4. Rahul Jasuja - Noble Life Science Partners noblelsp.com/research RJ: ”Thanks for taking my question and glad to know that PS is now being recognized by big pharma and the immunology mafia so to say. So couple of questions pertaining to how PS with checkpoint inhibitors is differentiated from the conventional checkpoints inhibitors, like the CTLA-4, PD-1, PD-L1 pathways. From the data that's been represented at ImVacS, and also in discussions they’ve had with you guys, besides blocking just PS binding to its receptors on immune cells, there is an FC- FC gamma -based effector function leading to ADCC and so on and so forth - an immune effector function that other checkpoint inhibitors do not have blocking PD-1 or blocking CTLA-4. So, you’ve got a component here that is beyond other checkpoint inhibitors, that brings in an effector function that others do not have. Looking at that aspect or looking at some of the translational data, do you think that beyond the PD-1, PD-L1 non-immunogenic tumors, there is a possibility that PS blockade will have far more effect potentially driving [ph??] antigen presentation. Any comments on that?” .. ... ...
So Memorial Sloan Kettering signs on with Peregrine and Dr. Jedd Wolchock was on record for saying ="The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Wolchok. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114118480
...now I think it is important to look at what Dr. Jedd Wolchok says below and pay attention to the "immune modulator" and "effector function.." and I'm convinced he is referring to Bavituximab and here we have another very likely Peregrine collaborator/partner. Infinity & Beyond taking on an entire new meaning
Loof, its time to make sure that rocket is ready for launch : )
Infinity Expands Pipeline with Addition of IPI-549, an Immuno-Oncology Development Candidate for the Treatment of Solid Tumors
9-18-2015
– IPI-549, a Selective PI3K-Gamma Inhibitor, Targets the Immune-Suppressive Tumor Microenvironment –
– Preclinical Data for IPI-549 Presented at CRI-CIMT-EATI-AACR - The Inaugural International Cancer Immunotherapy Conference –
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the expansion of its pipeline with the addition of IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), for the treatment of solid tumors. Preclinical data demonstrating the potential of IPI-549 to disrupt the immune-suppressive tumor microenvironment and enable a heightened anti-tumor immune response are being presented today at CRI-CIMT-EATI-AACR - The Inaugural International Cancer Immunotherapy Conference: Translating Science into Survival Meeting in New York City. IPI-549 was discovered at Infinity and is expected to enter Phase 1 clinical development in early 2016.
“Infinity is committed to developing first-in-class and best-in-class medicines, and the expansion of our pipeline with the addition of IPI-549 represents an important step toward fulfilling our vision of building a sustainable biopharmaceutical company that brings meaningful medicines to patients,” stated Vito Palombella, Ph.D., Infinity’s chief scientific officer. “Infinity’s ability to internally develop a selective PI3K-gamma inhibitor provides us with a unique opportunity to explore the impact that PI3K-gamma inhibition has on disrupting the tumor microenvironment. We look forward to initiating the first clinical study of IPI-549 in patients with solid tumors.”
“I have had the pleasure of collaborating with Infinity’s discovery team and am excited to have worked with IPI-549 in my laboratory,” Jedd Wolchok, M.D., Ph.D., chief of Melanoma and Immunotherapeutics Service, Lloyd J. Old/Ludwig Chair in Clinical Investigation Department of Medicine and Ludwig Center, at Memorial Sloan Kettering Cancer Center and the principal investigator for the planned Phase 1 clinical study of IPI-549. “IPI-549 is a novel, small molecule immuno-oncology agent, and I am looking forward to leading the Phase 1 study for this program.”
IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.
Preclinical Data for IPI-549 Presented at CRI-CIMT-EATI-AACR - The Inaugural International Cancer Immunotherapy Conference
Today at the AACR meeting in New York City Infinity researchers are presenting preclinical data for IPI-549 in a poster entitled, “The potent and selective phosphoinositide-3-kinase-gamma inhibitor, IPI-549, inhibits tumor growth in murine syngeneic solid tumor models through alterations in the immune suppressive microenvironment.”
In vitro data showed that IPI-549 blocks both the migration of murine myeloid cells and the differentiation of myeloid cells to the M2 phenotype, which is a type of myeloid cell known to promote cancer growth and suppress anti-tumor immune responses. In vivo data in murine solid tumor models demonstrated that IPI-549 treatment also decreased tumor-associated myeloid cells found in the immune suppressive microenvironment. Additionally, IPI-549 treatment increased the number of intratumoral CD8+ T-cells, which are known to play a role in inhibiting tumor growth.
IPI-549 has demonstrated dose-dependent, single-agent, anti-tumor activity in multiple solid tumor models, including murine models of lung, colon and breast cancer. Additionally, mice treated with IPI-549 in combination with checkpoint inhibitors showed greater tumor growth inhibition than either treatment as a monotherapy. Preclinical in vivo data also demonstrated that T-cells are required for the anti-tumor activity of IPI-549, which is a hallmark of immunotherapy.
Further details about the IPI-549 development program will be provided at Infinity’s R&D Day on Tuesday, October 6, 2015. R&D Day will be held in New York City from 7:30 a.m. to 12:00 p.m. ET. The event will be webcast beginning at 8:00 a.m. ET and can be accessed in the Investors/Media section of Infinity’s website, www.infi.com. A replay of the event will also be available.
Infinity is also developing duvelisib, an investigational, oral, dual inhibitor of PI3K-delta and PI3K-gamma. The PI3K pathway is also known to play a critical role in regulating the growth and survival of certain types of blood cancers. The investigational agent is being evaluated in registration-focused studies, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUOTM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company’s website at www.infi.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the Company’s expectations about:; the therapeutic potential of PI3K-gamma inhibition, PI3K-delta, gamma inhibition, IPI-549, and duvelisib, including in combination with other potential therapies; plans to initiate Phase 1 clinical development of IPI-549 in early 2016; plans to investigate IPI-549 in patients with solid tumors; the timing and type of the publication of additional details regarding IPI-549; and its ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that Infinity will report data in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that Infinity’s strategic collaboration with AbbVie will continue or that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing or intends to develop its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2015, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
José Baselga, M.D., Ph.D. - Dr. Baselga has served as Physician-in-Chief at Memorial Sloan-Kettering Cancer Center since January 2013. He was formerly Chief and Bruce A. Chabner Chair of the Division of Hematology/Oncology at Massachusetts General Hospital (MGH), Associate Director of the MGH Cancer Center, and Professor of Medicine at Harvard Medical School. Dr. Baselga was also Associate Director of Clinical Services at Dana-Farber/Harvard Cancer Center. From 1996-2010, Dr. Baselga was chairman of the Medical Oncology Service and director of the Division of Medical Oncology, Hematology and Radiation Oncology at the Vall d’Hebron Institute of Oncology in Barcelona, Spain. Dr. Baselga was previously the president of the European Society of Medical Oncology and served on the board of directors of the American Society of Clinical Oncology (ASCO). He is currently a member of the board of directors of the American Association for Cancer Research (AACR) and was the Chairman of the 2013 AACR annual meeting.
Dr. Baselga received his medical degree from the Universidad Autonoma of Barcelona in 1982. He did his Internal Medicine Residency at both Vall d’Hebron University Hospital in Barcelona, Spain and the State University of New York in the US. He completed a fellowship in Medical Oncology at Memorial Sloan Kettering Cancer Center in New York. Dr. Baselga has published more than 300 peer-reviewed articles and 400 abstracts and book chapters in his career.
Jeffrey Berkowitz
Anthony Evnin, Ph.D.-....a Member of the Boards of Overseers and Managers of Memorial Sloan-Kettering Cancer Center
Gwen Fyfe, M.D.-....Dr. Fyfe played an important role in the development of Genentech’s approved oncology agents including Rituxan(r), Herceptin(r), Avastin(r) and Tarceva(r). Dr. Fyfe sat on the development oversight committee for all of Genentech’s products and participated in the Research Review Committee that moved products from research into clinical development.
Eric Lander, Ph.D ....Dr. Lander has served as the founding director of The Eli and Edythe L. Broad Institute, a biomedical research institute formed by MIT and Harvard University, since 2003 and as a member of the Whitehead Institute for Biomedical Research since 1989.
Adelene Perkins
Norman Selby -Mr. Selby serves on the Board of Trustees of the Central Park Conservancy, the Memorial Sloan-Kettering Cancer Center and the Ralph Lauren Center for Cancer Care and Prevention. Ian Smith
In September 2014, we and AbbVie entered into a worldwide collaboration to develop and commercialize duvelisib (IPI-145), our oral PI3K-delta,gamma inhibitor, in oncology.
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!
