Hoffmann-La Roche

Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration

Retrieved on: 
Monday, December 19, 2022
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Under the terms of the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies long-standing collaboration on antibodies targeting CD20.

Key Points: 
  • Under the terms of the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies long-standing collaboration on antibodies targeting CD20.
  • Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody being developed by Roche for the treatment of B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, and other blood cancers1.
  • If approved, glofitamab has the potential to be a first-in-class fixed-duration CD20xCD3 T-cell engaging bispecific antibody in DLBCL.
  • The companies have had a collaboration on antibodies targeting CD20 since 1995.

FDA Grants Priority Review to Genentech’s Bispecific Antibody Glofitamab for People With Relapsed or Refractory Large B-Cell Lymphoma

Retrieved on: 
Friday, January 6, 2023
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The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1, 2023.

Key Points: 
  • The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1, 2023.
  • If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment.
  • The FDA will review the glofitamab BLA under the granted Fast Track Designation.
  • Glofitamab is part of Genentech’s industry-leading CD20xCD3 T-cell engaging bispecific antibody clinical program, which is the broadest and most advanced in lymphoma.

Nimble Therapeutics Announces Expansion of its Discovery and Development Partnership with Genentech

Retrieved on: 
Thursday, January 5, 2023
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“We are excited to significantly expand our partnership and strengthen our collaboration with Genentech,” said Jigar Patel, Founder & CEO of Nimble Therapeutics.

Key Points: 
  • “We are excited to significantly expand our partnership and strengthen our collaboration with Genentech,” said Jigar Patel, Founder & CEO of Nimble Therapeutics.
  • Nimble will apply its platform against multiple targets, and Genentech and Roche will be responsible for preclinical and clinical development, and commercialization of any resulting products.
  • “This expanded partnership with Genentech, and the multiple recently achieved milestones across all our partnered programs, demonstrates Nimble’s capability to deliver peptide therapeutic candidates,” said Pete Gough, CSO of Nimble Therapeutics.
  • Nimble is a biotechnology company dedicated to delivering on the promise of peptide therapeutics.

Belharra Therapeutics Announces Broad Collaboration with Genentech to Discover and Develop Novel Medicines Across Multiple Therapeutic Areas

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Wednesday, January 4, 2023
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Belharra Therapeutics, a privately held drug discovery company with a novel photoaffinity-based, non-covalent chemoproteomics platform, today announced a multi-year collaboration with Genentech, a member of the Roche Group.

Key Points: 
  • Belharra Therapeutics, a privately held drug discovery company with a novel photoaffinity-based, non-covalent chemoproteomics platform, today announced a multi-year collaboration with Genentech, a member of the Roche Group.
  • The companies will collaborate employing Belharra’s proprietary platform to discover and develop small molecule medicines in multiple therapeutic areas including oncology, immuno-oncology, autoimmune, and neurodegenerative diseases.
  • The company’s proprietary screening library enables Belharra scientists to identify any binding site, on any protein, in any conformational state, in any cell type.
  • “Partnering with early-stage companies like Belharra provides Genentech with yet another way to advance groundbreaking science to discover and develop medicines for patients with serious and life-threatening diseases.”

FoundationOne®Liquid CDx Receives FDA Approval as a Companion Diagnostic for Rozlytrek® (entrectinib)

Retrieved on: 
Wednesday, January 4, 2023
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FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib).

Key Points: 
  • FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib).
  • This decision from the FDA follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, FoundationOne®CDx, for the same therapy last year.
  • CGP has transformed the traditional ‘one-size fits-all’ approach to cancer and is an important tool for identifying rare and hard to find mutations, including ROS1 and NTRK.
  • Foundation Medicine’s two FDA-approved tests both meet rigorous analytical and clinical validation standards and demonstrate Foundation Medicine’s deep regulatory expertise – FoundationOne Liquid CDx has the broadest gene panel of any FDA-approved blood-based test, and the company’s tissue-based CGP test, FoundationOne CDx, was the first ever FDA-approved broad companion diagnostic test.

FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Friday, December 23, 2022
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Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment.
  • Lunsumio will be available in the United States in the coming weeks.
  • “This bispecific antibody is an off-the-shelf, accessible treatment option that has the potential to help those with relapsed or refractory follicular lymphoma achieve remission.”
    Lunsumio was developed based on Genentech’s broad expertise in creating bispecific antibodies.

FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults

Retrieved on: 
Wednesday, December 21, 2022
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Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.

Key Points: 
  • Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.
  • The FDA approval follows the FDA’s Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in June 2021.
  • More than one million people hospitalized with COVID-19 have been treated with Actemra worldwide since the beginning of the pandemic.
  • Around the world, Actemra is approved for use in more than 30 countries for patients hospitalized with severe COVID-19.

City of Hope-led trial leads to U.S. Food and Drug Administration's approval of a first of its kind bispecific antibody

Retrieved on: 
Thursday, January 5, 2023
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LOS ANGELES, Jan. 5, 2023 /PRNewswire/ -- A trial led by City of Hope, one of the largest cancer research and treatment organizations in the nation, contributed to the U.S. Food and Drug Administration's approval of mosunetuzumab (commercial name: Lunsumio), the first bispecific antibody to treat people with relapsed or difficult to treat follicular lymphoma (FL), a type of non-Hodgkin lymphoma, after they have received two or more standard therapies.

Key Points: 
  • Instead of concentrating on a singular target, bispecific antibodies are therapeutics that act on two cellular targets simultaneously.
  • "At City of Hope, the integration of scientific research and clinical trials allows us to deliver groundbreaking science and treatments from laboratory to patient.
  • Mosunetuzumab is a first in class T cell engaging bispecific antibody and could change the way advanced follicular lymphoma is treated."
  • Ninety patients with follicular lymphoma, who ranged in age from 29 to 90 years old, were enrolled in the multicenter international trial.

Remix Therapeutics Appoints Christopher Bowden, M.D., as Chief Medical Officer

Retrieved on: 
Thursday, January 5, 2023
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CAMBRIDGE, Mass., Jan. 5, 2023 /PRNewswire/ -- Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, today announced the appointment of Christopher Bowden, M.D., as Chief Medical Officer.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 5, 2023 /PRNewswire/ -- Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, today announced the appointment of Christopher Bowden, M.D., as Chief Medical Officer.
  • "We are especially pleased to welcome Chris to the Remix team as his wealth of strategic medical and corporate experience are ideally suited for this role.
  • We look forward to leveraging his extensive clinical expertise as we advance programs from our REMaster platform toward the clinic," said Peter Smith, Ph.D., Co-Founder and Chief Executive Officer of Remix Therapeutics.
  • Dr. Bowden joins Remix from Agios, where he served as a Strategic Advisor and Chief Medical Officer (CMO) from 2014-2022.

Dr. Reddy’s Successfully Completes Phase 1 Study of DRL_TC, a Proposed Biosimilar of Tocilizumab

Retrieved on: 
Monday, December 19, 2022
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Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 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 1 study.
  • This Phase 1 study used a subcutaneous 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 subcutaneous and intravenous formulations.