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Kyowa Kirin to Present Phase 3 Rocatinlimab Results for Atopic Dermatitis at EADV 2025

Monoclonal Antibody
  • Kyowa Kirin will present results from the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational anti-OX40 monoclonal antibody for moderate-to-severe atopic dermatitis, at the EADV 2025 Annual Meeting in Paris.
  • Rocatinlimab targets the OX40 receptor and has the potential to be the first T-cell rebalancing therapy that inhibits pathogenic T cells responsible for atopic dermatitis inflammation.
  • The ROCKET program comprises eight Phase 3 studies evaluating rocatinlimab's safety and efficacy in adults and adolescents with moderate to severe atopic dermatitis across multiple dosing regimens.
  • Atopic dermatitis affects 15-20% of children and up to 10% of adults, with more than half of moderate to severe patients experiencing severe itching that disrupts daily life.

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05882877RecruitingPhase 3
Amgen
Posted 5/31/2023

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05724199CompletedPhase 3
Amgen
Posted 2/21/2023

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

NCT05651711CompletedPhase 3
Amgen
Posted 12/14/2022

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

NCT05398445CompletedPhase 3
Amgen
Posted 5/31/2022

Therini Bio Initiates Phase 1b Trial of Novel Anti-Fibrin Antibody THN391 for Alzheimer's Disease

Monoclonal Antibody
  • Therini Bio has dosed the first patient in a Phase 1b trial of THN391, a first-in-class monoclonal antibody targeting fibrin-mediated neuroinflammation in Alzheimer's disease.
  • The randomized, placebo-controlled trial will evaluate safety and pharmacokinetics in 65-85 year old patients with early Alzheimer's disease and vascular risk factors.
  • THN391 demonstrated a 40-day half-life supporting monthly dosing and showed no serious adverse events in Phase 1a healthy volunteer studies.
  • Initial data from the multi-dose ascending trial is expected in mid-2026, with assessments including cognitive measures and neuroimaging biomarkers.

Formation Bio Licenses First-in-Class Anti-CD226 Monoclonal Antibody for Autoimmune Diseases

Monoclonal Antibody
  • Formation Bio has licensed worldwide rights to IMIDomics' first-in-class anti-CD226 monoclonal antibody, which has received IND clearance and will initially target ulcerative colitis.
  • The antibody targets CD226 (DNAM-1), a key immune checkpoint that regulates immune cells, offering a novel mechanistic approach for treating autoimmune conditions characterized by high treatment failure rates.
  • The licensing agreement includes upfront payments, development milestones, royalties, and equity in Riverview Bio, a new Formation Bio subsidiary created to develop this therapy.
  • The program is supported by IMIDomics' 20-year longitudinal dataset from Spain's Immune Mediated Inflammatory Diseases Consortium, providing robust mechanistic validation for clinical advancement.

OncoC4's ONC-841 Shows Promise as First-in-Class Alzheimer's Disease Immunotherapy in Preclinical Studies

Monoclonal Antibody
  • OncoC4 unveiled preclinical data showing ONC-841, a first-in-class anti-SIGLEC 10 monoclonal antibody, reduced amyloid plaques and improved memory in Alzheimer's disease mouse models.
  • SIGLEC 10 was identified as a genetic driver for amyloid plaque formation, with transgenic mice expressing the unmutated human gene developing Alzheimer's hallmarks.
  • The therapy demonstrated enhanced microglia function, including improved migration and phagocytosis of amyloid plaques, while normalizing microglia morphology.
  • ONC-841 represents a novel immunotherapy approach targeting the SIGLEC 10-CD24 innate immune checkpoint pathway with potential applications in both cancer and neurodegeneration.

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

NCT06352359RecruitingPhase 1
OncoC4, Inc.
Posted 8/23/2024

IsoBio Secures $5 Million Series Seed Funding to Advance Antibody-Isotope Conjugates for Cancer Treatment

Monoclonal AntibodyOncologyTargeted Therapy
  • IsoBio, Inc. has closed a $5 million Series Seed financing round led by ASP Isotopes Inc. to develop antibody-isotope conjugates (AICs) targeting both validated and novel tumor antigens for cancer treatment.
  • The strategic partnership with ASP Isotopes and its subsidiary PET Labs aims to address critical isotope supply chain challenges that have historically constrained radiotherapy development and commercialization.
  • IsoBio is developing radiotherapeutics containing Lutetium-177, Actinium-225, Terbium-161, and other novel radioisotopes using proprietary linker and conjugation technology.
  • The company is led by radiation oncologist Bruce Turner, M.D., Ph.D., who previously co-led the merger creating Immunome and has extensive experience in targeted oncology therapeutics.

Delhi High Court Rules Against Roche in Pertuzumab Patent Disclosure Case, Clarifies Section 104A Requirements for Biologics

Monoclonal AntibodyOncology
  • The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
  • The court established that Section 104A can be invoked at interim stages of patent litigation and prevails over general discovery provisions under the Commercial Courts Act.
  • The ruling clarifies that "identical product" requirements under Section 104A cannot be diluted for biological drugs, even though absolute replication is scientifically difficult.
  • The decision impacts ongoing patent disputes in India's biosimilar market, particularly for cancer treatments where regulatory reference to branded biologics does not automatically imply process infringement.

PTAB Director Denies Amgen's IPR Challenges Against Bristol Myers Squibb's Opdivo Patents Based on Settled Expectations

Monoclonal Antibody
  • The USPTO Acting Director discretionarily denied two of Amgen's inter partes review petitions challenging Bristol Myers Squibb's Opdivo and Yervoy patents, citing "strong settled expectations" due to the patents being in force for six and seven years respectively.
  • The decision marks a significant shift in PTAB policy, as settled expectations had not previously been cited as grounds for discretionary denial in biosimilar-related IPRs, potentially making it more difficult for biosimilar manufacturers to challenge older patents.
  • Amgen is developing ABP 206, a biosimilar version of Opdivo, which generated $5.35 billion in U.S. sales for Bristol Myers Squibb in 2024.
  • A third IPR petition challenging a newer 2022 patent was referred to the Board for merit review, suggesting that patent age may be a critical factor in future discretionary denial decisions.

Delhi High Court Rejects Roche's Bid to Force Zydus to Disclose Sigrima Manufacturing Process

Monoclonal Antibody
  • The Delhi High Court declined to order Zydus Lifesciences to disclose the manufacturing process of its breast cancer drug Sigrima after F. Hoffmann-La Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
  • Roche alleged that Zydus' Sigrima infringes its patent rights over monoclonal antibody biologic Pertuzumab (Perjeta), but the court ruled that mere similarity between end products does not establish identical manufacturing processes.
  • Justice Amit Bansal noted that Roche had not conducted analytical characterization or reverse engineering of Zydus' product to substantiate its claims, which is a statutory requirement under Section 104A.
  • The ruling represents a significant legal victory for Zydus, which launched Sigrima in the market in June 2024, protecting its proprietary manufacturing information from disclosure.

Amgen's Repatha Faces Safety Scrutiny as HEROIC Study Evaluates Cardiovascular Benefits

Monoclonal Antibody
  • Amgen's ongoing HEROIC study is evaluating Repatha (evolocumab) in combination with standard care to reduce major cardiovascular events in patients with atherosclerotic cardiovascular disease.
  • A 2022 reanalysis of the landmark FOURIER trial raised safety concerns, highlighting a 41.4% inconsistency rate in cause-of-death reporting and suggesting a potential 28% higher relative risk of cardiac deaths.
  • Despite safety controversies, Repatha achieved 31% year-over-year sales growth to $696 million in 2025, driven by improved payer coverage and 36% volume growth.
  • The PCSK9 inhibitor market faces intensifying competition from Novartis' Leqvio and emerging therapies, while Amgen advances olpasiran for lipoprotein(a) reduction in Phase 3 trials.

European Regulators Recommend Expanding Novo Nordisk's Alhemo for Hemophilia A and B Without Inhibitors

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending label expansion of Alhemo (concizumab) to treat severe hemophilia A and moderate/severe hemophilia B without inhibitors.
  • Phase 3 explorer8 trial results showed Alhemo prophylaxis reduced bleeding episodes by 86% in hemophilia A patients and 79% in hemophilia B patients compared to no prophylaxis treatment.
  • The label expansion would make Alhemo available to approximately 12,000 EU patients with hemophilia A and B without inhibitors, representing 79.2% of the market segment.
  • Patient-reported outcomes demonstrated 70.9% of participants preferred Alhemo over their previous hemophilia treatment, with improvements in quality of life and reduced treatment burden.

A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)

NCT05878938CompletedPhase 3
Novo Nordisk A/S
Posted 6/26/2023

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

NCT04083781Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 10/21/2019

A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors

NCT05306418CompletedPhase 3
Novo Nordisk A/S
Posted 4/4/2022

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

NCT05053139CompletedPhase 3
Novo Nordisk A/S
Posted 12/2/2021

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

NCT04082429Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 11/13/2019

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)

NCT05685238Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 2/13/2023

A Research Study Investigating Mim8 in People With Haemophilia A

NCT04204408CompletedPhase 2
Novo Nordisk A/S
Posted 1/10/2020

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