#107 - Spike soldiers & sailboat suspects
The coffee break biotech roundup, by SomX.
Ahoy, my seafaring sleuths,
The waters are busy this week: COVID’s immune legacy resurfaces for a second deployment, the vagus nerve is mapped for the first time, an inhaled drug finds its sea legs in bronchiectasis, FDA advisers crack open the peptide hatch, and federal marshals board a sailboat off New Jersey to find someone who has been hiding in plain sight for 21 years.
Anchors aweigh,
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🦠 New cancer vaccine harnesses COVID-19 immune memory to fight tumours (News Medical): A Cleveland team at Celloram, University Hospitals and Case Western Reserve has developed a dendritic cell vaccine that leverages residual immunity to the COVID Spike protein. PROTEXI pairs tumour antigens with Spike fragments, so that the helper T-cells (CD4+) a patient already carries can recruit killer T-cells (CD8+) against the cancer. The target is “immune-cold” tumours, which evade immune recognition and against which cancer vaccines have long struggled. In mice, PROTEXI slowed melanoma and breast tumour growth, and improved survival.
Our take: Nothing else in modern medicine comes close to the scale of shared immune memory the pandemic left behind, and very few people have worked out what to do with it. Celloram’s answer is cancer, but logic suggests that if a Spike epitope can lend help to a tumour antigen, it could do so for any target too weak to elicit help on its own. A human trial in sarcoma is up next.
🫁 Revagenix doses first Participant in Phase 1 Trial of Rev-56, an inhaled therapy for non-CF bronchiectasis (BioSpace): Up to half a million American adults live with non-cystic fibrosis bronchiectasis, but there is no approved therapy for the Pseudomonas aeruginosa driving their flare-ups and hospital admissions, so clinicians fall back on off-label antibiotics. Revagenix has dosed the first participant in a Phase 1 trial of Rev-56, an inhaled antibacterial designed to fill that gap. The two-part trial covers both healthy volunteers and patients with confirmed P. aeruginosa infection, with the first topline data due by year-end.
Our take: Rev-56 works by inhibiting LpxC, an enzyme that Gram-negative bacteria need to build their outer membrane. Companies Achaogen and Recida have also had a crack at it, but both abandoned their candidates in Phase 1 after their circulating drugs raised cardiovascular safety concerns. Rev-56 aims to overcome this by not circulating at all; bronchiectasis is an airway infection, so inhaling the drug gets it directly to the bacteria without entering the bloodstream.
🩻 Comprehensive human vagus nerve map unveiled (GEN): 30 donors, 60 nerves, and three years of microCT imaging have produced what Northwell Health’s Feinstein Institutes call the first comprehensive anatomical map of the human vagus nerve, the sprawling cranial nerve running from brainstem to gut. Each nerve carries roughly 100,000 fibres, some half a micrometre across. The $6.7 million NIH-funded dataset is now free on SPARC Science for anyone building neuromodulation devices.
Our take: Vagus nerve stimulation has become a wellness category, sold through breathing apps, cold plunges and ear clips. But even clinical devices – such as the rheumatoid arthritis implant the FDA approved in July 2025 – stimulate the whole trunk, which increases the risk of unwanted effects. A fibre-level reference map finally makes targeted stimulation possible.
💊 FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What’s next? (ABC News): A committee of outside advisers to the FDA has recommended adding six peptides, including BPC-157, to the controlled list of ingredients compounding pharmacies may use, overruling the agency’s own scientists who opposed all seven under consideration on the grounds of thin trial data and possible immune reactions. The peptides – none of which are FDA-approved as medicines – are promoted for a wide range of uses, including muscle growth and fat loss. Scientists worry this will confuse consumers, who may mistake a place on the compounding list for medical approval.
Our take: The committee’s recommendation was based on harm reduction; Americans buy peptides online anyway, so a pharmacy is safer than an unknown vendor. While that’s not a bad argument, it’s worth asking who stands to gain from wider access, especially since panellists included people who work for peptide businesses and clinics – appointments that FDA officials reportedly questioned as the panel was being assembled. The agency is not bound by the recommendation, though it usually follows such advice.
And finally…
⛵ In the biotech industry, a most-wanted fugitive was long hiding in plain sight (STAT News): Federal marshals boarded a 56-foot sailboat off New Jersey this month, arresting the man Immix Biopharma had until recently employed as its chief medical officer. Richard Graydon was the most recent of many aliases used by Ronald Fischer, 70, a former anaesthesiologist who failed to appear at his Rhode Island trial in 2005 and was convicted in absentia of first-degree sexual assault. He had already lost his medical licence in the 1990s, after pleading guilty to assault in an earlier case.
Our take: Companies associated with Graydon/Fischer are now distancing themselves from him. Atossa, which named him interim CMO in 2022, now says he was a contractor for less than two weeks; J&J says he was never an employee; and Immix fired him the day after news of his capture broke – for reasons, it told financial regulators, unrelated to his activities at the company. This is a pertinent reminder to employers that due diligence matters, and that scrutiny ought to rise with seniority, not the other way round.
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