Tocilizumab

Mustang Bio Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, March 11, 2024

WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.
  • Research and development expenses were $40.5 million for the year ended December 31, 2023, compared to $62.5 million for 2022.
  • 2023 and Recent Corporate Highlights:
    In July 2023, Mustang announced that it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. (“uBriGene”) and closed the transaction.
  • In October 2023, Mustang completed a registered direct offering priced at-the-market for approximately $4.4 million in gross proceeds.

Mustang Bio Presents Updated Phase 1/2 Multicenter Clinical Data for MB-106 at the 2023 American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Monday, December 11, 2023

WORCESTER, Mass., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced updated encouraging safety and efficacy data from Mustang’s multicenter Phase 1/2 clinical trial of MB-106, a CD20-targeted, 3rd-generation autologous CAR T-cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“NHL”) and chronic lymphocytic leukemia (“CLL”). The data were presented during a poster session on December 9th (Abstract #2102) at the 65th American Society of Hematology (“ASH”) Annual Meeting and build upon previously reported data from a single-institution Phase 1/2 clinical trial conducted at Fred Hutchinson Cancer Center (“Fred Hutch”). MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

Key Points: 
  • The data were presented during a poster session on December 9th (Abstract #2102) at the 65th American Society of Hematology (“ASH”) Annual Meeting and build upon previously reported data from a single-institution Phase 1/2 clinical trial conducted at Fred Hutchinson Cancer Center (“Fred Hutch”).
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutch.
  • “All nine patients have responded clinically to treatment in this multicenter trial and the safety and efficacy profile of MB-106 appears to be consistent with the original single-institution trial.
  • It is especially encouraging that complete responses were observed in all patients with follicular lymphoma in this multicenter trial,” said Mazyar Shadman, M.D., M.P.H., Study Chair, Innovators Network Endowed Chair at Fred Hutch, Associate Professor and physician at Fred Hutch and University of Washington.

FDA Approves TOFIDENCE™ (tocilizumab-bavi) a Biosimilar of ACTEMRA® developed by Bio-Thera Solutions

Retrieved on: 
Sunday, October 8, 2023

The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Key Points: 
  • The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
  • TOFIDENCE (BAT1806 / BIIB800) is Bio-Thera's first FDA approved product in the United States, and the first biosimilar developed and manufactured by a Chinese pharmaceutical company approved in the United States.
  • Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in all countries excluding China (including Hong Kong, Macau and Taiwan).
  • The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022.

FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®

Retrieved on: 
Friday, September 29, 2023

TOFIDENCE is the first tocilizumab biosimilar approved in the United States.

Key Points: 
  • TOFIDENCE is the first tocilizumab biosimilar approved in the United States.
  • Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy1.
  • The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022.
  • The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.

Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab

Retrieved on: 
Monday, June 5, 2023

Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.
  • This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products.
  • Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product** was successfully demonstrated.
  • Dr. Reddy’s is developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations.

Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 18, 2023

The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.
  • In these volatile market conditions, the biosimilars market is still expanding dramatically, and the outlook is as promising.
  • It provides a detailed analysis of biosimilar market dynamics, covering clinical trials, patent data, financial deals, and company profiling details.
  • In addition, this report provides analyst commentary on key trends, drivers, strategies, innovations, and regulations in the field of biosimilars.

Annals of Rheumatic Diseases Publishes Results from Phase 2 Study of emapalumab in Patients with Secondary HLH/Macrophage Activation Syndrome

Retrieved on: 
Tuesday, April 4, 2023

In the published study, 14 patients with sJIA or AOSD and sHLH/MAS who did not respond to high-dose glucocorticosteroids received emapalumab.

Key Points: 
  • In the published study, 14 patients with sJIA or AOSD and sHLH/MAS who did not respond to high-dose glucocorticosteroids received emapalumab.
  • All 14 patients completed the trial, entered long-term follow-up and were alive at the end of follow-up.
  • Based on the results of this study, Sobi decided to continue to evaluate emapalumab in this patient population and initiated the EMERALD phase 3 study, which is ongoing.
  • “We remain committed to evaluating emapalumab as a potential new treatment option for patients affected by this severe condition.

Enlivex Announces Issuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy, Infectious Diseases or Any Non-Infectious Source of CRS

Retrieved on: 
Wednesday, February 15, 2023

Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.

Key Points: 
  • Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.
  • CAR T-cells are T-cells that have been genetically modified to include a receptor that allows them to specifically target and destroy cancer cells.
  • While certain CAR T-cell treatments were recently approved by the FDA in several cancer indications, such treatments have been associated in many patients with a side effect named cytokine release syndrome, which describes a collection of potentially severe or life-threatening symptoms that stem from over-activation of immune pathways.
  • Preclinical data indicate that Allocetra™ has the potential to prevent or ameliorate cytokine release syndrome associated with CAR T-cell therapies.

China Anti-Rheumatic Drug Market Forecasts Report 2022: A $24.65 Billion Market by 2027 - ResearchAndMarkets.com

Retrieved on: 
Friday, January 20, 2023

The "China Anti-Rheumatic Drug Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "China Anti-Rheumatic Drug Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.
  • The market is projected to grow at a CAGR of 3.73% to attain a value of US$24.654 billion by 2027.
  • A growing number of patients suffering from arthritis in China is the major driver of the antirheumatic drugs market in the country.
  • As such, changing lifestyles will continue this trend during the next five years, thus positively impacting the market growth of antirheumatic drugs in China.

Tonix Pharmaceuticals Announces Acquisition of Preclinical Infectious Disease Portfolio from Healion Bio, Inc.

Retrieved on: 
Thursday, February 2, 2023

CHATHAM, N.J., Feb. 02, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has acquired all of the assets of Healion Bio, Inc. (Healion) including its entire portfolio of next-generation antiviral technology assets. Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed mechanism of action. Host-directed antivirals modulate human cells and tissues and are different from direct-acting antivirals which inhibit virus proteins and processes. Tonix’s TNX-3900, formerly known as HB-121, are cathepsin protease inhibitors, some of which have strong activity in vitro against SARS-CoV-2.

Key Points: 
  • Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed mechanism of action.
  • Host-directed antivirals modulate human cells and tissues and are different from direct-acting antivirals which inhibit virus proteins and processes.
  • Tonix’s TNX-3900, formerly known as HB-121, are cathepsin protease inhibitors, some of which have strong activity in vitro against SARS-CoV-2.
  • On behalf of the talented scientific team that I direct at our 48,000 square-foot cutting-edge infectious disease research facility in Frederick, Md., I am pleased to add this technology to the therapeutic development programs underway.”