On June 10, 2019 Immunicom, Inc., a medical technology company awarded FDA Breakthrough Device Designation for Immunopheresis, its non-pharmaceutical solution for treating stage IV metastatic cancer, reported began treating its first of 170 triple-negative breast cancer (TNBC) patients on Friday, May 31 at the Jagiellonian University Medical College – Hospital in Cracow, Poland (Press release, Immunicom, JUN 10, 2019, View Source [SID1234536983]).

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Immunicom’s Immunopheresis therapy is a revolutionary new non-drug, blood-filtering immunotherapy treatment, with the potential to effectively treat a wide variety of cancer types more effectively and with fewer side effects, including those that have failed response to other treatment approaches. Immunopheresis works by removing cancer-produced proteins that inhibit the body’s natural immune defenses from recognizing and attacking tumors, potentially enabling a patient’s own body to effectively battle the disease. To learn more about how Immunicom’s technology works, see Immunopheresis Treatment Overview.

This randomized, multi-center, TNBC clinical study compares Immunopheresis alone and its use in combination with low-dose paclitaxel and carboplatin weekly chemotherapy, versus a control arm of low-dose chemotherapy. Clinical trial results, which include endpoints of progression free survival (PFS) and objective response rate (ORR), will be used by Immunicom to pursue global regulatory approvals and European CE marking.

The trial is being conducted under the direction of Principal Investigator, Piotr Wysocki, MD, PhD, who serves as Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow and President of the Polish Society of Clinical Oncology. Professor Wysocki is a renowned leader in immunotherapy and breast & genitourinary cancer research having authored more than 100 published textbook chapters and scientific articles.

"I am extremely pleased to serve as the Principal Investigator for this groundbreaking clinical study" said Professor Wysocki. "While I continue to see exciting advancements in the field of immuno-oncology, most involve expensive new drug therapies which are financially out of reach for many health systems and patient populations. Every week, patients from all over the Europe who have failed all available treatments are coming to my department looking for last chance therapies such as combinations of metronomic chemotherapy and molecularly targeted approaches, we have been developing for many years. In this context, we hope, Immunopheresis may become the ultimate and universal therapy of choice we have been all waiting for. I am really optimistic that the results of this trial will demonstrate Immunopheresis alone or in combination with existing, low-cost, low-toxic standard of care chemotherapy can be an effective, affordable treatment option for TNBC patients."

According to Amir Jafri, Founder and CEO of Immunicom, "Successfully completing the first patient treatment in this pivotal TNBC study is an incredible company milestone. And, with this trial being the first of multiple international clinical studies planned to begin enrollment in 2019, this achievement demonstrates the strong momentum our organization and outstanding team of partners and advisors have created."

On June 10, 2019 Alliance HealthCare Services, Inc., a leading national provider of outsourced healthcare services, is reported two executive changes: William (Bill) Larkin as Executive Vice President & Chief Financial Officer, and Douglas (Doug) McCracken as President of Alliance HealthCare Oncology ("Alliance Oncology") (Press release, Alliance HealthCare Services, JUN 10, 2019, View Source [SID1234536981]).

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"We are pleased to welcome Bill to the Alliance family, and to promote Doug—a fifteen-year veteran of Alliance—to his new role," said President & Chief Executive Officer Rhonda Longmore-Grund. "Both assume these roles at an exciting and important time for our organization and within the wider healthcare landscape."

Larkin takes on the chief financial officer role from Longmore-Grund, who was promoted to chief executive officer in November of 2018. Larkin’s experiences span a diverse set of corporate environments ranging from entrepreneurial startups, high growth mid-caps and mature multi-billion enterprises across varied industries including automotive, battery materials R&D and fuel system design and manufacturing. Over the last ten years, Bill has served as chief financial officer of both public and privately held companies at Fuel Systems Solutions, Westport Innovations and SouthWest Dealer Services Inc. In each case, the companies were experiencing significant growth, expansion and change in operating complexities both in the U.S. and internationally. Larkin began his career as a CPA with Deloitte & Touche and is a veteran of the US Army; he has a B.S. in Accounting from the University of Southern California.

"We are very excited to have Bill join the Alliance team with his capital markets and global finance experiences," said Longmore-Grund. "His experiences will be invaluable to the leadership team and organization as we continue building on our growth strategy as the partner of choice to hospitals, health systems and providers who seek to accelerate the performance of their radiology, oncology and interventional service lines."

McCracken became president of Alliance Oncology following the retirement of Greg Spurlock in May. McCracken has had extensive experience across the Alliance portfolio, most recently serving as chief operating officer of Alliance HealthCare Radiology ("Alliance Radiology"). Prior to that role, he was a cross-division senior vice president with responsibilities in the Oncology and Interventional divisions, as well as operational start-up responsibilities with Alliance International. McCracken was also a vice president of finance for the Radiology division for the first seven years of his tenure. Prior to joining the company, McCracken served in a variety of positions in the telecommunications and chemical industries. McCracken received his B.A. in Business from Michigan State University and M.B.A. in Finance and Marketing from Indiana University.

"Doug’s success over the years in leading and serving across divisions, functions and areas of the country is a testament to his acumen, collaborative leadership style and solutions-oriented approach. His leadership within our organization is well-known and respected and we look forward to his leadership of our Oncology division’s expansion," Longmore-Grund said.

"We are entering our next phase of strategic growth at Alliance, based on providing exceptional care to our patients and essential solutions to our partners. Together with our shareholder Tahoe Investment Group and our Executive Leadership Team, we warmly welcome Bill to our company and congratulate Doug on his promotion. We look forward to their important contributions to our mission and our success," Longmore-Grund added.

On June 10, 2019 F-star, a clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy, reported the appointment of Louis Kayitalire, MD, as Chief Medical Officer (CMO), which will be effective on 17 June 2019 (Press release, f-star, JUN 10, 2019, View Source [SID1234536980]).

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F-star believes this newly created management position will be crucial to F-star’s transition to a wholly-owned portfolio strategy as it expands its clinical operation capabilities and accelerates progression of its proprietary pipeline.

Dr Kayitalire will oversee the clinical development of F-star’s lead product candidate, FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody currently in a Phase 1 clinical trial, recruiting the expansion cohorts of the two highest dose levels. He will also lead the clinical strategy and operations for F-star’s pipeline of potential first- and best-in-class immuno-oncology bispecific antibody therapeutics, including FS120 and FS222, two proprietary product candidates currently in cGMP production and on track for investigational new drug application submissions this year.

Louis Kayitalire said: "This is an exciting time for me to join F-star as the company pivots to a wholly-owned portfolio strategy and accelerates the clinical development of its pipeline. As we saw at the recent ASCO (Free ASCO Whitepaper) meeting, bispecific antibodies are leading a paradigm shift in cancer care and the potential to improve the outcome for cancer patients has never been greater. I believe F-star is ideally positioned to become the next leader in this field."

Dr Kayitalire will bring over 20 years’ experience in oncology and immuno-oncology, having previously held positions at major pharmaceutical companies including Bristol-Myers Squibb, Celgene and Eli Lilly. Dr Kayitalire has strong commercial acumen to complement his extensive clinical expertise with a proven track record of developing and delivering clinical research programmes and ensuring alignment with overall medical and commercial strategies. Dr Kayitalire completed his medical training at Butare University, Rwanda and later held a position as Assistant Professor in Oncology at the Paris XI University of France. He is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Eliot Forster, CEO of F-star, said: "We are delighted to welcome Louis to the F-star team. His oncology expertise and extensive experience advancing clinical research programmes will be invaluable at this stage in F-star’s evolution as we accelerate development of our lead product candidate, FS118, and work to rapidly progress more assets into the clinic."

On June 10, 2019 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and research reagents, reported that it has selected the clinical development candidate for first-time-in-human clinical trials of the Affimer platform (Press release, Avacta, JUN 10, 2019, View Source [SID1234536979]). This important milestone means that the Group remains on track to submit an IND/CTA application for an Affimer PD-L1 inhibitor by the end of 2020.

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The Group has generated a wide range of Affimer inhibitors of PD-L1, a well known cancer immunotherapy target. This target was chosen to demonstrate safety and tolerability of the Affimer platform in human and, importantly, to provide a proprietary basis for its novel tumour microenvironment activated drug conjugate (TMAC) and bispecific cancer immunotherapies.

Avacta has selected a specific Affimer molecule (AVA004) as its clinical candidate because of its excellent in vitro and in vivo pharmacological properties. This Affimer has been shown to have equivalent tumour growth inhibition to three approved monoclonal antibody inhibitors of PD-L1 (Tecentriq, Imfinzi and Bavencio) in several in vivo animal efficacy models.

This molecule will therefore now be taken forwards into clinical manufacturing and IND/CTA enabling studies, allowing the Group to remain on track for an IND/CTA application in late 2020 and dosing of first patients shortly afterwards.

The planned phase I study will be in patients with advanced PD-L1 positive solid tumours. This study will explore both intra-venous and sub-cutaneous routes of administration to provide proof-of-concept with primary endpoints of safety, tolerability and appropriate pharmacokinetics/pharmacodynamics, and with a secondary efficacy endpoint. The study will include 20-30 patients in at least two sites in North America and Europe.

The cancer immunotherapy market is currently worth $60bn and is predicted to double by 20251. Avacta’s combinatorial approach to treatment through its TMAC and bispecific cancer immunotherapies, which build upon inhibition of PD-L1, are designed not only to compete strongly in this market through improved clinical benefit to patients, but also to expand the market to patients who do not respond to single checkpoint inhibitors.

Avacta will provide an on-line analyst briefing on the AVA004 in vitro and in vivo pharmacology data at 16:00 BST on Wednesday, 12 June 2019. To register for this analyst briefing please contact [email protected].

Dr Alastair Smith, Chief Executive Officer, Avacta Group plc, commented:

"Selection of the Affimer PD-L1 inhibitor candidate for clinical development is an important milestone in our development of the Affimer therapeutic platform. The Group remains firmly on track to submit an application to the regulators for a first-time-in-human clinical study late in 2020.

Demonstration of appropriate safety and tolerability in humans is key to de-risking the platform overall for partners and therefore key to the number and value of licensing deals in the future.

Not only will the PD-L1 programme be used to demonstrate the safety of the Affimer platform in humans, but it will provide us with a proprietary inhibitor of the PD-1/PD-L1 checkpoint pathway which will be central to our ground-breaking TMAC drug conjugates and bispecifics. These novel programmes will allow us to build a clinically differentiated pipeline to address the lack of a durable response to single immune checkpoint therapies for most patients.

It is a hugely exciting period for Avacta and I look forward to keeping the market updated on our progress."

1. View Source

On June 10, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson have reported the latest research to be presented at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress taking place in Amsterdam, The Netherlands, from 13–16 June 2019 (Press release, Johnson & Johnson, JUN 10, 2019, View Source [SID1234536978]). Janssen will present 28 company-sponsored abstracts from its leading haematological malignancy portfolio at the congress, including the latest results for DARZALEX (daratumumab) and IMBRUVICA (ibrutinib).

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"With more than 11,000 attendees, EHA (Free EHA Whitepaper) is the premier congress for the latest innovations in haematology in Europe and Janssen is proud to be presenting important data from our clinical development programmes," said Dr Patrick Laroche, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen-Cilag France. "We are committed to changing outcomes and improving options for patients diagnosed with cancer. Therefore, we are pleased to present results from the daratumumab CASSIOPEIA study, which has been selected for inclusion in the Presidential Symposium. We are also encouraged by the five-year ibrutinib RESONATETM-2 follow-up findings, which provide longer-term evidence supporting the efficacy and safety of this BTK inhibitor in the treatment of chronic lymphocytic leukaemia."

Highlights of the data to be presented by Janssen include:

First-Time Daratumumab Data in the Treatment of Newly Diagnosed Patients with Relapsed/Refractory Multiple Myeloma, and its Investigational Subcutaneous Formulation1,2
Fourteen daratumumab abstracts have been selected for presentation at the EHA (Free EHA Whitepaper) Annual Congress this year, four of which will be featured in oral sessions. Notably, results from the Phase 3 CASSIOPEIA study evaluating daratumumab in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant eligible have been selected for presentation as part of the Presidential Symposium (Abstract #S145).1 The Presidential Symposium includes the six best abstracts of the Congress, reflecting ground-breaking research as chosen by the Scientific Program Committee. These data recently supported regulatory filings in both the European Union and the U.S., seeking to expand the current indication for daratumumab in the frontline setting.

Findings from the Phase 3 COLUMBA study will be presented (Abstract #S823) evaluating a daratumumab subcutaneous formulation in the treatment of patients with relapsed or refractory multiple myeloma.2

Ibrutinib Long-Term Data in Chronic Lymphocytic Leukaemia3
Results from the final analysis of the Phase 3 RESONATETM-2 study (PCYC-1115/1116) study evaluating ibrutinib monotherapy in previously untreated patients with chronic lymphocytic leukaemia (CLL) will be presented in an oral session (Abstract #S107).3 Ibrutinib, a once daily oral BTK inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.3

Select company-sponsored abstracts follow below. Abstracts for additional Janssen therapies will also be presented and can be found through the EHA (Free EHA Whitepaper) abstract database here.

Abstract No. Title Date/Time
Daratumumab
Oral Presentations
Abstract #S1451

Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results Presidential Symposium,
Friday, June 14 3:45 – 4:00 PM CEST

Abstract #S8744

Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA Saturday, June 15
4:45 – 5:00 PM CEST

Abstract #S8232

Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA Saturday, June 15
11:30 – 11:45 AM CEST

Abstract #S8755

Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA Saturday, June 15
5:00 – 5:15 PM CEST

Poster Presentations
Abstract #PF5986

Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF5927

Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF6038

Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF5919

Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF59610

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF64111

Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF64312

Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PS137713

Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA Saturday, June 15
5:30 – 7:00 PM CEST

Abstract #PS142514

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma Saturday, June 15
5:30 – 7:00 PM CEST

Abstract #PS139515

Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible Saturday, June 15
5:30 – 7:00 PM CEST

Ibrutinib
Oral Presentation
Abstract #S1073

Five Year Follow-Up of Patients Receiving Ibrutinib For First-Line Treatment of Chronic Lymphocytic Leukemia Friday, June 14
12:00 – 12:15 PM CEST

Poster Presentations
Abstract #PF38416

Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice: Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38717

French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Chronic Lymphocytic Leukemia (CLL) in France Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38318

Prognostic Testing and Treatment Approaches Based on Real-World Clinical Experience from An Interim Analysis of the INFORMCLL Registry of Patients With Chronic Lymphocytic Leukemia [ASH encore] Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF49419

Clinical Outcomes with Single-Agent Ibrutinib for Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38920

Progression-Free Survival Predicts Overall Survival in Frontline CLL Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PS126421

French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Mantle Cell Lymphoma (MCL) in France Saturday, June 15
5:30 – 7:00 PM CEST

#ENDS#

About daratumumab
Daratumumab is a first-in-class22 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.23 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.24 A subset of myeloid-derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.26 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.25,26,27,28,29,30,31,32 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.33,34 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.35

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.36 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying the progression of the cancer.37

Ibrutinib is currently approved in Europe for:38

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell lymphoma.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.
Ibrutinib is approved in more than 90 countries, and, to date, has been used to treat more than 140,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g. bruising), musculoskeletal pain, nausea, rash, and pyrexia.38

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.