Sponsor Pipeline Insights: The Top 10 Most Active Clinical Study Registrants in New York


Written by:
Sean Cannon

We live in a time where lists make up much of the content that appears in our timelines each day. So, why not ride the wave? Everybody loves a good list, after all!

To start off our new Sponsor Pipeline Insights series, we’ll begin with the Empire State. With 876 studies currently active, 234 of which being registered in the previous 12 months, New York is squarely planted within the top 10 most active states across the country, neatly keeping up with our "Top 10" theme.

It comes as no surprise that the focus of the largest study registrants is dominated by Oncology, much like the rest of the country. Cancer goes 10/10 in the primary therapeutic area of focus for the most active study registrants across the United States! (1)

#10a - Phosplatin Therapeutics

Phosplatin Therapeutics Logo

Starting the list in a 3 way tie, with 2 studies registered in the previous 12 months, is Manhattan’s privately-held Phosplatin Therapeutics. The exclusive rights holder to Phosplatins are focused on the development of cancer treatments, targeting solid tumor as well as hematological malignancies with PT-112. The first enrollment in their latest Phase I/II study of PT-112 in relapsed or refractory multiple myeloma was announced in February 2018. Their current total count for active studies is up to 3.

Have a Zymewire account? Click here to view all of Phosplatin’s global activity!

#10b - Vaccinex Inc.

Vaccinex Inc. Logo

Rochester’s Vaccinex Inc. is also tied for spot #10, with 2 new studies registered in the last 12 months to bring their active total to 3. The privately held, clinical stage biotech company focuses on developing biologic products for the treatment of serious oncologic, neurological, and autoimmune indications.

Vaccinex’s multi-indication candidate, VX15, on their Semaphorin 4D (SEMA4D) platform received both FDA Fast Track and Orphan Drug designations for the treatment of Huntington’s Disease. VX15 is also in Phase 1 for the treatment of Non-Small Cell Lung Cancer, Melanoma, and Osteosarcoma.

Have a Zymewire account? Click here to view all of Vaccinex’s global activity!

#10c - Tonix Pharmaceuticals ($TNXP)

Tonix Pharmaceuticals Logo

Headquartered on Madison Avenue and about a stone’s throw away from Bristol Myers Squibb’s Park Avenue location, Tonix currently has 3 active studies, 2 of which were registered in the previous 12 months. They are focused on developing treatments for CNS disorders as well.

Two of Tonix’s therapeutic programs are focused on Post Traumatic Stress Disorder (PTSD). Tonmya (TNX-102 SL), their upcoming bedtime treatment, is currently in Phase III and is focused on the military related PTSD population. Their daytime counterpart (TNX-601) is in preclinical development. Outside of PTSD, they are also running a biological program for TNX-801 to potentially target Smallpox through the vaccine containing live synthetic horsepox.

Have a Zymewire account? Click here to view all of Tonix’s global activity!

#9 - Axsome Therapeutics ($AXSM)

Axsome Therapeutics Logo

Rounding out the list is NYC’s Axsome Therapeutics, the clinical stage company focused on CNS treatments. Their pipeline includes 2 late stage candidates (AXS - 05 & AXS - 02) and 3 early stage (AXS - 07, AXS - 06, & AXS - 09). Of their 5 currently active studies, 2 were registered in the previous 12 months.

Indications for their two leading candidates are: Treatment Resistant Depression (TRD) & Agitation in Alzheimer’s patients (AXS - 05), and pain treatment for Knee Osteoarthritis associated with bone marrow lesions & chronic low back pain (CLBP) associated with Modic changes. The studies for all indications, aside from  CLBP, have all been granted Fast Track designations.

Indications for their early stage candidates include: Migraines, Osteoarthritis, Rheumatoid Arthritis, and other CNS indications.

Have a Zymewire account? Click here to view all of Axsome’s global activity!

#8 - Y - mAbs Therapeutics Inc.

Y-mAbs Logo

Based on Park Avenue in Manhattan, the clinical stage biopharmaceutical company sets their sights on Oncologic therapies, building their pipeline from 2 platforms (Bispecific Antibodies & MULTI TAG Protein). They currently have 9 active studies, 2 from the past 12 months, across their pipeline that examines multiple adult and pediatric oncologic indications.

Have a Zymewire account? Click here to view all of Y-mAbs’ global activity!

#7 - Kadmon Corporation LLC ($KDMN)

With 2 of their 12 active studies registered in the previous 12 months, Kadmon is focusing on small molecule and biologic therapies to target various autoimmune, fibrotic, and neurodegenerative conditions.

They most recently released a positive update for a Phase 2 trial for KD025 platform, an oral small-molecule inhibitor of the ROCK (Rho-associated coiled-coil kinase) pathway targeting autoimmune and fibrotic indications. This particular study examines the safety and activity of KD025 in adults with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).

Have a Zymewire account? Click here to view all of Kadmon’s global activity!

#6 - Progenics Pharmaceuticals Inc. ($PGNX)

Progenics Pharmaceuticals Logo

With HQ situated down the Hudson River from their existing Tarrytown location, Progenics’ recently (2016) leased view from the 47th floor of the coveted One World Trade Center is undoubtedly sweet. At a reported $78 per square foot, it would have to be!

Running 7 active studies across their oncology pipeline, 3 are new within the last year. The furthest 2 candidates are their ultra-orphan radiotherapeutic, Azedra, and their radioimaging candidate, 1404, which targets prostate specific membrane antigen (PMSA). With a PDUFA date of July 30 2018, Azedra will be used in the treatment of SNS tumors (malignant pheochromocytoma and paraganglioma).

Have a Zymewire account? Click here to view all of Progenics’ global activity!

#5 - Athenex Inc. ($ATNX)

Athenex Inc. Logo

Headquartered in Buffalo, the oncology focused Athenex Inc. has 11 active studies across their pipeline of candidates for a range of oncologic indications, including: breast, ovarian, gastric, Glioblastoma, solid tumor, liquid tumor, and multiple tumors. Their existing KX-01 ointment for Actinic Keratosis is also in early stages for additional indications (Psoriasis & skin cancers). Of their active studies, 3 have been registered in the previous 12 months.

Have a Zymewire account? Click here to view all of Athenex’s global activity!

#4 - Intra-Cellular Therapies Inc. ($ITCI)

Intra-Cellular Therapies Inc. Logo

Focusing primarily on CNS disorders, Intra-Cellular Therapies has 3 pipeline platforms which their candidates are based from. 4 of ITCI’s studies have been launched within the last year, bringing their total active count to 7.

Their main platform, ITI-007, has their lead candidate, Lumateperone, which is being studied for numerous indications such as: Schizophrenia, Bipolar Depression, Dementia related behavioural disturbances, Neuro-psychiatric disorder related sleep disturbance, and other Neuro-Psychiatric disorders like MDD & Autism.

Have a Zymewire account? Click here to view all of Intra-Cellular Therapies’ global activity!

#3 - TG Therapeutics Inc. ($TGTX)

TG Therapeutics Logo

Having just announced a $195m global licensing agreement with Novimmune for developing a novel Hematologic B Cell antibody, and expecting trials on the newly renamed TG-1801 to begin Q4 2018/Q1 2019, things will be busy for TG. The remainder of TG Therapeutics’ pipeline focuses on treatments for B-Cell Malignancies and autoimmune diseases.

Of their 22 currently active studies, 5 have been registered in the last 12 months.

Have a Zymewire account? Click here to view all of TG’s global activity!

#2 - Regeneron Pharmaceuticals ($REGN)

Regeneron Logo

Ramping the action up as we approach the end of our list (Don’t worry, there’ll be many more in the future if you’d like!), is Regeneron. They have almost 100x the employees of TGTX, so it only makes sense to have many more open studies. They are currently running 101 active studies, with 38 registered within the last year. They most recently registered a PII study with the M.D Anderson Cancer Center to examine REGN2810 prior to surgery in patients with Advanced Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head & Neck.

It was also recently announced that Invovio Pharmaceuticals out of Pennsylvania treated their first patient in a PI/PII Glioblastoma study with INO-5401 in combination with Regeneron’s PD-1 Inhibitor.

Have a Zymewire account? Click here to view all of Regeneron’s global activity!

#1 - Pfizer ($PFE)

Pfizer Logo

Coming as no surprise, Pfizer is the ruler of the Empire (State). The pharma behemoth launched 145 of their 510 currently active studies this past year, ensuring that they keep their almost 120 000 employees busy. They recently completed a long running (2009 start) study of the effects of temsirolimus when added to standard chemotherapy with carboplatin and paclitaxel. The target indication of the study was Recurrent or Metastatic Head and Neck Squamous Cell Cancer.

Undoubtedly, Pfizer must have their eyes set on Roche in the USA v. Switzerland battle for big pharma’s silver medal. Novartis is closer behind though, threatening to knock Pfizer from the top 3(2).

Have a Zymewire account? Click here to view all of Pfizer’s global activity!

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The fine print:

  1. Overall primary therapeutic area of focus for the sponsor company, not the primary focus of studies registered.
  2. Based on Q1 2018 revenue.