Avid Bioservices Inc (CDMO)

[freethemice]

The NHS76 antibody story. The AACR abstract #1536: ”A Novel Immunocytokine Generates a CD8+
T Cell-Mediated Anti-Tumor Response In Vivo”, which uses NHS-IL12 and spurred me to do a little research on the antibody NHS76,
which was developed by Peregrine quite a while ago, and licensed to Merck KGaA.

Then I found that there is a new National Cancer Institute phase I trial using the immunocytokine NHS-IL12, and will recruit up to 78 patients.
http://clinicaltrials.gov/ct2/show/NCT01417546
NHS-IL12 for Solid Tumors
"The NHS-IL12 immunocytokine is composed of 2 IL-12 heterodimers, each fused to one of the H-chains of the NHS76 antibody,
which has affinity for both single- and double-stranded DNA. Thus, NHS-IL12 targets delivery to regions of tumor necrosis where DNA
has become exposed."

This immunocytokine, NHS-IL12, is owned by EMD Serono, and is listed in their current pipeline.
http://www.emdserono.com/en/therapies/pipeline/pipeline.html#
EMD SERONO IS AN AFFILIATE OF MERCK KGAA, DARMSTADT, GERMANY

On further research I found that from 2008-2011 there was a trial using dogs and was carried out at
many vet schools around the country. I found at least these vet schools were involved:
Colorado State, Cornell, Ohio State,Texas A & M, Univ of California, Davis, Univ of Tennessee, Univ of Missouri
Evaluation of NHS-IL12-IL2 and NHS-IL12 Fusion Proteins in Tumor-bearing Dogs
The grants for this trial were awarded by EMD Serono.

A few past press releases from Peregrine about NHS76.

Peregrine Pharmaceuticals Announces Publication of Data Related to Its Tumor Necrosis
Therapy Technology Platform
Pre-clinical Data Presented at the American Association of Cancer
Research Annual Meeting
TUSTIN, Calif., March 30, 2004 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals (Nasdaq: PPHM) announced today that data
related to its Tumor Necrosis Therapy (TNT) technology platform was presented at the American Association of Cancer
Research annual meeting. The presented research describes the expression and testing of Peregrine's human TNT
monoclonal antibody (NHS76) linked to the human cytokine Interleukin-2 (IL-2). The expressed fusion protein retained
functional activity of IL-2 and had a very low toxicity profile in animal studies. TNT directed cytokines are currently under
development by Merck KGaA of Darmstadt, Germany, under a licensing agreement with Peregrine.

The first Peregrine News Release about NHS76 is here:
Peregrine Pharmaceuticals Announces Publication of Data Demonstrating Similar
Characteristics of Chimeric and Human TNT Monoclonal Antibodies
TUSTIN, Calif, Dec 17, 2001 (BW HealthWire) --
Study Concludes That Human TNT Antibody Shows Promise for Human Use
Peregrine Pharmaceuticals Inc. (Nasdaq:PPHM) today announced that an article published in the journal Hybridoma and
Hybridomics has verified the similarity of chimeric and human Tumor Necrosis Therapy (TNT) monoclonal antibodies.
The article is titled "Characterization of a Phage Display-Derived Human Monoclonal Antibody (NHS76) Counterpart to Chimeric
TNT-1 Directed Against Necrotic Regions of Solid Tumors." It appears in the current issue of the journal (Volume 20, Number 5,
2001).
The study compared the genetically engineered NHS76 human TNT monoclonal antibody (MAb) with the chimeric TNT-1
(chTNT-1) MAb, which is in advanced human clinical testing. It demonstrated that the two MAbs display similar pharmacokinetic
characteristics, in vivo behaviors and targeting abilities.
Tumor Necrosis Therapy is Peregrine's tumor-targeting platform technology, which targets DNA-associated antigens in the
nucleus of necrotic cancer cells. The concept behind TNT is to take advantage of the fact that all tumors produce numerous
necrotic cells as a by-product of their growth.
Healthy tissues quickly flush away necrotic cells, but tumors retain them, holding them locked inside the core of the tumor mass.
The outer membranes of necrotic cancer cells become leaky, thus exposing the DNA on the inside of the cell. TNT selectively
targets this DNA and anchors its deadly, cancer-killing radioactive isotope at the core of the tumor.
Since DNA exists in all cells, TNT can potentially target all solid tumor cancers.
"The NHS76 and chTNT-1 monoclonal antibodies were tested rigorously in parallel to compare affinity, pharmacokinetics,
biodistribution in vivo and tumor targeting," said Alan L. Epstein, M.D., Ph.D., Peregrine's scientific consultant, inventor of the
TNT platform technology, and co-author of the study.
"Our demonstration of the comparability of NHS76 to chTNT-1 indicates that the human monoclonal antibody has the potential
to accomplish all of the therapeutic goals already demonstrated with the chimeric antibody.
"As a fully human, nonantigenic counterpart to the chimeric TNT antibody, it therefore appears to be a good candidate to be
used in future clinical trials for the treatment of refractory solid tumors in man."

So my question is will Peregrine ever get any money from the NHS76 license ?