On September 4, 2018 Puma Biotechnology, Inc. (Nasdaq:PBYI) reported that the European Commission (EC), has granted marketing authorisation for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy (Press release, Puma Biotechnology, SEPT 4, 2018, View Source [SID1234529268]).

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EC approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. Patients (n=2,840) with early stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.

The results of the ExteNET trial demonstrated that after two years of follow-up, for patients with hormone receptor positive, HER2-positive early stage breast cancer patients who were treated within one year after the completion of trastuzumab based adjuvant therapy, invasive disease-free survival (iDFS) was 95.3% in the patients treated with neratinib compared with 90.8% in those receiving placebo (hazard ratio = 0.49; 95% CI: (0.30, 0.78); p=0.002)

The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.

"Reducing the risk of disease recurrence remains a need for patients, despite advances in the treatment of early stage HER2-positive breast cancer," said Puma Biotechnology CEO and President Alan H. Auerbach. "We are pleased to bring this new medicine to patients in Europe and would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial. We are committed to continuing to expand NERLYNX accessibility to patients worldwide. We expect NERLYNX to be commercially available in Europe in 2019, beginning with our launch in Germany during the first half of 2019 and followed by additional countries throughout Europe in the second half of 2019."

The approval of NERLYNX by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in June 2018.

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

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.

On September 4, 2018 Tempest Therapeutics Inc., a development-stage biotechnology company advancing small molecules that modulate anti-tumor immunity pathways, reported that Ginna Laport, M.D., joined the company as Chief Medical Officer (Press release, Tempest Therapeutics, SEPT 4, 2018, View Source [SID1234529267]). Dr. Laport brings significant expertise in hematology, oncology and clinical drug development, and will lead the evaluation and clinical development of Tempest’s portfolio of novel first-in-class drug candidates in patients with advanced malignancies.

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"We are very excited to welcome Ginna to the Tempest team. She has an impressive academic and biotech pedigree together with a track record of advancing multiple modalities of cancer therapeutics. Ginna will be integral in the transition of Tempest into a clinical-stage biotechnology company in 2019," said CEO Tom Dubensky, Ph.D.

Prior to joining Tempest, Dr. Laport served as vice president of clinical development at Corvus Pharmaceuticals, where she led the clinical development of small molecules and antibodies targeting the adenosine pathway to treat advanced solid tumors. Additionally, Dr. Laport was a member of the Executive Committee and oversaw clinical development and operations.

Before Corvus, Dr. Laport was faculty in the Stanford University School of Medicine, most recently as professor of medicine in the Division of Blood and Marrow Transplantation (BMT). Her research focused on adoptive immunotherapies for malignant diseases and she served as director of clinical research in the BMT Division and as an associate director of the Stanford Cancer Institute. Prior to Stanford, Dr. Laport was an assistant professor in hematology/oncology at the University of Pennsylvania. Dr. Laport served on the FDA’s Oncologic Drugs Advisory Committee (ODAC), was national chair of the NIH-sponsored BMT Clinical Trials Network that directs multicenter clinical trials, and has co-authored over 80 publications.

Dr. Laport received her M.D. from the University of Texas-Houston and a B.A. from Baylor University. She completed her internal medicine residency and fellowship in hematology/oncology at The University of Chicago.

In addition, Tempest has promoted Dr. Alicia Levey to Chief Business Officer. Dr. Levey previously was Tempest’s VP of business development and strategy. Prior to Tempest, she was VP of business development at Inception Sciences, a small molecule drug discovery company formed in collaboration with Versant Ventures, a global venture capital firm focused primarily on early stage investing and biotechnology company creation.

Dr. Levey is an operating principal at Versant where she has led the diligence on multiple deals including several that have been acquired or are now public. She holds a Ph.D. from the Stanford University School of Medicine.

"We are delighted to have Alicia in the CBO role," said Dr. Dubensky. "She has been a critical component in establishing Tempest and has a deep track record of successful business development."

On September 4, 2018 Turnstone Biologics, a clinical-stage immuno-oncology company developing the next generation of oncolytic viral therapies, and the La Jolla Institute for Allergy and Immunology reported that they have entered into a collaboration and licensing agreement whereby Turnstone will utilize La Jolla Institute’s proprietary neoantigen identification methodology to select personalized neoantigens to target with its proprietary viral technologies for the development of new cancer immunotherapies (Press release, Turnstone Biologics, SEPT 4, 2018, View Source [SID1234529266]).

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Under the terms of the agreement, Turnstone will license the neoantigen identification methods developed by La Jolla Institute professors Dr. Stephen Schoenberger, Division of Developmental Immunology, and Dr. Bjoern Peters, Division of Vaccine Discovery, for use in cancer immunotherapies. Turnstone will fund collaborative research to further develop antigen identification methods for use in a Phase I/II clinical trial using its proprietary MG1 viral platform, expected to commence in 2019. Turnstone will also make development and regulatory milestone payments for therapies that utilize La Jolla Institute’s technology.

"Neoantigen-based treatments have the potential to transform cancer patient care by targeting specific genetic mutations in cancer malignancies," said Dr. Mike Burgess, MBChB, Ph.D., President of Research and Development of Turnstone. "Neoantigens identified using the highly-predictive functional-based approach developed at La Jolla Institute will be incorporated into our MG1 viral platform to form powerful immunotherapies. We are excited to be collaborating with the La Jolla Institute with the goal of developing best-in-class personalized cancer medicines."

"The field of neoantigens has evolved tremendously, and we are diligently working to more accurately predict patient-specific cancer mutations that can be targeted to drive more effective cancer treatments," says Dr. Stephen Schoenberger. "Turnstone has exciting proprietory technologies for eliciting strong anti-tumor immune responses and we are looking forward to capitalizing on their novel approach to bring personalized neoantigen therapies to patients."

On September 4, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova will attend the Morgan Stanley Global Healthcare Conference which will be held at the Grand Hyatt New York in New York City from September 12 – 14, 2018 (Press release, MediciNova, SEPT 4, 2018, View Source;p=irol-newsArticle&ID=2366038 [SID1234529265]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Morgan Stanley

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On September 4, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it has dosed the first patient in the Company’s Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology drug candidate targeting HER2 and 4-1BB, plus atezolizumab (Tecentriq), an approved PD-L1 inhibitor (Press release, Pieris Pharmaceuticals, SEPT 4, 2018, View Source [SID1234529264]).

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The trial, a multicenter, open-label, Phase 1 dose escalation study, is designed to determine the safety, tolerability, and potential synergistic anti-tumor effects of PRS-343 plus anti-PD-L1 immunotherapy in patients with advanced or metastatic HER2-positive solid tumors. Elevated HER2 expression is associated with multiple cancers, including gastroesophageal, bladder, breast, and a range of other tumor types. The trial is fully funded and sponsored by Pieris, while Roche is supplying atezolizumab.

"The initiation of the combination trial of PRS-343 with an anti-PD-L1 immunotherapy marks the beginning of Pieris’ investigation into the potential synergistic effects of its 4-1BB-targeted therapy with PD-1/L1 blockade," said Louis Matis, M.D., Senior Vice President and Chief Development Officer of Pieris. "Given evidence from multiple preclinical studies demonstrating synergistic anti-tumor activity from concurrent 4-1BB activation and PD-(L)1 pathway blockade, we believe that combination therapy with PRS-343 and atezolizumab has the potential to provide significant clinical benefit for patients. We are enthusiastic to be initiating this trial and look forward to reporting our findings from this combination study next year."

About PRS-343

PRS-343 is a bispecific monoclonal antibody-Anticalin fusion protein comprised of a HER2 tumor-targeting antibody genetically linked to a potent Anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based bispecific therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes, and is, therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.

About HER2-Positive Malignancies

HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells and is associated with aggressive disease progression. Multiple tumor types can express HER2 including breast, gastroesophageal, bladder, biliary (cholangiocarcinoma), colorectal, endometrial, ovarian, non-small cell lung, pancreatic, head and neck, and other cancers.