AbbVie and Rice University establish K.C. Nicolaou Research Accelerator to advance therapies in oncology

On April 30, 2018 AbbVie, a research-based global biopharmaceutical company, and Rice University reported they have entered into a joint research collaboration to establish the K.C. Nicolaou Research Accelerator (Press release, AbbVie, APR 30, 2018, View Source [SID1234525846]). The research at the Accelerator will focus on synthesizing novel cytotoxic agents for use in the fight against cancer. The collaboration will complement AbbVie’s existing expertise in oncology discovery and early development.

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The K.C. Nicolaou laboratory has unique expertise in the art of replicating complex natural molecules that have cancer-fighting properties. The process, called total synthesis, allows researchers to apply organic chemistry strategies and technologies to optimize anti-tumor agents. When combined with AbbVie’s medicinal chemistry and antibody engineering capabilities, these anti-tumor agents have the potential to transform cancer treatment paradigms and significantly benefit patients.

"Dr. Nicolaou and his team at Rice University are conducting world-class research in organic chemistry that has the potential to aid in the development of new and effective cancer therapies for patients," said Tom Hudson, M.D., vice president, oncology discovery and early development, AbbVie. "Our goal is to transform the way cancer is treated and we look forward to aligning our development capabilities with the team’s expertise in chemistry to better address patient needs."

Dr. Nicolaou, the Harry C. and Olga K. Wiess Professor of Chemistry at Rice University, will lead the Accelerator’s research team at Rice. He is globally renowned for his research on total organic synthesis. He achieved the first total synthesis of the widely used chemotherapy agent paclitaxel (trade name Taxol), along with multiple other complex molecules. Dr. Nicolaou has received numerous prestigious awards, including the Wolf Prize in Chemistry in 2016 for advancing the field of chemical synthesis to the extremes of molecular complexity and expanding the interface among chemistry, biology and medicine.

"The K.C. Nicolaou Research Accelerator is a new model for university-industry collaboration," said Yousif Shamoo, vice provost for research at Rice University. "It is a true partnership between AbbVie and Rice scientists to conduct the highest-quality cutting-edge research and development in cancer therapeutics. Rice is moving away from more transactional relations with industry and replacing them with an integrative and deeper collaborative structure that we think will produce better outcomes for industry as well as better research and knowledge creation for the University."

"Collaborations like this one afford exciting opportunities for the commercialization of Rice research," said Asha Rajagopal, director of technology transfer at Rice University. "University-industry partnerships can marry academic exploration to market need and help streamline the translation of academic results into products with commercial impact. Such partnerships help foster a culture of entrepreneurship and innovation in the university community."

Taxol is a registered trademark of Bristol-Myers Squibb Company

A photo of Nicolaou is available at the link below.
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Cutline: K.C. Nicolaou (Credit: Jeff Fitlow/Rice University)

RhoVac AB participates in two international conferences and in an investor meeting in Sweden

On April 30, 2018 RhoVac AB ("RhoVac") reported that the company will be presenting at Aktiespararnas Aktiefrukost in Stockholm, Sweden and at 3rd Annual Advances in Immuno Oncology Congress, London, UK (Press release, RhoVac, APR 30, 2018, View Source [SID1234525838]). In June, RhoVac will attend the International Convention, Boston, USA.

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RhoVac’s CEO Anders Ljungqvist will present status and plans for the company’s drug candidate RV001 at Aktiespararnas Aktiefrukost, Operatorrassen, Stockholm, Sweden May 3, 2018. Registration for this event is via View Source

Anders Ljungqvist will attend 3rd Annual Advances in Immuno-Oncology Congress 24-25 May 2018 in London, UK (View Source). Not only research institutes, but also global pharmaceutical companies and biotechnology companies are attending this conference.

RhoVac will also attend the Biotechnology Innovation Organization’s (BIO) Conference International Convention, Boston, USA, between 4-7 June 2018. At BIO more than 1100 biotechnology companies, academic institutions and other related organizations from USA and over 30 other countries are represented.

For more information, please contact:
Anders Ljungqvist – VD, RhoVac AB
Phone: +45 4083 2365
E-mail: [email protected]

ISA Pharmaceuticals Appoints Leon Hooftman as Chief Medical Officer

On April 30, 2018 ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, reported the appointment of Leon Hooftman, MD, to the position of Chief Medical Officer (CMO), effective May 1, 2018 (Press release, ISA Pharmaceuticals, APR 30, 2018, View Source [SID1234525837]). He brings many years of experience in drug development and academic research and has a strong track record in early- and late-stage clinical development with specific expertise in immuno-oncology.

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"As we are planning to start two new clinical programs with ISA101b together with Regeneron as well as other clinical trials, we are happy to further strengthen the team with a new Chief Medical Officer. We are delighted to welcome Leon Hooftman to the ISA team, he brings very valuable experience in the clinical development of immuno-oncology therapies in big pharma as well as in biotech companies." said Ronald Loggers, CEO of ISA. "We would like to thank Rick Stead for his valuable support over the recent years and are pleased that he will continue to be involved as an advisor to ISA."

After academic medicine, Leon Hooftman became an accomplished pharmaceutical physician with more than 20 years of experience in drug development in immunology, haematology, and oncology, and with several New Drug Applications to his credit. Previous positions include Head of Clinical Development at Celltech Group Plc (UCB), and Chief Medical Officer of Chroma Therapeutics. Dr. Hooftman joins ISA from Allecra Therapeutics Ltd, a French-German biopharmaceutical company, where he served as CMO. Before moving into biopharmaceutical drug development, Leon was Director Clinical Science, Oncology and Immunology, at F. Hoffmann-LaRoche, where, amongst others, he led the clinical team that successfully completed a registration study with rituximab which gave the antibody its first approval in a first-line cancer indication (first-line NHL). Dr. Hooftman is an experienced clinician and has initiated and successfully completed multiple clinical studies in immunology, oncology and immuno-oncology. He is also an accomplished scientist and author of more than 50 scientific papers and publications.

"I am excited to join the team at ISA Pharmaceuticals," said Leon Hooftman. "The clinical data generated with ISA’s SLP- and AMPLIVANT-based product candidates so far look very promising and I am looking forward to advancing these unique therapeutic candidates closer towards pivotal development stage which will benefit patients with early as well as advanced cancer."

Humanigen Names Dr. Tarek Sahmoud as Chief Medical Officer

On April 30, 2018 Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments, reported Tarek Sahmoud, M.D., Ph.D., as its chief medical officer, initially a part-time role reporting to the company’s chief executive officer (Press release, Humanigen, APR 30, 2018, View Source [SID1234525836]).

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Dr. Sahmoud brings more than 25 years of experience in oncology drug development and medical and regulatory affairs to Humanigen. During his career, Dr. Sahmoud has led global oncology drug development programs in solid tumor and hematologic malignancies through regulatory approval and has advised on CAR-T programs. Dr. Sahmoud currently consults with leading CAR-T companies on their clinical and regulatory plans. He recently served as chief medical officer for H3 Biomedicine, a precision medicine company, and prior to that, he was vice president, oncology clinical development and medical affairs (USA), and global associate therapeutic area head (global) at Boehringer Ingelheim. He has served at Celgene as corporate vice president and global head of clinical development in solid tumors and immunoncology. Previously, Dr. Sahmoud was at Novartis as vice president and senior global clinical program head, oncology global drug development. He also held roles at Bristol-Myers Squibb as executive director, global medical affairs, oncology and at AstraZeneca as senior global medical director and US physician for breast cancer. In addition, he served at EORTC where he was responsible for all clinical trials coordination for several of the disease groups. Dr. Sahmoud received his medical degree from Cairo University Medical School, Egypt, and he holds a Ph.D. in public health, epidemiology and biostatistics from the University of Bordeaux II, France.

"Tarek is a strong addition to the Humanigen team, as he brings world-class abilities in oncology drug development and global regulatory strategy, coupled with domain expertise in the rapidly evolving CAR-T and immunoncology fields," said Cameron Durrant, M.D., chairman and chief executive officer of Humanigen. "Tarek will be instrumental in helping to guide the impending start of our clinical work to show lenzilumab’s potential to optimize CAR-T therapy to make it safer, better and more routine – and position our platform portfolio for maximum value for our stakeholders."

"I am excited to work with Humanigen and its clear opportunity and scientific rationale in granulocyte-macrophage colony-stimulating factor’s (GM-CSF) role in CAR-T-induced toxicities, including the unmet need of neurotoxicity, and optimizing CAR-T therapy overall," said Dr. Sahmoud. "I look forward to guiding the strategy and execution of Humanigen’s development programs to fulfill the ultimate goal of helping patients with significant unmet needs in oncology."

About Lenzilumab

Lenzilumab is a first-in-class, novel Humaneered recombinant monoclonal antibody designed to target and neutralize circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), the myeloid inflammation factor involved in the recruitment of myeloid cells to a tumor and a central actor in leukocyte differentiation, autoimmunity and inflammation. There is also extensive evidence linking GM-CSF expression to serious and potentially life-threatening side effects in chimeric antigen receptor T-cell (CAR-T) therapy, such as neurotoxicity and Cytokine Release Syndrome (CRS). Humanigen is working with leading CAR-T experts to develop lenzilumab as a potential prophylactic treatment to minimize neurotoxicity associated with CAR-T cancer therapy. In addition, lenzilumab is currently being evaluated as a potential treatment for rare leukemias in a phase 1 trial (NCT02546284) in patients with chronic myelomonocytic leukemia (CMML) with additional potential in juvenile myelomonocytic leukemia (JMML), a rare pediatric cancer. In previous clinical trials, lenzilumab has shown to be safe and well-tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers. It is a potent inhibitor of GM-CSF in vivo.

Genocea Files Investigational New Drug Application for Neoantigen Cancer Vaccine Candidate GEN-009

On April 30, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical program testing the safety, immunogenicity, and clinical efficacy of GEN-009, the company’s lead personalized neoantigen cancer vaccine candidate (Press release, Genocea Biosciences, APR 30, 2018, View Source [SID1234525835]).

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"We are excited to have advanced GEN-009 one step closer to the clinic," said Chip Clark, president and chief executive officer of Genocea. "Our GEN-009 program is designed to use our proprietary ATLAS platform to include only empirically confirmed neoantigens and to exclude what we’ve identified as inhibitory neoantigens in each patient’s vaccine. Our scientific data continue to demonstrate that widely used in silico-based neoantigen prediction methods fail to identify most empirically confirmed neoantigens and, critically, misclassify as good the inhibitory neoantigens that vastly outnumber stimulatory neoantigens. We therefore believe that ATLAS distinguishes GEN-009 from other neoantigen vaccine approaches and should enable better immune responses and, ultimately, therapeutic benefit for patients."

Genocea plans to commence the GEN-009 Phase 1/2a clinical program later this year, first studying the safety and immunogenicity of GEN-009 as monotherapy in cancer patients with no evidence of disease, but at high risk of relapse. This part of the program is expected to enroll at least six patients previously treated for melanoma, non-small cell lung cancer, head or neck cancer, or urothelial carcinoma. Genocea expects to announce the first top-line data from this study in the first half of 2019. Following proof of immunogenicity, Genocea expects to study GEN-009 in combination with checkpoint inhibitors in patients with advanced or metastatic solid tumors and as monotherapy in patients who have failed checkpoint inhibitory therapy.