Scientists rehabilitate disease-causing T cells into tolerance builders
For 75 years, the standard tools for autoimmune disease have consisted of steroids, cytotoxics and broad biologics that tamp down the entire immune system. They can help, but they are rarely curative. “They’re blunt instruments,” Regcell Inc. CEO Mike McCullar told BioWorld. “They can’t distinguish good immune cells and bad immune cells,” which is why many carry black-box warnings and must be taken for years, sometimes for life.

Scientists rehabilitate disease-causing T cells into tolerance builders
For 75 years, the standard tools for autoimmune disease have consisted of steroids, cytotoxics and broad biologics that tamp down the entire immune system. They can help, but they are rarely curative. “They’re blunt instruments,” Regcell Inc. CEO Mike McCullar told BioWorld. “They can’t distinguish good immune cells and bad immune cells,” which is why many carry black-box warnings and must be taken for years, sometimes for life.
Cryo-EM unveils multiple potential targets in an HSV-1 replication protein
Current treatments for herpes simplex virus 1 (HSV-1) mainly target the viral DNA polymerase, but resistance is becoming an increasing problem. By understanding how HSV-1 initiates replication, scientists hope to find new ways to intervene before this stage, which could potentially contribute to avoid resistance.
IBI-3034 shows promise for B-cell-related autoimmune diseases
Innovent Biologics Co. Ltd. presented data for IBI-3034, a chimeric Fc fusion protein comprising transmembrane activator and CAML interactor (TACI) and B-cell maturation antigen (BCMA) for the treatment of autoimmune diseases.
Celebrating BioWorld's 35th anniversary
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them.
Other news to note for Nov. 3, 2025
Additional early-stage research and drug discovery news in brief.
Manifold Bio and Roche partner on brain shuttles in neurology
Manifold Biotechnologies Inc. has signed a strategic research collaboration and license agreement with F. Hoffmann-La Roche Ltd. to develop next-generation brain shuttles for neurological diseases. The collaboration will apply Manifold’s proprietary tissue-targeting shuttle portfolio and mDesign AI-driven in vivo discovery engine.
New triazole compounds disclosed in Guangdong Yinzhu patent
Guangdong Yinzhu Pharmaceutical Technology Co. Ltd. and Guangzhou Yinzhu Biomedical Technology Co. Ltd. have divulged triazole compounds reported to be useful for the treatment of cancer, psoriasis, rheumatoid arthritis and inflammatory bowel disease.

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Bioxcel Therapeutics Inc.’s phase III results in bipolar disorders or schizophrenia could bring Igalmi (BXCL-501) out of the clinic and into patients' homes for easier treatment.

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Conferences

Lunan’s LNF-2102 performs well in preclinical gastric cancer
European Society for Medical Oncology
The overexpression of fibroblast growth factor receptor 2b (FGFR2b) is tied to tumor progression in several malignancies, such as cholangiocarcinoma, HER2-negative gastric cancer and breast cancer. Lunan Pharmaceutical Group Corp. has developed a novel IgG1 monoclonal antibody against FGFR2b,...
HM-101207 enhances KRAS-MAPK therapy via SOS1/pan-KRAS modulation
AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics
KRAS acts as a key molecular switch in cell signaling, activated by the guanine nucleotide exchange factor SOS1. Mutant KRAS drives many cancers, yet has been difficult to target directly. SOS/pan-KRAS modulators represent a new approach that blocks the SOS1-KRAS interaction, preventing KRAS...
Tango’s first-in-class HBS1L/PELO degrader for FOCAD-deleted cancers
New compound
Loss of FOCAD in cells impairs normal mRNA surveillance, creating a dependency on the HBS1L/PELO complex for ribosome rescue and identifying HBS1L as a potential synthetic lethal target and therapeutic vulnerability.
KT-502 exerts B-cell depletion through CD19 targeting
American College of Rheumatology
Kali Therapeutics Inc. has developed a novel T-cell engager (TCE) bispecific antibody, KT-502, targeting CD19 and CD3 for the treatment of autoimmune diseases, including systemic lupus erythematosus and rheumatoid arthritis.

Cancer

Regimmune reports on antibody program
Antibody
Regimmune Ltd. has reported preclinical data from its antibody program, including RGI-6004 and AB08-H1.

Infection

Microbiotix gains IND clearance for bacteriophage therapy MP-101
Regulatory
Microbiotix Co. Ltd. has obtained IND approval from the Korean Ministry of Food and Drug Safety (MFDS) for MP-101, a bacteriophage therapy for patients with acute pneumonia. A phase I study in adult patients with Pseudomonas aeruginosa-induced pneumonia is expected to enroll its first patient...

Chinese researchers patent new photosensitizers for photodynamic therapy
Patents
Scientists at Technical Institute of Physics and Chemistry, Chinese Academy of Sciences have disclosed hypocrellin derivatives acting as photosensitizers for photodynamic therapy reported to be useful for the treatment of cancer, bacterial infections and fungal infections.
Hamlet Biopharma presents new approach to bacterial infections
Hamlet Biopharma AB has announced the presentation of new preclinical-stage molecules that have originated from its long-term collaboration with Lund University and Linnane Pharma AB with the aim of treating bacterial infections by targeting the disease response of the host rather than the pathogen...

Neurology/psychiatric

NLS Pharmaceutics and Aexon Labs add new series to DOXA platform
NLS Pharmaceutics Ltd. and Aexon Labs Inc. have announced the expansion their dual orexin receptor agonist (DOXA) platform with the AEX-6xx series.
Image anomalies found in 40% of brain hemorrhage animal studies
Cardiovascular
Two in five preclinical studies on subarachnoid hemorrhage (SAH) published in peer-reviewed scientific journals contain problematic images. A team of researchers from Radboud University Medical Center, who had previously identified several such cases, analyzed the literature in this field to assess...
RAGE antagonism prevents post-traumatic trigeminal neuropathy
A recent study published in the journal Biochemical Pharmacology has uncovered a promising new approach to prevent post-traumatic trigeminal neuropathy (PTTN) development by targeting the advanced glycation end-products receptor (RAGE).
Korean scientists describe new KDM4C inhibitors
Patents
Researchers at Dankook University and Korea University Research & Business Foundation Sejong Campus have identified thiophene derivatives acting as lysine-specific demethylase 4C (KDM4C; GASC-1; JMJD2C) inhibitors reported to be useful for the treatment of Alzheimer’s disease.
Bial-Portela divulges new OX2 receptor agonists
Patents
Bial-Portela & Ca SA has synthesized orexin OX2 receptor agonists reported to be useful for the treatment of type 1 narcolepsy.

Endocrine/metabolic

Ascletis Pharma selects new clinical development candidate
Cardiovascular
Ascletis Pharma Inc. has selected ASC-36, a once-monthly, potentially best-in-class subcutaneously administered amylin receptor peptide agonist, as a clinical development candidate.

Biomarkers

Biomarker panel of three serum microRNAs predicts cervical cancer prognosis
Cancer
MicroRNAs (miRNAs) play key roles in cancer development by regulating genes involved in cell growth, differentiation, invasion, metastasis and angiogenesis. Because their expression patterns differ across tumor types and stages, miRNA profiles hold strong potential as noninvasive diagnostic and...

LINC01354 is a prognostic marker in esophageal cancer
Cancer
Esophageal cancer is among the most lethal cancers with a high mortality rate worldwide. Chinese researchers have explored the potential link between long intergenic non-protein coding RNA 1354 (LINC01354) and esophageal cancer.
FGF5 gene involved in excessive hair growth
Conferences
Hirsutism is the excessive hair growth in women in male-typical areas, usually associated with androgen excess and other conditions such as polycystic ovary syndrome (PCOS). The genetic basis of hirsutism remains poorly understood; researchers from the University of Oulu and collaborators performed...

Gastrointestinal

Interline Therapeutics patent reports RIPK2 inhibitors for IBD
Patents
Interline Therapeutics Inc. has identified new compounds receptor-interacting serine/threonine-protein kinase 2 (RIPK2; RIP-2) inhibitors reported to be useful for the treatment of inflammatory bowel disease (IBD).
Daewon Pharm patent reveals new H+/K+-ATPase inhibitors
Patents
Daewon Pharmaceutical Co. Ltd. has reported new compounds acting as H+/K+-ATPase inhibitors useful for the treatment of reflux esophagitis.
Proqr’s AX-0810 gains European clinical trial clearance
Regulatory
Proqr Therapeutics NV has received clinical trial application (CTA) authorization under the EMA’s new centralized review process for a phase I study of AX-0810, which is being developed for the treatment of cholestatic diseases such as primary...
New mPGES-1 inhibitors disclosed in Nippon Shinyaku patent
Patents
Nippon Shinyaku Co. Ltd. has divulged quinazoline compounds acting as microsomal prostaglandin E2 synthase-1 (mPGES-1) inhibitors reported to be useful for the treatment of irritable bowel syndrome, psoriasis, arthritis, bacterial infection,...
Salubris Pharmaceuticals divulges new MIR124 activators
Patents
Shenzhen Salubris Pharmaceuticals Co. Ltd. has synthesized compounds acting as MIR124 activators reported to be useful for the treatment of inflammatory bowel disease and inflammatory disorders.
Esperion nominates ESP-2001 as preclinical candidate for PSC
Esperion Therapeutics Inc. has nominated ESP-2001 as a preclinical development candidate for the treatment of primary sclerosing cholangitis (PSC). The company will now begin IND-enabling studies with the aim of filing an IND application with the...

podcast microphone, sound waves on purple background Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.

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