Periodic Reporting for period 2 - PanC-ASAP (AbilityPharma: Accelerating Solutions for Pancreatic Cancer)
Periodo di rendicontazione: 2021-10-01 al 2023-06-30
The PanC-ASAP project, led by AbilityPharma, aimed to address an unmet medical need by developing a safe and effective therapeutic strategy for pancreatic cancer patients. Within the EU, pancreatic cancer ranks as the third leading cause of cancer-related fatalities, displaying the poorest survival rates among all cancer types. Despite modest advancements over recent decades, chemotherapy continues to serve as the established standard of care.
ABTL0812, a first-in-class oral targeted anticancer compound developed by AbilityPharma has shown promising results in previous clinical stages as the phase 1b First-in-Human and the phase 2a trials in lung and endometrial cancer patients. ABTL0812 has a unique mechanism of action that specifically eradicates tumour cells by inducing cytotoxic autophagy, arising as an innovative approach that holds the potential to significantly improve patient outcomes while preserving their quality of life.
AbilityPharma had two main objectives for this project:
1.- We sought to complete the next stage of clinical development for their pioneering drug candidate, ABTL0812, which could be a game changer in pancreatic cancer treatment.
2.-The company aimed to commercialize the study's results through a licensing agreement.
By securing a licensing agreement with a major pharmaceutical company, AbilityPharma aims to expedite the availability of this groundbreaking therapy to patients. The collaboration with a large pharmaceutical partner, equipped with the necessary logistical capabilities, promises to accelerate the distribution and implementation of the treatment.
Looking ahead, once ABTL0812 is successfully licensed, AbilityPharma will continue its focus on developing new anti-cancer candidates that leverage the induction of cytotoxic autophagy in cancer cells. This commitment underscores their dedication to advancing cancer research and offering hope for better treatment options in the future.
ABTL0812, a first-in-class oral targeted anticancer compound developed by AbilityPharma has shown promising results in previous clinical stages as the phase 1b First-in-Human and the phase 2a trials in lung and endometrial cancer patients. ABTL0812 has a unique mechanism of action that specifically eradicates tumour cells by inducing cytotoxic autophagy, arising as an innovative approach that holds the potential to significantly improve patient outcomes while preserving their quality of life.
AbilityPharma had two main objectives for this project:
1.- We sought to complete the next stage of clinical development for their pioneering drug candidate, ABTL0812, which could be a game changer in pancreatic cancer treatment.
2.-The company aimed to commercialize the study's results through a licensing agreement.
By securing a licensing agreement with a major pharmaceutical company, AbilityPharma aims to expedite the availability of this groundbreaking therapy to patients. The collaboration with a large pharmaceutical partner, equipped with the necessary logistical capabilities, promises to accelerate the distribution and implementation of the treatment.
Looking ahead, once ABTL0812 is successfully licensed, AbilityPharma will continue its focus on developing new anti-cancer candidates that leverage the induction of cytotoxic autophagy in cancer cells. This commitment underscores their dedication to advancing cancer research and offering hope for better treatment options in the future.
AbilityPharma has achieved a significant breakthrough by successfully developing a novel solid formulation presented in capsule form. This advancement replaces the previous liquid formulation, which caused unwanted taste effects and throat discomfort, particularly troublesome for pancreatic cancer patients with preexisting gastric and digestive issues. With this innovation, treatment adherence has improved, and patients' overall quality of life has been enhanced, as they can now avoid the unpleasant side effects associated with the previous formulation. So far, more than 100.000 capsules containing the active ingredient have been administered to approximately 100 patients with no safety issues reported.
AbilityPharma has reached another significant milestone by obtaining approval from all regulatory agencies in the countries participating in the study, Spain, France, USA and Israel. This validation confirms the study's safety and potential efficacy, as no major concerns have been reported during this process.
Despite significant delays in the initiation of Phase 2b, AbilityPharma took corrective measures by incorporating additional hospitals into the study to accelerate patient recruitment. As of today, the study is progressing exceptionally well, with over 80% of the total required patients already enrolled.
In a proactive effort to ensure smooth progress, AbilityPharma has diligently collected all the necessary regulatory documentation required by the EMA and the US FDA for the forthcoming application to conduct a Phase 3 trial. This comprehensive package of information is strategically prepared to facilitate license negotiation, positioning the project optimally for future agreements. AbilityPharma has initiated activities necessary to enable a future licensing agreement such as project dissemination and participation in partnering meetings.
Additionally, the interim analysis, specifically designed to accelerate negotiations by evaluating the study's efficacy and futility, has undergone significant improvements. With the inclusion of a larger patient cohort, the analysis now will yield more mature and valuable data, significantly enhancing the project's appeal during the negotiation phase.
Furthermore, AbilityPharma has initiated a biomarker program with the ultimate goal of identifying a gene mark capable of predicting treatment response. This development has the potential to significantly enhance the therapeutic effectiveness of their approach, opening up new possibilities for personalized treatment plans.
After the successful inclusion of approximately 80% of the intended patients, the study is expected to be completed by September 2024, signalling the availability of the results and the finals steps of licensing agreement negotiations.
AbilityPharma has reached another significant milestone by obtaining approval from all regulatory agencies in the countries participating in the study, Spain, France, USA and Israel. This validation confirms the study's safety and potential efficacy, as no major concerns have been reported during this process.
Despite significant delays in the initiation of Phase 2b, AbilityPharma took corrective measures by incorporating additional hospitals into the study to accelerate patient recruitment. As of today, the study is progressing exceptionally well, with over 80% of the total required patients already enrolled.
In a proactive effort to ensure smooth progress, AbilityPharma has diligently collected all the necessary regulatory documentation required by the EMA and the US FDA for the forthcoming application to conduct a Phase 3 trial. This comprehensive package of information is strategically prepared to facilitate license negotiation, positioning the project optimally for future agreements. AbilityPharma has initiated activities necessary to enable a future licensing agreement such as project dissemination and participation in partnering meetings.
Additionally, the interim analysis, specifically designed to accelerate negotiations by evaluating the study's efficacy and futility, has undergone significant improvements. With the inclusion of a larger patient cohort, the analysis now will yield more mature and valuable data, significantly enhancing the project's appeal during the negotiation phase.
Furthermore, AbilityPharma has initiated a biomarker program with the ultimate goal of identifying a gene mark capable of predicting treatment response. This development has the potential to significantly enhance the therapeutic effectiveness of their approach, opening up new possibilities for personalized treatment plans.
After the successful inclusion of approximately 80% of the intended patients, the study is expected to be completed by September 2024, signalling the availability of the results and the finals steps of licensing agreement negotiations.
The combination of ABTL0812 and chemotherapy is a potential novel breakthrough treatment for metastatic pancreatic cancer. ABTL0812 has clear competitive advantages over investigational treatments for pancreatic cancer based on:
- New mechanism of action
- Proven synergy with chemotherapy
- Strong preclinical data in pancreatic cancer models
- High safety and tolerability (more than 100.000 capsules already administered with no safety issues reported)
Additionally, ABTL0812 has an orphan drug designation status which provides the benefits of a faster market access and extended patent protection
The project has impact at two levels:
Societal:
- Improved quality of life of pancreatic cancer patients and carers
- Increased life expectancy for patients with pancreatic cancer
Economic:
- Reduced healthcare cost thanks to improved efficacy of ABTL0812 combined with current standard of care chemotherapy.
Furthermore, building on the success of the ongoing project, AbilityPharma plans to extend the clinical development of ABTL0812 to other indications where it has demonstrated promising results in humans, including advanced endometrial and lung cancer patients. This expansion holds the potential to benefit patients facing different medical conditions.
Additionally, the extensive expertise accumulated by AbilityPharma in this innovative therapeutic approach will drive the continued development of new anti-cancer candidates. These candidates will leverage the induction of cytotoxic autophagy in cancer cells, reflecting the company's unwavering commitment to advancing cancer research and providing a promising outlook for improved treatment options in the future.
- New mechanism of action
- Proven synergy with chemotherapy
- Strong preclinical data in pancreatic cancer models
- High safety and tolerability (more than 100.000 capsules already administered with no safety issues reported)
Additionally, ABTL0812 has an orphan drug designation status which provides the benefits of a faster market access and extended patent protection
The project has impact at two levels:
Societal:
- Improved quality of life of pancreatic cancer patients and carers
- Increased life expectancy for patients with pancreatic cancer
Economic:
- Reduced healthcare cost thanks to improved efficacy of ABTL0812 combined with current standard of care chemotherapy.
Furthermore, building on the success of the ongoing project, AbilityPharma plans to extend the clinical development of ABTL0812 to other indications where it has demonstrated promising results in humans, including advanced endometrial and lung cancer patients. This expansion holds the potential to benefit patients facing different medical conditions.
Additionally, the extensive expertise accumulated by AbilityPharma in this innovative therapeutic approach will drive the continued development of new anti-cancer candidates. These candidates will leverage the induction of cytotoxic autophagy in cancer cells, reflecting the company's unwavering commitment to advancing cancer research and providing a promising outlook for improved treatment options in the future.