Phase 2a trial of Lomecel-B for patients with mild Alzheimer’s is on track and company has $27m to fund operations into 2024.
Longeveron Inc, a clinical stage biotech developing cellular therapies with the aim of tackling specific aging-related, life-limiting and life-threatening conditions, has provided a business update and reported its financial results for the Q2 ending 30 June 2022, confirming its cash and short-term investments was $27 million (compared with $35m at 31 December 2021).
Longevity.Technology: Longeveron, which is based in Miami, filed the first longevity biotech IPO of 2021, raising $26.6m. Its lead investigational product is Lomecel-B; this is a cell-based therapy derived from culture-expanded medicinal signalling cells which have been sourced from the bone marrow of young, healthy, adult donors.
“Longeveron has made steady progress advancing Lomecel-B, our lead medicinal signaling cell (MSC) therapy product, through clinical trials for four different indications,” said Chris Min, MD, PhD, Interim Chief Executive Officer and Chief Medical Officer, reporting that he was proud to announce multiple updates on all Longeveron’s projects.
“First, we have enrolled 50% of our planned patient population of 48 in our Phase 2a trial of Lomecel-B in patients with mild Alzheimer’s Disease,” he said. “Furthermore, a pre-planned total of 89 patients have been consented to undergo eligibility screening, and we expect to fully enroll the study on schedule.”
Min also confirmed that on 8 August, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an amendment to the company’s Japanese Aging Frailty Trial.
“We reevaluated our Aging Frailty strategy in Japan given the large unmet need there, and the supportive regulatory framework including the pathway recognizing the therapeutic potential of cell therapies through the Act on the Safety of Regenerative Medicine (ASRM),” he explained. “ASRM approval, if granted, could allow Longeveron to provide Lomecel-B in Japan at selected sites, permitting us to enter the market in that country on an accelerated basis. We have increased confidence in the near-term, value-driving opportunity in Japan.”
The company also announced that it met the primary safety endpoint in the randomised phase of its Phase 1/2 ‘HERA’ Aging Frailty trial, confirming that in that study, Lomecel-B does not appear to interfere with the potency of vaccines such as HD Fluzone in the adult population with aging frailty.
“In the remainder of 2022 through early 2023, we expect to publish manuscripts for the ELPIS 1 trial and for the previously completed Phase 2b study in Adult Frailty in quality peer-reviewed journals, enroll the first Japanese patient with aging frailty in our Phase 2 study in that country, and complete enrollment of our Phase 2a trial in Alzheimer’s Disease,” said Min .
Longeveron plans to pursue additional studies of the immune system and will be making highly sophisticated measures of B-cell responses using samples obtained in its studies; B-cells are the cells that mount the body’s antibody response to vaccination. These new study findings continue to broaden Longeveron’s database regarding the potential impact of Lomecel-B in diseases of aging, such as aging frailty and Alzheimer’s disease. Longeveron plans to publish the full study results once all study assessments are finalised.
“Like any intervention to be applied in older adults, proving safety of Lomecel-B is the critical and necessary first step, and this trial has achieved that,” said Dr Sean Leng, a board-certified geriatrician, Professor of Medicine, Molecular Microbiology and Immunology at Johns Hopkins.
“The result suggestive of potential boosting effect on heterotypic antibody response to HD Fluzone is very encouraging,” he said. “The planned in-depth B cell studies including plasmablast response to the vaccine is an extremely important next step as it will provide further insights into potentially beneficial impact of Lomecel-B on the aging immune system with significant clinical relevance to senior health .”