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Pilatus Biosciences Partners with Roche for First-in-Human Trial of PLT012 in Hepatocellular Carcinoma

Monoclonal Antibody
  • Pilatus Biosciences announced a clinical trial collaboration with Roche to evaluate PLT012 in combination with atezolizumab in a first-in-human Phase 1 trial for hepatocellular carcinoma patients.
  • PLT012 is designed to reprogram the immunosuppressive tumor microenvironment by targeting CD36-mediated lipid uptake, potentially enhancing immune activation when combined with checkpoint inhibitors.
  • The collaboration aims to overcome resistance mechanisms in hepatocellular carcinoma, where current checkpoint inhibitor monotherapies often fail to generate durable responses.
  • Hepatocellular carcinoma remains one of the leading causes of cancer-related death worldwide, representing a significant unmet medical need.

Acumen Pharmaceuticals Advances Alzheimer's Pipeline with JCR Partnership and ALTITUDE-AD Phase 2 Trial

Monoclonal Antibody
  • Acumen Pharmaceuticals expects topline results from its Phase 2 ALTITUDE-AD study evaluating sabirnetug for early Alzheimer's disease in late 2026, with the trial having enrolled 542 participants.
  • The company announced a collaboration with JCR Pharmaceuticals to develop Enhanced Brain Delivery therapy combining Acumen's oligomer-targeting antibodies with JCR's blood-brain barrier-penetrating technology.
  • Sabirnetug demonstrated 8,750-fold selectivity for amyloid beta oligomers over monomers and achieved the highest binding affinities among tested monoclonal antibodies in surface plasmon resonance testing.
  • The company maintains $166.2 million in cash reserves expected to support operations into early 2027, while implementing cost-efficient screening strategies that reduced trial costs by approximately 40%.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

Early Long COVID Trials of Paxlovid and Monoclonal Antibodies Show No Significant Benefits, But Research Continues

Monoclonal Antibody
  • Three prominent clinical trials testing Paxlovid and monoclonal antibodies for Long COVID failed to show significant health improvements compared to placebo groups.
  • The trials were designed as "proof of concept" studies to test viral persistence theory, with researchers acknowledging they expected challenging results but hoped for better outcomes.
  • Future trials are being designed with longer treatment durations, larger patient populations, and more specific biomarkers to better target viral persistence in Long COVID patients.
  • New monoclonal antibody trials are underway, including sipavibart at Nova Southeastern University and planned studies with Pemgarda, which may offer longer-lasting effects than short-course antivirals.

Lupin Partners with Sandoz to Commercialize Ranibizumab Biosimilar Across Multiple Global Markets

Monoclonal Antibody
  • Lupin Limited has entered into a strategic partnership with Sandoz Group AG to commercialize its biosimilar ranibizumab across the European Union, Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia.
  • Under the agreement, Sandoz will handle commercialization while Lupin maintains responsibility for manufacturing and regulatory submissions, with Sandoz holding exclusive marketing rights in most markets except France, Australia, Vietnam, and Malaysia.
  • The biosimilar ranibizumab targets multiple retinal conditions including neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion-related macular edema.
  • A separate agreement grants Sandoz sole commercialization rights for the biosimilar in Canada, expanding the partnership's global reach for this VEGF-A inhibitor therapy.

WuXi Biologics Launches WuXia293Stable Platform to Address Manufacturing Challenges for Complex Biologics

Monoclonal Antibody
  • WuXi Biologics has launched WuXia293Stable, a new HEK293-based cell line platform designed to overcome manufacturing challenges for difficult-to-express biologics that struggle with traditional CHO cell systems.
  • The platform achieves fed-batch titers up to 5.0 g/L for monoclonal antibodies while eliminating truncation issues that compromise product quality in complex molecules.
  • WuXia293Stable enables scalable manufacturing at 2000L for fed-batch and 1000L for perfusion processes, maintaining stable expression during long-term cell passages.
  • The launch expands WuXi Biologics' WuXia platform family, which has generated over 1000 cell lines for clinical and commercial manufacturing as of 2024.

Faron Secures Extended Patent Protection for Bexmarilimab Cancer Immunotherapy Through 2040

Monoclonal Antibody
  • Faron Pharmaceuticals received US Patent No. 12,371,486 covering treatment of Clever-1 positive cancers with bexmarilimab, extending patent protection from 2037 to February 2040.
  • The new patent specifically covers treating cancers with Clever-1 positive cells in the tumor microenvironment, including acute myeloid leukemia and myelodysplastic syndrome.
  • Bexmarilimab is currently being investigated in Phase I/II clinical trials as an immunotherapy that reprograms macrophages to enhance immune response against tumors.
  • The extended patent life provides additional commercial protection for the investigational anti-Clever-1 antibody, which targets immunosuppressive pathways in cancer treatment.

Almirall and Absci Expand AI Drug Discovery Partnership with Second Dermatology Target

AIDrug DiscoveryMonoclonal Antibody
  • Almirall and Absci have expanded their AI drug discovery collaboration to include a second dermatology target following successful delivery of AI-designed antibody leads against a difficult-to-drug target.
  • The collaboration combines Absci's Integrated Drug Creation™ platform with Almirall's dermatology expertise to develop novel therapeutics for chronic and debilitating skin diseases.
  • Under the expanded partnership terms, Absci is eligible to receive up to approximately $650 million in milestone payments across both programs, plus royalties on potential product sales.
  • The partnership demonstrates the potential of AI de novo drug design to unlock novel biology where traditional drug discovery approaches have previously failed.

Chai Discovery Raises $70M Series A to Revolutionize Antibody Design with AI Platform Achieving 20% Hit Rate

AIDrug DiscoveryMonoclonal Antibody
  • Chai Discovery secured $70 million in Series A funding led by Menlo Ventures, bringing total funding to $100 million to advance AI-driven drug discovery.
  • The company's breakthrough Chai-2 platform achieves a near-20% hit rate in fully de novo antibody design, dramatically outperforming traditional methods and previous computational approaches.
  • Former Pfizer Chief Scientific Officer Mikael Dolsten joins the board, bringing experience from advancing 150 molecules into clinical trials and delivering 36 approved medicines.
  • The AI platform can generate successful antibody binders from scratch using only target antigen and epitope information, potentially transforming therapeutic development timelines.

Novo Nordisk Advances Coramitug to Phase 3 for ATTR Cardiomyopathy Following Successful Phase 2 Trial

Monoclonal Antibody
  • Novo Nordisk announced plans to initiate Phase 3 trials for coramitug, a potential first-in-class amyloid depleter antibody for ATTR amyloidosis with cardiomyopathy, following successful completion of a Phase 2 study.
  • The Phase 2 trial evaluated once-monthly intravenous coramitug versus placebo in 105 patients with ATTR cardiomyopathy, measuring functional endpoints including six-minute walking test and NT-proBNP changes.
  • Prothena Corporation, the original developer of coramitug, stands to receive milestone payments from a deal worth up to $1.2 billion as Novo Nordisk advances the therapy through clinical development.
  • The advancement addresses significant unmet medical needs in ATTR cardiomyopathy patients who face high mortality risk and morbidity from amyloid deposition in vital organs.

Astria Therapeutics Secures $16 Million Japan Partnership for Hereditary Angioedema Treatment Navenibart

Monoclonal AntibodyRare Disease
  • Astria Therapeutics has granted exclusive development and commercialization rights for navenibart in Japan to Kaken Pharmaceutical in a deal worth up to $32 million.
  • Navenibart is a long-acting monoclonal antibody currently in Phase 3 trials designed for the preventative treatment of hereditary angioedema.
  • The partnership includes an upfront payment of $16 million, potential milestone payments of another $16 million, and tiered royalties up to 30 percent.
  • Kaken will support the ongoing ALPHA-ORBIT Phase 3 trial in Japan and manage regulatory submissions for commercialization.

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