Oncothyreon Announces Merck Serono Decision to Continue the Development of Tecemotide in Stage III Non-Small Cell Lung Cancer

  Oncothyreon Announces Merck Serono Decision to Continue the Development of
              Tecemotide in Stage III Non-Small Cell Lung Cancer

PR Newswire

SEATTLE, Sept. 25, 2013

SEATTLE, Sept. 25, 2013 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today
announced that Merck Serono, the biopharmaceutical division of Merck KGaA, has
decided to continue clinical development of the investigational MUC1
antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25 and
formerly known as Stimuvax®). Merck Serono, which is developing tecemotide
under a license agreement with Oncothyreon, will conduct a new Phase 3 trial
called START2 for patients with unresectable, locally advanced Stage III
non-small cell lung cancer (NSCLC). This decision is based on the outcome of
the prior START trial. While the START trial did not meet the primary endpoint
of improving overall survival (OS) in the overall patient population, data
from an exploratory analysis of a predefined subgroup of patients, who
received tecemotide after concurrent chemoradiotherapy (CRT), showed that
these patients achieved a median OS of 30.8 months versus 20.6 months in
patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64-0.95; p=0.016).
Concurrent CRT is a combination of chemotherapy and radiotherapy given at the
same time.

START2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled
clinical trial designed  to assess  the efficacy, safety  and tolerability  of 
tecemotide in  patients with  unresectable, locally  advanced (Stage  IIIA  or 
IIIB) NSCLC who  have had  a response  or stable  disease after  at least  two 
cycles of  platinum-based  concurrent  CRT.  Concurrent  CRT  is  the  current 
standard of care for these patients. The trial's primary endpoint is OS. Merck
Serono also announced  that it  received Scientific Advice  from the  European 
Medicines Agency (EMA) on  the program and has  reached an agreement with  the 
U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA)
for the Phase 3 international randomized trial.

"The results  from  the  START  trial provided  insights  into  the  potential 
clinical utility of tecemotide and raised a lot of interest in the  scientific 
community. We haven't seen this type of clinically meaningful survival benefit
with any  other  investigational  therapy in  unresectable  Stage  III  NSCLC. 
Further investigation might help to better understand the potential role  that 
tecemotide could  play  in successfully  treating  these patients,"  said  Dr. 
Charles Butts,  Cross  Cancer  Institute,  University  of  Alberta,  Edmonton, 
Canada,  clinical  investigator  of  the   START  trial  and  member  of   the 
corresponding steering committee.

Dr. Annalisa Jenkins, Head  of Global Drug Development  and Medical for  Merck 
Serono, said: "The  START data  delivered important insights  that we  believe 
justify further investigation in a new Phase 3 program. NSCLC is a devastating
disease, and we are  pleased to be able  to continue supporting innovation  in 
this important emerging field of immuno-oncology."

"We are pleased that Merck Serono will be moving forward with the  development 
of tecemotide," said Robert  L. Kirkman, M.D.,  President and Chief  Executive 
Officer of Oncothyreon. "We believe the data from START support the  validity 
of MUC1 as a target for immunotherapy and are gratified that Merck Serono will
seek to confirm the results seen in START in patients receiving concurrent CRT
in a new Phase 3 trial."

About Tecemotide

Tecemotide is an  investigational MUC1  antigen-specific cancer  immunotherapy 
that is designed to stimulate the body's immune system to identify and  target 
cells expressing the cell-surface glycoprotein MUC1. MUC1 is expressed in many
cancers, such as non-small cell lung cancer (NSCLC), and has multiple roles in
tumor growth and survival. Tecemotide  is currently being investigated in  the 
Phase 3 START and  INSPIRE trials for the  treatment of unresectable,  locally 
advanced Stage III NSCLC.

Merck  obtained   the  exclusive   worldwide   rights  for   development   and 
commercialization of tecemotide  from Oncothyreon  Inc., Seattle,  Washington, 
U.S., in  2007,  in an  agreement  replacing prior  collaboration  and  supply 
agreements originally  entered  in  2001.  In  Japan,  Merck  entered  into  a 
co-development  and   co-marketing   agreement   for   tecemotide   with   Ono 
Pharmaceutical Co., Ltd., Osaka, Japan.

The  START2  trial  is  a  Phase  3,  multicenter,  randomized,  double-blind, 
placebo-controlled clinical trial designed to assess the efficacy, safety  and 
tolerability of tecemotide  in patients suffering  from unresectable,  locally 
advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable  disease 
after at  least  two  cycles of  platinum-based  concurrent  chemoradiotherapy 
(CRT). The primary endpoint of START2 trial is overall survival.

The initial START Phase 3  trial is a multicenter, randomized,  double-blind, 
placebo-controlled clinical trial designed to assess the efficacy, safety  and 
tolerability of tecemotide  in patients suffering  from unresectable,  locally 
advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable  disease 
after at least two cycles  of platinum-based chemoradiotherapy (concurrent  or 
sequential). The trial involves  1,239 patients in  33 countries. The  primary 
endpoint of an improvement in overall survival was not met in the START trial.

INSPIRE   is    a   Phase    3,   multicenter,    randomized,    double-blind, 
placebo-controlled clinical trial  designed to evaluate  the efficacy,  safety 
and tolerability  of  tecemotide  in  patients  suffering  from  unresectable, 
locally advanced Stage IIIA or  IIIB NSCLC who have  had a response or  stable 
disease   after   at   least   two   cycles   of   platinum-based   concurrent 
chemoradiotherapy.  INSPIRE  is  enrolling  approximately  420   unresectable, 
locally advanced  Stage III  NSCLC patients  across China,  Hong Kong,  Korea, 
Singapore and Taiwan.

Tecemotide is currently under clinical investigation and has not been approved
for use in  the U.S., Europe,  Canada, or elsewhere.  Tecemotide has not  been 
proven  to  be  either  safe  or  effective  and  any  claims  of  safety  and 
effectiveness can  be  made only  after  regulatory  review of  the  data  and 
approval of the labeled claims.

About Oncothyreon

Oncothyreon is  a biotechnology  company specializing  in the  development  of 
innovative therapeutic  products for  the treatment  of cancer.  Oncothyreon's 
goal is to  develop and  commercialize novel synthetic  vaccines and  targeted 
small molecules that have the potential  to improve the lives and outcomes  of 
cancer patients. For more information, visit www.oncothyreon.com.

Forward-Looking Statements

In order  to provide  Oncothyreon's  investors with  an understanding  of  its 
current results and  future prospects, this  release contains statements  that 
are forward-looking. Any statements contained  in this press release that  are 
not statements  of  historical  fact  may  be  deemed  to  be  forward-looking 
statements. Words  such  as  "believes,"  "anticipates,"  "plans,"  "expects," 
"will,"  "intends,"  "potential,"  "possible"  and  similar  expressions   are 
intended  to  identify   forward-looking  statements.  These   forward-looking 
statements include Oncothyreon's  expectations regarding clinical  development 
activities.

Forward-looking  statements  involve  risks   and  uncertainties  related   to 
Oncothyreon's business and the general economic environment, many of which are
beyond its control. These risks,  uncertainties and other factors could  cause 
Oncothyreon's actual  results to  differ materially  from those  projected  in 
forward-looking statements, including  those predicting  the timing,  duration 
and results of clinical trials, the timing and results of regulatory  reviews, 
the safety and  efficacy of our  product candidates, and  the indications  for 
which our product  candidates might be  developed. There can  be no  guarantee 
that the results of preclinical studies or clinical trials will be  predictive 
of either safety or efficacy  in future clinical trials. Although  Oncothyreon 
believes that the forward-looking statements contained herein are  reasonable, 
it  can   give  no   assurance  that   its  expectations   are  correct.   All 
forward-looking statements are expressly qualified  in their entirety by  this 
cautionary statement. For  a detailed description  of Oncothyreon's risks  and 
uncertainties, you  are encouraged  to  review the  documents filed  with  the 
securities regulators in the  United States on EDGAR  and in Canada on  SEDAR. 
Oncothyreon  does  not  undertake  any  obligation  to  publicly  update   its 
forward-looking statements based  on events  or circumstances  after the  date 
hereof.

Additional Information

Additional information relating to Oncothyreon can be found on EDGAR at
www.sec.gov and on SEDAR at www.sedar.com.

SOURCE Oncothyreon Inc.

Contact:

Investor and Media Relations Contact:

Julie Rathbun
Rathbun Communications
206-769-9219
ir@oncothyreon.com
 
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