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Advaxis Announces Executive Leadership Changes

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.

CBT Pharmaceuticals and CrystalGenomics Announce Partnership for Co-development of Global Immuno-Oncology Therapy

On April 23, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, and CrystalGenomics, Inc., (KOSDAQ:083790), a Korea-based biopharmaceutical company with drug discovery, development and commercialization capabilities, reported a co-development agreement for an investigational combination therapy of CBT-501 and CG200745 across a variety of solid tumors with high unmet medical needs (Press release, CBT Pharmaceuticals, APR 23, 2018, View Source [SID1234525574]).

Under the terms of the exclusive agreement, CBT and CrystalGenomics will be responsible for the co-development and global commercialization of the combination of CBT-501 and CG200745 in multiple tumor types. A Phase Ib/II study is expected to be initiated by the end of this year.

"This partnership with CrystalGenomics enables CBT to leverage their clinical development expertise while further strengthening our immuno-oncology combination approach to deliver promising best-in-class treatments to patients with cancer," Sanjeev Redkar, Ph.D., President and Chief Executive Officer. "We believe the combination therapy of CBT-501 and CG200745 has the potential to be synergistic for patients across a range of cancers where alternative therapies are needed."

"We are excited to work with the CBT team, who are uniquely qualified to accelerate development of our novel HDAC inhibitor in combination with CBT-501, a differentiated anti-PD1 antibody" said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics.

Immune checkpoint inhibitors such as the programmed death receptor-1 (PD-1) and ligand (PD-L1) have been considered as major breakthroughs in the treatment of various cancers including melanoma, renal, lung, and bladder cancers. However, despite the robust efficacy observed in these cancers, the majority of patients either do not respond or eventually relapse due to resistance which may be innate or acquired. There has been recent reports suggesting immune enhancing effects of HDAC inhibitors, in addition to their direct anti-tumor properties, making CG200745 a good candidate for combination therapy with CBT-501 for its immunomodulatory effects in addressing the patient population that do not respond to single agent immunotherapy.

About CBT-501

CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. It has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti-PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile with very low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity. CBT-501 is under evaluation in two Phase I trials designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced solid tumors, recurrent or refractory to standard of care therapies (NCT03053466, NCT03374007).

About CG200745

CG200745, is a novel pan-HDAC inhibitor currently in Phase II clinical study for pancreatic cancer (NCT02737228) and Phase Ib for myelodysplastic syndrome (NCT02737462) in Korea. CG200745 has the potential to be a best-in-class compound based on preclinical and interim Phase Ib/II clinical data and is projected to have superior pharmacokinetic (PK) profile, pharmacodynamic (PD) response, efficacy, and safety, over other HDAC inhibitors. In its first-in-human study of the toxicity, PK and PD in patients with refractory solid malignancies, stable disease was observed in 57.1% of the subjects treated with CG200745 as monotherapy and excellent safety profile was observed as the maximum tolerated dose (MTD) was never reached (NCT01226407).

Teva to Report First Quarter 2018 Financial Results on May 3, 2018

On April 23, 2018 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported that it will release its first quarter 2018 financial results on Thursday, May 3, 2018 at 7:00 a.m. ET (Press release, Teva, APR 23, 2018, View Source;p=RssLanding&cat=news&id=2343903 [SID1234525573]).

Teva will host a conference call and live webcast on the same day, at 8:00 a.m. ET to discuss its first quarter 2018 results and overall business environment. A Question & Answer session will follow this discussion.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time):

United States 1-866-254-0808
International 44 (0) 1452 541003
for a list of other international toll-free numbers, click here.
Passcode: 9496209
A live webcast of the call will also be available on Teva’s website at: ir.tevapharm.com Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until May 31, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222 or International 44(0)1452550000; passcode: 9496209

EORTC and ESTRO announce a new collaboration to maximise the benefits of radiation oncology

Despite being very effective and widely used, radiation oncology treatment still suffers from a lack of collective knowledge on how some treatments affects patients’ functioning, symptoms and quality of life, and how best to optimise their effectiveness (Press release, EORTC, APR 23, 2018, View Source [SID1234525569]). Such information is available through the outcome of clinical trials, but formal data-sharing is rather haphazard, particularly where new treatments are involved. With the advent of personalised cancer medicine, this means that patients may not always receive the most effective treatment in their particular case. In a bid to put this situation to rights, the European Organisation for the Research and Treatment of Cancer (EORTC) and the European Society for Radiotherapy and Oncology (ESTRO) have joined forces to launch a new initiative, E2-RADIatE (EORTC-ESTRO Radiation Infrastructure for Europe). The project will be presented for the first time at the ESTRO 37 conference, which starts today (Friday).

The initiative aims to put in place a pan-European infrastructure for a more efficient framework across the field of radiation oncology by encouraging collaboration that will also involve other oncology disciplines, in order to generate robust data on its role in cancer treatment and to further develop and integrate the discipline into therapeutic strategies. "We believe that, through E2-RADIatE, we will be able to improve the efficiency of research projects, both in their take-up and conduct, and offer effective pan-European models to research partners," says EORTC President, Professor Bertrand Tombal, Chairman of the Division of Urology and Professor of Urology at the Université Catholique de Louvain (UCL), Cliniques Universitaires Saint-Luc, Brussels, Belgium.

E2-RADIatE will commence activity with two innovative projects. OligoCare will collect evidence for best practice in the treatment of oligometastases, where the primary cancer has spread (metastasised) to only a limited number of regions. Patients in this state have a good chance of survival if the metastases can be ablated, but evidence on how best to do this is lacking. Additionally, there is the problem of selecting which patient is most likely to benefit from which treatment. "These questions are unlikely to be answered within the traditional framework of prospective randomised trials because the situation of oligometastasis is diverse on so many fronts" says ESTRO President Professor Yolande Lievens, head of the department of radiation oncology at Ghent University Hospital, Belgium.

The proton therapy project aims to provide an effective data-sharing platform for particle therapy treatments. This is a rapidly developing technology with considerable potential in the treatment of cancer. But national healthcare providers face budget restrictions and, as a consequence, health technology assessment authorities are requiring more and more evidence of its effectiveness. E2-RADIatE aims to recruit all patients treated in proton therapy centres throughout Europe to provide this through, for example, a Europe-wide assessment of whether proton therapy leads to less clinical toxicity in treated patients. It is expected to be up and running in one year with approximately 2000 patients recruited in five years.

The partners believe that the outcomes of these projects, together with further initiatives to be undertaken by E2-RADIatE, will improve not only the health of patients, but also the competitiveness of EU radiation and multidisciplinary oncology. "They will create a significant critical mass that we believe will be influential at all levels of clinical research, regulation, and healthcare systems," says EORTC Director General Dr Denis Lacombe.

Molecular Partners presented preliminary results from the ongoing phase 2 study of MP0250 at the European Myeloma Network Meeting in Turin

On April 21, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that preliminary results from the ongoing Phase 2 study of MP0250 with bortezomib and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) were presented at the 1st European Myeloma Network Meeting in Turin (Press release, Molecular Partners, APR 21, 2018, View Source [SID1234525567]).

The presentation in Turin focused on results from the first dose cohort of MP0250 with respect to safety and efficacy. Eight patients were treated with 8 mg/kg of MP0250 and five out of these eight patients showed a documented response: Four patients reached a partial response (PR) and one patient reached a very good partial response (VGPR) at the cut-off date. Four out of the five patients are still on treatment with individual treatment durations of 13, 21, 24 and 33 weeks, respectively. The safety profile was consistent with the known safety profiles of bortezomib and MP0250, respectively. The independent dose escalation committee recommended to continue the clinical study at the higher dose of 12mg/kg and the first patient in the second dose cohort has been dosed recently.

Prof. Dr. Hartmut Goldschmidt (Medical Clinic V, University clinic Heidelberg), the Primary Investigator of the phase 2 study, commented: "We are encouraged by the initial efficacy and good tolerability data of MP0250 in combination with bortezomib and dexamethasone. Despite upcoming new treatment options, multiple myeloma remains an incurable disease and new molecules with innovative mechanism of actions are needed."

"We are pleased by the remarkable activity and the good safety profile that we have seen in the first cohort of this study. We are looking forward to patients being treated with the higher dose of MP0250 (12 mg/kg) and the additional phase 1b/2 study of MP0250 in combination with osimertinib in EGFR-mutated NSCLC," said Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners.

MP0250 is a proprietary DARPin drug candidate neutralizing VEGF and HGF and thus blocking key escape pathways and resistance. Increases in VEGF and HGF are associated with disease progression in multiple myeloma and have been linked to poor prognosis. They are known to be able to stimulate neovascularization, bone destruction, and myeloma proliferation, migration, and adhesion in the bone marrow. MP0250 shows activity in many preclinical tumor models, including in multiple myeloma models in which it enhances the effects of bortezomib on inhibition of M protein production and bone lysis and reduces invasion of tumor cells. MP0250 has shown a favorable safety profile in a phase 1 clinical study in 45 patients with advanced solid tumors.

In the ongoing phase 2 clinical study[1], the safety and efficacy of MP0250 is examined in combination with bortezomib (Velcade) and dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM) who have failed standard therapies. The study is performed in Germany, Poland and Italy. A total of 40 patients are planned to be treated, 12 patients in the dose-escalation phase (Part 1) to establish a safe dose, and an additional 28 patients in the dose-expansion phase (Part 2) resulting in a total of 34 patients at the target dose.

Additional safety and efficacy data are expected by the end of 2018.

An additional phase 1b/2 study will evaluate MP0250 in combination with osimertinib in patients with EGFR-mutated NSCLC pretreated with osimertinib. The study is conducted in the US and is open for patient enrollment2.

[1] ClinicalTrials.gov identifier NCT03136653
2 ClinicalTrials.gov identifier NCT03418532

Financial Calendar
April 26, 2018 – Q1 2018 Management Statement
August 30, 2018 – Publication of 2018 Half-year Results
November 01, 2018 – Q3 2018 Management Statement
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.
Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.