The probability that a single ״off label״ drug will modulate treatment outcome is slim. However when combined, these drugs can create a novel synergistic activity that can enhance treatment response. Using this approach, ReInvent pharma is changing the landscape of cancer therapy and research by aiming to combine “off label” drugs with immune and targeted therapies to increase their effectiveness and reach desired outcomes. This means patients who have been desensitized, developed resistance or have not responded to immune or targeted-based treatments might respond to the treatment when combined with these “treatment modifiers” drugs.

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Our novel cancer treatment combines active pharmaceutical ingredients (API) from pairs of “off-label” drugs to synergize therapeutic activities to form one Fixed Dose Combination (FDC) that will supplement immune and targeted therapies. The “off label” drugs are already in the market and therefore take advantage of the FDA’s 505(b)(2) approval pathway and Breakthrough Therapy Designation to decrease their development time and cost. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDCs can be linked to class-selected products (like Immune checkpoint inhibitor drugs [ICI]) to address their clinical and commercial shortcomings or as a stand-alone supportive immune modulator, especially when ICI therapies have not yet been approved. 

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Initial Focus on Immune Checkpoint Inhibitor (ICI) Based – Therapies; mainly the PD1/PDL1 family drugs:

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Immune checkpoint inhibitor therapies are based on blocking key proteins involved in a selected pathway that help promote tumor growth via inhibition of natural antitumoral immune response; the current approved drugs mainly belong to the ICI therapies blocking membrane proteins PD1/PDL-1 and CTLA4 that are responsible for tumor invisibility to the patient’s immune system. However, ICI therapy is only 20-30% effective for “hot” tumors that are considered to be immunogenic, like melanoma and lung cancer and 2- 3% for “cold” tumors that are not, like prostate and pancreatic cancers. It is still unclear why the response is low and seemingly ineffective despite continuous effort for identification of biomarkers for response.

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The concept of treating cancer tumors by targeting one biological inhibitory pathway is appealing in terms of safety and regulatory considerations but many years of clinical experience indicates, that in most cases, it proves to be of limited efficacy. Combining the anti-CTLA4 (Yervoy) with anti-PD1 (Nivolumb) monoclonal antibodies, clinical response is reported to be superior in many cases than the response of each drug alone, as multiple pathways are targeted. However, this at the expense of increased incidences and severity of adverse side effects, not to mention the associate costly price of the combined treatment.  With our FDC approach, ReInvent Pharma provides a tool that will target several immunogenic and/or metabolic pathways to increase chances of response with minimum concern of unpredictable adverse side effects, and not inflecting on core therapeutic cost.  We envision that our FDC approach when combined with ICI’s key players, PD-1/PD-L1 and CTL4A, will bring their clinical response from 20-30% to 50- 60% (hot tumors) and presumably drive the current response of cold tumor (2-3%) to the current figure of today's hot tumor response (20-30%).

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Secondary Focus - Targeted Therapies

 

Targeted therapies work by targeting proteins of tumor cells that express cancer-signaling and promoting activity. EGFR, a protein important in cell growth and division, VEGF, a key regulator in the process of angiogenesis and protein kinases, enzymes that can turn a protein on and off, are all targets of targeted therapies because tumor cells have usurped their regular function for their rapid growth and expansion. These proteins are found in excessive amounts on tumor cells surfaces and therefore can be targeted by inhibitor drugs to cease their function; ceasing tumor growth. But just like ICI therapies, targeted therapies have fallen short. Cancer cells show resistance to targeted therapies; in most cases after 9-12 months and drugs for targets are difficult and expensive to develop. Our goal is to extend targeted therapies effects so that resistance will be delayed or not occur. By using our unique FDC ‘on top’ of therapeutic approach patients will see real and affordable clinical outcomes.

 

Reinvent Pharma's current research and development efforts within this therapeutic segment are focusing on target proteins within the EGFR. VEGF and PARP families

 

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