On April 24, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments (Press release, AstraZeneca, APR 24, 2018, View Source [SID1234525609]). This randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, versus standard-of-care chemotherapy (SoC) in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).

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In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to SoC. Activity and safety of monotherapy arms of sub-study B were consistent with prior published data.

Sub-study A was not powered for statistical significance; however, Imfinzi monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy.

Full data from the ARCTIC trial will be presented at a forthcoming medical meeting.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in this heavily pre-treated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting."

AstraZeneca recently received approval from the US FDA for Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

NOTES TO EDITORS
About ARCTIC

The ARCTIC trial was a randomised, open-label, multi-centre, global Phase III trial containing two sub-studies: sub-study A (1:1 randomisation of patients with PDL1-high tumours to Imfinzi (durvalumab) vs. SoC) and sub-study B (2:3:1:2 randomisation of patients with PDL1-low/negative tumours to Imfinzi monotherapy, Imfinzi plus tremelimumab or tremelimumab vs SoC). Tumour PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay with PD-L1 high defined as ≥25% of tumour cells with membrane staining.

About Imfinzi

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In February 2018, Imfinzi received US FDA approval for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi also received accelerated approval in the US for the treatment of patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new medicine, as a first-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

About tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicines that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in an extensive clinical-trial programme in combination with Imfinzi in NSCLC, locally-advanced or metastatic urothelial carcinoma, head and neck cancer, liver cancer and blood cancers.

On April 24, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reported that its first quarter 2018 financial results will be released after market close on Thursday, May 10, 2018 (Press release, Coherus Biosciences, APR 24, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2344193 [SID1234525630]). Starting at 4:30 p.m. EDT, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing first quarter 2018 financial results, we will post them on the Coherus BioSciences website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, May 10, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 2767588
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On April 24, 2018 Autolus Limited, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the execution of a license agreement under which Autolus has acquired global rights from UCL Business plc (UCLB), the technology-transfer company of University College London (UCL), to develop and commercialize a novel CD19 chimeric antigen receptor (CAR) T cell therapy with novel targeting properties for the treatment of B cell malignancies (Press release, UCLB, APR 24, 2018, View Source [SID1234525647]).

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The product candidate, which we have designated as AUTO1, is an investigational therapy in which a patient’s T cells are genetically modified to express a novel CD19-specific CAR designed to reduce side effects related to cytokine release syndrome (CRS). CD19 is a protein expressed by B-cell lymphomas and leukaemias. CD19 CAR T cells have proven effective in treating leukaemia and lymphoma, with efficacy dependent on engraftment and expansion of CAR T cells. However, rapid activation and expansion of CAR T cells can result in CRS, which in some cases can be life-threatening, particularly for elderly patients and patients with higher tumour burden that have poor tolerance for toxicity. Furthermore, excessive activation of CAR T cells can lead to cell exhaustion and limit their persistence.

AUTO1 is currently the subject of two Phase 1 studies, one in paediatric acute lymphoblastic leukaemia (ALL) and the other in adult ALL*. AUTO1 has been designed to recognise CD19 with a fast-off binding kinetic, which allows CAR T cells to efficiently recognize cancer cells, inject cytotoxic proteins to initiate the natural self-destruction process present in all human cells and then rapidly dissociate from them in order to engage the next cancer cell – a process also known as serial killing. We believe that avoiding prolonged residence on targeted cells may minimize excessive activation of CAR- T cells and reduce toxicity and CAR T cell exhaustion. In a UCL Phase 1 clinical study (CARPALL) in paediatric ALL patients evaluating the properties of AUTO1, investigators observed levels of efficacy similar to those in other reported studies, without observing grade 3 or 4 CRS and without the need to administer immunosuppressive drugs. Data from the CARPALL study were presented at the 2017 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)**.

Dr Martin Pule, Chief Scientific Officer of Autolus Limited and Senior Lecturer in Haematology at UCL, commented:"Current CARs in the clinic are designed with high affinity binders that can engage the CD19 target for an extended period of time. This can lead to excessive T cell activation and cytokine release, as well as exhaustion of the T cell.We developed a CD19 CAR that is designed to bind to its target with a fast on-rate but then releases quickly, which is more similar to naturally occurring T cell activity. The initial clinical data supports the premise that this kinetic profile reduces toxicity and increases CAR T cell engraftment."

Dr Christian Itin, Chief Executive Officer of Autolus Limited, added:"This licensing arrangement represents an exciting opportunity for Autolus as we continue to expand our broad pipeline of clinical-stage T cell programs, with clinical trials currently ongoing for five programmes in six indications. With AUTO1, we are collaborating with UCLB in an ongoing trial in adult ALL patients and also expect to leverage the improved safety profile of the CD19 binder in future generations of our programmed T cell therapies for the treatment of patients with B cell malignancies."

Cengiz Tarhan, Managing Director of UCLB, said:"The development of this product candidate represents the culmination of several years of research led by Martin Pule and his collaborators, drawing on funding from multiple government and charitable sources. UCLB is delighted to be able to partner with Autolus to support the continued development of this promising approach."

* Paediatric ALL "CARPALL Study": View Source and adult ALL "ALLCAR19 Study": View Source;
**Abstract: View Source;

Media Contact:

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Julia Wilson
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[email protected]

On April 23, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that Kenneth A. Berlin has been appointed as President and Chief Executive Officer, effective April 23, 2018, and will also serve as a Director of the company (Press release, Advaxis, APR 23, 2018, View Source [SID1234525582]). Interim CEO Anthony Lombardo will remain with Advaxis for a period of time to ensure a smooth transition to Mr. Berlin.

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In addition, Andres A. Gutierrez, M.D., Ph.D. has been named Executive Vice President, Chief Medical Officer, effective April 23, 2018. Advaxis also announced that CFO Sara Bonstein will be leaving the company as of April 30, 2018 to pursue a new professional opportunity. The Company is actively engaged in the search for a new CFO, and will announce an interim appointment shortly.

"After a comprehensive and methodical search, we are very pleased to announce that Ken Berlin has agreed to join Advaxis as President and CEO, and that Dr. Andres Gutierrez is joining our team as CMO. Both of these executives are eminently qualified for their new positions, and we expect to benefit greatly from their expertise. Under their leadership, we look to the future of the company with excitement and confidence," stated David Sidransky, M.D., Chairman of the Board. "On behalf of the Board, I would like to take this opportunity to sincerely thank Sara Bonstein and Anthony Lombardo for their valued service to the company as CFO and interim CEO, respectively, and extend best wishes to both of them."

Mr. Berlin joins Advaxis from Rosetta Genomics, where since 2009 he was President and Chief Executive Officer. During his tenure at Rosetta, Mr. Berlin spearheaded the effort of repositioning the company for commercial success with various microRNA-based oncology diagnostic products and raised nearly $100 million in capital to fund these efforts. Prior to Rosetta Genomics, Mr. Berlin was Worldwide General Manager at cellular and molecular cancer diagnostics developer Veridex, LLC, a Johnson & Johnson company. At Veridex he grew the organization to over 100 employees, launched three cancer diagnostic products, led the acquisition of its cellular diagnostics partner, and delivered significant growth in sales as Veridex transitioned from an R&D entity to a commercial provider of oncology diagnostic products and services. During Mr. Berlin’s tenure, Veridex received numerous awards including recognition from the Cleveland Clinic and Prix Galien for the use of its innovative CellSearch technology in the fight against cancer.

Mr. Berlin joined Johnson & Johnson in 1994 and served as corporate counsel for six years. He led and participated on the legal team that oversaw several mergers, acquisitions, divestitures and commercial transactions. He then held positions of increasing responsibility within Johnson & Johnson and a number of its subsidiary companies. From 2001 until 2004 he served as Vice President, Licensing and New Business Development in the pharmaceuticals group, and from 2004 until 2007 served as Worldwide Vice President, Franchise Development, Ortho-Clinical Diagnostics. He has been responsible for numerous licensing and/or research collaboration deals in oncology, metabolic disease, cardiovascular disease, CNS and women’s health, including the ex-U.S. license to Millennium Pharmaceutical’s VELCADE, a first-in-class, oncology therapeutic with peak reported sales outside the U.S. of approximately $1.8 billion.

"Ken brings to Advaxis a truly valuable combination of executive leadership experience with large and small, development-stage and commercial companies with a particular expertise in oncology. He has a proven ability to raise capital, launch products, achieve rapid sales growth, build businesses and complete strategic M&A and licensing transactions. We are fortunate to have Ken as our new chief executive," commented Dr. Sidransky.

"The opportunity to join Advaxis at such a pivotal and active time is very exciting," stated Mr. Berlin. "I look forward to building on the company’s strong foundations and to maximize the value of our Lm-based platform technology worldwide and in multiple indications."

Mr. Berlin holds an A.B. degree from Princeton University and a J.D. from the University of California Los Angeles School of Law.

Dr. Gutierrez will be responsible for all global clinical development and regulatory initiatives for Advaxis’ novel Lm-based antigen delivery platform. He has more than 25 years of experience in clinical oncology and drug development and joins Advaxis from Oncolytics Biotech, Inc., where he served as Chief Medical Officer. Prior to Oncolytics, Dr. Gutierrez was Chief Medical Officer at SELLAS Life Sciences Group and was Medical Director, Early Development Immuno-Oncology at Bristol-Myers Squibb, where he oversaw the development of translational and clinical development of immuno-oncology programs in solid tumors and hematological malignancies. Earlier, Dr. Gutierrez was Medical Director for several biotechnology companies including Sunesis Pharmaceuticals, BioMarin Pharmaceutical, Proteolix and Oculus Innovative Sciences, leading key programs with talazoparib and carfilzomib, among others . Prior to Oculus, he served as Director of the Gene & Cell Therapy Unit at the National Institutes of Health in Mexico City and as a consultant physician at the Hospital Angeles del Pedregal.

"We are delighted to welcome Dr. Gutierrez to Advaxis and are confident he will be a valuable addition to our executive team. He is an accomplished leader and physician with a track record of success in developing novel oncology drugs, putting patients first and delivering results," said Dr. Sidransky. "Dr. Gutierrez has played a key role in the advancement of clinical trials in all stages of development, through to drug approvals. We look forward to benefitting from his expertise in oncology drug development as he leads the clinical development of our immune-oncology platform."

"I am excited to be joining Advaxis at this important time in the company’s evolution with multiple clinical programs planned and underway, and look forward to contributing to the impressive progress made to date by the Advaxis team in advancing its innovative Lm-based antigen delivery technology across a number of important cancer indications," said Dr. Gutierrez. "Advaxis has a promising future as we continue to accelerate the development of our pipeline and bring innovative new medicines to patients."

Dr. Gutierrez received his M.D. and a Ph.D. in biomedical science from the National University of Mexico, with board certification in internal medicine and a fellowship in clinical oncology at the Hammersmith Hospital in London. He has presented clinical data at more than 85 scientific and medical meetings, has written numerous peer-reviewed articles, is a contributing author on nine medical textbooks and is named on 20 patents relating to drug development.

On April 23, 2018 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the first quarter of 2018 before the market opens on Monday, May 7, 2018 (Press release, ArQule, APR 23, 2018, View Source [SID1234525583]).The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

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The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."