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FDA grants breakthrough status for Pfizer’s leukaemia drug inotuzumab ozogamicin

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Inotuzumab ozogamicin
RN: 635715-01-4
UNII: P93RUU11P7

Pfizer Inc., Oncology Institute Of Southern Switzerland  INNOVATOR

2D chemical structure of 635715-01-4

http://chem.sis.nlm.nih.gov/chemidplus/rn/635715-01-4

  • MF 1680.6764
  • Oncological Treatment

FDA grants breakthrough status for Pfizer’s leukaemia drug inotuzumab ozogamicin
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer’s investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin to treat acute lymphoblastic leukaemia (ALL).

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer’s investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin to treat acute lymphoblastic leukaemia (ALL).

The breakthrough status was based on data from the Phase III INO-VATE ALL trial, which enrolled 326 adult patients with relapsed or refractory CD22-positive ALL and compared inotuzumab ozogamicin to standard of care chemotherapy………….http://www.pharmaceutical-technology.com/news/newsfda-grants-breakthrough-status-pfizer-leukaemia-drug-inotuzumab-ozogamicin-4697877?WT.mc_id=DN_News

Inotuzumab ozogamicin (CMC-544) is an antibody-drug conjugate for the treatment of cancers.[1] It consists of the humanized monoclonal antibody inotuzumab (for CD22), linked to a cytotoxic agent from the class of calicheamicins (which is reflected by ‘ozogamicin‘ in the drug’s name).[2]

This drug is being developed by Pfizer and UCB.

It is undergoing numerous clinical trials,[3] including two phase II trials for Non-Hodgkin lymphoma (NHL).

A phase III trial in patients with follicular b-cell NHL has been terminated due to poor enrollment.[4] A Phase III trial in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma (NHL) who were not candidates for intensive high-dose chemotherapy was terminated for futility.[5]

Monoclonal antibodies (mAbs) and derivatives are currently the fastest growing class of therapeutic molecules. More than 30 G-type immunoglobulins (IgG) and related agents have been approved over the past 25 years mainly for cancers and inflammatory diseases. In oncology, mAbs are often combined with cytotoxic drugs to enhance their therapeutic efficacy. Alternatively, small anti-neoplastic molecules can be chemically conjugated to mAbs, used both as carriers (increased half-life) and as targeting agents (selectivity). Potential benefits of antibody-drug conjugates (ADCs), strategies, and development challenges are discussed in this review. Several examples of ADCs are presented with emphasis on three major molecules currently in late clinical development as well as next generation thio-mAbs conjugates with improved therapeutic index.

PATENT

http://www.google.com/patents/WO2013088304A1?cl=en

Inotuzumab ozogamicin:

Figure imgf000012_0001

is described in U.S. Patent Application No. 10/428894

 

 

U.S. Patent Application No. 10/428894

 

 

 

 

References

  1.  Statement On A Nonproprietary Name Adopted By The Usan Council – Inotuzumab ozogamicin, American Medical Association.
  2.  Takeshita, A; Shinjo, K; Yamakage, N; Ono, T; Hirano, I; Matsui, H; Shigeno, K; Nakamura, S; Tobita, T; Maekawa, M (2009). “CMC-544 (inotuzumab ozogamicin) shows less effect on multidrug resistant cells: analyses in cell lines and cells from patients with B-cell chronic lymphocytic leukaemia and lymphoma.”. British journal of haematology 146 (1): 34–43.doi:10.1111/j.1365-2141.2009.07701.x. PMID 19388933.
  3.  http://clinicaltrials.gov/ct2/results?term=Inotuzumab+ozogamicin
  4.  http://clinicaltrials.gov/ct2/show/NCT00562965
  5.  http://pfizer.newshq.businesswire.com/press-release/pfizer-discontinues-phase-3-study-inotuzumab-ozogamicin-relapsed-or-refractory-aggress
  6. http://pubs.rsc.org/en/content/articlelanding/2008/np/b514294f#!divAbstract

Structure of inotuzumab ozogamicin. ABOVE

Inotuzumab ozogamicin?
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target CD22
Identifiers
CAS Registry Number 635715-01-4 
ATC code None
UNII P93RUU11P7 
KEGG D08933 Yes
Chemical data
Formula C6518H10002N1738O2036S42
Molecular mass 150,000 Daltons

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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