Avid Bioservices Inc (CDMO)

[sulaco]

microbe, SAFETY, SAFETY, SAFETY

YERVOY (ipilimumab) FDA BLACK BOX - microbeman


Before we all go GAGA over BMS' anti-CTLA-4 ipilimumab activity in the now infamous Figure 2A of the just-released preclinical PPHM study, check the BLACK BOX FDA warning on the drug:

"YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY (ipilimumab). Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. Patients should be assessed for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and clinical chemistries should be evaluated, including liver function tests and thyroid function tests, at baseline and before each dose."

Uh-oh. So while it seems Yervoy can be a SHERMAN TANK against melanoma, apparently crushing Bavi in the competition, it can also crush patients...FATALLY. That's not an easy side effect to overcome. Thus, the BLACK BOX warning on this anti-CTLA-4 agent.


Veterans of biotech investing have seen this too many times to count. A new drug shows very good efficacy at destroying its target, yet also carries the potential to destroy the patient as well.

Be careful with Mother Nature. The human immune system is FAR from fully understood, and firing up T cells by blocking the inhibitory CTLA-4 may have hidden dangers and already has proven risks. Multiple patients died after receiving the drug in the initial study.

Don't count Bavi out quite yet.


GLTAL!

Best,

Joe