IgG4-related disease

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 24, 2024

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Future Treatments for Rare Organ Disease Raise Hope, New Paper Explains

Retrieved on: 
Thursday, February 29, 2024

WASHINGTON, Feb. 29, 2024 /PRNewswire/ -- IgG4-RD patients may finally have a treatment developed specifically for their condition, explains a clinician-authored white paper from the Alliance for Patient Access. "Addressing Access Barriers for IgG4-RD Patients" highlights that the rare condition has flown under the radar for many years and a treatment for IgG4-RD is sorely needed. Increasing awareness, thankfully, is leading to more correct diagnoses, greater social support and innovative options.

Key Points: 
  • Physicians describe patients' years of inaccurate diagnoses and off-label treatment, look toward forthcoming FDA approvals
    WASHINGTON, Feb. 29, 2024 /PRNewswire/ -- IgG4-RD patients may finally have a treatment developed specifically for their condition, explains a clinician-authored white paper from the Alliance for Patient Access. "
  • Addressing Access Barriers for IgG4-RD Patients " highlights that the rare condition has flown under the radar for many years and a treatment for IgG4-RD is sorely needed.
  • Increasing awareness, thankfully, is leading to more correct diagnoses, greater social support and innovative options.
  • As treatments tailored to these patients finally emerge, patients, providers and advocates must still overcome a number of challenges:
    Policymakers can play a key role in protecting patient care by implementing policies that tackle utilization management barriers and ensure new treatments are accessible.

Zenas BioPharma Announces Strategic License and Collaboration Agreement with Bristol Myers Squibb to Develop and Commercialize Novel Bi-Functional Antibody Obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia

Retrieved on: 
Tuesday, September 5, 2023

WALTHAM, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immunology-based therapies, today announced that it has entered into a license and collaboration agreement with Bristol Myers Squibb Company to develop and commercialize obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia.

Key Points: 
  • Obexelimab is an investigational bifunctional, non-cytolytic, humanized monoclonal antibody that binds CD19 and FcγRIIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells.
  • The compound is also being studied in a global Phase II/III trial in patients with warm antibody Auto-Immune Hemolytic Anemia (wAIHA).
  • In exchange, Bristol Myers Squibb will receive exclusive rights to develop and commercialize obexelimab in the licensed territory.
  • In addition, Bristol Myers Squibb is making an equity investment in Zenas.

Horizon Therapeutics plc Reports Second-Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 8, 2023

Second-quarter and year-to-date 2023 UPLIZNA net sales included $15.4 million and $22.0 million, respectively, in international net sales.

Key Points: 
  • Second-quarter and year-to-date 2023 UPLIZNA net sales included $15.4 million and $22.0 million, respectively, in international net sales.
  • Second-quarter and year-to-date 2022 UPLIZNA net sales included $8.6 million and $13.8 million, respectively, in international net sales.
  • The second-quarter results were driven by execution across all phases of the patient journey – demand generation, stakeholder education and adherence to treatment.
  • In light of the announced agreement to be acquired by Amgen Inc. and applicable securities laws, the Company will not be hosting a conference call to discuss its financial results.

Zenas BioPharma Announces Publication of Phase 2 Study of Obexelimab, an Investigational Treatment for IgG4-Related Disease (IgG4-RD), in The Lancet Rheumatology

Retrieved on: 
Tuesday, August 1, 2023

WALTHAM, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, announces The Lancet Rheumatology has published findings from a Phase 2 study evaluating obexelimab for the treatment of patients with IgG4-Related Disease (IgG4-RD). Based on the results of this study, a Phase 3 study in patients with IgG4-RD is ongoing to further investigate the efficacy and safety of obexelimab administered as a subcutaneous injection.

Key Points: 
  • IgG4-RD is a chronic, immune-mediated fibro-inflammatory disease that can affect multiple organs including the major salivary glands, orbits, lacrimal glands, pancreas, biliary tree, lungs, kidneys, and retroperitoneum.
  • Despite its increasing recognition, there remains a need for further research and effective therapeutic options for individuals living with this debilitating disease.
  • Across the world, the use of glucocorticoids is widely considered to be the standard of care for treating IgG4-RD.
  • “Our team is honored to have our research recognized by The Lancet Rheumatology, and we are immensely grateful to the patients who participated in this groundbreaking study.”

Rare Disease Initiative Will Tackle Awareness and Treatment Access Challenges

Retrieved on: 
Wednesday, January 25, 2023

WASHINGTON, Jan. 25, 2023 /PRNewswire/ -- A new initiative from the nonprofit Alliance for Patient Access brings together clinicians from across the country to identify unmet needs and to improve treatment access for patients living with IgG4-RD. The rare and chronic autoimmune disease is sometimes associated with type 1 autoimmune pancreatitis.

Key Points: 
  • The rare and chronic autoimmune disease is sometimes associated with type 1 autoimmune pancreatitis .
  • The group will work to provide solutions to access challenges and to raise awareness, in addition to encouraging treatment research and innovation.
  • The Alliance for Patient Access released a " Fast Facts ," an educational Q&A document, to coincide with the IgG4-RD initiative launch.
  • The paper provides introductory information on the disease for patients as well as for providers for whom the disease may be unfamiliar.

Zenas BioPharma Announces First Patient Dosed in Phase 3 Clinical Study of Obexelimab for the Treatment of Immunoglobulin G4-Related Disease (IgG4-RD)

Retrieved on: 
Wednesday, January 11, 2023

WALTHAM, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced that the first patient has been dosed in the INDIGO Phase 3 registrational study of obexelimab. The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare. Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.

Key Points: 
  • The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare.
  • Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.
  • “There are no currently approved treatments for patients living with IgG4-RD.
  • Based upon the promising data from a Phase 2 study of obexelimab in IgG4-RD patients, we are excited to continue to evaluate the potential of obexelimab in the INDIGO study.”

Zenas BioPharma Secures $118 Million to Advance Its Broad Pipeline of Autoimmune Disease Therapeutics

Retrieved on: 
Wednesday, November 9, 2022

WALTHAM, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced proceeds of $118 million in connection with the issuance of Series B preferred shares. In addition to Enavate Sciences, which led the Series B equity financing, new Zenas shareholders include Longitude Capital, Vivo Capital, Rock Springs Capital, Perceptive Advisors, Agent Capital, Pivotal bioVenture Partners and Superstring Capital. Existing investors Fairmount, Wellington Management, Tellus BioVentures, Quan Venture Fund, and Xencor, Inc. also participated in the financing, which included the infusion of new capital as well as the conversion of convertible notes issued to certain of the investors in advance of the closing of the Series B financing.

Key Points: 
  • In addition, the new funding will progress the companys other global autoimmune disease programs into clinical development in 2023.
  • We believe Zenas will successfully commercialize innovative therapies to improve the lives of those facing autoimmune and rare diseases, said James Boylan, Chief Executive Officer of Enavate Sciences.
  • Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world.
  • For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn .

Zenas BioPharma Secures $118 Million to Advance Its Broad Pipeline of Autoimmune Disease Therapeutics

Retrieved on: 
Monday, November 7, 2022

WALTHAM, Mass., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced proceeds of $118 million in connection with the issuance of Series B preferred shares. In addition to Enavate Sciences, which led the Series B equity financing, new Zenas shareholders include Longitude Capital, Vivo Capital, Rock Springs Capital, Perceptive Advisors, Agent Capital, Pivotal bioVenture Partners and Superstring Capital. Existing investors Fairmount, Wellington Management, Tellus BioVentures, Quan Venture Fund, and Xencor, Inc. also participated in the financing, which included the infusion of new capital as well as the conversion of convertible notes issued to certain of the investors in advance of the closing of the Series B financing.

Key Points: 
  • In addition, the new funding will progress the companys other global autoimmune disease programs into clinical development in 2023.
  • Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world.
  • For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn .
  • Through the application of capital support and operational experience, Enavate strives to enable and empower a diverse portfolio of therapeutics companies to accelerate innovation.

Xencor Reports Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 7, 2022

XmAb564 (IL2-Fc): Today, Xencor announced initial results from its single-dose Phase 1a study of XmAb564, administered subcutaneously in healthy volunteers.

Key Points: 
  • XmAb564 (IL2-Fc): Today, Xencor announced initial results from its single-dose Phase 1a study of XmAb564, administered subcutaneously in healthy volunteers.
  • Vir Biotechnology, Inc.: In the third quarter of 2022, Xencor reported $17.8 million in royalty revenue under the Companys agreement with Vir.
  • Financial Results for the Third Quarter Ended September 30, 2022
    Cash, cash equivalents, receivables and marketable debt securities totaled $654.6 million as of September 30, 2022, compared to $664.1 million on December 31, 2021.
  • ET (1:30 p.m. PT) to discuss the third quarter 2022 financial results, provide a corporate update and present results from the Phase 1a study of XmAb564.