On October 2, 2018 Compass Therapeutics, a biotechnology company committed to the ambitious goal of comprehensively drugging the human immune system, 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 biotech companies in the industry (Press release, Compass Therapeutics, OCT 2, 2018, View Source [SID1234529744]).

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Compass, which completed its $132 million Series A financing this year, is forging a new approach to identifying antibody drug candidates that engage all targets in the biologically complex human immune synapse. The company’s antibody discovery platform enables the rapid identification of therapeutic candidates that engage with a broad range of epitopes and its StitchMabs bispecific screening platform enables the empirical, high-throughput identification of novel synergistic combinations and bispecifics. To date, the company’s integrated R&D approach has generated therapeutic candidates for more than 30 targets in cancer, inflammation and autoimmune disease. More than 15 of them are now advancing through preclinical development.

"We’re honored that the editors of FierceBiotech have recognized Compass for our pioneering approach to antibody-based therapeutics," said Thomas Schuetz, M.D., Ph.D., the company’s co-founder and chief executive officer. "We believe our empirical, unbiased approach to drug discovery will lead to therapeutics with new mechanisms to modulate the human immune system."

The Fierce 15 celebrates the spirit of being "fierce"— championing innovation and creativity, even in the face of intense competition. Selection to the list is based on factors including the strength of a company’s technology, partnerships and venture backers and its competitive market position.

On October 2, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the Transparency Committee of the French Haute Autorité de Santé (HAS) has recommended that Axumin (fluciclovine (18F)) is included on the list of medicines approved in France for hospital use, in line with its European indication (Press release, Blue Earth Diagnostics, OCT 2, 2018, View Source [SID1234529924]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. The positive recommendation marks a further milestone in the roll-out of Axumin across Europe, following receipt of Marketing Authorisation from the European Commission in May 22, 2017.

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Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe. The company now has six European manufacturing and distribution agreements for Axumin in place, covering seventeen countries. Axumin is already commercially available in Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "We’re delighted to announce another significant step towards our mission of making Axumin commercially available to clinicians and their patients across Europe. Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin across Europe."

On October 2, 2018 Tocagen Inc. (Nasdaq: TOCA) reported it has received Protocol Assistance from the European Medicines Agency (EMA) under the Company’s PRIME (PRIority MEdicines) designation for Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) for the treatment of patients with recurrent high grade glioma (HGG) (Press release, Tocagen, OCT 2, 2018, View Source;p=RssLanding&cat=news&id=2369807 [SID1234529957]). In particular, the EMA indicated that the statistical analyses, seamless design, and the use of overall survival as the primary endpoint in the ongoing Phase 3 Toca 5 clinical trial are appropriate for a potential marketing authorization application for Toca 511 & Toca FC.

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"We are pleased the global Toca 5 trial has the potential to serve as the basis for a regulatory application in Europe, which we believe may expedite the advancement of Toca 511 & Toca FC as a treatment for patients with brain cancer. If the pivotal trial data are positive, our gene therapy would be the first medicine in over 20 years to show a treatment benefit in a randomized trial in patients with this disease," said Marty Duvall, chief executive officer of Tocagen. "Our interactions with the European regulators under the PRIME pathway are conducted in the spirit of collaboration and urgency to bring forward a new treatment for brain cancer as quickly as possible."

Toca 5 is an international, randomized, multi-center study evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent HGG. The trial recently completed the planned enrollment of 380 patients. The primary endpoint of the trial is overall survival. Secondary endpoints of the Toca 5 trial include durable response rate, defined as complete or partial responses lasting at least 24 weeks, which is being assessed as a novel endpoint in the post-surgical setting of recurrent HGG. Tocagen plans to conduct a second interim analysis of Toca 5 in the first half of 2019 and the final planned safety and efficacy analyses by the end of 2019. More information about Toca 5 can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165.

The Committee on Orphan Medicinal Products (COMP) of the EMA has designated both Toca 511 & Toca FC as orphan medicinal products indicated for the treatment of glioma. In addition, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Toca 511 & Toca FC in recurrent HGG.

Recurrent HGG is among the most common and aggressive primary brain cancers and often strikes in the prime of life. The two most common forms of HGGs are glioblastoma and anaplastic astrocytoma. The total number of new diagnoses of HGG expected in 2018 is about 197,000 worldwide, with approximately 38,000 in Europe. Unfortunately, HGG recurs in most patients after frontline treatment, and standard of care treatment typically offers a median survival of only seven to nine months.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

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.