On July 14, 2015 Fate Therapeutics, Inc. reported that it has entered into a research collaboration with Regents of the University of Minnesota for the development of natural killer (NK) cell-based cancer immunotherapeutics (Press release, Fate Therapeutics, JUL 14, 2015, View Source [SID1234516709]). The collaboration will foster the advancement of two distinct therapeutic programs, both of which aim to leverage the inherent ability of NK cells to rapidly detect and effectively destroy malignant cells without prior antigen exposure or administration of a patient’s own immune cells. While adoptive transfer of NK cells has demonstrated anti-tumor activity, the isolation and generation of clinically-relevant quantities of homogeneous populations of highly-persistent NK cells has been challenging. Fate Therapeutics will utilize its cell programming approach and proprietary induced pluripotent stem cell technology under the collaboration to pursue the development of optimized "off-the-shelf" NK cell-based cancer therapeutics.

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"Cell-based immunotherapies are rapidly emerging as one of the most promising treatment paradigms for many oncology indications, and NK cell-based therapeutics in particular may offer a compelling off-the-shelf therapeutic approach to adoptive cancer immunotherapy," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "The University of Minnesota has pioneered the basic research and clinical investigation of NK cell-based therapeutics, and we look forward to collaborating with their expert team in the development of NK cell-based immunotherapies that may provide distinct advantages in transforming the treatment of cancer."

The antibody-dependent cellular cytotoxicity program will be led by renowned NK cell biologist Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer Center and the Deputy Director of the Clinical and Translational Science Institute at the University of Minnesota. Dr. Miller and his team have recently identified an "adaptive" NK cell phenotype that exhibits a unique metabolic program shown in preclinical studies to promote long-term persistence in vivo, and that has an epigenetic profile similar to that of cytotoxic T lymphocytes, which may induce potent anti-tumor activity against a variety of tumors. Under the collaboration, Dr. Miller and Fate Therapeutics will apply the Company’s cell programming approach with the intent to optimize NK cell persistence and cytotoxicity and accelerate the development of a programmed "adaptive" NK cellular therapeutic for use in combination with tumor-specific monoclonal antibodies.

"We are excited about the prospects of utilizing cell programming to optimize the anti-tumor properties of the phenotype, and look forward to collaborating with Fate Therapeutics in the development of programmed adaptive NK cell-based immunotherapeutics to treat cancer," said Dr. Miller. "Our data demonstrate that the adaptive phenotype is functionally distinct from conventional NK cells upon triggering through the CD16 receptor, which may make these cells ideal effectors to elicit an enhanced antibody-mediated cytotoxic effect."

The second program, focusing on induced pluripotent stem cell (iPSC)-derived targeted cancer immunotherapy, will be led by Dan Kaufman, M.D., Ph.D., Professor of Medicine and a member of the Masonic Cancer Center at the University of Minnesota. Dr. Kaufman has pioneered the derivation of NK cells from pluripotent stem cells (iNK cells), including the establishment of a clinically-compatible culture system and differentiation protocol that enable the efficient generation of large quantities of cytotoxic NK cells. Leveraging the Company’s proprietary iPSC technology, Dr. Kaufman and Fate Therapeutics will genetically-modify iPSCs to express tumor cell-targeting modalities, creating an immune-engineered pluripotent cell source for use in the derivation of "off-the-shelf" NK cell-based targeted immunotherapies.

"The introduction of antigen-specificity by genetically engineering induced pluripotent stem cells, combined with the unlimited proliferative potential and differentiation capacity of such cells, may prove to be the cornerstone of off-the-shelf targeted cancer immunotherapy," said Dr. Kaufman. "We look forward to developing engineered iNK cell-based cancer therapeutics in collaboration with Fate Therapeutics that may overcome key limitations of adaptive autologous cell therapy including the requirement to isolate and engineer cells for each individual patient."

In consideration for funding the collaboration activities, Fate Therapeutics has the option to secure exclusive patent rights to all intellectual property arising under the collaboration. Additionally, Fate Therapeutics has secured an exclusive option to certain background intellectual property of the University of Minnesota. Drs. Miller and Kaufman will serve as advisors to the Company in the development of hematopoietic cell-based immunotherapies, including those derived from induced pluripotent stem cells.

(Filing, 10-K, Peregrine Pharmaceuticals, JUL 14, 2015, View Source [SID:1234506333])

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On July 14, 2015 Mersana Therapeutics, Inc. and Recepta Biopharma S.A. reported that they have entered into an exclusive license agreement in which Mersana will use its proprietary Fleximer technology to develop and commercialize an immunoconjugate with the undisclosed cancer antibody licensed from Recepta (Press release, Mersana Therapeutics, JUL 14, 2015, View Source [SID1234609623]).

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Under the terms of the agreement, Recepta will provide Mersana exclusive rights to its novel monoclonal antibody to an undisclosed target, and Mersana will leverage Fleximer to develop an immunoconjugate against the target. Financial terms of the agreement include an upfront payment and subsequent payments to Recepta, which together could total $86 million plus royalties if certain development, regulatory and commercial milestones are achieved. Mersana will conduct and fund clinical development and regulatory activities. Recepta will have rights to commercialize in Brazil, while Mersana will have rights to commercialize in the rest of the world. Mersana will be eligible to receive royalties from Recepta on sales in Brazil.

"This licensing deal with Mersana follows pioneering R&D conducted by Recepta with this antibody, which was discovered by Ludwig Cancer Research, our partner and a global nonprofit research organization. It will enable the development of a novel immunoconjugate that has the potential to improve patient outcomes in oncology," said José Fernando Perez, PhD, Chief Executive Officer of Recepta.

"We are excited to develop a Fleximer-based immunoconjugate with this antibody to address unmet needs in cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana. "This will expand our pipeline of oncology therapies that address the limitations of currently available antibody-drug conjugates and complement our objective to pursue one IND each year, starting with XMT-1522 later this year."

On July 14, 2015 Celator Pharmaceuticals reported that patients have been enrolled in an investigator-initiated Phase 2 clinical study evaluating CPX-351 (cyatarabine:daunorubicin) Liposome Injection as a treatment for patients with newly diagnosed Acute Myeloid Leukemia (AML) at high risk for induction treatment mortality (Press release, Celator Pharmaceuticals, JUL 14, 2015, View Source [SID:1234506326]).

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"Patients with newly diagnosed AML at increased risk of early death urgently need safer and more effective treatment," said Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "Our earlier experiences with CPX-351 in newly diagnosed and first relapse AML patients make us optimistic about this trial."

Phase 2 studies with CPX-351 observed improved efficacy and reduced early mortality in the majority of patients studied directly supporting evaluating CPX-351 in this population of newly diagnosed AML patients at high risk for induction treatment mortality.

The Phase 2 study will enroll up to 55 patients, with the primary objective to assess the preliminary efficacy and safety of multiple dose levels of CPX-351 in patients with newly diagnosed AML at high risk for induction treatment mortality. High risk for induction treatment mortality is defined as 30%-50% predicted risk of expiring by day 60. Estimation of risk for induction treatment mortality will be based on factors associated with lower likelihood of AML response with or without factors that reduce tolerance to treatment-associated adverse events. Every patient must have at least one AML-related factor (adverse cytogenetics, secondary AML, MDR phenotype, etc.) that contributes to elevated risk of induction treatment mortality. Patients may or may not have patient-related factors (poor performance status, co-morbidities, poor organ function, etc.) that also contribute to elevated risk of induction treatment mortality.

"We are pleased that Dr. Cortes and MD Anderson Cancer Center chose to study CPX-351 in this patient population," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. "As we await overall survival data from our CPX-351 Phase 3 trial in patients with high-risk AML, we believe there is significant potential for CPX-351 in other AML populations as well as other blood cancers, and we believe it important to evaluate these opportunities."

On July 14, 2015 Johnson & Johnson reported sales of $17.8 billion for the second quarter of 2015, a decrease of 8.8% as compared to the second quarter of 2014 (Press release, Johnson & Johnson, JUL 14, 2015, View Source [SID:1234506328]). Operational results decreased 0.9% and the negative impact of currency was 7.9%. Domestic sales decreased 2.4%. International sales decreased 14.3%, reflecting operational growth of 0.5% and a negative currency impact of 14.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.7%, domestic sales increased 0.6% and international sales increased 2.7%.* Additionally excluding hepatitis C sales, underlying operational growth worldwide was 5%.*

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Net earnings and diluted earnings per share for the second quarter of 2015 were $4.5 billion and $1.61, respectively. Second quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.1 billion. Second quarter 2014 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.4 billion. A reconciliation of non-GAAP financial measures is included as an accompanying schedule. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.8 billion and adjusted diluted earnings per share were $1.71, representing decreases of 6.3% and 3.9%, respectively, as compared to the same period in 2014.* On an operational basis, adjusted diluted earnings per share increased 6.7%.*

"Our solid sales and earnings results in the quarter reflect the strong underlying growth we’re seeing across the enterprise," said Alex Gorsky, Chairman and Chief Executive Officer. "Our diverse portfolio and scale are enabling this performance, and we’ve continued to invest in building a robust enterprise pipeline that will drive our growth over the long term. Our passion to deliver transformational new medicines and products reflects the ongoing commitment of our dedicated employees to improve health and well-being."

The Company increased its adjusted earnings guidance for full-year 2015 to $6.10 – $6.20 per share. The Company’s guidance excludes the impact of after-tax intangible amortization expense and special items.

Worldwide Consumer sales of $3.5 billion for the second quarter represented a decrease of 7.0% versus the prior year, consisting of an operational increase of 2.3% and a negative impact from currency of 9.3%. Domestic sales increased 2.7%; international sales decreased 12.2%, which reflected an operational increase of 2.1% and a negative currency impact of 14.3%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 3.1%, domestic sales increased 2.9% and international sales increased 3.2%.*

Positive contributors to Consumer operational results were sales of over-the-counter products including ZYRTEC allergy medications and TYLENOL analgesics; international feminine protection products; and LISTERINE oral care products.

Worldwide Pharmaceutical sales of $7.9 billion for the second quarter represented a decrease of 6.6% versus the prior year with operational growth of 1.0% and a negative impact from currency of 7.6%. Domestic sales decreased 1.5%; international sales decreased 12.7%, which reflected an operational increase of 3.8% and a negative currency impact of 16.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.5%, domestic sales decreased 0.6% and international sales increased 3.9%.* Additionally excluding hepatitis C sales, underlying operational growth worldwide was 9.7%.*

Worldwide operational sales growth was driven by new products and the strength of core products. New product sales growth was negatively impacted by lower sales of OLYSIO (simeprevir) in the U.S and lower sales of SOVRIAD (simeprevir) in Japan due to competitive entrants. Strong growth in new products include INVOKANA/INVOKAMET (canagliflozin), for the treatment of adults with type 2 diabetes; international sales of OLYSIO (simeprevir), for combination treatment of chronic hepatitis C in adult patients; IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, or blood cancers; XARELTO (rivaroxaban), an oral anticoagulant; and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer.

Additional contributors to operational sales growth were STELARA (ustekinumab), a biologic approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis; INVEGA SUSTENNA/XEPLION (paliperidone palmitate), a once-monthly, long-acting, injectable atypical antipsychotic for the treatment of schizophrenia in adults; domestic sales of CONCERTA (methylphenidate HCI), for the treatment of attention deficit hyperactivity disorder; and SIMPONI/SIMPONI ARIA (golimumab), biologics approved for the treatment of a number of immune-mediated inflammatory diseases.

During the quarter, the U.S. Food and Drug Administration (FDA) granted approval of INVEGA TRINZA (paliperidone palmitate), an atypical antipsychotic injection administered four times a year for the treatment of schizophrenia. In July, a rolling submission was completed with the FDA for the Biologic License Application for daratumumab for the treatment of multiple myeloma. The European Commission approved STELARA (ustekinumab) for the treatment of adolescents with moderate-to-severe psoriasis, SIMPONI (golimumab) for treatment of non-radiographic axial spondyloarthritis and IMBRUVICA (ibrutinib) for the treatment of Waldenström’s Macroglobulinemia.

Also in the quarter, an exclusive worldwide license and collaboration arrangement was entered into with Achillion Pharmaceuticals, Inc. to develop and commercialize one or more of Achillion’s lead hepatitis C virus assets.

Worldwide Medical Devices sales of $6.4 billion for the second quarter represented a decrease of 12.2% versus the prior year consisting of an operational decrease of 4.7% and a negative currency impact of 7.5%. Domestic sales decreased 5.8%; international sales decreased 17.3%, which reflected an operational decrease of 3.9% and a negative currency impact of 13.4%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.4%, domestic sales increased 1.6% and international sales increased 1.4%.*

Primary contributors to operational growth were sales of endocutters in the Surgical Care business; electrophysiology products in the Cardiovascular Care business; joint reconstruction products in the Orthopaedics business; international sales of contact lenses in the Vision Care business; and sales of biosurgicals and energy products in the Specialty Surgery business.

During the quarter, the Company announced the acceptance of the March 1, 2015 binding offer from Cardinal Health to acquire its Cordis business for an approximate value of $2 billion.