Alligator Biosciences vd om nyemissionen
I september meddelade Alligator Bioscience att den första patienten doserats i deras fas II-studie OPTIMIZE-1 med läkemedelskandidaten mitazalimab i spridd bukspottkörtelcancer. Strax därefter beslutade bolaget att genomföra en företrädesemission om 257 Mkr för att accelerera och utvidga det kliniska programmet med mitazalimab och för ytterligare investeringar i bolagets pipeline. BioStock kontaktade vd Søren Bregenholt för att få veta mer om nyemissionen och fråga honom varför just nu är en bra tidpunkt att investera i bolaget.
Svenska Alligator Bioscience har under hösten startat en fas II-studie, OPTIMIZE-1, med deras ledande kandidat mitazalimab i spridd bukspottkörtelcancer. Bolaget genomför nu också en fullt garanterad företrädesemission om 257 Mkr med teckningstid fram till den 26 november.
Investeringar i pipeline
Alligator kommer att använda huvuddelen av kapitalet för att genomföra fas II-studien med mitazalimab, men kommer även att använda det för ytterligare investeringar i sin pipeline.
Läkemedelskandidaten ATOR-1017, som nu befinner sig i fas I, har visat lovande data och Alligator förbereder en fas II-studie med kandidaten under tredje kvartalet 2022.
Portföljen innehåller också den prekliniska ALG.APPV-527 som utvecklats tillsammans med Aptevo Therapeutics i USA och kandidaten är klar för fas I. Neo-X-Prime är ett koncept tagits fram med Alligators egna teknologiplattformar och man samarbetar sedan i april med amerikanska MacroGenics för att ta fram en antikropp i detta nya format. Utöver detta driver bolaget egna utvecklingsprojekt baserade på Neo-X-Prime-plattformen.
Fullt garanterad emission
Alligator har erhållit stöd för sin investeringsplan från existerande aktieägare motsvarande 43 Mkr och har nått garantiöverenskommelser om 214 Mkr, vilket innebär att emissionen är fullt garanterad.
Vd om projekten och nyemissionen
BioStock kontaktade vd Søren Bregenholt för att få höra mer om emission och varför det är en bra tidpunkt att investera i Alligator Bioscience.
Søren, Alligator carried out a rights issue as late as January 2021 – why have you decided to do another issue at this point?
– What is it that bankers always say? Raise money when you can and not necessarily when you want to. We think it is important to have a financing plan that is in line with Alligator’s goal to take our key assets through phase II.
– The funds generated with this rights issue will allow us to accelerate and expand our phase II program study with mitazalimab and enable us to move the needle even more on our other assets including ATOR-1017 and Neo-X-Prime.
How will you allocate the use of proceeds from the ongoing rights issue?
– The proceeds will be used primarily for mitazalimab’s phase II program, funds will also be allocated to advancing ATOR-1017 and developing our preclinical projects.
Much focus lies on mitazalimab and regarding OPTIMIZE-1, what endpoints are you hoping to reach in this study?
– Mitazalimab is a human CD40 agonistic antibody and is our most advanced drug candidate for immunotherapy and is designed for the treatment of metastatic cancers, initially pancreatic cancer. Mitazalimab stimulates the CD40 receptor on the surface of dendritic cells, enabling the immune system to attack tumors more efficiently.
– Our OPTIMIZE-1 study is being carried out at clinical sites in Belgium and France, evaluating mitazalimab in combination with chemotherapy mFOLFIRINOX in patients with metastatic pancreatic cancer. It is a first line pancreatic cancer in combination with mFOLFIRINOX – we will be looking at both safety and efficacy endpoints.
– The plan is for the trial to include 67 patients with an interim safety readout in Q1 2022 and an interim efficacy readout expected in Q4 2022.
How is the patient recruitment going?
– We were pleased to announce first patient dosed in Q3 2021. Recruitment is ongoing and remains on track.
When will you be able to present data from OPTIMIZE-1?
– We will present an interim safety readout in Q1 2022 and an interim efficacy readout expected in Q4 2022.
You are also planning for OPTIMIZE-2, what are you aiming for in this part of the study?
– We are narrowing in on another cancer indication also characterised by clear involvement of CD40 biology, has and a high unmet, need for innovative treatment options. We are targeting 2Q/3Q 2022 for this study to begin.
– In addition, we recently announced the initiation of REACtiVe-2, an exploratory phase I study assessing the safety and efficacy of mitazalimab, in combination with an investigational cancer vaccine in patients with pancreatic cancer. This broadens our commitment to develop mitazalimab.
Alligator is not only Mitazalimab – how are the other projects advancing?
– ATOR-1017 is a 4-1BB agonist with best-in-class potential that targets metastatic cancer by stimulating the 4-1BB receptors on T cells and NK cells. 4-1BB has the ability to stimulate the immune cells which is the key for tumor control. ATOR-1017 is being developed to improve combination therapy for metastatic cancer. Novel supportive data from the ongoing phase I clinical trial was presented at the 2021 ASCO Annual Meeting. We expect to present data from the ongoing phase 1 study during Q1 2022
– ALG.APV-527 is a bispecific antibody that targets the 4-1BB and 5T4 molecules, designed for the treatment of metastatic cancer. The drug candidate has been co-developed with Aptevo Therapeutics Inc. since 2017, and preparations are under way to initiate clinical testing during 2022.
– Neo-X-Prime is a drug concept for more personalised immunotherapy, which we launched in 2020. The concept builds on bispecific antibodies that physically link circulating tumour material to the immune system, to allow neoantigen-specific T cell priming with potential for superior anti-tumour efficacy.
– In April 2021, we entered into a joint research collaboration with US-based MacroGenics, Inc., a Nasdaq listed biopharmaceutical company focused on developing and commercialising innovative monoclonal antibody-based therapeutics for the treatment of cancer. The research collaboration utilises Alligator’s proprietary patient specific immunotherapy Neo-X-Prime to develop bispecific antibodies against an undisclosed target. In addition, we are advancing a proprietary discovery project based on the Neo-X-Prime platform.
– In addition, we have several partnerships and out-licensing agreements. We are working in collaboration with AbClon on AC101 (HER2 anti-body), which is now being further developed by the Chinese Company Shanghai Henlius. We have a technology agreement with Chinese company Biotheus for an antibody from the ALLIGATOR-GOLD antibody library.
– In 3Q 2021, we entered into a collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland, to discover new bispecific antibody cancer therapeutics against immuno-oncology targets selected by Orion. The agreement covers an option to develop three bispecific antibodies. Under the agreement, Alligator will employ its proprietary phage display libraries and RUBY bispecific platform.
Finally, the subscription in the issue is ongoing, why would it be worth investing in Alligator?
– We have a diversified best-in-class pipeline that addresses unmet needs in immune-oncology. Our combination therapies have a high safety profile and are designed for optimal efficacy for the treatment of hard-to-treat cancers.
– Mitazalimab and ATOR-1017 are key value drives in our key pipeline, which provide multiple strategic opportunities and will be transaction catalysts. Additionally, our preclinical and clinical partnerships validate our approached and provide opportunities to build future pipeline projects while sharing risks and costs.
– Lastly, our Neo-X-Prime platform provides long-term growth opportunities through proprietary and partnered programs.
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