Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On September 14, 2016 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company, reported that they have entered into a definitive agreement under which Allergan will acquire Vitae for $21.00 per share, in cash, for a total transaction value of approximately $639 million (Press release, Allergan, SEP 14, 2016, View Source [SID1234523885]). The Boards of Directors of both companies have unanimously approved the transaction.

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The acquisition will strengthen Allergan’s dermatology product pipeline, with the addition of VTP-43742, a Phase 2 first-in-class, orally active RORγt (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis and other autoimmune disorders. VTP-43742 acts through the potent inhibition of IL-17 activity. In preclinical studies, VTP-43742 has been observed to inhibit RORγt activity, is highly selective versus other ROR isotypes and may provide a treatment that could be administered as a once-daily oral dose. The compound recently completed a Phase 2 proof-of-concept multiple ascending dose trial in patients with moderate to severe psoriasis.

The acquisition also adds VTP-38543, a topical LXRβ (Liver X Receptor beta) selective agonist for the potential treatment of atopic dermatitis. It is believed that VTP-38543 works by decreasing inflammation in damaged skin tissue and repairing the damaged outer layer of skin. VTP-38543 is currently in a Phase 2a proof-of-concept clinical trial assessing the safety, tolerability and efficacy in patients with mild to moderate atopic dermatitis.

Vitae has developed and utilizes its Contour structure-based drug design platform to discover product candidates for validated therapeutic targets where biopharmaceutical research and development has traditionally struggled to develop drugs due to challenges related to potency, selectivity and pharmacokinetics. This has provided Vitae’s R&D team the ability to create first-in-class product candidates for challenging therapeutic targets.

"The acquisition of Vitae is a strategic investment for Allergan that adds strength and depth to our innovative medical dermatology franchise," said Brent Saunders, CEO and President of Allergan. "Vitae has pioneered the discovery and development of highly differentiated first-in-class compounds in atopic dermatitis, psoriasis and autoimmune diseases, areas of medicine where innovation is needed for patients."

"The Vitae team has been tremendously successful in discovering and conducting early development work in areas of medicine that can benefit from significant innovation," said Jeff Hatfield, President and Chief Executive Officer of Vitae. "Allergan has a long track record in developing and commercializing innovative dermatologic treatments. I believe our programs will be poised for successful development as part of Allergan’s portfolio. I am very proud of the tremendous contributions of our research teams and the clinical community who have led the discovery and development of our pipeline programs, and I thank them for their dedication to this science that may one day help many patients with dermatologic conditions, autoimmune disorders and potentially other conditions."

"Both the VTP-43742 and VTP-38543 programs offer the potential for highly differentiated mechanisms of action for the treatment of dermatologic conditions where patients are underserved by currently approved treatments," said David Nicholson, Chief Research & Development Officer, Allergan. "In addition, Vitae’s novel Contour drug discovery platform and its team, which have been instrumental in the discovery of novel ‘difficult to drug’ compounds, will be highly complementary to Allergan’s existing R&D discovery efforts in key therapeutic areas."

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Vitae common stock for $21.00 per share. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Vitae common stock. The merger agreement contemplates that Allergan will acquire any shares of Vitae that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pending approvals, Allergan anticipates closing the transaction by the end of 2016.

Additional information about Vitae, VTP-43742 and VTP-38543, as well as the unmet medical need in the treatment of psoriasis and atopic dermatitis, is available as a slide presentation on the Allergan web site at View Source

Debevoise & Plimpton LLP is serving as Allergan’s legal counsel. J.P. Morgan is serving as financial advisor to Vitae and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as Vitae’s legal counsel.

On September 14, 2016 Aviragen Therapeutics, Inc. (NASDAQ:AVIR) reported its financial results for the fourth quarter and 2016 fiscal year ended June 30, 2016, and also provided an update on recent corporate and clinical developments (Press release, Nabi Biopharmaceuticals, SEP 14, 2016, View Source [SID:SID1234515155]).

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"Over the last twelve months we have made significant advances with our three next generation direct-acting antivirals that address serious infections with limited therapeutic options. Enrollment is 90% complete in the SPIRITUS Phase 2b trial of vapendavir for the treatment of human rhinovirus infections in moderate and severe asthmatic patients, and we look forward to announcing top-line data from the trial around the end of the year. We also announced today comparable bioavailability results for two new formulations of vapendavir that are appropriate for pediatrics, Phase 3 and commercial scale-up," remarked Joseph M. Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics.

"For our RSV program, we were pleased to resume enrollment in the Phase 2a RSV challenge study of BTA585, a RSV fusion inhibitor, following a short delay. We anticipate that top-line viral load data will be available around the end of the year. Finally, we strengthened our balance sheet with $20 million of non-dilutive cash from the partial monetization of our Inavir royalty stream. This positions us well to aggressively advance our pipeline of clinical-stage antivirals."

Recent Corporate Highlights

Vapendavir Phase 1 Bioavailability Trial. The Company reported today that it has successfully completed a single-center, open-label, bioavailability study in healthy volunteers assessing the comparability of the vapendavir phosphate salt capsule, and two new formulations of vapendavir free base in the forms of an oral suspension and tablet. Forty-six (46) subjects completed three periods of oral dosing and the plasma pharmacokinetic results indicated that the bioavailability of the oral suspension and tablet formulation were comparable to the capsule form of vapendavir which is currently being used in the Phase 2b SPIRITUS trial. The oral suspension formulation is intended to enable the conduct of future pediatric trials, and the tablet formulation will allow an increase in manufacturing scale appropriate for Phase 3 trials and commercial development.

Resumed Enrollment in the Phase 2a Efficacy Study of BTA585 for the Treatment of Respiratory Syncytial Virus (RSV) Infections. In July 2016, the Company reported that, subsequent to receiving approval from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), enrollment has resumed in the double-blind, placebo-controlled, Phase 2a trial that is designed to evaluate the safety, pharmacokinetics, and antiviral activity of orally-dosed BTA585 in healthy volunteers challenged intranasally with RSV. In May, the Company announced that it was voluntarily delaying enrollment in the trial to investigate an aberrant lab result from a subject that was coupled with transient ECG changes. The Company also reported in July that it expects to submit a complete response to the U.S. Food and Drug Administration (FDA) in the first quarter of calendar 2017 regarding the clinical hold of BTA585’s investigational new drug (IND) application. The clinical hold was related to the aberrant lab report.

Entered into a License and Sponsored Research Agreement with Georgia State University Research Foundation (GSURF). In July 2016, the Company announced that it entered into an exclusive, worldwide license and sponsored research agreement with GSURF to jointly develop and commercialize RSV replication inhibitors discovered by Professor Richard Plemper and his team in the Institute for Biomedical Sciences (IBMS) at Georgia State University.

Financial Results for the Three Month Period Ended June 30, 2016

The Company reported net loss of $7.0 million for the three month period ended June 30, 2016, as compared to a net loss of $19.9 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.18 for the three month period ended June 30, 2016, as compared to a basic and diluted net loss per share of $0.55 in the same period of 2015. The major components of net loss in both periods are as follows:

Revenue decreased to $0.6 million for the three month period ended June 30, 2016 from $4.1 million in the same period in 2015 due to a $3.7 million reduction in royalty revenues resulting from lower government stockpiling sales of the flu product Relenza.

Research and development expense increased to $6.0 million for the three month period ended June 30, 2016 from $5.2 million in the same period in 2015. The increase reflected higher clinical costs related to the initiation of a Phase 2a challenge trial investigating the use of BTA585 as a treatment for RSV, and higher expenses for producing clinical supplies of BTA074 for its Phase 2 clinical trial for the treatment of condyloma caused by human papillomavirus (HPV) types 6 and 11.

In June 2015, the Company recorded a $17.6 million non-recurring, in-process research and development (IPR&D) expense in connection with the acquisition of Anaconda Pharma. There was no IPR&D expense recorded in 2016.

General and administrative expense was $1.3 million for both the three month period ended June 30, 2016 and the same period in 2015, as higher consulting and professional fees were fully offset by lower employee compensation costs.

Accounting Treatment for the Sale of Royalty Interest to HealthCare Royalty Partners (HCRP):

In April 2016, Aviragen sold a portion of its interest in future royalty payments related to Inavir, a flu product marketed in Japan by Daiichi Sankyo, to HCRP for gross proceeds of $20 million. As a result of a limit on the amount of royalties that HCRP can earn under the arrangement, U.S. accounting rules require Aviragen to account for this transaction under the debt accounting method. Aviragen has no obligation to pay any amounts to HCRP other than to pass through to HCRP its share of royalties as they are received from Daiichi Sankyo. In addition, although the royalty payments were sold to HCRP, the debt accounting rules require the Company to continue to recognize HCRP’s share of the royalties as non-cash revenue in its Statement of Operations and to record the proceeds of $20 million, net of expenses, as a liability on its Balance Sheet. As royalties are passed through Aviragen to HCRP under this arrangement, the liability is reduced. Non-cash implied interest expense will be recognized on the liability. In the fourth quarter of 2016, Aviragen recognized $0.2 million of non-cash royalty revenue and $0.3 million in non-cash interest expense related to this arrangement.

The Company held $69.0 million in cash, cash equivalents, and short-term investments as of June 30, 2016.

Financial Results for the Fiscal Year Ended June 30, 2016

The Company reported a net loss of $25.4 million for its fiscal year ended June 30, 2016, as compared to a net loss of $19.1 million in the prior year. The $6.3 million increase in net loss from the prior year was primarily due to a $15.5 million decrease in revenues reflecting a reduction of $7.0 million in royalty revenue, principally related to Relenza, and $8.5 million in lower service revenue, due to the cancellation of the BARDA contract in 2014. The net loss comparison was also impacted by a $6.5 million increase in research and development expense, largely related to higher costs for the Company’s vapendavir and BTA585 clinical development programs. These items were partially offset by the impact of a non-recurring $17.6 million IPR&D expense recorded in fiscal 2015 related to the acquisition of Anaconda Pharma. Basic and diluted net loss per share was $0.66 for the fiscal year ended June 30, 2016, as compared to a basic and diluted net loss per share of $0.54 in the prior year.

On September 14, 2016 Ipsen (Euronext:IPN; ADR:IPSEY), a global specialty-driven pharmaceutical group, reported that the European Commission has approved Cabometyx (cabozantinib) 20, 40, 60 mg tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (Press release, Ipsen, SEP 14, 2016, View Source [SID:SID1234515138]). Cabometyx (cabozantinib) is the only single agent to demonstrate significant clinical benefits across all three efficacy endpoints (OS, PFS, ORR) in a phase 3 study in previously treated patients with RCC. This approval allows for the marketing of Cabometyx (cabozantinib) in previously treated advanced RCC in all 28 member states of the European Union, Norway and Iceland.

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David Meek, Chief Executive Officer, Ipsen stated: "The approval of Cabometyx (cabozantinib) in Europe provides a breakthrough treatment to physicians and their patients suffering from renal cancer who failed on initial therapy. This oral drug has the potential to become a new standard of care in the second line setting of advanced renal cell carcinoma as it prolongs survival, slows disease progression, and shrinks tumors, with a clinically-acceptable safety and tolerability profile."

Dr. Bernard Escudier, oncologist, kidney cancer and immunotherapy specialist at Institut Gustave Roussy, Villejuif (France) added: "The approval of Cabometyx (cabozantinib) by the European Commission brings a new treatment option offering survival benefit for patients with renal cancer who failed a prior treatment with a VEGFR-targeted therapy. This oral drug, in addition to targeting VEGF, has a unique mechanism of action targeting MET and AXL which are common pathways of resistance in renal cell carcinoma. Cabometyx also offers a convenient oral schedule for patients and flexibility of dosing for individualized treatment. "

The approval is based on the results of a large, randomized phase 3 trial METEOR.

About CABOMETYX (cabozantinib)

Cabometyx (cabozantinib) targets include MET, AXL and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown to inhibit the tyrosine kinase activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.

On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.

On September 9, 2016, the European Commission approved Cabometyx (cabozantinib) for the treatment of advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland.

February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan.

About the METEOR Phase 3 Pivotal Trial

METEOR was an open-label, event-driven trial of 658 patients with advanced renal cell carcinoma who had failed at least one prior VEGFR TKI therapy. The primary endpoint was PFS in the first 375 patients randomized. Secondary endpoints included OS and objective response rate in all enrolled patients. The trial was conducted at approximately 200 sites in 26 countries, and enrollment was weighted toward Western Europe, North America, and Australia. Patients were randomized 1:1 to receive 60 mg of Cabometyx (cabozantinib) daily or 10 mg of everolimus daily and were stratified based on the number of prior VEGFR TKI therapies received and on MSKCC risk criteria. No cross-over was allowed between the study arms.

METEOR met its primary endpoint by significantly improving PFS. Compared with everolimus, Cabometyx (cabozantinib) was associated with a 42 percent reduction in the rate of disease progression or death. Median PFS for Cabometyx (cabozantinib) was 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Cabometyx (cabozantinib) also significantly improved the objective response rate compared with everolimus, be it through investigator assessment (24% versus 4%, p<0.0001) or through central review (17% versus 3%, p < 0.0001). These data were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.1

Cabometyx (cabozantinib) also demonstrated a statistically significant and clinically meaningful increase in OS in the METEOR trial. Compared with everolimus, Cabometyx (cabozantinib) was associated with a 34 percent reduction in the rate of death. Median OS was 21.4 months for patients receiving Cabometyx (cabozantinib) versus 16.5 months for those receiving everolimus (HR=0.66, 95% CI 0.53-0.83, P=0.0003).

Cabometyx (cabozantinib) benefit in OS was robust and consistent across all pre-specified subgroups. In particular, benefit was observed regardless of risk category, location and extent of tumor metastases, and tumor MET expression level. These results were presented on June 5, 2016 at the ASCO (Free ASCO Whitepaper) Annual Meeting and concurrently published in The Lancet Oncology.2

At the time of the analysis, the median duration of treatment in the trial was 8.3 months with Cabometyx (cabozantinib) versus 4.4 months with everolimus. The most frequent adverse events regardless of causality were diarrhea, fatigue, decreased appetite and hypertension for Cabometyx and fatigue, anemia, decreased appetite and cough for everolimus. Dose reductions occurred for 62 percent and 25 percent of patients, respectively. Discontinuation rate due to an adverse event not related to disease progression was 12 percent with Cabometyx (cabozantinib) and 11 percent with everolimus.

About Advanced Renal Cell Carcinoma

Renal cell carcinoma (RCC) represents 2-3% of all cancers3, with the highest incidence occurring in Western countries. Generally, during the last two decades until recently, there has been an annual increase of about 2% in incidence both worldwide and in Europe, though in Denmark and Sweden a continuing decrease has been observed4. In 2012, there were approximately 84,400 new cases of RCC and 34,700 kidney cancer related deaths within the European Union5. In Europe, overall mortality rates for RCC have increased up until the early 1990s, with rates generally stabilizing or declining thereafter6. There has been a decrease in mortality since the 1980s in Scandinavian countries and since the early 1990s in France, Germany, Austria, the Netherlands, and Italy. However, in some European countries (Croatia, Estonia, Greece, Ireland, Slovakia), mortality rates still show an upward trend with increasing rates6.

The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.7,8 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.9-12 MET and AXL may provide escape pathways that drive resistance to VEGFR inhibitors.8,9