On October 2, 2018 AskAt Inc. (AskAt) (Headquarters: Nagoya, Japan, CEO: Akihiro Furuta) reported that Arrys Therapeutics, Inc. (Headquarters: Cambridge, Massachusetts), which licensed AAT-007 in immuno-oncology from AskAt in December 2017, has initiated a clinical study with AAT-007 (grapiprant) (ARY-007) in combination with pembrolizumab (anti PD-1 antibody, KEYTRUDA) (Press release, AskAt, OCT 2, 2018, View Source [SID1234535044]).

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The study is an Open-label, Single-arm, Phase 1b clinical trial to evaluate the safety and efficacy of grapiprant in combination with pembrolizumab in patients with advanced or progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC).

Arrys is the sponsor of the study, in collaboration with Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

On October 2, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that it has been advised that its licensing partner CANbridge Pharmaceutical Inc received confirmation that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab based-therapy (Press release, Puma Biotechnology, OCT 2, 2018, View Source [SID1234529704]). NERLYNX was approved in the United States for the same indication in July 2017 and in the European Union for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in September 2018.

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James Xue, PhD, Founder, Chairman and CEO of CANbridge Pharmaceutical Inc, said, "The fact that CANbridge has so rapidly advanced CAN030 (neratinib), our first Western-approved target therapy, along the regulatory pathway in China demonstrates our capacity to new bring medical breakthroughs to China swiftly, where they can potentially address the unmet needs of millions. HER2-positive breast cancer is on the rise in China, particularly in younger women, and the patient outcomes, with limited current treatment options relative to Western countries, are not as good. We are committed to bringing this important new treatment to these patients, as well as to exploring its potential application in other HER2-positive cancers, such as gastric."

"We are very pleased with the progress that CANbridge has made in the regulatory process for NERLYNX in greater China. This is a testament to their dedication to helping breast cancer patients in China and we are very pleased to see this dedication to the patients, which helps Puma to recognize its goal of making NERLYNX available to patients worldwide," said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. "We look forward to CANbridge’s continued progress in this regulatory process for NERLYNX."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

About CANbridge Pharmaceutical

CANbridge Pharmaceutical Inc is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). The company develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia, or address medical needs that are underserved in the region. It also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China).

CANbridge is privately-held and headquartered in Beijing, China. Further information may be found at www.canbridgepharma.com.

On October 2, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that data from the Phase 2b trial of nelipepimut-S (NeuVax) in combination with trastuzumab (Herceptin) for the treatment of women with triple-negative breast cancer (TNBC) will be presented in a poster presentation at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 9-11, 2018 in Washington, D.C (Press release, Sellas Life Sciences, OCT 2, 2018, View Source;Herceptin-at-the-2018-Society-for-Immunotherapy-of-Cancer-SITC-Annual-Meeting/default.aspx [SID1234529724]).

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Details for the presentation are as follows:

Title: Correlation between response and HLA type in a randomized phase IIb trial of NeuVax + trastuzumab in HER2 low-expressing breast cancer patients to prevent recurrence
Poster Hall Location: Hall E
Poster Hall Hours: Friday, November 9 from 8:00 a.m. – 8:00 p.m. ET;
Saturday, November 10 from 8:00 a.m. – 8:30 p.m. ET
Abstract ID: 11073
SELLAS previously announced that the full dataset from the Phase 2b trial of nelipepimut-S (NeuVax) in combination with trastuzumab (Herceptin) will be presented in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany.

On October 2, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer of Synlogic, effective immediately (Press release, Synlogic, OCT 2, 2018, View Source [SID1234530532]). Dr. Brennan joined Synlogic as chief medical officer in 2016 and has served as interim president and chief executive officer since May 2018.

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"After conducting a thorough search process, it was clear to the board of directors that Aoife is the right person to lead Synlogic at this time in the company’s evolution," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife stepped into the interim role and rapidly demonstrated her effectiveness. Her broad experience across multiple stages of drug development and therapeutic areas, her demonstrated leadership abilities, and her ambitious vision for Synlogic, make her uniquely qualified for the job. We are confident that under her leadership, Synlogic will be well-positioned to deliver Synthetic Biotic medicines to patients."

"I appreciate the confidence and support of the board of directors and am thrilled to be selected to lead Synlogic as we pioneer the development of a completely new class of living medicines," said Dr. Brennan. "We have made great progress to date, advancing two Synthetic BioticTM programs into the clinic. I look forward to continuing to execute on our plans for the clinical development of our lead candidates while capitalizing on the broad applicability and potential of our novel platform to build a pipeline of therapies for patients with serious and life-threatening diseases."

Prior to joining Synlogic, Dr. Brennan spent six years at Biogen in roles of increasing responsibility, most recently as vice president and head of the Rare Disease Innovation Unit, which included programs ranging from pre-clinical to commercial. She has also led programs across multiple therapeutic areas including the late-phase development of nusinersen for spinal muscular atrophy and treatments for Hemophilia B and Hemophilia A, ALPROLIX and ELOCTATE. Earlier, Dr. Brennan was director of clinical development at Tolerx, a start-up biotech company focused on immunotherapy for Type 1 diabetes. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland and completed her post-graduate training in internal medicine, endocrinology and metabolism at the Royal College of Physicians in Ireland. Additionally, she completed post-doctoral training in clinical research and metabolism at the Beth Israel Deaconess Medical Center in Boston and is a graduate of the Harvard Medical School Scholars in Clinical Science Program.

On October 2, 2018 Gossamer Bio, Inc. ("Gossamer Bio") reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Gossamer Bio, OCT 2, 2018, View Source [SID1234529746]).

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"We are honored to be selected as a Fierce 15 company for 2018," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio. "We have an exciting portfolio of innovative clinical and research stage programs across multiple indications that leverage our deep mechanistic understanding of immunobiology. With a focus on immunology, inflammation and immuno-oncology, our world-class team is committed to applying our collective expertise in discovery and development to bring forth important new medicines to patients who are suffering."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 16th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.