Respirator drug candidate VAL001 is being developed for the treatment of diffuse large B-cell lymphoma, an aggressive form of lymph node cancer. The candidate has shown positive efficacy results in combination with standard treatment R-CHOP, with a reduced mortality risk of 80 percent. This should be seen in the context that mortality reductions for drug candidates of 20–30 percent are usually considered a clinically relevant improvement.
Great interest in VAL001
The fact that VAL001 is being developed for a rare disease has led to it receiving Orphan Drug Designation in both the US and Europe. Overall, this led to the European Medicines Agency EMA directly qualified the project for a pre-market phase III study.
Respiratorius' strategy has never been to fund and carry out the final clinical step itself, and therefore the focus is now on working together with Partner International Inc.. find a major pharmaceutical company willing to take over VAL001. In a interview with BioStock, the company's CEO told Johan Drott that around twenty potential participants have expressed their interest in the project.
Learn more about VAL001.
Increasing focus on RESP9000
The company's second main candidate RESP9000 is being developed for the treatment of COPD and severe asthma. Despite the fact that the market for the treatment of respiratory diseases is very large, today's drugs are largely based on old, often side-effect-heavy, mechanisms. Respiratorius wants to change this with its drug candidate. There are indications that RESP9000 is more effective than existing drugs when it comes to counteracting the underlying mechanisms that create respiratory problems.
Learn more about RESP9000.
With the newly recruited project manager Carl Magnus Andersson at the helm, Respiratorius hopes to accelerate the preclinical development work with the candidate, where toxicological studies are expected to begin in early 2021. In parallel with this, GMP production will be ongoing to take the project to Phase I in the first half of 2022.
Further strengthen the team with a Clinical Director
Last week, the company also announced that it had recruited Mia Sandberg Lundblad as Clinical Director. Lundblad has a doctorate in clinical pharmacology and has extensive experience from companies such as Novo Nordisk and ferring where she was responsible, among other things, for bringing preclinical drug candidates to early clinical development.
Heavily oversubscribed issue during the summer
To drive the projects forward, Respiratorius raised just over SEK 25 million in a heavily oversubscribed new share issue this summer. At the same time, warrants were issued which, if fully subscribed, will provide the company with an additional approximately SEK 17,9–23,9 million after issue costs. The warrants are traded on Spotlight Market Place and gives the right to subscribe for new shares in the company between June 21 and July 5, 2021 at a minimum of SEK 1,20 and a maximum of SEK 1,60 per share.
To find out more about how the company views the past year and what awaits in 2021, BioStock has contacted CEO Johan Drott.
First of all, Johan, how would you sum up the past year?
– The successful capital raising has meant high activity in the projects and that we can focus on building an organization to manage the two prioritized projects. A first step is the recruitment of Carl-Magnus Andersson, who is an important resource with his broad and deep experience.
– In addition to progress made in the ongoing development work, the process for patent approval is underway for both VAL001 and RESP9000.
For many, Covid-19 has caused a lot of headaches this year. How has it affected you?
– As with society at large, we have had minor delays due to sick leave. Since we work with consultants and contract laboratories on an international basis, the handling of the pandemic in different countries has also had some impact. But in general, work is proceeding according to our original plan.
One of the big questions that shareholders will be asking themselves in 2021 is of course whether you will find a partner for VAL001 during the year. Can you tell us something about how this work is progressing?
– We continue to develop the contacts that we consider to be prioritized, which means answering the questions that exist. Of course, reaching an agreement is a priority, but at the same time we are building value in the project by continuing to prepare for a phase III study, which is why we do not see it as crucial to rush into an agreement.
You still have a few steps to take before a phase III study can begin. Can you tell us a little about how this work is going and what the status is now?
– The single most important step is the new formulation of VAL001, which has the potential to place the drug in an advantageous pricing position. It also remains to meet regulatory requirements for the initiation of a Phase III study and marketing approval.
You have now recruited a project manager in Carl-Magnus Andersson who will primarily drive the RESP9000 project forward. What do you hope he will contribute?
– Carl-Magnus's extensive experience in drug development is a welcome addition. Especially for leading the CMC and initiating studies for the documentation required before starting clinical development.
Finally, what milestones would you say are the most important for Respiratorius in 2021?
– 2021 has the potential to be a big year for Respiratorius, with important milestones for the projects. Through the financial situation, we have the opportunity to accelerate development and I have high hopes for patent approvals and achieved milestones of a more technical nature. Of course, we also have a focus on the exit process with the goal of a favorable agreement.
– I have great confidence that 2021 will be an exciting and good year for Respiratorius.
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