(CNDO) New Subsidiary, Checkpoint Therapeutics For Immuno-Oncology Antibodies

Checkpoint licenses rights to 3 novel immuno-oncology targeted antibodies, including Anti-PD-L1, Anti-GITR and Anti-CAIX

Dr. Wayne Marasco to chair Checkpoint’s Scientific Advisory Board

Checkpoint and TG Therapeutics execute a collaboration agreement to accelerate the development of Anti-PD-L1 antibody and Anti-GITR antibody in hematological malignancies

NEW YORK, March 4, 2015  — Coronado Biosciences, Inc., (Nasdaq:CNDO) announced today the formation of a new subsidiary company, Checkpoint Therapeutics, Inc., to develop a portfolio of fully human immuno-oncology targeted antibodies generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a Professor in the Department of Cancer Immunology and AIDS at Dana-Farber Cancer Institute (Dana-Farber). Dr. Marasco will chair the Scientific Advisory Board of the Company. Under the terms of the agreement, Checkpoint will pay Dana-Farber an up-front licensing fee in addition to development and sales-based milestone payments and royalties on net sales.

The portfolio of antibodies licensed from Dana-Farber includes antibodies targeting PD-L1, GITR and CAIX. Checkpoint plans to develop these novel immuno-oncology and checkpoint inhibitor antibodies on their own and in combination with each other, as data suggests that combinations of these targets can work synergistically together. Clinical trials are expected to start in the second half of next year.

In connection with the license agreement with Dana-Farber, Checkpoint Therapeutics entered into a collaboration agreement with TG Therapeutics, Inc. (Nasdaq:TGTX) to develop and commercialize the Anti-PD-L1 and Anti-GITR antibody research programs in the field of hematological malignancies. Checkpoint retains the right to develop and commercialize these antibodies in solid tumors. Both programs are currently in pre-clinical development. Under the terms of the agreement, TG Therapeutics will pay Checkpoint an up-front licensing fee as well as make development and sales-based milestone payments and will pay a tiered single digit royalty on net sales.

Dr. Lindsay A. Rosenwald, Chairman and CEO of Coronado Biosciences stated, “We are absolutely delighted to partner with one of the pioneers in this field, Dr. Wayne Marasco.” Dr. Rosenwald continued, “Immuno-oncology is one of the most exciting areas in cancer drug development. Drugs that inhibit key immune checkpoint proteins have the potential to unlock the immune system to kill cancer cells. Results for PD-1 inhibitors in melanoma and lung cancer have been impressive but these are early innings of a long game to optimize the right combination of checkpoint inhibitors and other targeted agents to provide lasting cures to all patients. The early work will pave the way for novel combinations, which is where Checkpoint plans to play a pivotal role. The three antibodies licensed today may work synergistically together as well as with other agents. To accelerate development in one area, hematological malignancies, Checkpoint partnered with TG Therapeutics. With TG’s impressive early results with its drug candidates, expertise and relationships in hematological malignancies, we believe we can accelerate development of these important antibodies in this area.”

About anti-PD-L1 and anti-GITR                  

Anti-PD-L1 antibodies target programmed cell death ligand 1 (PD-L1). Signals from PD-L1 on tumor cells and in tumor microenvironment help those tumors avoid immune attack and elimination by preventing activation of tumor specific effector T-cells. Anti-PD-L1 antibodies are designed to block that signal permitting effector T-cells to attack the cancer. Anti-GITR antibodies target glucocorticoid-induced tumor necrosis factor receptor related protein (GITR), which is regularly expressed on the surface of regulatory T-cells (Tregs) and is expressed on the surface of effector T-cells after their activation. Modulation of GITR with agonistic antibodies has been shown to amplify the antitumor immune responses in animal models via multiple mechanisms. Anti-GITR antibodies are designed to activate the GITR receptor thereby increasing the proliferation and function of effector T cells. At the same time, ligation of GITR on surface of Tregs could abrogate suppressive function of these cells on tumor specific effector T-cells thus further augmenting T-cell immune response. While targeting PD-1/PD-L1 axes alone has already demonstrated impressive anticancer efficacy and durable responses in humans, its efficacy appears to be limited to certain patients. It is believed the effects of anti-PD-L1 intervention can be enhanced by utilizing a co-stimulatory antibody, like one targeting GITR, that can turn on tumor specific effector T-cells. Combining immunotherapies like anti-PD-L1 that counters the tumor’s immune-evading defense system with an anti-GITR that activates effector T-cells, represents a rational approach to use the body’s own immune system to help fight cancer. Pre-clinical research on the combination of the two approaches has yielded very encouraging results to support synergistic potential of this combination. Anti-CAIX antibodies target carbonic anhydrase IX (CAIX), which is over-expressed on the surface of renal cell carcinoma (RCC) and hypoxic solid tumors making it a promising therapeutic target. RCC is a significant public health issue with over 60,000 new cases and over 13,000 deaths predicted in US last year. As a number of RCC cases have already been shown to be sensitive to anti-tumor immune response generated as a result of PD-1/PD-L pathway inhibition, it makes it reasonable to attempt improving the response rate in this malignancy further by additional targeting of immune responses to this tumor with other immune stimulating agents such as anti-CAIX and anti-GITR antibodies.

About Checkpoint Therapeutics

Checkpoint Therapeutics is an innovative, immuno-oncology company spun out of the laboratory of Dr. Wayne Marasco of Dana-Farber Cancer Institute, a principal teaching  affiliate of Harvard Medical School, as a newly formed subsidiary of Coronado Biosciences, Inc. (Nasdaq:CNDO). Checkpoint is developing novel checkpoint inhibitors and other immuno-oncology drug candidates that may be active on their own but are designed to also work synergistically together and with other immuno-oncology agents and targeted drugs. Checkpoint plans to build a portfolio of complimentary drug candidates to treat a wide variety of solid tumors and, through its partnership with TG Therapeutics, hematological cancers. Currently, the company is developing three antibodies targeting anti-PD-L1, anti-GITR and anti-CAIX.  Checkpoint Therapeutics is headquartered in New York City.

About Coronado Biosciences

Coronado Biosciences is a biopharmaceutical company dedicated to investing in, acquiring, developing and commercializing novel pharmaceutical products. The Company’s portfolio includes novel immunotherapy agents for the treatment of autoimmune diseases and cancer. As part of its growth strategy, the company plans to leverage its biopharmaceutical business and drug development expertise to acquire rights to, or to finance, innovative pharmaceutical and biotechnology products, technologies and/or companies, using a variety of approaches including licensing, partnerships, joint ventures, direct financing and/or public and private spin-outs. For more information, visit www.coronadobiosciences.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs as may be implemented by us and/or our subsidiaries and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

CONTACT: Lucy Lu, MD, Executive Vice President &
         Chief Financial Officer
         Coronado Biosciences, Inc.
         781-652-4525; ir@coronadobio.com