As Alligator Bioscience makes headways with its clinical development of cancer immunotherapy mitazalimab, the company’s bispecific antibody technology RUBY is also turning heads. Alligator has announced extending its collaboration with Orion Corporation for the discovery of a second novel bispecific antibody directed towards immuno-oncology targets. BioStock spoke with Alligator’s CEO Søren Bregenholt to learn more.
Alligator Bioscience is a clinical-stage biotech company focused on developing tumour-directed immunotherapies. Lead asset mitazalimab, a CD40 agonist, is currently being evaluated in the OPTIMIZE-1 phase II trial in pancreatic cancer, and interim data published last week suggests the drug can make a significant impact on patients when combined with chemotherapy.
Alligator’s CEO Søren Bregenholt talked about the results in a BioStock video interview. Watch it here.
RUBY – a novel bispecific antibody format
The company also has several patented in-house antibody engineering technologies used for the discovery and development of new immunotherapy candidates.
One of these technologies is RUBY, a novel concept in bispecific antibody formats. According to Alligator, bispecific antibodies have emerged as the next generation of promising and efficient antibody drugs in cancer immunotherapy. Bispecific compounds have the potential to be more tissue specific, have higher potency and efficacy and importantly render drugs with mechanism of actions beyond what can be achieved with monoclonal antibodies.
RUBY is designed for easy generation of highly functional bispecific antibodies while at same overcome some of the hurdles associated with current bispecific formats leading to improved manufacturability and shorter development timelines. Thus, the RUBY format enables Alligator to move better drug candidates faster from the preclinical to the clinical phase, thus giving the company a competitive edge in the field of Immuno-oncology by delivering pipeline leads at increased speed for successful out-licensing. RUBY is also the basis of Alligator’s Neo-X-prime bispecific antibody platform.
Collaboration with Orion Corporation
Pharma has taken notice of this advantage. In 2021, the global pharma company Orion Corporation, based in Finland, signed a collaboration and licensing agreement with Alligator to use RUBY for up to three development programmes. Under the initial terms of the collaboration, Orion selects the targets through its own design criteria, while Alligator employs its proprietary phage display libraries and RUBY bispecific platform to develop the immuno-oncology product candidates.
The collaboration seems to be going strong. Last week, Alligator announced that the two parties have agreed to extend their agreement to start working on a second immuno-oncology programme. Outi Vaarala, Senior Vice President R&D of Orion, commented in a press release:
”We are excited to start another joint project with Alligator Bioscience and continue our development of new immuno-oncology treatments, which has started very well.”
Through the extension, Alligator remains eligible for development, approval and sales milestone payments of up to 469 MEUR across the three potential programmes, in addition to royalties if Orion exercises its options to continue development and commercialisation of the resulting product candidates.
The initiation of the second programme provides Alligator with an additional upfront payment of 1.25 MEUR, and a 500 000 EUR payment being due to Alligator when the technical feasibility of the bispecific antibody has been demonstrated.
BioStock contacted Alligator’s CEO Søren Bregenholt to get his take on the news.
Søren, could you tell us more about RUBY and how it adds value to Alligator’s already extensive product pipeline?
– So, RUBY is not a product in its own right, but an important technology that allows us to design and develop better bispecific antibodies faster. There are a number of intrinsic challenges with existing bispecific antibody format, and we believe that RUBY overcomes most of them. We use the RUBY format in our Neo-X-prime bispecific antibody platform.
How would you evaluate the collaboration with Orion thus far?
– The collaboration is very good. We are making excellent progress on the first project; the joint team follow the plan and reaching the milestones that we agreed at the beginning of the collaboration. The initiation of a second programme testifies to the quality of what we are doing together.
Considering the successful collaboration with Orion, are new collaborations on the horizon for Alligator involving the RUBY platform?
– Yes, we are discussing similar collaborations with several potential partners. Our integrated antibody discovery platforms, including RUBY, and our know-how and proven ability to deliver as promised make Alligator an attractive partner for designing, engineering, and developing innovative bispecific antibody drugs.
Lastly, since we are on the theme of partnerships, now that you have presented positive interim results from your OPTIMIZE-1 trial with mitazalimab, will partnership talks be intensifying there?
– The strong interim data we presented last week has eliminated a lot of risk from the OPTIMIZE-1 trials and mitazalimab as our leading drug candidate. A natural consequence is that mitazalimab has become more interesting for pharma. We continue the ongoing dialogues and expect to start new to give the best opportunity to make the most valuable and meaningful deal with the best possible timing.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.