16th February 2018
Full Year Report January - December 2017
Comments from the CEO
2017 ended on a highly positive note. Results from our ADC-1013 clinical Phase I study provided support for further clinical development, and a 6 MUSD milestone was triggered on the initiation of a combination study with ADC-1013 and one of Janssen’s proprietary PD-1 inhibitors. We have grown considerably as a team this year and have had the pleasure of welcoming 14 new colleagues to Alligator. With our pooled talents and combined efforts, we are well placed to execute on our strategy and goals. Looking back at 2017, I am proud to say that we have delivered all that we promised in the IPO - and more - and I am confident that 2018 will be another exceptional year.
Positive results in ADC-1013 first-in-human study
During 2017, we completed the first clinical Phase I study with ADC-1013, our CD40-activating antibody. This was a first in-human dose escalation study of intratumoral ADC-1013 in patients with late-stage cancer. While the primary objective was to identify a safe and well tolerated dose, also secondary parameters such as biomarker responses and anti-tumor effects were evaluated. The study showed ADC-1013 to be well tolerated at clinically relevant doses after intratumoral administration. Side effects were generally of low grade and transient. One cancer patient showed stable disease for at least 12 months. While this is encouraging, it is early evidence of efficacy and we therefore await the results of larger studies for confirmation on the clinical efficacy of ADC- 1013. A second clinical Phase I study has been ongoing since October 2016, performed by Janssen Biotech.
Milestone payment from Janssen
Janssen recently took the decision to initiate a combination study with ADC-1013 and one of Janssen’s proprietary PD-1 inhibitors which triggered a milestone payment of 6 MUSD to Alligator. This is the first of a number of pre-defined milestones related to the start of combination or Phase II studies, which have an aggregated potential value of 35 MUSD. The total milestone potential under the license agreement is 695 MUSD, plus tiered royalties on worldwide net sales of ADC-1013.
ATOR-1015 to enter the clinic in 2018
Our innovative drug candidate ATOR-1015 leads the way for next generation of CTLA-4 bispecific antibodies. During 2017, clinical drug material has successfully been manufactured and we have appointed Theradex Oncology, a global company with extensive expertise in oncology clinical development, as contract research organization (CRO). The first clinical study is planned to start during second half of 2018.
We continued to expand our R&D operations, bringing the total number of employees to 47 at the end of 2017. In the beginning of 2018, Chief Medical Officer Charlotte Russell and Vice President, Discovery, Peter Ellmark, both joined the management team. We have also recruited Anudharan Balendran as Vice President, Business Development. He will join Alligator from AstraZeneca in Q2 2018.
This expansion is critical for the realization of our strategy to establish Alligator as a key player in the development of the next generation of immuno-oncology agents. Our goal is that these products will make a real difference to cancer patients.
Four clinical projects by next year
Finally, I would like to emphasize the fact that we are in the process of building a solid clinical pipeline. Our lead asset ADC-1013 is approaching clinical Phase II, ATOR-1015 is planned to enter clinical Phase I this year, and both ATOR-1017 and ALG.APV-527 are expected to enter clinical development next year.
This means that we can have a pipeline with four drug candidates in clinical development already next year, all with first- or best-in-class potential in immuno-oncology.
For further information, please contact:
Per Norlén; CEO
Phone: +46 46 286 42 80
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
This press release contains such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8:00am CEST on 16 February 2018.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s growing pipeline includes four lead clinical and pre-clinical drug candidates (ADC-1013, ATOR-1015, ATOR-1017 and ALG.APV-527). ADC-1013 (JNJ-64457107) is licensed to Janssen Biotech, Inc., part of J&J, for global development and commercialization. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 50 employees. For more information, please visit www.alligatorbioscience.com.