TG Therapeutics Inc (TGTX)

[XenaLives]

It seems that MOA is similar to Roche Ocrevus

Summary

TG Therapeutics announced additional positive data of TG-1101 in MS in late April.

Roche's Ocrevus has the potential to become new standard of care in MS, which bodes well for TG-1101.

If TG-1101 is approved, the company intends to compete on convenience and price.

TG Therapeutics (NASDAQ:TGTX) announced additional promising data of TG-1101 (ublituximab) from its ongoing phase 2 study in patients with relapsing forms of multiple sclerosis (RMS) at the 69th American Academy of Neurology (AAN) annual meeting in Boston, MA, in late April. I initiated coverage on TG Therapeutics back in January (the article is exclusive to Growth Stock Forum subscribers), and this article provides an overview of TG-1101's opportunity in MS.

Background - Ocrevus's potential to become new standard of care in MS

Before delving into '1101's potential, let's take a look at current market dynamics.

Roche (OTCQX:RHHBY) developed Ocrevus, an anti-CD20 monoclonal antibody, as a replacement for Rituxan, which showed promising efficacy in MS, but the company never bothered to conduct pivotal trials to expand the label, since Rituxan will lose patent protection soon. Rituxan is used off-label for MS, but reimbursement can be hard to obtain. Ocrevus is an improved version of Rituxan, and it has all the hallmarks of a new market leader. Roche conducted two large MS studies which showed superiority over Rebif (interferon beta-1a):

Annualized relapse rate of 0.16 versus 0.29 - 46% lower rate with ocrelizumab; p<0.001.
Percentage of patients with disability progression confirmed at 12 weeks was lower with Ocrevus (9.1% versus 13.6%; hazard ratio 0.60, p<0.001).
Percentage of patients with disability progression confirmed at 24 weeks was also lower with Ocrevus (6.9% versus 10.5%, hazard ratio 0.60, p=0.003).
Mean number of gadolinium-enhancing lesions per T1-weighted magnetic resonance scan was 0.02 with Ocrevus and 0.29 with Rebif in trial 1 (94% lower number of lesions with Ocrevus, p<0.001) and 0.02 versus 0.42 in trial 2 (95% lower number of lesions, p<0.001).
Change in Multiple Sclerosis Functional Composite score favored Ocrevus in trial 2 (0.28 versus 0.17, p=0.004) but not in trial 1 (0.21 versus 0.17, p=0.33), though it trended in the right direction.

https://seekingalpha.com/article/4075549-tg-therapeutics-promising-ms-data