On April 3, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that interim data from its Phase 2 study of prexigebersen in combination with low-dose cytarabine (LDAC) (BP1001-201) for the treatment of acute myeloid leukemia (AML) has demonstrated that the combination therapy continues to be well-tolerated and has shown early anti-leukemic activity in nearly 50% of evaluable AML patients including four patients with complete remission and four with stable disease to date in this study (Press release, Bio-Path Holdings, APR 3, 2018, View Source [SID1234525173]).

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The open-label Phase 2 study is evaluating the efficacy and safety of prexigebersen in conjunction with LDAC, a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than what would be expected with LDAC alone in this de novo patient population. The study had a pre-determined decision point at 19 evaluable patients in which the study would be terminated if less than 5 patients responded and the study would be expanded to 54 patients if five or more patients responded.

The interim analysis was performed on 17 evaluable patients instead of 19, since criteria to move to the next steps in the study had been met. Of the 17 evaluable patients, there were four patients who achieved complete responses, one patient who achieved a morphologic leukemia free state, two patients who had significantly reduced bone marrow blasts and four patients with stable disease. In total, 47% of the evaluable patients showed some form of response, including stable disease, to the combination treatment. The average age of patients in the study was 73.5 years old.

Based on the recommendations of the principal investigators of the study, the Company is amending the protocol to change the dosing schedule to that used in the Phase 1b study in relapsed and refractory AML patients in which a higher dose of prexigerbesen was administered prior to LDAC treatment starting at day 10 versus LDAC treatment starting on day four as was the case in the BP1001-201 study to date. In addition, the investigators endorse the inclusion of a decitabine cohort based on relatively new and positive data with this compound.

"We are very pleased with these encouraging interim data as they demonstrate the potential for the combination of prexigerbesen and LDAC to effectively treat these de novo AML patients. These early results are encouraging when you consider that the complete response rate in elderly AML patients greater than 65 years of age on LDAC alone have been estimated (Lin Journal of Clinical Oncology Abstract) to be only 10%1," noted Peter H. Nielsen, chief executive officer of Bio-Path. "We look forward to advancing the planned protocol amendments as we expect they will provide even better results for these patients suffering with AML. If successful, it will provide for approvals in the U.S. and Europe for both combination therapies."

On April 3, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, reported that members of Nicox’ management team will participate in the following conferences in April 2018 (Press release, NicOx, APR 3, 2018, View Source [SID1234525160]):

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Gavin Spencer, Executive Vice President, Chief Business Officer, will present at the H.C. Wainwright Global Life Sciences Conference on Tuesday, April 10, 2018 at 9:00 a.m. Central European Summer Time. The conference is being held at the Le Meridien Beach Plaza Hotel in Monte Carlo, Principality of Monaco.
Michele Garufi, Chairman and Chief Executive Officer, will present a corporate overview during the Public Spotlight session at the Ophthalmology Innovation Summit (OIS) being held in conjunction with the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting on Thursday, April 12 at 3:05 pm Eastern Daylight Time. The conference is being held in Washington D.C.

On April 3, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported it will host a Research Reception at the 2018 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, OncoSec Medical, APR 3, 2018, View Source [SID1234525161]). The reception, for which registration is required, will be held on Sunday, April 15, 2018 at 6:00 p.m. CT at the JW Marriott in Chicago, IL.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The OncoSec Research Reception will feature the following presentations:

OMS-140 Protocol; Review of Intratumoral IL-12 Data in TNBC Presented at AACR (Free AACR Whitepaper)
Pamela Munster, MD, UCSF Helen Diller Family Comprehensive Cancer Center
OMS-141 Protocol; Upcoming PD-1 Combination Clinical Trial in TNBC
Melinda Telli, MD, Stanford University Medical Center
Melanoma Data Update: OMS-100 & OMS-102 Combination Study
Alain Algazi, MD, UCSF Helen Diller Family Comprehensive Cancer Center
PISCES/KEYNOTE-695 Operational Update
Sharron Gargosky, PhD, Chief Clinical and Regulatory Officer, OncoSec
Attendees will also have the opportunity to view the TNBC data featured as an oral poster at AACR (Free AACR Whitepaper) and ask questions of the lead author. All speakers will be available for questions. Space is limited. For those interested in attending this event in person, please contact [email protected].

An archived version of the presentation will be available for 90 days on OncoSec’s website: www.oncosec.com.

On April 3, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy (Press release, AstraZeneca, APR 3, 2018, View Source [SID1234525473]). The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set for the third quarter of 2018.

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The Phase III (‘1053’) moxetumomab pasudotox clinical trial met its primary endpoint of durable complete response in adult patients with relapsed or refractory HCL, for which there is currently no established standard of care and few treatments available.[i],[ii] Results from the 1053 Phase III trial will be presented at a forthcoming medical meeting.

Priority Review is granted by the FDA to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.[iii]

NOTES TO EDITORS
About Moxetumomab Pasudotox

Moxetumomab pasudotox (formerly CAT-8015 or HA22) is an investigational anti-CD22 recombinant immunotoxin and a potential new medicine with the opportunity to be a first-in-class treatment in the US for patients with relapsed or refractory HCL who have received at least two prior lines of therapy. Immunotoxins are a class of anticancer agents that combine the selectivity of antibodies to target drug delivery and the potency of toxins to kill target cancer cells.[iv] Moxetumomab pasudotox is composed of a binding portion of an anti-CD22 antibody fused to a toxin. CD22 is a B-lymphocyte restricted transmembrane protein with a higher receptor density in HCL cells relative to normal B cells, making it an attractive therapeutic target for the treatment of this cancer.[v] After binding to CD22, the molecule is internalised, processed and releases its modified protein toxin that inhibits protein translation, leading to apoptotic cell death. Moxetumomab pasudotox has been granted Orphan Drug Designation by the FDA for the treatment of HCL.

About Hairy Cell Leukaemia

HCL is a rare, incurable slow-growing leukaemia in which the bone marrow overproduces abnormal B cells or lymphocytes.[vi] HCL can result in serious and life-threatening conditions, including infections, bleeding and anaemia.[vii] Approximately 1,000 people are diagnosed with HCL in the US each year.[viii],[ix],[x] While many patients initially respond to treatment, up to 40% will relapse.[xi] With no established standard of care and very few treatments available, there remains significant unmet medical need for people with relapsed or refractory HCL.1,2

About the ‘1053’ Phase III Trial

The ‘1053’ trial is a single-arm, multicentre Phase III clinical trial assessing the efficacy, safety, immunogenicity and pharmacokinetics of moxetumomab pasudotox monotherapy in patients with relapsed or refractory HCL who have received at least two prior therapies. The trial is being conducted in 80 patients across 34 sites in 14 countries.[xii]

About AstraZeneca in Haematology

Leveraging its collective heritage in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus, and is accelerating development of a broad portfolio of potential blood cancer treatments. AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, recently received US FDA approval for Calquence (acalabrutinib), the first medicine in this franchise.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that have the potential to transform patients’ lives and the Company’s future. With at least six new medicines aimed to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com.

On April 3, 2018 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported that Peter Garcia, PDL’s vice president and chief financial officer, will present at the H.C. Wainwright Global Life Sciences Conference next week in Monaco (Press release, PDL BioPharma, APR 3, 2018, View Source [SID1234525162]). The session will be webcast live and will occur on Tuesday, April 10, 2018 at 1:45 p.m. CEST.

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To access the live and subsequently archived webcast of the presentation, go to the company’s website at View Source and go to "Presentations and Events." Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary. The archived webcast will be available for at least seven days following the presentation.