Natalizumab

Cadenza Bio, Inc. Appoints Michael A. Panzara, MD, MPH, to its Board of Directors

Retrieved on: 
Thursday, April 4, 2024

He also serves on the board of directors of Athira Pharma, Inc., a neurology-focused clinical-stage biopharmaceutical company.

Key Points: 
  • He also serves on the board of directors of Athira Pharma, Inc., a neurology-focused clinical-stage biopharmaceutical company.
  • "We are delighted to welcome Dr. Panzara to our board of directors," said Dr. Carol Curtis, chief executive officer of Cadenza Bio.
  • "His extensive experience in developing therapies for MS and other neurological disorders aligns perfectly with our mission at Cadenza Bio.
  • "I look forward to joining the board of directors at Cadenza Bio at such an exciting time in the growth of the company," said Dr. Panzara.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

Retrieved on: 
Wednesday, March 6, 2024

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

Good News--MS Drugs Taken While Breastfeeding May Not Affect Child Development

Retrieved on: 
Tuesday, March 5, 2024

MS is a disease in which the body's immune system attacks myelin, the fatty white substance that insulates and protects the nerves.

Key Points: 
  • MS is a disease in which the body's immune system attacks myelin, the fatty white substance that insulates and protects the nerves.
  • For the study, researchers used the German MS and Pregnancy Registry to identify 183 infants born to mothers taking monoclonal antibodies while breastfeeding.
  • The first exposures to the medications through breastfeeding ranged from the day a child was born to the ninth month of life.
  • After comparing infants exposed to the medications to infants not exposed, researchers found no differences in their health or development.

BioLineRx Announces First Patient Dosed in Randomized Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC)

Retrieved on: 
Wednesday, February 28, 2024

TEL AVIV, Israel, Feb. 28, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed in the randomized CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC). The investigator-initiated trial is being conducted in collaboration with Columbia University and is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.

Key Points: 
  • The investigator-initiated trial is being conducted in collaboration with Columbia University and is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.
  • "We are encouraged by our early pilot data and look forward to continuing to advance the expanded, randomized Phase 2 CheMo4METPANC trial for patients living with this cancer."
  • The findings were previously presented during an oral presentation at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer in Boston, Massachusetts, September 28, 2023.
  • Motixafortide is also being evaluated in a Phase 1 clinical trial evaluating motixafortide as a monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).

Sandoz launches first and only biosimilar for multiple sclerosis, Tyruko® (natalizumab), in Germany

Retrieved on: 
Wednesday, January 31, 2024

53 SIX Swiss Exchange Listing Rules

Key Points: 
  • 53 SIX Swiss Exchange Listing Rules
    Basel, January 31, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Tyruko® (natalizumab) in Germany from February 1.
  • Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat RRMS.
  • Rebecca Guntern, President Europe, Sandoz, said: “Early treatment with disease-modifying therapies can have a significant impact on people living with multiple sclerosis and their potential future disabilities.
  • Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets.

PRISM MarketView Honors National Biotechnology Month with a Spotlight on Emerging Biotech Innovators

Retrieved on: 
Tuesday, January 9, 2024

NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- In celebration of National Biotechnology Month, PRISM MarketView acknowledges the significant advancements in biotechnology since its establishment by President Clinton in 2000.

Key Points: 
  • NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- In celebration of National Biotechnology Month, PRISM MarketView acknowledges the significant advancements in biotechnology since its establishment by President Clinton in 2000.
  • Aligning with this spirit of innovation and progress, PRISM MarketView is spotlighting the PRISM Emerging Biotech Index .
  • In honor of National Biotechnology Month, PRISM MarketView is excited to spotlight three trailblazing companies within our biotech index.
  • During National Biotechnology Month and throughout the year, PRISM MarketView’s Biotech index keeps a close eye on small and micro-cap stocks that are contributing to innovation in this critical sector.

BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease

Retrieved on: 
Thursday, December 21, 2023

TEL AVIV, Israel, Dec. 21, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). The proof-of-concept trial, which plans to enroll five patients diagnosed with SCD, is being conducted in collaboration with Washington University School of Medicine in St. Louis and will assess the safety and tolerability of the two regimens.

Key Points: 
  • "This is an exciting area of clinical research with the potential to meaningfully increase patients' access to stem-cell based gene therapies."
  • Approved gene therapies rely on the collection of significant quantities of CD34+ hematopoietic stem cells to enable therapeutic manufacturing and backup storage.
  • However, available mobilization regimens may not reliably yield desired numbers of HSCs for gene therapy, and the common mobilization agent G-CSF is contraindicated in patients with SCD.
  • Difficulties in obtaining target quantities of HSCs may extend patient treatment journeys and increase patient and caregiver burdens.

BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

Retrieved on: 
Monday, November 20, 2023

- Management to host conference call today, November 20, at 10:00 a.m. EST -

Key Points: 
  • - Management to host conference call today, November 20, at 10:00 a.m. EST -
    TEL AVIV, Israel, Nov. 20, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the third quarter ended September 30, 2023, and provided corporate and portfolio updates.
  • "In addition, the company also closed its motixafortide licensing agreement covering the important Asia market.
  • The highly encouraging data triggered a change in the protocol, from a small, single-arm study to a much larger randomized study.
  • A dial-in replay of the call will be available until November 22, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

Pasithea Therapeutics Selects PAS-003 Lead Development Candidate, a Humanized Monoclonal Antibody that Targets α5β1 Integrin for the Treatment of both Sporadic and Familial ALS

Retrieved on: 
Thursday, November 9, 2023

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that it has selected a lead therapeutic candidate for its PAS-003 program, a proprietary humanized monoclonal antibody (mAb) that targets α5β1 integrin, a protein found to be overexpressed in both human and mouse subjects with amyotrophic lateral sclerosis (ALS).

Key Points: 
  • Scientists at Pasithea have performed extensive mAb screening and characterization to enable selection of a lead therapeutic candidate with optimal properties for the treatment of ALS.
  • This work included further validation of α5β1 integrin as a target in both familial (SOD1) and sporadic (TDP-43) ALS mouse models with reproducible improvements on behavior and survival.
  • Extensive mechanism of action studies link disease model efficacy to effects on the migration and adhesion of immune cells.
  • Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea commented, “We have chosen the most optimal anti-α5β1 humanized mAb for the treatment of both sporadic and familial ALS.

Discovery of Genetic Link to PML Honored by Largest MS Conference in the World

Retrieved on: 
Tuesday, October 17, 2023

NEWPORT BEACH, Calif., Oct. 17, 2023 /PRNewswire/ -- The discovery of rare genomic variants leading to cases of drug-induced PML shared Best of MSMilan2023 honors for the latest and most breakthrough results at the 9th Joint ECTRIMS-ACTRIMS Meeting.

Key Points: 
  • Two of the variants have a Positive Predictive Value of 100%, the strongest possible indication they are causative.
  • Progressive Multifocal Leukoencephalopathy (PML) is a rare but frequently fatal serious infection of the brain by the JC virus.
  • Out of 1,500 abstracts presented, Dr. Hatchwell's was one of eight highlighted as Best of MSMilan2023 in its content area.
  • Many MS medications currently carry a PML warning, including Tysabri, Ocrevus, and Rituxan, as well as Briumvi, Gilenya, Kesimpta, Mavenclad, Mayzent, Ponvory, and Tecfidera.