Immunology

Biologics
Pharmaceuticals
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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.
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.
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
Biologics
Pharmaceuticals

Solstice Oncology launches with $225m Series A for CTLA-4 antibody

The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
Biologics
Cell & Gene Therapy

Transgene TG4050 sustains 100% disease-free survival at three years

All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
Biologics
Pharmaceuticals

Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Biologics
Regulatory Science

Alvotech wins FDA review acceptance for AVT80 vedolizumab biosimilar

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Biologics

argenx acquires Forte Biosciences, adding anti-CD122 antibody

argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
Biologics

Corvus Pharmaceuticals publishes Phase 1 soquelitinib data in Blood

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Biologics

Priovant wins FDA approval for brepocitinib in dermatomyositis

LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
Biologics
Regulatory Science

Roivant's brepocitinib wins FDA approval for dermatomyositis

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
Biologics

Priovant's brepocitinib hits skin remission targets in Phase 3 DM trial

JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
Biologics

Spyre Therapeutics' SPY072 misses RA monotherapy bar in SKYWAY Phase 2

SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
Biologics

Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
Biologics

Leads Biolabs' opamtistomig posts 65% ORR in Phase 2 NSCLC study

Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Biologics
Regulatory Science

FDA awards Orphan Drug status to Lakefront's gamgertamig in pemphigus

Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
Biologics

AC Immune NLRP3 inhibitor clears Phase 1 with CSF penetration

ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.
ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.
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