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Forty Seven Inc. to Collaborate on a Novel Immuno-Oncology Combination for Leukemia and Bladder Cancer

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.

Forty Seven Inc. to Collaborate with Merck KGaA, Darmstadt, Germany, on a Novel Immuno-Oncology Combination for Ovarian Cancer

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]).

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."

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

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).

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.

Puma Biotechnology met SAG 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.

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.

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

Novartis appoints Elizabeth Barrett as Oncology Head

On January 11, 2018 Novartis reported that Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the Executive Committee of Novartis, effective February 1, 2018 (Press release, Novartis, JAN 11, 2018, View Source [SID1234523064]). She will be based in Basel. Mrs. Barrett succeeds Bruno Strigini who decided to retire from Novartis for personal reasons.

Vasant (Vas) Narasimhan, designated CEO of Novartis, said: "Liz is a highly accomplished and recognized oncology and people leader with an impressive record of building successful business organizations in the US, Europe and globally. She has been instrumental in creating new commercial models, driving innovation in close partnership with research and development and leveraging business development opportunities. Her long-time commercial pharma industry experience, marketing skills and perspectives make Liz a great fit to further develop our oncology business."

Mrs. Barrett said: "I feel honored to join Novartis, a recognized pioneer in the oncology area. It is key to me to contribute to transformative advancements in oncology, and to serve in a highly impactful leadership role to this end."

Mrs. Barrett has held numerous leadership positions in the pharmaceutical industry as well as in the consumer sector. In her most recent role at Pfizer, she led the oncology business through a significant period of growth achieved in less than three years. Before joining Pfizer in 2009, she worked at Cephalon, Inc. and Johnson & Johnson. She started her career at Kraft Foods Group, Inc. in 1984.

Mrs. Barrett is a US citizen and has lived and worked in the US and Europe. She obtained an MBA in Marketing from the Saint Joseph’s University in Philadelphia and a BSc in Business Administration from the University of Louisiana.

Novartis also announced today that Robert Kowalski, Pharm.D., Head of Global Regulatory Affairs, will assume ad interim leadership of the Drug Development Organization, effective February 1, 2018. Dr. Kowalski has been Head of Global Regulatory Affairs for Novartis since February 2016 and has played an important leadership role in securing approvals for several breakthrough medicines including our revolutionary CAR-T therapy Kymriah. The definitive Head of Global Drug Development will be announced in due course.

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