Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Biologics
Pharmaceuticals

Immunocore completes TEBE-AM enrolment as tebentafusp Phase 3 matures

Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.
Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

J&J's amivantamab plus chemo hits 34-month OS in EGFR Ex20ins NSCLC

Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to
Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Revelyx Bio Phase 2 data back recombinant liquid botulinum toxin YY003

YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Leads Biolabs opamtistomig hits 87% ORR in squamous NSCLC at WCLC

Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
The Biotech Times Editorial Team  · 
Pharmaceuticals
Bioprocessing
Biologics

WuXi AppTec outlines long-acting oligonucleotide manufacturing hurdles

WuXi AppTec's TIDES platform sets out the chemistry, purification and stability challenges that arise when engineering oligonucleotides for monthly or longer dosing
WuXi AppTec's TIDES platform sets out the chemistry, purification and stability challenges that arise when engineering oligonucleotides for monthly or longer dosing
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Oncolytics reports pelareorep active alongside pan-RAS inhibitor in CRC

Preclinical data show pelareorep maintained tumour-reducing activity when combined with a pan-RAS inhibitor, with no evidence of antagonism between the two agents.
Preclinical data show pelareorep maintained tumour-reducing activity when combined with a pan-RAS inhibitor, with no evidence of antagonism between the two agents.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Genelux publishes SCLC case report showing 16.7-month PFS with Olvi-Vec

A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Immutep refocuses efti on HNSCC and sarcoma after trial failure

Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Rhythm Pharma setmelanotide shows BMI gains in paediatric HO data

Real-world French data and Phase 3 post-hoc analyses reinforce setmelanotide's cardiometabolic benefits in paediatric acquired hypothalamic obesity.
Real-world French data and Phase 3 post-hoc analyses reinforce setmelanotide's cardiometabolic benefits in paediatric acquired hypothalamic obesity.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Tam-Peli cuts SCLC death risk 54% in Phase III, Roche reports

MediLink's B7-H3 ADC beat topotecan on overall survival and response rate in 451-patient Chinese trial, with an NDA now accepted by China
MediLink's B7-H3 ADC beat topotecan on overall survival and response rate in 451-patient Chinese trial, with an NDA now accepted by China
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Electra Therapeutics starts Phase 1 of SIRPγ antibody ELA822

Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pharming wins FDA approval for Joenja in children aged 4 to 11 with APDS

The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Resolution Therapeutics completes enrolment in EMERALD liver trial

All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 prostate data at CIRSE 2026

The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teitur Trophics reports Phase I safety and CNS exposure for TT-P34

The Danish biotech said its Parkinson's peptide TT-P34 was well tolerated and crossed the blood-brain barrier, with biomarker signals supporting lysosomal pathway
The Danish biotech said its Parkinson's peptide TT-P34 was well tolerated and crossed the blood-brain barrier, with biomarker signals supporting lysosomal pathway
The Biotech Times Editorial Team  · 
Biologics
Medical Devices
Regulatory Science

Biora Therapeutics to start first human trial of oral biologic capsule

The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Regulatory Science

Ethris secures €30M EIB loan to advance mRNA antiviral ETH47

The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.
The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

IMUNON signs NCI CRADA to expand IMNN-001 into new solid tumours

IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

Legend Biotech to present five-year CARVYKTI data at IMS 2026

Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Medical Devices

MannKind and Rose Pharma partner on inhaled GLP-1 for weight loss

MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
The Biotech Times Editorial Team  · 
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