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 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of important research in the peer-reviewed journal Cancer Immunology Research (Press release, Oncolytics Biotech, OCT 2, 2018, View Source [SID1234530640]). The research showed that pelareorep, a systemically delivered oncolytic reovirus, can destroy tumor cells via a monocyte-mediated process even after the virions have been exposed to antibodies designed to neutralize the reovirus.

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"For some time there have been two schools of thought regarding oncolytic viruses: those that believe intratumoral delivery is necessary for treatment due to potential neutralization of the virus in the bloodstream and those that believe intravenous delivery is also an efficacious means of treatment with a virus," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This key publication validates the systemic delivery of oncolytic viruses by proving that oncolytic viruses delivered intravenously can be effective even in the presence of neutralizing antibodies. It sends a message to everyone in the oncology community that systemic delivery of this drug class is not only viable, but may increase its effectiveness in the presence of neutralizing antibodies."

The study was conducted by Dr. Elizabeth Ilett and Dr. Rob Berkeley from the University of Leeds and Professor Alan Melcher from The Institute of Cancer Research, London. Oncolytics Biotech donated pelareorep for research.

In the study, researchers treated pelareorep with neutralizing antibodies derived from patients undergoing virus therapy and added the antibody-coated virions to melanoma cells, which resulted in no killing of melanoma cells. However, addition of monocytes to the culture led to reactivation of the neutralized virus particles, allowing them to effectively target and destroy the melanoma cells. Three different viruses that are currently being evaluated in clinical trials were tested in the study, with neutralized forms of two of the three viruses being reactivated by monocytes, a finding with immediate clinical significance.

"This discovery suggests that cancer treatments using systemic virus therapy could be significantly expanded in the future, as we previously, but erroneously, believed that follow-up doses were useless once the body had produced antibodies against the virus," said Dr. Ilett.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

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.

On October 2, 2018 Kronos Bio, Inc. (Kronos), a Two River portfolio company, 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 for its pursuit of novel therapies against some of the most important and intractable targets in cancer research (Press release, Kronos Bio, OCT 2, 2018, View Source [SID1234529766]).

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"It is an honor to have Kronos named by FierceBiotech as one of their Fierce 15 biotechnology companies for 2018," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "Fierce adeptly describes our pursuit of targets many have viewed as ‘undruggable.’ We believe our small molecule microarray (SMM) technology will enable us to engage recalcitrant targets and develop innovative therapies for cancer and other life altering diseases."

The foundation of Kronos was built on over a decade of research into high-throughput screening strategies for chemical modulators of transcription factors and other recalcitrant targets in oncology. By combining small molecule microarrays with extensive know-how in biological assay development, Kronos’ technology platform enables high-throughput screens of chemical libraries against target proteins in a more physiologically relevant context. As a result, a single screening assay can identify compounds that bind or interfere with target protein activity directly, disrupt protein-protein or protein-DNA interactions, or indirectly modulate target protein activity by binding to co-factors or
other protein complex members. This approach is ideally suited for rapid discovery of unique ligands that can be utilized in the generation of novel modulators or degraders of historically challenging targets such as transcription factors.

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