Immunology
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CRISPR Overhauls CAR-T Pipeline With Next-Gen Candidates, Autoimmune Expansion
Experts see allogeneic CAR-Ts as less likely to carry potential risks of T-cell malignancies, and an opportunity for differentiation against the crowded autologous CD19-directed CAR-T space.

Seismic Rumbles Into Clinic With $121m For Novel Immunology Biologics
Less than two years after its $101m series A round, Seismic’s machine-learning powered IMPACT platform for biologics drug discovery yielded two clinical trial-ready assets worthy of a $121m series B.

Risk/Benefit Of CAR-T For Autoimmune Diseases May Shift With FDA Investigation
CAR-T therapy-associated T-cell malignancies that the US FDA is investigating could make the treatments less attractive in autoimmune diseases than in oncology, but patients in both settings already accept some cancer risk with other available medicines.

CAR-T Safety Probe Causes Alarm, But Is Unlikely To Upend Therapies
Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.

Roivant Won’t Continue With Brepocitinib In Lupus After Phase II Failure
The company wants to focus efforts with the TYK2/JAK1 inhibitor in orphan rheumatology indications like dermatomyositis where current treatment options are inadequate.

Novartis Looks To Lead CAR-T Expansion Into Autoimmune Disease
Novartis pioneered CAR-Ts for leukemia and lymphoma, and inspired by pioneering physician Georg Schett, it also hopes to be first in the race to revolutionize autoimmune disease treatment with the therapies, and has unveiled the first clinical data for its candidate.

After IPO Success, Apogee Prepares To Take On Lilly And Sanofi Dupixent Across I&I
Using a 'de-risked business model' of targeting established drug categories with next-generation antibodies, Apogee is looking to take on Lilly’s lebrikizumab and Sanofi’s Dupixent.

Q32 Bio Resets As A Public Company With Two Mid-Stage Assets
The company announced a reverse merger with Homology Medicines that will take the company public while also regaining full rights from Amgen to bempikibart for atopic dermatitis and alopecia areata.

Bayer Switches Focus Of Recursion AI Pact To Oncology
After streamlining its R&D strategy in the summer, Bayer’s rewritten pact with Recursion Pharmaceuticals looks like a vote of confidence in its AI-enabled drug discovery platform.

Takeda Will Take TYK2 Inhibitor Into Phase III, Looks For Dosing Edge Over BMS Rival
The Japanese pharma company has bet big on its TYK2 inhibitor, but it must demonstrate competitive safety and efficacy if it is to challenge Bristol Myers Squibb’s first-to-market Sotyktu.

Placebo Response Hurts MoonLake In Psoriatic Arthritis
Sonelokimab follows a mid-stage slam-dunk in hidradenitis suppurativa with a rather more equivocal result in a different immune condition in the ARGO study.
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