On February 28, 2017 Baxter International Inc. (NYSE: BAX) and ScinoPharm Taiwan, Ltd. (TWSE: 1789) reported a strategic partnership to develop, manufacture and commercialize five injectable drugs used in a range of cancer treatments, including lung cancer, multiple myeloma and breast cancer, as well as medication to treat nausea and vomiting, common side effects of chemotherapy (Press release, Baxter International, FEB 28, 2017, View Source [SID1234517907]). The arrangement also provides Baxter the option to partner with ScinoPharm—one of the world’s leading active pharmaceutical ingredient (API) manufacturers—on as many as 15 additional injectable molecules.

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Under the terms of the partnership, Baxter and ScinoPharm will collaborate on product development and manufacturing. Baxter will hold commercialization rights, with products included in the arrangement expected to launch beginning in 2020.

"Combining Baxter’s differentiated manufacturing expertise and global commercialization capabilities with ScinoPharm’s recognized API experience enables Baxter to increase patient access to difficult-to-manufacture, high-quality oncolytic medicines," said Robert Felicelli, president, Pharmaceuticals, Baxter. "The ScinoPharm collaboration will further expand Baxter’s presence in generic injectables, which will continue to be enhanced through our recently executed agreement to acquire Claris Injectables Limited."

Current branded sales of the initial five products included in this partnership total more than $4 billion annually. These products will join Baxter’s existing portfolio of generic injectable medications, which includes difficult-to-manufacture oncology drugs and a broad portfolio of standard-dose, ready-to-use premixed injectable products such as anti-infectives, analgesics and critical care medicines.

ScinoPharm has a 17-year history of manufacturing APIs for the global pharmaceutical industry with a high level of quality and safety. Under the arrangement, ScinoPharm will provide APIs for the initial five generic injectables, and Baxter and ScinoPharm will share manufacturing responsibilities, with the majority of the molecules to be manufactured at Baxter’s state-of-the-art facility in Halle, Germany, one of the most advanced facilities in the world for manufacturing oncology drugs.

"We are very excited to partner with Baxter. We bring complementary strengths to this arrangement that will ultimately lead to more injectable oncology products on the market," said ScinoPharm CEO Dr. Yung Fa Chen. "This strategic partnership will boost our expansion in the formulation business, increase market coverage of our products and eventually fuel our further operating performance."

On March 1, 2017 The National Cancer Center of Japan and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported a collaboration to develop an inhibitor for mutant isocitrate dehydrogenase IDH1 (DS-1001) as a new molecular targeting drug for malignant brain tumors (gliomas)*1 and the commencement of a first-in-human phase 1 clinical trial*2 (Press release, Daiichi Sankyo, FEB 28, 2017, View Source [SID1234517902]).

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Mutations in the IDH1 and IDH2 genes are frequently observed in patients with malignant tumors, such as gliomas, acute myeloid leukemia (AML), cholangiocarcinoma, and chondrosarcoma. The National Cancer Center Research Institute, Division of Hematological Malignancy research group led by Issay Kitabayashi discovered that inhibitions of mutant IDH1/2 were able to eliminate AML cancer stem cells*3. In addition, preclinical studies using patient-derived xenograft (PDX) models*4 showed that DS-1001, which has high blood-brain barrier permeability, was effective in suppressing the proliferation of malignant gliomas, AML, and chondrosarcoma.

Most molecular targeted drugs developed to date target molecules that are active or highly expressed in tumors. However, these drugs may have problematic side effects because the targeted molecules are to some extent also active in normal, healthy cells. DS-1001 selectively inhibits the mutant form of IDH1, which is expressed only in cancer cells, and has minimum effect against wild-type IDH1, which is expressed in normal cells.

Mutations in the IDH1 genes are observed in more than 70% of patients who are diagnosed as grade 2 or 3 gliomas (astrocytomas or oligodendrogliomas) *5. These types of glioma with IDH1 mutation are most frequently observed in 30 to 50 years old population, with multiple relapse and long term treatment course*6. DS-1001 may be effective in such a patient population.

This multicenter phase I clinical trial is planned to enroll patients with recurrent IDH1 mutant gliomas who have no standard treatment at the National Cancer Center Hospital (Chuo-ku, Tokyo) and other facilities in Japan.

On February 28, 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 and fibrotic diseases, reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Tracon Pharmaceuticals, FEB 28, 2017, View Source [SID1234517901]).

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"During the fourth quarter of 2016 and beginning of this year, we made significant progress toward several important corporate objectives, and anticipate a number of additional potentially value-creating milestones over the remainder of 2017," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We have recently initiated dosing in the first pivotal study of TRC105 in patients with angiosarcoma in both the U.S. and Europe following beneficial discussions with regulators in both regions. In addition, we intend to initiate the first-in-human clinical trial of TRC253, one of the two compounds in-licensed from Janssen last year, in patients with prostate cancer in the first half of 2017. Finally, we expect our partner, Santen, to initiate Phase 2 development of DE-122, the ophthalmic formulation of TRC105, in wet AMD later this year. Importantly, we are leveraging our unique and differentiated product development platform to complete all of our development activities, and look forward to continued progress throughout the course of the year."

Fourth Quarter 2016 and Recent Corporate Highlights

In February 2017, the Company initiated dosing in the Phase 3 TAPPAS (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105. In January 2017, the Company announced that agreement was reached with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the TAPPAS trial. This one-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus single agent Votrient features an adaptive enrichment design which allows for greater flexibility and efficiency to identify potential signs of clinical benefit.
In February 2017, the Company announced that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed survival data and the correlative analyses are expected to be presented at an oncology conference later this year.
In January 2017, the FDA cleared the IND for TRC253, a small molecule competitive inhibitor of the wild type androgen receptor and androgen receptor mutations that confer resistance to Xtandi (enzalutamide) and other drugs approved to treat prostate cancer. TRC253 was in-licensed as part of the Company’s strategic licensing collaboration with Janssen Pharmaceutica N.V. in September 2016. TRACON expects to initiate dosing in a Phase 1/2 trial of TRC253 in the first half of 2017.
In November 2016, the Company closed an underwritten public offering of a total of 3,018,750 shares of its common stock resulting in total gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of $17.4 million.
In November 2016, updated data from the ongoing Phase 1b/2 study of TRC105 and Votrient in patients with angiosarcoma were presented at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentation indicated the combination of TRC105 and Votrient continued to demonstrate encouraging signs of activity, including ongoing durable complete responses, and was well-tolerated.
In November 2016, preclinical data from two separate liver fibrosis models were presented in a poster at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting entitled, "Endoglin Antibody Reduces the NAFLD Activity Score in the STAM Model of NASH and Reduces Liver Fibrosis Following Carbon Tetrachloride Treatment." The poster also highlighted a marked reduction in cutaneous neurofibromatosis in a sarcoma patient following dosing with TRC105 and Votrient in a Phase 2 clinical trial, suggesting the potential clinical utility of an endoglin antibody for the treatment of patients with fibrosis.
Additional Expected 2017 Milestones

Initiation of dosing in the Phase 1/2 trial of TRC253 in patients with prostate cancer.
Presentation of data from expanded cohorts in the Phase 1 trial of TRC102 and Temodar (temozolomide) by the National Cancer Institute.
Completion of the Phase 1/2 PAVE study of DE-122 in patients with wet AMD by TRACON’s partner, Santen Pharmaceutical Co., Ltd. (Santen).
Initiation of dosing in Santen’s Phase 2 AVANTE study, a randomized controlled Phase 2 trial of DE-122 and Lucentis (ranibizumab) versus single agent Lucentis in patients with wet AMD.
Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma.
Completion of dose escalation in the Phase 1/2 clinical trial of TRC253.
Fourth Quarter 2016 Financial Results

Cash, cash equivalents and short-term investments were $44.4 million at December 31, 2016, compared to $35.1 million and $52.2 million at September 30, 2016 and December 31, 2015, respectively.
Collaboration revenue for the fourth quarter of 2016 was $0.6 million, compared to $1.4 million for the fourth quarter of 2015.
Research and development expenses for the fourth quarter of 2016 were $4.8 million, compared to $10.6 million for the fourth quarter of 2015. The decrease in 2016 as compared to 2015 primarily resulted from decreased TRC105 drug manufacturing expenses.
General and administrative expenses for the fourth quarter of 2016 were $1.9 million, compared to $1.7 million for the fourth quarter of 2015.
The net loss for the fourth quarter of 2016 was $6.3 million, compared to a loss of $11.0 million for the fourth quarter of 2015.

On February 28, 2017 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, reported consolidated financial results for the fourth quarter and year ended 2016, as well as progress in its clinical development programs (Press release, NewLink Genetics, FEB 28, 2017, View Source [SID1234517892]). NewLink Genetics also outlined key 2017 business priorities related to the clinical development programs for the Company’s immuno-oncology pipeline.

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"NewLink Genetics has two separate and distinct IDO pathway inhibitors in clinical development. In 2017, we look forward to advancing clinical validation of IDO as an immuno-oncology target," said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "Our priorities going into 2017 are clear. For GDC-0919, we anticipate continued progress in the clinic in collaboration with our partner Genentech/Roche. We believe indoximod will emerge as one of the leading IDO pathway inhibitor programs in 2017."

2016 Highlights

The IDO pathway, which helps cancer escape the patient’s immune system, became increasingly validated as an immuno-oncology target, with clinical data coming from NewLink Genetics and others.
Presented early Phase 2 clinical data of indoximod plus gemcitabine/nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, suggesting evidence of safety and clinical activity.
Presented promising interim Phase 2 clinical data from a cohort of patients with advanced melanoma treated with indoximod plus pembrolizumab at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting.
Our Ebola vaccine candidate (rVSV∆G-ZEBOV GP), partnered with Merck, received breakthrough therapy designation from the FDA and PRIME status from the European Medicines Agency. In December 2016 the final results of the Guinea trial were published on-line in The Lancet and confirmed efficacy of the vaccine.
Finished 2016 with $131.5 million in cash and equivalents.
Anticipated Highlights in 2017

Our investigators have submitted an abstract to the American Association for Cancer Research (AACR) (Free AACR Whitepaper) on the Phase 2 study cohort of patients with advanced melanoma treated with indoximod in combination with pembrolizumab.
We have been informed by the AACR (Free AACR Whitepaper) committee that our abstract concerning our new chemical entity NLG802, a novel prodrug of indoximod, has been accepted for a poster presentation.
Genentech is expected to update on progress on a Phase 1b study of GDC-0919 in combination with atezolizumab for patients with solid tumors.
We intend to update progress from the Phase1b, dose-escalation study of indoximod and standard of care therapy in patients with Acute Myeloid Leukemia (AML).
We expect to finish the year with approximately $75 million in cash. This excludes potential payments from partners, the proceeds from any offering, and any costs associated with any strategic acquisitions.
"We are excited to be presenting clinical data for indoximod at upcoming scientific meetings in 2017 beginning at AACR (Free AACR Whitepaper) next month," said Nicholas Vahanian, M.D., President and Chief Medical Officer.

Financial Results

Cash Position: NewLink Genetics ended the year on December 31, 2016, with cash, cash equivalents, and certificates of deposit totaling $131.5 million compared to $197.8 million for the year ending December 31, 2015. The Company’s cash position is sufficient to fund current operations in the near and medium term.

R&D Expenses: Research and development expenses were $19.5 million and $93.3 million in the fourth quarter and year ended December 31, 2016 compared to $14.8 million and $71.4 million during the comparable periods in 2015. The increase year-over-year was due primarily to $11.1 million of charges incurred as a result of the restructuring during the second quarter of 2016, including a non-cash charge of $4.0 million related to impaired assets, with the remainder of the increase due to increases in contract manufacturing costs, supplies and equipment and clinical trial expenses.

G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2016 were $7.2 million and $33.2 million compared to $7.7 million and $30.7 million during the comparable periods in 2015. The increase was due to an increase of $2.9 million in personnel-related expenses due to changes in transiently increased staffing levels, share-based compensation expense and compensation increases, an increase of $500,000 due to charges incurred as a result of the restructuring, offset by a decrease of $930,000 in consulting, legal and licensing fees, and supplies.

Net Loss: NewLink Genetics reported a net loss of $13.5 million or $0.46 per diluted share for the fourth quarter of 2016 and a net loss of $85.2 million or $2.94 per diluted share for the year ended December 31, 2016, compared to a net loss of $21.6 million or $0.75 per diluted share for the fourth quarter of 2015 and a net loss of $40.4 million or $1.41 per diluted share for the year ended December 31, 2015.

NewLink Genetics ended 2016 with 29,163,673 shares outstanding.