Laminar Pharma is a biotechnological company that was born in 2006 in Mallorca with the aim of designing and developing new treatments against diseases with a high therapeutic need, including rare or orphan diseases, based on an innovative technology, membrane lipid therapy or mellitherapy.
To date, Laminar Pharma has designed several families of drugs that are in different stages of development, from preclinical to human studies. These molecules share their ability to control the functionality of cells by regulating their lipid membranes, rather than targeting proteins or nucleic acids as most treatments do. In addition, the compounds designed by Laminar Pharma share two very important characteristics, a high safety profile and promising therapeutic activity for the treatment of different high-impact pathologies, such as cancer (including very aggressive and low-incidence cancers), neuropathies (such as Alzheimer’s disease, neuropathic pain, spinal cord injury and dementia in the population with Down syndrome), infectious or metabolic diseases (such as APBD and SPG35).
Several of these diseases are classified as rare or orphan, affecting a small number of the population and therefore do not normally arouse the interest of pharmaceutical or biotechnological companies. Laminar Pharma has recognized the lack of investment in its research and develops treatments that can help patients diagnosed with a rare disease and their families.
In its objective to address these indications, Laminar Pharma has focused the development of its most advanced product, LAM561, on the treatment of glioblastoma in adult patients and pediatric cancer. Glioblastoma is the most frequent primary malignant brain tumor, even though it is a rare disease, with 25,000 new cases diagnosed in Europe each year and more than 100,000 worldwide. The prognosis of those affected is devastating, the average survival is 14.5 months despite receiving standard treatment, which has not changed in more than 15 years and involves invasive intracranial surgery followed by radiotherapy and chemotherapy with significant side effects. .
Unfortunately, even with aggressive treatments, after diagnosis, survival at two years is 15% and at five years, 5%. Laminar Pharma is getting closer every day to changing this scenario. About to complete its last phase of clinical development, the company says that LAM561 “has shown promising preliminary activity in the treatment of aggressive brain tumors such as glioblastoma.”
It has now reached the milestone of enrolling the first 45 patients in its phase II/III clinical study in newly diagnosed glioblastoma patients. This trial is being carried out in 18 hospital centers distributed in Spain, France, Italy and the United Kingdom. Although the clinical trial will continue until reaching 140 patients, its design provides for a provisional analysis when 45 progressions occur or after 12 months of follow-up of 45 patients.
This point is a remarkable milestone due to the possibility of applying for conditional marketing authorization to the European Medicines Agency (EMA) in early 2024, if the treatment shows significant clinical benefit by delaying tumor progression at that point.
Laminar Pharma also plans to apply for conditional market approval in the United States through the FDA, where a pediatric clinical study is already active. The recruitment of patients continues until reaching 140 patients and completing the study. Likewise, the clinical benefit of LAM561 will be evaluated at two more points: after 66 progressions and in a final analysis to evaluate the effect of LAM561 on the life expectancy of patients.
Laminar is defined as a team committed to improving the quality of life of patients, for which safety and comfort for the patient are essential. From its discovery in the laboratory to its pharmaceutical design: medicines are developed for oral consumption at home (capsules or powder for suspension in water) without the need for extra visits to the hospital. In addition, if the surprising safety profile shown in its studies is confirmed, it may not require close medical monitoring, allowing long-term, safe and comfortable treatments that do not limit the activities of patients.
Laminar Pharma’s commitment to pathologies with high therapeutic needs extends to other rare diseases, such as dementia in the population with Down Syndrome, APBD (adult polyglucosan body disease) and SPG35 (spastic paraplegia of type 35).In addition, Laminar Pharma has licensed two of its products to companies (Neurofix and Ability) that have advanced in their clinical development for the treatment of neuropathic pain and pancreatic cancer, respectively, and have already demonstrated high safety, with therapeutic potential, validating mellitherapy.In addition, 9% of the drugs currently under development in Spain, according to the Asebio website, have left the Laminar Pharma factory, reflecting the company’s broad portfolio for the treatment of various pathologies.
Currently, the biggest challenge that Laminar faces is foreign investment, mainly due to the world situation of social and economic instability. According to its Financial Director, David Roberto: “The current clinical trial with LAM561 consumes 95% of all the financial resources of the company and that to date have been received thanks to the more than 1,800 investors who have placed their trust in the company, competitive public subsidies (which guarantee the quality of the research) and other additional sources of financing received”.
The biotech company has achieved its biggest financial milestone in 2022 after raising more than six million euros of private financing (closing two consecutive rounds with more than three million euros) and LAM561 has obtained the Fast-Track designation for the treatment of glioblastoma by the FDA, which would speed the arrival of the product to the US market, the largest in the world.
The success of the last two years has allowed the financial needs for the LAM561 clinical study to be halved (up to the application for market approval), from 30 million euros to only 15, which the company expects to raise in the next round capital increase that will open in March or through a license agreement with a large pharmaceutical company.
Any investment will bring the product a little closer to patients. Spain is one of the main powers in the world in scientific research, being in the top 10. Unfortunately, it falls to 42nd place when it comes to innovation, that is, turning that scientific knowledge into products that can lead to an economic return. That is why more investment in biotechnological companies is necessary to transform our economic model into one in accordance with a country with such scientific capacity.
