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Biosergen towards first-in-patient trial with antifungal therapy

Biosergen towards first-in-patient trial with antifungal therapy

Biosergen towards first-in-patient trial with antifungal therapy

11 June, 2024

During Q1, Biosergen took major steps towards its goal to address the hidden threat of fungal infections. Not only was the company able to secure the necessary funding for the upcoming clinical phase Ib trial with BSG005, it also received the approval from the local authorities in India to procceed with the study. BioStock reached out to CEO Tine Kold Olesen for a comment on the company’s progress.

Swedish biotech company Biosergen is targeting an important unmet medical need and major global health threat: invasive life-threatening fungal infections. These infections arise primarily in patients with a weakened immune system, e.g. cancer patients, transplant recipients or HIV patients, and are characterised by a mortality rate of up to 90 per cent within the first two weeks of onset. Designated as an emerging global health threat by WHO, it is estimated that 2.5 million people die from invasive fungal disease each year.

Change in management to tackle clinical development

The company’s lead candidate is BSG005, a broad spectrum anti-fungal. Thanks to a specific genetic modification, BSG005 has an improved safety profile over the current anti fungal medications. The beneficial safety profile has been validated in a phase Ia trial, and the company is now looking to advance the project through clinical development.

With that goal in mind, Biosergen started off the year by transitioning Tine Kold Olesen from COO to CEO. Her 25 years of global experience in developing novel treatments from very early clinical stage, as well as strategic partnering, made her the clear choice to run the company through this key development stage.

Capital raise and regulatory challenges

The next step in the clinical development of BSG005 is a first-in-patient trial evaluating the candidate as a rescue therapy in patients with invasive fungal infections. The trial will be run with partner Alkem Laboratories – the fifth largest pharmaceutical company in India with global subsidiaries. Right after Olesen’s appointment as CEO, Biosergen successfully raised SEK 26.4 million through a rights issue subscribed at 65 per cent to fund this trial.

This funding round also reshaped the company’s ownership structure, with Ribbskottet Aktiebolag and Tuvedalen Limited emerging as significant shareholders, each holding over 5 per cent of the company. Read more about the capital raise here.

Shortly thereafter, the regulatory authorities in India approved a clinical trial application by Alkem to initiate the phase Ib study. However, as preparations for the clinical trial are progressing, some challenges remain. For patient recruitment, besides the regulatory approval, Biosergen requires an import license to import BSG005 into India. This license has been pending since early March and has yet to be granted.

External valuation of Biosergen

In addition to these operational updates, Biosergen commissioned an external valuation by Xplico at the start of the year. This analysis benchmarked the company against others in the same therapeutic area, considering factors such as development time and cost, probability of success, market share, and competitor analysis. The valuation estimated that Biosergen could achieve a market share of 15 per cent and peak sales between USD 600 million – 900 million.

CEO insights

BioStock reached out to CEO Tine Kold Olesen to get her take on the latest achievements for the company.

Tine Kold Olesen, vd Biosergen
Tine Kold Olesen, vd Biosergen

Tine, overall, how happy are you with your first quarter as CEO at Biosergen?

– Biosergen is working in an area where there is a huge unmet medical need and very little attention is given. This first quarter we have had two major external mileposts to increase the attention to treatment of life threatening fungal disease. One is a new better estimation on the seriousness of the disease in the most prestigious scientific journal and the second is that three major private institutions decided to join forces and made an initiative to financially support the area of life threatening fungal disease. These mileposts is confirmation of what we do is important. It stimulates the external interest and motivate us internal into believing that we have one of the keys to ensure a higher survival rate for these patients. In other words it has been a very good start.

How does the addition of Ribbskottet Aktiebolag and Tuvedalen Limited as new shareholders strengthen Biosergen’s position?

– To get two new major shareholders in at this critical moment where we are about to get into patients is a valuation of that what we do is heading in the right direction. It means that we finally have the possibility to realise a long awaited desire to test our compound in patients that have no other treatment options. We are very grateful that two so esteemed and experienced investors have decided to join our circle of investors.

What is causing the delay in granting the import license for starting the first-in-patient trial with BSG005?

– We have the regulatory approval of our trial i.e. the scientific content of our trial has the blue stamp to start, so we passed the first step. We lack the import license of the drug to India. Alkem as our partner in India where the trial is going to take place. They have people on the ground and have insight in the governmental environment. They are on a daily basis trying to influence the situation. There is right now major frustration with many companies in India as granting the import licenses is an overall problem for the industry. It seems to be external factors influencing the delay as slow procedure due to change in personnel, many offices to pass to get the correct signature. We know it is in process as we get questions and we have Alkem following up daily.

Could you tell us more about your strategy to mitigate the impact of the current delay?

– To make up for the time lost, the most impact full activity we have decided on is that we have doubled the number of sites to recruit and we further addition sites as back ups. We have Ethics Committee approval at all sites (including the back up sites) by now which is another step in the process. We prepare ourselves for a flying start.

What does Biosergen’s recent valuation say about the company’s potential in the antifungal treatment market.

– The external valuation was very thorough and contained many important facts and elements. It has been a sanity check for us. There are many assumptions in the estimations you can discuss. Personally to me a market share of 15 per cent is low and I want to aim for more. A valuation also means that you can begin to prepare for the future. It guides on potential partners and future activities to include in your program as data collection needed for price estimation. Our product saves lives almost instantly this means lower development costs but with major impact on mortality which is an excellent value proposition.

Finally, what are your expectations for the second half of 2024?

– We will focus on the clinical trial and will on an ongoing basis share key information on the clinical trial.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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