Precision medication is a time period generally related to most cancers therapy, however Lexeo Therapeutics applies it to gene therapies addressing underlying causes of sure cardiovascular and neurological ailments. Lexeo now has $100 million to assist two clinical-stage applications and others in its pipeline, however the biotech needed to reduce the value of its IPO to tug it off.
Lexeo initially deliberate to supply 9 million shares within the vary of $13 and $15 apiece, which might have raised $126 million on the pricing midpoint. Late Thursday, the corporate provided 9.09 million shares priced at $11 apiece. These shares will commerce on the Nasdaq below the inventory image “LXEO.”
The gene remedy analysis of New York-based Lexeo focuses on bigger uncommon ailments (affecting 5,000 to 200,000 sufferers) in addition to prevalent ailments with a genetically outlined subset of sufferers. Lexeo’s most superior program is for Friedreich’s ataxia, a uncommon neuromuscular dysfunction that to date has solely one FDA-approved therapy. The illness stems from a genetic mutation that results in low ranges of frataxin, a protein key to mobile operate. Friedreich’s ataxia sufferers expertise progressively worsening skeletal muscle weak point. Almost all of those sufferers additionally develop coronary heart issues, or cardiomyopathy. In most genetic cardiomyopathies, current therapies don’t modify the illness, Lexeo stated in its IPO submitting.
“In instances the place a disease-modifying therapy choice is offered, the present commonplace of care solely forestalls illness development,” the corporate stated. “We imagine our cardiovascular precision medication focus presents the chance to deal with the underlying root reason behind the illness and extra successfully reverse illness development with a single dose.”
Lexeo’s LX2006 treats Friedreich’s ataxia-driven cardiomyopathy by delivering a useful model of the gene that codes for frataxin. In Part 1 testing, Lexeo says a rise within the expression of frataxin has been noticed within the coronary heart of 1 affected person to date within the low-dose group. Further interim knowledge are anticipated in mid-2024.
The prevalent dysfunction that Lexeo is concentrating on is Alzheimer’s illness. Probably the most superior Lexeo Alzheimer’s program, LX1001, has reached human testing in those that have inherited two copies of the APOE4 gene, a identified threat issue for the neurodegenerative dysfunction. Lexeo’s gene remedy delivers the APOE2 gene, which is considered neuroprotective.
Within the submitting, Lexeo says a rise in APOE2 ranges has been noticed within the first dose group, together with a development towards enchancment within the organic indicators of Alzheimer’s. The corporate expects enrollment will probably be full by the top of the yr; extra interim knowledge are anticipated within the second half of subsequent yr.
New York-based Lexeo shaped in 2017 primarily based on the analysis of scientific founder Ronald Crystal, a professor and the chairman of Weill Cornell Drugs’s genetic medication division. The corporate is led by CEO Nolan Townsend, the previous head of Pfizer’s uncommon illness business enterprise unit. Lexeo’s preliminary applications got here from a collaboration between the corporate, Crystal, and Cornell College. The Part 1/2 take a look at of LX1001 in cardiomyopathy started at Cornell in 2019.
Lexeo has one other cardiomyopathy program on monitor for the clinic. LX2020 is a possible therapy for arrhythmogenic cardiomyopathy brought on by mutations within the PKP2 gene. In July, the FDA cleared this gene remedy to start medical testing. Lexeo stated within the IPO submitting that it expects the primary affected person will probably be dosed within the first half of 2024. Interim knowledge are anticipated within the second half of subsequent yr.
Lexeo Faces Litigation From a Gene Remedy Rival
LX2020 places Lexeo in potential competitors with Rocket Prescription drugs, which is set to start medical testing of its gene remedy for PKP2 arrhythmogenic cardiomyopathy. However earlier than both remedy reaches the market, competitors might play out in a courtroom. 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 staff transferred 122,987 work-related emails and paperwork to his private laptop and likewise took images of Rocket labs. The Cranbury, New Jersey-based biotech alleges that the data its two former staff supplied to Lexeo allowed that firm to “shut the hole” and safe FDA clearance of an investigational new drug utility for its PK2P program simply weeks after Rocket’s. Rocket claims Lexeo “couldn’t have independently developed its PKP2 gene remedy program, significantly within the timeframe it did, with out the wrongful acquisition and use of Rocket Pharma’s commerce secrets and techniques.”
Lexeo’s IPO submitting acknowledges the Rocket lawsuit, stating that the agency is reviewing the allegations with its legal professionals. Nevertheless, Lexeo didn’t reply on to any of Rocket’s claims.
“We intend to defend this litigation vigorously, and whereas it isn’t doable to foretell the end result with certainty, we presently don’t anticipate the ultimate end result could have a cloth antagonistic impact on our timelines for improvement of our product candidates,” Lexeo stated within the submitting.
The case is Rocket Prescription drugs, Inc. v. Lexeo Therapeutics et. al., case no. 1:23-cv-09000-PKC
Money for the Clinic
Within the IPO submitting, Lexeo stated it has raised $183.7 million since its inception. Earlier than the IPO, its most up-to-date financing was a $100 million Sequence B spherical in 2021. As of the top of the second quarter of this yr, Lexeo reported a money place of $45.5 million. That capital, together with the IPO proceeds, will assist the Lexeo pipeline.
About $45 million is budgeted for finishing the Part 1/2 medical take a look at of LX2006 in Friedreich’s ataxia sufferers and for getting ready this gene remedy for a pivotal examine that would assist an FDA submission. One other $40 million is put aside for the continued Part 1/2 testing of LX2020 for treating PKP2-arrhythmogenic cardiomyopathy. The corporate plans to spend $10 million for finishing the Part 1/2 examine evaluating LX1001 in Alzheimer’s illness.
Lastly, $15 million is put aside for improvement of its different gene remedy applications, together with the preclinical-stage LX2021, a possible therapy for Desmoplakin cardiomyopathy.
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