On January 12, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Richard Paulson as Executive Vice-President and Chief Executive Officer of Ipsen North America, responsible for all commercial operations throughout the region. Mr Paulson will assume oversight of all areas supporting the North American business effective from February 5th (Press release, Ipsen, JAN 12, 2018, View Source [SID1234523076]). The role reports directly to David Meek, CEO of Ipsen, and Mr Paulson will be a member of the Ipsen Executive Leadership Team. He joins Ipsen from Amgen where he most recently served as Vice-President and General Manager of the Oncology Business Unit.

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David Meek, Ipsen’s CEO, commented, "We are extremely delighted to welcome Richard to Ipsen, to drive the continued growth of our North American business and further our development as a leading biopharma company focused on innovation and specialty care. Richard brings a wealth of great leadership experience, vision, and a track record of exceptional execution in leading and growing businesses, both in the US and internationally. He will bring great passion and energy to our work with patients."

During a 10-year career at Amgen, Richard Paulson held a number of positions in the company, including General Manager, Central and Eastern Europe, and subsequently General Manager Germany, before assuming leadership positions in Amgen’s Oncology Business Unit. Prior to joining Amgen, he held international positions in general management, marketing and market access with Pfizer. He also served in a number of sales and marketing roles with increasing seniority for GlaxoWellcome in Canada. He holds an MBA from the University of Toronto.

Richard Paulson added: "I am honored to join Ipsen at this time of rapid transformation and growth, as the company progresses in its evolution as a leading global biopharma company. Throughout my career, in markets around the world, I have been passionate about building and leading diverse, high-performing teams, and driving innovation for patients. I am extremely excited to join this dynamic company, with its clear mission and commitment to developing patient-focused solutions that put the patients’ needs first."

With the former President North America Cynthia Schwalm leaving Ipsen to pursue other interests, Ipsen would like to thank Cynthia for her many contributions to the growth of Ipsen’s North American business, and wishes her well in her future endeavors

On Jan. 11, 2018 /Forty Seven Inc., a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable patient’s immune systems to defeat their cancer, reported an agreement with Genentech Inc., a member of the Roche Group., for Genentech to sponsor two clinical trials combining Forty Seven’s CD47 antibody, Hu5F9-G4, with Genentech’s PD-L1 antibody, atezolizumab (TECENTRIQ), in patients with acute myeloid leukemia (AML) and with urothelial (bladder) cancer (Press release, Hoffmann-La Roche, JAN 11, 2018, View Source [SID1234531337]).

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CD47 is an immune modulator molecule overexpressed on cancer cells that sends inhibitory signals to macrophages. Binding of Hu5F9-G4 to CD47 takes the brakes off macrophages enabling them to phagocytose, or swallow, tumor cells.

Craig Gibbs, Ph.D., M.B.A., Chief Business Officer at Forty Seven Inc. said, "There is a large unmet medical need for new therapies for AML and bladder cancer patients, particularly those who are elderly or have compromised organ function and are not able to withstand the side-effects of chemotherapy. We are excited to evaluate these novel combinations in collaboration with a global leader in oncology."

References
CD47 blockade as another immune checkpoint therapy for cancer. Robert H. Vonderheide, Nature Medicine 21, 1122, 2015.

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

On Jaunuary 11, 2018 Forty Seven Inc. a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable a patient’s immune system to defeat their cancer, reported an agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase 1b clinical trial combining Hu5F9-G4 with avelumab in patients with ovarian cancer (Press release, Forty Seven, JAN 11, 2018, View Source [SID1234527432]).

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PD-L1 and CD47 are immunosuppressant molecules overexpressed on cancer cells that send inhibitory signals to T cells and macrophages, respectively. Binding of avelumab to PD-L1 takes the brakes off T cells and, in a similar way, binding of Hu5F9-G4 to CD47 takes the brakes off macrophages.

"PD-L1 inhibitors, like avelumab, belong to a class of new immunological therapies for cancer known as checkpoint inhibitors that offer the opportunity for long-term remissions in some cancer patients," said Forty Seven Inc. CMO Chris Takimoto. "Not all patients however, respond to checkpoint inhibitors, so additional scientifically driven combination approaches are required."

"Ovarian cancer patients have limited treatment options, especially as they are often diagnosed at a late stage in their disease," says Dr. Alise Reicin, Head of Global Clinical Development at the Biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "We have two ongoing registrational studies exploring the role that avelumab could play both as a monotherapy and in combinations in ovarian cancer. This collaboration enhances our strategic approach to novel I-O combinations in this disease setting. We are hopeful that through these efforts we will discover viable options to help patients with this hard-to-treat cancer."

On January 11, 2018 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported the publication of clinical and pre-clinical results by research collaborators at Rgenix and The Rockefeller University (Press release, Rgenix, JAN 11, 2018, View Source [SID1234523092]). The results of the collaboration, published in the January 11 online issue of Cell, reveal that the Liver-X Receptor/Apolipoprotein E (LXR/ApoE) pathway regulates anti-tumor immunity via effects on myeloid-derived suppressor cells (MDSCs).

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Rgenix Announces Publication In Cell Demonstrating Activation of LXR/ApoE with RGX-104 Enhances Antitumor Immunity

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MDSCs are an immunosuppressive cell population that have been found to be circulating at high levels in cancer patients who are also commonly found to be non-responders to immunotherapy. RGX-104 was able to deplete MDSCs both in cancer patients participating in the dose escalation portion of the Phase 1a/b trial and in mice. This resulted in robust activation of relevant T cell populations in both settings.

"We are pleased to have this opportunity to share our latest research results in Cell that illustrate the effects our first-in-class RGX-104 compound has on one of the key cells that are responsible for suppressing the immune response in cancer patients," said Masoud Tavazoie, M.D., Ph.D., and Chief Executive Officer and co-founder of Rgenix. "We believe RGX-104 represents a novel strategy for stimulating anti-tumor immunity, and this data cements this belief and furthers our resolve to continue developing this compound both as monotherapy as well as in combination with checkpoint inhibitor therapy."

Sohail Tavazoie, M.D., Ph.D., Leon Hess Associate Professor and Head of Elizabeth and Vincent Meyer Laboratory of Systems Cancer Biology at the Rockefeller University who was the senior-author of the study as well as co-founder of Rgenix, added: "The data our research has generated at this stage is exciting and supports our perspective that RGX-104 has the potential to modulate the immune response in a broad array of cancers. We will continue to progress in our research and our pursuit of unique treatments for patients affected by cancers with a high unmet medical need."

The paper, titled "LXR/ApoE Activation Restricts Innate Immune Suppression in Cancer", was published today and is available online.

On January 11, 2018 Puma Biotechnology, Inc. (the "Company") reported it met today with the Committee for Medicinal Products for Human Use ("CHMP") Scientific Advisory Group on Oncology ("SAG") (Press release, Puma Biotechnology, JAN 11, 2018, View Source [SID1234523065]). SAG was asked to provide an opinion on the clinical relevance of the 5-year absolute treatment difference in invasive disease free survival seen in the Phase III ExteNET trial and on the risk of gastrointestinal toxicity with neratinib and its acceptability in the proposed patient population in the Company’s Marketing Authorization Application ("MAA") for neratinib. Based on the feedback from SAG and the rapporteurs, the Company intends to modify the summary of product characteristics ("SmPC"), sometimes referred to as the European product label, in its MAA for neratinib to further refine the intended population to patients at a high risk of disease recurrence.

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CHMP will be conducting an oral hearing to discuss the MAA for neratinib on January 23, 2018, and the Company has been invited to present the risk benefit profile of neratinib in the identified population at this meeting