Attacking tumor with patient’s own anti-tumor CD8+ T-killer cells and Natural Killer Cells
To get rid of the residual tumor and metastases…
FDA USA: = 27 april 2010, “ Provenge ” Cancer Vaccine, Dendreon,
But the success rate is still low: ~ + 4 months?
Why?-Tumor protects itself from anti-tumor T-killer cells;
“ Hellstrom Paradox”…
Immunotherapy of Cancer ( “Our last hope”… )
The “Hellstrom” Paradox”, Natur e, 1968; ? Anti-tumor T cells destroy tumor cells in vitro : The “Hellstrom-Schreiber” Paradox: -“ Equilibrium lesions ”(Nature, 2007) The Motivation: 1974, Moscow University In vivo tumor seems to be protected :
Adenosine puts anti-tumor T killer cells to sleep … The Solution Ohta and Sitkovsky, Nature 2001
The Skolkovo may have chance to develop the most superior treatment using the next Generation Herceptin;
The answer #1: Recruiting the Discoverer of Herceptin
S22-Fc - a multi-specific binder to EGFR, Her3 and Her2/neu Binding to T6-17 (Her2) and NE91(EGFR) cells by S22-Fc MCF7 NE91 T6-17 S22-Fc S22 Fc
“ Creation of a trivalent antibody like molecule with picomolar activity against EGFr, HER2/neu and HER3” The molecule is already fully “human” …; Has potential to help all HER+ breast cancer patients as compared with 25% for original herceptin Ab… as compared with Zero with no “old” herceptin. Is not it something that “ everybody wants and nobody has ”?
Drugs that are not novel, but are much needed… and can be “novel again”…
These drugs can be also very lucrative
Multi-$ Billion market
-The IP- is getting “old”…
But the international IP on them is still possible!
Disease specific mAB libraries detect the natural form of the proteome
Easy to translate
Generation of the BSI mAb library against native human plasma proteins using mAb proteomics (patent pending) Patent pending proteome normalization (10,000 mABs / experiment) No translation bottleneck Record speed form bench to market
“ In Skolkovo” created mAb/Proteomics diagnostics
A test for early detection of lung cancer is in late development phase
Expectation is improvement of survival from 16% to 50%
1. Identifying top scientists with cutting-edge discoveries that have significant translational potential
2. = SITM:
Skolkovo Institute of Translational Medicine
Novel Treatments and drugs IP-Creating companies in Skolkovo
Contacts USA numbers 617-669-88-16 - works in Moscow 617-800-52-65
Skolkovo is also uniquely qualified to catapult the medical care in Russia to the much higher levels
One can think about the MedTechSOP-Transfer enterprise in Skolkovo;
The Medical Treatments, Standard Operating Procedures (SOP) and Technology transfer
Top clinician-scientists of Dana Farber Cancer Institute, Harvard Institutes of Medicine,Harvard Medical School..
A lot of people to persuade, but there is some initial interest..
Molecular Weight hGH ~ 3000 atoms Factor VIII ~ 55,000 atoms Need for Trials Biosimilars – Complexity leads to unknowns - If you don’t run trials – you won’t know the safety or efficacy Aspirin 21 atoms Complexity of biotech products IgG Antibody ~ 25,000 atoms 0 200,000 350,000 250,000 50,000 150,000 100,000 300,000 COOH OCOCH 3
Drug Discovery from Uncultur-able before Microorganisms ● 99% of all species of microorganisms on the planet do not grow in the lab ● Millions of new species, an enormous untapped resource for drug discovery ● A general method to grow uncultured microorganisms developed based on cultivation in situ in diffusion chamber and subsequent “domestication” for growth in the lab ● Growth factors for many uncultured species identified, an additional tool for growing them in the lab Patent: US 7,011,957 Kaeberlein et al., Science 296:1127-1129. Schumacher et al., 2009. Science 323:396-401. Dörr et al., PLoS Biol 8(2): e1000317. Lewis, K. 2007. Nature Rev. Microbiol. 5:48-56. D’Onofrio et al., 2010. Chem. & Biol. 17: 254–264.
Generation of the BSI mAb library against native human plasma proteins using mAb proteomics (patent pending) Plasma Normalization Patent pending Shotgun Immunization Library characterization screening mAb Production mAb microarray Production QuantiPlasma™ PlasmaScan™ Microarray Libraries >600 mABs “ 10 000 mABs” Plasma Collection Nascent library generation HT Hybridoma Cloning mAb validation ELISA Characterization mAb/epitope/protein ID
An Open Forum on the Scientific and Regulatory Issues of Biosimilars and Follow-on Biologics Boston, MA USA Copley Marriott Hotel Address by: Senator Edward Kennedy Chairman of the Senate Health, Education, Labor and Pensions Committee Plenary by: Dr. Randall Lutter Acting Deputy Commissioner for Policy, US FDA Organizing Chair: Prof. Barry Karger Director, Barnett Institute, and James L. Waters Chair, Northeastern University Hosted by: A high level meeting of the international biotechnology and generics industries, together with government regulators and academic laboratories, for an open forum and collegial debate on the scientific and regulatory issues in the introduction of generic complex biological drugs. www.barnett.neu.edu/biogenerics/ For additional information or to receive updates, email Biogenerics2008@neu.edu BIOGENERICS March 2-4, 2008
BIOSYSTEMS INTERNATIONAL The antibody technology company