This material has been prepared for marketing purposes and is not and should not be considered a prospectus under applicable laws and regulations. The full terms of the rights issue and further information about the company have been presented in the EU Growth Prospectus published on alligatorbioscience.se on April 26, 2023.
Alligator Biosciences main goal is to develop tumor-targeted antibody-based treatments for cancer, based on the company's proprietary technology platforms. The Swedish immuno-oncology company currently has a broad pipeline of projects consisting of the drug candidates mitazalimab, ALG. APV-527 and ATOR-1017, and the pharmaceutical concept Neo-X-Prime.
In early 2023, Alligator presented promising interim data from the Phase II OPTIMIZE-1 trial with its lead candidate mitazalimab – a CD40 agonist – in metastatic pancreatic cancer. The trial evaluates the candidate as a first-line treatment in combination with mFOLFIRINOX – the most common chemotherapy for patients with pancreatic cancer.
With patient recruitment for OPTIMIZE-1 completed, Alligator is on track to deliver topline data in Q1 2024.
ALG.APV-527 in solid tumors
Alligator's second major clinical milestone this year came in February. Together with American partners Aptevo Therapeutics Alligator announced the dosing of the first patient in the companies' Phase I study evaluating the bispecific antibody ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated antigen 5T4.
The antibody has a tumor-targeted 4-1BB agonistic effect and the ability to specifically stimulate antitumor-specific T cells and natural killer (NK) cells involved in tumor control.
Issuance of units drives development forward
Alligator is currently conducting a rights issue of units for an initial amount of approximately SEK 199 million. The company has received subscription commitments from a selection of Alligator's major existing shareholders, including Concentrate Holding (part of Allegro Investment Fund) and Roxette Photo and from members of the company's board and management, amounting to approximately SEK 68 million. This corresponds to approximately 34 percent of the rights issue.
»We will not slow down, we are working hard to finalize 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, CEO Alligator Bioscience
In addition, Alligator has entered into an agreement for guarantee commitments of approximately SEK 113 million. This, together with the subscription commitments, secures the rights issue up to approximately 91 percent. The proceeds will be used primarily to continue the Phase II development and preparations for the Phase III study with mitazalimab in pancreatic cancer. In addition, Alligator will be able to advance ALG.APV-527 in the Phase I study and continue the development of other pipeline candidates, including ATOR-4066, the first drug candidate based on Neo-X-Prime Platform.
Eight warrants of series TO6 entitle to subscribe for one new common share between August 17–31, 2023. If the warrant program is fully subscribed, it could provide Alligator with at least an additional SEK 22 million before issue costs.
CEO comments
BioStock spoke with Alligator's CEO Soren Bregenholt to find out more.
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 tumor cells, thereby helping patients to better fight their cancer. We believe mitazalimab has a strong potential to help patients with solid tumors like metastatic pancreatic cancer, and we are currently testing mitazalimab in combination with chemotherapy. In January we released data showing that more than 50 per cent of the patients treated with mitazalimab in combination with chemotherapy experienced a 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 tumor reduced in size or a stabilization of tumor 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 enrollment 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 positive 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 a 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 tumors. 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 finalize 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.