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District Court Grants MorphoSys’s Request to Add Second Patent in Lawsuit

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.

Cytori Completes Acquisition of Azaya Therapeutics Assets, Initiates Nanomedicine Program

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.

"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.

Medtronic’s OsteoCool(TM) RF Ablation System Receives Expanded Indication for Palliative Treatment of Metastatic Bone Tumors

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.

"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.

TRILLIUM THERAPEUTICS TO PRESENT NEW DATA FROM TTI-621 PHASE 1 TRIAL

On February 15, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will present new data from the Phase 1 trial of its anti-CD47 checkpoint inhibitor TTI-621 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 24, in Orlando, Florida (Press release, Trillium Therapeutics, FEB 15, 2017, View Source [SID1234517738]).

The presentation will highlight new pharmacokinetic and pharmacodynamic data from patients having received multiple weekly infusions of TTI-621. After 6 weeks of treatment, the terminal serum half-life of TTI-621 is significantly increased compared to the first infusion and is accompanied by an increase in circulating drug levels and target receptor occupancy. These data suggest that repeat dosing of TTI-621 overcomes the antigen sink and achieves circulating drug concentrations that are associated with biological activity in preclinical studies. The presentation will also feature an expanded pharmacodynamic biomarker analysis, with a focus on cytokines associated with macrophage-mediated phagocytic activity.

"These evolving data significantly advance our understanding of TTI-621 pharmacology," said Trillium’s Chief Scientific Officer, Dr. Bob Uger. "We believe continued weekly dosing overcomes the antigen sink while maintaining clinically acceptable platelet levels. In fact, emerging evidence suggests that the transient decrease in platelets observed immediately following TTI-621 exposure was attenuated in most patients receiving multiple infusions."

Leerink Partners Presentation

Trillium will provide a corporate update at Leerink Partners 6th Annual Global Healthcare Conference at the Lotte New York Palace Hotel at 3:30 pm ET today. A live audio webcast of this presentation will be available under the investor relations section of Trillium’s website at www.trilliumtherapeutics.com. A replay of the presentation will be available following the event.

TapImmune Advances TPIV 200 Phase 2 Triple-Negative Breast Cancer Trial After Favorable DSMB Safety Review

On February 15, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, reported its lead cancer vaccine candidate, TPIV 200, received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue dosing triple-negative breast cancer (TNBC) patients in an ongoing Phase 2 clinical trial (Press release, TapImmune, FEB 15, 2017, View Source [SID1234517725]).

The planned safety review was performed when enrollment had reached 25 percent benchmark (20/80 patients). The four-arm trial is designed to test the safety, dosing level and optimal treatment regimen of TPIV 200, the company’s novel five-peptide vaccine designed to elicit a long-lasting adaptive immune response against TNBC cells, involving both "helper" and "killer" T-cells. The study tests two vaccine dose levels with and without cyclophosphamide priming of the immune system and will monitor for sustained immune response and relapse-free survival for three years. TapImmune will be enrolling the remaining patients at 12 clinical centers in the U.S. with enrollment completion targeted for the end of 2017.

"Successful completion of this safety review represents yet another clinical milestone achieved for TPIV 200," said Dr. Glynn Wilson, chairman and CEO of TapImmune. "This is now our second TPIV 200 clinical study to complete a successful interim safety review allowing the continuation of recruitment according to the protocol. Our Phase 2 clinical trial in platinum-resistant ovarian cancer at Memorial Sloan Kettering Cancer Center, in combination with Astra-Zeneca’s durvalumab, had previously passed its initial safety review and this study has now recruited over 50 percent of total patients. We have two additional Phase 2 trials now enrolling or about to enroll ovarian and triple-negative breast cancer patients, and continue to believe TPIV 200 will have a significant impact in the cancer immunotherapy space. We look forward to bringing this product to these ovarian and breast cancer patients in need of advanced therapy in the most expeditious manner possible."