PeptiDream Announces the Development of a New Broad Strain Anti-Influenza Macrocyclic Peptide Therapeutic

  PeptiDream Announces the Development of a New Broad Strain Anti-Influenza
  Macrocyclic Peptide Therapeutic

Business Wire

TOKYO -- April 8, 2014

PeptiDream Inc., a public Tokyo-based biopharmaceutical company
(“PeptiDream”)( TOKYO:4587) announced today, in collaboration with The Tokyo
Metropolitan Institute of Medical Science (“Tokyo Metropolitan Institute”) the
discovery and development of a novel macrocyclic peptide inhibitor for the
treatment of multiple influenza strains.

Tokyo Metropolitan Institute has been leading a broad-based discovery effort
for novel treatments for influenza, funded by the Japanese government and
initiated in 2008. PeptiDream joined the discovery consortium taking a
peptide-based approach using PeptiDream’s proprietary Peptide Discovery
Platform System (PDPS) to identify novel macrocyclic peptide inhibitors for

Two marketed therapeutics, Relenza (GSK) and Tamiflu (Roche), inhibit the
neuraminidase enzyme on the influenza virus surface, yet these therapeutics
are only effective shortly after viral exposure and are less effective against
newer influenza strains, thus there is immediate need for other more effective
treatments with different mechanisms of action.

The partnership focused on the discovery of novel peptide inhibitors of the
influenza hemagglutinin (HA) protein found on the surface of influenza viruses
and responsible for the binding and entry of virus to cells. PeptiDream
identified lead peptide candidate iHA-24 which exhibited high affinity and
selectivity for the HA protein. In addition, the macrocyclic peptide was
highly effective in preventing both viral infection and viral proliferation in
both cell-based experiments and mouse-based animal studies, and was more
effective than any commercially available treatments. Peptide iHA-24 also
exhibited broad influenza strain efficacy against H1N1 (2009 pandemic strain),
H5N1 (bird flu, SARS), and H2N2 strains.

In light of these breakthrough results, pre-clinical testing in cynomolgus
monkeys is slated to begin in May 2014. Successful validation of efficacy will
lead to the preparation of a complete preclinical development data package for
investigational new drug (IND) application slated for 2015.

[Comments from Dr. Michinori Kohara, Director of Viral Infectious Disease
Project at Tokyo Metropolitan Institute of Medical Science]

“We have been working for some time to develop an antibody therapeutic to
treat influenza targeting the HA protein, and PeptiDream provided an
attractive alternative by developing a peptide therapeutic, capable of
recognizing antigenic regions that conventional antibodies cannot reach
because of their significantly larger size. iHA-24 was found to exhibit
inhibition activity equal to or even higher than that of the current
neuraminidase inhibitors. In addition, we showed that iHA-24 could effectively
inhibit the pandemic H1N1 2009 strain, of which some variants were resistant
to neuraminidase therapeutics. These exciting findings establish peptide
therapy as new anti-viral agents for the treatment of influenza. We intend to
continue pre-clinical testing in monkey trials, while we rapidly prepare for
clinical testing.”

[Comments from Kiichi Kubota, CEO of PeptiDream Inc]

“We believe our macrocylic peptides represent an exciting new approach to more
effectively treating influenza virus, and also toward the prevention of future
influenza outbreaks. In collaboration with Dr. Kohara’s team, we are excited
to start preclinical testing in monkeys with the aim of bringing these
peptides into human testing in 2015. This program represents one of the many
exciting discovery and development programs progressing at PeptiDream, and we
would like to thank Dr. Kohara and the staff at the Tokyo Metropolitan
Institute of Medical Science for all of their efforts.”


PeptiDream Inc.
Patrick C Reid, +81-3-3468-9022 (Tokyo)
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