Avid Bioservices Inc (CDMO)

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Thanks Exwannabe for your reply. PPHM already has a conjugated TNT product ( NHS-76 HUMANIZED TNT CONJUGATED WITH MODIFIED HUMANINTERLEUKIN 2-IL-2LT )in cinical trials run by licensee Merck KGaA.


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PPHM licensee Merck KGaA adds 2nd Ph.1 trial
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cjgaddy Member Profile cjgaddy

Sunday, May 24, 2009 12:15:21 PM
Re: None
Post # of 110617
PPHM licensee Merck KGaA adds 2nd Ph.1 trial for SELECTIKINE, this one for Selectikine+RAD vs. NSCLC in The Netherlands. Recall that “SELECTIKINE” is the brand name for the TNT-based immunocytokine fusion protein “NHS-IL2-LT (EMD 521873)”, which Merck KGaA licensed from Peregrine in 2000. In Dec.2006, Merck began its 1st Ph.1 trial (Selectikine+Chemo vs. Solids-Tumors or NHL) at 2 sites in Switzerland.

2nd SELECTIKINE PHASE I TRIAL:
“EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)”
Phase I: This study is not yet open for participant recruitment.
First Received: April 10, 2009, Sponsored by: Merck KGaA
Est. Enrollment: 12
Study Start Date: April 2009
Est. Completion Date: March 2010
Location: Netherlands, Dept. of Thoracic Oncology, Netherlands Cancer Instiute
http://clinicaltrials.gov/ct2/show/NCT00879866

History of the Merck KGaA licensing arrangement:

I. 10-2000 MERCK-KGAA (GERMANY) TNT-BASED “CYTOKINE FUSION PROTEINS” LICENSING AGREEMENT:
$400k upfront plus future milestone payments and royalties on net sales…
10-23-2000 PR: “Techniclone & Merck KGaA Sign Agreement On Use of Tumor Necrosis Therapy Technology”
… Under the agreement, Techniclone will grant Merck the right to use its proprietary TNT antibodies for producing immunocytokines - novel antibody-cytokine fusion proteins used in the treatment of various diseases...
http://tinyurl.com/rbo62u
4-30-2001 10K:
TUMOR NECROSIS THERAPY (COTARA)
“During Oct.2000, the Company entered into a licensing agreement with Merck KGaA to license a segment of its TNT technology for use in the application of cytokine fusion proteins. Under the terms of the licensing agreement, the Company will receive up-front payments of up to $400,000 upon the satisfaction of certain conditions set forth in the agreement, of which, the Company received $50,000 in Nov.1999. The Company will also receive a royalty on net sales, as defined in the agreement, upon the commencement of commercial sales.”
http://tinyurl.com/ostw9a

II. 4-2004: MERCK-KGAA PRESENTS NHS76:IL-2 (SELECTIKINE) AT AACR’04:
AACR 2004 Abstract #654: “Engineering of an IL-2 Immunocytokine with Very Low Toxicity That Retains Potent Anti-Tumor Activity in Immune Competent and Immune Deficient Mouse Tumor Models”
Stephen D. Gillies… Kin-Ming Lo, EMD-Lexigen Research Center [subsidiary of Merck KGaA]
The use of IL-2 for cancer therapy has been limited by its side effect profile that primarily includes effects in the vascular compartment such as vascular leak syndrome and hypotension… In our studies of IL-2 toxicity we have identified a specific IL-2 mutant, D20T, which has little selectivity for high over intermediate affinity IL-2 receptors as a free IL-2 molecule but which has profound selectivity when it is fused to the carboxyl terminus of an antibody to form an immunocytokine… The final molecule was engineered using the V regions from a human antibody, NHS76, with high affinity for the necrotic core of solid tumors, thus allowing for selective targeting of this modified IL-2 to virtually any tumor with necrosis… Studies in several mouse tumor models demonstrate that this immunocytokine, NHS-IL2 (D20T), is extremely well tolerated in immune competent mice and retains most of its anti-tumor activity against established metastases…
http://tinyurl.com/pxl2aa

III. 2-2007: MERCK/GER 1ST PH.1 TRIAL OF SELECTIKINE+CHEMO VS. SOLID-TUMORS OR NHL:
2-22-07 PR: “Peregrine's Licensee Initiates Phase I Clinical Trial in Europe With Novel Tumor Necrosis Therapy Cancer Agent”
http://pphm.client.shareholder.com/releasedetail.cfm?ReleaseID=266050
PH.1 Trial Protocol: Selectikine (EMR 62235-001)
“A Phase 1, Open-Label, Two-Group, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of EMD 521873 Alone and in combination With Fixed Low Doses of Cyclophosphamide in Patients With Metastatic or Locally Advanced Solid Tumors or B-Cell non-Hodgkin Lymphoma”
Sponsor: Merck KGaA, Darmstadt, Germany
Local Principal Investigator: Dr. R. Stupp
http://www.cancer-chuv.ch/ccl_zoom_merck_selectikine.pdf
5-2007: 2nd SELECTIKINE site added, Univ. of Lausanne, Switz: http://tinyurl.com/2l933s
Site1: Oncology Institute of So. Switzerland, Bellinzona, Switzerland
Site2: Multidisciplinary Oncology Center, Univ. of Lausanne Hospital (CHUV), Lausanne, Switzerland http://tinyurl.com/pthokh

IV. 4-2008: LAUSANNE HOSP. (SITE #2) GIVES UPDATE ON SELECTIKINE PH.1 TRIAL:
2007 ANNUAL SCIENTIFIC REPORT – 4-8-08
Prof. C. Ruegg, Head, Div. of Experimental Oncology (DEO)
2. RESEARCH PROJECTS
2.2. Cancer immunotherapy with tumor-specific T lymphocytes
#9: “Characterization Of Cellular Immune-Responses In Cancer Patients Treated With The Immunocytokine Selectikine, An IL2/Anti-DNA Fusion Protein”
J. Laurent, P. Romero, R. Stupp, and D.E. Speiser
Selectikine (EMD 521873) is a fusion protein consisting of a human antibody fused to 2 molecules of a genetically modified human interleukin-2 (hIL2). Preclinical data suggest that immunocytokines exert antitumor-activity via CD8 T cell mediated mechanisms. Experiments in mice with the wild-type-IL2 containing immunocytokine ch.14.18-IL2 demonstrated CD8 T cell responses against tumors. Other experiments with ch14.18.IL2 showed that immunocytokine-treatment induced clonal expansion of T cells. Since 2007, 20 patients have been treated with escalating doses of selectikine from 0.075 mg/kg to 0.6 mg/kg. Analysis of T cell populations revealed an increase of proliferation and activation state of CD8 and CD4 T cells, but no significant effect on natural killer cells as expected. No dose depending effect has been observed between the different groups, showing that T cells react well already at low doses. Analysis of sub-populations of CD4 T cells revealed that T-reg cells are also sensitive to Selectikine, likely due to their expression of the high avidity IL2 receptor CD25. As a consequence, T-reg cells proliferate considerably upon treatment with Selectikine. Functional analysis of T cells, including T-reg cells are ongoing (Study Sponsored by Merck KGaA, Darmstad & EMD Pharmaceuticals Durham, USA).
http://www.cancer-chuv.ch/ccl_home/ccl_recherche/annual_scientific_report.htm

V. 6-2008: MERCK-KGAA PROFILES SELECTIKINE IN FACT SHEET:
Early Stage Products…
• NHS-IL2-LT (EMD 521873) – this immunocytokine delivers a localized high dose of a genetically modified human interleukin 2 (IL-2LT) to the dead and dying cells, which are found in the center of solid tumors. This activates a cellular immune response. The antibody part of the molecule is designed to target DNA, which is released by necrotic cells. The resulting immune response is expected to kill viable tumor cells surrounding the necrotic regions. NHS-IL2-LT is currently in Phase I trials for solid tumors.
ORIG-LINK: http://www.merck.de/servlet/PB/show/1803080/IR_About%2520Merck.pdf

VI. 9-2008: EMD-SERONO (SUBSID. OF MERCK-KGAA) PRESENTS SELECTIKINE:
9-18-08 4-5:30pm: “DF/HCC Pipelines in Oncology: EMD Serono”
Dana-Farber Cancer Institute, Boston
• Jens Oliver Funk, MD, Senior VP, Merck Serono Res.; Global Head TA Oncology
• Frank T Weber, MD, PhD, Senior VP, Merck Serono Res., Head of Exploratory Medicine
• Oscar Kashala, MD, PhD, DSc, Senior Medical Dir., Dev., Head US Oncology Dev.
PROGRAMS/PRODUCTS PRESENTED:
• Erbitux
• Cilengitide - Cyclic RGD peptide integrin inhibitor
• DI17E6 - Anti- Integrin Antibody
• Stimuvax - Therapeutic MUC-1-based cancer vaccine
• Survivac - Therapeutic survivin-based cancer vaccine
• Selectikine - NHS-IL2-LT immunocytokine
• Aurora Multikinase Inhibitor (AS703569)
• MEK Inhibitor (AS703026)
http://tinyurl.com/phmeac

VIi. 4-2009: MERCK-KGAA ADDS 2ND PH.1 SELECTIKINE TRIAL:
“EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)”
First Received: April 10, 2009, Sponsored by: Merck KGaA
Est. Enrollment: 12
Study Start Date: April 2009
Est. Completion Date: March 2010
Location: Netherlands, Dept. of Thoracic Oncology, Netherlands Cancer Instiute
http://clinicaltrials.gov/ct2/show/NCT00879866

= = = = = = = = =
Note: Merch/KGaA vs. Merck & Co. - the similarities in the names of the two companies are a result of common roots in Germany, beginning with the purchase of the pharmacy Engel-Apotheke in Darmstadt in 1668 by Friedrich Jacob Merck. The American subsidiary Merck & Co. was founded in 1891 in the course of expansion. In 1917 Merck & Co. became an independent company with no relations to Merck KGaA.
http://www.merck.de/en/company/history/history.html


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