On August 23, 2018 bluebird bio, Inc. (Nasdaq: BLUE) and Gritstone Oncology, Inc. reported a collaboration to research, develop and commercialize products for the treatment of cancer using cell therapy (Press release, bluebird bio, AUG 23, 2018, View Source [SID1234529037]). Gritstone Oncology will leverage its proprietary EDGE artificial intelligence platform to analyze specific tumor types to identify tumor-specific targets and natural T-cell receptors (TCRs) directed to those targets for use in bluebird bio’s established cell therapy platforms. bluebird bio will conduct all development, manufacturing and commercial activities. Gritstone Oncology will utilize its proprietary technology platform to enable patient selection for clinical development of such therapies.

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"By combining our expertise in gene and cell therapy with Gritstone Oncology’s unique target identification and TCR technology, we hope to bring the power of cell therapy to a broader set of newly-validated targets, enabling us to treat previously unaddressable patient populations," said Philip Gregory, D.Phil., chief scientific officer of bluebird bio. "As we expand our immuno-oncology focus and portfolio, this collaboration with Gritstone Oncology is highly complementary to our goal of rapidly advancing novel cellular therapies with the potential to transform the lives of people with cancer, particularly in solid tumor indications."

"As the field of immuno-oncology has evolved, it has become clear that targeting T-cell therapeutics to solid tumors in a highly specific manner is vital to enable potent tumor cell killing with sparing of normal tissues," said Andrew Allen, M.D., Ph.D., president and chief executive officer of Gritstone Oncology. "We believe that our artificial intelligence-based approach to identifying tumor-specific targets and corresponding, naturally occurring TCRs, combined with bluebird bio’s expertise in gene and cell therapy, will allow us to develop cellular immunotherapies against differentiated oncology targets. We look forward to collaborating with the bluebird bio team in order to develop innovative treatments for patients in need."

Under the terms of the agreement, Gritstone Oncology will provide 10 tumor-specific targets across several tumor types and, in certain cases, TCRs directed to those targets to bluebird bio. Gritstone Oncology will receive $20 million in an upfront payment and an additional $10 million in the form of a Series C preferred equity investment. In addition, Gritstone Oncology is eligible for significant development, regulatory and commercial milestones on any therapies, and tiered royalties on certain approved therapies.

On August 23, 2018 Vical Incorporated (Nasdaq:VICL) reported that the company will provide an overview of its technologies, development programs, and outlook on Wednesday, September 5, at 11:40 a.m. ET at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC (Press release, Vical, AUG 23, 2018, View Source;Renshaw-Global-Investment-Conference/default.aspx [SID1234529039]). The conference is being held on September 4-6, 2018, at the St. Regis New York Hotel in New York City. A webcast of the company’s presentation will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at www.vical.com.

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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 [SID1234529022]). 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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