On October 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI) reported that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer (Press release, Puma Biotechnology, OCT 2, 2019, View Source [SID1234540020]). With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

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In the ongoing CONTROL Trial, patients with HER2-positive early stage breast cancer who have completed trastuzumab-based adjuvant therapy receive neratinib daily for a period of one year. The trial initially tested high dose loperamide prophylaxis given for the first 2 cycles (56 days) of treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL Trial (NCT02400476) was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide. For the 64 patients who received the combination of loperamide plus budesonide, the incidence of grade 3 diarrhea was 28% compared to 32% in patients treated with loperamide alone. Diarrhea leading to treatment discontinuation declined to 11% in the loperamide plus budesonide cohort, compared to 18% in the loperamide alone cohort.

"We are pleased to be able to update the label for NERLYNX to include the data on the use of prophylactic loperamide plus budesonide," said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. "We believe FDA approval of the labeling supplement will help us to ensure that physicians and patients are better informed in selecting prophylactic therapy that may improve the tolerability of the drug."

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 October 2, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported that clinical data on the company’s pipeline of candidates will be presented at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 6-10, 2019, in Washington, D.C (Press release, Celyad, OCT 2, 2019, View Source [SID1234540004]).

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"SITC 2019 remains an important avenue for us to provide updated results of our clinical programs in metastatic colorectal cancer, and in particular, data from the industry’s first trial investigating an ‘off-the-shelf,’ non-gene edited allogeneic CAR-T candidate for the treatment of solid tumors," commented Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad. "In addition, disclosing clinical and scientific data from the SHRINK and alloSHRINK dose-escalation Phase 1 trials in parallel will allow the comparison of results obtained with an autologous CAR-T and its equivalent allogeneic version. As such, this comparison highlights our efforts to understand analytical development in CAR-T space and our ongoing mission to get this much-needed therapy to people living with this deadly cancer, for which there are few treatment options".

Poster Details:

Abstract P147: Effect of chemotherapy on cellular kinetics of NKG2D-based CAR T-cells in metastatic colorectal cancer patients.
Date & Time: November 8, 7:00 am. – 8:00 p.m.
Abstract P330: Results from the completed dose-escalation of the alloSHRINK phase I study evaluating the allogeneic NKG2D-based CAR T-cell therapy CYAD-101 in metastatic colorectal cancer patients
Date & Time: November 9, 7:00 am. – 8:30 p.m. EDT
Abstract P331: Results from the completed dose-escalation phase I SHRINK study evaluating the autologous NKG2D-based CAR T-cell therapy CYAD-01 in metastatic colorectal cancer patients
Date & Time: November 8, 7:00 am. – 8:00 p.m. EDT

www.celyad.com | 1

LOGO

Press Release

02 October 2019

07:00 am CEDT

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.

On October 2, 2019 Viela Bio, Inc., a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, reported the pricing of its initial public offering of 7,900,000 shares of its common stock at a price to the public of $19.00 per share (Press release, Viela Bio, OCT 2, 2019, View Source [SID1234540021]). The gross proceeds to Viela Bio from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $150 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 3, 2019 under the symbol "VIE." The offering is expected to close on October 7, 2019, subject to customary closing conditions. In addition, Viela Bio has granted the underwriters a 30-day option to purchase up to an additional 1,185,000 shares of common stock at the initial price to the public less underwriting discounts.
Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC, and Cowen and Company, LLC are acting as the joint book-running managers for this offering. Guggenheim Securities, LLC is acting as lead manager for this offering.

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The offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering, when available, may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, email: [email protected], telephone: 1-866-471-2526, fax: 1-212-902-9316;
Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, NY 10014; or
Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, email: [email protected], telephone: 1-833-297-2926.
Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 2, 2019. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 2, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company addressing key mechanisms of tumor drug resistance, reported that it has appointed Matthew L. Sherman, M.D. as Executive Vice President and Chief Medical Officer (Press release, Deciphera Pharmaceuticals, OCT 2, 2019, View Source [SID1234540005]). Dr. Sherman brings over 25 years of experience as a physician-scientist in clinical drug development in oncology and hematology at leading biotechnology and pharmaceutical companies. Dr. Sherman will be responsible for leading the clinical development and medical affairs strategy for the Company’s pipeline of small molecule drug candidates designed using its proprietary kinase switch control inhibitor platform.

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"We are thrilled to welcome Matt to the Deciphera team at this exciting time for our company," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Matt’s deep expertise in successfully developing oncology therapeutics will be an incredible asset to Deciphera as we prepare the new drug application, or NDA, for ripretinib and advance our pipeline of novel product candidates. I look forward to working with Matt as we continue our mission to develop important new medicines for the treatment of cancer."

"Deciphera’s proprietary kinase switch control inhibitor platform has generated a diverse portfolio of product candidates spanning late-stage to preclinical development that are designed to address unmet needs in the treatment of cancer," said Dr. Sherman. "I am excited to join Deciphera and its impressive leadership team at this pivotal moment for the Company, and I look forward to contributing to its future success."

From 2006 to 2018, Dr. Sherman served as Chief Medical Officer of Acceleron Pharma, Inc., where he led medical research, clinical operations, biostatistics, data management, clinical pharmacology, medical writing, outsourcing and pharmacovigilance. Before joining Acceleron, Dr. Sherman was Senior Vice President and Chief Medical Officer at Synta Pharmaceuticals (now Madrigal Pharmaceuticals). Prior to Synta, Dr. Sherman spent over a decade at Wyeth-Ayerst Research/Genetics Institute, where he led the successful submission, positive Oncologic Drug Advisory Committee recommendation, and FDA approval for the first antibody immune-drug conjugate for acute myeloid leukemia. He has published 260 original papers, book chapters, reviews and abstracts, and is listed as an inventor on 13 patents. He currently serves as a director of Pieris Pharmaceuticals, Pulmatrix, and NewLink Genetics. He also serves on the Geisel School of Medicine at Dartmouth Board of Advisors and Alumni Council. Dr. Sherman received a S.B. in Chemistry from the Massachusetts Institute of Technology and a M.D. from Dartmouth Medical School. He completed his internal medicine residency at Georgetown University Medical Center and fellowship in Medical Oncology at the Dana-Farber Cancer Institute. Dr. Sherman is board certified in Internal Medicine and Medical Oncology and has held various academic and teaching positions at Harvard Medical School with corresponding clinical appointments at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.

On October 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that four abstracts highlighting its TIL therapy will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting from November 6-10, 2019 in National Harbor, Maryland (Press release, Iovance Biotherapeutics, OCT 2, 2019, View Source [SID1234540022]). One of the abstracts is a late-breaking submission and presentation details will be made available to the public on November 1, 2019. Details on the three posters that will be presented as part of the regular submissions are below.

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Title: Expanding Iovance’s tumor infiltrating lymphocytes (TIL) from core biopsies for adoptive T cell therapy using a 22-day manufacturing process
Author: Abelson et al.
Poster #: P145
Presentation date/time: November 8, 2019, 7:00 am – 8:00 pm

Title: Silencing PD-1 using self-delivering RNAi PH-762 to improve Iovance TIL effector function using Gen 2 manufacturing method
Author: Azoulay-Alfaguter et al.
Poster #: P149
Presentation date/time: November 8, 2019, 7:00 am – 8:00 pm

Title: Iovance Gen2 TIL manufacturing process produces drug products that exhibit favorable quality attributes for adoptive cell transfer across 5 solid tumor indications
Author: Wardell et al.
Poster #: P226
Presentation date/time: November 9, 2019, 7:00 am – 8:30 pm

The SITC (Free SITC Whitepaper) abstract titles are listed on the conference website under Abstracts at View Source