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PTX-200 (TCN-P)

PTX-200, previously known as TCN-P (triciribine phosphate monohydrate), is a potent small molecule inhibitor of the AKT pathway, which plays a key role in the development of many cancers, including breast, ovarian cancer as well as hematologic cancers such as Acute Myeloid Leukemia.

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PTX-200 is currently the subject of two proof of concept trials in breast and ovarian cancer that have commenced at prestigious US Cancer Centers. The first is a Phase 1b/2 study examining PTX-200 in breast cancer patients at the prestigious Montefiore Cancer Center/ Albert Einstein College of Medicine in New York, and the Moffitt Cancer Center and Research Institute in Tampa, Florida. A Phase 1b/2 trial of PTX-200 in combination with current standard of care carboplatin is also underway in patients with recurrent or persistent platinum resistant ovarian cancer at Moffitt Cancer Center. In addition, a Phase 1b/2 trial evaluating PTX-200 in combination with cytarabine in acute myeloid leukemia is scheduled to begin accrual in mid-2016.

Cue Biopharma Debuts With $26 Million in Invested Capital to Develop Next-Generation Biologics to Selectively Control T Cell Activity

On January 24, 2017 Cue Biopharma, Inc., an immunotherapy company developing biologics engineered to selectively modulate disease-relevant T cell subsets to treat cancer and autoimmune disease, reported a total of $26 million of invested private capital, led by MDB Capital Group (Press release, Cue Biopharma, JAN 24, 2017, View Source [SID1234521075]). Guided by an experienced management team and preeminent board members and scientific advisors, Cue Biopharma will use the proceeds to accelerate development of its novel platform of T cell receptor (TCR) targeted biologics to control immune responses in patients. The Company was founded in 2015 with $10 million of seed funding, followed by a $16.4 million follow-on financing.

"It has become increasingly clear that more effective and less toxic approaches to immune modulation are needed via precise communication with and control of T cells," said Daniel Passeri, M.Sc., J.D., President and Chief Executive Officer of Cue Biopharma. "With our platform, we have demonstrated selectivity for and modulation of disease-relevant T cells. Our lead candidate has exhibited significant potential in preclinical cancer models and has shown impressive synergy when combined with checkpoint inhibitors. Our approach to modulating the immune system to treat disease could have great clinical benefit for patients, while reducing collateral toxicities often seen with less selective immunotherapies."

"Our biologics are engineered to engage and modulate specific disease-relevant subpopulations of T cells within a patient’s body, without activating T cells with similar signaling receptors, that are not relevant to the disease," said Steven Almo, Ph.D., Chair of the Department of Biochemistry at Albert Einstein College of Medicine, scientific founder of Cue Biopharma and Chairman of its Scientific and Clinical Advisory Board. "The company has made impressive progress and I look forward to working closely with the Company as it brings its drug candidates into the clinic and advances its growing pipeline."

The Cue Biopharma platform was developed in Dr. Almo’s laboratory at the Albert Einstein College of Medicine as part of a five-year, Specialized Center grant from the National Institutes of Health (NIH). This funding enabled the technology to be built into an industry-scale drug design platform capable of rapid and efficient molecular prototyping and development. The Company is leveraging these design capabilities in its discovery efforts.

Immune Responses, On Cue
Cue Biopharma has developed a highly productive platform for designing biologic drugs that generate tailored immune responses from disease-relevant T cell populations by emulating the signals, or cues, delivered by the body’s antigen presenting cells. This approach has the potential to be highly effective both as a monotherapy and also in combination with checkpoint inhibitors, while simultaneously avoiding the toxicity limitations experienced when non-specific T cell activation is involved.

The Company’s biologics are being designed to achieve a high level of specificity through the fusion of engineered T cell costimulatory signaling molecules (ligands) with a T cell receptor targeting complex (peptide-MHC) on a traditional antibody scaffold. The peptide interacts with disease-relevant T cells and the biologic delivers one of the Company’s engineered signaling ligands, thereby enabling exclusive modulation of the T cell population of interest. The Company’s biologics are expected to be capable of eliciting targeted T cell stimulation and expansion in the context of oncology or T cell downregulation in the context of autoimmune disease. The peptides capable of selectively targeting T cell subsets are interchangeable on the construct, allowing for rapid extension to different indications simply by changing the specific peptide.

The versatility and flexibility of the the Company’s platform allows for highly efficient design and development of biologics that provide a rapid path from concept to in-vivo validation and selection of clinical candidates.

Cue Names Management Team, Board of Directors, Scientific Advisory Board

In conjunction with the launch of the company, Cue Biopharma is announcing the members of its management team, which will be led by Daniel Passeri, M.Sc., J.D., President and Chief Executive Officer; Ronald Seidel, Ph.D., Executive Vice President, Head of Research and Development; and Rodolfo Chaparro, Ph.D., Executive Vice President, Head of Immunology.

Daniel Passeri is a seasoned biotechnology executive with more than 20 years of experience managing drug discovery and development programs as well as business development activities on behalf of publicly traded companies, with deep experience in both oncology and strategic partnership generation. Prior to joining Cue, Mr. Passeri served as President and Chief Executive Officer as well as Vice Chairman of the Board of Curis, Inc.

Dr. Ronald Seidel is a co-founder of Cue Biopharma and co-inventor of its technologies, and previously served as Research Assistant Professor of Biochemistry and Associate Director of the Macromolecular Therapeutic Development Facility (MTDF) at the Albert Einstein College of Medicine.

Dr. Rodolfo Chaparro is also a co-founder of Cue Biopharma and co-inventor of its technologies, and previously served as a faculty member in the Department of Biochemistry at the Albert Einstein College of Medicine in New York.

Cue Biopharma also named the independent members of its Board of Directors, which include Peter Kiener, D.Phil.; Barry Simon, M.D.; and Steven McKnight, Ph.D. Dr. Kiener has deep experience in both biologics and immunotherapy, including as EVP and Global Head of Biologics at MedImmune/AstraZeneca, and is currently the Chief Scientific Officer at Sucampo. Dr. Simon is President and COO of NantKwest and has held senior level roles at several companies including F. Hoffmann-La Roche, Roche Labs, Connetics Corp. and Immunomedics. Dr. McKnight leads an active research laboratory at UT Southwestern Medical Center, was co-founder of San Francisco-based, Tularik, Inc., and founder of Dallas-based Peloton Therapeutics.

Cue Biopharma has formed an industry-leading Scientific and Clinical Advisory Board, comprising Steven Almo, Ph.D.; Hidde Ploegh, Ph.D.; and David Baker, Ph.D. Dr. Almo is best known for his high resolution structural and biochemical characterization of the CTLA-4 and PD-1 immune checkpoint proteins and their respective ligands. Dr. Ploegh is a member of the Program in Cellular and Molecular Medicine at Boston Children’s Hospital. He is also recognized for his contributions to molecular immunology. Dr. Baker is a Professor of Biochemistry, Director of the Institute for Protein Design, Investigator of the Howard Hughes Medical Institute, and adjunct professor of Genome Sciences, Bioengineering, Chemical Engineering, Computer Science, and Physics at the University of Washington. His research group is focused on the prediction and design of macromolecular structures, interactions and functions.

About Cue Biopharma

Immune Responses, On Cue. Cue Biopharma is an immunotherapy company developing biologics engineered to selectively communicate with disease-relevant T cell subsets to treat cancer and autoimmune disease. Cue Biopharma biologics have the potential to be highly effective as monotherapies as well as synergistic with existing checkpoint inhibitors, while reducing collateral toxicities often seen with less selective immunotherapies. Through this platform approach, Cue Biopharma has developed a promising pipeline with its lead candidate currently approaching the clinic. Headquartered in Kendall Square, Cambridge, MA, the Company is led by a strong, experienced management team and scientific and clinical advisory board with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology.

Johnson & Johnson Reports 2016 Fourth-Quarter Results:

On January 24, 2017 Johnson & Johnson (NYSE: JNJ) reported sales of $18.1 billion for the fourth quarter of 2016, an increase of 1.7% as compared to the fourth quarter of 2015 (Press release, Johnson & Johnson, JAN 24, 2017, View Source [SID1234517545]).

Operational sales results increased 2.3% and the negative impact of currency was 0.6%. Domestic sales increased 2.6%. International sales increased 0.6%, reflecting operational growth of 1.9% and a negative currency impact of 1.3%. As a reminder, there were additional shipping days in the fourth quarter of 2015 that negatively impacted the current quarter by 480 basis points. Excluding the net impact of acquisitions, divestitures, hepatitis C, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 7.6%, domestic sales increased 9.5% and international sales increased 5.6%.*

Worldwide sales for the full-year 2016 were $71.9 billion, an increase of 2.6% versus 2015. Operational results increased 3.9% and the negative impact of currency was 1.3%. Domestic sales increased 6.0%. International sales decreased 0.9%, reflecting operational growth of 1.8% and a negative currency impact of 2.7%. The additional shipping days in 2015 negatively impacted the current year by 130 basis points. Excluding the net impact of acquisitions, divestitures, hepatitis C, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 7.4%, domestic sales increased 8.9% and international sales increased 5.7%.*

Net earnings and diluted earnings per share for the fourth quarter of 2016 were $3.8 billion and $1.38, respectively. Fourth-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.3 billion and a net charge for after-tax special items of approximately $0.3 billion. Fourth-quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a net charge for after-tax special items of approximately $0.6 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.4 billion and adjusted diluted earnings per share were $1.58, representing increases of 7.9% and 9.7%, respectively, as compared to the same period in 2015.* On an operational basis, adjusted diluted earnings per share also increased 10.4%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

Net earnings and diluted earnings per share for the full-year 2016 were $16.5 billion and $5.93, respectively. Full-year net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $1.3 billion. Full-year 2015 net earnings included after-tax intangible amortization expense of approximately $1.1 billion and a charge for after-tax special items of approximately $0.9 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the full-year of 2016 were $18.8 billion and adjusted diluted earnings per share were $6.73, representing increases of 7.6% and 8.5%, respectively, as compared to the same period in 2015.* On an operational basis, adjusted diluted earnings per share also increased 9.4%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"We are pleased to report that we accelerated our adjusted growth for 2016 over the prior year, and delivered a strong total shareholder return of greater than 15 percent. The strong adjusted sales and EPS growth was driven by the impressive performance of our Pharmaceutical business and continued momentum in our Medical Device business and share gains while improving profitability in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer. "Looking forward to 2017, we expect to continue driving sustainable, long-term growth through the new products, science and innovation that our talented colleagues and partners of Johnson & Johnson are advancing to positively impact human health."

The Company announced its 2017 full-year guidance for sales of $74.1 billion to $74.8 billion reflecting expected operational growth in the range of 4.0% to 5.0%. Excluding the impact of acquisitions and divestitures, operational sales growth is expected to be in the range of 3.0% to 3.5%.* Additionally, the Company announced adjusted earnings guidance for full-year 2017 of $6.93 to $7.08 per share reflecting expected operational growth in the range of 4.8% to 7.0%.* Adjusted earnings guidance excludes the impact of after-tax intangible amortization expense and special items.

Additionally, as part of the Company’s ongoing portfolio management, the Company is announcing it is engaging in a process to evaluate potential strategic options for the Johnson & Johnson Diabetes Care Companies, specifically LifeScan, Inc., Animas Corporation, and Calibra Medical, Inc. Strategic options may include the formation of operating partnerships, joint ventures or strategic alliances, a sale of the businesses, or other alternatives either separately or together. All options will be evaluated to determine the best opportunity to drive future growth and maximize shareholder value. There can be no assurance that this process will result in any transaction or other strategic alternative of any kind.

Worldwide Consumer sales of $13.3 billion for the full-year 2016 represented a decrease of 1.5% versus the prior year, consisting of an operational increase of 1.5% and a negative impact from currency of 3.0%. Domestic sales increased 3.8%; international sales decreased 4.8%, which reflected an operational increase of 0.1% and a negative currency impact of 4.9%. Excluding the net impact of acquisitions, divestitures, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 4.3%, domestic sales increased 5.6% and international sales increased 3.4%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by over-the-counter products, including TYLENOL analgesics, digestive health products and anti-smoking aids; NEUTROGENA and AVEENO beauty products and LISTERINE oral care products.

Worldwide Pharmaceutical sales of $33.5 billion for the full-year 2016 represented an increase of 6.5% versus the prior year with an operational increase of 7.4% and a negative impact from currency of 0.9%. Domestic sales increased 9.8%; international sales increased 1.8%, which reflected an operational increase of 4.0% and a negative currency impact of 2.2%. Excluding the net impact of acquisitions, divestitures, hepatitis C, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 11.5%, domestic sales increased 13.8% and international sales increased 8.3%.*

Worldwide operational results, excluding the net impact of acquisitions, divestitures and hepatitis C sales, were driven by new products and the strength of core products. Strong growth in new products include IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer; DARZALEX (daratumumab), for the treatment of patients with multiple myeloma; XARELTO (rivaroxaban), an oral anticoagulant and INVOKANA/INVOKAMET (canagliflozin), for the treatment of adults with type 2 diabetes.

Additional contributors to operational sales growth included STELARA (ustekinumab), REMICADE (infliximab) and SIMPONI/SIMPONI ARIA (golimumab), biologics approved for the treatment of a number of immune-mediated inflammatory diseases; INVEGA SUSTENNA/XEPLION/TRINZA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults and EDURANT (rilpivirine) for the treatment of HIV.

Sales results were negatively impacted by generic entrants for ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol) oral contraceptive and INVEGA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The European Commission approved STELARA for the treatment of adults with moderately to severely active Crohn’s disease. Subsequent to the quarter, in January, the FDA approved IMBRUVICA (ibrutinib) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20- based therapy.

Additionally, regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Regulatory applications for approval were also submitted to the FDA for SIMPONI ARIA (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis and for STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis.

Worldwide Medical Devices sales of $25.1 billion for the full-year 2016 represented a decrease of 0.1% versus the prior year consisting of an operational increase of 0.9% and a negative currency impact of 1.0%. Domestic sales increased 1.1%; international sales decreased 1.2%, which reflected an operational increase of 0.7% and a negative currency impact of 1.9%. Excluding the net impact of acquisitions, divestitures, Venezuela and the additional shipping days in 2015, on an operational basis, worldwide sales increased 3.8%, domestic sales increased 2.9% and international sales increased 4.7%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters, energy and biosurgicals in the Advanced Surgery business; ACUVUE contact lenses in the Vision Care business; and joint reconstruction and trauma products in the Orthopaedics business.

During the quarter, the FDA approved OneTouch Vibe Plus Insulin Pump and Continuous Glucose Monitoring System for the treatment of patients age two and older living with diabetes.

Also during the quarter, the purchase of expandable cage technologies for spinal fusion was completed, and a development agreement was entered into, with Interventional Spine, Inc.

TapImmune Announces Progress In Its Phase 2 Ovarian Cancer Clinical Trial

On January 24, 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 that Memorial Sloan Kettering Cancer Center (MSKCC) successfully completed the first safety cohort in its Phase 2 ovarian cancer study (Press release, TapImmune, JAN 24, 2017, View Source [SID1234517564]). The study is designed to examine the efficacy of the TapImmune lead investigational product candidate, TPIV 200, in combination with AstraZeneca’s investigational checkpoint inhibitor, durvalumab.

The Phase 2 ovarian cancer study is sponsored by MKSCC under the leadership of Dr. Jason Konner. This clinical milestone allows MSKCC to increase the number of patients that can be enrolled and will subsequently increase the study’s enrollment rate. Patients in this study are resistant to platinum chemotherapy and have few treatment options. Since TPIV 200 and durvalumab have not been used before in combination, the protocol required the start of the study to proceed cautiously for the first four patients. There have been no safety issues to date, and the enrollment is now allowed to proceed at a faster rate.

"This study and the TapImmune-sponsored Phase 2 study in triple negative breast cancer study represent the company’s progress in clinical development of its lead product, TPIV 200," said Glynn Wilson, Chairman and CEO of TapImmune, Inc. "We also recently announced the opening of our second ovarian cancer study with FDA Fast Track designation in platinum-sensitive patients. As we have previously stated, TapImmune has Fast Track designation for TPIV 200 as maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy."

Onxeo Completes Enrollment in Phase III Study of Livatag® for the Treatment of Hepatocellular Carcinoma

On January 24, 2017 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported the completion of enrollment in ReLive, the international Phase III clinical trial evaluating Livatag for the treatment of advanced hepatocellular carcinoma (HCC) (Press release, Onxeo, JAN 24, 2017, View Source [SID1234517561]).

"Advanced HCC is a particularly severe form of liver cancer with a high mortality and very few treatment options", commented Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the ReLive study. "All patients have now been enrolled in the Phase III trial of Livatag and the DSMB recommendations point towards an adequte safety profile. We hope this treatment will become a new option for patients with advanced HCC for whom there is a strong unmet therapeutic need and we are now looking forward to the preliminary efficacy data expected within a few months."

The ReLive trial is evaluating the efficacy of intravenous (IV) administration of Livatag (doxorubicin transdrug) in patients with advanced HCC after failure or intolerance to sorafenib compared to the best standard of care chosen by the physician. In line with Onxeo’s international development plan, the company has conducted this Phase III trial in 11 countries (Europe, USA, MENA*).

To date, 390 patients have been randomized, with about 260 patients in the Livatag treatment group and 130 in the the comparative group (best standard of care). The completion of patient randomization is an important milestone that confirms the expected timeline of issuing the preliminary efficacy outcomes of the study mid-2017.

"Completion of enrollment in ReLive marks a significant milestone for the HCC community. This is a major step forward in the development of Livatag as a new therapeutic option in a pathology for which there is a strong need for new treatment. It is also a major achievement for Onxeo, which demonstrates its ability to complete a large international Phase III trial and marks a major value creation catalyst, in line with the expected publication of preliminary results in mid-2017," concludes Judith Greciet, Chief Executive Officer of Onxeo. "On behalf of Onxeo, we would like to extend our warmest thanks to the investigators and coordinators of the clinical sites for their active participation that enabled us to carry out this trial".

From a safety standpoint, nine DSMB** reviews of the ReLive study have already been conducted over the course of the study. During these reviews, the experts did not identify unexpected adverse effects or signals and unanimously recommended each time the continuation of the trial without modification. These repeated positive recommendations – based on data from the administration of almost 1,000 Livatag infusions – seem to indicate an adequate safety profile of the drug to date. These findings are important because they reflect the likelihood that this profile will be acceptable to both physicians and regulators.

Livatag, an innovative therapeutic approach to hepatocellular carcinoma
Livatag is a nanoparticle formulation of doxorubicin, developed using Onxeo’s proprietary Transdrug technology designed to facilitate the penetration of the drug into the tumor cell and increase the target DNA exposure to the drug, thereby bypassing the mechanisms of multi-drug resistance developed by tumor cells. By specifically accumulating in the liver cells and overcoming resistance to doxorubicin, Livatag represents a potentially significant breakthrough in the treatment of hepatocellular carcinoma.

Hepatocellular Carcinoma, an aggressive form of primary liver cancer
Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the primary liver cancers (85% to 90%). According to Globocan (2012 data), liver cancer is the 6th most common cancer in terms of incidence (782,000 new cases worldwide each year, 5.6% of all new cancer cases) with the 2nd highest mortality rate (95% lethality) after lung cancer. The major risk factors are infection by hepatitis viruses (B and C), overconsumption of alcohol and metabolic diseases, especiallynon-alcoholic steato-hepatitis, a growing cause of cirrhosis and HCC.