On May 17, 2018 Provectus and POETIC reported preclinical PV-10 data from pediatric cancer research that will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, IL (Press release, Provectus Pharmaceuticals, MAY 17, 2018, View Source [SID1234526789]).

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PV-10 induced cell death in pediatric solid tumor cell lines derived from relapsed pediatric neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma with a measurable therapeutic window compared to normal cells. Western blot analyses of cells treated with PV-10 indicated induction of apoptosis. Drug combination studies showed synergy with radiation and agents that target mitosis. Xenograft studies showed significant reduction of tumor burden in PV-10-treated mice compared to control animals, with a corresponding increase in overall survival.

Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company") is a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for adult and pediatric solid tumor cancers. The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium ("POETIC") is a group of North American academic medical centers developing new pediatric cancer therapies.

Findings will be highlighted in a poster presentation on Saturday, June 2 from 8:00 to 11:30 a.m. CDT in Hall A as part of the Pediatric Solid Tumors topic during the Pediatric Oncology session. The POETIC poster title is "In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors," the poster board number is 230, and the abstract number is 10557.

This preclinical pediatric cancer research was led by Aru Narendran, MD, PhD and researchers at the POETIC Laboratory for Pre-Clinical and Drug Discovery Studies at the University of Calgary (Canada), together with Tanya Trippett, MD, Director of POETIC and researchers at Memorial Sloan Kettering Cancer Center.

Dr. Trippett said, "POETIC’s mission is to promote the early clinical development of promising therapies for the treatment of children, adolescents, and young adults with cancer. We hope our collaboration with Provectus on PV-10 leads to an opportunity to improve cancer care for children around the world."

Ed Pershing, Chair of Provectus’ Board of Directors, said, "We are thrilled to work alongside POETIC and its member institutions in Canada and the U.S. in an effort to jointly advance options for pediatric cancer patients around the globe."

About PV-10

Provectus’ lead investigational cancer drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers such as Ewing sarcoma, neuroblastoma, osteosarcoma, and rhabdomyosarcoma.

About the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium

The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) was founded in February 2003 by Dr. Tanya Trippett at Memorial Sloan Kettering Cancer Center and Dr. Lia Gore at the University of Colorado Cancer Center. POETIC is composed of ten large academic medical centers in North America with a major emphasis on comprehensive cancer care and research that provide the collaborative and research strength needed to complete intensive phase I and II studies. Each of the institutions is uniquely suited to complete early studies in the pediatric and adolescent populations. POETIC’s assets include membership in NCI-designated Comprehensive Cancer Centers, on-site NIH-funded pediatric and/or general clinical translational research centers (CTRCs/CTSAs), and active collaborations with developmental therapeutics programs for adults at a majority of its member institutions. The availability of strong basic science and translational research programs at the institutions allows focus on the development and evaluation of new therapeutic strategies for patients with cancer and related disorders. POETIC’s pediatric oncology studies focus on the biologic basis for anti-cancer therapy, and in particular, attempt to explore and evaluate novel agents and/or combinations of therapies early in clinical development as well as new approaches to targeted delivery. For additional information about POETIC, please visit the Consortium’s website at www.poeticphase1.org.

On May 17, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported the pricing of a global offering of 1,800,000 ordinary shares, comprised of 523,913 ordinary shares in the form of American Depositary Shares (ADSs) offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $26.28, and 1,276,087 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €22.29 (the "global offering") (Press release, Celyad, MAY 17, 2018, View Source [SID1234532516]). Each ADS represents the right to receive one ordinary share. The price per ADS was determined based on an exchange rate of $1.1789 per euro. The gross proceeds to Celyad from the global offering are expected to be approximately $47.3million (approximately €40.1 million), before deducting underwriting commissions and estimated offering expenses.
In addition, Celyad has granted the underwriters a 30-day option to purchase up to an additional 270,000 ordinary shares, which may be in the form of ADSs, on the same terms and conditions. The closing of the global offering is expected to occur on May 22, 2018, and is subject to customary closing conditions.

Celyad’s ADSs are currently listed on the NASDAQ Global Select Market under the symbol "CYAD" and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris.

Wells Fargo Securities, LLC and Bryan, Garnier & Co. are acting as joint bookrunning managers for the offering. Bank Degroof Petercam NV is acting as a co-manager for the private placement and LifeSci Capital LLC is acting as a co-manager for the global offering. Kempen & Co NV is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement dated May 15, 2018 relating to and describing the terms of the offering was filed with the SEC on May 16, 2018. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or email a request to [email protected] or Bryan, Garnier & Co., Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was enrolled in a Phase 3 clinical trial in China of pamiparib (BGB-290), an investigational PARP inhibitor, in patients with platinum-sensitive recurrent ovarian cancer (Press release, BeiGene, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349570 [SID1234526756]).

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"We are pleased to announce the initiation of this Phase 3 trial of pamiparib in China as a potential maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer. This trial is designed to provide important confirmatory clinical data that could enable registration in the maintenance setting, as well support our planned initial regulatory submission for the treatment of patients with advanced ovarian cancer who carry a germline BRCA1/2 mutation," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.

"In China there are currently no approved PARP inhibitors, despite the multiple approvals of PARP inhibitors in other regions of the world and in a variety of settings. Our development program in ovarian cancer is designed to address the limited treatment options that currently exist for these patients in China," commented Lai Wang, Ph.D., Senior Vice President and Head of China Development of BeiGene.

The Phase 3 randomized, double-blind, placebo-controlled, multi-center trial is designed to evaluate the efficacy of maintenance therapy with pamiparib versus a placebo in patients with recurrent ovarian cancer who achieved a complete response or partial response after platinum-based chemotherapy, as measured by progression-free survival (PFS) determined by independent review. Secondary objectives include PFS per RECIST version 1.1 determined by investigator, overall survival, objective response rate, duration of response, time to response, safety, and tolerability. Approximately 215 patients are planned to be enrolled in this trial at 15-20 cancer centers in China.

"As we look to improve the current 30 to 40 percent five-year survival rate for patients with advanced ovarian cancer, I look forward to evaluating pamiparib as a potential new maintenance therapy. We are excited to build upon the knowledge base we have of pamiparib from its Phase 1 and 2 studies as well as from other PARP inhibitors in ovarian cancer," said Professor Ding Ma, M.D., Director of Obstetrics and Gynecology, Tongji Medical College of Huazhong University of Science and Technology; and Principal Investigator of the trial.

For more information about the trial, patients and physicians should email [email protected].

About Ovarian Cancer in China

In China, over 50,000 women are diagnosed with ovarian cancer and more than 22,000 die from the disease each year1. More than 70 percent of patients are diagnosed with advanced disease2. The standard therapy for ovarian cancer consists of surgery followed by postoperative platinum-based chemotherapy. An estimated 85 percent of patients with epithelial ovarian cancer who achieve a full remission following first-line therapy will develop recurrent disease3.

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models. Pamiparib is being evaluated in pivotal clinical trials in China. It is currently in global clinical development as a monotherapy, and in combination with other agents, including BeiGene’s investigational anti-PD1 antibody, tislelizumab (BGB-A317), for a variety of solid tumor malignancies.

On May 17, 2018 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a leading U.S.-based multi-platform gene therapy company, and the Stanford University School of Medicine reported a strategic collaboration to support the advancement of Fanconi Anemia (FA) and Pyruvate Kinase Deficiency (PKD) gene therapy research (Press release, Rocket Pharmaceuticals, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349565 [SID1234526774]). Rocket’s lentiviral vector (LVV)-based gene therapy program for FA is currently in clinical trials with academic partners in the U.S. and Europe. The LVV-based gene therapy program for PKD is currently in preclinical development in Europe.

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Under the terms of the agreement, Stanford will serve as a lead clinical trial research center in the United States for a planned upcoming registrational trial for FA, and would also be the lead site for PKD clinical trials. Maria Grazia Roncarolo, M.D., director of the Stanford Center for Definitive and Curative Medicine and co-director of the school’s Institute for Stem Cell Biology and Regenerative Medicine, will lead the school’s effort. The center is a joint initiative of the School of Medicine, Stanford Health Care and Stanford Children’s Health and is focused on bench to bedside development of innovative cell- and gene-based therapies.

Gaurav Shah, M.D., Chief Executive Officer and President of Rocket, commented, "Rocket is delighted to expand the reach of our gene therapy program in the U.S. and prepare for our registrational trial. We are committed to developing FA and PKD programs in collaboration with outstanding gene therapy centers and pioneers in the field. This collaboration with the Stanford Center for Definitive and Curative Medicine is a critical step within our overall strategy of building relationships with gene therapy experts, with investigators who have dedicated their careers to improving the care of patients afflicted with these disorders, and within the broader FA and PKD communities."

"This project will also evaluate the introduction of conditioning regimens for both FA and PKD, where we hope to develop best-in-class gene therapy approaches for both clinical indications. The regulatory design and preparation for our registrational trial for FA is ongoing and we remain on track to advance this program to a registration study in 2019. Our PKD program continues to advance in preclinical studies with an Investigational Medicinal Product Dossier (IMPD) expected to be filed in early 2019," continued Dr. Shah.

For more information about this news on the Stanford website, please visit View Source

On May 17, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that two abstracts on its lead product candidate BPX-501 have been selected for presentation at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden on June 14-17, 2018 (Press release, Bellicum Pharmaceuticals, MAY 17, 2018, View Source [SID1234526757]).

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The presentations will include updated interim survival results from pediatric patients with primary immunodeficiencies (PIDs) and acute myelogenous leukemia (AML) who are undergoing a curative haplo-HSCT with BPX-501.

Oral Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Primary Immunodeficiencies Abstract: S871
Session Title: Stem cell transplantation – Clinical II
Date: Saturday, June 16
Time: 4:00 – 4:15 p.m. CEST

Poster Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Acute Myelogenous Leukemia Abstract: PS989
Session Title: Acute myeloid leukemia – Clinical
Date: Saturday, June 16
Time: 5:30 – 7:00 p.m. CEST

The BPX-501 clinical presentations at the conference will include updated information beyond that included in the abstracts currently available online on the EHA (Free EHA Whitepaper) conference website.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.