- With four programs currently in clinical trials and five more expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body's immune system to combat cancers.
- Deals add IL-15, adenosine receptor and TGF-beta inhibition programs to Novartis immuno-oncology portfolio.
- All three programs will be explored as monotherapies and in combination with chimeric antigen receptor T-cell (CART) technology, novel checkpoint inhibitors, STING agonists and Novartis' deep portfolio of targeted therapies.
Basel, October 21, 2015 - Novartis announced today that it is broadening its portfolio of cancer immunotherapies with the acquisition of Admune Therapeutics and licensing agreements with Palobiofarma and XOMA Corporation.
With four candidates currently in clinical trials and five more agents expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body's immune system to combat cancers that includes novel checkpoint inhibitors, chimeric antigen receptor T-cell (CART) technology, myeloid cell targeting agents, and STING agonists. Currently Novartis' myeloid cell targeting program (MCS-110) and checkpoint inhibitors targeting PD-1 (PDR001), LAG-3 (LAG525), are in phase 1 clinical trials. The CART program (CTL019) is in phase 2 clinical trials. The anti-TIM-3 program (MGB453) is expected to enter the clinic by the end of 2015 and a STING agonist (MIW815), through collaboration with Aduro Biotech, and GITR agonist are progressing toward first-in-human clinical trials in 2016.
The acquisition of Admune adds an IL-15 agonist program currently in phase I clinical trials for metastatic cancer. The licensing agreement with Palobiofarma gives Novartis development and commercialization rights to PBF-509, an adenosine receptor antagonist currently in phase I clinical trials for non-small cell lung cancer. The agreement with XOMA gives Novartis development and commercialization rights to XOMA's TGF-beta antibody programs. All three programs will be explored as monotherapies and in combination with therapies in Novartis' immuno-oncology and targeted therapy portfolios.
"The first wave of immuno-oncology therapies has demonstrated the impact this approach can have in treating certain types of tumors, " said Mark Fishman, President of the Novartis Institutes for BioMedical Research. "To realize its full potential requires exploration of the complex system of biological pathways in the tumor microenvironment with agents that can stimulate the immune system to attack a wider variety of tumors."
In pre-clinical studies, IL-15 therapies have been shown to activate CD8+, CD4+ memory T cells and Natural Killer (NK) cells that play a critical role in stimulating the immune system. Adenosine and TGFß both drive immune suppression in the tumor microenvironment, which allows cancer cells to escape immune surveillance, making inhibition of these two pathways an attractive next-generation immuno-oncology approach.
The foregoing release contains forward-looking statements that can be identified by words such as "pipeline," "programs," "expected," "will," "portfolio," "candidates," "progressing toward," "can," "potential," "next-generation," or similar terms, or by express or implied discussions regarding potential marketing approvals for the Admune Therapeutics IL-15 agonist program, PBF-509, Xoma's TGF-beta antibody programs, MCS-110, PDR001, LAG525, CTL019, MGB453, MIW815, GITR agonist, and the other investigational programs in the Novartis and Admune Therapeutics immuno-oncology pipelines, or regarding potential future revenues from such investigational programs, and potential future revenues from the acquisition of Admune Therapeutics or the licensing agreements with XOMA and Palobiofarma. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 any of the Admune Therapeutics IL-15 agonist program, PBF-509, Xoma's TGF-beta antibody programs, MCS-110, PDR001, LAG525, CTL019, MGB453, MIW815, GITR agonist or any other investigational program in the Novartis and Admune Therapeutics immuno-oncology pipelines will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that the acquisition of Admune Therapeutics or the licensing agreements with XOMA and Palobiofarma will achieve any or all of their intended goals and objectives, or be commercially successful. Nor can there be any guarantee that any of the investigational programs subject to the licensing agreements with XOMA and Palobiofarma or the investigational programs in the Novartis and Admune Therapeutics immuno-oncology pipelines will be commercially successful in the future. In particular, management's expectations regarding such investigational programs, and the acquisition of Admune Therapeutics and the licensing agreements with XOMA and Palobiofarma could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing or quality issues, 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.
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, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
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