Nordic Nanovector to present preclinical studies with 212Pb-NNV003, a novel CD37-specific Targeted Alpha Therapy for CLL and NHL, at TRP 2019

On June 6, 2019 Nordic Nanovector ASA (OSE: NANO) reported that its Chief Scientific Officer, Jostein Dahle, will present results from preclinical studies with 212PB-NNV003, a novel Targeted Alpha Therapy comprising its proprietary CD37-specific antibody (NNV003) coupled with the alpha-particle generating radioisotope lead-212 (212Pb) in models of chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL) at the Targeted Radiopharmaceuticals Summit taking place in Munich, Germany on 12-13 June (Press release, Nordic Nanovector, JUN 6, 2019, View Source [SID1234553448]).

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The presentation will take place at 13th June 09:30-10:00 CEST and is entitled:

Targeted alpha therapy with 212Pb-NNV003 for the treatment of CD37 positive B-cell chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL)

CD37 is highly and selectively expressed on the surface of mature B lymphocytes and B-cell malignancies and may become a useful alternative to the CD20 target, due to the emergence of resistance to anti-CD20 therapies.

Alpha-emitting radionuclides have demonstrated good potential for cancer targeted therapies because of short-range alpha energy deposition (50–100 µm) that causes irreparable DNA double-strand breaks and localized cytotoxicity while sparing surrounding healthy tissues.

The targeted alpha therapy 212Pb-NNV003 has been developed under a collaboration between Nordic Nanovector and Orano Med.

Kiadis Pharma completes acquisition of CytoSen Therapeutics, Inc.

On June 6, 2019 Kiadis Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, reported that it has closed the previously announced acquisition of CytoSen Therapeutics, Inc. ("CytoSen") (Press release, Kiadis, JUN 6, 2019, View Source [SID1234551152]).

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The transaction creates a leader in cell-based cancer immunotherapy with proprietary and synergistic NK-cell and T-cell therapy platforms that have the potential to revolutionize HSCT and create a pipeline with novel cancer treatments. Kiadis now has a complementary development pipeline focused on improving outcomes for patients undergoing hematopoietic stem cell transplants (HSCT) with a T-cell therapy (ATIR101; in EU registration and a global Phase 3 clinical trial) and a NK-cell therapy (CSTD002; expected to enter the clinic in the US in 2020).

Arthur Lahr, CEO of Kiadis commented: "Our vision is to leverage the strengths of the human immune system to help patients with life-threatening diseases and through this acquisition we can now create novel cell therapies that combine the innate and adaptive arms of the immune system. This transaction is transformative for Kiadis as we now have two synergistic proprietary cell-based immunotherapy platforms and the ability to create a pipeline of innovative treatments for cancer patients."

Total upfront consideration paid to the holders of CytoSen shares and options on closing consists of 1,513,052 newly issued Kiadis shares and 159,778 options to acquire Kiadis shares. Upon acceptance by aforementioned parties of the shares issued to them, the newly issued Kiadis shares shall be admitted to trading on Euronext Amsterdam and Euronext Brussels on the basis of the listing prospectus within the meaning of Directive 2003/71/EC, as amended and Directive 2010/73/EU consisting of the registration document approved by the Netherlands Authority for the Financial Markets (Autoriteit Financiële Markten, "AFM") dated May 31, 2019 and the summary and securities note approved by the AFM dated May 31, 2019 that have been made generally available. Of the 1,513,052 newly issued Kiadis shares, 874,129 shares (57.8%) are subject to lock-up restrictions during a two-year period, and the other 638,923 shares (42.2%) are subject to lock-up restrictions during a 180-day period.

Further to the abovementioned 1,513,052 newly issued Kiadis shares, the holders of CytoSen shares have a conditional entitlement to receive 267,012 newly issued Kiadis shares – the Holdback Shares as defined in the listing prospectus. The Holdback Shares serve as a source for the satisfaction of indemnification and other claims that Kiadis may have on the CytoSen shareholders pursuant to the acquisition agreement. Subject to reduction in respect of these indemnification and other claims, the Holdback Shares will be issued 18 months from the completion date. Also, as per the acquisition agreement, the holders of CytoSen shares and options are eligible to potential future consideration of up to 5,819,460 additional Shares upon the achievement of six clinical development and regulatory milestones.

About ATIR101 and CSTD002
Administered as adjunctive immunotherapeutics on top of HSCT, ATIR101 and CSTD002 provide a lymphocyte infusions with functional, mature and potent immune cells from a haploidentical family member. The T-cells in ATIR101 and NK-cells in CSTD002 will help fight infections and remaining tumor cells, until the immune system has fully re-grown from stem cells in the transplanted graft. In addition, CSTD002 has shown promise in the treatment of relapse/refractory AML.

In ATIR101, T-cells that would cause GVHD are depleted from the donor lymphocytes, using our photodepletion technology. At the same time, ATIR101 contains potential cancer-killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease.

In CSTD002, nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting multiple high-dose infusions with potent anti-cancer cytotoxicity.

Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASCERTAIN study of the novel oral cedazuridine and decitabine fixed-dose combination (ASTX727) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML)

On June 6, 2019 Astex Pharmaceuticals, Inc. a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., reported top-line results from the ASCERTAIN phase 3 study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) vs decitabine IV in adults with intermediate and high-risk MDS or CMML (Press release, Astex Pharmaceuticals, JUN 6, 2019, View Source [SID1234536948]).

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The study met its primary endpoint of decitabine exposure equivalence of 5-day dosing between orally administered ASTX727 and IV decitabine as per the protocol analysis plan. Safety and clinical activity were similar to that observed in a previous phase 1/2 study. The full data will be presented at an upcoming scientific meeting.

Astex plans to file an NDA with the US FDA by the end of 2019.

"We are delighted with the outcome of the ASCERTAIN trial, and the demonstration that the fixed dose combination of cedazuridine with decitabine enables successful oral delivery of decitabine, alleviating the significant burden of five days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years," said Mohammad Azab, Astex Pharmaceuticals’ president and chief medical officer. "Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who contributed to this effort."

About Cedazuridine and Decitabine Fixed-Dose Combination (ASTX727)

ASTX727 is a novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase, with the anti-cancer DNA hypomethylating agent, decitabine.1 By inhibiting cytidine deaminase in the gut and the liver, ASTX727 allows for oral delivery of the approved DNA hypomethylating agent, decitabine at exposures which are equivalent to the approved intravenous form of decitabine administered over 5 days.

ASTX727 has been evaluated in a phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study in patients with MDS and CMML to define appropriate doses of the individual components of ASTX727 (cedazuridine and decitabine) so that decitabine exposure after oral administration of ASTX727 is similar to exposure after IV decitabine at the approved daily dose of a 1-hour infusion at 20 mg/m2 (see View Source NCT02103478). This study demonstrated that ASTX727 allowed decitabine to be delivered orally at a dose that emulates parenteral pharmacokinetics, as measured by 5-day area-under-the-curve (AUC).3 The drug’s safety profile was similar to that of IV decitabine. Of particular note was the low level of gastrointestinal adverse events.3

The concept of using cedazuridine to block the action of cytidine deaminase is also being evaluated in a low dose formulation of cedazuridine and decitabine for the treatment of lower risk MDS (see View Source NCT03502668). ASTX727 may also have potential in all-oral combination regimes for the treatment of a range of different tumor types.

Astex is also expanding the evaluation of cedazuridine – decitabine combinations through a program of investigator-sponsored trials.

ASTX727 is an investigational compound and is not currently approved in any country.

About the ASCERTAIN Study

The ASCERTAIN study was designed to demonstrate that the cedazuridine and decitabine fixed-dose combination (ASTX727) could deliver orally a pharmacokinetically equivalent exposure of decitabine compared to IV decitabine in adults with previously untreated or treated MDS, including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and CMML), and subjects with MDS International Prognostic Scoring System (IPSS) int-1, int-2, or high-risk MDS. (see View Source NCT03306264). The study was designed as a randomized, open-label cross-over study in which patients were randomized in a 1:1 ratio to receive ASTX727 daily x 5 in the first 28-day cycle followed by IV decitabine daily x 5 in the second 28-day cycle, or the converse order. Following completion of the first two cycles, patients continued to receive treatment with ASTX727 in 28-day cycles until disease progression, unacceptable toxicity, or the subject decided to discontinue treatment or withdrew from the study. The primary endpoint of the study was total 5-day AUC exposures of decitabine after treatment with ASTX727 versus IV decitabine as measured across the first two cycles. Secondary endpoints included safety assessments, pharmacodynamic measurements, secondary PK parameters, clinical responses, red blood cell transfusion independence, leukemia-free survival, and overall survival. The study was conducted in 138 patients at 46 sites in the US and Canada.

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. US incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.4,5 The prevalence has been estimated to be from 60,000 to 170,000 in the US.6 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.7 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML. CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the US is approximately 1,100 new cases per year,8 and CMML may transform into AML in 15% to 30% of patients.9 The hypomethylating agents decitabine and azacitidine are effective treatment modalities for hematologic cancers and are FDA-approved for the treatment of higher risk MDS and CMML. These agents are administered by IV infusion, or by large-volume subcutaneous injections.

Magenta Therapeutics to Present at the 40th Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 11th

On June 6, 2019 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that the Company is scheduled to present at the Goldman Sachs Global Healthcare Conference on June 11, 2019 at 2:40 p.m. PT/5:40 p.m. ET at the Terranea Resort in Rancho Palos Verdes, Calif (Press release, Magenta Therapeutics, JUN 6, 2019, View Source [SID1234536941]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.magentatx.com. A replay of the webcast will be archived on the Magenta website for 60 days following each presentation.

Insmed to Present at the Goldman Sachs 40th Annual Global Healthcare Conference

On June 6, 2019 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that Will Lewis, Chairman and Chief Executive Officer of Insmed, will present at the Goldman Sachs 40th Annual Global Healthcare Conference in Rancho Palos Verdes on Thursday, June 13, 2019 at 8:00 a.m. PDT (Press release, Insmed, JUN 6, 2019, View Source [SID1234536938]).

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The presentation will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. The webcast will be archived for a period of 30 days following the conclusion of the live event.