Alligator Bioscience rivstartade 2023 med att presentera positiva interimsresultat från fas II-studien OPTIMIZE-1 med mitazalimab i bukspottkörtelcancer. Bolaget har fortsatt att leverera positiva nyheter under Q1. Nu genomför Alligator en företrädesemission om cirka 199 Mkr för att bland annat avancera studien ytterligare. BioStock pratade med vd Søren Bregenholt för att få en mer ingående förklaring till syftet med företrädesemissionen.

Detta material har upprättats för marknadsföringsändamål och är inte och ska inte betraktas som ett prospekt enligt gällande lagar och förordningar. De fullständiga villkoren för företrädesemissionen och mer information om bolaget har presenterats i det EU-tillväxtprospekt som offentliggjordes på alligatorbioscience.se den 26 april 2023.

Alligator Biosciences huvudmål är att, baserat på bolagets egenutvecklade teknologiplattformar, utveckla tumörriktade antikroppsbaserade behandlingar mot cancer. För närvarande har det svenska immunonkologibolaget en bred pipeline av projekt bestående av läkemedelskandidaterna mitazalimab, ALG. APV-527 och ATOR-1017, samt läkemedelskonceptet Neo-X-Prime.

I början av 2023 presenterade Alligator lovande interimsdata från fas II-studien OPTIMIZE-1 med sin primära kandidat mitazalimab – en CD40-agonist – inom metastaserad bukspottkörtelcancer. I studien utvärderas kandidaten som en första linjens behandling i kombination med mFOLFIRINOX – den vanligaste kemoterapin för patienter med bukspottkörtelcancer.

Med slutförd patientrekrytering till OPTIMIZE-1 är Alligator på rätt spår för att leverera topline-data under Q1 2024.

ALG.APV-527 i solida tumörer

Alligators andra stora kliniska milstolpe i år kom i februari. Tillsammans med amerikanska samarbetspartners Aptevo Therapeutics tillkännagav Alligator doseringen av den första patienten i bolagens fas I-studie som utvärderar den bispecifika antikroppen ALG.APV-527 för behandling av solida tumörer som uttrycker det tumörassocierade antigenet 5T4.

Antikroppen har en tumörriktad 4-1BB-agonistisk effekt och förmågan att specifikt stimulera antitumörspecifika T-celler och NK-celler (natural killer) som är involverade i tumörkontroll.

Emission av units driver utvecklingen framåt

Alligator genomför för närvarande en företrädesemission av units om initialt cirka 199 Mkr. Bolaget har erhållit teckningsförbindelser från ett urval av Alligators större befintliga aktieägare, däribland Koncentra Holding (del av Allegro Investment Fund) och Roxette Photo samt från medlemmar i bolagets styrelse och ledning, uppgående till cirka 68 miljoner kronor. Detta motsvarar cirka 34 procent av företrädesemissionen.

»We will not slow down, we are working hard to finalise the phase II study with mitazalimab, prepare the molecule for phase III, engage with regulators and intensify our discussions with potential partners. Besides that, we have several other valuable clinical and preclinical drug candidates and collaborations that we progress in parallel« — Søren Bregenholt, VD Alligator Bioscience

Därutöver har Alligator ingått avtal om garantiåtaganden om cirka 113 Mkr. Detta, tillsammans med teckningsåtagandena, säkrar företrädesemissionen upp till cirka 91 procent. Likviden kommer huvudsakligen att användas för att fortsätta fas II-utvecklingen och förberedelserna av fas III-studien med mitazalimab i bukspottkörtelcancer. Dessutom kommer Alligator att kunna avancera ALG.APV-527 i fas I-studien och fortsätta utvecklingen av andra pipelinekandidater, inklusive ATOR-4066, den första läkemedelskandidaten baserad på Neo-X-Prime-plattformen.

Åtta teckningsoptioner av serie TO6 berättigar till teckning av en ny stamaktie mellan den 17–31 augusti 2023. Om optionsprogrammet fulltecknas kan det tillföra Alligator ytterligare minst 22 Mkr före emissionskostnader.

VD kommenterar

BioStock pratade med Alligators vd Søren Bregenholt för att få veta mer.

Søren, Alligator got off to a rock-and-roll start this year with the announcement of positive OPTIMIZE-1 data with mitazalimab in pancreatic cancer. For those who are not aware, what is mitazalimab and why is it so promising?

– Yes, we have had a very busy and successful first four months of the year – and no, there is no sign that it will slow down. 

– Mitazalimab is an antibody that helps educate and activate the body’s immune system to more efficiently locate and attack tumour cells, thereby helping patients to better fight their cancer. We believe mitazalimab has a strong potential to help patients with solid tumours like metastatic pancreatic cancer, and we are currently testing mitazalimab in combination with chemotherapy. In January we released data showing that more that 50 per cent of the patients treated with mitazalimab in combination with chemotherapy experienced clinical response to the treatment, compared to only around 32 per cent with chemo alone. In addition, more than 90 per cent experienced that their tumour reduced in size or a stabilisation of tumour size.  Combined with mitazalimab’s advantageous safety profile, these results data have re-affirmed our belief in the clinical and commercial potential of mitazalimab.

– We recently announced the full enrolment of OPTIMZE-1, thereby eliminating a lot of risk from the trial. So, we are on track to deliver further interim data by mid this year, and full topline data from the trial in the beginning of Q1, 2024. We see both of these read-outs as significant value inflection points for Alligator, and good opportunities to intensify our partnering discussions.

– Mitazalimab is our top priority and we are working hard to finalize the phase II study as promised. In parallel we are investing in activities to prepare mitazalimab for phase III development, while we engage with regulators and intensify our discussions with potential partners.

Besides the postive development with mitazalimab, what else stands out as a key moment in 2023 thus far?

– Importantly we announced the initiation of a second project under our collaboration and license agreement with Orion, to discover a novel bispecific antibody using our proprietary antibody technologies including our proprietary RUBY antibody format. This collaboration is important as it generates short- and long-term revenue and validates our technology platforms, our discovery approach, and our ability to deliver as promised.

Collaborations are a big part of Alligator’s business strategy. You have several ongoing collaborations, and a key one is the one with Aptevo Therapeutics evaluating the bispecific antibody ALG.APV-527. How valuable is this collaboration?

–  We have been collaborating with Aptevo since 2017 on developing ‘527, and we initiated clinical development in February this year. I see a lot of value and potential in this collaboration. It allows us to combine resources and develop a best-in-class antibody at reduced cost and risk. It is still early days, but I see a clear opportunity that ‘527 can make significant difference for patients with for instance breast and lung cancer in the future.

Your third clinical asset is the monoclonal antibody ATOR-1017. Where does this project stand?

– We announced phase I clinical data in Q4 last year, where safety and pharmacology data were encouraging, clearly supporting the continued development of ‘1017 in solid tumours.  However, as I just mentioned, mitazalimab is our number one priority and we need to focus our resources on bringing that molecule forward. Therefore, we have decided to find a partner for 1017 before continuing the development. That process is underway.

Can you tell us more about Neo-X-Prime and ATOR-4066?

– Yes, Neo-X-prime is our next generation platform, building on our experience with mitazalimab antibody engineering, and we see the platform as a future growth avenue for Alligator. Neo-X-prime molecules are even more precise, efficacious and safe than molecules from previous generations, and we believe they will be able to provide benefits across a number of cancer indications. ATOR-4066 is the first molecule coming from the platform, designed to treat certain types of cancers expressing a specific molecule called CEACAM5. Two examples of such cancers are gastric and colorectal cancer, and I am pleased to say that preclinical data looks very promising.

Finally, you’ve had a busy 2023 so far. Are things about to slow down, or do you think the wind is still at your back?

– We will not slow down, we are working hard to finalise the phase II study with mitazalimab, prepare the molecule for phase III, engage with regulators and intensify our discussions with potential partners. Besides that, we have several other valuable clinical and preclinical drug candidates and collaborations that we progress in parallel.

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