m. PST.
As was previously announced, the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101 in combination with standard-of-care (SoC) therapy in AL amyloidosis has begun. Enrollment is underway in two parallel Phase 3 studies one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease and will collectively enroll approximately 370 patients globally. The Phase 2 program continues with the addition of a study arm to evaluate CAEL-101 in combination with SoC therapy plus daratumumab.
About CAEL-101
CAEL-101 is a first-in-class monoclonal antibody (mAb) designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes. In a Phase 1a/1b study, CAEL-101 demonstrated improved organ function, including cardiac and renal function, in 27 patients with relapsed and refractory AL amyloidosis who had previously not had an organ response to standard of care therapy. CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a potential therapy for patients with AL amyloidosis.
About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded immunoglobulin light chains produced by plasma cells aggregate and form fibrils that deposit in tissues and organs. This deposition can cause widespread and progressive organ damage and high mortality rates, with death most frequently occurring as a result of cardiac failure. Current standard of care includes plasma cell directed chemotherapy and autologous stem cell transplant, but these therapies do not address the organ dysfunction caused by amyloid deposition, and up to 80 percent of patients are ineligible for transplant.
AL amyloidosis is a rare disease but is the most common form of systemic amyloidosis. There are approximately 22,000 patients across the United States, France, Germany, Italy, Spain and the United Kingdom. AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis.
About Caelum Biosciences
Caelum Biosciences, Inc. (Caelum) is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Caelums lead asset, CAEL-101, is a novel antibody for the treatment of patients with amyloid light chain (AL) amyloidosis. In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data. Caelum was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.caelumbio.com.
About Alexion
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: http://www.alexion.com.
[ALXN-P]
Forward-Looking Statement
This press release may contain forward-looking statements, including as such term is defined within Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include, but are not limited to, any statements relating to Caelums or Alexions growth strategy and our respective product development programs, plans related to clinical trials (including, commencement, completion and future patient enrollment), the anticipated benefits of CAEL-101 and any other statements that are not historical facts. Forward-looking statements are based on Caelum and Alexion managements current expectations and are subject to risks and uncertainties that could negatively affect each of our businesses, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks that CAEL-101 is not shown to be safe and effective in clinical trials or does not receive regulatory approval to be marketed, risks relating to each companys growth strategy; ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing (including, commencement, completion and future patient enrollment); risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on each Companys employees and consultants ability to complete work in a timely manner and on the ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; Caelums need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in each Companys SEC filings. Alexion and Caelum expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our respective expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 or any other protections afforded by applicable law. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Go here to see the original:
Caelum and Alexion Announce Upcoming Data Presentations at the 62nd American Society of Hematology Annual Meeting and Exposition - Business Wire
- Worldwide Industry for Biopreservation to 2026 - Key Drivers, Restraints and Opportunities - Yahoo Finance - January 5th, 2021
- Vape Flavorings Are Cardiotoxic and Can Damage the Heart - SciTechDaily - December 28th, 2020
- Outlook on the Biopreservation Global Market to 2026 - Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others - GlobeNewswire - December 26th, 2020
- UC Davis researchers find a way to help stem cells work ... - December 17th, 2020
- I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic - PRNewswire - December 17th, 2020
- Flavors added to vaping devices damage the heart, vanilla custard the most toxic of all - Study Finds - December 17th, 2020
- Covid-19 can have impact on heart too, say experts - Hindustan Times - December 17th, 2020
- Network of Genes Involved in Congenital Heart Disease Identified - Technology Networks - December 17th, 2020
- Industry News: Hamamatsu Photonics UK Ltd and the Medical Technologies Innovation Facility enter into a partnership agreement - SelectScience - December 17th, 2020
- Osteoporosis treatments could be on the way after scientists identify aging gene - iNews - November 30th, 2020
- Global Myocardial Infarction Drug Market to have sustainable growth over the forecast period 2020-2028| Leading Players BioCardia, Inc., Laboratoires... - November 30th, 2020
- Breakthroughs in Stem Cell Based Treatment of Heart Disease - The Connecticut College Voice - November 24th, 2020
- Mount Sinai Cardiologist Awarded $2.9 Million NIH Grant to Advance Work with Stem Cells and Heart Repair after Heart Attack - Cath Lab Digest - November 24th, 2020
- Autologous Stem Cell Based Therapies Market Share, Growth by Top Company, Region, Application, Driver, Trends & Forecasts by 2026 - PRnews Leader - November 24th, 2020
- 3D Cardiac Mapping Systems Market Competitive Landscape Analysis with Forecast by 2028 - The Haitian-Caribbean News Network - November 24th, 2020
- Organoids mimic the early development of the heart in mouse embryos - BioNews - November 18th, 2020
- Mimicking the early development of the heart - Tech Explorist - November 18th, 2020
- Cell Therapy and Gene Therapy Markets, 2019-2020 & Forecast to 2025 and 2030 - ResearchAndMarkets.com - Business Wire - November 18th, 2020
- UPDATED: Merck's Keytruda nets another approval, this time in triple negative breast cancer. Can it catch up to Tecentriq? - Endpoints News - November 18th, 2020
- Can Hearts Repair Themselves Via Stem Cells - The Niche - November 13th, 2020
- Stem cells as therapy for heart disease: iPSCs, ESCs, CSCs ... - November 13th, 2020
- Global Autologous Stem Cell Based Therapies Market 2020 Segmentation, Statistics, Top Manufacturers, Regional Analysis and Forecast to 2025 - The... - November 13th, 2020
- The Amniotic Fluid Stem Cell Therapy market to be in conjunction to growth from 2018 to 2026 - PRnews Leader - November 13th, 2020
- BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights - GlobeNewswire - November 13th, 2020
- Exploring Genetic Variation and COVID-19 Clinical Variability - Technology Networks - November 13th, 2020
- Autologous Stem Cell Based Therapies Market 2020 Emerging Trend and Advancement - News by aeresearch - November 10th, 2020
- KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall... - November 10th, 2020
- Global Progenitor Cell Product Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2026 - Zenit News - November 10th, 2020
- Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients... - November 10th, 2020
- Advancement: Know the Rapid Growth Factors of Biopreservation Market| Stay Up-To-Date With Emerging - PharmiWeb.com - November 10th, 2020
- Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030 - PRnews Leader - November 4th, 2020
- California Prop 14 would keep taxpayer funding of stem cell therapy research, which can change lives: Meet the Langenhop kids - AZCentral.com - November 4th, 2020
- Stem Cell Therapy Market to Surge at a Robust Pace in Terms of Revenue Over2017 2025 - Royal Sutton News - November 4th, 2020
- Autologous Stem Cell Based Therapies Market to Witness Increase in Revenues by 2020-2026 - PRnews Leader - November 3rd, 2020
- Orphan Drug Designation Granted for CSL Behring's Investigational Plasma-Derived Hemopexin Therapy for Sickle Cell Disease - PRNewswire - November 3rd, 2020
- Ready To Use Autologous Stem Cell Based Therapies Market Industry Analysis, Trend and Growth, 2020-2020 - Royal Sutton News - November 1st, 2020
- Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia - GlobeNewswire - November 1st, 2020
- Regenerative Medicine Market Poised to Garner Maximum Revenues During 2025 - The Think Curiouser - November 1st, 2020
- The role of induction therapy before autologous stem cell transplantation in low disease burden AL amyloidosis patients - DocWire News - October 23rd, 2020
- COVID-19 can affect the heart - Science Magazine - October 23rd, 2020
- Stem Cell Assay Market expected to Witness a Sustainable Growth over 2025 - TechnoWeekly - October 23rd, 2020
- Exosome Therapeutic Market 2020-2026 Demand Analysis and Projected Huge Growth by Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH,... - October 23rd, 2020
- Stem Cell Assay Market In-Depth Analysis & Forecast 2017-2025 - The Think Curiouser - October 22nd, 2020
- Five Indian American Researchers Named Among NIH 2020 New Innovator Awardees - India West - October 22nd, 2020
- Exosome Therapeutic Market 2020-2026 to Witness Excellent Growth || Major Gaints Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH,... - October 22nd, 2020
- Banking wisdom: Teen saving stem cells in hopes of future treatment - LubbockOnline.com - October 16th, 2020
- Global Cell Based Assay & High Content Screening Markets to 2024: Updated Report - Understand Growth Expectations and the Potential Market Size -... - October 16th, 2020
- Merck Presents Three-Year Survival Data for KEYTRUDA (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational... - October 16th, 2020
- Preclinical Study Shows Improvement In Recovery From Heart Attack With Exosomes - Anti Aging News - October 10th, 2020
- Autologous Stem Cell Based Therapies Market Size, Business Revenue Forecast, Leading Competitors And Growth Trends 2026| Regeneus, Mesoblast,... - October 10th, 2020
- Recording thousands of nerve cell impulses at high resolution - Newswise - October 4th, 2020
- Wisconsin Medicine Livestream: The future of medicine - Wisbusiness.com - October 2nd, 2020
- Measuring chips amplify and record nerve cells - Futurity: Research News - October 2nd, 2020
- Recording thousands of nerve cell impulses at high resolution - ScienceDaily - Up News Info - October 2nd, 2020
- Kyoto University project aims to supply iPS cells widely at low cost - The Japan Times - September 30th, 2020
- Heart attack patches may save lives in US and beyond - Galveston County Daily News - September 30th, 2020
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020-2025 Global Briefing, Growth Analysis And Opportunities Outlook | Major Giants ... - September 30th, 2020
- Exosome Therapeutic Market Latest Industry Size, Growth, Share, Emerging Demands, and Competitive Landscape || Major Gaints Jazz Pharmaceuticals,... - September 30th, 2020
- James T. Willerson, Revered Clinician, Editor, and Mentor, Dies at 81 - TCTMD - September 22nd, 2020
- Researchers Discover a Way To Create Induced Tropoblast Stem Cells - Technology Networks - September 18th, 2020
- What Is Covid-19 Doing to Our Hearts? - The New Republic - September 18th, 2020
- Astellas and Seattle Genetics Announce PADCEV (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated... - September 18th, 2020
- Alexion and Caelum Biosciences Announce Start of Phase 3 Studies of CAEL-101 in AL Amyloidosis - BioSpace - September 14th, 2020
- David Shavelle, MD, Named Medical Director of Adult Cardiology for the MemorialCare Heart & Vascular Institute at Long Beach Medical Center -... - September 14th, 2020
- Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations - BioSpace - September 14th, 2020
- How the coronavirus causes 'carnage' in the heart - The Daily Briefing - September 9th, 2020
- Innovative treatments for heart failure - Open Access Government - September 9th, 2020
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market Scope And Price Analysis 2020 | Major Giants Fibrocell, Genesis Biopharma, Georgia... - September 9th, 2020
- Microengineered 3D pulmonary interstitial mimetics highlight a critical role for matrix degradation in myofibroblast differentiation - Science... - September 9th, 2020
- COVID-19 Drug Discovery and Development Why Diverse Strategies Are Critical - Technology Networks - September 9th, 2020
- Much-loved son Joe Brown saved three lives after tragic death at just 29 - Birmingham Live - September 9th, 2020
- Market Growth of Global Stem Cells to Remain Sluggish through 2020 2030 - The News Brok - September 4th, 2020
- Global and Asia Pacific Progenitor Cell Product Market to Witness Huge Growth by 2027 Major Manufacturers included in report NeuroNova AB, StemCells,... - September 4th, 2020
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020-2025 | Major Giants Fibrocell, Genesis Biopharma, Georgia Health Sciences... - August 29th, 2020
- Keio University gets OK for iPS-based heart cell transplant plan - The Japan Times - August 29th, 2020
- Scientists grow the first functioning mini human heart model - MSUToday - August 22nd, 2020
- First lab-made 'mini-hearts' mimic the real thing - Futurity: Research News - August 22nd, 2020
- Merck's KEYTRUDA (pembrolizumab) in Combination With Chemotherapy Significantly Improved Overall Survival and Progression-Free Survival Compared With... - August 19th, 2020
- Exosome Therapeutic Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 -... - August 19th, 2020
- Stem Cell Therapy Market Landscape Assessment By Type and Analysis Current Trends by Forecast To 2025 - The Daily Chronicle - August 17th, 2020