On August 22, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported it has acquired the drug candidate momelotinib from Gilead Sciences (Press release, Sierra Oncology, AUG 22, 2018, View Source [SID1234529036]). Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control.

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"The majority of myelofibrosis patients have anemia at diagnosis or develop it during treatment with other therapies, including ruxolitinib. Anemia is the most significant negative prognostic indicator in myelofibrosis patients and, as a result, one of the most important disease consequences to address," said Dr. Srdan Verstovsek, Medical Oncologist and Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas. "The therapeutic focus in myelofibrosis has traditionally been on treating the enlarged spleen and constitutional symptoms common to the disease. However, optimal drug therapy would also address disease-related cytopenias, including anemia and transfusion dependency, while also improving splenomegaly and symptoms. The Phase 3 clinical data for momelotinib demonstrate clinical benefits in all of these categories and I believe the drug candidate warrants further development. Given its anemia benefit, momelotinib could potentially become an important option for the treatment of myelofibrosis."

"Opportunistically adding this compelling Phase 3 asset to our existing pipeline of next generation oncology drug candidates, SRA737 and SRA141, helps establish Sierra as a diversified late-stage drug development company with a commercial orientation," said Dr. Nick Glover, President and CEO of Sierra Oncology. "The company is uniquely positioned to advance momelotinib towards potential registration with several members of the Sierra senior management team having played key roles in the development of momelotinib from its discovery through to Phase 3 clinical trials. The body of clinical data generated from more than 1,200 patients dosed to date will guide and support our momelotinib development strategy. We believe an additional clinical study likely will be required to consolidate these clinical data, and over the coming months we plan to engage with key opinion leaders and regulators to further define an expeditious regulatory path for momelotinib."

"Unlike other JAK inhibitors, momelotinib addresses myelofibrosis-related anemia. The Phase 2 and Phase 3 data to date demonstrate that momelotinib consistently improves the anemia that frequently occurs in advanced myelofibrosis, postulated via ACVR1 inhibition. ACVR1 is a member of the TGFβ superfamily of receptors that regulate the iron metabolism pathway. ACVR1 activates the transcription of hepcidin, which leads to decreased erythropoiesis. Demonstrable splenic responses and constitutional symptom control have also been achieved with momelotinib, suggesting that the compound is able to address a spectrum of unmet medical needs in myelofibrosis," noted Dr. Barbara Klencke, Chief Development Officer for Sierra Oncology. "Momelotinib also has a well-defined, predictable safety profile, with more than 180 patients still remaining on active long-term therapy, some benefitting from treatment for more than seven years, reinforcing its potential durable efficacy and favorable long-term tolerability."

Deal terms

Sierra will pay Gilead a $3 million upfront fee for momelotinib and potential aggregate milestone payments of up to $195 million, which are largely associated with commercial sales of the drug. Sierra will also pay Gilead royalties on any sales of momelotinib, which will be tiered based on commercial success and range from mid-teens to high-twenties. Sierra will assume all currently ongoing clinical studies with momelotinib following a transition period.

Fenwick & West LLP served as legal counsel to Sierra in connection with the transaction. Mizuho Securities USA LLC served as exclusive financial advisor to Gilead. Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel to Gilead.

Analyst & Investor Call Thursday, August 23st at 4:00 p.m. Eastern Time (1:00 p.m. Pacific Time)
Sierra will host an Analyst and Investor conference call on Thursday, August 23st at 4:00 p.m. ET where the company will introduce momelotinib and respond to questions. Members of the professional investment community may participate by phone by calling (866) 548-4713 (Toll-free in North America) or (323) 794-2093 (International Dial-in) and enter the Conference ID number: 6356543. The call will be webcast live and will be accessible through the company’s website at www.sierraoncology.com. An archived replay of the webcast will also be available.

About momelotinib
Momelotinib is a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis encompassing a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, as well as achieving substantive spleen and constitutional symptom control. More than 1,200 subjects have received momelotinib since clinical studies began in 2009. Momelotinib is covered by patents anticipated to provide exclusivity to 2035 in the U.S. and 2033 in the EU.

Momelotinib was discovered and initially developed at Cytopia Ltd., an Australian biotechnology company whose CSO, Dr. Andrew Wilks, discovered the JAK1 and JAK2 kinases while at the Ludwig Institute for Cancer Research. Cytopia was acquired in 2011 by YM BioSciences Inc. (YM), a drug development company. Dr. Nick Glover, President & CEO of Sierra Oncology, previously led YM where he and his team advanced momelotinib through Phase 1/2 studies that first identified momelotinib’s unique anemia benefit. YM was acquired by Gilead in 2013. Current members of Sierra’s management team have prior experience developing momelotinib while at Cytopia, YM and Gilead.

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 Nordic Nanovector ASA (OSE: NANO) reported its second quarter and first half 2018 results (Press release, Nordic Nanovector, AUG 22, 2018, View Source [SID1234553495]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented: "I am pleased to report a quarter marked by important progress in the development of lead candidate Betalutin in follicular lymphoma (FL). The first patients in the PARADIGME trial have now been dosed. Betalutin was also granted Fast Track designation in June for relapsed or refractory 3L FL, adding to the Orphan drug designation for treating FL it received in 2014. These designations, granted based on the potential of Betalutin to address an unmet patient need in FL, could support a quicker and smoother regulatory process and path to market, if PARADIGME is successful. We are also pleased that Archer-1 has been approved in Norway and we expect the first patient to be dosed before the end of 2018.

"Betalutin is an exciting therapeutic candidate for non-Hodgkin’s lymphoma (NHL) and Nordic Nanovector is well positioned to drive its development through clinical trials. I’m excited to join the Company at this important time and look forward to working with the excellent board and management team to realise the significant potential of Betalutin and to provide a new treatment option to NHL patients who are in need of effective therapies."

Operational Highlights

• Eduardo Bravo appointed as Chief Executive Officer
o Brings more than 25 years’ experience from the biopharmaceutical industry

• First patient dosed in pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed antiCD20 refractory follicular lymphoma (3L R/R FL)
o Site activations continuing – as of August 21st, 41 (of 80-85) sites in 13 (of 20) countries are open for enrolment
o First data read-out targeted for 1H 2020

• Betalutin granted Fast Track designation in the US for FL
o Based on promising safety and preliminary efficacy data from the LYMRIT 37-01 study

• Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients approved in Norway
o First patient expected to be dosed in 2H 2018

• Phase 1 study with Betalutin in DLBCL advances to next dosing level
o First dosing levels found to be safe and well-tolerated

• Further appointments to strengthen the Management Team and Board of Directors
o Maureen Deehan, PhD, appointed as Head of Corporate Development and Strategy
o Rainer Boehm, MD, elected as a member of the Board of Directors

Financial Highlights Q2 and 1H 2018

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the second quarter amounted to NOK 0 (NOK 0.1 million). Revenues for the first half of 2018 were NOK 0 (NOK 0.1 million).

• Total operating expenses for the second quarter were NOK 84.5 million (NOK 76.3 million). Total operating expenses for the first half of 2018 amounted to NOK 166.8 million (NOK 142.1 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 72.2 % of total operating expenses (71 %) for the first half of 2018.

• Comprehensive loss for the second quarter amounted to NOK 82.9 million (loss of NOK 66.3 million). Comprehensive loss for the first half was NOK 173.6 million (loss of NOK 122.1 million)

• Cash and cash equivalents amounted to NOK 570.1 million at the end of June 2018 (NOK 641.5 million at 31 March 2018 and NOK 756.6 million at 31 December 2017)

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with initial clinical data read-outs targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Betalutin has been granted Fast Track designation in the US for the treatment of patients with R/R FL.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Second Quarter and First Half 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team in English will take place today at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.

Results presentation in Norwegian

A separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO, and its VP IR & Corporate Communications, will take place on Thursday, 23 August 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

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