The roadmap and conservative substitution methods Amgen Inc. laid out to “enable” its genus claims for antibodies that inhibit PCSK9 to lower LDL cholesterol are “little more than two research assignments,” the U.S. Supreme Court said in a unanimous opinion handed down today in Amgen Inc. v. Sanofi SA that gave the win to Sanofi. Although the justices agreed with the Federal Circuit that if a patent claims an entire class, its specification must enable a person skilled in the art to make and use the entire class, they added some clarity to the appellate court’s full-scope-of-the-patent theory.

Immix to address ASGCT as efforts in AL amyloidosis continue

Among highlights of the annual meeting of the American Society of Gene & Cell Therapy is a presentation slated for May 19 from Immix Biopharma Inc. related to data with NXC-201. Immix has the only CAR T therapy in the works for the disease, against which others are striving as well. AL amyloidosis represents the most common type of systemic amyloidosis in Western countries.

Gene therapy to reverse T2D shows proof of concept at ASGCT

The most ambitious objective of any treatment is to eradicate the disease, acting on its origin to cure it instead of treating its symptoms. This is the purpose of the gene therapy against type 2 diabetes (T2D) and obesity that Fractyl Health Inc. is developing. Scientists from the company have designed a strategy based on glucagon-like peptide-1 (GLP-1) to transform pancreatic cells and reverse the disease. Co-founder and CEO Rajagopalan introduced the firm’s GLP-1 platform called Rejuva at the American Society for Gene and Cell Therapy meeting, in a talk titled, “A Pancreatic Gene Therapy Delivery Platform for the Treatment of Type 2 Diabetes.”

MDS heats up as data coming shortly from BMS, Geron, Keros

Keros Therapeutics Inc. recently talked up its KER-050, an ActRIIA-Fc fusion protein in myelodysplastic syndrome (MDS) and myelofibrosis. Phase II data are due this year, as Keros shares the MDS stage with the big pharma likes of Bristol Myers Squibb Co. with luspatercept as well as Geron Corp. with imetelstat, both at the phase III stage in low-risk disease. The latter two firms are expected to roll out more findings soon, too.

Myeloid Therapeutics raises $73M to advance mRNA immunotherapies

Four years after its founding, Myeloid Therapeutics Inc. raised $73 million in a series A-2 round to advance its mRNA immunotherapy technology, which targets and activates myeloid cells. The financing was led by Hatteras Investment Partners and included participation from new investors Arch Venture Partners and Moore Strategic Ventures, as well as all existing investors, Newpath Partners, 8VC and Alexandria Venture Investments. Proceeds from the financings will go toward MT-101, the company’s first autologous CAR monocyte, which is in a phase I/II trial for T-cell lymphoma. It also will accelerate development of MT-302, a first-in-class TROP2-FcA mRNA-LNP candidate, which is ready for a phase I/II study for TROP2-expressing solid tumors. “We’re humbled by the support from these great investors,” said Myeloid co-founder and CEO Daniel Getts. “We have a large responsibility” as a pioneer in technology that places a CAR “directly into a human as an RNA construct.”

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