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Clovis Oncology to Announce Fourth Quarter/Fiscal Year 2018 Financial Results and Host Webcast Conference Call on February 26

On February 12, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its fourth quarter/fiscal year 2018 financial results on Tuesday, February 26, 2019, before the open of the U.S. financial markets (Press release, Clovis Oncology, FEB 12, 2019, View Source [SID1234533259]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss Q4/FY 2018 results on Tuesday, February 26, at 8:30am ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.393.4306, International participants 734.385.2616, conference ID: 6675335.

PROVECTUS ANNOUNCES GRANT OF ORPHAN DRUG DESIGNATION IN U.S. TO PV-10 FOR TREATMENT OF OCULAR MELANOMA

On February 12, 2019 Provectus (OTCQB: PVCT) reported that orphan drug designation (ODD) status was granted by the U.S. Food and Drug Administration (FDA) to small molecule oncolytic immunotherapy PV-10 for the treatment of ocular melanoma (to include all melanoma disease affecting the eye and orbit) (Press release, Provectus Biopharmaceuticals, FEB 12, 2019, View Source [SID1234533258]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death (ICD) in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1-4

Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

Preliminary data from Provectus’ uveal melanoma expansion cohort of its Phase 1 "basket study" of PV-10 for the treatment of cancers metastatic to the liver were presented in a poster presentation at the 15th International Congress of the Society for Melanoma Research (SMR 2018 Congress) in late-2018: a total of four patients had received PV-10 for at least one uveal melanoma liver tumor, two patients had received a second round of PV-10 treatment to an additional liver tumor, and one patient initiated standard of care immunotherapy (Opdivo + Yervoy) between PV-10 treatments; treatment-related adverse events were consistent with established patterns; and, tumor reduction was observed in 5 of 6 PV-10-injected tumors. A copy of the poster presentation is available on the Company’s website.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. ODD status qualifies companies for benefits that include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.

ODD status previously was granted to PV-10 for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, and neuroblastoma in 2018.

About PV-10

Provectus’ lead investigational oncology drug, 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.

SELLAS Life Sciences Provides Galinpepimut-S and Nelipepimut-S Program Update

On February 12, 2019 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 an update on its galinpepimut-S (GPS) and nelipepimut-S (NPS) clinical development programs (Press release, Sellas Life Sciences, FEB 12, 2019, View Source [SID1234533257]).

The Company announces that Richard Maziarz, M.D., Medical Director of the Adult Blood and Marrow Stem Cell Transplant & Cellular Therapy Program at the Knight Cancer Institute and Professor of Medicine at Oregon Health and Science University (OHSU) in Portland, OR, and Roisin O’Cearbhaill, M.D., Assistant Attending Physician in Gynecologic Medical Oncology Service at the Memorial Sloan Kettering Cancer Center (MSKCC), will serve as co-principal investigators of the Company’s Phase 1/2 open-label, non-comparative, multicenter, multi-arm study of GPS in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with selected WT1-positive advanced cancers, including both hematologic malignancies and solid tumors. This study, which is being conducted under a Clinical Trial Collaboration and Supply Agreement (CTSA) with Merck (known as MSD outside the United States and Canada), will assess the efficacy and safety of the combination, with exploratory long-term follow-up for overall survival and safety. The study will enroll approximately 90 patients at up to 20 centers in the United States. The initial tumor types to be treated will be acute myelogenous leukemia (AML) (patients unable to attain deeper morphological response than partial on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant) and ovarian cancer (second or third line), to be followed by triple negative breast cancer (second line), small cell lung cancer (second line), and colorectal cancer (third or fourth line).

"We are thrilled to announce that Drs. Maziarz and O’Cearbhaill will serve as co-principal investigators of this important study," said Dr. Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Both Rich and Roisin will be indispensable in overseeing the scientific rigor of the investigation, helping to interpret both clinical and correlative immuno-response data, and guiding us to optimally advance the development of GPS as a uniquely positioned active immunizer of the peptide vaccine type for the treatment of recalcitrant malignancies in the presence of measurable disease."

Additionally, the Company announces preliminary immune response data in a subgroup of patients with triple-negative breast cancer (TNBC) from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical study of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS, NeuVax) targeting HER2 low-expressing breast cancer patient cohorts. These data originate from an analysis of the patterns of induction of antigen (NPS)-specific T-cell responses over time in patients treated in this study. CD8+ cytotoxic T-lymphocytes (CTLs) from peripheral blood samples from study patients with TNBC were measured using specifically designed NPS-specific dextramers in a flow cytometry-based assay in duplicate. In 64 evaluable TNBC patients (39 in the NPS plus trastuzumab arm; 25 in the trastuzumab alone arm) across a median of four time-points (including baseline), NPS + trastuzumab administration generated up to 3-fold higher frequencies of NPS-specific CTLs compared to trastuzumab alone. Moreover, CTL frequencies were much higher among non-recurrent patients compared with those who recurred (on either arm). The complete set of data from these correlative analyses will be presented in an upcoming major scientific meeting.

"These new data provide important insights on the immunobiological mechanism underlying the statistically significant and clinically meaningful decrease in detectable tumor relapses and associated increase in 24-month disease-free survival (DFS) rate with the combination of NPS plus trastuzumab versus trastuzumab alone observed within the TNBC cohort of the Phase 2b study we have previously reported. We are looking forward to completing the underlying correlative analyses in order to further dissect the intriguing association between induction of antigen-specific T-cell immunity and clinical effect post-vaccination, which strongly suggests a contribution of NPS in the emergence of antitumor activity in TNBC patients in the adjuvant treatment setting. We are continuing our discussions with the FDA on the most optimal development path forward for NPS in TNBC and will provide the immune response data to the Agency as well," commented Dr. Stergiou.

Herceptin and Keytruda are registered trademarks of Genentech, Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

Diplomat to Present at Investor Conferences in February, March 2019

On February 12, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO) executives reported that it will participate in four upcoming investor conferences (Press release, Diplomat Speciality Pharmacy, FEB 12, 2019, View Source [SID1234533256]).

Brian Griffin, chairman and CEO, and Atul Kavthekar, chief financial officer, will represent the company at these events:

8th Annual SVB Leerink Global Healthcare Conference in New York: Feb. 27 at 9 a.m. ET
Raymond James 40th Annual Institutional Investors Conference in Orlando: March 4 at 4 p.m. ET
Cowen and Company 39th Annual Health Care Conference in Boston: March 11 at 1:30 p.m. ET
Barclays Global Healthcare Conference in Miami: March 14 at 8:30 a.m. ET

Live audio webcasts of each presentation will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. Audio recordings will be available online for approximately 30 days following each presentation.

Iomab-B One of Four Late Breaking Oral Presentations to be Presented at the 2019 Transplantation & Cellular Therapy Annual Meeting

On February 12, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that a presentation of data from the pivotal Phase 3 SIERRA trial of Iomab-B has been selected as one of four late breaking oral presentations at the 2019 TCT or Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR, which is being held February 20 – 24 in Houston, Texas (Press release, Actinium Pharmaceuticals, FEB 12, 2019, View Source [SID1234533255]). In addition, three abstracts related to Actinium’s targeted conditioning pipeline have been accepted for poster presentations.

Sandesh Seth, Chairman and CEO of Actinium, said, "TCT is the ideal venue for us to present data and highlight our targeted conditioning programs as it is the pre-eminent medical meeting focused on bone marrow transplant and cellular therapy. We are excited to have multiple opportunities to highlight clinical data for Iomab-as well as update on Iomab-ACT, our newest program focused on lymphodepletion prior to CAR-T. In addition, we are involved with several events, educational and otherwise, that will enable us to educate a broad audience of investigators, researchers and potential partners about the SIERRA trial and our highly differentiated multi-disease, multi-target targeted conditioning pipeline. We expect this meeting to be a highly productive and consequential one for our company."

Highlights of Actinium’s key meeting activities are:

Late Breaking Oral Presentation

Title:

Novel Re-Induction and Anti-CD45 Targeted Conditioning with Iodine (131I) Apamistamab [Iomab-B] Yields Encouraging Results in Older Patients with Active, Relapsed or Refractory AML: Safety & Feasibility Data from the Prospective Randomized Phase III SIERRA Trial

Presenter:

Sergio Giralt, MD, Chief Attending Physician, Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center

Time:

Sunday, February 24th, 12:30-12:45 PM CT

Location:

Hilton Americas – Grand Ballroom A

Poster Presentations

Poster Title:

Lymphodepletion with CD45 Radioimmunotherapy as a Targeted Conditioning Regimen Prior to Adoptive Cell Therapy or CAR-T

Presenter:

Dale Ludwig, PhD, Chief Scientific Officer, Actinium Pharmaceuticals, Inc.

Time:

Wednesday, February 20th, 6:45 – 7:45 PM CT

Location:

George R. Brown Convention Center – GRB Exhibit Hall B3

Poster Title:

Survival of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients Receiving Stem Cell Transplantation (SCT)

Presenter:

Rajneesh Nath, MD, Director Bone Marrow Transplant & Acute Leukemia Program, Banner MD Anderson Cancer Center

Time:

Wednesday, February 20th, 6:45 – 7:45 PM CT

Location:

George R. Brown Convention Center – GRB Exhibit Hall B3

Poster Title:

Burden of Hospitalization in Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia

Presenter:

Vijay Reddy, MD, PhD, Vice President, Clinical Development and Head of Bone Marrow Transplant, Actinium Pharmaceuticals, Inc.

Time:

Wednesday, February 20th, 6:45 – 7:45 PM CT

Location:

George R. Brown Convention Center – GRB Exhibit Hall B3

TCT 2019 Satellite Symposium

Satellite symposia are attended by nearly 2,000 physicians, scientists and allied health professionals working in blood and marrow transplantation in BMT programs throughout the United States, Canada and over 30 other countries.

Title:

Integrating Innovative Therapeutics with Allogeneic HSCT in AML: Insights and Evidence from Induction to Maintenance

Presenters:

James Foran, MD, Associate Professor of Medicine, Mayo Clinic and Alexander Perl, MD, Associate Professor of Medicine, University of Pennsylvania

Time:

Saturday, February 23rd, 12:30 – 1:30 PM

Location:

George R. Brown Convention Center, Grand Ballroom ABC

Dr. Mark Berger, Chief Medical Officer of Actinium commented, "TCT brings together the close-knit community of BMT and CAR-T physicians and health professionals resulting in an incredibly productive and valuable meeting. We are honored to have the opportunity to share so much of our research and clinical programs with the meeting attendees this year. Given the recent promising data presented at ASH (Free ASH Whitepaper) for Iomab-B, our late breaking oral presentation for Iomab-B and the recent launch of our Iomab-ACT program for CAR-T, I expect this year to be our most productive and rewarding conference yet."

About Transplantation & Cellular Therapy Meetings (TCT)
TCT, formerly known as the BMT Tandem Meetings, are the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Each year the conference brings together several thousand investigators, clinicians, researchers, nurses and other allied health professionals from over 500 transplant centers from over 50 countries around a full scientific program focused on bone marrow transplant and cellular therapies.