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Replicate’s srRNA rabies vaccine effective in Phase 1

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Hello! And it’s Meghana again. Today, we discuss how Biogen’s missed the mark with Leqembi, but how it’s also not exactly a surprise. We see a new startup emerge that aims to compete with Vertex Pharmaceuticals, and learn of Phase 1 results for Replicate’s srRNA rabies vaccine.

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A startup aims to compete with Vertex in pain

A new startup, Latigo Biotherapeutics, has launched with $135 million and the intention to compete with Vertex Pharmaceuticals. The company, which was incubated by the Los Angeles-area venture firm Westlake Village BioPartners, is in the midst a Phase 1 trial for a non-opioid pain medicine called LTG-001. It’s an oral drug meant to silence pain-signaling neurons by blocking a sodium channel called NaV 1.8.

Vertex, too, is pursuing the same goal here. Last month, the company announced that its medicine VX-548, which also targets NaV 1.8, succeeded in two clinical Phase 3 studies. Latigo told STAT that it believes that its drug will be safe and perhaps work even faster than Vertex’s — but hasn’t yet published its Phase 1 data.

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Leqembi usage low, triggering a stock slump for Biogen

Last year, Biogen’s Alzheimer’s drug Leqembi launched to great aplomb — but that hasn’t yet translated to sales. Only about 2,000 patients are taking the medicine in the U.S., the company said in a fourth-quarter earnings call. This has caused the company’s stock to fall more than 7% — its most dramatic plunge in two years.

CEO Christopher A. Viehbacher said he expects an uptick in use: About 3,800 patients with early-stage disease have signed up on registries to receive the drug as of last month. It’s a complex endeavor to receive the medicine, which costs $26,500 a year: Patients must undergo a brain scan or spinal tap to confirm they have a buildup of beta-amyloid. Biogen and Eisai had said previously that they wanted 10,000 patients to be taking the medicine by April — but Viehbacher said they always knew it would take time for patients to be eligible for the drug.

“There’s plenty of demand from patients,” Viehbacher said. “It really is a question of the system being able to accommodate this new flow of patients.”

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Humira biosimilars are stunningly underused

Nine biosimilars for the blockbuster Humira have become available in the last year. But so far, these lower-cost alternatives to treat autoimmune diseases like rheumatoid arthritis and Crohn’s disease haven’t gained much traction. That’s because policymakers haven’t done enough to advance their uptake, opines Juliana M. Reed, executive director of the Biosimilars Forum.

Humira, these days, can cost more than $84,000 a year — and its price has increased 470% since its 2003 launch. But of the 42,000 potential Medicare beneficiaries, fewer than 1,000 received a biosimilar for the drug, she writes. Humira biosimilar competition accounts for less than 2% of the market, even though their prices can be as much as 85% lower.

But PBMs continue to favor the branded version of the biologic, making it easier for patients to access. Some PBMs even deny biosimilars outright without any explanation. To change this, policymakers need to step up: They need to crack down on anti-competitive schemes from PBMs, Reed writes, and prioritize patient access to affordable drugs.

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Replicate’s srRNA rabies vaccine effective in Phase 1

San Diego-based Replicate Bioscience, a clinical stage company, reported Wednesday that its self-replicating RNA (srRNA) rabies vaccine induced strong immune responses in a Phase 1 clinical trial, even at extremely low doses — doses that contained fractions of the volume found in messenger RNA Covid vaccines on the market.

The company reported that at all three doses tested — which went from 10 micrograms, a third of the volume of Pfizer’s Covid vaccine, down to an ultra-low 0.1 micrograms — the experimental vaccine induced neutralizing antibody titers at levels that exceeded the World Health Organization’s defined surrogate level of protection for rabies virus. (Replicate’s press release said “most” recipients of the 0.1 mcg-dose arm generated antibody titer levels that met the WHO’s standard.) The vaccine, RB1-4000, was well tolerated at all doses tested, with no severe adverse events among the 84 people in the trial. “These results have exceeded our expectations and show the power and potential of our srRNA technology,” CEO Nathaniel Wang said.

More reads

  • New cancer vaccines could treat some types of pancreatic, colorectal and other deadly forms of the disease, Scientific American
  • Roche returns solid tumor asset to Repare weeks after $40 million milestone payment, BioSpace
  • Organon shelves contraceptive with ‘natural’ estrogen, Endpoints
  • BMS signs $647 million bio bucks pact with Roivant-backed VantAI for molecular glues, FierceBiotech
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Correction: An earlier version of this newsletter incorrectly stated that a Phase 1 trial had been completed. It is still ongoing.