Counseling and Management of R&D Activities in Immunotherapy and Targeted Biologics in Oncology and Immune Diseases

email: remip@immthera.com - Linkedin profile

IMMTHERA CONSULTING 

HELPS YOU TO BUILD ON THE COMPLEX

SCIENTIFIC AND R&D EQUATIONS 

FOR THE DEVELOPMENT OF INNOVATIVE BIOLOGICS  IN ONCOLOGY, 

FOR THE PROMISING FUTURE IMMUNOTHERAPIES TO TREAT HUMAN DISEASES  

The time has come to conceive a new wave of immune-based innovative products  for the treatment of cancer. True !

But how complex is it and what is the path to success ?

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In 2011, a turning point in cancer treatment with the first FDA approved immune checkpoint inhibitor (ICI), ipilimumab, an anti-CTLA4, paved the way to further ICI successes (anti-PD(L)-1 +/- anti-CTLA4 or +/- anti-LAG3). Great ! But which one in the so many in development and tested in combination is the next success ?

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We also know that T-cell can do the job:  When they are genetically modified (CAR-T), but most importantly adoptive transfer of autologous TILs expended ex vivo (non-genetically modified)  can treat cancer patients resistant  to ICI (ie. FDA approval of Lifuleucel in advanced melanoma in 2024) .

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Surprisingly, after 40 years of unsuccessful clinical attempts to induce an anti-tumor specific immune response by therapeutic immunization using immunostimulants,  we learned that to efficiently leverage the therapeutic power of the patient's own immune system to induce anti-tumor immunity, i.e. to mobilize patient's endogenous T cell army to eliminate tumor, it is better to release the brakes that inhibit immune cells than to push on the gaz pedal cells.  

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Wait ! Therapeutic cancer vaccines targeting the immunogenic tumor neoantigens by mRNA vaccine may succeed (Moderna's mRNA4157 vaccine + pembrolizumab phase II trial results presented at AACR 2023)

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Almost unexpected, after decades of unsuccessful attempts the Antibody-Drug Conjugates are booming (12 have been recently approved by FDA), they show that beyond their chemotherapy tumor targeted MoA, their  potential may lie in their capacity to induce tumor immunity and immune memory.

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The multiplicity of the possible therapeutic combinations between different ICIs as well as between tumor-targeting drugs and ICIs, makes the choices and trust in the predictive value of the  preclinical models crucial and very complex.

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The cell therapies in hematological tumors are successful. Great ! But they are not yet successful for solid tumors or as  a cell allogenic-based approach; however, this is where is the largest value for oncology. 

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The emergence of new molecular technologies & AI are providing incomparable capacities and "infinite" possibilities ! The question may be:  how to use them at best for therapies ? ..

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A much deeper understanding of cellular and molecular immunology, pathophysiology, biomarkers, and homeostasis (innate & adaptive immunity, immune tolerance, Immune Checkpoint Blockade, biomarkers, tumor neoantigens, disease-related antigens...). So many information... What is truly important and useful for new treatment ?

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Accessibility to a broader choice of preclinical models and key technologies, eg. humanized mice, organoids, targeting, Big data, WES, NGS, single cell analysis, gene editing … Which one for which drug and objective ?

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A changing  environment, ie. regulatory constraints & opportunities,  multiplication of CROs...

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The advent of immuno-oncology as a specific, measurable, actionable, and realistic tool for treatment

A surge of new biologics & targeted therapies getting closer to the root-cause of the intimate of cancer progression processes

A broad variety of highly promising and risky new projects, targets & technical opportunities based on immune-mediated MoA         

IMMTHERA SOLUTIONS 

> MAKE THE LINKS & HELP TO FIND THE RIGHT PATH AND PROJECT AND BUILD A REALISTIC PRODUCT VISION

> DEVELOP THE RIGHT PROJECT THE RIGHT WAY

> BUILD R&D STRATEGY PLAN

> IMPLEMENT & MANAGE PROJECTS FROM DISCOVERY TO CLINICAL DEVELOPMENT STAGE 

> A STRONG EXPERIENCE ON WHAT MAY WORK AND WHAT WILL UNLIKELY WORK FOR PATIENTS AND COMMERCIAL SUCCESS