BioInvent and its partner Transgene have reported positive results in the phase I/IIa study with the oncolytic virus BT-001. In 11 of the 18 included patients, the lesions were stabilised. In two patients, objective antitumour activity was also seen. This means that both partners can continue the evaluation as planned with the part of the study where BT-001 will be studied in combination with pembrolizumab.
Swedish biotech company BioInvent develops drug candidates to improve the effectiveness of checkpoint inhibitors and activate the immune system in patients who no longer respond to existing cancer treatments. Central to the development of the company’s candidates is the proprietary technology platform F.I.R.S.T., which is combined with the company’s antibody library n-CoDeR. Four candidates, BI-1206, BI-1808, BT-001 and BI-1607, are undergoing clinical evaluation. A fifth candidate, BI-1910, recently received IND approval and is scheduled to begin clinical development in the second half of 2023.
Success reported with BT-001
BT-001 is being developed in collaboration with Transgene using their oncolytic Invir.IO platform and BioInvent’s technology platforms n-CoDeR/F.I.R.S.T. The candidate is being evaluated in a phase I/IIa multicenter dose-escalation study and is designed to produce a combination of a Treg-eliminating human anti-CTLA-4 antibody and human GM-CSF cytokine.
BioInvent recently reported progress in the first part of the phase I/IIa study with BT-001. The phase Ia single agent part of the study has now been completed, in which 18 patients with advanced solid tumour disease with at least one accessible superficial lesion were treated in three dose groups with BT-001 as intratumoural monotherapy. Of the 18 patients, a stabilisation of the lesions was achieved in 11 patients. In addition, objective antitumour activity, defined as at least a 50 per cent reduction in the size of an injected lesion, was seen in a total of two patients. No safety issues were reported.
Evaluation in combination with pembrolizumab to follow
The result led to the independent Safety Review Committee approving the start of the combination part of the study, where BT-001 will be evaluated intratumourally together with KEYTRUDA (pembrolizumab) in several patient groups with different types of tumours. This enables the evaluation of combination therapy for other types of malignancies that are not normally treated in this way. For this phase of the study, the first patient is expected to be recruited during H2 2023.
BioInvent’s CEO Martin Welschof and Dr Alessandro Riva, Chairman of the Board of Transgene, had this to say about the results: “These data are a further positive indication of the efficacy of BT-001 against solid tumors. While the advanced disease setting of this first in human trial did not allow long-term monitoring of patients, the effect on injected lesions has the potential to translate into the induction of a systemic immune response, antitumor effect and ultimately clinical benefit in combination with pembrolizumab. There were no safety concerns and antitumor activity was observed even at the lowest dose. We are looking forward to investigating BT-001 further in combination with pembrolizumab.”
The development of drugs for the treatment of Alzheimer’s is accelerating, with a record number of clinical studies in full swing. One problem that researchers face, however, is that a shortage of patients. According to a report from the University of Nevada, there are thousands of patients missing from the currently nearly 200 clinical studies underway.
Alzheimer’s disease is a neurodegenerative disease that affects millions of people globally. “We are facing an acute global crisis regarding Alzheimer’s. There is no cure for this disease and current treatment options are inadequate,” said Maria C. Carrillo, director of research at the Alzheimer’s Association.
Several new treatments on the market
Although there is an urgent need for effective treatments, it is only recently that they have begun to appear on the market. One example is Aduhelm, which was approved by the US FDA in June 2021. Aduhelm is an antibody drug that targets amyloid-beta plaques in the brain, one of the main pathological markers of Alzheimer’s disease.
Another drug that targets the same plaque is Leqembi, developed by Eisai and Biogen under license from Swedish BioArctic. Another treatment that is on its way to the market is developed by Eli Lilly. The company recently presented positive phase III results with its Alzheimer’s candidate donanemab. Learn more.
Record number of studies
According to a report published in the journal Alzheimer’s & Dementia: Translational Research and Clinical Interventions, there are currently 187 ongoing clinical studies with drugs targeting the disease. This is the highest number recorded so far. Some examples can be found here at home in Sweden in Alzecure with its candidate ACD856 and Alzinova with ALZ-101.
A driving factor behind the growing number of studies is the pharmaceutical industry’s increased investments in the field. Of all the studies that are ongoing, about 58 per cent are currently sponsored by the pharmaceutical industry.
Studies need over 50,000 patients
Although there are a large number of drugs under development, there is also a shortage of patients who can participate in the clinical studies. According to a report from University of Nevada, Las Vegas (UNLV), at least 50,000 patients are needed to be able to conduct the current clinical studies effectively.
Recruitment for phase II and phase III studies is challenging and the average recruitment time is currently more 100 weeks. In some studies, the recruitment time may even exceed 200 weeks. The time frame for phase I studies is only slightly shorter.
According to Maria C. Carrillo, many patients are not aware of the possibility of participating in clinical studies, which contributes to the problem. Carrillo emphasises, “It is critical that patients and their families access and understand clinical trial information. Their participation is crucial for progress.”
Strict rules an obstacle
According to her, there is also a problem with strict criteria for participation in the studies. Many patients are excluded because of these criteria, leading to a decrease in potential participants. “By broadening the criteria, we can include more patients and get a more robust set of data,” Carrillo comments.
She thinks it is clear that there is an urgent need to solve the problem of patient shortage in clinical trials for Alzheimer’s and concludes:
“To find effective treatments for this devastating disease, it is critical that we engage a broad population of patients in these studies.”
Many eyes turned to WntResearch last year after the company presented unexpectedly positive observations from the phase II study NeoFox with Foxy-5. The observations have led the company to update the study plan and they have carried out a rights issue to finance the ongoing work. BioStock spoke to the company’s co-founder, Professor Tommy Andersson, about the observations and the work ahead.
The cancer therapy company WntResearch’s aim is for cancer patients to receive better treatment with the help of the drug candidate Foxy-5. The candidate is a peptide that mimics the endogenous protein WNT5A, a protein that has the ability to reduce the risk of cancer cells spreading that can then form metastases.
New observations in the phase II study
During 2022, Foxy-5 has been tested in the phase II study Neofox, which investigates its ability to reduce the risk of cancer cells spreading and thereby giving rise to metastases in patients with colon cancer. The patients in the study are diagnosed with stage II/III colon cancer and are considered to have a high risk of recurrence in the form of metastases after the primary tumour has been surgically removed.
During the summer of 2022, WntResearch announced that it had made unexpectedly positive observations in the patients treated with Foxy-5 in the study. After three weeks of treatment, the company noted a clearly reduced spread and invasion of cancer cells in the treated patients.
Right issue funds the continuation of the study
As a result of these observations, the company decided that the study would not be completed as planned and the recruitment of patients was paused. WntResearch developed an updated study plan for NeoFox, where the new observed effects are included as new endpoints.
To finance the continued study and operations, WntResearch carried out a rights issue around the turn of the year and subscription of the warrant program TO5 in April. In total, the company received approximately 24.1 MSEK and 10.6 MSEK, respectively.
Comments from WntResearch co-founder
BioStock talked to Professor Tommy Andersson, co-founder of WntResearch, about the new observations and the way forward.
Tommy Andersson, co-founder WntResearch
To begin with, Foxy-5 aims to prevent the onset of metastases in cancer patients. Why is that important?
– Metastases are the main cause of cancer deaths. About 90 per cent of all deaths caused by solid tumours are due to metastases that have spread to organs in the body other than the organ where the tumour originally arose. The five-year survival rate in patients with non-metastatic disease (stage II/III) is approximately 71 per cent, while the five-year survival rate in patients with manifest metastasis (stage IV) is only 14 per cent.
In the first stage, you target colon cancer. How do you treat this type of cancer today and how is Foxy-5 supposed to help?
– The primary target group for Foxy-5 is high-risk patients with stage II/III colon cancer. At present, they are treated with surgery and in most cases with a subsequent chemotherapy called FOLFOX, a protocol that has been standard treatment for 15 years. Today, there are few new drugs under development for this patient group.
– Since Foxy-5 has shown a good safety profile with few treatment-related side effects in the patients treated, the idea is that our drug candidate can be combined with the established treatment given to the patient.
The observations that you communicated regarding Foxy-5 last summer, can you tell us a little more about them?
– Being able to see the same effect as we have seen in our preclinical studies, now in our phase II study so early, i.e., already after the patient received Foxy-5 before surgery, was very surprising. The observations are fully consistent with our in vitro and in vivo studies. We could already see that the cells’ adhesion capacity increased, which means that they did not have the same ability to spread and give rise to distant metastases.
– Therefore, it is very exciting to follow up the observations made in a larger population, where the new endpoints will be studied and hopefully further confirm our preclinical studies.
What new conclusions have you been able to draw about Foxy-5 after the new discoveries?
– Our conclusion is that Foxy-5 reaches the tumour and that it very quickly inhibits the ability of cancer cells to spread and thus their ability to metastasize.
– However, it should be emphasised that it is too early to draw any conclusions and therefore we have taken the decision to revise the study plan in our ongoing study to include new endpoints and change the treatment time to focus on and confirm the observations made.
What does the new study plan look like and how does the timetable change?
– The study will focus on the early effects of Foxy-5, up until surgery. The treatment with Foxy-5 will therefore be adjusted and only take place during the three weeks before surgery. Any further treatment with Foxy-5 after surgery will no longer be relevant, as the focus will now be on confirming the effects of Foxy-5 we observed on the primary tumour and surrounding lymph nodes until surgery.
– This will be done by the patients undergoing computed tomography, both before and after treatment with Foxy-5, and by microscopic examination of surgically removed primary tumours and lymph nodes.
Do you conduct any other development work in addition to the ongoing study?
– Yes, I lead a research group that conducts continued preclinical research regarding new knowledge about Foxy-5’s properties and mechanisms of action. The goal of this research is to use new knowledge to optimise how Foxy-5 is used in the treatment of cancer patients, and not only for patients with stage II/III colon cancer.
What are your best arguments for investing in WntResearch?
– It is primarily WntResearch’s work to develop a new therapy focusing on the great need for a new treatment that reduces the risk of recurrence after a successful surgical removal of the primary tumour and gives the patients a longer cancer-free survival.
– If WntResearch, through its clinical trial of Foxy-5, can show effects that counteract the early spread of cancer cells, I think we can make a real difference. In addition, various research groups have shown that the conditions exist for also treating several other cancers with Foxy-5.
Mesothelioma is a rare but aggressive form of cancer with limited treatment options. Norwegian biotech Ultimovacs is addressing the need for new therapies with its universal cancer vaccine UV1. BioStock got in touch with the Director Medical Affairs at Ultimovacs, Espen Basmo Ellingsen, to learn more about the overall burden caused by this disease as well as the phase II trial NIPU evaluating UV1 in combination with standard of care.
Asbestos is a naturally-occurring mineral known for its heat-trapping and anti-corrosive properties. During the 19th century and much of the 20th century, asbestos was commonly used as an insulating material for construction purposes, as well as other industrial applications.
The toxic, carcinogenic properties of asbestos were discovered and studied in the early 1900s when researchers noticed a large number of early deaths and lung problems in asbestos-mining towns. However, it was not until the latter part of the century that many governments, including those in the US and the EU, instituted severe restrictions and even total bans on the use of asbestos.
Despite those bans, the average latency period for the development of any health issues related to asbestos exposure is around 40 years. This translates to an elevated risk of health complications for past and current blue-collar workers who have come in direct contact with asbestos. Those within the construction industry are mostly affected, but so are civil service workers, firefighters in particular.
Mesothelioma – a deadly disease
One of the leading causes of death from asbestos exposure is mesothelioma, an aggressive form of cancer that develops in the lining of internal organs. The most common type of mesothelioma is malignant pleural mesothelioma (MPM), which affects the thin layer of tissue that surrounds the lungs and the inside of the chest. The disease often leads to a life expectancy of less than one year after diagnosis, and 5-year survival is 12 per cent.
MPM is so aggressive that it is usually diagnosed in the late stages, making treatment extremely challenging. By then, surgery is possible, but it is usually accompanied by chemotherapy. And as of 2020 in the US and 2021 in Europe, immune checkpoint inhibitors like nivolumab and ipilimumab have also become first-line treatments.
However, even if these therapies can make the cancer retreat at first, recurrence is highly likely. Upon relapse, the disease becomes more resistant to treatment, escaping the defences of the immune system, therefore reducing survival chances even further. Unfortunately, as of today, there is no standard treatment protocol for relapsed malignant mesothelioma, meaning that there is a significant medical gap to fill.
Ultimovacs’ cancer vaccine
Striving to fill this gap is Ultimovacs. The Nordic biotech is developing UV1, a universal cancer vaccine aimed at boosting a patient’s immune system enough to put the brakes on cancer. The company has five ongoing phase II clinical trials evaluating UV1 within different cancer indications – the NIPU trial is the one focused on mesothelioma.
The trial evaluates UV1 as a second-line treatment in combination with both checkpoint inhibitors nivolumab and ipilimumab. The research done with UV1 so far suggests that the therapeutic vaccine is able to work together with the immune checkpoints to unleash the full power of the immune system to attack cancer if it were to relapse.
An initial readout from the study is expected in the coming weeks. The results, if positive, will be proof-of-concept for UV1 in this indication, and a major step forward in the development of the vaccine.
A conversation with Ultimovacs’ DMA
BioStock reached out to Ultimovacs’ Director Medical Affairs Espen Basmo Ellingsen to discuss the challenges related to mesothelioma and how to treat it, as well as expectations for the NIPU trial.
Espen Basmo Ellingsen, Director Medical Affairs at Ultimovacs
Espen, why is mesothelioma such a difficult disease to treat?
– Mesothelioma is a rare and aggressive disease characterized by irregular growth of the mesothelial cells, which form the protective lining of internal organs. The early symptoms of mesothelioma can be similar to those of less severe respiratory conditions. Mesothelioma, therefore, often goes undiagnosed in its early stages, and by the time a definitive diagnosis occurs, the cancer is typically more advanced, resulting in fewer therapeutic options and an established tumor biology that is harder to treat. Mesothelioma has shown to harbor genetic and molecular characteristics that make the cancer cells less susceptible to conventional treatments. For immunotherapies specifically, the tumors may hold certain immunosuppressive features that counteract the spontaneous anti-tumor immune responses.
What is the difference between first-line and second-line treatment in cancer therapy?
– Treatment lines refer to the order treatments are given as a tumor progresses or recurs. For advanced cancers, first-line treatment refers to the initial treatment alternative a patient receives after diagnosis, whereas second-line treatment refers to the treatment alternative the patient receives after the disease progresses on first-line treatment. Each successive treatment line is initiated when the previous treatment is no longer effective or the disease has shown resistance to it. The goal of the different treatment lines is to provide additional therapeutic options to control the disease and extend survival. However, generally, the later the treatment line, the less response to therapy is expected.
Why isn’t UV1 being evaluated as a first-line treatment?
– The NIPU trial evaluates UV1 in combination with nivolumab and ipilimumab as second-line therapy. At the time the trial was initiated, there were no approved immunotherapies for malignant pleural mesothelioma. It is common to evaluate experimental treatments in later treatment lines, when standard treatment options have been exhausted. However, with the recent approval of the checkpoint inhibitors nivolumab and ipilimumab as first-line therapy, positive results from the NIPU trial may facilitate further development of UV1 in the first-line setting.
Why is NIPU looking at UV1 in a triple combination with both nivolumab and ipilimumab, and not in combination with chemotherapy or even on its own?
– Nivolumab and ipiliumab represent drugs that are classified as immune checkpoint inhibitors. Physiologically, the immunological checkpoints are the body’s way of containing T cell responses within a desired range, maintaining a balance between attacking harmful invaders and avoiding unnecessary damage to healthy cells. During the development of cancer, however, tumors exploit these checkpoint molecules to evade an attack from the patient’s T cells. When a patient receives a checkpoint inhibitor, naturally occuring T cells targeting the tumors can be released from these contraints, leading to cancer cell killing. Although many patients experience durable responses to checkpoint inhibition, unfortunately, most patients progress due to an insufficient natural immunity against the tumors.
– Therapeutic vaccination with UV1 induces T cell responses that aim to strengthen the overall anti-tumor immune response. The combination of UV1 and the checkpoint inhibitors is based on a scientific rationale that releasing the immune cells from these immune checkpoints will result in stronger immune responses after vaccination, and that these immune cells will more effectively kill cancer cells. Although both being checkpoint inhibitors, the two drugs differ in the immune checkpoint molecule they block. Ipilimumab blocks CTLA-4, whereas nivolumab blocks PD-1. Blocking CTLA-4 is expected to strengthen the immune response after vaccination, whereas blocking PD-1 is expected to reduce the tumors ability to resist the induced immune response. With the characteristic features of mesothelioma, we believe the triple combination may be necessary to overcome the immunosuppressive tumor microenvironment and provide tangible cancer cell killing.
When can we expect top-line results from NIPU?
– Topline results from the NIPU trial is expected to occur this month of June, so rather soon.
If the study brings positive results, what will it mean for UV1 and the future development,especially considering that mesothelioma is considered a rare disease?
– If the NIPU trial reads positive:
– it will prove the overall concept of UV1 as a telomerase targeted vaccine works when added to CPIs, and increases the probability of success in the other indications
– further development plans will be discussed with the regulatory authorities to ensure the most effective and speedy way forward. This also includes filing for breakthrough/fast track designation, and orphan drug designation
– it will definitely trigger further support for bringing UV1 to mesothelioma patients, a population with a true unmet medical need.
– The imminent read-out of the NIPU trial represents the first-ever randomized data package on the UV1 vaccine. Following closely are the read-outs of the randomized INITIUM trial in melanoma (H2 2023) and the randomized FOCUS trial in head and neck cancer (H1 2024). The DOVACC and LUNGVACC trials are expected to complete later in 2024 and 2025, respectively. The outcomes of all these trials will guide the broader development of UV1.
BrainCool has entered into a distribution agreement with US-based ZOLL, one of the world’s largest manufacturers and distributors of medical devices. The agreement covers the company’s IQool System for the treatment of neurological fever. BrainCool’s CEO Martin Waleij visited BioStock’s studio to talk about the deal, worth more than SEK 100 million.
Watch Martin Waleij present BrainCool and talk about the agreement with ZOLL below (in Swedish).
With an impressive 300 per cent increase in sales in the first quarter, Invent Medic continues its upward trend. The company aims to maintain a high pace and recently signed framework agreements with five new regions regarding Efemia Bladder Support. CEO Anna Lindström says that the agreement clearly shows the appreciation that exists for the product.
Lund-based Invent Medic is a medical technology company that specialises in the development of innovative products in women’s health. The first product in the portfolio, Efemia Bladder Support, is an effective aid for women suffering from stress urinary incontinence. Efemia has been developed to give women the possibility of an active and carefree life by reducing or completely eliminating the symptoms of incontinence.
Invent Medic reported robust growth of 300 per cent in the first quarter, a success that can be attributed to a combination of the recently acquired FlowCup and the continued strong performance from Efemia Bladder Support. You can read more about the good development during Q1 here.
Framework agreements signed with five new regions
Even though the sales successes have been significant, Invent Medic sees no reason to slow down. The company recently announced that it had signed framework agreements with five new regions for Efemia – Dalarna, Sörmland, Uppsala, Västmanland and Örebro, also known as ‘femklövern’, (Eng: five-leaf clover). The agreement, which follows the completion of the public procurement, will effectively start in January 2024 and extend over a total contract period of a maximum of three years.
Following this agreement, Efemia Bladder Support will be available for prescription in 16 of Sweden’s 21 healthcare regions. The company sees it as an important step towards the long-term ambition to sign agreements with all Swedish regions.
“Five new regions at once, that’s a big one! We have worked methodically both before and during the procurement. The fact that we are now signing an agreement proves that our offer is attractive for healthcare. The work continues in these and other procured regions to train prescribers and healthcare professionals. Those who meet patients needs to feel safe with Efemia Bladder Support”, says Invent Medic’s CEO Anna Lindström in a comment to BioStock.
She emphasises that the framework agreement with ‘femklövern’ clearly shows that Efemia Bladder Support is a product that the healthcare system appreciates and wants to offer to women so that they can manage their stress urinary incontinence in a simple and smooth way.
Expects continued growth
According to Anna Lindström, the good sales development is not a coincidence, but the result of hard work and a committed team. At the same time, the positive response from customers has given the company a solid foundation to stand on. The expectation is that sales will continue to increase as the company is able to reach more potential customers.
Spago Nanomedical recently submitted the application to start the phase I/IIa study with Tumorad in Australia. Spago’s Chief Development Officer Paul Hargreaves visited BioStock’s studio to talk about the new radionuclide therapy and the upcoming study.
Watch the interview with Spago Nanomedical’s CDO Paul Hargreaves in the link below.
Learn more about Spago Nanomedical on the company’s website.
Biopharma company Xintela develops stem cell products with therapeutic properties aiming to treat diseases that currently lack effective treatment options. The company´s stem cells stand out from others through a selection step in the production process that provides quality-assured, homogenous and pure stem cell preparations. BioStock talked to Lucienne Vonk, Director Musculoskeletal Diseases at Xintela, about the benefits of the company’s stem cell products.
Biopharma company Xintela develops the stem cell products XSTEM, for the treatment of osteoarthritis and difficult-to-heal leg ulcers in humans, and EQSTEM for the treatment of joint diseases in horses.
The company’s research and development are based on the cell surface marker integrin α10β1, which was discovered in the 90s by Xintela’s CEO Evy Lundgren-Åkerlund and her research group at Lund University.
Mesenchymal stem cells with therapeutic properties
Xintela’s stem cell products consist of mesenchymal stem cells (MSCs), a type of multipotent cell that can differentiate into a variety of cell types, such as cartilage cells.
Stem cells have the capacity to regenerate damaged tissues and organs, and stimulate cells in damaged tissue to repair the damage. MSCs can also signal immune cells and have anti-inflammatory effects.
Stem cells from adult donors
Xintela develops stem cell-based treatments from donors (allogeneic) stem cells from donated adipose tissue from healthy adults. Stem cells from one donor can be used to treat many patients, which is more cost-effective than using the patient’s own stem cells.
Pure stem cell preparations by selection
However, stem cell preparations from tissues are often heterogeneous, meaning they are contaminated with other cell types. In addition, stem cell preparations may differ from donor to donor. This can create both regulatory and functional problems.
Xintela’s solution is to purify stem cells using an antibody that binds the company’s stem cell marker, integrin α10β1. The selection means that Xintela receives pure and homogeneous stem cell preparations of high quality that are reproducible between donors.
Focus on knee osteoarthritis and difficult-to-heal leg ulcers
Xintela is conducting two clinical studies with XSTEM; one in patients with knee osteoarthritis and the other for difficult-to-heal leg ulcers. The patient recruitment is ongoing in the phase I/IIa leg ulcer study and the third and last dose level has started in the phase I/IIa osteoarthritis study. The goal is to present safety and preliminary efficacy data from both studies in 2023.
Osteoarthritis is a joint disease associated with the breakdown of cartilage, severe pain and impaired mobility. Standard treatment typically involves relieving the symptoms and as a final option replacing the degenerated osteoarthritis joint with a prosthesis.
Xintela expect that the stem cell product XSTEM will lead to reduced pain and improvement the of the joint function. Previous results from the company’s preclinical studies also suggest that XSTEM is a disease-modifying treatment that can regenerate damaged articular cartilage. Learn more.
Xintela’s Director Musculoskeletal Diseases comments
Lucienne Vonk, Director Musculoskeletal Diseases, Xintela
BioStock contacted Lucienne Vonk, Director Musculoskeletal Diseases at Xintela, to find out more about the benefits of Xintela’s stem cell technology and the competition in the field.
First, could you give us a more detailed explanation of how Xintela’s selection of stem cells is conducted?
– For the selection of the stem cells, we use magnetic beads that are coated with an antibody that binds the company’s stem cell marker, integrin α10β1. The stem cells have integrin α10β1, like a flag, on their cell surface. The magnetic beads will bind to these flags and then, by using a magnet, we can select the stem cells from other cells that do not have the marker on the surface and are thus washed away. After this step, the selected homogenous stem cells population is further expanded in bioreactors to generate the stem cell product XSTEM.
What are the main benefits of the selection technology?
– The main benefit is that the selection generates a homogenous and high-quality stem cell product that can meet the regulatory requirements of identity, purity and potency and that is very consistent between different donors.
– A stem cell preparation without stem cell selection is heterogenous and contains more or less contaminating cells, such as epithelial cells, endothelial cells and fibroblasts. These contaminating cells can have a negative impact on the safety and the therapeutic effects of the stem cell preparation. In addition, since the number of contaminating cells varies between each preparation, it is difficult to give the product a clear identity and to control the therapeutical effect.
– With our selection technology, we can control the stem cell preparations and ensure quality and therapeutic effect of the products. In addition to our selection technology, we also manufacture our cell product in our own GMP-certified facility. Together, these allow us to maintain full control over both the production process and the final cell product.
»With our selection technology, we can control the stem cell preparations and ensure quality and therapeutic effect of the products. In addition to our selection technology, we also manufacture our cell product in our own GMP-certified facility. Together, these allow us to maintain full control over both the production process and the final cell product.«
Why are you using donor (allogeneic) stem cells instead of autologous and/or genetically modified stem cells?
– There are several advantages of using allogeneic instead of autologous stem cells. First of all, it is only possible to offer a true single-stage, off-the-shelf, stem cell therapy with allogeneic cells. For autologous stem cells, patients first need to undergo a primary procedure to harvest tissue (such as adipose or bone marrow) from which the stem cells can be isolated, and culture expanded. Using allogeneic cells also omits a procedure at another (not the affected) location in the body, that could lead to damage at the harvest location such as an infection (donor site morbidity).
– Furthermore, since allogenic stem cells, like XSTEM, can be stored in the freezer in the clinic the patients can be directly treated and start their rehabilitation without going through the procedure to collect the autologous tissue and culture of the cells. Another advantage of using allogeneic cells is the reduced treatment cost per patient as several thousands of patients can be treated with stem cells from one donor. In addition, donors and cells with the highest quality and therapeutic effects can be selected.
»Furthermore, since allogenic stem cells, like XSTEM, can be stored in the freezer in the clinic the patients can be directly treated and start their rehabilitation without going through the procedure to collect the autologous tissue and culture of the cells. Another advantage of using allogeneic cells is the reduced treatment cost per patient as several thousands of patients can be treated with stem cells from one donor.«
– The advantages of allogeneic mesenchymal stem cells over genetically modified stem cells are that the risk of genetic instability is very low as clinically relevant numbers of cells can be reached with a relatively short cell culture expansion, while genetically modified stem cells are usually exhaustively expanded. Further, allogeneic tissue derived stem cells can also home to the site of damage and differentiate into several cell types and act immunomodulatory and anti-inflammatory. So, they have the potential to treat a wide range of diseases without the need for pre-differentiation, while genetically modified stem cells need to be fully differentiated before administration into the body, as they can otherwise form teratoma (tumors that contain different types of tissue).
– So far, tissue derived mesenchymal stem cells such as stem cells from adipose tissue, are the most used type of stem cell in clinical studies and therefore they are already extensively tested for safety.
Are other stem cell companies using a similar technology as Xintela?
– There are several companies working on allogeneic stem cell-based treatments for osteoarthritis. For example Stempeucel (Stempeutics, India) is undergoing phase III studies, CYP-004 (Cynata, Australia) which is in phase III studies, AlloJoin (CBMG, China) which is in phase II and Progenza (Regeneus, Australia) which is in phase II. Furthermore, Cartistem, which is developed by Medipost, has market approval in South Korea. However, none of these companies use a cell-selection in their production process.
There are already clinics that use mesenchymal stem cells from adipose tissue for the treatment of osteoarthritis. In what way is Xintela’s stem cell treatment different to these?
– There are clinics that use minimally manipulated tissue products, but those are not mesenchymal stem cell products. The minimally manipulated tissues are for instance bone marrow, concentrated bone marrow, or the stromal vascular fraction of adipose tissue. Only a very small percentage of the cells in these products are mesenchymal stem cells (0.001% to 0.01% in bone marrow and bone marrow concentrate, 1% to 4% in the stromal vascular fraction of adipose tissue). Thus these products should not be called “stem cells”. Especially in the USA, the Food and Drug Administration (FDA) is very strict with this terminology.
»There are clinics that use minimally manipulated tissue products, but those are not mesenchymal stem cell products. The minimally manipulated tissues are for instance bone marrow, concentrated bone marrow, or the stromal vascular fraction of adipose tissue. Only a very small percentage of the cells in these products are mesenchymal stem cells«
– Also, these minimally manipulated tissue products are less strictly regulated, but only if they are intended for homologous use, meaning to perform the same basic function as they did before administration. These products are not considered drug products and therefore no safety and efficacy studies or quality tests are required, they cannot be marketed and sold as medicinal product, and thus they are usually not covered by healthcare insurance. Xintela´s stem cell products are regulated as advanced therapy medicinal product (ATMP). ATMPs are required to possess proven safety and efficacy, each product is quality tested and they can be covered by healthcare insurance and thereby become available for everybody.
The BioStock Life Science Spring Summit gets underway today, May 30 at 10 a.m. Over the next two days, more than 25 life science companies will present their innovations digitally. Additionally, industry experts from Vator Securities and Novo Nordisk will offer their insights on business development and investments.
BioStock Life Science Spring Summit is one of the Nordic region’s most important platforms for private and listed innovation companies to present their projects to both Swedish and international investors, industry colleagues and potential partners.
Industry experts from Novo Nordisk and Vator securities will also share their thoughts on the steps smaller companies should take before and after an acquisition. The conversations will also touch upon raising capital in the current bear market.
During the packed two-day programme, which can be easily and conveniently followed via this link, the Summit will showcase the great breadth and level of innovation that the Nordic life science sector has to offer.
Expert Insights: Big Pharma’s perspective on M&A and integration
Anna Gran, Associate Director Corporate Integration at Novo Nordisk, gives her view on how a smaller company should prepare for acquisitions and for a life after the agreement is in place.
11.00am,Tuesday30May.
Expert Insights: Strategies forraising capital inabearmarket
As Emplicure reports the first quarter of 2023, it is fully focused on the launch of the new tobacco-free nicotine product småå. The company has also carried out a directed share issue of 25 MSEK, gaining a new majority shareholder. BioStock contacted CEO Håkan Engqvist to find out more about his view on the latest developments and the near future.
Emplicure’s development is based on a patented bioceramic platform technology. The bioceramic materials are then combined with approved substances to create new and improved products. The business is divided into two subsidiaries. Emplipharm is currently developing drug formulations for the treatment of chronic pain. The other subsidiary, Amplicon, uses the platform to develop nicotine products aimed at the consumer market.
Amplicon launches småå
Right now, Amplicon is in an exciting phase, as it recently launched småå, the company’s first product on the Swedish market. Småå is a small nicotine pouch that, according to the company, offers a longer taste and nicotine experience for the user compared to other nicotine products.
The product is currently being launched in selected stores and online. To start with, focus is on taking in feedback to further refine the concept. Amplicon’s CEO Tomas Hammargren recently visited BioStock’s studio to tell us more about the launch.
Emplicure continues to work with drug formulation
While the commercialisation of småå is ongoing, the work within Emplipharm continues. After this winter’s results in the exploratory PK study with a candidate formulation, Emplipharm has continued working on the formulation. In the study, the long-term release of the active substance proved to be stable, and the aim is now to strengthen the initial release.
During the quarter, the company also initiated a collaboration with Swedish OnDosis. The two companies will jointly evaluate new solutions for oral delivery of active ingredient.
New majority shareholder in Emplicure strengthens finances
During the first quarter, cash flow in the company amounted to -6 MSEK and at the end of the period the cash position was 7.2 MSEK. During the quarter, the Board of Directors decided to request that the entire loan of 9.8 MSEK raised at the end of 2022 be converted into new shares in the company. In addition, the Annual General Meeting on May 2 gave the Board the green light to carry out further capital raising to strengthen the financial position of the company.
On May 24, a rights issue of 25 MSEK was announced, directed at the investment company TomEQT Private. The issue was carried out at a subscription price of 0.5 SEK per share, which according to the company exceeds the volume-weighted average price in the share between 9 and 23 May. The issue means that TomEQT Private will gain an ownership stake of 50.6 per cent of the total number of shares and votes in the company.
Comments from the CEO
To find out more about everything that is happening in the company right now, BioStock contacted Emplicure’s CEO Håkan Engqvist.
Håkan Engqvist, CEO Emplicure.
You are in the middle of launching småå. What feedback have you received from customers so far?
– Customers say that the taste and nicotine experience is strong and long-lasting even though the pouch size is small.
What are the plans for a broader rollout of the product?
– We continue to work on finding licensing and distribution partners for a broader launch of our technology. We will continue to sell through e-commerce and selected stores.
In your communication, you see small å as an important alternative to smoking, while your product itself may be more like snus. How do you view småå in relation to snus?
– Småå is a tobacco-free product and the formulation is not similar to traditional tobacco snus.
What types of active ingredients can be used to create products in collaboration with OnDosis?
– The collaboration is still in an early technological phase, and we have not focused on specific active ingredients yet. The choice of active ingredient and indication will be discussed later, provided that we together reach set milestones.
Finally, you get a new majority shareholder in the company in TomEQT. What’s your take on that?
– It’s great and important that we have a new major owner and new financing in the company. This allows us to look further ahead and implement our business plan with greater vigour.
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