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Intas Pharmaceuticals and Accord BioPharma Acquire UDENYCA Biosimilar, Expanding Global Pegfilgrastim Market Presence

Oncology
  • Intas Pharmaceuticals and Accord BioPharma have completed the acquisition of UDENYCA (pegfilgrastim-cbqv), a biosimilar to Amgen's Neulasta, from Coherus BioSciences.
  • The acquisition positions the companies as one of the largest global suppliers of pegfilgrastim, significantly expanding their FDA-approved biosimilar portfolio.
  • UDENYCA is indicated to decrease infection incidence in cancer patients receiving myelosuppressive chemotherapy and offers three patient-friendly administration options.
  • Accord was the first company to commercialize a pegfilgrastim biosimilar in Europe and the only company to launch an autoinjector formulation.

Minghui Pharmaceutical Secures $131 Million Pre-IPO Funding to Advance Oncology Pipeline and Commercial Launch

Oncology
  • Minghui Pharmaceutical closed a $131 million Pre-IPO financing round led by OrbiMed and co-led by Qiming Venture Partners to advance its late-stage clinical programs.
  • The funding will specifically support the company's PD-1/VEGF bispecific antibody development and combination strategies with antibody-drug conjugates (ADCs).
  • Proceeds will also enable the planned commercial launch of Minghui's topical JAK inhibitor currently under NDA review in China.
  • The company's pipeline includes multiple late-stage assets targeting oncology and immunology, including a B7-H3 ADC in Phase 3 trials for second-line small cell lung cancer.

Expert Highlights Optimal Positioning of Bispecific T-Cell Engagers in Multiple Myeloma Treatment

CAR-TOncology
  • Bispecific T-cell engagers demonstrate variable effectiveness in multiple myeloma depending on treatment setting, with talquetamab showing promise as pre-CAR T therapy to reduce cytokine release syndrome and neurotoxicity.
  • These agents produce deeper and more durable responses compared to standard therapies but carry increased infection risk, particularly with BCMA-targeting bispecifics.
  • Approximately 30% of patients fail to respond to bispecific treatment, potentially due to host immune system factors, patient fitness, and cancer cell soluble BCMA levels.
  • Researchers are exploring fixed-duration treatment strategies followed by observation periods to mitigate prolonged adverse effects associated with infections.

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

NCT05243797RecruitingPhase 3
Stichting European Myeloma Network
Posted 9/8/2022

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

NCT05552222RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/25/2022

Cartherics Opens Advanced Cell Therapy Manufacturing Facility to Support CTH-401 Clinical Development

Oncology
  • Melbourne-based Cartherics has opened a state-of-the-art cleanroom facility in Victoria to support clinical-scale manufacturing of its cell therapy products, marking a critical milestone for the company's manufacturing capabilities.
  • The facility will enable production of clinical batches of CTH-401, the company's lead CAR-iNK cell therapy targeting TAG-72 for relapsed and refractory ovarian cancer treatment.
  • Cartherics plans to submit an investigational new drug (IND) application for CTH-401 to the US FDA by mid-2026, advancing its mission to develop off-the-shelf immunotherapies for women's health conditions.
  • The facility incorporates advanced manufacturing technologies including closed processing systems, bioreactors, and comprehensive environmental controls to meet strict cell therapy manufacturing standards.

Dual Clinical Trials Advance Mesothelioma Treatment with Novel Immunotherapy Combinations

Oncology
  • Baylor College of Medicine and Duke University are conducting a clinical trial combining chemotherapy and immunotherapy before and after surgery for resectable mesothelioma patients, enrolling 52 participants.
  • AstraZeneca's global eVOLVE-Meso Phase III trial is testing Volrustomig, a dual-protein blocking immunotherapy, in 600 patients with unresectable pleural mesothelioma.
  • Both trials represent significant advances for a disease with less than 10% five-year survival rate, offering new hope through innovative treatment combinations.
  • The Baylor-Duke study focuses on surgical candidates while AstraZeneca's trial targets inoperable cases, addressing different patient populations with this aggressive cancer.

Percheron's HMBD-002 Shows Promise Against Triple-Negative Breast Cancer in Preclinical Studies

Oncology
  • Percheron Therapeutics released preclinical data published in Cancer Research showing HMBD-002 effectively blocked tumor growth in triple-negative breast cancer mouse models with statistically significant results (p < 0.0001).
  • The investigational drug targets VISTA immune checkpoint, which is expressed in 25-30% of TNBC tumors, addressing a significant unmet medical need affecting approximately 30,000 new US patients annually.
  • HMBD-002 demonstrates a potential dual mechanism of action, targeting both immune pathways and growth signals like EGFR, differentiating it from conventional immunotherapies such as pembrolizumab.
  • The company plans to advance HMBD-002 into phase II clinical trials with additional data expected in Q4 2025, following completion of ongoing phase I studies in advanced cancer patients.

Merck's Ifinatamab Deruxtecan Receives FDA Breakthrough Designation for Small Cell Lung Cancer

AIDrug DiscoveryOncology
  • Merck and Daiichi Sankyo's ifinatamab deruxtecan received FDA Breakthrough Therapy Designation for extensive-stage small cell lung cancer patients who progressed after platinum-based chemotherapy.
  • The B7-H3 directed antibody-drug conjugate represents the first BTD for the collaboration and addresses significant unmet medical needs in SCLC, a disease with limited therapeutic options.
  • The designation follows positive Phase 2 IDeate-Lung01 trial data and accelerates regulatory pathways, potentially expediting approval timelines for this innovative cancer therapy.
  • Merck also announced a strategic AI partnership with Turbine to create virtual tumor models for hard-to-treat cancers, leveraging Simulated Cells™ technology to accelerate drug discovery.

Cyclacel's Plogosertib Shows Promise Against Biliary Tract Cancer in Preclinical Study

Oncology
  • Independent researchers found that biliary tract cancer cell lines demonstrated sensitivity to plogosertib, a PLK1 inhibitor, both as monotherapy and in combination treatments.
  • The study identified BUBR1 as a potential biomarker, with cancer cells showing high BUBR1 expression being more sensitive to plogosertib treatment.
  • Plogosertib showed synergistic effects when combined with ATR inhibitors, suggesting a promising therapeutic strategy for treating this aggressive cancer with poor prognosis.
  • Early Phase 1 clinical data indicate plogosertib is well-tolerated with no dose-limiting toxicity observed across five dosing schedules.

INmune Bio's INKmune Therapy Meets Primary Endpoints in Phase 1/2 Prostate Cancer Trial

Oncology
  • INmune Bio's phase 1/2 CaRe PC trial of INKmune therapy in metastatic castration-resistant prostate cancer has successfully met both primary and secondary endpoints, demonstrating favorable safety and tolerability across all three dose levels.
  • The NK cell-priming therapy showed greatest biomarker improvements in patients with low baseline NK cell activation, helping define the target population for future trials.
  • Individual tumor lesions were observed reducing in size or completely disappearing in some patients during treatment, suggesting direct anti-tumor effects.
  • The company plans to advance to a randomized phase 2b trial in patients with less severe disease to enable more robust measurement of clinical benefits.

Study of INKmune in Patients With mCRPC (CaRe Prostate)

NCT06056791Active, Not RecruitingPhase 1
Inmune Bio, Inc.
Posted 11/30/2023

Knight Therapeutics Submits MINJUVI Supplemental Application for Follicular Lymphoma in Brazil

Monoclonal AntibodyOncology
  • Knight Therapeutics' Brazilian affiliate has submitted a supplemental application to ANVISA seeking approval for MINJUVI (tafasitamab) in combination with rituximab and lenalidomide for previously treated follicular lymphoma patients.
  • The submission is based on the pivotal Phase 3 inMIND trial results, which demonstrated a 57% reduction in disease progression risk with median progression-free survival of 22.4 months versus 13.9 months for placebo.
  • Follicular lymphoma represents 20-25% of adult non-Hodgkin lymphoma cases in Brazil, with limited treatment options available for relapsed or refractory disease.
  • The application was selected for review under Project Orbis, with Knight planning additional regulatory submissions across Latin America in the coming months.

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

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