On August 23, 2018 Novartis reported the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS) (Press release, Novartis, AUG 23, 2018, View Source [SID1234529033]). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor[1].

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"BYL719 is the only alpha-specific PI3K inhibitor and the first one to show potential increased benefit and acceptable tolerability for patients," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "We are encouraged by the results observed in the SOLAR-1 study and look forward to submitting the data to an upcoming medical congress and starting discussions with health authorities worldwide."

Currently, there are no approved PI3K inhibitors for HR+ advanced breast cancer. The PI3K pathway plays an important role in regulating cell processes and is the most frequently altered pathway promoting tumor growth, disease progression and treatment resistance in HR+ advanced breast cancer[4],[5].

Adverse events observed with investigational BYL719 in combination with fulvestrant in SOLAR-1 were generally consistent with those observed in previous BYL719 and fulvestrant studies[1]. The SOLAR-1 trial will continue to assess data for secondary endpoints. Novartis will begin discussions with global health authorities based on these results.

About PI3K inhibition in advanced breast cancer
Studies have established the role of PI3K signaling in several processes critical for cancer progression, including cell metabolism, growth, survival and motility[9]. Activation of the PI3K pathway in breast cancer is associated with resistance to endocrine therapy, disease progression and poorer prognosis[4],[6].

Proteins in the PI3K pathway consist of four smaller parts called isoforms[7]. Approximately 40% of HR+ advanced breast cancer patients have genetic mutations that activate the alpha isoform, called PIK3CA mutations[2]. Mutations in the three other isoforms are typically not associated with advanced breast cancer[7].

About SOLAR-1
SOLAR-1 is a global, Phase III randomized, double-blind, placebo-controlled trial studying investigational BYL719 in combination with fulvestrant for postmenopausal women and men with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer that progressed on or following prior aromatase inhibitor treatment with or without a CDK4/6 inhibitor[10].

The trial randomized 572 patients in a 1:1 ratio to receive continuous oral treatment with BYL719 300mg or placebo once daily in combination with fulvestrant 500mg intramuscular injections on days 1 and 15 on the first cycle and day 1 of each subsequent 28-day cycle as per fulvestrant prescribing information. Patients were allocated based on tumor tissue assessment to either a PIK3CA-mutant cohort or a PIK3CA non-mutant cohort. Stratification was based on visceral metastases and prior CDK4/6 inhibitor treatment[10].

The primary endpoint is PFS for patients with the PIK3CA mutation. Secondary endpoints include but are not limited to: overall survival, overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA non-mutant cohort, safety and tolerability[10].

About BYL719 (alpelisib)
BYL719 is an investigational, orally bioavailable, alpha-specific PI3K inhibitor. In breast cancer cell lines harboring PIK3CA mutations, BYL719 has been shown to potentially inhibit the PI3K pathway and have antiproliferative effects. In addition, cancer cell lines with PIK3CA mutations were more sensitive to BYL719 than those without the mutation across a broad range of different cancers[11].

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 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. (Paris:ALCLS) (NASDAQ:CLLS) 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 [SID1234530610]). 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 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.