Novartis teams up with Harvard to develop next generation biomaterial systems to deliver immunotherapies

• Collaboration and licensing agreement combine Harvard's expertise in tumor biology and materials science with Novartis' diverse immuno-oncology pipeline
   
• Teams will explore the development of novel implantable and injectable biomaterial systems for delivering Novartis' portfolio of second-generation cancer immunotherapies
   
• Investigators at Harvard's Wyss Institute and Dana-Farber Cancer Institute have reported evidence of anti-cancer immunity in preclinical experiments of the biomaterial systems[2]-[5].

Basel, March 20, 2018   Novartis announced today that it is teaming up with scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Dana-Farber Cancer Institute to develop biomaterial systems for its portfolio of immuno-oncology therapies.

The licensed biomaterial systems aim to overcome barriers that have hampered traditional cancer vaccines, including their limited duration of action and lack of targeting to specific cancer cells. Through many years' work, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), the Wyss Institute, and Dana-Farber have engineered the biomaterial systems with an aim to provide sustained delivery of immunotherapies and target specific types of cancer. Novartis will further collaborate with the team at the Wyss Institute to advance development of the biomaterial systems, investigating their use to deliver agents from its broad and deep portfolio of second-generation immunotherapies.

"Our collaborators have combined the fields of immuno-oncology and material science to develop novel platforms for delivering immunotherapies to combat cancer," said Jay Bradner, President of the Novartis Institutes for BioMedical Research (NIBR). "We look forward to collaborating with the Wyss Institute to further develop this technology in conjunction with our growing immunotherapy portfolio."

The licensing agreement with Harvard's Office of Technology Development and the collaboration with the Wyss Institute support Novartis' efforts to develop combination immunotherapy regimens.  New immunotherapies have benefited subsets of cancer patients, presenting opportunities to develop new immuno-oncology treatment strategies to help more patients [1]. Novartis is developing combination immunotherapies in clinical trials.

The implantable and injectable systems are made of biodegradable materials that assemble into porous, three-dimensional structures. In lab experiments, the systems release cell-recruiting factors to attract host dendritic cells and present tumor antigens to those specialized immune cells, intending to bolster immune responses to cancer [2]. While these systems have yet not been proven in human clinical trials, they hold great promise because of their potential to serve as engineered microenvironments to educate the immune system about cancer and initiate immune responses against tumors over a sustained period of time.

The technologies licensed under this agreement for target-specific applications are owned or co-owned by Harvard University, Dana-Farber, and the University of Michigan.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "teaming up," "to develop," "next generation," "aim," "yet," "promise," "potential," "will,"  "look forward,"  "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding the collaboration and license agreement with the Wyss Institute and the Dana-Farber Cancer Institute, or regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products or the collaboration and license agreement with the Wyss Institute and the Dana-Farber Cancer Institute. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the collaboration and license agreement with the Wyss Institute and the Dana-Farber Cancer Institute will achieve any or all of its intended goals and objectives, or be commercially successful. Neither can there be any guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products and the collaboration and license agreement with the Wyss Institute and the Dana-Farber Cancer Institute could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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References
[1]    Nat Rev Cancer. Prospects for combining targeted and conventional cancer therapy with immunotherapy. Gotwals P. et. al. 2017.
[2]    Nat Commun. Injectable cryogel-based whole-cell cancer vaccines. Bencherif S.A. et al. 2015.  
[3]    Ali OA, Emerich D, Dranoff G, Mooney DJ. In situ regulation of DC subsets and T cells mediates tumor regression in mice. Science Transl Med. 2009 Nov 25;1(8):8ra19. PMCID: PMC2872791.
[4]    Kim J, Li WA, Choi Y, Lewin SA, Verbeke CS, Dranoff G, Mooney DJ. Injectable, spontaneously assembling, inorganic scaffolds modulate immune cells in vivo and increase vaccine efficacy. Nature Biotechnology. 2015 Jan;33(1):64-72. doi: 10.1038/nbt.3071. Epub 2014 Dec 8. PMCID: PMC4318563
[5]    Li AW, Sobral MC, Badrinath S, Choi Y, Graveline A, Stafford AG, Weaver JC, Dellacherie MO, Shih TY, Ali OA, Kim J, Wucherpfennig KW, Mooney DJ. A facile approach to enhance antigen response for personalized cancer vaccination. Nat Mater. 2018 Mar 5. doi: 10.1038/s41563-018-0028-2

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