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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: I. Luttichuys who wrote (501)3/20/1997 3:10:00 PM
From: Webhead   of 1762
 
Hi all,

I found the news release describing the notice of allowance for IDEC's primatized antibodies (appended below). Somehow I was under the impression that IDEC simply swapped constant regions with monkey IgG but in looking at IDEC's prepectus (appended after news release) I see that Max is quite right that IDEC actually generates monkey monoclonal antibodies that are then recombined with the human constant region. This does mean that they cannot simply convert someone else's monoclonal to Primatized format but actually have to generate such a monoclonal from scratch. This is fine for their own use and may generate some more nice manufacturing contracts but PDL clearly has the upper hand in resusitating other comanies' mouse monoclonals. Oh well...


Here is the news release:

IDEC PHARMACEUTICALS TO RECEIVE U.S. PATENT
COVERING
PRIMATIZED ANTIBODY TECHNOLOGY

SAN DIEGO, CA (February 28, 1996): IDEC Pharmaceuticals Corporation (NASDAQ:IDPH) today
announced the receipt of a notice of allowability for a United States patent providing broad protection for the
Company's PRIMATIZEDt antibodies. Four of the Company's products utilize this technology which, through
genetic engineering, combines components of macaque monkey antibodies and human antibodies for use in
human therapy.

PRIMATIZED antibodies are potentially suitable for long-term treatment of chronic diseases. Structurally
indistinguishable from human antibodies, these antibodies may be less prone to rejection by patients' immune
systems than conventional mouse-derived monoclonal antibodies or even "humanized" antibodies, which also
retain certain mouse-derived antibody components.

IDEC Pharmaceuticals is developing PRIMATIZED antibodies in collaboration with four separate corporate
partners which may contribute up to $135 million for R& D, license fees and milestone payments. The most
advanced PRIMATIZED antibody is IDEC-CE9.1 targeting the T cell CD4 receptor, which is currently being
developed with SmithKline Beecham for treatment of rheumatoid arthritis. Clinical trials to date with
IDEC-CE9.1 have demonstrated clinical activity of the PRIMATIZED antibody with no infusion-related
adverse effects or serious therapy-related adverse effects. IDEC's partner, SmithKline Beecham, is currently
conducting a randomized, double-blinded and placebo-controlled Phase II trial to confirm the safety and activity
of IDEC-CE9.1.

Three additional collaborations focused on PRIMATIZED antibody therapeutics are in earlier stages of
development. These corporate partnerships targeting immune cell receptors D B7 with Mitsubishi Chemical,
CD23 with Seikagaku Corporation and gp39 with Eisai Co., Ltd. D focus on the development of
PRIMATIZED antibodies for the treatment of graft rejection and a variety of autoimmune, inflammatory or
allergic conditions.

====
Here is the snippet from the prospectus
=======

The Company has developed a proprietary PRIMATIZED antibody technology to
overcome HAMA responses and to avoid other immunogenicity problems by developing
monoclonal antibodies from primate rather than mouse B cells. These antibodies
are characterized by their strong similarity to human antibodies and by the
absence of mouse components. In March 1996, the Company received a Notice of
Allowance for a United States patent application claiming the Company's
PRIMATIZED antibodies. Underlying this proprietary technology is the Company's
discovery that macaque monkeys produce antibodies that are structurally
indistinguishable from human antibodies in their variable (antigen-binding)
regions. Further, the Company found that the macaque monkey can be immunized to
make antibodies that react with human, but not with macaque, antigens. Genetic
engineering techniques are then used to isolate the portions of the macaque
antibody gene which encode the variable region from a macaque B cell. This
genetic material is combined with constant region genetic material from a human
B cell and inserted into a host cell line which then expresses the desired
antibody specific to the given antigen. The result is a part human, part macaque
PRIMATIZED antibody which appears structurally to be so similar to human
antibodies that it may be accepted by the patient's immune system as "self."
This development allows the possibility of therapeutic intervention in chronic
diseases or other conditions that are not amenable to treatment with antibodies
containing mouse components.

==========
Cheers,

Ed
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