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Picketers greet 15,000 participants at BIO 2012 Convention in Boston

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AC Immune/Genentech to Partner on R&D for Alzheimer’s Antibody; $418M Agree’t

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PRESS RELEASE

· New antibody program targets Tau protein, a major cause of Alzheimer’s disease

· License agreement potentially worth more than Swiss Francs 400 Million (approximately USD 418 million*)

Lausanne, Switzerland, 18 June, 2012 – AC Immune SA, today announced that it has entered into a second exclusive worldwide license agreement and research collaboration with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) for the research, development and commercialization of AC Immune’s anti-Tau antibodies for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases.

Under the terms of the agreement, AC Immune will receive an undisclosed upfront payment and is eligible to receive research, development and commercialization milestone payments totaling more than Swiss Francs 400 million (approximately USD 418 million*) for Alzheimer´s disease and other indications. Additionally, AC Immune is eligible to receive royalties on net sales of products resulting from the collaboration. Under the multi-year joint research collaboration, AC Immune will work in partnership with Genentech to identify and formulate several pre-clinical candidates. Genentech will have global responsibility for pre-clinical and clinical development, manufacturing and commercialization of antibodies resulting from the collaboration.

Prof. Andrea Pfeifer, CEO of AC Immune said: “We are delighted to continue our excellent relationship with Genentech through this second landmark deal to fight Alzheimer’s disease. This underlines Genentech’s trust in AC Immune’s proprietary technology platform and we are confident in our joint abilities to develop not only
first-in-class but also best-in-class medication for one of the biggest healthcare problems of this century.”

“This second licensing deal gives us financial security to continue AC Immune’s
world-leading efforts to develop disease modifying therapies and diagnostics. We are now recognized as having one of the broadest and most advanced Alzheimer’s pipelines in the industry”, remarked Martin Velasco, Chairman of The Board of AC Immune .

Commenting on the deal, James Sabry, Genentech’s Vice President of Partnering , said: “Genentech is committed to bringing innovative treatments to patients suffering from devastating neurodegenerative diseases, and is developing a number of approaches to tackle Alzheimer’s disease. The addition of this anti-Tau program to our CNS pipeline complements other approaches we are investigating, including crenezumab which we in-licensed from AC Immune in 2006.”

About the anti-Tau Program

The Tau protein forms twisted fibers inside brain cells and build tangles that are considered by many in the scientific community as the second major cause of Alzheimer’s disease besides Abeta-plaques. The anti-Tau antibodies were discovered and humanized by AC Immune through its proprietary SupraAntigen TM technology.

“The anti-tau-antibodies have proven highly specific to misfolded Tau in relevant animal models for Alzheimer’s disease and are therefore well suited to be developed as a disease-modifying drug. This has significant potential as there are at present no known cures for Alzheimer’s disease,” said Dr. Andreas Muhs, Chief Scientific Officer
of AC Immune .

About Crenezumab

An anti-Abeta antibody, crenezumab was discovered and humanized by AC Immune. It is designed to bind to amyloid beta (Abeta), the main constituent of amyloid plaque in the brains of patients with Alzheimer’s disease. Abeta is considered to be a major cause in the development of the disease. Genentech is currently evaluating crenezumab in a Phase II clinical study in Alzheimer’s patients with mild to moderate symptoms. At the time the deal with Genentech was announced in December 2006, it was stated to have a potential total value of more than USD 300 million in clinical and regulatory milestone payments to AC Immune, excluding royalties.

In May 2012, crenezumab was selected to be tested in the world’s first-ever prevention trial in healthy individuals who are genetically destined to develop Alzheimer’s disease. This landmark study to investigate whether an anti-amyloid treatment can stave off the disease is being run by the US National Institutes of Health (NIH), the Banner Alzheimer’s Institute (BAI), the University of Antioquia in Colombia and Genentech.

About Alzheimer’s Disease

Alzheimer´s is the most common form of dementia. It is degenerative, irreversible and terminal. The memory and thinki ng of the patients is progressively destroyed. Besides the personal aspect there is a huge social and economic impact. Alzheimer´s disease is recognized as a significant health crisis of the 21st century with currently more than
36 million patients worldwide. This number is expected to double in the next 20 years and to triple to more than 116 million by 2050. In 2010 global worldwide costs were estimated to be USD 604 billion and were exceeding 1% of the global domestic product (Reference: World Alzheimer Report 2011, Alzheimer’s Disease International).

Scientists don’t yet fully understand what causes Alzheimer’s disease, but it has become increasingly clear that it develops because of a complex series of events that take place in the brain over a long period of time. Two proteins – Tau and Abeta – are perceived as the major causes of neurodegeneration: tangles and other abnormal forms of Tau protein accumulate inside the brain cells, while plaques and oligomers formed by Abeta occur outside the brain cells of people with Alzheimer’s disease.

About AC Immune SA
AC Immune SA is a Swiss-based biopharmaceutical company and a leader in Alzheimer´s disease drug development. AC Immune develops innovative therapeutics with “best in class” potential against Alzheimer´s disease and other conformational diseases along three axes: vaccines, antibodies and small molecules. The anti-Abeta antibody (crenezumab) for passive immunization is partnered with Genentech and is in Phase II development. The company continues to develop in house the small molecule ACI-91 and the vaccine ACI-24 in Phase II and Phase I/IIa clinical development respectively. These three clinical programs are focused on Alzheimer’s disease, and are backed by a rich portfolio of preclinical compounds. The therapeutic molecules are also leveraged for Alzheimer´s disease diagnostic and other central nervous system and non-CNS diseases, such as Glaucoma. Since its foundation in 2003, AC Immune has raised CHF 64 million from private investors.

 

-Anita M. Harris
Disclosure: I will be working with AC Immune at the Biotechnology Industry Organization today in Boston.

 

New Cambridge Observer is a publication of the Harris Communications Group, an award-winning strategic public relations,  marketing communications and thought leadership firm in Cambridge, MA.



International & MA Cancer R&D Clusters Showcased at Whitehead Institute

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Four Boston-area startups were among those showcased  in an international program on collaborative cancer research & therapy clusters held today at the Whitehead Institute in Kendall Square, Cambridge.

All four of the Boston companies are developing methods and technologies that aim to better diagnose or cure cancer; all are hopeful; all are seeking funding, investors, or purchasers.

The program, called the International Cancer Cluster Showcase,  was sponsored by Sanofi, which recently purchased Cambridge-based Genzyme  Corporation, and by cancer  research and treatment clusters in the Norway, the UK, France and  in Massachusetts.

The program was held in conjunction with the International Biotechnology Industry Organization (BIO) Convention, to start tomorrow.

In introducing the Boston area companies, Abigail Barrow of the Massachusetts Technology Transfer Center,  who chaired  the Boston and the overall sessions,  pointed out that Cambridge is, perhaps, the paramount biotechnology and cancer research center in the US.

  • AcuityBio, Inc. a Boston University Spinoff,  is developing a  biodegradable polymer mesh  to be implanted during cancer surgery for later, sustained use in local administration of cancer drugs, according to John Schwartz, the AcuitBio CEO.  The goal is to  prevent cancer recurrences in specific soft tissues thus improving the quality of patients’ lives, recucing the cost of care, increasing the length of disease-free progression and sigificantly improving cure rates for early stage cancer patients,  Schwartz said.
  • Joel Beriac, PhD, the president & CEO of Akrivis Technologies said that his company is developing an ultrasensitive ” Z-Tect,” (TM) technology platform that promises to allow much earlier cancer detection and more effective personalized therapies than is currently possible. Z-tect will save numerous lives and reduce healthcare costs by lowering “several thousand fold” the current limit-of-detection of early cancer biomarkers, imaging much smaller cancer lesions. Akrivis plans to ultimately develop, beyond ultrasenstivie diagnostics, safer and more efficacious targeted therapies.
  • BIOARRAY Therapeutics  is developing molecular diagnostics to improve cancer treatment decisions that are currently made on a trial-and-error basis, according to  Marcia V. Fournier, PhD, the BIOARRAY founder and CEO.  BIOARRAY’s core technology identifies relevant cancer biomarkers based on the normal biology and micro-environment representing underlying biological processes involved in the progression of tumors– independent of any specific patient set, cancer subgroup or treatment, Fournier said. The company’s lead diagnostic is a response prediction test for breast cancer–targeting the growing molecular diagnostics and personalized medicine markets.
  • CanThera Therapeutics is a development stage oncology therapeutics company built on technology from the Mass General Hospital laboratories and the Broad Institute.  According consultant Peter Leone, the investigators have found that a natural substance, piperlongumine (PL) appears to kill cancer cells by jamming the machinery that dissipates high oxidative stress (ROS). Normal cells have low levels of ROS and don’t need high levels of the antioxidant enzymes that PL stymies. CanThera aims to advance a selected novel analog of PL into the clinic in 2012.

The showcase also featured:


QUEBEC PRESENTERS:

Q-CROC (Quebec – Clinical Research Organization in Cancer)    http://qcroc.ca      

 

OSLO PRESENTERS:

 

TOULOUSE/CANCER BIO SANTE CLUSTER PRESENTERS

 

UK PRESENTERS

  • Acublate  Limited

 

Poster Session Companies

Oncocat: www.oncocat.org/principal.php?idiom=eng

AB-therapeutics: www.ab-therapeutics.com

Oryzon: www.oryzon.com/es/inicio 

 

–Anita M. Harris

 

New Cambridge Observer is a publication of the Harris Communications Group, an award-winning strategic public relations,  marketing communications and thought leadership firm in Cambridge, MA.

 

 

 

 

 



UK Life Science Consulting Firm Alacrita To Open US HQ in Cambridge, MA

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UK-based Alacrita, a global life science consulting firm with consultants worldwide, will soon be opening an office in Cambridge, MA, according to Robert Johnson, who will head the office, here.

The company was co-founded two years ago by Anthony Walker, who had previously served as Executive Director of Global External R&D Europe at Eli Lilly,  and  by Johnson, who had led business development at Onyvax, a biotech company that developed biopharmaceuticals to combat cancer.

Drawing on the capabilities of more than 50 consultants worldwide, Alacrita  provides strategic, operational,  technical  advice or  hands-on project management to organizations of all sizes in  the pharma, biotechnology and life science industries, Johnson said.

According to the Alacrita Web site, clients may be academic institutes, tech transfer experts,  life science investors, startups  or  established companies in need of expertise in:

  • Business development and marketing
  • Intellectual property
  • Product development
  • Regulatory affairs

Recent whitepapers available on the  company Website   include:

Alacrita’s US offices will be located in the Cambridge Innovation Center in Kendall Square.  The company name comes from the Latin, “alacritas,” or “lively.”  It is meant to convey “a cheerful readiness,” Johnson said.

–Anita M. Harris

New Cambridge Observer is a publication of the Harris Communications Group, an award-winning strategic public relations,  marketing communications and thought leadership firm in Cambridge, MA.

 

 



Pasteur Institute Spin-out Ariana Pharma Opens Cambridge Office; Analytics Tech to Streamline Clinical Trials

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SHANAHAN NAMED VP OF BUSINESS DEVELOPMENT

—One of the newest international companies to expand into Cambridge is Ariana (R)  Pharma–a 2003 spin-out of the Pasteur Institute in Paris.  Its  subsidiary, Ariana Data Intelligence, Inc., located in the Cambridge Innovation Center at 1 Broadway,  will provide novel non-statistical clinical data analysis technology to pharma and the FDA,  Ariana announced today.

The technology,  “Knowledge Extraction and Management Technology (KEM)” is aimed at reducing cost, bias, and risk in clinical trials.

“The US pharma and biotech markets tend  to be early technology adopters and are searching for better data analytics tools to advance personalized medicine using all the new biomarker, genomic, proteomic and metabolomic data now being generated,” said  Dr. Mohammad Afshar, Ariana’s President and CEO.

KEM   “is the only FDA-tested technology that  can simultaneously analyze all these variables and pull out patient responder sub-groups, optimize biomarker signatures and remove bias from clinical trials,” Afshar said.

A “unique” association rules-based (non-statistical) analytical technology, KEM  finds patient responder sub-populations and biomarker signatures that statistical methods are unable to detect, according to Afshar.  KEM thus optimizes clinical trial inclusion/exclusion criteria, thereby lowering the number of patients needed to reach clinical endpoints and saving sponsors both time and cash, and reducing clinical drug development risk.

In conjunction with the opening, Ariana has appointed James M. Shanahan as Vice President  of Business Development.  Shanahan was previously a co-founder and is currently a  board member of SynDevRx, Inc., an oncology-focused biotech company. He was also a co-founder and VP Corporate Development of JAM Technologies, Inc.

Ariana offers something “special and desperately needed “by the pharmaceutical industry, Shanahan said.   “Companies spend tens of millions generating data.  Now, it’s all about making sense of that data.  KEM identifies useful, complex biological relationships that statistics routinely miss.”

More information is available at  http://www.arianapharma.com/  .

–Anita M. Harris