Regeneron Pharmaceuticals Inc (NASDAQ:REGN) has been gaining traction as a force in the biotech space, and now has launched a new direction called bispecific antibodies, which was highlighted at ASH 2018 a few days ago.
Every so often, some R&D program in the industry spits up a new innovation in what we call “mechanism”. CAR-T was a great example a few years ago. It was a new way of impacting the systems involved in supporting cancerous conditions. You extract the white blood cells and put them on roids and then pop them back into the body as Superhero white blood cells to go fight cancer.
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) just introduced what could be The Next Big Thing in Mechanisms with bispecific antibodies.
The name is really a reference to adding one target to a monoclonal antibody. In other words, it’s basically a packaging of two monoclonal-type cell service targets in one punch.
So, at ASH, the company presented data from an extremely small study for REGN1979 in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL), including promising clinical results in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) which are the two most common types of NHL.
According to the company, “In this Phase 1 proof-of-concept trial, REGN1979 demonstrated an acceptable safety and tolerability profile with no observed dose-limiting toxicities (DLTs). There were no clinically-significant neurotoxicities, including no occurrence of seizures or encephalopathy. REGN1979 is a wholly-owned, investigational, full-length bispecific monoclonal antibody designed to trigger tumor killing by binding CD3 on immune system T-cells and CD20 on B-cell malignancies.”
In other words, this signals an activation for an asset. Think of a Jason Bourne movie. The mission leader presses a button on a cell phone, and a text signal goes through to a guy in Morocco who then packs some heat and heads out the door to go take out the bad guy up the street.
Why is this so important? Because it actually works as a strong potential competitor to CAR-T therapies in specialized cases. But the problem for the CAR-T plays is about making it work in the marketplace. The cost of CAR-T is prohibitively high.
Bispecific antibody treatment is lining up as a much more affordable option at this point.
If it proves to be as effective (which is a high bar to hit), the implications for how insurance companies will organize around it in the market are enormous and possibly hold the key to where many oncology treatment programs will lean in coming years.
So, how did REGN1979 do against Follicular lymphoma? 100% overall response rate. Boom.
Looking forward, you want to keep REGN on your radar as the primary Bispecific play in what may become an interesting new mechanism fetish for Wall Street in 2019.
Just the Facts
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) bills itself as a biopharmaceutical company with a strong program in macular degeneration. But this is a diversified play with a ton in the pipeline, and R&D that spans eyes, skin, and oncology.
In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($2.2B against $1.4B).
For a sense of perspective, the company’s products include EYLEA injection to treat wet age-related macular degeneration and diabetic macular edema (DME); myopic choroidal neovascularization; and diabetic retinopathy in patients with DME, as well as macular edema following retinal vein occlusion, including macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion.
It also provides Dupixent injection to treat adult patients with moderate-to-severe atopic dermatitis; Praluent injection, an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease; and Kevzara solution for subcutaneous injection to treat rheumatoid arthritis in adults.
In addition, the company offers ARCALYST injection for cryopyrin-associated periodic syndromes; and ZALTRAP, an injection for intravenous infusion, which is used in combination with 5-fluorouracil, leucovorin, and irinotecan for the treatment of metastatic colorectal cancer.
Further, it develops EYLEA, a trap-based clinical product that is in Phase III study for the treatment of neovascular glaucoma; and Dupixent, Praluent, Kevzara, Suptavumab, Cemiplimab, Fasinumab, Evinacumab, Nesvacumab/aflibercept, Trevogrumab, REGN1908-1909, REGN1979, REGN3470-3471-3479, REGN2477, REGN3500, REGN3767, and REGN3918, which are antibody-based clinical programs under various stages of development.
REGN also has a number of key CLA’s, including agreements with Sanofi, Bayer, Mitsubishi Tanabe Pharma, Teva, Intellia Therapeutics, Adicet Bio, Decibel Therapeutics, Astellas, Alnylam Pharmaceuticals, Inc., bluebird bio, Inc., and others.
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) managed to rope in revenues totaling $1.7B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 10.8%, as compared to year-ago data in comparable terms.