Full Press Release Details
Theraclone Sciences Announces Universal
Therapeutic Antibody for Influenza A Demonstrates
Reductions in Clinical Symptoms Score and Viral Load in a Phase 2a Human Viral
Seattle, WA - September 8, 2013
- Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced results from a
Phase 2a viral challenge study of TCN-032 for the universal treatment of influenza A. The results of this study represent the first
demonstration that a non-neutralizing antibody can provide immediate immunity and potential therapeutic benefit in influenza. TCN-032
is a recombinant, fully human monoclonal antibody that has the potential to treat patients who are hospitalized with serious influenza,
as well as during pandemic outbreaks.
In the Phase 2a study, TCN-032 treatment
resulted in significant reductions in clinical symptoms score as well as viral load as compared to placebo-treated subjects. While
the Phase 2a study did not meet its pre-specified primary endpoint, the overall data support an anti-influenza effect, providing
the impetus to proceed to clinical studies in patients with natural infection. TCN-032 was well-tolerated with no serious adverse
events or immunogenicity observed. Pharmacokinetic parameters were consistent with a human antibody as previously confirmed in
the Phase 1 study. Data were presented at the international scientific conference, Options for the Control of Influenza VIII, September
5-10, 2013, in Cape Town, South Africa.
"TCN-032's mechanism of action
holds promise as an alternative or additional therapy to current treatments, particularly in cases of anti-viral resistance potentially
providing an important new treatment option for patients with influenza, including those who are hospitalized with serious disease,"
said Michael G. Ison, MD, MS, FIDSA, Associate Professor, Divisions of Infectious Diseases and Organ Transplantation, Northwestern
University Feinberg School of Medicine and Medical Director, Transplant & Immunocompromised Host Infectious Diseases Service,
Northwestern University Comprehensive Transplant Center. "These data suggest that TCN-032 likely has antiviral activity and
should be further evaluated in clinical studies."
"We are highly encouraged by the
biological efficacy demonstrated in this Phase 2a study," added Eleanor Ramos, M.D., Chief Medical Officer, Theraclone. "TCN-032
was developed using our I-STAR technology for its ability to target a highly conserved portion of the influenza virus, including
highly pathogenic or pandemic strains such as H5N1 and H1N1, and the emerging H7N9, greatly reducing the likelihood of the virus
developing resistance to this antibody."
The randomized, placebo-controlled, double-blind
Phase 2a study was designed to assess the safety and efficacy of TCN-032 in normal human volunteers challenged with influenza A
infection. Twenty-four hours after viral inoculation, subjects were randomized 1:1 to TCN-032 or placebo and monitored for development
of clinical symptom scores and viral load.
A total of 61 subjects were randomized,
of whom 60 received intravenously administered study drug, TCN-032, at a dose of 40 mg/kg, or placebo. A total of 48 subjects met
the definition of laboratory-confirmed infection (TCN-032, n=24 and placebo n=24). A numerical reduction in the primary efficacy
parameter of the proportion of subjects who developed any grade 2 or greater influenza symptom or pyrexia was observed, but not
statistically significant (p>0.10). TCN-032 treated subjects showed significant reductions in both clinical symptom scores and
viral load via qPCR. Median clinical symptom AUC (Day 1-7) was reduced by 35% (p=0.047, Wilcoxon rank-sum test) in TCN-032 subjects
compared to placebo. Time to resolution and duration of symptoms, and nasal mucus weights were reduced in TCN-032 subjects compared
to placebo. Median viral AUC (by qPCR, Day 2-7) was reduced by 2.2 log10 TCID50/mL*Day (p=0.095, Wilcoxon rank-sum test) in TCN-032
subjects compared to placebo. Viral resistance analysis showed no change in the epitope recognized by TCN-032.
The trial was supported in part by Zenyaku
Kogyo Co., Ltd. through its multi-year research and development agreement with Theraclone to identify and develop candidates for
the treatment of pandemic and serious seasonal influenza. Zenyaku Kogyo has an exclusive license in the territory of Japan to Theraclone's
influenza monoclonal antibody program. Theraclone retains worldwide development and commercialization rights outside of Japan.
Theraclone is currently seeking additional commercial partners in other territories of the world.
TCN-032 is a recombinant fully human monoclonal
antibody being developed for the treatment of patients hospitalized with severe influenza A infection and as a stockpiled product
for preventative and therapeutic treatment options in the event of pandemic flu outbreaks. TCN-032 recognizes and binds to an epitope
of the virus protein M2 that is present in virtually all influenza A virus strains. Based on in vitro data, TCN-032 binds
virus and infected cells and triggers antibody-mediated effector functions, resulting in the lysis of infected cells and viral
clearance. TCN-032 is intended to be a universal therapeutic monoclonal antibody against all influenza A virus strains, including
the new avian H7N9 strain, future pandemic strains or other drug-resistant strains.
Theraclone is a biopharmaceutical company
focused on the discovery and development of novel, monoclonal antibody therapeutics for diseases that are devastating for patients
and their families and which are a significant threat to human health. Theraclone leverages its proprietary antibody discovery
technology, I-STAR (In-Situ Therapeutic Antibody Rescue), to identify rare human antibodies that may be developed into antibody
product candidates that are potentially safer and more effective than current therapies. Theraclone has a portfolio of innovative
antibodies in clinical and preclinical development targeting serious medical conditions with a significant unmet medical need and
a primary focus on infectious disease and cancer, which include:
For more information about Theraclone,
please visit www.theraclone-sciences.com. On August 1, 2013, Theraclone Sciences and PharmAthene (NYSE
MKT: PIP) announced a definitive merger agreement.
PharmAthene is a leading biodefense company
engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats.
PharmAthene's current biodefense portfolio includes the following product candidates:
In addition, in May 2013, the Delaware
Supreme Court issued its ruling on the appeal in our litigation with SIGA Technologies, affirming the Court of Chancery's
finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back
to the Court of Chancery to reconsider the appropriate remedy and award of attorney's fees and expert witness costs in light of
the Supreme Court's opinion. For more information about PharmAthene, please visit www.PharmAthene.com.
Important Additional Information about
This communication is being made in respect
of the proposed merger involving Theraclone and PharmAthene. On August 1, 2013, PharmAthene filed with the Securities and Exchange
Commission (the "SEC") a current report on Form 8-K, which includes the merger agreement and related documents. In
addition, PharmAthene intends to file a registration statement on Form S-4 with the SEC, which will contain a proxy statement/prospectus/consent
solicitation and other relevant materials, and plans to file with the SEC other documents regarding the proposed transaction. The
final proxy statement/prospectus/consent solicitation will be sent to the stockholders of PharmAthene and Theraclone in connection
with the stockholder votes on matters relating to the proposed transaction. The proxy statement/prospectus/consent solicitation
will contain information about PharmAthene, Theraclone, the proposed transaction, and related matters. STOCKHOLDERS ARE URGED
TO READ THE PROXY STATEMENT/PROSPECTUS/CONSENT SOLICITATION (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND OTHER DOCUMENTS
FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION THAT STOCKHOLDERS
SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE MERGER AND RELATED MATTERS. In addition to receiving the proxy statement/prospectus/consent
solicitation and proxy card by mail, stockholders will also be able to obtain the proxy statement/prospectus/consent solicitation,
as well as other filings containing information about PharmAthene, without charge, from the SEC's website (http://www.sec.gov)
or, without charge, by contacting Stacey Jurchison at PharmAthene at (410) 269-2610.
No Offer or Solicitation
This communication is not intended to and
does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe
for any securities or the solicitation of any vote or approval in any jurisdiction in connection with the merger or otherwise,
nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer
of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933,
Participants in Solicitation
PharmAthene and its executive officers
and directors may be deemed to be participants in the solicitation of proxies from PharmAthene's stockholders with respect
to the matters relating to the proposed merger. Theraclone may also be deemed a participant in such solicitation. Information regarding
PharmAthene's executive officers and directors is available in Amendment No. 1 to PharmAthene's proxy statement on
Schedule 14A, filed with the SEC on May 9, 2013. Information regarding any interest that PharmAthene, Theraclone or any of the
executive officers or directors of PharmAthene or Theraclone may have in the transaction will be set forth in the proxy statement/prospectus/consent
solicitation that PharmAthene will file in connection with the stockholder votes on matters relating to the proposed transaction.