1stOncology™: Cancer Intelligence Service – Page 14465 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

INDEPENDENT DATA MONITORING COMMITTEE RECOMMENDS DISCONTINUATION OF BAVARIAN NORDIC’S PHASE 3 STUDY OF PROSTVAC IN METASTATIC PROSTATE CANCER

On September 14, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that an independent Data Monitoring Committee (DMCB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 PROSPECT study of PROSTVAC in patients with metastatic castration-resistant prostate cancer (mCRPC) is futile (Press release, Bavarian Nordic, SEP 14, 2017, View Source [SID1234520525]).

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!

"We are extremely disappointed for patients that this study of PROSTVAC as monotherapy was not successful," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. "On behalf of Bavarian Nordic, I want to express our gratitude to the PROSPECT investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of combination treatments, including immunotherapies, to transform the future of cancer therapies."

The contents of this announcement do not affect the Company’s expectations for the financial results for 2017.

About the PROSPECT study
PROSPECT was a global, randomized, double-blind, placebo-controlled Phase 3 study conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the study was to determine whether PROSTVAC alone or in combination with GM-CSF could prolong overall survival in men with asymptomatic or minimally symptomatic mCRPC. The study enrolled 1,297 patients at more than 200 sites in 15 countries.

About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec, or "rilimogene") is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body’s immune response, specifically T cells that will home to and kill prostate cancer cells, altering the course of the disease and improving overall survival of patients with prostate cancer. PROSTVAC employs two poxviruses (vaccinia and fowlpox) in a prime-boost vaccine regimen. A robust data package has been established that includes 19 ongoing or completed clinical studies, comprising more than 2,000 patients, the majority of which have been actively treated with PROSTVAC, which has been generally well-tolerated.

PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement.

Champions Oncology Reports Record Quarterly Revenue of $5 Million

On September 14, 2017 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the first quarter ended July 31, 2017 (Filing, Q2, Champions Oncology, 2017, SEP 14, 2017, View Source [SID1234520524]).

First Quarter and Recent Business Highlights:

•
Record quarterly revenue of $5.0 million, an increase of 37.1% year-over-year
•
Record Translational Oncology Services ("TOS") revenue of $4.6 million, an increase of 45.4% year-over-year
•
Engaged in a multi-year, strategic collaboration with AstraZeneca to develop models to be used in oncology R&D programs for breast and lung cancer
•
Collaborated with The Addario Lung Cancer Medical Institute ("ALCMI") to develop models in patients with ROS1 gene rearrangement
•
Reiterated expectations for fiscal year 2018 revenue growth of at least 20% over fiscal year 2017

Ronnie Morris, CEO of Champions, commented, "We delivered substantial increases in revenue and bookings for the first fiscal quarter and reduced our operating expenses both sequentially and year-over-year, reinforcing our confidence in achieving operating profitability for fiscal year 2018. Interest in our products and services drove quarterly revenues to more than $5 million for the first time in our history. We are rapidly approaching an inflection point in our business model where we expect the volume of solutions we sell to generate revenue that will soon exceed our total expenses, which are largely fixed. The first quarter included approximately $100,000 in non-recurring expenses related to the move to our new lab facility in Maryland, a move we expect will save approximately $1 million a year in a combination of fixed and variable costs based on current revenue levels beginning November 1, 2017. Excluding these one-time expenses and non-cash stock compensation expense, we would have realized income from operations for the quarter, a solid marker towards achieving sustained, similar quarterly result in the second half of fiscal 2018."

"Our multi-year collaboration with AstraZeneca and a research collaboration with Addario further expands the size, uniqueness and value of our TumorBank while also increasing our total addressable market to provide additional future growth opportunities," added Morris. "These relationships illustrate the breadth of our capabilities, the value we provide to our clients in their pre-clinical and clinical drug development research and the opportunities within our market."

Exhibit 99.1

Financial Results

For the first quarter of fiscal 2018, revenue increased 37.1% to $5 million, as compared to $3.7 million for the first quarter 2017. Total operating expenses for the first quarter fiscal 2018 and 2017 was $5.7 million and $6.2 million, respectively, a decrease of $500,000 or (8.7%).

For the first quarter of fiscal 2018, Champions reported a loss from operations of $619,000, including $564,000 in stock-based compensation, an improvement of $1.9 million or (75.5%) compared to the loss from operations of $2.5 million, inclusive of $1.1 million in stock-based compensation, in the first quarter of fiscal 2017.

For the first quarter of fiscal 2018 and 2017, Champions reported a loss from operations of $619,000 and $2.5 million, respectively, a decrease of $1.9 million or (75.5%). Excluding stock-based compensation of $564,000 and $1.1 million for the three months ended July 31, 2017 and 2016, respectively, Champions recognized a loss from operations of $55,000 and $1.4 million for first quarter 2018 and 2017, respectively.

The first quarter included approximately $100,000 in non-recurring expenses related to the new move to our new lab facility, a move the Company expects will save approximately $1 million a year off of current revenue levels beginning November 1, 2017. Excluding these one-time expenses and stock based compensation, the Company would have generated positive net income from operations.

Net cash used in operations was $1.9 million and $2.4 million for the three months ended July 31, 2017 and 2016, respectively, a decrease of $500,000 or (20.1%). The reduction in cash burn is the result of revenue growth and aggressive expense management; however, the total cash outflows for the quarter were mainly the result of fixed asset investments for our new lab facility along with a reduction in deferred revenue.

The Company ended the quarter with $430,000 of cash and cash equivalents. Despite the cash burn in the first quarter, the Company reiterates its position that it does not intend to raise capital in the equity market.

Translational Oncology Services (TOS) revenue was $4.6 million for the three months ended July 31, 2017 compared to and $3.2 million for the three months ended July 31, 2016, respectively, an increase of $1.4 million or 45.4%. The increase is due to continued strength in bookings from prior quarters, both in the number and size of the studies.

TOS cost of sales was $2.3 million for the three months ended July 31, 2017, an increase of $300,000, or 10.1%, compared to $2.0 million for the three months ended July 31, 2016. For the three months ended July 31, 2017 and 2016, gross margin for TOS was 50.9% and 35.1%, respectively. The increase in TOS cost of sales was due to an increase in the number and size of TOS studies. While gross margin often fluctuates quarter to quarter, resulting from timing differences between revenue and expense recognition, the improvement in gross margin was due to higher TOS revenue leveraged off the fixed cost component of the lab and effective management of the variable lab costs.

Personalized Oncology Services (POS) revenue was $439,000 and $511,000 for the three months ended July 31, 2017 and 2016, respectively, a decrease of $72,000 or (14.1%). The decrease is due mainly to a decrease in implant and drug panel revenue of $48,000 and $17,000, respectively.

Exhibit 99.1

POS cost of sales was $387,000 for the three months ended July 31, 2017, a decrease of $87,000, or (18.4%), compared to $474,000 for the three months ended July 31, 2016. For the three months ended July 31, 2017 and 2016, gross margin for POS was 11.8% and 7.2%, respectively. The improvement is attributed to the increase in higher margin sequencing revenue and aggressive management of lab-related costs.

Research and development expense was $1.1 million for the three months ended July 31, 2017, a decrease of $100,000, or (7.7%), compared to $1.2 million for the three months ended July 31, 2016. Sales and marketing expense for the three months ended July 31, 2017 was $683,000, a decrease of $242,000, or (26.2%), compared to $925,000 for the three months ended July 31, 2016. The decrease is mainly due to a reduction in stock based compensation expense. General and administrative expense was $1.2 million for the three months ended July 31, 2017, a decrease of $300,000 or (21.2%), compared to $1.5 million for the three months ended July 31, 2016. The decrease is mainly due to the decrease in stock based compensation expense.

Mirati Therapeutics Presents Positive Preliminary Data From On-Going Clinical Trials Of Sitravatinib In Non-Small Cell Lung Cancer

On September 14, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology biotechnology company, reported that positive preliminary data from two ongoing clinical trials of sitravatinib in non-small cell lung cancer (NSCLC) will be presented Friday, September 15th, 2017 at the IASLC 2017 Chicago Multidisciplinary Symposium in Thoracic Oncology (learn more at www.iaslc.org) (Filing, 8-K, Mirati, SEP 14, 2017, View Source [SID1234520523]).

Initial safety data and efficacy information will be presented from the ongoing Phase 2 study of sitravatinib in combination with nivolumab (OPDIVO) as a treatment for NSCLC patients with cancer progression following previous treatment with a checkpoint inhibitor. Additionally, a case study will be presented, documenting an objective response of a NSCLC patient with a CBL inactivating mutation. This was the first evaluable NSCLC patient harboring a CBL mutation treated in the ongoing Phase 1b study of sitravatinib as a single agent. In both clinical studies, sitravatinib alone and in combination with nivolumab was well tolerated with a manageable safety profile.

"For the majority of NSCLC patients who progress following checkpoint therapy, there is a need for new therapeutic options," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We are evaluating sitravatinib in combination with nivolumab in this checkpoint resistant population and are very encouraged by the responses observed, since responses would not be expected from re-treatment with a checkpoint inhibitor alone."

"In addition, in the single agent trial, the objective partial response is the first example of clinical activity in a patient with a CBL mutation. Inactivating mutations in CBL occur in approximately 1.5% of NSCLC patients and currently represent an unmet medical need."

Sitravatinib and Nivolumab Combination Study

Poster Presentation: Evidence of Clinical Activity of Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy

Clinical Trial: NCT02954991, A Phase 2 study evaluating the tolerability and clinical activity of sitravatinib in combination with nivolumab in patients with non-squamous NSCLC who have experienced progression of disease on or after treatment with checkpoint inhibitor therapy.

Presenter: Ticiana A. Leal, M.D.

This presentation provides a preliminary safety and efficacy update of the Phase 2 trial of sitravatinib in combination with nivolumab in NSCLC patients who have experienced progression of disease on or after treatment with checkpoint inhibitor therapy. In the efficacy data presented, 3 patients experienced a confirmed partial response out of 11 evaluable patients. Early safety data demonstrated an acceptable profile and manageable adverse events. Based on the data presented, the pre-defined criteria have been met for expansion from stage 1 to stage 2, which will enroll a combined total of 34 patients.

This study is designed to assess the potential of sitravatinib to inhibit several important immunosuppressive pathways that may be important in overcoming resistance to checkpoint inhibitor therapy.

Sitravatinib Single Agent Study

Poster Presentation: CBL Mutations as Potential Mediators of EGFR TKI Resistance Effectively Treated with Sitravatinib

Clinical Trial: NCT02219711, A Phase 1b study evaluating safety, PK, metabolism, PD and clinical activity of Sitravatinib in patients with advanced solid tumor malignancies

Presenter: Lyudmila A. Bazhenova. M.D.

The poster describes a case study of a NSCLC patient with a CBL mutation treated with sitravatinib. CBL loss of function mutations result in the increased activation of multiple oncogenic receptor tyrosine kinases (RTKs) in tumors, including PDGFRA, VEGFR2, KIT, Axl, and Mer. In preclinical models, sitravatinib has demonstrated the ability to potently inhibit these RTKs and induce tumor regression in NSCLC models harboring inactivating CBL mutations. In the case study presented, a heavily pre-treated NSCLC patient harboring an inactivating CBL mutation was treated with sitravatinib and demonstrated a confirmed partial response (PR) with a maximum decrease of 77% in target lesions. Early safety data is also provided; sitravatinib was well tolerated and the side effects observed were manageable. This trial is on-going and actively recruiting patients harboring CBL and other genetic mutations.

CBL mutations are present in 1.5% of NSCLC, 3.5% of melanoma, and 2% of cancers of unknown origin.

Both posters will be available on the Company’s website on the sitravatinib page, located in the Pipeline section, at: View Source

About Sitravatinib

Sitravatinib (MGCD-0516) is a spectrum-selective kinase inhibitor which potently inhibits receptor tyrosine kinases (RTKs) including RET, TAM family receptors (TYRO3, Axl, Mer), and split family receptors (VEGFR2, KIT). Sitravatinib is being evaluated as a single agent in a Phase 1b expansion trial enrolling patients that harbor RET, CHR4Q12, and CBL genetic mutations in NSCLC and other tumors.
As an immuno-oncology agent, sitravatinib is being tested in combination with BMS’ anti PD-1 checkpoint inhibitor nivolumab (OPDIVO) in NSCLC patients who have progressed after prior

treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family receptors may help overcome resistance to checkpoint inhibitor therapy through targeted depletion of immunosuppressive Type 2 tumor associated macrophages, regulatory T cells and myeloid-derived suppressor cells and increasing antigen presentation capacity of dendritic cells in the tumor microenvironment.

Janssen Submits Supplemental New Drug Application to U.S. FDA for ZYTIGAÂ® (abiraterone acetate) to Treat Men with Earlier Stages of Metastatic Prostate Cancer

On September 14, 2017 – Janssen Biotech, Inc. reported the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of ZYTIGA in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC). The filing is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in newly diagnosed patients with high-risk mHNPC, ZYTIGA in combination with prednisone and ADT significantly increased overall survival (OS) and radiographic progression-free survival (rPFS), compared to placebo plus ADT.

"We are excited about the promising results from the LATITUDE study which suggest that ZYTIGA can benefit men with newly diagnosed, high-risk metastatic prostate cancer, rather than waiting for them to become resistant to conventional hormonal treatments," said Craig Tendler, M.D., Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care at Janssen. "We look forward to working with the FDA on the review of this application to provide a new therapeutic option for men with newly diagnosed, high-risk metastatic prostate cancer."

LATITUDE was a multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial which examined the use of ZYTIGA 1,000 mg once daily in combination with prednisone 5 mg once daily and ADT, compared to placebo plus ADT (N=1,199) in patients with newly diagnosed, high-risk mHNPC. The study was presented at the plenary session of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, and simultaneously published in the New England Journal of Medicine.Additional data from the study were presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Conference on September 8 in Madrid, Spain.1 2
The LATITUDE study showed ZYTIGA in combination with prednisone and ADT reduced the risk of death by 38 percent compared to placebo plus ADT (median OS not reached vs. 34.7 months, respectively; hazard ratio: 0.62; 95% confidence interval [CI], 0.51 to 0.76; P<0.001) in patients with mHNPC. Additional study results found patients with mHSPC who received ZYTIGA in combination with prednisone and ADT had a 53 percent lower risk of radiographic progression or death, compared to placebo plus ADT (median rPFS 33.0 months vs. 14.8 months, respectively, HR: 0.47; 95% CI, 0.39 to 0.55; P<0.001). Concerning the secondary end points, ZYTIGA in combination with prednisone and ADT, reduced the risk of pain progression by 31 percent (HR=0.695; 95% CI: 0.583, 0.829; P<0.0001) and skeletal-related events by 30 percent (HR=0.703; 95% CI: 0.539, 0.916; p=0.0086) and reduced the risk of needing to start chemotherapy by 56 percent (HR=0.443; 95% CI: 0.349, 0.561, P<0.0001) compared to placebo plus ADT.
Additional data, presented at ESMO (Free ESMO Whitepaper), demonstrated clinically meaningful and statistically significant improvements in patient reported outcomes (PRO) in patients with high-risk mHNPC who received ZYTIGA in combination with prednisone and ADT compared to placebo plus ADT alone. ZYTIGA in combination with prednisone and ADT, significantly delayed the time to health-related quality of life degradation by 15 percent (HR=0.853; 0.736, 0.989; p=0.0322) and significantly delayed the time to worst fatigue intensity progression by 35 percent (HR=0.652; 95% CI: 0.527, 0.805; P=0.0001) for patients with mHNPC.
Overall, the safety profile of ZYTIGA in combination with prednisone and ADT, was similar to prior studies in patients with metastatic castration resistant prostate cancer (mCRPC). Grade 3/4 events reported in ≥5 percent of patients were hypertension (20%/0% vs. 10%/0.2%), hypokalemia (10%/0.8% vs. 1%/0.2%) and increase in alanine aminotransferase (5%/0.3% vs. 1%/0%) in ZYTIGA in combination with prednisone and ADT vs. placebo plus ADT groups, respectively.

Since its first approval in the U.S. in 2011, ZYTIGA has been approved in combination with prednisone or prednisolone in 105 countries. In April 2017, Janssen submitted a Type II variation application to the European Medicines Agency (EMA), seeking to expand the existing marketing authorization for ZYTIGA in combination with prednisone or prednisolone to include the treatment of men with mHNPC. Similar submissions have been made in Japan, Canada, Mexico, Brazil, Switzerland, Taiwan, Singapore, and the Philippines. If approved, these submissions will broaden the use of ZYTIGA in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.

Kancera and Recipharm collaborate to manufacture clinical trial supply

On September 14, 2017 Kancera pharmaceutical reported that KAND567 works by blocking the Fractalkine system and has been shown in preclinical disease models to effectively counteract the onset of autoimmune disorders, as well as neuritis and pain in connection with chemotherapy against cancer (Press release, Kancera, SEP 14, 2017, View Source [SID1234520517]). In future clinical studies, Kancera intends to treat patients with the pharmaceutical candidate KAND567 filled into capsules and taken orally.

As part of the collaboration, Recipharm will develop the preparation that is required for effective release of KAND567 from the capsules, as well as manufacturing the pharmaceutical product. The work will be performed at Recipharm’s development facility in Solna.

Thomas Olin, CEO of Kancera said: "The decision to commence development of capsules for an active dosage of KAND567 shows that Kancera has reached an important milestone in the Fractalkine project. We are delighted to now be collaborating with Recipharm to produce the pharmaceutical product that will be used to study how KAND567 can help patients."

Torkel Gren, General Manager at Recipharm in Solna commented: "We are happy to be able to contribute to the development of a new drug with the potential to be of great medical value. We have extensive experience in developing drugs for clinical trials as well as commercial manufacture and this will be very valuable in the collaboration with Kancera."