Precision medication is a time period repeatedly related to most cancers remedy, however Lexeo Therapeutics applies it to gene remedies addressing underlying reasons of sure cardiovascular and neurological illnesses. Lexeo now has $100 million to toughen two clinical-stage methods and others in its pipeline, however the biotech needed to reduce the cost of its IPO to tug it off.
Lexeo to start with deliberate to provide 9 million stocks within the vary of $13 and $15 apiece, which might have raised $126 million on the pricing midpoint. Past due Thursday, the corporate introduced 9.09 million stocks priced at $11 apiece. The ones stocks will business at the Nasdaq below the inventory image “LXEO.”
The gene treatment analysis of New York-based Lexeo specializes in higher uncommon illnesses (affecting 5,000 to 200,000 sufferers) in addition to prevalent illnesses with a genetically outlined subset of sufferers. Lexeo’s maximum complex program is for Friedreich’s ataxia, an extraordinary neuromuscular dysfunction that thus far has handiest one FDA-approved remedy. The illness stems from a genetic mutation that ends up in low ranges of frataxin, a protein key to cell serve as. Friedreich’s ataxia sufferers revel in step by step worsening skeletal muscle weak spot. The vast majority of those sufferers additionally broaden middle issues, or cardiomyopathy. In maximum genetic cardiomyopathies, present remedies don’t regulate the illness, Lexeo mentioned in its IPO submitting.
“In instances the place a disease-modifying remedy possibility is to be had, the present usual of care handiest forestalls illness development,” the corporate mentioned. “We imagine our cardiovascular precision medication center of attention gives the chance to regard the underlying root explanation for the illness and extra successfully opposite illness development with a unmarried dose.”
Lexeo’s LX2006 treats Friedreich’s ataxia-driven cardiomyopathy by means of turning in a useful model of the gene that codes for frataxin. In Segment 1 trying out, Lexeo says an build up within the expression of frataxin has been seen within the middle of 1 affected person thus far within the low-dose workforce. Further meantime knowledge are anticipated in mid-2024.
The prevalent dysfunction that Lexeo is concentrated on is Alzheimer’s illness. Essentially the most complex Lexeo Alzheimer’s program, LX1001, has reached human trying out in those that have inherited two copies of the APOE4 gene, a recognized possibility issue for the neurodegenerative dysfunction. Lexeo’s gene treatment delivers the APOE2 gene, which is regarded as neuroprotective.
Within the submitting, Lexeo says an build up in APOE2 ranges has been seen within the first dose workforce, in conjunction with a development towards development within the organic signs of Alzheimer’s. The corporate expects enrollment will likely be whole by means of the tip of the yr; further meantime knowledge are anticipated in the second one part of subsequent yr.
New York-based Lexeo shaped in 2017 according to the analysis of medical founder Ronald Crystal, a professor and the chairman of Weill Cornell Drugs’s genetic medication division. The corporate is led by means of CEO Nolan Townsend, the previous head of Pfizer’s uncommon illness business trade unit. Lexeo’s preliminary methods got here from a collaboration between the corporate, Crystal, and Cornell College. The Segment 1/2 take a look at of LX1001 in cardiomyopathy started at Cornell in 2019.
Lexeo has some other cardiomyopathy program not off course for the health facility. LX2020 is a possible remedy for arrhythmogenic cardiomyopathy brought about by means of mutations within the PKP2 gene. In July, the FDA cleared this gene treatment to start medical trying out. Lexeo mentioned within the IPO submitting that it expects the primary affected person will likely be dosed within the first part of 2024. Intervening time knowledge are anticipated in the second one part of subsequent yr.
Lexeo Faces Litigation From a Gene Treatment Rival
LX2020 places Lexeo in attainable pageant with Rocket Prescribed drugs, which is set to start medical trying out of its gene treatment for PKP2 arrhythmogenic cardiomyopathy. However prior to both treatment reaches the marketplace, pageant may play out in a court docket. A lawsuit filed on Oct. 12 within the Southern District of New York alleges that Lexeo employed two Rocket scientists, who took with them confidential and proprietary details about Rocket for the advantage of their new employer.
Amongst Rocket’s claims in its 57-page grievance is that a kind of former workers transferred 122,987 work-related emails and paperwork to his private laptop and likewise took footage of Rocket labs. The Cranbury, New Jersey-based biotech alleges that the tips its two former workers supplied to Lexeo allowed that corporate to “shut the distance” and safe FDA clearance of an investigational new drug software for its PK2P program simply weeks after Rocket’s. Rocket claims Lexeo “may now not have independently advanced its PKP2 gene treatment program, in particular in the time frame it did, with out the wrongful acquisition and use of Rocket Pharma’s business secrets and techniques.”
Lexeo’s IPO submitting recognizes the Rocket lawsuit, declaring that the company is reviewing the allegations with its attorneys. On the other hand, Lexeo didn’t reply at once to any of Rocket’s claims.
“We intend to shield this litigation vigorously, and whilst it isn’t conceivable to are expecting the end result with walk in the park, we these days don’t be expecting the overall result could have a subject matter hostile impact on our timelines for building of our product applicants,” Lexeo mentioned within the submitting.
The case is Rocket Prescribed drugs, Inc. v. Lexeo Therapeutics et. al., case no. 1:23-cv-09000-PKC
Money for the Health facility
Within the IPO submitting, Lexeo mentioned it has raised $183.7 million since its inception. Sooner than the IPO, its most up-to-date financing was once a $100 million Collection B spherical in 2021. As of the tip of the second one quarter of this yr, Lexeo reported a money place of $45.5 million. That capital, in conjunction with the IPO proceeds, will toughen the Lexeo pipeline.
About $45 million is budgeted for finishing the Segment 1/2 medical take a look at of LX2006 in Friedreich’s ataxia sufferers and for making ready this gene treatment for a pivotal find out about that might toughen an FDA submission. Any other $40 million is put aside for the continuing Segment 1/2 trying out of LX2020 for treating PKP2-arrhythmogenic cardiomyopathy. The corporate plans to spend $10 million for finishing the Segment 1/2 find out about comparing LX1001 in Alzheimer’s illness.
In spite of everything, $15 million is put aside for building of its different gene treatment methods, together with the preclinical-stage LX2021, a possible remedy for Desmoplakin cardiomyopathy.
Photograph: Getty Photographs