4873 English

Bioteknikbolaget Saniona har avancerat fram på bred front under de senaste tolv månaderna med såväl övertygande data från parallella kliniska studier, regulatoriska interaktioner med hälsomyndigheter, rekrytering till nyckelpositioner i bolaget och ett andra potentiellt lukrativt samarbetsavtal med läkemedelsjätten Boehringer Ingelheim. BioStock kontaktade bolagets vd, Rami Levin, för att få hans syn på det första halvåret 2020 och få veta mer planerna för det kommande halvåret. Tydligt är att Levin har höga ambitioner, såväl på kort som lång sikt.

Sanionas egenutvecklade pipeline inom sällsynta sjukdomar är bolagets viktigaste värdedrivare, där Tesomet är den behandling som kommit längst i utvecklingen. Kandidaten närmar sig de avslutande stadierna av registreringsstudier inom både hypotalamisk fetma (HO) och Prader-Willis syndrom (PWS), två sällsynta ätstörningar, och Saniona avser att fortsätta utveckla kandidaten inom dessa indikationer upp till registrering och kommersialisering.

Saniona har även två egenägda projekt i tidigare utvecklingsstadier: SAN711 och SAN903, molekyler som Saniona också avser att utveckla och i slutändan kommersialisera på egen hand.

SAN711 är en first-in-class molekyl som är speciellt utformad för att normalisera avvikande aktivitet förknippad med sällsynta neuropatiska smärtstörningar eller tillstånd inom området sällsynt intraktabel neuropatisk klåda – sällsynta tillstånd där det inte finns någon effektiv behandling vilket leder till försämrad livskvalitet för de drabbade patienterna.

SAN903 befinner sig för närvarande i preklinisk utveckling och är positionerat för behandling av sällsynta inflammatoriska / fibrotiska sjukdomar där det idag antigen saknas behandlingsalternativ eller där de tillgängliga behandlingarna är mycket ineffektiva.

Positiva studieresultat

I slutet av april kunde Saniona meddela positiva premliminära resultat från fas II-studien med Tesomet i HO. Utöver att resultaten visade att Tesomet var säkert och tolererades väl, kunde man även presentera robusta effektdata med statistiskt signifikanta förbättringar i kroppsvikt, midjemått och glykemisk kontroll jämfört med placebo.

Även i PWS har bolaget rönt framgångar inom PWS i år, senast i form av en positiv återkoppling från FDA rörande den regulatoriska vägen framåt för Tesomet i PWS och det föreslagna upplägget för den kommande fas IIb-studien. Detta följde de viktiga framsteg som gjordes under 2019, då positiva fas IIa-resultat påvisade att behandling med Tesomet resulterade i förbättringar gällande hyperfagi (starka hungerskänslor) samt I viktnedgång.

Vd kommenterar framstegen

För att få veta mer om året som gått hittills samt hur planerna ser ut framåt, kontaktade BioStock Sanionas vd, amerikanen Rami Levin, som med bas i Boston drar i trådarna för att transformera Saniona till ett fullfjädrat kommersiellt bolag med en allt större närvaro i USA och som nu börjar kontemplera hur en fullständig kommersiell lansering skulle kunna se ut.

»It has been an extremely productive and collaborative dialogue with the FDA in an effort to bring Tesomet [in PWS] to the market as quickly as possible and address the unmet needs of these patients and caregivers. Moving forward, we will be having similar discussions with the FDA on HO later this year.« – Rami Levin, vd Saniona 

Rami Levin, your main goals right now are to advance the clinical development of Tesomet all the way to registration and commercialization, and to advance the earlier stage molecules SAN711 and SAN903 into phase I clinical trials and beyond. What are the most important milestones you have reached so far?

– There have been several key milestones we have reached so far:

Rami Levin, vd Saniona

– In clinical development, we were able to continue the development of Tesomet in two rare disease indications, where there are no approved treatments available today. Tesomet will be entering late stage pivotal trials in both indications within the next 6-10 months.

– We announced positive preliminary results of Tesomet in HO. The results are extremely encouraging and support to continued development of Tesomet in HO and moving into a phase III registration trial.

– We also had positive discussions with the FDA on the regulatory path forward for Tesomet in PWS. It has been an extremely productive and collaborative dialogue with the FDA in an effort to bring Tesomet to the market as quickly as possible and address the unmet needs of these patients and caregivers. Moving forward, we will be having similar discussions with the FDA on HO later this year.

– From our early stage pipeline, we continued to develop SAN711, a first-in-class molecule that is specifically designed to normalize aberrant activity associated with rare neuropathic pain disorders or rare intractable neuropathic itch conditions – rare conditions where no efficient treatment exists today, resulting in poor quality of life for the affected patients. SAN711 is now ready to enter into phase I of clinical development. In addition, our preclinical development stage molecule, SAN903, is positioned for treatment of rare inflammatory/fibrotic diseases.

Another important focus is to build a presence in the US. How is this work progressing and what does it entail?

– Building our presence in the US has a broad meaning and ranges from recruiting top talent into the organization, to interacting with key stakeholders including key opinion leaders, clinical trial sites investors and banks and finally patients and patient organizations.

– We have made progress on all fronts. Recently we have hired a CMO & Head of Clinical Development to the company. This is a key role that will build the clinical development team and advance our clinical development programs in both HO and PWS. We are also in the process of hiring a US based Chief Financial Officer (CFO). A key role both for financing and investor relations. Following this there will be other roles to hire in order to manage the growing business needs.

– In July we also moved into our new Saniona office in the Boston area.

»If all goes well, we anticipate that Tesomet could reach the market as early as mid 2023.«

Looking ahead 12 months, which are the most important potential value drivers for Saniona?

– The next 12 months will focus on advancing the programs and activities across all three of our strategic priorities. The main value drivers over this period will be:

    • The FDA approval of the IND submission followed by the initiation of two pivotal trials, one in HO and one in PWS, that will take Tesomet all the way to registration
    • Advancing SAN711 and SAN903 into phase I clinical trials
    • Building our US presence and hiring top talent in key roles

When do you hope to receive market approval for Tesomet in HO and PWS?

– We still have a way to go and many milestones ahead of us. If all goes well, we anticipate that Tesomet could reach the market as early as mid 2023.

In addition to the proprietary focused research in rare diseases, you also focus on establishing collaborations, which are expected to generate milestone payments and royalties once the products are commercialized. Recently you struck a second lucrative collaboration deal with Boehringer Ingelheim. Would you say this is a typical deal for Saniona, given the company´s strategy and business model, and are there more in the pipeline going forward?

– Our main focus is on our growth drivers which you rightfully point out are our proprietary research, development and ultimately commercialization. As part of the research we will identify molecules better suited for development in larger indications and not rare diseases. In those instances, we intend to partner/out-license those molecules to larger companies, like Boehringer Ingelheim, who would be able to develop and commercialize these molecules. In return we will get milestone payments throughout the development and royalty payments once the products reach the market.

– This business model will ensure that in the future we will have two parallel revenue streams:

  1. The main revenue stream coming from the commercialization of proprietary treatments that we develop and commercialize ourselves
  2. A secondary revenue stream coming from milestone payments and royalties of out licensed molecules.

On June 22, you announced that Saniona has raised 22 MSEK through the sale of shares in Scandion Oncology A/S. The sale of shares brings Saniona’s ownership stake in Scandion Oncology below 15%. Could you comment on the timing of the sale? 

– Continuing to hold Scandion shares is not a strategic focus for Saniona. The timing was very simply linked with the significant development in the share price of Scandion and in parallel, our need to focus our efforts on our strategic priorities, including the initiation of our late stage clinical development programs, which require increasing levels of resources.

»Our main focus is on our proprietary treatments in development […] We anticipate bringing these treatments to market and commercializing them ourselves. They will represent the majority of our future revenues. I also anticipate having a second revenue stream stemming from partnerships, out-licensing agreements and spinouts.«

Scandion Oncology, which has become a highly successful cancer start-up, is a spin-out from Saniona´s oncology assets. Other successful spinouts from Saniona are Ataxion (Cadent Therapeutics Inc.) and Initiator Pharma. Looking ahead, do you foresee additional future spinouts on dormant assets in your pipeline?

– Our main focus is on our proprietary treatments in development, including Tesomet for hypothalamic obesity and Prader Willi Syndrome, SAN711 for rare neuropathic pain disorders or rare intractable neuropathic itch conditions and SAN903 for rare inflammatory/fibrotic diseases. We anticipate bringing these treatments to market and commercializing them ourselves. They will represent the majority of our future revenues.

– I also anticipate having a second revenue stream stemming from partnerships, out-licensing agreements and spinouts, such as the ones you mentioned.

Finally, what are your plans for the summer?

– At the moment it’s very dependent on Covid-19, but I intend to spend time with the family at a lake house enjoying boating, jet skiing and other water sport activities.

 

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