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Bio-Thera Solutions Receives Positive CHMP Opinion for Ustekinumab Biosimilar USYMRO

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara.
  • The positive recommendation was based on comprehensive analytical, non-clinical and clinical data demonstrating biosimilarity through Phase 1 and Phase 3 studies in healthy volunteers and severe plaque psoriasis patients.
  • Bio-Thera partnered with Gedeon Richter in October 2024 for commercialization rights in the EU, UK and Switzerland following potential European Commission approval.
  • USYMRO targets IL-12 and IL-23 pathways involved in chronic inflammatory conditions including psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

Memo Therapeutics to Present Phase II Results for First-in-Class BK Polyomavirus Treatment at World Transplant Congress

Monoclonal Antibody
  • Memo Therapeutics will present interim Phase II results for potravitug, a monoclonal antibody targeting BK polyomavirus infection in kidney transplant recipients, at the World Transplant Congress in August 2025.
  • The SAFE KIDNEY II trial enrolled 95 patients across 22 U.S. sites to evaluate potravitug's efficacy against BKPyV infection, which affects up to 50% of kidney transplant recipients.
  • Potravitug represents a potential first-in-class therapy for BKV infection, addressing a significant unmet medical need with no currently approved treatment options available.
  • The drug received FDA fast-track designation in May 2023, recognizing the high medical need in this indication with market potential estimated at up to $2 billion annually.

Safety, Tolerability and Efficacy of AntiBKV As Treatment of BKV Infection in Kidney Transplant Recipients

NCT05769582Active, Not RecruitingPhase 2
Memo Therapeutics AG
Posted 4/10/2023

Avalo Therapeutics Appoints Rita Jain to Board as AVTX-009 Phase 2 Trial for Hidradenitis Suppurativa Progresses

Monoclonal Antibody
  • Avalo Therapeutics has appointed Rita Jain, M.D., a rheumatologist with over two decades of biopharmaceutical leadership experience, to its Board of Directors.
  • The appointment comes as the company advances AVTX-009, a high-affinity anti-IL-1β monoclonal antibody, through a Phase 2 LOTUS trial for hidradenitis suppurativa.
  • Dr. Jain previously served as Chief Medical Officer at ChemoCentryx, where she advanced Tavneos (avacopan), a first-in-class treatment for ANCA-associated vasculitis.
  • The Phase 2 LOTUS trial results for hidradenitis suppurativa are expected to read out in the middle of next year.

FDA Approves Tafasitamab Triple Combination for Relapsed/Refractory Follicular Lymphoma

Drug ApprovalMonoclonal Antibody
  • The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma.
  • The phase 3 inMIND trial demonstrated a median progression-free survival of 22.4 months with the tafasitamab combination versus 13.9 months with placebo plus lenalidomide and rituximab.
  • This approval provides the first CD19- and CD20-targeted immunotherapy combination for this patient population, offering a chemotherapy-free treatment option.
  • Serious adverse effects were reported in 33% of patients receiving tafasitamab, with serious infections occurring in 24% of patients.

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

NCT05718869RecruitingPhase 2
City of Hope Medical Center
Posted 5/18/2023

MInimal Residual Disease Adapted Strategy

NCT04934475Active, Not RecruitingPhase 3
Intergroupe Francophone du Myelome
Posted 12/8/2021

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

NCT04401748Active, Not RecruitingPhase 3
AbbVie
Posted 9/10/2020

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

NCT04680052Active, Not RecruitingPhase 3
Incyte Corporation
Posted 4/15/2021

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT02598661Active, Not RecruitingPhase 2
Geron Corporation
Posted 1/12/2016

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

NCT06434363RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 7/31/2024

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197Active, Not RecruitingPhase 3
Pfizer
Posted 12/18/2017

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

NCT02942290Active, Not RecruitingPhase 1
AbbVie
Posted 1/12/2017

Climb Bio Strengthens Leadership Team with Key Executive Appointments to Advance Immune-Mediated Disease Pipeline

Monoclonal Antibody
  • Climb Bio appointed Edgar D. Charles, M.D., MSc as Chief Medical Officer, bringing over 20 years of immunology-focused pharmaceutical development experience from Bristol Myers Squibb and Merck & Co.
  • The company also hired Cindy J. Driscoll, MBA as Senior Vice President, Finance, a seasoned executive with over two decades of biotechnology industry experience.
  • Dr. Charles will lead clinical development of budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for immune-mediated diseases.
  • The appointments come at a pivotal time as Climb Bio prepares to execute clinical studies for both therapeutic programs targeting B-cell mediated diseases.

Fareva Opens New GMP Sterile Pilot Unit in France to Support Biotech Drug Manufacturing

Monoclonal Antibody
  • Fareva has launched a new GMP sterile pilot unit at its Pau site in France, designed to produce liquid and lyophilized injectable forms for biotechnology-derived medicines.
  • The facility features advanced isolator technology compliant with revised Annex 1 requirements and can handle products ranging from small molecules to highly potent substances up to OEB 5 classification.
  • The unit supports flexible batch production from 200 to 8,000 vials and enables manufacturing of monoclonal antibodies, mRNA in LNP form, proteins, peptides, and ADCs for clinical trials and small commercial batches.
  • The new capability strengthens Fareva's position in sterile Fill & Finish services and supports pharmaceutical development from Phase 1 studies through commercialization via the company's network of five sterile production sites.

Scholar Rock's Apitegromab Preserves Lean Muscle Mass During Weight Loss with Tirzepatide in Phase 2 Trial

Monoclonal Antibody
  • Scholar Rock's Phase 2 EMBRAZE trial demonstrated that apitegromab preserved 54.9% more lean mass compared to tirzepatide alone, adding 4.2 pounds of lean muscle during weight loss treatment.
  • Patients receiving the combination therapy achieved higher quality weight loss with 85% fat mass reduction versus 70% fat mass reduction with tirzepatide alone over 24 weeks.
  • The myostatin inhibitor apitegromab was well tolerated with no serious adverse events related to treatment, addressing concerns about muscle loss associated with GLP-1 obesity medications.
  • The positive results validate Scholar Rock's platform for developing selective myostatin inhibitors while the company remains focused on apitegromab's potential approval for spinal muscular atrophy.

Tislelizumab Shows Promise as Adjuvant Therapy for High-Risk Hepatocellular Carcinoma Patients

Monoclonal Antibody
  • A multicenter retrospective study of 108 patients demonstrated that tislelizumab, with or without tyrosine kinase inhibitors, significantly extended recurrence-free survival in high-risk hepatocellular carcinoma patients after curative resection.
  • Patients receiving adjuvant therapy for at least 6 months showed significantly longer recurrence-free survival compared to those treated for less than 6 months, with RFS rates of 89.8%, 71.3%, and 59.3% at 6, 12, and 24 months respectively.
  • Combination therapy with TKIs did not provide additional survival benefit over tislelizumab monotherapy but resulted in significantly higher rates of grade 3 or higher treatment-related adverse events (38.5% vs 18.6%).
  • The findings suggest tislelizumab monotherapy may be the optimal adjuvant approach for preventing HCC recurrence, balancing efficacy with acceptable toxicity profiles.

Aragen to Launch GMP Biologics Manufacturing in India with Advanced Fed-Batch Platform

Monoclonal Antibody
  • Aragen will commence GMP manufacturing at its Bangalore biologics facility in July 2025, utilizing an intensified fed-batch platform that delivers titers greater than 25 g/L.
  • The facility features flexible single-use 2-KL bioreactors capable of producing one batch every four to five days at full capacity, supporting both multi-client projects and rapid commercial scale-up.
  • Combined with Aragen's California site, the integrated facilities will offer end-to-end biologics services from cell line development to commercial manufacturing of monoclonal antibodies and biosimilars.
  • The expansion aligns with projections that India's CRDMO sector could grow to $22-25 billion by 2035, driven by increasing global pharma outsourcing and biologics demand.

Agenus Partners with Noetik to Develop AI-Powered Biomarkers for Precision Immunotherapy

AIPrecision MedicineMonoclonal Antibody
  • Agenus and Noetik announced a research collaboration to develop predictive biomarkers for the BOT/BAL immunotherapy combination using AI-powered virtual cell models.
  • The partnership leverages Noetik's OCTO foundation model, trained on data from nearly 200 million tumor and immune cells across thousands of patients with various cancer types.
  • The collaboration aims to identify which patients are most likely to respond to botensilimab and balstilimab treatment, potentially improving clinical trial outcomes and patient care.
  • Botensilimab has been evaluated in over 1,200 patients across nine tumor types and has shown responses even in immunotherapy-resistant "cold" tumors.
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