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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On June 6, 2019 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Goldman Sachs 40th Annual Global Healthcare Conference on Wednesday, June 12 at 3:20 p.m. PT in Palos Verdes, CA (Press release, Arvinas, JUN 6, 2019, View Source [SID1234536931]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available here and at www.arvinas.com on the Events page. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On June 6, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of newly expanded performance results for DecisionDx-Melanoma at the 2019 Fall Clinical Dermatology Conference for PAs & NPs held in Scottsdale, Arizona (Press release, Castle Biosciences, JUN 6, 2019, View Source [SID1234536932]). The poster, titled "The prognostic 31-gene expression profile (31-GEP) test improves risk prediction in cutaneous melanoma (CM) patients within current AJCC stages," demonstrated the utility of DecisionDx-Melanoma in identifying risk for patients with cutaneous melanoma beyond traditional staging.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Using a newly expanded performance cohort of 901 archival cutaneous melanoma samples (211 of which were not previously reported) from 22 centers, the analysis was designed to examine whether incorporating the DecisionDx-Melanoma test result in treatment decisions improves upon traditional melanoma staging methods. Patients assessed in the expanded cohort had a median age of 60 years and a median Breslow thickness of 1.4 mm. Forty-four percent of melanomas were American Joint Committee on Cancer (AJCC) Stage I, 24% were Stage II and 32% were Stage III.

Key Study Findings

DecisionDx-Melanoma was a significant and independent predictor of recurrence-free survival, distant metastasis-free survival and melanoma-specific survival (MSS) in the cumulative cohort of 901 cutaneous melanoma patients.
Within each AJCC stage, DecisionDx-Melanoma further stratified risk of melanoma-specific mortality. Using AJCC staging alone, patients with Stage I melanoma have an estimated 5-year MSS rate of 98%. Within that group, those with a Class 1A (lowest risk) DecisionDx-Melanoma test result had an estimated 5-year MSS rate of 99.7%, a risk equivalent to AJCC Stage IA. Stage I, Class 2B (highest risk) patients had a 92.8% 5-year MSS rate, lower than patients with Stage IIIA disease.
Patients with Stage II cutaneous melanoma have an estimated 5-year MSS rate of 90% using AJCC staging alone. Stage II patients who had a Class 1A DecisionDx-Melanoma test result had a 5-year MSS rate of 97%, equivalent to Stage IB. The MSS rate for Stage II patients with a Class 2B test result was 87.4%, aligned with risk estimates for AJCC Stage IIB.
"Accurate risk assessment in cutaneous melanoma is important because most treatment decisions are based on the patient’s expected risk of metastasis or recurrence," commented study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. "These results show that DecisionDx-Melanoma provided a more comprehensive assessment of patient risk compared to AJCC staging alone, supporting its utility in developing individualized patient management plans."

The poster can be found in the Publications section of the Castle Biosciences website.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 3,100 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

More information about the test and disease can be found at www.SkinMelanoma.com.

On June 6, 2019 AstraZeneca reported positive results from the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults (Press release, AstraZeneca, JUN 6, 2019, View Source [SID1234536914]).1 This is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.

The trial also met a key secondary endpoint showing Calquence monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen.

The safety and tolerability of Calquence was consistent with its established profile.

José Baselga, Executive Vice President, Oncology R&D said: "These findings confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year."

AstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting. Additionally, AstraZeneca will present full results from the Phase III ASCEND clinical trial in relapsed or refractory CLL as a late-breaking abstract at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress on 16 June 2019 (Abstract #LB2606).

Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, the UAE, and Qatar and is being developed for the treatment of CLL and other blood cancers.

About ELEVATE-TN

ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence alone or in combination with obinutuzumab vs. chlorambucil in combination with obinutuzumab in previously-untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression).2

The primary endpoint is PFS in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.2

About Calquence

Calquence (acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Calquence is an inhibitor of Bruton tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.3 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 26 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrom macroglobulinaemia, follicular lymphoma, and multiple myeloma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating acalabrutinib vs. ibrutinib in patients with previously-treated high-risk CLL, and ACE-CL-311 evaluating acalabrutinib in combination with venetoclax and with/without obinutuzumab in patients with previously-untreated CLL without 17p deletion or TP53 mutation.

About chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 191,000 new cases globally and 20,720 new cases in the US annually, and prevalence that is expected to grow with improved treatment.1,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.1 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.1 This could result in anaemia, infection and bleeding.1 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZeneca’s haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

In October 2018, AstraZeneca and Innate Pharma announced a global strategic collaboration that included Innate Pharma licensing the US commercial rights of Lumoxiti (moxetumomab pasudotox-tdfk), and with support from AstraZeneca, will continue EU development and commercialisation, pending regulatory submission and approval.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance oncology as a key growth driver for AstraZeneca 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.

On June 6, 2019 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported that Hans Bishop has been appointed as Chief Executive Officer, effective immediately (Press release, Grail, JUN 6, 2019, View Source [SID1234536933]). He succeeds Jennifer Cook, who has stepped down from the Board and her role as Chief Executive Officer for family health reasons. Mr. Bishop has served on GRAIL’s Board of Directors since August 2018 and will continue to serve as a Director on the GRAIL Board.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

GRAIL also announced the appointment of Joshua Ofman as Chief of Corporate Strategy and External Affairs. In addition, Maykin Ho has joined GRAIL’s Board as an Independent Director. The company also announced that Renée Galá has decided to step down from her role as Chief Financial Officer.

During her tenure as Chief Executive Officer, Ms. Cook led the company through the transition from discovery-stage research to advancing an investigational multi-cancer early detection test into clinical development and toward commercialization. In addition, the company has fully enrolled two of its population-scale clinical studies with approximately 115,000 participants, and initiated a third 50,000-participant clinical study.

"We are very grateful to Jennifer for her important contributions to the company, resulting in the pivotal milestone of the recently presented impressive data from CCGA that support advancement of GRAIL’s investigational multi-cancer early detection test toward commercialization. While we are disappointed to see Jennifer go, we respect and support her decision," said Catherine Friedman, Chair of the GRAIL Board of Directors. "We are thrilled that Hans is stepping into the CEO role to continue building upon this positive trajectory. Hans is a widely respected corporate leader with significant experience building successful companies and guiding novel products through commercialization."

Ms. Friedman continued: "In addition, we are delighted to welcome Josh, an accomplished industry expert in health economics, market access, and health policy with deep experience integrating innovation into healthcare systems, and Maykin, a distinguished biotech leader with unparalleled expertise in healthcare strategy and finance, to GRAIL."

"GRAIL is guided by its bold vision to improve cancer survival rates by creating a single blood test that can detect multiple deadly cancer types at one time," said Mr. Bishop. "For much of my career, I’ve been involved in the fight against cancer, and during that time, I have seen real progress for patients. However, cancer is still the second leading cause of death globally, and I believe early detection is key to changing that. I’m excited to step into the CEO role at a time where the team at GRAIL has delivered such exciting results. I look forward to working with the Board and the entire GRAIL team in this new role to ensure a smooth transition as we advance our test toward commercialization."

Mr. Bishop has more than 30 years of experience in the biotechnology industry. He will continue to serve as the Executive Chair of the Sana Board of Directors and as a Director of Celgene, Agilent Technologies, and Lyell Immunopharma. Mr. Bishop founded Juno Therapeutics in 2013 and served as its President and Chief Executive Officer until the company was acquired by Celgene in March 2018. Prior to this, he served as an Executive in Residence at Warburg Pincus. Earlier, he was Executive Vice President and Chief Operating Officer for Dendreon, Inc. He also previously served as President of Specialty Medicine at Bayer Healthcare, Senior Vice President of Global Commercial Operations at Chiron Corporation, and Vice President and General Manager of European Biopharmaceuticals. Mr. Bishop holds a bachelor’s degree in chemistry from Brunel University in London.

Joshua Ofman, MD, MSHS, joins GRAIL from Amgen where he spent 16 years in several roles, most recently as Senior Vice President, Global Health Policy. Prior to joining Amgen in 2003, Dr. Ofman was a member of the academic faculty in the Department of Medicine and Health Services Research, University of California, Los Angeles (UCLA) School of Medicine, Cedars-Sinai Medical Center. Dr. Ofman also served as Senior Vice President of Zynx Health Inc., a healthcare IT company and subsidiary of the Cerner Corp. Dr. Ofman obtained his undergraduate degree from the University of California, Berkeley and his MD from the University of California, Irvine, School of Medicine. He conducted his internship and residency in internal medicine and fellowship in digestive diseases at the UCLA Department of Medicine. In addition, Dr. Ofman completed a RAND/VA/UCLA fellowship in ambulatory care and health services research, specializing in technology assessment, and obtained his MSHS from the UCLA School of Public Health. He is widely published in health economics and technology assessment, public health program evaluation, and health policy analysis.

Maykin Ho, PhD, has more than 30 years of experience in the healthcare and finance industries. She is a venture partner of Qiming Venture Partners and a member of the Biotech Advisory Panel of the Stock Exchange of Hong Kong. She is also a retired partner of the Goldman Sachs Group, where she served as senior biotechnology analyst, co-head of healthcare for global investment research, and advisory director for healthcare investment banking. Prior to Goldman Sachs, Dr. Ho held various managerial positions in licensing, strategic planning, marketing, and research at DuPont-Merck Pharmaceuticals and DuPont de Nemours & Company. Dr. Ho serves on the Board of Directors for FibroGen, Agios Pharmaceuticals, Parexel International Corporation, the Aaron Diamond AIDS Research Center, and the Institute for Protein Innovation. She was a postdoctoral fellow at Harvard Medical School. Dr. Ho received a PhD in Microbiology and Immunology and a BS from the State University of New York, Downstate Medical Center.