Periodic Reporting for period 1 - CancERVacc (Targeting Cancer with ERV Vaccines)
Período documentado: 2022-07-01 hasta 2023-06-30
Inprother, in collaboration with the European Innovation Council, is advancing a groundbreaking cancer therapy to benefit the EU society.
InProTher was established to develop immunotherapies designed to overcome the limitations of cancer vaccines. InProTher is targeting the human endogenous retroviruses (HERVs) to treat cancer. HERVS are well recognized as tumor specific antigens, but until now, have been undruggable. InProTher is targeting HERV tumor antigens with a powerful technology that stimulates both arms of the immune system, the humoral and the cellular response. The Company delivers the immunogen by using Adenoviral and RNA vectors.
InProTher has generated robust pre-clinical, proof-of-concept data that demonstrate therapeutic potential for multiple oncology indications including pancreatic, ovarian, breast and prostate cancer. It plans to enter First-In-Human (FIH) trials in 2024.
InProTher will solve bottlenecks and unleash the full potential of immuno-oncology, not only in terms of cancer vaccines but also in further expanding the use of checkpoint inhibitors to multiple indications and patient populations.
More information to be found in the Joint Press Release InProTher – EICF here:
https://www.inprother.com/2023/05/24/inprother-press-releases-in-relation-to-eicf-funding/(se abrirá en una nueva ventana)
InProTher was established to develop immunotherapies designed to overcome the limitations of cancer vaccines. InProTher is targeting the human endogenous retroviruses (HERVs) to treat cancer. HERVS are well recognized as tumor specific antigens, but until now, have been undruggable. InProTher is targeting HERV tumor antigens with a powerful technology that stimulates both arms of the immune system, the humoral and the cellular response. The Company delivers the immunogen by using Adenoviral and RNA vectors.
InProTher has generated robust pre-clinical, proof-of-concept data that demonstrate therapeutic potential for multiple oncology indications including pancreatic, ovarian, breast and prostate cancer. It plans to enter First-In-Human (FIH) trials in 2024.
InProTher will solve bottlenecks and unleash the full potential of immuno-oncology, not only in terms of cancer vaccines but also in further expanding the use of checkpoint inhibitors to multiple indications and patient populations.
More information to be found in the Joint Press Release InProTher – EICF here:
https://www.inprother.com/2023/05/24/inprother-press-releases-in-relation-to-eicf-funding/(se abrirá en una nueva ventana)
Objectives of the work performed:
Complete the preclinical data package and proof of concept data
Complete the CMC process development for the manufacture of the lead candidate IPT001
Engage with Regulators (Scientific Advice) to define the Regulatory plan and activities
Complete the Team with key hirings
Complete the preclinical data package and proof of concept data
Complete the CMC process development for the manufacture of the lead candidate IPT001
Engage with Regulators (Scientific Advice) to define the Regulatory plan and activities
Complete the Team with key hirings
Main results achieved and potential impact:
Positive results of the preclinical data package (efficacy proven in several models and in several regimes), and definition of the components of the IPT001 candidate (the HERVK-ISDmut immunogen delivered in Ad19 + Ad5F35 vectors)
Stellar outome of the process development activities: confirmation that both vectors Ad19 and Ad5F35 can robustly be manufactured at scale and with excellent yield, stability and purity
Positive feedback of the Regulatory Authorities in key aspects:
Validation of the strategy for the GMP characterization and release to trial of the 2 vaccine components
Validation of the design of the toxicology study needed (1 single small rodent species)
Validation that the proof of concept clinical data currently available is enough to ensure clinical trial application (CTA) approval
Confirmation of the target population in our planned first in human clinical trial (high-risk prostate cancer patients in the adjuvant setting)
Key hirings in place: (Chief Medical Officer, Chief Financial Officer), and strengthening of the Board of Directors and the KOLs advisors
Extensive communications and PR campaign among investors, clinicians and stakeholders
Adaptation of the name of the company to the new paradigm: from “InProTher” to “HERVOLUTION Therapeutics”
Signed a MTA with Curevac (Germany) to develop an RNA version of our immunogen
Potential impact
First company targeting HERVS as completely novel tumor specific antigen, present in multiple cancer types
Targeting HERVs can be useful in the treatment of dozens of cancer indications, in multiple settings, from the preventive / initial setting (neoadjuvant and adjuvant setting) to the advanced setting. InProTher / HERVOLUTION is the first company that makes HERVs druggable
Huge potential of combinations with other immunooncology drugs
Real potential to completely change the paradigm in cancer immunotherapy
Potential to extend beyond HERVs, to other senescence-related diseases like ALS, and others
Positive results of the preclinical data package (efficacy proven in several models and in several regimes), and definition of the components of the IPT001 candidate (the HERVK-ISDmut immunogen delivered in Ad19 + Ad5F35 vectors)
Stellar outome of the process development activities: confirmation that both vectors Ad19 and Ad5F35 can robustly be manufactured at scale and with excellent yield, stability and purity
Positive feedback of the Regulatory Authorities in key aspects:
Validation of the strategy for the GMP characterization and release to trial of the 2 vaccine components
Validation of the design of the toxicology study needed (1 single small rodent species)
Validation that the proof of concept clinical data currently available is enough to ensure clinical trial application (CTA) approval
Confirmation of the target population in our planned first in human clinical trial (high-risk prostate cancer patients in the adjuvant setting)
Key hirings in place: (Chief Medical Officer, Chief Financial Officer), and strengthening of the Board of Directors and the KOLs advisors
Extensive communications and PR campaign among investors, clinicians and stakeholders
Adaptation of the name of the company to the new paradigm: from “InProTher” to “HERVOLUTION Therapeutics”
Signed a MTA with Curevac (Germany) to develop an RNA version of our immunogen
Potential impact
First company targeting HERVS as completely novel tumor specific antigen, present in multiple cancer types
Targeting HERVs can be useful in the treatment of dozens of cancer indications, in multiple settings, from the preventive / initial setting (neoadjuvant and adjuvant setting) to the advanced setting. InProTher / HERVOLUTION is the first company that makes HERVs druggable
Huge potential of combinations with other immunooncology drugs
Real potential to completely change the paradigm in cancer immunotherapy
Potential to extend beyond HERVs, to other senescence-related diseases like ALS, and others