On February 7, 2017 CANCER RESEARCH TECHNOLOGY, Cancer Research UK’s commercial arm, Tusk Therapeutics, an immuno-oncology company, and UCL (University College London) reported that they have signed a licence and collaboration agreement to research, develop and commercialise an antibody-based therapeutic against a target that plays a key role in immune suppression in cancer (Press release, Cancer Research Technology, JUL 7, 2017, View Source [SID1234523169]).

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!

Under the terms of the agreement, Tusk Therapeutics will receive an exclusive world-wide licence from CRT to develop and commercialise therapeutic antibodies against the target, originating from the Cancer Research UK-funded research of Dr Sergio Quezada and Professor Karl Peggs at UCL. In return, CRT will receive an upfront payment, future success-based milestones and royalty payments, which will be shared with UCL.

Tusk Therapeutics has additionally entered into a three-year collaboration with CRT and UCL to part-fund a programme of preclinical work, led by Dr Quezada, to evaluate candidate antibodies in various cancer models prior to initiation of formal preclinical and clinical development. At the end of the collaboration, Tusk Therapeutics will assume responsibility for accelerating the progress of selected antibody candidates into the clinic.

Dr Quezada said: "It is extremely exciting seeing years of preclinical work move closer to a potential real therapy for patients. We are very happy with the work to date and that which we will continue doing with the Tusk Therapeutics’ team."

Luc Dochez, CEO of Tusk Therapeutics, said: "We are proud to work together with Cancer Research UK and the group of Dr Quezada. The collaboration fits Tusk’s strategy of working with top researchers in the immune-oncology field and to bring promising assets from early stage discovery through development and to the clinic."

Dr Phil L’Huillier, CRT’s director of business management, said: "This collaboration brings together Cancer Research UK’s and UCL’s world-leading immune-oncology expertise with Tusk Therapeutics’ growing industry reputation for developing promising immune-modulating antibodies. It’s one of several projects now in our portfolio focused on the up-and-coming field of immune-oncology that we hope will accelerate progress towards exciting new treatments for cancer patients."

On February 7, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal second-quarter 2017, provided an update on recent business highlights, updated its fiscal year 2017 financial guidance and issued fiscal third-quarter 2017 financial guidance (Press release, Myriad Genetics, FEB 7, 2017, View Source [SID1234517654]).

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!

"Revenues this quarter reached their highest level in the last three years, driven by a return to sequential growth in hereditary cancer revenue and strong results from GeneSight," said Mark C. Capone, president and CEO, Myriad Genetics. "Importantly, our diversification strategy is working with new products now contributing more than two thirds of testing volume. We also made steady progress on increasing reimbursement that will ultimately unlock significant operating leverage and long-term shareholder value."

Financial Highlights

The following table summarizes the financial results and product revenue for our fiscal second-quarter 2017:

Revenue
Fiscal Second-Quarter
($ in millions) 2017 2016 %
Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 143.9 $ 165.6 (13%)

GeneSight testing revenue 21.7 NA NM

Vectra DA testing revenue 10.7 11.3 (5%)

Prolaris testing revenue 3.1 1.9 63%

EndoPredict testing revenue 1.6 0.9 78%

Other testing revenue 2.9 2.9 0%

Total molecular diagnostic testing revenue 183.9 182.6 1%

Pharmaceutical and clinical service revenue 12.6 10.7 18%

Total Revenue $ 196.5 $ 193.3 2%

Income Statement
Fiscal Second-Quarter
($ in millions) 2017 2016 %
Change
Total Revenue $ 196.5 $ 193.3 2%

Gross Profit 152.1 152.7 (0%)
Gross Margin 77.4% 79.0%

Operating Expenses 138.9 107.5 29%

Operating Income 13.2 45.2 (71%)
Operating Margin 6.7% 23.4%

Adjusted Operating Income 23.6 48.4 (51%)
Adjusted Operating Margin 12.0% 25.0%

Net Income 5.9 37.1 (84%)

Diluted EPS 0.09 0.50 (82%)

Adjusted EPS $ 0.26 $ 0.45 (42%)

Business Highlights

myRisk Hereditary Cancer
– Delivered sequential hereditary cancer growth of three percent in the fiscal second-quarter with hereditary cancer revenue of $144 million.
– Oncology volumes grew on a sequential basis fueled by preferred provider agreements, the customizable myRisk panel launch and improved sales force productivity.
– Signed a contract with Highmark Blue Shield to remain an in-network provider for hereditary cancer testing; ended the quarter with 65 percent of revenue under long-term contracts and greater than 95 percent of insurance plans in network.

GeneSight
– Volume grew 61 percent year-over-year to approximately 57,000 tests performed in the fiscal second-quarter.
– Anticipate completing enrollment this month and ahead of schedule in a 1,200 patient clinical utility study evaluating GeneSight in patients with treatment resistant depression.
– Presented a health economic analysis at the Neuroscience Education Institute Conference comparing the total costs for patients with anxiety whose medications were congruent versus incongruent with their GeneSight test report. The results showed that medication cost savings were $6,747 higher per member per year for patients that followed the GeneSight test recommendations.
– Completed a payer demonstration project using the Optum healthcare informatics platform from United Health that demonstrated substantial cost savings associated with the use of GeneSight. Initiated similar demonstration projects with Humana and Anthem Blue Cross Blue Shield.

Vectra DA
– Volumes declined three percent in the second-quarter year-over-year with approximately 37,000 tests performed.
– Demonstrated that the AMPLE study when analyzed in a conventional way corroborates prior studies showing Vectra DA can predict radiographic progression with high statistical significance. This analysis along with data from 25 published clinical studies will be presented to refute a draft local non-coverage determination (LCD) issued by Medicare.
– Published an important clinical utility study for Vectra DA in Arthritis and Rheumatology. The study evaluated the ability of Vectra DA to predict response to biologic or non-biologic therapy in methotrexate incomplete responders. In the study, patients with a low Vectra DA score were statistically significantly more likely to respond to triple therapy relative to a biologic, and patients with high Vectra DA scores were statistically significantly more likely to respond to a biologic than triple therapy.
– Vectra DA was included in the United Rheumatology professional guidelines that represent approximately 10 percent of rheumatologists in the United States.
– Initiated our first payer demonstration project with an independent practice association in Southern California. This project will evaluate the impact of Vectra DA on patient outcomes and healthcare costs in a real world setting and will be used to support potential coverage of the test.

Prolaris
– Volumes grew 33 percent year-over-year with approximately 4,700 tests ordered.
– Received a draft LCD from Palmetto GBA for favorable intermediate patients that would represent a market expansion of approximately 30,000 patients per year in the United States. Prolaris is the only test to receive proposed Medicare coverage in this patient population.

EndoPredict
– Revenues grew 78 percent year-over-year to $1.6 million in the fiscal second-quarter.
– Received a favorable technical assessment for EndoPredict from the Blue Cross Blue Shield association tech assessment organization Evidence Street. In total, we have received positive coverage decisions from payers that represent 70 million lives.
– The Integrated Oncology Network (ION) recently made EndoPredict its preferred test for their physicians. ION is the largest physician service organization in oncology representing 50 percent of community oncologists in the United States.
– Confirmed that EndoPredict will be launched in the United States in fiscal year 2017.

myPath Melanoma
– The third clinical validation study and second clinical utility study were accepted for publication. Myriad intends to submit its reimbursement dossier to Medicare and private payers by the end of fiscal year 2017.

Companion Diagnostics
– Completed the submission of the myChoice HRD pre-market approval (PMA) application to the FDA for review in conjunction with niraparib.
– Data from the AstraZeneca SOLO2 study, which compared maintenance therapy with olaparib versus placebo in patients with platinum-sensitive relapsed ovarian cancer met its primary endpoint. These results further validate that BRCA status as determined by BRACAnalysis CDx test can identify patients who are likely to benefit from therapy with olaparib.

International
– International revenue grew to five percent of total product revenue.
– Signed an agreement with AstraZeneca in Japan to submit BRACAnalysis CDx for approval by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in parallel with the PMDA review of AstraZeneca’s novel PARP inhibitor, olaparib.
– Signed an agreement with AstraZeneca to perform Tumor BRACAnalysis testing in six Latin American countries.

Share Repurchase
– During the quarter, the Company repurchased approximately 600,000 shares, or $10 million, of common stock under our share repurchase program and ended the quarter with approximately $161 million remaining on our current share repurchase authorization.

Fiscal Year 2017 and Fiscal Third-Quarter 2017 Financial Guidance
Below is a table summarizing Myriad’s updated fiscal year 2017 and fiscal third-quarter 2017 financial guidance:

Revenue GAAP Diluted
Earnings Per
Share Adjusted
Earnings Per
Share
Fiscal Year 2017 $745-$755
million $0.31-$0.36 $1.00-$1.05

Fiscal Third-Quarter 2017 $188-$190
million $0.08-$0.10 $0.23-$0.25

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal second-quarter financial results and fiscal year 2017 and fiscal third-quarter 2017 financial guidance.

On February 6, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has updated its 2016 Financial Guidance (Press release, Genmab, FEB 6, 2017, View Source [SID1234517639]). Based on preliminary reporting, Genmab is improving its 2016 financial guidance published on December 20, 2016 .

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 table below summarizes our revised and previous guidance.
MDKK Revised Guidance Previous Guidance
Revenue 1,790 — 1,840 1,720 — 1,770
Operating expenses (750) — (800) (800) — (850)
Operating income 1,015 — 1,065 895 — 945
Cash position at end of year* 3,850 — 3,950 3,650 — 3,750
*Cash, cash equivalents, and marketable securities
The revenue range has increased primarily due to higher royalties on net sales of DARZALEX by Janssen and achievement of additional DuoBody milestones. Among other items, the operating expense range has decreased due to timing of clinical and pre-clinical expenses. The operating income range has increased due to the combination of higher revenue and lower expenses. Our cash position has increased mainly due to timing of operating expenses and other working capital adjustments.
As previously announced, the annual report for 2016 will be published on February 22, 2017.

On February 6, 2017 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that the first patient has been enrolled and dosed in its AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial, the only company-sponsored global phase 3 trial enrolling patients with advanced stage cervical cancer (Press release, Advaxis, FEB 6, 2017, View Source [SID1234517644]).

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!

AIM2CERV is a global, randomized, 450-patient study evaluating axalimogene filolisbac as an adjuvant therapy following primary treatment with chemotherapy and radiation in patients with high-risk locally advanced carcinoma of the cervix (HRLACC). The primary objective of the trial is to compare disease-free survival (DFS) in patients receiving axalimogene filolisbac to DFS in patients receiving placebo, with secondary objectives including overall survival, safety and tolerability. AIM2CERV is being conducted in collaboration with the GOG Foundation, Inc. under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA).

"While some women with cervical cancer are considered cancer-free after chemotherapy and radiation, a significant number will experience a recurrence of the disease that is often more aggressive and results in a poor prognosis. The global reach of the AIM2CERV study is intended to determine whether treatment with axalimogene filolisbac after chemotherapy and radiation can help prevent or delay such recurrences," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "Following recently published data that revealed cervical cancer mortality rates may be exponentially higher in African American women and significantly underestimated for all women, coupled with research last year showing fewer than half of patients with locally advanced cervical cancer receive standard-of-care therapy, the need for new treatment options is more clear now than ever."

Cervical cancer occurs most often in women who have been infected by the human papillomavirus (HPV) and is the most common HPV-associated cancer in women. According to the American Cancer Society, approximately 12,000 women in the United States will be diagnosed with cervical cancer in 2017. Approximately 4,900 of these patients will be diagnosed with HRLACC, according to the Surveillance, Epidemiology and End Results (SEER) Program. While there are multiple vaccines available to prevent HPV, only one-third of the U.S. population has been vaccinated against the virus and the vaccination rate is lower worldwide. Cervical cancer largely affects women who have not received vaccines or regular screenings.

"Through our National Cervical Cancer Coalition (NCCC), every day we talk to women struggling with cervical cancer and the families of those who have lost loved ones to cervical cancer," said Deborah Arrindell, Vice President, Health Policy at the American Sexual Health Association, an umbrella organization which includes NCCC. "Just as we need options to prevent HPV-related cancers, there is a significant need for more therapeutic options to treat those with cancer. No woman should die from cervical cancer."

Axalimogene filolisbac, which received orphan drug designation and Fast Track designation for adjuvant therapy in HRLACC and orphan drug designation for stage II-IV cervical cancer from the FDA and was classified as an advanced therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), has shown encouraging activity and a manageable safety profile in phase 2 studies. Last year, the company presented positive data from the completed Phase 2 GOG-0265 study showing a promising rate of survival in persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). Top-line data released in 2016 showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This was a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors. The most commonly reported side effects were hypotension and symptoms related to cytokine release, including nausea, chills and fever. The full data set from the GOG-0265 study will be presented at the Society of Gynecologic Oncology’s 48th Annual Meeting on Women’s Cancer in March.

The company plans to enroll approximately 450 patients at 150 global sites. For additional information, please visit www.clinicaltrials.gov (NCT 02853604) or call 844-783-1529.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide and the second leading cause of cancer death in women under age 50. An estimated 500,000 new cases are diagnosed in globally and approximately 270,000 people die of the disease each year. Persistent HPV infection is the most important factor in the development of cervical cancer, research shows. According to the ICO Information Centre on HPV and Cervical Cancer, about 70 percent of cervical cancers are attributed to high-risk HPV strains. The prognosis for women with advanced and recurrent cervical cancer remains poor, with survival of only 4 to 7 months following failure of first-line treatment, research has shown. According to the American Cancer Society, the 5-year survival rate for metastatic disease is at just 15 percent, with the area continuing to be a high unmet medical need.

On February 6, 2017 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported the submission of a Marketing Authorization Application (MAA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the European Medicines Agency (EMA) (Press release, Ariad, FEB 6, 2017, View Source;p=RssLanding&cat=news&id=2243225 [SID1234517645]). ARIAD is seeking marketing approval in the European Union of brigatinib in adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been previously treated with crizotinib. The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application for brigatinib filed by ARIAD and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).

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!

"ARIAD’s submission of the brigatinib MAA to the EMA is one of many recent milestones highlighting our strong investment in internally discovered rare cancer therapies," said Paris Panayiotopoulos, president and chief executive officer of ARIAD. "Since announcing our definitive agreement to combine with Takeda, we remain focused on our accountability to our patients by propelling brigatinib forward and by preparing for its anticipated U.S. launch."

"The brigatinib clinical trials have provided patients with refractory ALK+ NSCLC, including those patients who have metastatic brain lesions, with a potential important treatment option," said Maurice Perol, MD, Léon Bérard Cancer Center, Lyon, France. "Based on the clinical data we’ve seen to date, we are really excited by the prospect that appropriate patients in the EU may have access to brigatinib as a new targeted treatment."

ARIAD’s MAA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. Results from the ALTA trial and central nervous system (CNS) activity in the ALTA and Phase 1/2 trials were reported at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer (WCLC) in December 2016. In the ALTA trial, 222 patients received either 90 mg of brigatinib once per day (QD) continuously or 180 mg QD, preceded by a lead-in dose of 90 mg QD for seven days. Data from the ALTA trial demonstrated that of 110 patients on the 180-mg regimen QD with a seven-day lead-in at 90 mg QD with a median follow-up of 11.0 months, 55 percent achieved confirmed objective response as assessed by the investigator. In this arm, the median progression-free survival (PFS) was 15.6 months in this post-crizotinib setting, by both investigator and independent review committee (IRC) assessment. Additionally, in this arm, 67 percent (12/18) of patients with measurable brain metastases achieved a confirmed intracranial objective response. The most common treatment-emergent adverse events (TEAEs; ≥ 25% of all patients in this arm, regardless of relationship to treatment), were nausea (43%), fatigue (40%), diarrhea (39%), cough (36%), increased blood creatine phosphokinase (CPK) (33%), headache (30%), rash (28%), and vomiting (26%). The most common serious adverse reactions other than neoplasm progression reported in 2% or more of patients included pneumonia (5.0%), pneumonitis (5.0%) and epilepsy (2.3%). A subset of pulmonary adverse events (AEs) with early onset (median: Day 2; range: Day 1-9) occurred in 6.4 percent of all patients (grade ≥3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD following the lead-in dose of 90 mg for seven days.

About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD. It is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). The global Phase 2 ALTA trial, in patients with locally advanced or metastatic ALK+ NSCLC who were previously treated with crizotinib, is the primary basis for brigatinib’s initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy and safety of brigatinib in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor. More information on brigatinib clinical trials can be found here.

Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted Orphan Drug designation by the FDA for the treatment of ALK+, ROS1+ and EGFR+ NSCLC.

About ALK+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 80 to 85 percent of the estimated 222,500 new cases of lung cancer diagnosed each year in the United States, according to the American Cancer Society. Anaplastic lymphoma kinase (ALK) was first identified as a chromosomal rearrangement in anaplastic large-cell lymphoma (ALCL). Genetic studies indicate that chromosomal rearrangements in ALK are key drivers in a subset of NSCLC patients as well. Approximately five percent of patients with NSCLC have a rearrangement in the ALK gene, according to the American Cancer Society.