Guidance on primate testing is ‘genuine’ animal welfare progress
On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.”

Guidance on primate testing is ‘genuine’ animal welfare progress
On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.”
CTAD 2025: The challenges of combination therapies for dementia
At the Clinical Trials on Alzheimer’s Disease 2025 meeting, a panel of experts discussed the need for developing combination therapies for the complex diseases that result in Alzheimer's disease and other dementias.
Arrakis reports preclinical progress of rSM program to treat DM1
Arrakis Therapeutics Inc. has announced the presentation of preclinical data demonstrating the progress of its RNA-targeted small molecule (rSM) drug program for the treatment of myotonic dystrophy type 1 (DM1).
Series B financing supports Triana’s molecular glue degraders
Triana Biomedicines Inc. has closed an oversubscribed $120 million series B financing round to advance its molecular glue degrader pipeline.
Animate’s peptides reduce inflammation and fibrosis signals
Animate Biosciences Inc. has released new preclinical results demonstrating that AI-designed peptides generated by its Animateiq discovery platform significantly reduced hallmark inflammation and fibrosis signals across multiple human cell types, including skin, lung, heart and liver.
Junevity raises funds to advance siRNA metabolism program
Junevity Inc. has raised $10 million in new funding, bringing its seed financing to a total of $20 million. The new funding will enable Junevity to advance JUN-01, its lead siRNA program for type 2 diabetes and obesity, through IND-enabling and initial clinical studies.
Université de Montréal patents new GTPase KRAS inhibitors
Université de Montréal has disclosed GTPase KRAS G12D mutant inhibitors reported to be useful for the treatment of cancer, inflammatory disorders and immunological disorders.
RMC-6272 synergizes with MEK inhibitors in glioblastoma
Previous findings have shown that the bisteric mTORC1 inhibitor Rapalink-1 exerts superior efficacy than the parent inhibitors rapamycin and sapanisertib in orthotopic xenograft models of glioblastoma. The bitopic clinical derivative of this compound is RMC-5552 from Revolution Medicines Inc., which is currently in phase I/II clinical studies for glioblastoma.
ARV-102 targets LRRK2 to prevent neurodegeneration
LRRK2 plays a key role in the biology of multiple neurodegenerative disorders, including Parkinson’s disease (PD) and progressive supranuclear palsy (PSP), where mutations or altered activity are associated with impaired cellular signaling and neuronal decline.

Conferences

Abion’s ABN-202 has antitumor activity in acidic microenvironment
Society for Immunotherapy of Cancer
Abion Inc. has presented data for ABN-202, a hyperglycosylated interferon (IFN) β mutein fused to a monoclonal antibody targeting tumor-associated calcium signal transducer 2 (TROP2) that retains activity under acidic conditions.
CX-908 drives tumor regression with improved safety margin
Society for Immunotherapy of Cancer
T cell-engaging bispecific antibodies (TCEs) are engineered molecules designed to bring cytotoxic T cells into proximity with tumor cells, triggering a targeted, antigen-dependent immune attack. However, TCE may activate T cells in healthy tissues, leading to off-tumor toxicity.
Akeso’s AK-135 relieves chemotherapy-induced pain
Society for Immunotherapy of Cancer
Akeso Biopharma Inc. has developed an anti-IL-1RAP therapeutic, AK-135, for the potential treatment of chemotherapy-induced peripheral neuropathy.
AZD-6750 enhances CD8+ T-cell activity
Society for Immunotherapy of Cancer
IL-2 is clinically validated as an immunotherapeutic, but its use is limited by toxicity issues. AZD-6750 is an approach from Astrazeneca plc that applies cis-guiding to deliver a modified IL-2 mutein to CD8+ T cells.

Cancer

Activated leukocyte cell adhesion molecule is neuroblastoma target
Immuno-oncology
Neuroblastoma is a pediatric extracranial solid tumor arising from the sympathetic nervous system. Disialoganglioside GD2-based therapies, including CAR T cells and other immunotherapies, have shown some success. However, GD2 is also expressed on pain fibers and other neurons, raising safety...

Infection

HIV remission after heterozygous CCR5Δ32 stem cell transplant
Science
2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1, the Joint United Nations Program on HIV/AIDS...

Aerolysin-producing Aeromonas is behind ulcerative colitis
Gastrointestinal
Researchers from the Medical School of Nanjing University hypothesized that in ulcerative colitis, the gut-resident macrophages may be compromised, leading to impaired integrity of the epithelial barrier. “From a basic science standpoint, our work uncovers a novel etiology of ulcerative colitis....
Harmane-based quaternary ammonium salt against drug-resistant S. aureus
Researchers at Shandong Second Medical University have developed a dimethyl quaternary ammonium derivative of harmane that shows strong potential for attacking the bacterium through diverse mechanisms.

Neurology/psychiatric

Lynk’s allosteric TYK2 inhibitor LNK-01006 gains IND clearance
Regulatory
Lynk Pharmaceuticals Co. Ltd. has received IND clearance from the FDA for LNK-01006, an allosteric TYK2 inhibitor with potential to treat neurodegenerative diseases.
Vectory’s VTX-002 gains IND clearance for ALS
Regulatory
Vectory Therapeutics BV has obtained IND clearance from the FDA for a phase I/II trial (PIONEER-ALS) of VTX-002, a first-in-class vectorized antibody targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS). VTX-002 delivers an engineered antibody designed to selectively target toxic...
FDA clears Latus Bio’s LTS-101 to enter clinic for CLN2 disease
Regulatory
Latus Bio Inc. has reported IND clearance by the FDA for LTS-101, a gene therapy candidate to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease. The FDA has also granted orphan drug, rare pediatric disease and fast track designations to LTS-101.
Shenzhen Icarbonx Intelligent Peptide Pharmaceutical patents new peptides targeting BRAG2
Patents
Shenzhen Icarbonx Intelligent Peptide Pharmaceutical Technology Co. Ltd. has disclosed peptides targeting IQ motif and SEC7 domain-containing protein 1 (IQSEC1; BRAG2) reported to be useful for the treatment of stroke, major depression, substance abuse and dependence, and Alzheimer’s disease.
Derivatized TRPM2 inhibitor to more safely treat ischemic stroke
Inhibiting transient receptor potential melastatin 2 (TRPM2) may mitigate injury arising from ischemic stroke. Researchers at Zhejiang University and its medical school previously reported a small-molecule inhibitor of TRPM2, which also inhibited the human ether-a-go-go-related gene (hERG) channel,...

Endocrine/metabolic

TSHR antagonists disclosed in Genescience patent
Patents
Genescience Pharmaceuticals Co. Ltd. has divulged thyroid-stimulating hormone (thyrotropin) receptor (TSHR) antagonists reported to be useful for the treatment of hyperthyroidism, Grave’s disease and thyroid-associated ophthalmopathy (Grave’s ophthalmopathy).

Biomarkers

Mesothelin is biomarker, potential target in arthritic bone damage
Musculoskeletal
In a recent study published in Cell Reports Medicine, researchers from the Institute of Chinese Materia Medica of the China Academy of Chinese Medical Sciences and Xi’an Jiao Tong University Health Science Center found that Mesothelin (MSLN) was significantly elevated in rheumatoid arthritis (RA)...

UK Biobank delivers largest metabolomics dataset of 500K profiles
Science
It’s the biological resource that keeps on giving, and now UK Biobank has released the final tranche of data on the levels of 249 metabolites in the blood of its half a million participants.
With transdiagnostic approach, smaller target groups aren’t inevitably smaller markets
Neurology/psychiatric
Despite the formidable challenges for developing precision psychiatry, the approach is notching its first successes in the preclinical and even some clinical settings. Many individual studies as well as large projects like the Psychiatric Ratings using Intermediate Markers (PRISM) studies and the...

Gastrointestinal

Tangram seeks clinical trial clearance for TGM-312 for MASH
Regulatory
Tangram Therapeutics plc has submitted a clinical trial application (CTA) to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II trial of TGM-312 for metabolic dysfunction-associated steatohepatitis (MASH).
Opko’s OPK-88006 shows hepatoprotection in MASH
Conferences
Opko Health Inc. has recently presented data for their GLP-1/glucagon receptor dual agonist OPK-88006, which is in preclinical development for the treatment of metabolic disease, including metabolic dysfunction-associated steatohepatitis (MASH)...
UK study reveals inconsistencies in global microbiome research
Regulatory
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of...
Samjin Pharmaceutical patents new compounds for MASH
Patents
Samjin Pharmaceutical Co. Ltd. has disclosed inhibitors of 17-β-hydroxysteroid dehydrogenase 13 (HSD17B13; 17-β-HSD 13) and/or estradiol 17-β-dehydrogenase 1 (HSD17B1; 17β-HSD1) and/or HSD17B2 (17β-HSD2). As such, they are believed to be...
Imhotex patents new NOD2 activators for Crohn’s disease
Patents
Imhotex Ltd. has disclosed desmuramylpeptide (DMP) analogues of muramyl dipeptide (MDP) acting as nucleotide-binding oligomerization domain-containing protein 2 (NOD2) activators reported to be useful for the treatment of Crohn’s disease.
Numab and Kaken sign agreement for NM-81 for IBD
Collaboration
Numab Therapeutics AG and Kaken Pharmaceutical Co. Ltd. have entered into a strategic licensing and co-development agreement for NM-81, a multi-specific antibody for the treatment of inflammatory bowel disease (IBD).

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