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Two-dose CAR-T therapy cures hepatoblastoma in a 3-year-old
health18 days ago

Two-dose CAR-T therapy cures hepatoblastoma in a 3-year-old

A 3-year-old with chemo-resistant hepatoblastoma that had spread to the lungs (and possibly bones) achieved complete remission after just two doses of an experimental GPC3-targeted CAR-T cell therapy, with a year of no disease signs reported. The findings, published in The New England Journal of Medicine as part of the CARE study, suggest CAR-T approaches may be safe and effective for select GPC3+ solid tumors in children, though more research is needed to confirm efficacy and safety across more patients.

via New York Post|
#cancer#car-t#health
Safety signals pause autoimmune CAR-T trials at Novartis and BMS
pharma1 month ago

Safety signals pause autoimmune CAR-T trials at Novartis and BMS

Novartis and Bristol Myers Squibb have paused several autoimmune CAR-T trials after inflammatory safety events were seen, including IEC-HS cases in rap-cel studies across lupus, myasthenia gravis, and multiple sclerosis, and transient inflammatory events in zola-cel programs. Both companies say the pauses are precautionary while safety data are reviewed with regulators, with cancer trials continuing. A faster production approach for CAR-Ts may influence toxicity, but the companies emphasize ongoing monitoring and a potential quick resume once reviews are complete.

via BioPharma Dive|
#autoimmune-disease#car-t#pharma
NHS CAR-T lupus trial yields remission in five patients
health3 months ago

NHS CAR-T lupus trial yields remission in five patients

Nine patients with severe lupus in London took part in an NHS-led CAR-T cell therapy trial; five of the lower-dose recipients went into remission within months, with kidney function stabilization and notable quality-of-life gains (including skiing and dancing for one patient). Higher-dose patients are still being followed. If confirmed in larger studies, this immune‑reset approach could offer a potential cure and reduce lifelong medications.

via The Guardian|
#car-t#clinical-trial#health
Lilly to acquire Kelonia to push off-the-shelf in vivo CAR-T for multiple myeloma
business5 months ago

Lilly to acquire Kelonia to push off-the-shelf in vivo CAR-T for multiple myeloma

Eli Lilly will acquire Kelonia Therapeutics for up to $7 billion in cash (upfront $3.25B) to gain Kelonia's in vivo gene delivery platform and KLN-1010, an in vivo anti-BCMA CAR-T therapy for multiple myeloma in Phase 1, with the aim of simplifying manufacturing and broadening access versus ex vivo CAR-T; the deal is expected to close in the second half of 2026, subject to regulatory approvals and milestone-driven payments.

via PR Newswire|
#biotechnology#business#car-t
Off-the-shelf CAR-T shows potential to delay lymphoma relapse in interim Phase 3 results
biotech5 months ago

Off-the-shelf CAR-T shows potential to delay lymphoma relapse in interim Phase 3 results

Allogene Therapeutics reported interim Phase 3 data for its off-the-shelf CAR-T therapy cema-cel in B-cell lymphoma, showing 58% MRD negativity in treated patients versus 16% in those observed with standard care, a result that could delay or prevent cancer relapse in high-risk patients, though the data are preliminary.

via statnews.com|
#allogene-therapeutics#b-cell-lymphoma#biotech
biotech5 months ago

Allogene’s off-the-shelf CAR-T shows early MRD clearance and outpatient potential in first-line LBCL (ALPHA3 interim)

Allogene Therapeutics reported interim futility data from the ALPHA3 trial in first-line consolidation LBCL, showing 58.3% MRD negativity with cemacabtagene ansegedleucel (Cema-Cel) vs 16.7% in the observation arm, a 41.6-point absolute difference that aligns with literature suggesting meaningful potential benefit. Day-45 plasma ctDNA decreased 97.7% in the Cema-Cel arm versus a 26.6% median increase in the observation arm. The regimen was generally well-tolerated with no CRS, ICANS, or GvHD and most patients managed outpatient; enrollment is ongoing with interim EFS expected in mid-2027 and primary EFS in mid-2028, and a potential BLA submission if results remain favorable. Community centers contributed about one-third of screening and infusions, underscoring broader access potential for an off-the-shelf CAR-T therapy.

via Allogene|
#alpha3#biotech#car-t
healthcare6 months ago

Off-the-shelf CAR-T cema-cel lights up MRD clearance in first-line LBCL, hinting at MRD-guided consolidation

Allogene Therapeutics reported interim futility data from the ALPHA3 trial in first-line LBCL showing cemacabtagene ansegedleucel (cema-cel) achieved MRD negativity in 58.3% of patients vs 16.7% with observation (a 41.6-point edge), and a median 97.7% drop in plasma ctDNA versus a 26.6% rise. The treatment was well tolerated with no CRS/ICANS/GvHD and most patients managed outpatient; community centers contributed about a third of activity. Enrollment aims for ~220 patients with interim EFS data due mid-2027 and primary EFS in mid-2028, and positive results could support an MRD-guided approach and potential BLA submission.

via Allogene|
#allogene-therapeutics#car-t#ctdna
CAR-T immune reset cures trio of autoimmune diseases in patient
health6 months ago

CAR-T immune reset cures trio of autoimmune diseases in patient

A 47-year-old woman with autoimmune haemolytic anaemia (AIHA), immune thrombocytopenia (ITP) and antiphospholipid syndrome (APS) achieved rapid, lasting remission after CD19-targeted CAR-T cell therapy, effectively resetting her immune system and enabling a near-normal life; she has remained in treatment-free remission for about 14 months, while researchers note the need for trials to determine durability and wider applicability.

via The Guardian|
#aiha#aps#autoimmune-diseases
From flu-like symptoms to remission: a lymphoma patient’s CAR-T comeback
health7 months ago

From flu-like symptoms to remission: a lymphoma patient’s CAR-T comeback

A Pilates instructor’s flu-like symptoms led to a diffuse large B-cell lymphoma diagnosis; after initial chemotherapy, the cancer recurred in her brain, but a personalized CAR-T immunotherapy treatment induced complete remission. She experienced no major side effects, returned to daily life, and will continue regular scans to monitor for recurrence, marking a hopeful turnaround.

via CBS News|
#car-t#diffuse-large-b-cell-lymphoma#health
business7 months ago

Gilead to Acquire Arcellx for $7.8B to Accelerate Anito-cel and CAR-T Platform

Gilead will acquire Arcellx for $115 per share in cash plus a $5-per-share contingent value right (CVR), valuing the deal at about $7.8 billion and giving Gilead full control of Anito-cel, its BCMA-directed CAR-T therapy for multiple myeloma. The transaction aims to accelerate development and commercialization, with Anito-cel’s BLA accepted by the FDA and a PDUFA date of December 23, 2026; the deal is expected to close in Q2 2026 and to be accretive to EPS after FDA approval, with the CVR tied to cumulative global net sales milestones through 2029.

via Gilead Sciences|
#anito-cel#arcellx#business
Gilead buys Arcellx for $7.8B to bolster CAR-T push against Carvykti
business7 months ago

Gilead buys Arcellx for $7.8B to bolster CAR-T push against Carvykti

Gilead agreed to acquire Arcellx for about $7.8 billion in cash to take full control of the BCMA-targeted CAR-T therapy anito-cel as FDA review proceeds, paying $115 a share—a 68% premium to Arcellx's 30-day VWAP with a $5-per-share contingent payout if global sales reach $6 billion by 2029; the deal aims to sharpen Gilead's cell-therapy portfolio and compete with J&J/Legend's Carvykti, with analysts noting anito-cel's safety profile and potential to restore momentum for Gilead's Kite unit.

via Fierce Biotech|
#biotech#business#car-t