Avid Bioservices Inc (CDMO)

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After all else has failed for (DLBCL) diffuse large B-cell lymphoma, then and only then may GILD’s CAR T be used for treatment.

Why? because CAR T has a BIG safety problem:

IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.

Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.

Cytokine Release Syndrome (CRS)


Gilead’s “Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy”

http://www.gilead.com/news/press-releases/2017/10/kites-yescarta-axicabtagene-ciloleucel-becomes-first-car-t-therapy-approved-by-the-fda-for-the-treatment-of-adult-patients-with-relapsed-or-refractory-large-bcell-lymphoma-after-two-or-more-lines-of-systemic-therapy

CAR T therapies need a major assist with safety.

Long investors in Peregrine who follow Peregrine’s anti-PS development program are aware of the excellent safety data resulting when CAR T is combined with anti-PS mAbs.

“Targeting phosphatidylserine in combination with adoptive T cell transfer eliminates advanced tumors without off-target toxicities in a melanoma preclinical model”

Memorial Sloan Kettering/Peregrine Pharmaceuticals collaboration.

http://www.peregrineinc.com/images/stories/pdfs/aacr2017hirschhorn.pdf

When CAR T companies solve their safety issues, they should quickly move to an expanded market of front line treatments of solid and liquid cancers. That would be a move from being a $billion dollar treatment in annual revenues to multi $billions of dollars annually.

Peregrine owns the anti-PS IP that solves CAR T safety issues.

How big is the market??

I have access to a long list of cancer indications that expresses the expanse of the potential oncology market that needs safe and efficacious solutions.

IMO

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