Featuring news, events and industry trends
Innovative Medical Robotics Company, Clarapath, Passes First Round of Certifications; Expands Global Headquarters

Hawthorne headquartered, Clarapath, a robotics company aimed at catalyzing change in the way pathology laboratories process human and animal tissues, announced its first robotic instrument, SectionStar™, will result in standardization in the quality of tissue sections for molecular mapping of human disease and in the development of new treatment pathways. Additionally, SectionStar™ has reached an important milestone – passing UL certification. This step is critical to both the non-clinical and clinical deployment of the device, enhancing reliability and efficiency of the pathology lab.

Fueled by the company’s recent $32 million fund raise and to support continued growth and demand for the SectionStar™ system, Clarapath also announced it is expanding its global headquarters space in Hawthorne, NY to include 30,000 more square feet allowing room for an expanded workforce, assembly, and manufacturing areas.
Regeneron Breaks Ground on Its Tarrytown Campus Expansion

A year af­ter an­nounc­ing it would spend $1.8 bil­lion to ex­pand its re­search and pre­clin­i­cal man­u­fac­tur­ing fa­cil­i­ties on its Tar­ry­town cam­pus, Re­gen­eron Phar­ma­ceu­ti­cals broke ground on the pro­ject. There to cel­e­brate with co-founders, Drs. Leonard Schleifer and George Yan­copou­los, was New York Gov­er­nor Kathy Hochul along with a host of state and lo­cal elected of­fi­cials bask­ing in the phe­nom­e­nal suc­cess of the $16 bil­lion in sales biotech gi­ant, an early star in the fight against COVID—19.

Re­gen­eron will add at least 1,000 full-time, high-skill jobs as it cre­ates, tests and de­vel­ops med­i­cines to treat a wide range of dis­eases. Con­struc­tion will take place in two phases with com­ple­tion tar­geted for 2027. The New York State Em­pire State De­vel­op­ment Cor­po­ra­tion is kick­ing in up to $100 mil­lion through Ex­cel­sior Jobs Pro­gram tax cred­its.

Dupilumab FDA Approved for AD Patients 6 Months to 5 Years

Sanofi and Tarrytown headquartered Regeneron Pharmaceuticals, Inc announced the FDA approval of dupilumab. It is now the first biologic medicine for children from 6 months to 5 years old with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This filing is also under review by the European Medicines Agency (EMA) for this age group along with and submissions to regulatory authorities in other countries worldwide. Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways and is not an immunosuppressant.

Regeneron to Buy Global License Rights to Sanofi’s Libtayo

Regeneron Pharmaceuticals and Sanofi have restructured an immuno-oncology partnership, through which the former will gain exclusive global license rights to Libtayo (cemiplimab) in a deal totaling $1.1bn. The companies entered the worldwide immuno-oncology license and collaboration agreement in 2015
Sanofi and Regeneron had equally divided the global operating profits of Libtayo and jointly marketed Libtayo in the US with the former overseeing the marketing of the product in the rest of the globe.

A fully human monoclonal antibody, Libtayo acts on the immune checkpoint receptor PD-1 on T cells. 

Regeneron will make an upfront payment of $900m to Sanofi as well as a 11% royalty on global net sales of Libtayo. 
Burke Neurological Institute Honors Those Who Are Impacted by Alzheimer’s Disease During Alzheimer’s Disease Awareness Month

During the month of June, we honor those affected by Alzheimer’s disease by raising awareness. Alzheimer’s disease impacts nearly 5.8 million Americans, their families and caregivers each year. While there is no cure for Alzheimer’s disease, the BNI community strives to improve the quality of life for those who have been impacted by the devastating disease. The Gibson Lab at White Plains headquartered Burke Neurological Institute, for example, focuses on the discovery of the underlying causes of age related neurodegenerative diseases and developing effective therapies. By continuing to study Alzheimer’s disease, there is hope for a cure for the millions of people who are affected by it daily.

Cognition Therapeutics Presents at JMP Securities Life Sciences

Purchase headquartered, Cognition Therapeutics, Inc. participated in the JMP Securities Life Sciences Conference on June 16th. Lisa Ricciardi, Cognition’s president and CEO presented an update on the company's progress developing small-molecule therapeutics targeting age-related degenerative diseases of the central nervous system and retina. More information on how to access the recorded webcast can be found here.
Alnylam Reports Positive Topline Results from Phase 2 Study of Investigational Cemdisiran for the Treatment of IgA Nephropathy

Alnylam Pharmaceuticals, Inc. announced topline results from the Phase 2 study of cemdisiran, an investigational RNAi therapeutic targeting the C5 component of the complement pathway that is in development in collaboration with Tarrytown-based Regeneron Pharmaceuticals for the treatment of immunoglobulin A nephropathy (IgAN). At Week 32, treatment with cemdisiran resulted in a 37 percent mean reduction from baseline in the 24-hour urine protein to creatinine ratio relative to placebo – the primary endpoint of the study and an important prognostic marker of disease progression. The results of secondary endpoints were also consistent with a therapeutic benefit of cemdisiran in IgAN. There were no significant drug-related safety signals. It is believed the collective efficacy and safety data support continued clinical development of cemdisiran monotherapy in patients with IgAN.

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