On February 16, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that it has initiated patient dosing in its Phase 3 TAPPAS (TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105 (Press release, Tracon Pharmaceuticals, FEB 16, 2017, View Source;p=irol-newsArticle&ID=2246642 [SID1234517740]).

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"Angiosarcoma is an aggressive cancer with limited therapeutic options, and we are excited to begin this randomized Phase 3 clinical trial of TRC105 as a potential therapy for patients with this disease," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "TRC105 has orphan drug designation for soft tissue sarcoma in the U.S. and the EU, and the first patient dosed represents the culmination of TRACON’s extensive work with regulators in both regions to design a robust Phase 3 trial. We are encouraged by the activity seen to date in the ongoing Phase 2 trial of TRC105 in combination with Votrient, and look forward to providing further updates as the TAPPAS trial progresses."

About the Phase 3 TAPPAS Study

TRACON is conducting the Phase 3 TAPPAS trial (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) under Special Protocol Assessment (SPA) with the FDA at sites in the U.S. and Europe. This one-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus single agent Votrient features an adaptive enrichment design that allows for greater flexibility and efficiency to identify potential signs of clinical benefit. The trial has an initial enrollment target of 124 patients and, based on an interim analysis, allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of potentially more responsive patients with cutaneous angiosarcoma. The primary endpoint is progression-free survival, with overall survival as a secondary endpoint.

Further details of the study are available on www.clinicaltrials.gov under NCT02979899.

About TRC105

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute (NCI) for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis.

On February 15, 2017 Medtronic plc (NYSE: MDT) reported that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for the OsteoCool(TM) RF Ablation System (Press release, Medtronic, FEB 15, 2017, View Source;p=RssLanding&cat=news&id=2246172 [SID1234517728]). Originally cleared for use in the spine, the FDA now allows the marketing of the OsteoCool System for palliative treatment of metastases in all bony anatomy – such as ribs, sacrum, extremities, and hip – in patients who have failed or are not candidates for standard therapy. The system uses targeted radiofrequency energy to ablate malignant metastatic bone tumors.

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"Patients with metastatic bone cancer may be treated with conventional therapies such as opioids, chemotherapy or radiation therapy for pain palliation," said Sandeep Bagla, M.D., an interventional radiologist with the Vascular Institute of Virginia in Woodbridge, Va. "With the expanded indication for the OsteoCool System, I now have the option to ablate these patients’ painful bone tumors when conventional therapies are considered ineffective, too slow-acting or cause unacceptable side effects."1

Metastatic bone disease has been reported to occur in 60-80 percent of cancer patients, most frequently among patients with primary malignancies of the breast, prostate, liver, and lung.2 More than 80 percent of bone metastases are found in the axial skeleton, which includes the skull, spine, and ribs.3
"Our Pain Therapies business is deeply rooted in the Medtronic Mission – which calls us to alleviate pain,"said Jeff Cambra, general manager of the Pain Therapies Interventional business, which is part of the Restorative Therapies Group at Medtronic. "With this expanded indication, we put an important treatment option into the hands of physicians so that they can help more patients suffering from debilitating pain."
Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further innovate the system.
"We’re pleased to broaden our partnership with Medtronic to improve the treatment of patients suffering from painful metastases," said Kris Shah, president of Baylis Medical. "The expansion of the OsteoCool System to include the ablation of malignant lesions in bone adds to our company’s track record of offering innovative clinical solutions and further enhancing patient access and treatment options."
The OsteoCool system is the only cooled radiofrequency (RF) ablation technology that offers simultaneous, dual-probe capabilities – providing for procedural flexibility and predictable, customized treatment. The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure.
The device also has a CE mark for the ablation of benign bone tumors such as osteoid osteoma and palliative treatment of metastatic malignant lesions involving bone, including the vertebral body. This indication is not available in the United States.

On February 15, 2017 Cytori Therapeutics, Inc. (NASDAQ:CYTX) reported it has completed its acquisition of assets of privately held Azaya Therapeutics, Inc., a leader in the research, development and manufacturing of nanoparticle therapeutics (the "Acquisition"). The Acquisition provides Cytori with a proprietary liposomal nanoparticle technology platform that is intended to complement Cytori’s leadership position in regenerative medicine and expand its pipeline with two promising nanoparticle oncology drugs.

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"This acquisition is a very important step in the development of Cytori," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "The Acquisition provides Cytori both a near term opportunity to seek regulatory approval in Europe for the acquired ATI-0918 drug candidate, a generic form of nanoparticle encapsulated doxorubicin, with the goal of launching it in Europe as early as 2019, and bolsters Cytori’s early and intermediate stage pipeline with new drug candidates in regenerative medicine and oncology".

Cytori plans to develop nanoparticle-based therapeutics under the name Cytori Nanomedicine in the areas of oncology and regenerative medicine. In addition to ATI-0918, the generic nanoparticle encapsulated doxorubicin, Cytori has added the clinical stage ATI-1123 drug candidate, a protein-stabilized nanoparticle formulation of docetaxel and a preclinical stage regenerative medicine drug candidate for scleroderma.

On February 15, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it has added a second patent with US Patent Number 9,200,061 to its lawsuit against Janssen Biotech, and Genmab, A/S (Press release, MorphoSys, FEB 15, 2017, https://www.morphosys.com/media-investors/media-center/district-court-grants-morphosyss-request-to-add-second-patent-in [SID1234556345]). This patent claims methods of treating hematologic cancer associated with the undesired presence of CD38-positive cells by administering antibodies that bind to a specific region of the target molecule, CD38. In a hearing that took place on February 6, 2017 the District Court granted MorphoSys’s request to add the 9,200,061 patent to the case.

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On April 4, 2016 MorphoSys filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746.

By its complaint, MorphoSys seeks redress for infringement by Janssen’s and Genmab’s daratumumab, a CD38-directed monoclonal antibody indicated for the treatment of certain patients with multiple myeloma. Janssen Biotech obtained FDA approval on daratumumab and markets the product as Darzalex(R) in the U.S. and other countries. MorphoSys continues to develop MOR202, its own investigational human antibody to CD38, for the treatment of cancer, including multiple myeloma.

On February 14, 2017 Incyte Corporation (Nasdaq:INCY) and Agenus Inc. (Nasdaq:AGEN) reported that the companies have amended the License, Development and Commercialization Agreement that was originally entered into January 9, 2015 (Press release, Incyte, FEB 14, 2017, View Source [SID1234517737]). The amended agreement converts the ongoing GITR and OX40 antibody programs from co-funded development and profit-sharing arrangements to royalty-bearing programs, with Incyte now responsible for funding and conducting global development and commercialization. Should candidates from either of these two programs be approved, Agenus would now become eligible to receive 15 percent royalties on global net sales of each approved product.

The ongoing TIM-3 and LAG-3 antibody programs remain royalty-bearing programs, at tiered rates of 6 to 12 percent, with Incyte retaining exclusive world-wide clinical development and commercial responsibilities.

Pursuant to the amended agreement, Agenus will receive today accelerated milestone payments of $20 million from Incyte related to the clinical development of INCAGN1876 (anti-GITR agonist) and INCAGN1949 (anti-OX40 agonist). Across all programs in the collaboration, Agenus will now be eligible to receive up to a total of $510 million in future potential development, regulatory and commercial milestones.

The parties have also entered into a separate Stock Purchase agreement whereby Incyte will purchase 10 million shares of Agenus common stock today at $6 per share.

"The antibody discovery collaboration between Incyte and Agenus has progressed well and has already resulted in two programs in clinical trials. We look forward to further developing our GITR and OX40 antibody programs, and exploring immunotherapy combinations with these compounds and other agents in the near future," said Hervé Hoppenot, CEO of Incyte.

"We believe the amended agreement will help streamline the development of our collaboration portfolio, provide the opportunity to prioritize our other internal programs towards rapid commercialization and help foster the development of our portfolio of novel I-O programs," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "The revised agreement will also strengthen Agenus’ balance sheet and reduce cash burn."

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