SNAPSHOT

Create Medicines raises $122M to accelerate in vivo CAR-T therapies for cancer and autoimmune diseases

Create Medicines closed a Series B financing round led by existing investors to expand development of its RNA-based in vivo CAR-T platform, which programs immune cells directly inside the body rather than engineering them outside the patient.

Why it matters: Traditional CAR-T therapies are expensive, complex and slow to manufacture. Create says its mRNA-lipid nanoparticle platform could compress production into a “one-day manufacturing process,” potentially making engineered immune therapies faster, cheaper and more scalable for both cancer and autoimmune conditions.

Backstory: The company launched in 2021 as Myeloid Therapeutics, initially focused on myeloid-cell therapies. It later expanded into RNA-based in vivo CAR-T treatments and rebranded as Create Medicines in 2025.

Big picture: Investors are increasingly backing “in vivo” cell therapy companies that aim to bypass the logistical hurdles of conventional CAR-T manufacturing. The approach could broaden access to cell therapies beyond specialized treatment centers and into larger patient populations.

Zoom in: The $122 million round was co-led by Arch Venture Partners, Newpath Partners and Hatteras Venture Partners. Create says it has treated more than 50 patients across its programs, which it describes as the field’s largest clinical dataset. Its lead candidate, MT-304, recently dosed the first patient in a Phase 1/2 trial targeting HER2-positive breast and gastric cancers. The company is also developing therapies targeting CD19 and BCMA for autoimmune diseases, both established CAR-T targets in approved therapies.

SNIPPETS

What’s happening in biotech today?

🏃‍♂️Muscle boost: Regenxbio reported a major success for its Duchenne muscular dystrophy gene therapy RGX-202, with its pivotal phase 3 trial meeting the primary endpoint after 28 of 30 patients achieved dystrophin protein expression levels at or above 10% of healthy controls within 12 weeks, and average expression reaching 71.1%. The company said the therapy showed advantages over Sarepta’s approved gene therapy Elevidys in protein expression, safety and functional outcomes, particularly in older boys, while also reporting a lower rate of severe liver injury. Early functional data indicated improvements in muscle performance measures compared with the expected progression of the disease, and Regenxbio believes the strong correlation between microdystrophin expression and physical improvement could support accelerated FDA approval.

🛑 FDA timeout: Aardvark Therapeutics plans to unblind early data from its phase 3 Prader-Willi syndrome (PWS) trial after the FDA imposed a full clinical hold on all studies of its lead candidate, ARD-101, following concerns over cardiac safety signals seen in healthy volunteer testing. The biotech had voluntarily paused the studies in March after observing significant cardiac QRS prolongation at doses higher than those used in phase 3 trials, and later extended the pause to related programs. Before the halt, Aardvark expected topline data in the third quarter of 2026, a key milestone given its cash runway extends only into mid-2027. With the hold delaying progress, the company will analyze unblinded efficacy and safety data from 68 randomized trial participants and 19 extension-study patients to determine next steps for the program. Investors reacted negatively, sending Aardvark shares down 16% in after-hours trading.

👁️ TED timeout: Alumis is seeking strategic alternatives for lonigutamab, its anti-IGF-1R antibody for thyroid eye disease (TED), instead of advancing the drug into phase 3 development as previously planned before its merger with Acelyrin. Although Alumis initially described the asset as a potential best-in-class competitor to Amgen’s Tepezza, the company decided after reviewing the data not to continue internal development, potentially leading to a write-down of the $51 million value assigned to the drug during the acquisition. The move reflects Alumis’ prioritization of its TYK2 inhibitor envudeucitinib, which has received substantially greater R&D investment. Competitive pressure in the TED market has also increased, with Amgen developing a more convenient subcutaneous version of Tepezza and Viridian Therapeutics advancing rival therapies.

🧠 Tau tango: Biogen plans to advance its experimental Alzheimer’s drug BIIB080, also called diranersen, into late-stage testing despite a Phase 2 trial failing to meet its primary endpoint of establishing a dose response. The company said the study produced “unprecedented and compelling” biomarker and efficacy results, including reductions in tau protein levels and signs of slowed cognitive decline across all dose groups, particularly at the lowest dose tested. Analysts reacted cautiously, noting the unusual lack of a linear dose response and limited disclosure of detailed data, though some viewed Biogen’s decision to continue development as a sign of confidence in the therapy’s potential. BIIB080 is an antisense oligonucleotide originally developed by Ionis Pharmaceuticals that aims to reduce toxic tau accumulation, representing a novel approach to Alzheimer’s treatment.

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