On August 22, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that the United States Patent and Trademark Office has issued a new composition of matter patent related to altered APRIL-binding antibodies, further enhancing the company’s B-select intellectual property portfolio (Press release, Aduro Biotech, AUG 22, 2018, View Source;p=RssLanding&cat=news&id=2364506 [SID1234529060]). Specifically, the granted claims cover BION-1301, Aduro’s first-in-class anti-APRIL antibody being evaluated in a Phase 1/2 dose escalation trial for the treatment of multiple myeloma.

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"Blocking APRIL represents a unique approach to treating patients with multiple myeloma and we believe BION-1301 has potential to treat a myriad of oncology indications as well as other autoimmune and inflammatory diseases," commented Stephen Isaacs, chairman and chief executive officer of Aduro Biotech. "Ensuring a robust intellectual property position around BION-1301 is inherent to advancing the program and the claims granted in this particular patent exemplify the novel science behind this exciting program."

U.S. patent 9,969,808 adds to previously issued U.S. and international counterpart patents and patent applications that form Aduro’s APRIL patent portfolio. Claims were granted on the basis that BION-1301 enables full blockade of APRIL binding to both its receptors BCMA and TACI. Preclinical studies have demonstrated that blocking APRIL with BION-1301 not only inhibited proliferation and survival of multiple myeloma cells but also alleviated drug resistance and immune suppression, leading to enhanced myeloma cell killing.1 Further preclinical research by Aduro and its collaborators indicate that blocking APRIL further enhances anti-BMCA cytotoxic cell killing and that prevention of APRIL binding to TACI may also be a potentially important mechanism for BION-1301 to inhibit the function of regulatory T cells.2

About APRIL
APRIL (A PRoliferation-Inducing Ligand) is a member of the tumor necrosis factor (TNF) superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with multiple myeloma and binds to BCMA (B cell maturation antigen) and TACI (Transmembrane Activator and CAML Interactor) to stimulate a wide variety of responses that promote multiple myeloma growth and survival and suppress the immune system so that the tumor cells are protected and sustained in the bone marrow.

About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for multiple myeloma. Despite new treatments recently approved in multiple myeloma, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that A PRoliferation-Inducing Ligand (APRIL) plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through the B cell maturation antigen (BCMA), was shown to be critically involved in the survival, proliferation and chemoresistance of multiple myeloma, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in multiple myeloma blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study.

On August 22, 2018 Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (NYSE: PFE) reported an agreement through 2021 to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer (Press release, Exact Sciences, AUG 22, 2018, View Source [SID1234530170]). Pfizer will join Exact Sciences’ sales representatives in reaching both physicians and health systems and will also actively participate in extending and deepening the Cologuard marketing campaign.

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Colorectal cancer is recognized as the most preventable yet least prevented form of cancer and remains the second leading cause of cancer death in the U.S., with more than 50,000 deaths each year. Nine out of 10 people survive more than five years when colorectal cancer is diagnosed in Stages I or II, but only one out of 10 people survive more than five years when the disease is diagnosed in Stage IV. While patient outcomes can be improved through early detection, fewer than two-thirds of people are up-to-date with recommended colorectal cancer screening guidelines.

"This partnership marks a turning point in the fight to end colorectal cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "Pfizer is joining Exact Sciences’ mission of eradicating colorectal cancer by helping detect the disease at its earliest, most treatable stages. Together we can help reduce the prevalence of colorectal cancer by combining the power of Cologuard and the talented Exact Sciences team with Pfizer’s experience, relationships and resources."

Exact Sciences and Pfizer seek to increase colorectal cancer screening rates by accelerating adoption of Cologuard, an accurate, easy-to-use test that’s fully covered by Medicare and most major health insurance plans. Exact Sciences brings a sales force with expertise in colorectal cancer, the innovative science of Cologuard and a recognizable direct-to-consumer marketing campaign. Pfizer brings a large and experienced sales force and relationships integrating with the leading health systems, two areas where Cologuard is most often prescribed, along with deep marketing expertise.

"There is a significant patient need to increase colorectal cancer screening, and our field force has long established relationships with providers who prescribe first-line preventative treatments to patients," said Nick Lagunowich, regional president, North America, Pfizer Internal Medicine. "By joining forces with Exact Sciences to bring this non-invasive colorectal cancer screening option to more providers and their patients, we hope to substantially increase the early detection of colorectal cancer."

Under the terms of the agreement, Pfizer will co-promote Cologuard with Exact Sciences beginning in the fourth quarter of 2018. Exact Sciences will maintain responsibility for all aspects of manufacturing and laboratory operations of Cologuard. Pfizer will share gross profits and marketing expenses equally above an agreed upon baseline.

More information about the agreement is available here, in a form 8-K that Exact Sciences will file in compliance with Securities and Exchange Commission rules.

Exact Sciences Conference Call & Webcast
Exact Sciences will host a conference call and webcast on Wednesday, Aug. 22, 2018, at 8:00 a.m. ET to discuss the agreement. The webcast will be available at www.exactsciences.com. Domestic callers should dial (877) 201-0168 and international callers should dial +1 (647) 788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 5278277. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in April 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not for everyone; not for high risk individuals, including those with a family history of colorectal cancer, a personal history of cancer or advanced adenoma, IBD, and certain hereditary syndromes. Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

On August 22, 2018 Jiangsu Hengrui Medicine reported that the China National Drug Administration (CNDA) granted a conditional approval to its self-developed compound pyrotinib for treating HER2-positive breast cancer (Press release, Hengrui Pharmaceuticals, AUG 22, 2018, View Source [SID1234591433]). The approval was based on clinical data from phase II studies, demonstrating China’s effort in marketing domestic innovative drugs faster.

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On August 22, 2018 Calyxt, Inc. (NASDAQ: CLXT) and Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) reported its Board of Directors has appointed Yves Ribeill, Ph.D., as Interim Chief Executive Officer, effective immediately (Press release, Cellectis, AUG 22, 2018, View Source [SID1234529062]). Dr. Ribeill replaces Federico Tripodi, who is leaving the Company to pursue other opportunities. Currently a member of Calyxt’s Board of Directors, Dr. Ribeill will work closely with the executive management team to promote the development of the Company’s products to benefit consumers, including the commercial launch of Calyxt’s high-oleic soybean oil.

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In addition, the Board of Directors of Calyxt appointed Jonathan Fassberg, founder of the Trout Group and currently Co-Chief Executive Officer of Solebury Trout, as a member of the Board of Directors and a member of the Audit Committee.

"Given Yves’ extensive prior experience in healthcare, coupled with his strategic abilities, business development experience and broad network, the Board is confident he will bring the right combination of skills necessary to succeed during this pivotal period for Calyxt," said Dr. André Choulika, Chairman of Calyxt’s Board of Directors. "The Company is making significant strides to develop healthy food products for consumers, and we expect Dr. Ribeill to solidify Calyxt’s position as a leader in the field." Dr. Choulika added, "the Company would like to thank Mr. Tripodi for his service as CEO and wishes him the very best in his future endeavors".

"Healthy eating and healthy living go hand-in-hand," added Dr. Ribeill. "I strongly believe that Calyxt will play a vital role in keeping people healthy across the world, and the Company has enormous potential to create foods that exhibit healthy characteristics. At Calyxt, we have the unique opportunity to lead an important trend in agriculture towards creating healthier crops and food ingredients. We view it as our duty to address the health and nutrition concerns of today’s society by developing better, more nutritious foods for consumers."

Yves Joseph Ribeill, Ph.D., founded SCYNEXIS, Inc (NASDAQ: SCYX) and served as President and CEO from 1999 to 2015. Dr. Ribeill has more than 35 years of experience in the healthcare industry, with an expertise in anti-infective diseases including bacterial, fungal, viral and parasiticidal and in microbiome-centric diseases. Prior to moving to the U.S. 21 years ago, Dr. Ribeill held several management positions during his international career with Rhône-Poulenc and Aventis in France and in the UK. Dr. Ribeill was a member of the Scientific Advisory Committee of the World Health Organization, the Medicines for Malaria Venture and is currently Vice Chairman of the Triangle Global Health Consortium in North Carolina.

Conference Call Details

Calyxt to hold a conference call for investors Wednesday, August 22, 2018 at 8:30a.m. ET – 7:30a.m. CT.

The live dial-in information for the conference call is:

US & Canada only: 877-407-9747

International: 412-902-0044

Replay Information

Conference ID #: 13673206

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): 201-612-7415

Expiration Date: 9/5/18

Webcast URL (archived for 6 months):

https://78449.themediaframe.com/dataconf/productusers/clxt/mediaframe/26097/indexl.html

On August 21, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal fourth-quarter and full-year 2018, provided an update on recent business highlights and issued its fiscal year and first-quarter 2019 financial guidance (Press release, Myriad Genetics, AUG 21, 2018, View Source [SID1234529019]).

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"Fiscal year 2018 was an excellent year for Myriad as record-setting growth in new products with increasing reimbursement added to a solid hereditary cancer business and a re-engineered cost structure," said Mark C. Capone, president and CEO, Myriad Genetics. "Based upon our operational momentum and the recent completion of the Counsyl acquisition, we are confident in our strategy to transform Myriad into the global leader in personalized medicine."

Financial Highlights

The following table summarizes the financial results for the fiscal fourth-quarter and fiscal full-year 2018

Revisions of Previously-Issued Financial Statements: During the financial close for fiscal year 2018, the Company determined that it had not fully reserved for its sales allowance for the financial periods from fiscal year 2015 through fiscal year 2018. These errors which represented less than one percent of total revenue during that time frame were determined to be. The financial information for prior periods has been restated to reflect these adjustments.

Business Highlights

Hereditary Cancer

Achieved sixth consecutive quarter of year-over-year hereditary cancer testing volume growth.

Announced the second major clinical validation study for riskScore at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The study evaluated 518 women and found that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=2.6×10-12 and p=2.5×10-12, respectively). Moreover, riskScore was statistically significantly superior to Tyrer-Cuzick alone for both 5-year and lifetime risk of breast cancer (1.9×10-8 and p=2.4×10-8, respectively), underscoring the independent contribution of the combined test score.

Based upon recent changes to the National Comprehensive Cancer Network professional treatment guidelines for prostate, pancreatic and colon cancer, we estimate 121,000 additional cancer patients now qualify for hereditary cancer testing in the United States every year.

GeneSight

Fiscal fourth-quarter revenue increased 33 percent year-over-year to $33.9 million with record volumes in the quarter.

A record 15,000 physicians, including almost 3,000 new ordering doctors, ordered a GeneSight test in the fiscal fourth-quarter.

Presented the results from the GeneSight GUIDED randomized controlled trial at the American Psychiatric Association annual meeting. The landmark study showed that patients receiving GeneSight had significantly better outcomes with a 50 percent increase in remission rates and a 30 percent increase in response rates relative to standard-of-care therapy.

Announced the results of the IMPACT study at the American Society of Clinical Psychopharmacology annual meeting. In the study, patients treated by primary care physicians had 33 percent greater symptom improvement, 34 percent increased response and 57 percent greater remission than those treated by psychiatrists.

CareFirst, the 15th largest commercial payer in the United States, announced a favorable coverage policy for GeneSight taking effect August 1, 2018 which included all physician specialties.

Announced a new coverage decision for GeneSight with a major U.S. company with 30,000 employees.

In late-stage negotiations with Kroger Prescription Plans on a potential favorable coverage decision for GeneSight.

Vectra DA

Fiscal fourth-quarter revenue increased 47 percent year-over-year to $15.1 million.

Announced a favorable coverage decision for Vectra DA from Kroger Prescription Plans, the pharmacy benefits manager for Kroger and other employers. Kroger is the fourth largest employer in the United States.

Prolaris

Fiscal fourth-quarter revenue increased 133 percent year-over-year to $7.0 million with record volumes in the quarter.

Received positive medical policy recommendations on Prolaris from eight commercial insurers, including a top-10 commercial insurer, and seven others, totaling over 20 million covered lives or 12 percent of total commercial lives in the United States. Prolaris is now covered for approximately 55 percent of prostate cancer patients in the United States.

EndoPredict

Fiscal fourth-quarter revenue increased 40 percent year-over-year to $2.8 million.

Received positive recommendation from the National Institute for Health and Care Excellence (NICE) in the United Kingdom to cover the EndoPredict test.

myPath Melanoma

Received positive medical policy recommendations on myPath Melanoma from eight commercial insurers.

Companion Diagnostics

Metastatic breast cancer patients tested by Myriad increased 13 percent sequentially based upon the recent launch of BRACAnalysis CDx as a companion diagnostic for Lynparza.

Received pre-market approval from the Japanese Ministry of Health, Labor, and Welfare for our BRACAnalysis CDx test for HER2- metastatic breast cancer.

Announced positive results from Phase III, SOLO-1 study which evaluated patients with advanced ovarian cancer treated in the first-line setting who tested positive with Myriad’s BRACAnalysis CDx test. Myriad intends to submit a supplementary pre-market approval (sPMA) to the U.S. Food and Drug Administration (FDA) for this indication.

Announced that the FDA has accepted Myriad’s sPMA application for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s PARP inhibitor, talazoparib, in HER2- metastatic breast cancer. The New Drug Application for talazoparib has been granted priority review by the U.S. FDA and has a Prescription Drug User Fee Act goal date of December 2018.

Closing of Counsyl Acquisition

Myriad signed a definitive agreement to acquire Counsyl, Inc., a global leader in reproductive genetic testing, which closed on July 31, 2018. The acquisition of Counsyl provides Myriad with two new products, ForeSightTM and PreludeTM, in the expanded carrier screening and non-invasive prenatal screening markets respectively. Myriad

estimates that these markets will grow to approximately 3 million tests performed annually in the United States and $1.5 billion of revenue over the next five years.

Fiscal Year 2019 and Fiscal First-Quarter 2019 Financial Guidance

Myriad’s fiscal year 2019 and fiscal first-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. 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 the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, August 21, 2018, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-616-4021. International callers may dial 1-303-223-2682. All callers will be asked to reference reservation number 21892392. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.