Lakefront Biotherapeutics American Depositary Shares NASDAQ: LKFT said it plans to begin registrational studies next year for its lead T-cell engager, gamgertamig, following a broad restructuring of its legacy cell-therapy operations and the acquisition of assets from Ouro Medicines.
Speaking at Morgan Stanley’s Global Healthcare Conference, Chief Executive Officer Henry Gosebruch said the clinical-stage biopharmaceutical company is now focused on a portfolio of four T-cell engager programs. The company expects to share additional data on gamgertamig toward the end of this year.
Gosebruch said the company, previously known as Galapagos, reviewed its ex vivo CAR-T portfolio after the current leadership team arrived about 18 months ago and concluded the programs were not commercially viable. Lakefront began winding down those operations in January after obtaining approvals from European works councils and unions. The legacy business had more than 650 employees and approximately $300 million in annual spending, he said.
Gilead Partnership and Ouro Transaction
Lakefront inherited a strategic alliance with Gilead Sciences that was established in 2019 and has approximately three years remaining. Gosebruch said Gilead has contributed about $5 billion to the company under the broader arrangement and retains rights to opt into company programs at proof-of-concept stages.
As part of the Ouro transaction, Gilead contributed half of the deal consideration and is sharing operational responsibilities for gamgertamig. Gilead is expected to commercialize the lead program, while Lakefront would receive a royalty, according to Gosebruch.
Lakefront pursued a broad search for business-development opportunities rather than concentrating exclusively on oncology or autoimmune disease, Gosebruch said. The company was drawn to Ouro after reviewing initial data on gamgertamig and ultimately obtained the asset in March following a competitive process.
Gosebruch said Lakefront saw efficacy and safety data from more than 60 patients during its initial diligence. The company believes the program could have a timing advantage over competitors and cited its subcutaneous formulation and dosing regimen as factors supporting advancement into registration studies.
Autoimmune Focus and Clinical Development
Chief Medical Officer Eric Hedrick said gamgertamig has generated its most mature data in autoimmune cytopenias, including immune thrombocytopenia, or ITP, and autoimmune hemolytic anemia, or AIHA. The program has also been studied in pemphigus vulgaris, an autoimmune skin disease. Ongoing research outside China includes Sjögren’s disease, myositis and additional pemphigus work.
Gamgertamig is a BCMA-directed T-cell engager. Hedrick said the approach is intended to address plasma cells and plasmablasts that produce autoantibodies, while studies suggest BCMA targeting may also lead to broader B-cell depletion than previously expected.
Lakefront expects its year-end update to focus on the cytopenia studies in ITP and AIHA. Gosebruch said enrollment in the U.S. and Australia has continued since the Ouro transaction, increasing the number of patients in the dataset. The company aims to show that patients experience an “immune reset,” in which B cells are depleted, return after treatment and patients remain free of disease for a meaningful period.
The company has not disclosed the precise planned dose or dosing regimen. However, Gosebruch said a meaningful portion of patients in the original dataset had received doses at or near the levels Lakefront expects to use in registrational studies. He described the desired product profile as a short initial treatment course followed by monitoring, rather than chronic therapy.
Hedrick said earlier Chinese autoimmune studies used higher and longer-duration dosing than the current regimen. Those studies showed an acceptable, though not necessarily optimized, safety profile, he said. Lakefront’s subsequent work has focused on dose de-escalation intended to preserve efficacy while improving tolerability.
Registrational Plans and Pipeline Expansion
Lakefront expects ITP and AIHA to be the first two registrational studies, with trial starts planned for next year. Gosebruch said the company still needs to discuss final trial designs and patient numbers with regulators. He said the company anticipates controlled studies but does not expect them to be especially large or lengthy because the diseases are orphan conditions and the company believes the treatment effect could be substantial.
The FDA has granted Orphan Drug Designation for gamgertamig in ITP, AIHA and pemphigus, according to Gosebruch. He said the company has been pleased with its regulatory engagement to date.
Lakefront also plans to begin two basket studies early next year covering additional clusters of autoimmune diseases. The company intends to disclose the specific indications at that time.
Beyond gamgertamig, Gosebruch said Lakefront acquired three preclinical programs from Ouro that are approaching investigational new drug application stages. Those programs are fully owned by Lakefront, though Gilead has opt-in rights that could convert the economics to a 50/50 profit-sharing arrangement.
Cash Position and Legacy Income
Chief Financial Officer Aaron Cox said Lakefront expects to end the year with about €2 billion in cash. The company previously estimated it would have approximately €1.6 billion after spending related to Ouro, other operations and the first approval of gamgertamig.
Cox said Gilead’s contribution to the Ouro transaction included a $500 million pool for activities independent of future Gilead involvement. That pool includes a $150 million sub-limit for share repurchases. Lakefront announced a €50 million share buyback in June and expects to complete it by year-end.
The company also receives annual royalties of approximately €15 million to €20 million related to Jyseleca from Gilead and Alfasigma, Cox said. Lakefront held roughly €125 million in legacy tax-credit receivables at the end of the second quarter, with expected receipts of approximately €20 million to €35 million annually over the next several years.
Gosebruch said the wind-down of Lakefront’s legacy cell-therapy operations is largely complete, with remaining work centered on clinical study reports and other closeout activities.
About Lakefront Biotherapeutics American Depositary Shares (NASDAQ:LKFT)
Galapagos NV, a biotechnology company, develops medicines focusing on oncology and immunology primarily in the United States and Europe. The company's pipeline products comprise GLPG3667 that has completed phase 1b trial; GLPG5101, a CD19 CAR-T product candidate manufactured at point-of-care, currently in Phase1/2 trial in relapsed/refractory non-hodgkin lymphoma; GLPG5201, a CD19 CAR-T product candidates manufactured at point-of-care, currently in phase 1/2 trial in replapsed/refractory chronic lymphocytic leukemia; and GLPG5301, a BCMA CAR-T product candidate manufactured at point-of-care, currently in phase 1/2 in relapsed/refractory multiple myeloma.
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