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CombiGene’s new COO wants to be involved in building a large gene therapy company

CombiGene

Peter Ekolind, previously Nordic Manager at Getinge Group, is the new Chief Operating Officer of gene therapy company CombiGene. BioStock contacted Ekolind to learn about his ambitions for the company, as well as how he views a potential broadening of the company’s portfolio.

CombiGene’s drug candidate CG01 is being developed as a new treatment for drug-resistant focal epilepsy, a disease that affects approximately 47,000 patients annually in the US, EU4, UK, Japan and China. Today’s treatment options are limited to relieving symptoms without addressing the root causes of the disease, and they require lifelong administration. CG01, on the other hand, aims to cure the disease after only one or a couple treatment sessions.

In 2021, and after a series of convincing preclinical data, CombiGene was able to sign an agreement with US gene therapy company Spark Therapeutics that gives Spark an exclusive global license to develop, manufacture and commercialise CG01.  CombiGene is eligible to receive up to 328.5 million USD excluding royalties, with 8.5 million USD upon signing, up to 50 million USD at preclinical and clinical milestones.

CombiGene’s new COO comments

Peter Ekolind, COO CombiGene
Peter Ekolind, COO CombiGene

This week, Peter Ekolind took up the part-time role of Chief Operating Officer at CombiGene, with responsibility for the company’s operational activities. BioStock contacted him to find out more about his background, why he chose to join the company and what his goals are going forward.

Peter, can you talk about your professional experiences?

– I have worked within the life science sector for most of my professional life. For the first 15 years, I was active in the pharmaceutical industry in Sweden and Norway, mainly within sales, marketing and management. In 2001, I switched to medtech when I became CEO and Nordic Manager of Getinge Sverige AB. Under my leadership, Getinge Sweden doubled its turnover from 100 million SEK to just over 200 million SEK when I left the company in 2008.  Since then, I have worked as CEO in smaller entrepreneurial companies such as Airsonett and the start-up company Avidicare. In recent years, I have worked as COO at Xintela on a consulting basis.

Recently, you were appointed acting CEO of oncology company Targinta as a part-time assignment. How do you combine these operational roles?

– I don’t see any problem with this. Both companies are active in biological drug development. The assignment at Targinta is also an interim assignment until a permanent CEO is recruited, and at CombiGene the assignment is to strengthen the operational management capacity of the company. Presently, we believe that part-time assignments in both companies are sufficient.

What made you interested in the role as COO of CombiGene?

– More recently, I have become increasingly focused on companies that are active in cell therapy and genetic engineering. Xintela focuses on stem cells and targeted cancer therapy, while Combigene invests in gene therapy, which today is an expansive and dynamic area. I believe that there is a huge opportunity in treating severe, painful and currently incurable diseases by “helping” the body along the way, with, for example, gene therapy. CombiGene’s business model is interesting, and, through the agreement with Spark Therapeutics for the epilepsy project, the company shows that it has a well-developed ability to sign agreements with Big Pharma companies. When CombiGene started looking for a COO, I became interested in the challenge and applied for the job.

Based on your experience, how do working methods and structures differ between larger global pharmaceutical companies compared to smaller and perhaps more agile biotech companies such as CombiGene?

– In many ways, of course. Resources in terms of staff and budget is an obvious difference, but the size of the global pharmaceutical companies also leads to development taking time, sometimes a very long time. What CombiGene lacks in resources can, to some extent, be compensated for by speed in decision-making and pace of development, which also applies to decisions on issues such as in-licensing of new projects.

CombiGene’s current business focus is to expand and inlicense additional gene therapy projects. How do you look upon the significance of this process?

– It is central to the company. The business model is based on CombiGene being able to identify and attract new gene therapy projects at an early stage where there is a commercial business opportunity. To succeed in this, a competent and active team is required. I’ve already gotten to know the team and look forward to working with them.

Looking ahead, in what ways do you want to be involved in developing CombiGene’s operations in a couple of years’ time?

– In a few years’ time, I envision that there is a larger and broader portfolio of gene therapy projects in the company. With more projects comes the need for an increasingly larger organisation and, with my background, I will be able to contribute to the development of the company. A continued recruitment of the right skills will be crucial for the company’s future development.

Medical advancements provide hope for long covid

Långtidscovid

Long covid is an undertreated condition, largely due to its complex nature and current knowledge gaps around it. In this article, BioStock takes a closer look at the mainstream treatment regimens for the condition as well as new medical innovations being developed by biotech companies aimed at improving both diagnostics and treatment for the many sufferers.

It is estimated that approximately 200 million people worldwide are affected by long covid, which means that we may be facing the next global health crisis. Because symptoms are complex, and because of large individual variations, many aspects of the condition are still shrouded in obscurity. Thanks to the ongoing research, new knowledge about long covid is gradually being added. This in turn increases the chance of developing better treatments for those affected, who today testify to inadequate care.

Read an introductory article on long covid here.

Undertreated and complex patient group

Patients with long covid are usually multisymptomatic, with fluctuating symptoms of often non-specific nature, which complicates diagnosis. Since the underlying causes of the condition are not fully understood, treatment of this patient group is also difficult.

The lack of medical care has been felt by the patients, who have experienced both mistrust and incorrect treatment. In Sweden, the possibility of quality care is further impaired by the lack of specialist clinics in large parts of the country. In specialised clinics, patients are treated by multidisciplinary teams, which experts believe is the best approach in the case of long covid given the complexity of the condition. The lack of specialised care thus leads to large differences in the treatment of the patients, hindering further research into the condition itself and possible treatment alternatives.

Today’s treatments

The treatments given to long covid patients depend on the symptoms exhibited by the individual patient. Physiotherapy interventions can be given such as breathing exercises, strategies for prolonged fatigue, adapted training for POTS (Postural Orthostathic Tachycardia Syndrome) or cardiovascular impact. There are not yet any pharmacologic treatments approved for long covid. However, some symptoms are treated with already existing drugs, for example immunosuppressive drugs, antihistamines such as famotidine, or heart rhythm stabilising medication such as propranolol or ivabradine.

Medical advancements provide hope

Both diagnosis and treatment of long covid thus have obvious shortcomings – but there is hope. At the end of August, this year, exciting news came about the American diagnostic company IncellDx having received CE-IVD marking in Europe for its diagnostic test incellKINE. The company has identified a distinct immunological profile relating to patterns of inflammatory marker expression specific to long covid, so the test is able distinguish long covid from other conditions with a number of similarities, such as ME/CFS (chronic fatigue syndrome).

The CE-IVD marking means the test is expected to be launched in September 2022 and is an important step forward for the large patient group.

A solution to fatigue?

In addition, there are a handful of companies that conduct research into potential treatments for long covid. One of these is American Axcella Health, which is investigating the effect of the candidate AXA1125 in a phase II study on the most common symptom of long covid – fatigue. The candidate is an active blend of five specific amino acids and derivatives whose mechanism of action is to restore mitochondrial dysfunction – a potential key mechanism in fatigue.

Recent phase IIa results, however, showed that the company did not reach the primary endpoint of phosphocreatine recovery rate following exercise – which is used as a measure of mitochondrial function. Still, secondary endpoints relating to mental and physical fatigue were reached. In addition to these results, previous studies that indicated a positive effect on fatty acid oxidation, inflammation and cellular energy, give the company good hopes for the candidate as a treatment for long covid. Axcella Health is currently in discussions with the MHRA regarding a registration-based study and plans to initiate regulatory talks with the FDA shortly.

ME/CFS drugs appear promising

Another US biotech with a different strategy for long covid is AIM Immunotech. The company is developing Ampligen, a drug that has received regulatory approval in Argentina for the treatment of ME/CFS. This makes the candidate the world’s first approved drug for the recognised difficult-to-treat disease. Ampligen works by modulating the immune system and has demonstrated antiviral activity.

In October 2020, AIM chose to include patients with long covid who experience fatigue in addition to patients with ME/CFS in its phase III study with Ampligen. This summer, the company announced positive interim data from the study, which demonstrated a statistically significant improvement in fatigue in all four patients with long covid. The company is now working on submitting an Investigational New Drug (IND) application to the FDA for a randomised phase II study with Ampligen exclusively for the treatment of long covid.

It remains to be seen whether these companies – or any others that might step into the field – will be able to offer a treatment for long covid. One thing is certain – many patients are anxiously waiting.

Long covid – next global public health crisis?

Långtidscovid

Almost three years into the Covid-19 pandemic, the immediate threat of death from the disease has dropped significantly. Now, healthcare faces another problem: long covid. The condition is estimated to affect 10–30 per cent of those infected by Covid-19, and the symptoms are numerous and complex. Additionally, existing gaps in knowledge make both diagnosis and treatment difficult. In this article, BioStock reviews the current knowledge regarding symptoms and underlying causes of long covid. Tomorrow we will take a look at current treatment options and companies that are active in the field.

There is no doubt that Covid-19 has affected us in ways we have not experienced in the recent past, both on a societal and an individual level. In addition to the direct threat on our lives posed by SARS-CoV-2, it has become clear that through the consequences of long-term symptoms, another type of medical challenge has arisen. The condition, clinically named Post-Acute Sequelae of Covid-19 (PASC) and commonly known as post covid syndrome, or long covid, can be anything from mild to severely disabling. With approximately 200 million people affected worldwide, experts believe we are on the brink of the next global public health crisis.

What is long covid?

When patients previously treated for Covid-19 returned with persistent or new-onset symptoms, the medical community began to suspect that the effects of the virus extend beyond the acute phase. But what do we actually know about long covid today?

Over time, several definitions have emerged, and there is still no real consensus. However, most agree that the condition involves symptoms developed during or after an infection compatible with Covid-19, which must have lasted for more than three months and cannot be explained by an alternative diagnosis. Thus, long covid is an umbrella term – and much is still unclear. Questions remain not least about whether everyone with long covid has been affected by the same disease, or whether it actually is several different conditions with different biological causes. In addition, symptoms are alarmingly consistent with another, very complicated condition that often debuts after a viral illness – ME/CFS, or chronic fatigue syndrome, which has grim consequences for those affected.

Long covid is further complicated by the fact that it manifests itself differently in different people, and symptoms often arise from several organ systems. In total, some 200 symptoms have been linked to the condition. But even if symptoms are numerous, some are more common than others, including:

  • Fatigue (excessive physical and mental tiredness that doesn’t resolve significantly with rest)
  • Shortness of breath
  • Cognitive dysfunction (eg, brain fog, memory problems)
  • Headache/migraine
  • Dysautonomia/POTS (postural orthostatic tachycardia syndrome)
  • Palpitations, high resting heart rate, chest pain (often included in the above-mentioned syndrome)
  • Loss or change of smell and taste

What is consistent is the fact that many patients clearly deteriorate after mental or physical exertion. In addition, the symptoms seem to fluctuate over time, and may disappear for periods only to later return.

Who is affected by long covid?

Studies show that between 10 and 30 per cent of those infected develop symptoms of long covid. Severe Covid-19 means a higher risk of prolonged symptoms, but the same type of symptoms and complications are found in people who have undergone Covid-19 with a mild illness.

It is also known that women are affected to a greater extent than men. In addition, it has been seen in several countries that long covid also affects children and young people – this despite the fact that the group has been relatively spared from Covid-19. Still, more knowledge is needed about possible differences in clinical characteristics between younger and older people.

Underlying causes

Despite everything, progress has been made and research has now begun to call on the biological explanations for long covid. Leading theories include, in no particular order: (i) consequences of organ damage caused by the virus in the acute stage, (ii) residual virus and viral antigen with consequent overactivation of the immune system, including inflammation, autoimmunity, and disruption of the microbiome. Abnormal blood markers in terms of inflammatory response have been demonstrated in patients with long covid, as well as autoimmune components that appear to be characteristic of the condition.

Another leading theory is (iii) mitochondrial dysfunction, which is believed to play a major role in long covid. Mitochondria are the cells’ powerhouses, converting energy from the food we ingest into energy necessary for our cells to function properly. Mitochondrial dysfunction can help explain why most patients suffer from fatigue, as well as worsening of symptoms following exertion – which requires more energy.

There is also strong evidence that patients with long covid suffer from (iv) endotheliopathy and micro clotting. A continuous formation of micro clots can obstruct the smallest vessels and cause a lack of oxygen in, for example, the muscles and the brain, which could explain both fatigue and pain as well as the worsening of symptoms following exertion, which places higher demands on oxygen supply.

Light at the end of the tunnel

Given the number of people affected by long covid worldwide, doctors and researchers believe that we may be facing the next global public health crisis. But even if it sounds dark, there is light at the end of the tunnel. The more pieces that are added to the biological background of long covid, the better the chances of finding treatments.

Tomorrow, BioStock will publish an article about research advancements and promising projects being conducted with the aim of diagnosing and treating long covid. Keep an eye out at biostock.se.

BioStock Investor Meeting: Interview with OssDsign

Anders Svensson, CFO på OssDsign

In connection with the BioStock Investor Meeting in Stockholm, BioStock’s reporter was visited by Anders Svensson, CFO of OssDsign. Svensson told us more about OssDsign’s products for regenerative implants and patient-specific solutions for the treatment of bone defects. He also answered the question of what distinguishes OssDsign’s products from competitors and elaborated on the company’s road map for growth.

See the interview with OssDsign’s CFO Anders Svensson below.

 

BioArctic soars amid positive phase III results with lecanemab

BioArtctic soars on phase III results

After the controversies surrounding Biogen’s Aduhelm, the resignation has been palpable among the many Alzheimer’s patients who have been looking forward to an effective treatment for the disease. Now, there is new hope after Swedish BioArctic’s partner Eisai presented positive phase III results for the drug candidate lecanemab. The announcement caused BioArctic’s share to soar on the Swedish stock exchange, which also boosted sector colleagues Alzinova and AlzeCure.

Stockholm-based BioArctic focuses on the development of drugs for the treatment of neurodegenerative diseases, where the company’s main candidate lecanemab targets Alzheimer’s disease. In Alzheimer’s, the beta-amyloid protein accumulates in the brain, contributing to the destruction of nerve cells, primarily in the temporal lobe and the cerebellum. Alzheimer’s is the most common form of dementia, and it affects over 55 million people worldwide.

In 2005, BioArctic initiated a long-term collaboration with Japanese pharma company Eisai regarding the development and commercialisation of drugs for the treatment of the severe disease, where lecanemab is the most important asset. Lecanemab is an antibody that targets beta-amyloid protofibrils and is being developed for the treatment of mild cognitive disorder and mild Alzheimer’s disease where amyloid pathology in the brain has been confirmed. After many years of development, today came the news that so many had been hoping for.

Achieved primary and secondary endpoints

Eisai has announced positive results from the global pivotal phase III study Clarity AD, which tested lecanemab in a total of 1795 patients. The primary endpoint – reduced clinical deterioration – was achieved when a high, statistically significant, reduction in clinical deterioration over time could be shown. This is an important parameter in a progressive disease such as Alzheimer’s. According to the company, lecanemab reduced clinical deterioration by 27 per cent compared to placebo, as measured by the global cognitive and functional scale CDR-SB (Clinical Dementia Rating-Sum of Boxes).

The company was also able to report that all secondary endpoints were achieved with high statistical significance compared to placebo. Regarding possible side effects, the risk of the most common side effect in anti-amyloid treatments, ARIA, is within the expected range.

CEO Gunilla Oswald comments

“The results fully meet our expectations, both in terms of the high degree of statistical significance and the consistency between the results for the primary endpoint and all secondary endpoints. This is a fantastic achievement by our employees and our partner Eisai who have worked tirelessly for almost two decades to achieve this success,” comments BioArctic’s CEO Gunilla Oswald in a press release and continues:

Gunilla Osswald, CEO BioArctic
Gunilla Osswald, CEO BioArctic

“We are proud that our founder Lars Lannfelt’s discoveries has the potential to fundamentally improve the treatment of Alzheimer’s disease, where there currently are very limited options. The results are also a confirmation of our technology platform and strengthens our hope to also be able to help improve the treatment of other neurodegenerative diseases such as Parkinson’s disease, ALS and others.”

Aiming for market approval in Q1 2023

Following the uplifting results, Eisai will now discuss with authorities in the US, Japan and Europe, where it hopes to receive full market approval in the three markets in the first quarter of 2023. The results will also be presented at the Alzheimer’s Congress Clinical Trials on Alzheimer’s Disease conference and they will also be published in a scientific medical journal.

Milestone payments await BioArctic

In the collaboration with Eisai, BioArctic has entered research agreements and license agreements with a total value of 222 million EUR, plus royalties. At the end of the second quarter, up to 151 million EUR remained in potential milestone reimbursements for BioArctic, including the 15 million EUR received in connection with the regulatory application with the drug candidate in the US.

Strong reaction on the stock market

This morning’s announcement didn’t just come as positive news for all of the world’s Alzheimer’s patients. During the morning trading, BioArctic’s share surged on the stock exchange and was traded up by almost 180 percent. Swedish sector colleagues Alzinova and AlzeCure were affected by the general frenzy and traded up by at most 80 and 30 percent, respectively.

BioStock Investor Meeting: Interview with Arcede Pharma

Mia Lundblad, CEO Arcede Pharma

Arcede Pharma, which just released its first quarterly report as a separately listed company, presented at the BioStock Investor Meeting in September. In connection with the event, BioStock took the opportunity to interview the company’s CEO Mia Lundblad regarding drug candidate RCD405. The candidate, which is developed to treat of COPD and severe asthma, is currently being prepared for clinical phase I.

See the full interview with Arcede Pharma CEO Mia Lundblad below.

BioStock Investor Meeting: Interview with Lipum

Einar Pontén, CEO Lipum

Biopharmaceutical company Lipum is approaching clinical studies with the candidate SOL-116, which targets chronic inflammatory diseases such as rheumatoid arthritis. CEO Einar Pontén presented the company at the BioStock Investor Meeting in Stockholm and BioStock had the opportunity to interview Pontén about the upcoming clinical study and what distinguishes SOL-116 from today’s treatments.

Watch the interview with Lipum’s CEO Einar Pontén below.

Please note that the presentation was recorded before the news that Lipum’s board of directors has resolved on a directed issue of approximately 39 MSEK and prior to the approval of a phase I study with SOL-116.

BioStock Investor Meeting: Interview with WntResearch

WntResearch's CEO Pernilla Sandwall

The last few months have been eventful for cancer therapy company WntResearch. In August, the company announced unexpected and promising findings with the candidate Foxy-5 in the phase II study Neofox, which prompted the company to change its plans for the study. CEO Pernilla Sandwall told us more about the updated study strategy in connection with the BioStock Investor Meeting.

See the interview with WntResearch’s CEO Pernilla Sandwall below.

BioStock Investor Meeting: Interview with Cyxone

Carl Magnus Högerkorp, interim CEO Cyxone

Cyxone’s interim CEO Carl-Magnus Högerkorp was interviewed by BioStock after his presentation at the BioStock Investor Meeting. In the interview, Högerkorp tells us more about the upcoming phase II study with the company’s leading candidate Rabeximod, and answers the question of where the company expects to be in a year.

See the interview with Cyxone’s interim CEO Carl-Magnus Högerkorp below.

Congress in Poland paves the way for Sensidose

Sensidose

Recently, Sensidose participated in the Polish Neurology Society’s annual science and education conference in Lublin. An increased presence is a strategic step ahead of the planned market launch of the company’s drug Flexilev for the treatment of Parkinson’s disease in Poland. The company’s CEO Jack Spira tells us more about the launch plans in Poland and the learnings from the congress.

Sensidose has developed an individualized treatment for patients with advanced Parkinson’s disease. The treatment is carried out with Flexilev, a drug in the form of microtablets of levodopa/carbidopa, which is dispensed with the company’s dosing device MyFID.

Flexilev is approved in many European countries but is so far only sold in Scandinavia where Sensidose now intends to increase sales. In parallel, Sensidose is preparing for geographical expansion to more markets. According to an interview with the company’s founder Sten-Magnus Aquilonius, the market introduction is affected by pricing in the country, which is something that will be negotiated in both Poland and Finland.

Annual Polish Neurology Society congress

As a preparatory step for launch on the Polish market, Sensidose participated in the Polish Neurology Society congress on September 14-17. This was the society’s first conference after two years of cancelled meetings due to the pandemic.

The event is Poland’s largest meeting in the field of neurology where all neurology specialists, relevant authorities and decision-makers participate. This made the event a great opportunity for Sensidose to promote its treatment concept:

»The meeting was an excellent opportunity for us to meet specialists in the Parkinson’s field, patient associations, and authority representatives and to present our treatment concept« – Jack Spira, CEO Sensidose

Positive feedback from doctors

During the congress, Sensidose brought with them the dose dispenser MyFID with Polish texts, which allowed them to discuss and demonstrate the treatment principle effectively. Doctors from all over the country got to test the dosing device and learn more about how the treatment is done, both from the patients’ and the healthcare staff’s point of view. According to Sensidose, the treatment was well received:

»We received many compliments that the system was uncomplicated, logical, and functional for both doctors and patients.«

Jack Spira
Jack Spira, CEO Sensidose

CEO comments on preparations for launch in Poland

Through the congress, Sensidose established an initial presence in Poland and laid the foundation for the planned launch. They also learned more about the subsidy application procedure and strengthened the relationship with the company’s agent in Poland.

BioStock contacted Sensidose’s CEO Jack Spira to learn more about the congress and the planned launch in Poland.

What lessons do you take with you from the Polish Neurology Society’s conference?

– Above all, how the Polish system for pharmaceutical subsidy is structured and how different it is from Sweden. Most of the presentations were in Polish, so it was hard to keep up with them. An important lesson was that patients want to avoid invasive treatments for as long as possible. This makes our concept extra interesting in this context.

»An important lesson was that patients want to avoid invasive treatments for as long as possible. This makes our concept extra interesting in this context.«

When do you plan to launch Flexilev in Poland?

– The application procedure for a subsidy is complex and even if it is stated that you should be notified in 180 days, you should expect it to take longer. How long is difficult to specify.

What is your sales strategy in Poland?

– We want leading neurology specialist clinics to get to know the treatment and feel confident with it during the waiting period of the application procedure. Therefore, we will perform a relatively simple so-called phase IV study where an appropriate number of patients will be treated. As soon as we have received the subsidy, we can, with the knowledge and information from these centers, move on to more neurologists. It is difficult to set up a detailed plan until we know that we are getting a subsidy and what the subsidy looks like. We will have to come back to that when we have more knowledge.