South San Francisco, CA, United States
South San Francisco, CA, United States

Onyx Pharmaceuticals Inc. is a biopharmaceutical company headquartered in South San Francisco, California. The company develops and markets medicines for the treatment of cancer. Onyx was founded in 1992 by Kevin J. Kinsella and Frank McCormick Ph.D., FRS. In 2009, the company acquired Proteolix, Inc., a private biotechnology company. In January 2012, the company was named "the top biotechnology takeover target in 2012" through an industry survey. Onyx CEO Tony Coles has said Onyx likes it prospects as an independent company and is focused on bringing new therapies to patients. However, at the end of August 2013, Amgen announced it was acquiring Onyx in an agreed $10.4 billion deal.Other backers of Onyx were Avalon Ventures, IVP, J. H. Whitney & Company, and Kleiner Perkins Caufield & Byers. Wikipedia.


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News Article | February 15, 2017
Site: www.businesswire.com

VANCOUVER, Canada--(BUSINESS WIRE)--Zymeworks Inc. (“Zymeworks”), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, today announced that Dr. Kenneth Hillan, CEO of Achaogen Inc., and Hollings Renton, former CEO and President of Onyx Pharmaceuticals Inc., have been appointed to Zymeworks’ board of directors. Concurrent with the appointment of Dr. Hillan and Mr. Renton, Zymeworks also announces that Dr. Donald Drakeman has retired from the Company’s board of directors, and is transitioning to the position of special advisor to Zymeworks and the board of directors. Dr. Drakeman will continue to contribute his knowledge and perspective to Zymeworks’ management and the board of directors. “ We are delighted to welcome Kenneth and Hollings to our board of directors,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “ Their collective experience working at the highest levels of the biotech and pharmaceutical industries will provide Zymeworks with valuable guidance as we move our lead product candidate, ZW25, through clinical trials and our preclinical assets closer to the clinic. We would also like thank Don for his service on the board since 2010. We look forward to continuing to benefit from his expertise as advisor to Zymeworks” “ Zymeworks’ next-generation therapies aim to advance the practice of medicine and make patients’ lives better, which is one of the most important contributions we can make to the healthcare challenges we face today,” said Dr. Hillan. “ I look forward to working with the board members and the Zymeworks leadership team to support the company’s mission of creating biotherapeutics that allow patients to return home to their loved ones, disease free.” Mr. Renton added, “ I am very pleased to join Zymeworks’ board of directors, and to work with the team to advance their versatile bispecific antibody capabilities. Zymeworks is well-positioned with their lead product candidate in clinical trials, and an exciting preclinical pipeline.” Dr. Kenneth J. Hillan is the CEO of Achaogen Inc. He has served as CEO and a member of the board of directors of Achaogen since October 2011. Prior to joining Achaogen, Dr. Hillan worked at Genentech Inc., a pharmaceutical company and a member of the Roche Group. Dr. Hillan worked in progressively senior roles after joining Genentech in 1994. He was responsible for numerous successful drug approvals and led the medical and scientific strategies for Genentech’s immunology, tissue growth and repair drug portfolio. Dr. Hillan also served on the board of directors of Relypsa Inc., a publicly traded biotechnology company that was acquired in 2016 by Galencia AG for $1.5 billion. Dr. Hillan has an M.B. Ch.B. (Bachelor of Medicine and Surgery) degree from the Faculty of Medicine at the University of Glasgow in the United Kingdom. Dr. Hillan is a Fellow of the Royal College of Surgeons, and a Fellow of the Royal College of Pathologists. Dr. Hillan has authored dozens of scientific publications and is a named inventor on approximately 50 issued patents. Hollings Renton served as CEO and President of Onyx Pharmaceuticals, Inc. from 1993 to 2008 and was the chairperson of the board of directors of Onyx from 2000 to 2008. Onyx was acquired by Amgen Inc. in 2013 for $10.4 billion. Before joining Onyx, Mr. Renton was the President and Chief Operating Officer of Chiron Corporation, a pharmaceutical company. Mr. Renton served in a variety of executive roles at Cetus Corporation from 1983 prior to its acquisition by Chiron in 1991. Mr. Renton currently serves as chairperson of the board of directors of Portola Pharmaceuticals Inc. and on the board of directors of AnaptysBio Inc. Mr. Renton received his M.B.A. from the University of Michigan and his B.S. in Mathematics from Colorado State University. Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.


- Data Continue to Reinforce the Efficacy and Safety of Selinexor in Patients with Heavily Pretreated Refractory Multiple Myeloma - - Company to Host Dinner Reception and Webcast Event with Interactive Expert Panel Discussion on Monday, December 5, 2016 at 8:15 p.m. PT - NEWTON, Mass., Dec. 04, 2016 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced updated results from its Phase 2b STORM study of selinexor (KPT-330), including robust rates and duration of response, compelling overall survival and a favorable safety profile, in patients with heavily pretreated refractory multiple myeloma (MM) at the American Society of Hematology (ASH) 2016 annual meeting held December 3-6, 2016 in San Diego.  Selinexor is the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export (SINE™) compound, in development for the treatment of a variety of malignancies, including MM and acute myeloid leukemia (AML). “The data presented today further support the rationale for selinexor as a promising new treatment for patients with refractory myeloma with no clearly beneficial treatment options,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “Based on the exciting STORM data and the existing unmet medical need, we have expanded the study to include additional patients with penta-refractory myeloma and expect to report top-line data from this study in early 2018.” In an oral presentation titled, “Selinexor and Low Dose Dexamethasone in Patients with Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib and Anti-CD38 Ab Refractory MM STORM Study,” Dan T. Vogl, MD, MSCE, Assistant Professor of Medicine, Perelman School of Medicine, University of Pennsylvania, presented updated clinical data from the ongoing Phase 2b STORM study, a single-arm clinical trial evaluating selinexor in combination with low-dose dexamethasone in patients with quad-refractory or penta-refractory myeloma.  Patients with quad-refractory disease have previously received two proteasome inhibitors (PIs) (bortezomib (Velcade®) and carfilzomib (Kyprolis®)) and two immunomodulatory drugs (IMiDs) (lenalidomide (Revlimid®) and pomalidomide (Pomalyst®)), and their disease is refractory to at least one PI, at least one IMiD, and has progressed following their most recent therapy.  Patients with penta-refractory myeloma have quad-refractory disease that is also refractory to an anti-CD38 monoclonal antibody, such as daratumumab (Darzalex®) or isatuximab. ORR=Objective Response Rate (VGPR+PR), CBR=Clinical Benefit Rate (VGPR+PR+MR), VGPR=Very Good Partial Response, PR=Partial Response, MR=Minor Response, SD=Stable Disease, PD=Progressive Disease, NE=Non-Evaluable 1One patient not included, did not have active myeloma All responses were adjudicated by an Independent Review Committee (IRC).  Among the 78 evaluable patients (median seven prior treatment regimens), the overall response rate (ORR) was 21%, and included very good partial responses (VGPR) and partial responses (PR).  Among the 48 patients in the quad-refractory group, the ORR was 21%.  For comparison, in a similar quad-refractory patient population, the anti-CD38 monoclonal antibodies Darzalex® and isatuximab had ORRs of 21% and 20%, respectively.  Among the 30 patients in the penta-refractory group, the ORR was 20%.  Clinical benefit rate (ORR + MR) was 32% (all patients), 29% (quad-refractory), and 37% (penta-refractory).  To the Company’s knowledge, no other agents have reported response rates in patients with penta-refractory MM.  Median overall survival (OS) was 9.3 months for all patients, greater than 11 months (median not reached) for patients with ≥MR, and 5.7 months for patients who did not have any response (≤SD).  Median duration of response (DOR) was 5 months.  Grade ≥3 cytopenias were the most common side effects and were generally not associated with clinical sequellae.  Nausea, anorexia and fatigue were the most common non-hematological side effects, primarily Grades 1 and 2, and were treatable with supportive care and/or dose modification.  There were low rates of Grade ≥3 non-hematologic toxicities, with no new safety signals identified.  In particular, there was one reported case of Grade 4 infection (1.3%), one case of Grade 2 neuropathy (1.3%) and one reported case of sepsis (1.3%). Dr. Vogl commented, “The quad- and penta-refractory populations are continuing to expand as patients live longer and cycle through a variety of treatment options, including immunomodulatory drugs, proteasome inhibitors, or anti-CD38 monoclonal antibodies, before their disease ultimately becomes refractory and non-responsive.  In my experience, selinexor is the first agent to be specifically investigated in this difficult to treat and currently underserved population.  The response rate and duration suggest that selinexor has the potential to be an exciting new option for myeloma treatment.” Karyopharm to Host Multiple Myeloma-focused Dinner Reception and Webcast at ASH 2016 On Monday, December 5, 2016, Karyopharm will host an investor and analyst dinner reception, which will feature a moderated panel discussion with recognized experts in the treatment of MM, updated selinexor data in MM, and a live Q&A session.  Confirmed external speakers include: In addition, Michael Kauffman, MD, PhD, CEO of Karyopharm Therapeutics will be joining. The event will take place during the ASH 2016 annual meeting and interested parties can access a live webcast of the event beginning Monday, December 5, 2016 at 8:15 p.m. PT under “Events & Presentations” in the "Investors" section of the company's website at http://investors.karyopharm.com/events.cfm.  A replay of the webcast will be archived on the company’s website for 90 days following the event. Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 1,800 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in acute myeloid leukemia (SOPRA), diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others.  Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017.  Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company's clinical development priorities for selinexor. The latest clinical trial information for selinexor is available at www.clinicaltrials.gov. Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1).  In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing.  Karyopharm, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development.  For more information, please visit www.karyopharm.com. 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 therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. 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 any of Karyopharm's SINE™ compounds, including selinexor (KPT-330), will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate 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: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which was filed with the Securities and Exchange Commission (SEC) on November 7, 2016, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited Revlimid® and Pomalyst® are registered trademarks of Celgene Corporation Kyprolis® is a registered trademark of Onyx Pharmaceuticals, Inc. Darzalex® is a registered trademark of Janssen Biotech, Inc.


- Diverse Data Continue to Reinforce the Efficacy and Safety of Selinexor in Patients with Heavily Pretreated Refractory Multiple Myeloma - NEWTON, Mass., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that 21 abstracts have been selected for presentation, including 9 oral presentations, at the American Society of Hematology (ASH) 2016 annual meeting being held December 3-6, 2016 in San Diego.  Two key abstracts being presented at the meeting will feature updated data from Karyopharm’s Phase 2b STORM and Phase 1b/2 STOMP studies, which are evaluating selinexor (KPT-330), the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export (SINE™) compound, for the treatment of patients with multiple myeloma (MM). Selinexor has demonstrated robust and durable responses with favorable safety profiles in both studies and these data will be updated for presentation at the meeting. “The STORM and STOMP studies continue to demonstrate robust response rates, with selinexor showing tolerability, both as a single-agent and in combination with other widely used therapies in heavily pretreated patients with MM,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “Collectively, the MM data being presented at ASH this year continue to support the efficacy and safety of oral selinexor, as well as our planned development path in MM, and we look forward to presenting even more mature data at the meeting in December.” In an oral presentation titled, “Selinexor and Low Dose Dexamethasone in Patients with Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib and Anti-CD38 Ab Refractory MM STORM Study,” Dan T. Vogl, MD, MSCE, Assistant Professor of Medicine, Perelman School of Medicine, University of Pennsylvania, will present updated clinical data from the ongoing Phase 2b STORM study, a single-arm clinical trial evaluating selinexor in combination with low-dose dexamethasone in heavily pretreated patients with quad-refractory or penta-refractory disease. Patients with quad-refractory disease have documented evidence that they have previously received two PIs (bortezomib (Velcade®) and carfilzomib (Kyprolis®)) and two IMiDs (lenalidomide (Revlimid®) and pomalidomide (Pomalyst®)), and their disease is refractory to at least one PI, at least one IMiD, and has progressed following their most recent therapy.  Patients with penta-refractory myeloma have quad-refractory disease that is also refractory to an anti-CD38 monoclonal antibody, such as daratumumab (Darzalex™) or isatuximab. All responses were adjudicated by an Independent Review Committee (IRC).  Among the 78 evaluable patients (median seven prior treatment regimens) at September 6, 2016, the overall response rate (ORR) was 21%, and included very good partial responses (VGPR) and partial responses (PR).  Among the 48 patients in the quad-refractory group, the ORR was 21%. For comparison, in a similar quad-refractory patient population, Darzalex had an ORR of 21% and isatuximab had an ORR of 20%.  Among the 30 patients in the penta-refractory group, the ORR was 20%.  Clinical benefit rate (ORR + MR) was 32% (all patients), 29% (quad-refractory), and 37% (penta-refractory).  Median overall survival (OS) was 9.3 months for all patients, greater than 11 months (median not reached) for responders (≥PR), and 5.7 months for non-responders.  Median duration of response (DOR) was approximately 5 months.  The progression free survival (PFS) in this heavily pretreated population was 2.1 months. Grade ≥3 cytopenias were the most common side effects and were generally not associated with clinical sequellae. There were low rates of Grade ≥3 non-hematologic toxicities, with no new safety signals identified.  In particular, there was one reported case of Grade ≥4 infection (1.3%) and there was one reported case of sepsis (1.3%). Dr. Vogl said, “Patients with penta-refractory myeloma are no longer responding to any of our most effective myeloma agents. This is a growing population for whom we currently have no specific therapy, representing an unmet need.   To my knowledge, selinexor is the first agent to show durable activity in this difficult-to-treat population.  The results are particularly intriguing because the response rate to oral selinexor is comparable to that achieved with daratumumab or isatuximab.  In addition, the overall survival seen in patients responding to selinexor is better than one would expect in this very refractory population. We look forward to further elucidating the potential benefits of selinexor in the STORM trial expansion, which will include approximately 120 additional patients with penta-refractory disease.” To Karyopharm's knowledge, no agent has previously shown activity in patients with penta-refractory MM. As a result, the Company has expanded the STORM study to include approximately 120 additional patients with penta-refractory MM and expects to report top-line data from the expanded cohort in early 2018.  Assuming a positive outcome, Karyopharm intends to use the data from the expanded STORM study to support a request that the FDA consider granting accelerated approval for selinexor in MM. In an oral presentation titled, “Selinexor in Combination with Bortezomib and Dexamethasone Demonstrates Significant Activity in Patients with Refractory Multiple Myeloma Including Proteasome-Inhibitor Refractory Patients,” Nizar Bahlis, MD, Associate Professor of Hematology, Southern Alberta Cancer Research Institute, will present updated clinical data from the selinexor + Velcade (bortezomib) + dexamethasone (SVd) arm of the ongoing Phase 1b/2 STOMP study in heavily pretreated relapsed/refractory MM patients. A summary of data from all 22 patients receiving selinexor in combination with Velcade and dexamethasone in the dose-escalation portion of the study treated as of July 25, 2016 is outlined in the following table and described below. Of the 22 patients enrolled in the SVd combination arm (median of four prior treatment regimens), 17 responded (1 patient with a complete response (CR), five patients with a very good partial response (VGPR) and 11 patients with a partial response (PR)) for an overall response rate (ORR) of 77%.  An additional three patients achieved a minor response (MR), for a clinical benefit rate (CBR) of 91%.  Only one patient had progressive disease.  All 10 patients with non-refractory disease responded (5 patients with a VGPR and 5 patients with a PR) for an ORR and CBR of 100%.  Twelve of the 22 patients in the SVd combination arm had MM previously refractory to a proteasome inhibitor and some patients had high-risk cytogenetics including deletion of chromosome 17p.  Seven of these 12 patients responded (1 CR and 6 PR) for an ORR of 58%.  An additional three patients achieved a MR for a CBR of 83% in this subgroup. Of note, the expected ORR for bortezomib-dexamethasone combination in patients with myeloma that is not refractory to a proteasome inhibitor is approximately 50%, and the ORR for those with refractory disease would be less than 10%. The most commonly reported adverse events were fatigue, anorexia, nausea and diarrhea, which were primarily grade 1 or 2 and reversible. Four grade 3 and two grade 4 incidences of thrombocytopenia (without bleeding) were also reported.  There was one reported case of grade 1 peripheral neuropathy in the selinexor (80 mg bi-weekly) cohort. “We continue to be impressed with the high level of durable activity of selinexor in combination with bortezomib, especially in patients whose disease is already refractory to proteasome inhibitors,” said Dr. Bahlis.  “The tolerability profile of the combination was quite favorable with low rates of neuropathy and cytopenias, particularly in this heavily pretreated population. Selinexor appears to have one of the most potent synergistic effects with bortezomib reported to date.” Based on the robust data from the SVd arm of the Phase 1b portion of the STOMP study, the Company plans to initiate a pivotal, randomized Phase 3 study, known as the BOSTON (Bortezomib, Selinexor and dexamethasone) study, which will evaluate SVd at the recommended dose compared to bortezomib and low-dose dexamethasone (Vd) in patients with MM who have had one to three prior lines of therapy.  Karyopharm has identified the combination dose of selinexor (100mg weekly), bortezomib (1.3 mg/m2 weekly given sub-cutaneously for 4 of 5 weeks) and dexamethasone (40mg weekly) to be used in the BOSTON study.  The study will be conducted worldwide and will enroll approximately 360 patients.  Based on feedback from the FDA, the protocol is currently being finalized and the Company remains on track to commence the BOSTON study in early 2017. Dr. Bahlis continued, “To our knowledge, this is the only Phase 3 study evaluating a triple combination therapy incorporating once-weekly Velcade.  We anticipate that this regimen will continue to show reduced rates of cytopenias, neuropathy and gastrointestinal side effects based on the continuing STOMP results.  From a patient convenience as well as a health economic perspective, these data are very exciting because the combination of oral selinexor and bortezomib requires fewer doses and fewer hospital visits, making this treatment regimen much more patient friendly, and potentially more cost effective than currently established therapies.” In addition to these updated data from the STORM and STOMP studies, other key multiple myeloma abstracts selected for presentation at ASH include an oral presentation describing a Phase 1 study evaluating the combination of selinexor with proteasome inhibitor Kyprolis (carfilzomib) and dexamethasone in relapsed/refractory MM (Andrzej Jakubowiak, University of Chicago; Pub ID 973) and a poster presentation describing data from the selinexor + Pomalyst (pomalidomide) + dexamethasone arm of the Phase 1b dose-escalation portion of the STOMP study, also in patients with relapsed/refractory MM (Christine Chen, Princess Margaret Hospital; Pub ID 3330). Karyopharm to Host Multiple Myeloma-focused Dinner Reception and Webcast at ASH 2016 On Monday, December 5, 2016, Karyopharm will host an investor and analyst dinner reception, which will feature a moderated panel discussion with recognized thought leaders in the treatment of MM, updated selinexor data in MM, and a live Q&A session.  The event will take place during the ASH 2016 annual meeting and interested parties can access a live webcast of the event beginning Monday, December 5, 2016 at 8:15 p.m. PT by going to the “Investors” section of the company's website at http://investors.karyopharm.com/events.cfm. Several other key abstracts focused on the investigation of selinexor for the treatment of AML were selected for presentation at ASH, including two oral and two poster presentations.  The first oral presentation describes updated data from the Phase 2 SAIL study evaluating the combination of selinexor, with Ara-C and Idarubicin in patients with relapsed/refractory AML (Walter Fiedler, University Medical Center Hamburg; Pub ID 341) and the second oral presentation highlights data from a clinical trial evaluating the combination of selinexor with high-dose cytarabine and mitoxantrone in patients with AML (Amy Wang, University of Chicago; Pub ID 212).  The two poster presentations (Bhavana Bhatnagar, Ohio State University; Pub ID 1651 and Kendra Sweet, Moffitt Cancer Center, Tampa FL; Pub ID 4040) highlight early-stage clinical data demonstrating the feasibility and tolerability of selinexor in combination with other standard of care agents in patients with AML, including in elderly patients, as well as early signs of clinical activity, including response rates that are superior to historical data. Details for the full list of ASH presentations are as follows: Title:  Selinexor and Low Dose Dexamethasone in Patients with Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib and Anti-CD38 Ab Refractory MM STORM Study Presenter:  Dan Vogl, Abramson Cancer Center, University of Pennsylvania Publication ID:  491 Session:  653. Myeloma: Therapy, excluding Transplantation: New Agents for Multiple Myeloma; Sunday, December 4, 2016; 4:30-6:00 PM PT Location:  San Diego Convention Center, Hall AB Date and Time:  Sunday, December 4, 2016 at 5:30 PM PT Title:  Selinexor in Combination with Bortezomib and Dexamethasone Demonstrates Significant Activity in Patients with Refractory MM Including Proteasome-Inhibitor Refractory Patients Presenter:  Nizar Bahlis, Southern Alberta Cancer Research Institute, University of Calgary Publication ID:  977 Session: 653. Myeloma: Therapy, excluding Transplantation: Novel Approaches; Monday, December 5, 2016; 2:45-4:15 PM PT Location:  Manchester Grand Hyatt San Diego, Seaport Ballroom BC Date and Time:  Monday, December 5, 2016; 3:45 PM PT Title:  Final Results of Phase 1 MMRC Trial of Selinexor, Carfilzomib, and Dexamethasone in Relapsed/Refractory MM Presenter:  Andrzej Jakubowiak, University of Chicago Publication ID:  973 Session:  653. Myeloma: Therapy, excluding Transplantation: Novel Approaches; Monday, December 5, 2016; 2:45-4:15 PM PT Location:  Manchester Grand Hyatt San Diego, Seaport Ballroom BC Date and Time:  Monday, December 5, 2016; 2:45 PM PT Title:  Phase II Results of Ara-C and Idarubicin in Combination with the Selective Inhibitor of Nuclear Export Compound Selinexor in Patients with Relapsed or Refractory AML Presenter:  Walter Fiedler, University Medical Center Hamburg, Hamburg, Germany Publication ID:  341 Session:  613. Acute Myeloid Leukemia: Clinical Studies: Optimizing Current AML Therapy; Sunday, December 4, 2016; 9:30-11:00 AM PT Location:  Marriott Marquis San Diego Marina, Pacific Ballroom Date and Time:  Sunday, December 4, 2016; 10:30 AM PT Title:  Combination of Selinexor with High-Dose Cytarabine and Mitoxantrone for Remission Induction in AML Is Feasible and Tolerable Presenter:  Amy Wang, University of Chicago Publication ID:  212 Session:  613. Acute Myeloid Leukemia: Clinical Studies: Innovations in Induction Therapy; Saturday, December 3, 2016; 4:00-5:30 PM PT Location:  Marriott Marquis San Diego Marina, San Diego Ballroom AB Date and Time:  Saturday, December 3, 2016; 4:15 PM PT Title:  Selective Inhibition of Nuclear Cytoplasmic Transport as a New Treatment Paradigm in Myelofibrosis Presenter:  Dongqing Yan, Huntsman Cancer Institute, University of Utah Publication ID:  636 Session:  635. Myeloproliferative Syndromes: Basic Science: Translational Studies; Monday, December 5, 2016; 7:00-8:30 AM PT Location:  Marriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17 Date and Time:  Monday, December 5, 2016; 8:15 AM PT Title:  XPO1 Inhibition By Selinexor Synergizes with BCR Inhibition, Blocks Tumor Growth and Prolongs Survival in a Bioluminescent Animal Model of Primary Central Nervous System Lymphoma Presenter:  Marta Crespo, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain Publication ID:  463 Session:  625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Novel Therapeutic Strategies Location:  San Diego Convention Center, Room 5AB Date and Time:  Sunday, December 4, 2016; 4:30 PM PT Title:  The mechanism by which mutant NPM1 creates Leukemic self-renewal is readily reversed Presenter:  Yogen Saunthararajah, Cleveland Clinic and Case Comprehensive Cancer Center, Cleveland, OH Publication ID:  444 Session:  603. Oncogenes and Tumor Suppressors: Transcriptional Networks Contributing to Leukemogenesis Location:  San Diego Convention Center, Room 6DE Date and Time:  Sunday, December 4, 2016; 5:45 PM PT Title:  Bromodomain and Extra-Terminal Motif Proteins (BETs) Mediate 5-Azacitidine Resistance in Myeloid Leukemia through Recruitment of an Active RNA Polymerase II Complex Presenter:  Li Chen, University of Chicago Publication ID:  746 Session:  604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Novel Epigenetic Modulators Location:  San Diego Convention Center, Room 24 Date and Time:  Monday, December 5, 2016; 10:45 AM PT Title:  Selinexor Shows Synergy in Combination with Pomalidomide and Low Dose Dexamethasone in Patients with Relapsed / Refractory Multiple Myeloma Presenter:  Christine Chen, Princess Margaret Hospital, Toronto, ON Publication ID:  3330 Location:  San Diego Convention Center, Hall GH Date and Time:  Sunday, December 4, 2016; 6:00-8:00 PM PT Title:  A Phase 1 Clinical Trial of Selinexor in Combination with Decitabine in Patients with Newly Diagnosed and Relapsed or Refractory AML Presenter:  Bhavana Bhatnagar, Ohio State University Publication ID:  1651 Location:  San Diego Convention Center, Hall GH Date and Time:  Saturday, December 3, 2016; 5:30-7:30 PM PT Title:  A Phase I Study of Selinexor in Combination with Daunorubicin and Cytarabine in Patients with Newly Diagnosed Poor-Risk AML Presenter:  Kendra Sweet, Moffitt Cancer Center, Tampa FL Publication ID:  4040 Location:  San Diego Convention Center, Hall GH Date and Time:  Monday, December 5, 2016; 6:00-8:00 PM PT Title:  A Phase 1/2 Study of the Second Generation Selective Inhibitor of Nuclear Export Compound, KPT-8602, in Patients with Relapsed Refractory MM Presenter:  Frank Cornell, Vanderbilt Ingram Cancer Center, Nashville; TN Publication ID:  4509 Location:  San Diego Convention Center, Hall GH Date and Time:  Monday, December 5, 2016; 6:00-8:00 PM PT Title:  Combination of Selective Inhibitor of Nuclear Export Compounds, Selinexor and KPT-8602, with Venetoclax (ABT-199) Displays Enhanced Activity in Leukemia and Large Cell Lymphoma Presenter:  Melissa Fischer, Vanderbilt University, Nashville, TN Publication ID:  3949 Location:  San Diego Convention Center, Hall GH Date and Time:  Monday, December 5, 2016; 6:00-8:00 PM PT Title:  Synergistic anti-tumor effects of KPT-8602 and Panobinostat a pan-HDAC inhibitor in multiple myeloma Presenter:  Christian Argueta, Karyopharm Therapeutics, Newton, MA Publication ID:  3298 Location:  San Diego Convention Center, Hall GH Date and Time:  Sunday, December 4, 2016; 6:00-8:00 PM PT Title:  Selinexor in combination with chemotherapy or Idelalisib elicits a synergistic cytotoxic effect in Primary CLL Cells and overcoming intrinsic and stromal cells-mediated Fludarabine resistance Presenter:  Marta Coscia, A.O.U. Città della Salute e della Scienza, University of Torino, Torino, Italy Publication ID:  3210 Location:  San Diego Convention Center, Hall GH Date and Time:  Sunday, December 4, 2016; 6:00-8:00 PM PT Title:  Combination therapy with Bortezomib or Carfilzomib and Selinexor Induces Nuclear Localization of IκBα and overcomes acquired proteasome inhibitor Resistance in Human Multiple Myeloma Presenter:  Joel Turner, Moffitt Cancer Center, Tampa FL Publication ID:  3299 Location:  San Diego Convention Center, Hall GH Date and Time:  Sunday, December 4, 2016; 6:00-8:00 PM PT Title:  Clinical Dosing Regimen of Selinexor Maintains Normal Immune Homeostasis and T Cell Effector Function in Mice: Implications for Combination with Immunotherapy Presenter:  Yosef Landesman, Karyopharm Therapeutics, Newton, MA Publication ID:  2525 Location:  San Diego Convention Center, Hall GH Date and Time:  Sunday, December 4, 2016; 6:00-8:00 PM PT Title:  Combination of selinexor and the proteasome inhibitor, bortezomib shows synergistic cytotoxicity in Diffuse Large B-Cells Lymphoma Cells In vitro and in vivo Presenter:  Trinayan Kashyap, Karyopharm Therapeutics, Newton, MA Publication ID:  4131 Location:  San Diego Convention Center, Hall GH Date and Time:  Monday, December 5, 2016; 6:00-8:00 PM PT Title:  XPO1 target occupancy measurements using Fluorescence Cross Correlation Spectroscopy (FCCS) support the Selinexor Recommended Phase 2 Dose Presenter:  Marsha Crochiere, Karyopharm Therapeutics, Newton, MA Publication ID:  1563 Location:  San Diego Convention Center, Hall GH Date and Time:  Saturday, December 3, 2016; 5:30-7:30 PM PT Title:  Identification of Specific HnRNPs as Novel Therapeutic Targets and Responsive Indicators of KPT330 (selinexor) in Leukemia Presenter:  Adam Cloe, University of Chicago Publication ID:  1657 Location:  San Diego Convention Center, Hall GH Date and Time:  Saturday, December 3, 2016; 5:30-7:30 PM PT Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 1,800 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in acute myeloid leukemia (SOPRA), diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others.  Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017.  Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company's clinical development priorities for selinexor. The latest clinical trial information for selinexor is available at www.clinicaltrials.gov. Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1).  In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing.  Karyopharm, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development.  For more information, please visit www.karyopharm.com. 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 therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. 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 any of Karyopharm's SINE™ compounds, including selinexor (KPT-330), will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate 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: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which was filed with the Securities and Exchange Commission (SEC) on August 4, 2016, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited Revlimid® and Pomalyst® are registered trademarks of Celgene Corporation Kyprolis® is a registered trademark of Onyx Pharmaceuticals, Inc. Darzalex™ is a trademark of Janssen Biotech, Inc.


News Article | December 21, 2016
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Batu Biologics, a San Diego based immuno-oncology company focused on the development of its tumor angiogenesis targeting immune therapy, ValloVax™, announced today the formation of a Clinical Advisory Board to guide the company in the development of its lead program. “Members of the Batu Biologics Clinical Advisory Board have aligned their vision to assess the clinical feasibility of targeting the tumor vasculature as an effective treatment for solid tumors,” said Samuel C. Wagner, President and CEO of Batu Biologics. “Our goal is to streamline and optimize the clinical development plan for the ValloVax™ program in order to ensure the highest likelihood of patient response in the clinical setting.” “Making advances in a challenging and competitive environment requires a team of experts who can share experiences, information and innovative ideas,” said Dr. Santosh Kesari, Chairman of Batu’s Clinical Advisory Board and Professor at the Pacific Neuroscience Institute and John Wayne Cancer Institute at Providence Saint John’s Health Center. “We are excited to explore various strategies in the areas of predictive biomarkers, personalized therapy, and combination approaches with FDA-approved cancer therapeutics in an effort to ensure the best patient response to the ValloVax™ therapy.” The newly appointed members of the Batu Biologics Clinical Advisory Board are: Dr. Santosh Kesari is a Professor and Chair of Translational Neurosciences and Neurotherapeutics at Pacific Neuroscience Institute and John Wayne Cancer Institute at Providence Saint John’s Health Center. His research investigates the biology of gliomas and brain metastases with the aim of developing new therapeutics. He has a long-standing interest in neural development, cancer stem cells, and neuroimmunology and translational research in these areas to accelerate drug development; Mai is a strategic advisor for biotechnology companies with a focus in oncology and immunotherapy. Dr. Le has over 8 years of oncology drug development experience that includes small molecules, biologics, medical devices and companion diagnostics strategy. She previously served as a medical director at Calithera Biosciences, Plexxikon Inc., Onyx Pharmaceuticals and Proteolix, Inc (acquired by Onyx Pharmaceuticals), and most recently, as the Chief Medical Officer at OncoSec Medical, Inc. Dr. Le obtained a medical degree from the University of Rochester School of Medicine and Dentistry and trained in Laboratory Medicine at University of California, San Francisco; and Boris is currently the President of Clinical and Scientific Affairs at StemImmune Inc. and Adjunct Professor at the Moores UCSD Cancer Center. Dr. Minev previously worked as Director of Immunotherapy and Translational Oncology at Genelux Corporation and was heading the Laboratory of Tumor Immunology and Immunotherapy at the Moores UCSD Cancer Center. Dr. Minev has an extensive experience in Immuno-Oncology and cancer vaccine development, having worked closely on the development of the first tumor vaccine to be approved by a regulatory body (Melacine). Batu Biologics is an immuno-oncology company developing novel gene and cellular based therapies for the treatment of cancer. The Company has filed an IND application for its lead therapeutic, ValloVax™, a multivalent therapeutic vaccine for Non Small Cell Lung Cancer targeting several tumor-angiogenesis associated antigens. ValloVax™ has demonstrated strong inhibition of tumor growth in several histologically distinct tumor models, and the company is currently raising funds that will enable the completion of a Phase I clinical study.


HORSHAM, Pa., Nov. 10, 2016 /PRNewswire/ -- Janssen Biotech, Inc. today announced that the company has entered into a master clinical trial collaboration and supply agreement with Onyx Pharmaceuticals, Inc., a wholly-owned subsidiary of Amgen, Inc., to evaluate the efficacy and safety of...


Basler M.,University of Konstanz | Kirk C.J.,Onyx Pharmaceuticals | Groettrup M.,University of Konstanz
Current Opinion in Immunology | Year: 2013

Treatment of cells with interferon-γ leads to the replacement of the constitutive catalytic proteasome subunits β1, β2, and β5 by the inducible subunits LMP2 (β1i), MECL-1 (β2i), and LMP7 (β5i), respectively, building the so-called immunoproteasome. The incorporation of these subunits is required for the production of numerous MHC class-I restricted T cell epitopes. Recently, new evidence for an involvement of the immunoproteasome in other facets of the immune response emerged. Investigations of autoimmune diseases in animal models and a genetic predisposition of β5i in human autoimmune disorders suggest a crucial function of the immunoproteasome in proinflammatory diseases. The recent elucidation of the high-resolution structure of the immunoproteasome will facilitate the design of immunoproteasome selective inhibitors for pharmacological intervention. © 2012 Elsevier Ltd.


News Article | March 2, 2017
Site: www.prnewswire.com

NEW YORK, March 2, 2017 /PRNewswire/ -- This report provides all the information you require to better understand Onyx Pharmaceuticals and its partnering interests and activities since 2010.Read the full report: http://www.reportlinker.com/p03605611-summary/view-report.htmlDescriptionThe...

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