TapImmune Completes Scale-Up and GMP Manufacturing of TPIV 200 Vaccine to Supply Additional Phase 2 Clinical Trials

On February 2, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, reported it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, the company’s multi-epitope T-cell vaccine targeting folate receptor alpha (Press release, TapImmune, FEB 2, 2017, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D [SID1234517634]). The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization."

"Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients," said Dr. John Bonfiglio, President and COO of TapImmune. "The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense."

CytomX Announces the First Patient Treated in Phase 1/2 PROCLAIM-072 Trial

On February 2, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the treatment of the first patient in the PROCLAIM (Probody Clinical Assessment In Man) CX-072 study, a Phase 1/2 clinical trial evaluating CX-072, a PD-L1-targeting Probody therapeutic, as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers (Press release, CytomX Therapeutics, FEB 2, 2017, View Source;p=irol-newsArticle&ID=2241629 [SID1234517635]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Treating the first patient with CX-072 marks a key milestone as we advance our broad pipeline of innovative Probody therapeutics into clinical development within the PROCLAIM program," said Rachel W. Humphrey, M.D., chief medical officer of CytomX Therapeutics. "Advancement of this potentially transformational treatment, derived from our Probody technology platform, would not be possible without the patients who are willing to engage with the scientific community by enrolling in clinical trials. We thank them for their participation."

About the PROCLAIM-072 Trial
The first clinical trial under the international umbrella program PROCLAIM is the open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers. As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.

More information about the trial is available at clinicaltrials.gov.

FY 2016 (Ending March 31, 2017) Third Quarter Financial Results Reference Data

On February 2, 2017 Eisai Co., Ltd. reported financial results for the Nine-Month Period Ended December 31, 2016 (Report, Eisai, FEB 2, 2017, View Source [SID1234517643]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Know more, wherever you are:
Latest on How to Stay Tuned to 10 Major Cancer Meetings, book your free 1stOncology demo here.

Gross profit for the the nine-month periods ended December 2016 was 261.4 billion Yen in comparison to that of 277.2 billion Yen for the the nine-month period ended December 2015.

For Eisai’s detailed sales figures, View Source

Baxter Reports 2016 Fourth-Quarter and Full-Year Results

On February 1, 2017 Baxter International Inc. (NYSE:BAX) reported results for the fourth quarter ended December 31, 2016, and provided its guidance for the first quarter and full-year 2017 (Press release, Baxter International, FEB 1, 2017, View Source [SID1234517613]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Baxter’s solid operational performance in 2016 was fueled by strong sales and disciplined execution across the organization," said José (Joe) E. Almeida, chairman and chief executive officer. "We’ll continue to build on this momentum in 2017 and beyond, driven by new product launches, effective portfolio management and further progress on our business transformation initiatives – all in support of delivering sustainable top-quartile results for our shareholders, and advancing our mission to save and sustain lives."

Fourth-Quarter Financial Results

Baxter reported income from continuing operations of $240 million, or $0.44 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the fourth quarter. These results included special items totaling $134 million ($72 million net after-tax), primarily related to business optimization initiatives and intangible asset amortization.

On an adjusted basis, excluding special items, Baxter’s fourth quarter income from continuing operations totaled $312 million, or $0.57 per diluted share, exceeding the company’s previously issued guidance of $0.49 to $0.52 per diluted share.

Baxter’s worldwide sales totaled $2.6 billion in the fourth quarter, an increase of 2 percent on both a reported and constant currency basis as compared to the prior-year period. Sales within the U.S. were $1.1 billion, advancing 5 percent, while international sales totaled $1.5 billion, representing a 1 percent decrease on a reported basis, and an increase of 1 percent on a constant currency basis. Adjusting for the impact of foreign exchange and generic competition for cyclophosphamide, Baxter’s sales increased 7 percent in the U.S. and rose 3 percent globally in the fourth quarter.

By business, Hospital Products sales of $1.6 billion in the fourth quarter increased 1 percent on a reported basis, and 1 percent on a constant currency basis. Adjusting for the impact of foreign exchange and cyclophosphamide, Hospital Products sales advanced 2 percent from the prior-year period. Hospital Products performance in the quarter benefited from strong sales of IV therapies, infusion pumps and related IV access administration sets in the U.S., along with favorable demand for anesthesia and critical care products globally. This performance was partially offset by lower sales of IV solutions internationally, as the company implements actions to optimize its global product portfolio, as well as lower manufacturing service revenues from Shire, under the company’s manufacturing and supply agreement with Baxalta.

Baxter’s Renal sales totaled $1 billion in the fourth quarter, representing a 3 percent increase on a reported basis, and a 5 percent increase on a constant currency basis. U.S. sales grew 7 percent to $222 million, and international sales totaled $793 million, representing growth of 2 percent on a reported basis, and an increase of 4 percent on a constant currency basis. Growth continued to be driven by robust sales of peritoneal dialysis products as well as increased demand for the company’s acute renal care products.

During the quarter, Baxter repurchased $247 million worth of common stock or approximately 5.4 million shares outstanding.

Summary of Full-Year 2016 Results

For full-year 2016, Baxter reported income from continuing operations of approximately $5 billion, or $9.01 per diluted share, on a GAAP basis. These results included a gain of $4.4 billion (on a pre and post-tax basis), related to the company’s disposition of its retained Baxalta shares. Partially offsetting these results were special items of $817 million ($557 million net after-tax) related to business optimization initiatives, intangible asset amortization, debt extinguishment costs, Baxalta-related spin-off costs and asset impairments.

On an adjusted basis, excluding special items, Baxter’s full-year income from continuing operations totaled $1.1 billion, or $1.96 per diluted share.

Baxter’s worldwide sales totaled $10.2 billion in 2016, an increase of 2 percent on a reported basis and 4 percent on a constant currency basis as compared to the prior year. Sales within the United States totaled $4.3 billion, improving 6 percent over the prior year. International sales totaled $5.9 billion, representing a 1 percent decrease on a reported basis, and an increase of 3 percent on a constant currency basis. Adjusting for the impact of foreign exchange and generic competition for cyclophosphamide, Baxter’s sales increased 9 percent in the U.S. and rose 5 percent globally.

Full-year sales for Hospital Products totaled $6.3 billion, reflecting growth of 2 percent on a reported basis and 4 percent at constant currency. Adjusting for the impact of foreign exchange and cyclophosphamide, sales increased 5 percent. Baxter’s Renal sales totaled $3.9 billion, increasing 2 and 5 percent on a reported and constant currency basis, respectively.

In 2016, Baxter generated $1.6 billion in operating cash flow, an increase of $371 million driven by improved operational performance and implementation of new programs focused on improving the company’s working capital. In addition, through disciplined management of expenditures Baxter reduced capital spending by $192 million to $711 million. As a result, the company generated an increase of $563 million in free cash flow to $905 million (operating cash flow less capital expenditures).

"We are extremely pleased with the significant improvements Baxter has made in free cash flow generation. Our progress in 2016 represented an increase of more than 2.5 times as compared to 2015, and further supports our ability to reinvest in the business both organically and inorganically to drive accelerated growth," said Jay Saccaro, Baxter’s chief financial officer.

Business Highlights

In 2016 Baxter continued delivering meaningful innovation for patients and expanded access to life-sustaining therapies through a combination of more than 20 new product launches, line extensions and geographic expansions, including: NUMETA G13E, the only triple-chamber commercially prepared parenteral nutrition system approved for vulnerable neonatal patients; HEMOPATCH, an advanced surgical patch; premix generic drugs such as VANCOMYCIN injection in 0.9% Sodium Chloride; new applications and features for the SIGMA SPECTRUM infusion system; and HDx therapy enabled by THERANOVA to provide high performance hemodialysis treatments.

Additionally, the company saw continued momentum with its new Automated Peritoneal Dialysis (APD) systems, AMIA in the U.S. and HOMECHOICE CLARIA outside the U.S., both featuring Baxter’s SHARESOURCE Connectivity Platform, the first and only two-way remote patient management system for home dialysis therapy.

In December, Baxter announced plans to expand its presence in the generic injectables space with the proposed acquisition of Claris Injectables Limited (Claris). The acquisition of Claris, which is expected to close in the second half of 2017, will provide Baxter with a currently marketed portfolio of molecules in anesthesia and analgesics, renal, anti-infectives and critical care in a variety of presentations including bags, vials and ampoules, along with a robust pipeline and high-quality manufacturing capabilities. This acquisition will provide Baxter with a platform to establish a leadership position in generic injectables.

Over the course of the year, the company also took actions to significantly improve its balance sheet position and return value to shareholders through the disposition of the Baxalta retained stake, a $1.6 billion debt offering to retire existing higher coupon rate bonds and pay off outstanding commercial paper, a 13 percent increase in its shareholder dividend and share repurchases of approximately $300 million.

Financial Outlook

Baxter is providing its outlook for the full-year and first quarter of 2017:

For full-year 2017, Baxter expects sales to be comparable to the prior-year period on a reported basis and to increase approximately 2 percent on a constant currency basis. Adjusting for the impact of generic cyclophosphamide competition (an estimated one percent) and selected strategic product exits the company is undertaking (an estimated one percent), Baxter expects underlying constant currency sales growth of approximately 4 percent. The company expects earnings from continuing operations, before special items, of $2.10 to $2.18 per diluted share. This guidance does not include any impact from the company’s proposed acquisition of Claris, which is expected to close in the second half of 2017.
For the first quarter, the company expects sales growth of approximately 2 to 3 percent on a reported basis, or 3 to 4 percent on a constant currency basis. Adjusting for the impact of generic cyclophosphamide competition (an estimated one-half percent) and selected strategic product exits the company is undertaking (an estimated one and a half percent), Baxter expects underlying constant currency sales growth of 5 to 6 percent. The company expects earnings from continuing operations, before special items, of $0.50 to $0.52 per diluted share.
The reconciliations between the projected 2017 adjusted diluted earnings per share and projected GAAP diluted earnings per share follows:

2017 Earnings per Share Guidance Q1 2017 FY 2017
Diluted Earnings per Share – Adjusted $0.50 – $0.52 $2.10 – $2.18
Estimated intangible asset amortization $0.04 $0.18
Estimated business optimization charges $0.05 – $0.06 $0.31 – $0.38
Estimated Baxalta separation-related expenses $0.01 $0.02
Diluted Earnings per Share – GAAP $0.39 – $0.42 $1.52 – $1.67
These estimates are based on information reasonably available at the time of this release and future events or new information may result in different actual results.

SignalRx Pharmaceuticals Announces Breakthrough Results on Novel Anti-Cancer Dual PI3K-BRD4 Inhibition Paradigm in PNAS Publication

On January 31, 2018 SignalRx Pharmaceuticals Inc., a clinical-stage company focused on developing new and more effective oncology drugs with designed multiple target-selected inhibition profiles, reported the publication of key research in the journal Proceedings of the National Academy of Sciences (doi: 10.1073/pnas.1613091114 PNAS January 30, 2017) (Press release, SignalRx, JAN 31, 2017, http://www.ireachcontent.com/news-releases/signalrx-pharmaceuticals-announces-breakthrough-results-on-novel-anti-cancer-dual-pi3k-brd4-inhibition-paradigm-in-pnas-publication-612341103.html [SID1234527325]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SignalRx Pharmaceuticals Inc., in collaboration with researchers at the University of California, San Diego School of Medicine and Moores Cancer Center, led by Dr. Donald L. Durden, Professor and Associate Director of Pediatric Oncology at the Moores UCSD Cancer Center, and senior scientific advisor at SignalRx along with Dr. Tatiana Kutateladze, Professor at the University Colorado, Department of Pharmacology, report on key preclinical findings using the small molecule SF2523 designed to inhibit the key cancer targets PI3K and BRD4.

Key results include:

Designed dual inhibition: The dual inhibitor SF2523 inhibits the acetyl-lysine binding of the epigenetic reader protein BRD4 as well the kinase activity of PI3K thus simultaneously disrupting two orthogonal cancer driving mechanisms that promote undesirable effects from the oncogene MYC which is responsible for activating the immuno-oncology targets CD47 and PD-L1. X-ray crystal structures of SF2523 bound to BRD4 isoforms were obtained and are consistent with in silico modeling predictions and thus provide insights for further investigations.
Mode of action: SF2523 blocks both PI3K and BRD4 signaling in vitro and in vivo promoting maximal MYC down-regulation.
Anticancer activity in vivo: SF2523 markedly inhibits cancer cell growth and metastasis in mouse models of neuroblastoma and an orthotopic pancreatic metastatic tumor model.
Safe in vivo profile: Most importantly, the dual PI3K/BRD4 inhibitor SF2523 is dramatically much safer in vivo than the administration of two separate inhibitors in combination (PI3K and BRD4). This proof of concept shows that designing 1 drug with the attributes of 2 distinct drugs (2 drugs in 1) can eliminate or significantly reduce unwanted added toxicity of combination drugs providing an exciting opportunity for the exploration of more sophisticated combinations for maximal anticancer efficacy.
SF2523, as discussed in the manuscript, inhibits phosphatidylinositol 3-kinase (PI3K) which, in addition to drive cancer on its own, also inhibits the epigenetic reader bromodomain-containing protein 4 (BRD4). This new anticancer paradigm harnesses the synergistic impact of inhibiting simultaneously PI3K and BRD4 to maximally inhibit MYC activity by enhancing MYC degradation (PI3K inhibition) and blocking MYC production (inhibition of MYC transcription via BRD4 inhibition). MYC inhibition is an important oncology outcome of this new anticancer paradigm because inactivation of MYC down-regulates immuno-oncology targets CD47 and PD-L1. This down-regulation offers a novel immune-oncology approach alone or in combination with checkpoint inhibitors.

SF2523 has arisen from SignalRx’s platform technology for cancer therapeutics that enables the engineering of one small molecule to inhibit two or more molecular targets in the cancer and stromal cell for maximum anticancer efficacy and unprecedented safety in vivo. While most anti-cancer drugs are made with a single cancer target in mind, the lead compound SF2523 was designed to inhibit two or more key orthogonal signaling biomolecules simultaneously within the cancer cell.

The cancer targets for this new technology approach are selected based on forward genetics and the discovery of important cancer synthetic lethalities for therapeutic exploitation. This effective engineering approach is in contrast to the industry paradigm which relies on random screening efforts of large collections of compounds hoping to find interesting dual-target activities. With SignalRx’s technology, it is possible now to molecularly design dual and triple inhibitory chemotypes for maximum in vivo antitumor activity while maintaining a safety advantage over using combinations of drugs to attempt similar attacks on cancer targets.

SignalRx is seeking a partner to accelerate the development of SF2523 and SF2535 into first-in-man clinical trials based on the promising profile of its PI3K/BRD4 inhibitors shown so far. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to develop them as single therapeutics and streamline their development in combination therapies focused on companion diagnostics built around synthetic lethality discoveries in human cancers such as kinome adaptation mediated by BRD4.