The biotech industry is being lit up with news of biologics flooding the wires. Biologics, which differ from traditional drugs, as they are complex molecules typically derived from an array of living organisms rather than being synthesized chemicals, have become a hot area for big pharma in recent years, led by blockbusters like AbbVie’s (NYSE: ABBV) Humira, which generated a jaw-dropping $14.1 billion in sales in 2015, Roche’s (OTC: RHHBY) Rituxan ($7.3 billion in 2015 sales) and Sanofi’s (NYSE: SNY) Lantus ($7.1 billion in 2015 sales).
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This week, Johnson & Johnson’s (NYSE: JNJ) Janssen Biotech received FDA approval of Stelara for the treatment of moderate to severe Crohn’s disease, making it the first biologic therapy for Crohn’s acting upon interleukin-12 and interleukin-23. Amgen’s (NASDAQ: AMGN) Amjevita, a biosimilar to Humira, was greenlighted by the FDA for treating a bevy of indications (just like Humira), including different types of arthritis and severe plaque psoriasis. Earlier in the month, MedImmune, the biologic unit of AstraZeneca (NYSE: AZN), said that two trials of the experimental injectable benralizumab hit their endpoints for reducing flare-ups in severe asthma patients where steroid inhalers don’t work adequately. If benralizumab can garner FDA approval, AstraZeneca will be looking to carve away market share from GlaxoSmithKline’s (NYSE: GSK) Nucala and Teva Pharma’s (NYSE: TEVA) Cinqair.
Clearly, all the big boys have come to the biologics table looking to get their share of a market that IMS Health analysts estimate will rise to $390 billion by 2020, meaning that biologics will command nearly one-third of all spending on drugs in the next few years.
With the space becoming ever-more competitive and several key patent expirations on the horizon, it won’t be surprising to see big pharma look to smaller firms with innovations in the biologic space to try and get an edge with next generation therapies. That is where Endonovo Therapeutics (OTCQB: ENDV) is positioning itself by patenting and developing its Cytotronics platform. While most biologics are formed using recombinant-DNA technology, Endonovo is taking a different route to produce biologics.
Endonovo’s platform, which has its roots going back to stem cell work at NASA to help keep astronauts healthy during extended periods in microgravity, uses Time-Varying Electromagnetic Field (TVEMF) technology to expand and enhance the therapeutic properties of stem cells, to produce fully human biologics, and to “train” stem cells to act as tiny drug factories. It does so primarily through stimulation of magnetically induced electrical field pathways of cells and tissues.
As potent as biologics are, there are still challenges related to inconvenient dosing, inducing an immune response (immunogenicity) and associated side effects. The hope is that next generation biologics can overcome these shortcomings. While Endonovo tends to gain more attention for its electroceutical technology called Immunotronics, recent patent filings provide valuable insight as to how the Cytotronics technology dovetails with future biologics. Endonovo’s recent patent application titled, “Methods and Compositions for Treating Chemical and Radiation Injuries,” covers the production of biologics, including cell therapies and biomolecules created using a proprietary bioreactor and their corresponding administration as a therapeutic for treating chemical and radiation injuries, such as chemotherapy and acute radiation syndrome.
Endonovo CEO Alan Collier describes the technology as effectively training cells to secrete therapeutic proteins. The secreted proteins can include those commonly used in biologics, including G-CSF (granulocyte-colony stimulating factor), GM-CSF (granulocyte-macrophage colony-stimulating factor), erythropoietin and interleukins that are used in angiogenesis, antigen-targeting, promoting white blood cell growth to fight infections and much more.
Endonovo is seeking to validate the potential of injecting “enhanced” or “trained” stem cells to not only replace damaged or lost cells, but also deliver a cocktail of therapeutic proteins. The potential of stem cells has yet to live up to expectations, ultimately leaving a trail of embattled companies in its wake, but strides are constantly being made. Scientists now better understand the complexity of stem cells, and that they primarily exert their therapeutic effect by secreting meaningful proteins to reduce inflammation and promote tissue healing. Hence, the convergence of biologics and stems cells is a natural progression, one that represents a significant medical advancement and one which little Endonovo is approaching in a unique manner.