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Cytokinetics to Participate in Upcoming Investor Conferences

On November 7, 2018 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the Credit Suisse 27th Annual Healthcare Conference on Tuesday, November 13, 2018 at 10:20 AM MT at The Phoenician in Scottsdale, AZ, and to participate in a Fireside Chat at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 10:00 am ET at the Lotte New York Palace in New York (Press release, Cytokinetics, NOV 7, 2018, View Source [SID1234530910]). Additionally, members of Cytokinetics’ senior management team will also participate in the Global Mizuho Investor Conference on December 3-4, 2018 at the Lotte New York Palace in New York.

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Interested parties may access the live webcast of these presentations by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of each presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

Transgene and BioInvent Present Positive Data at the SITC, Supporting the Co-development of a Next-generation Oncolytic Virus Encoding for an Anti-CTLA-4 Antibody

On November 7, 2018 BioInvent International AB (OMXS: BINV), focused on the discovery and development of novel and first-in-class immuno-regulatory antibodies to treat cancer, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, reported they will be presenting two back-to-back posters featuring positive data supporting their ongoing collaboration to develop a novel oncolytic virus encoding for an anti-CTLA-4 antibody at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) to be held November 7-11 in Washington, D.C (Press release, Transgene, NOV 7, 2018, View Source [SID1234530909]).

This novel oncolytic virus combines a Transgene Invir.IO Vaccinia virus (VV)-based oncolytic vector, with BioInvent’s human anti-CTLA-4 antibody (IgG1) and a human cytokine.

BioInvent and Transgene are together creating a novel armed oncolytic virus that will be able to infect and selectively replicate within the tumor, inducing cancer cell destruction, and to elicit a strong immune response that is further enhanced by the local expression of the immune checkpoint inhibitor and the cytokine. This novel oncolytic virus is expected to deliver better treatment outcomes with an improved safety profile as the patient is not exposed to the potential systemic toxicity of the anti-CTLA-4 antibody.

In the posters, Transgene and BioInvent provide further details on the strengths and advantages of their respective technologies:

Transgene’s VV is a highly oncolytic and immunogenic viral vector that has demonstrated its ability to ensure the expression of a fully functional, full-length antibody in the tumor and trigger a massive immune infiltration into the tumor with low systemic exposition to the molecule;
BioInvent has developed a potent anti-CTLA-4 antibody, selected and characterized for its improved FcγR-dependent Treg depleting efficacy. FcγR-dependent Treg depletion was recently found to play a key role in the anti-CTLA-4 antibody’s efficacy in vivo.
Björn Frendéus, Chief Scientific Officer of BioInvent said: "Having identified a lead human anti-CTLA-4 antibody candidate with improved Treg-depleting activity compared with ipilimumab, we are looking forward to advancing the program presented at the SITC (Free SITC Whitepaper) in collaboration with Transgene, and develop a potentially safe and more efficacious strategy to combine anti-CTLA-4 and anti-PD-1/PDL1 checkpoint inhibition in the context of oncolytic virotherapy."

Eric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene, said: "We are very pleased with the progress of our collaboration with BioInvent. The data that both companies present at SITC (Free SITC Whitepaper) underline the potential of combining our synergistic expertise to generate a novel oncolytic virus capable of delivering a potent anti-CTLA-4 antibody directly into the tumor micro-environment. The concept of combining the merits of our respective technologies was already demonstrated in preclinical experiments and we look forward to demonstrating its potential in the clinic."

The posters will be on display both Friday, November 9 and Saturday, November 10 in the Poster Hall (Hall E). They will also be available after the conference on the companies’ respective websites, www.transgene.fr and www.bioinvent.com.

Antibody-armed oncolytic Vaccinia virus to block immunosuppressive pathways in the tumor microenvironment – Poster P615

Authors: Marchand JB, Semmrich M, Fend L, Tornberg UC, Silvestre N, Frendéus B, Quéméneur E
Generation and characterization of a CTLA-4 antibody with improved FcγR-dependent

Treg deletion for tumor microenvironment-targeted oncolytic virotherapy of cancer – Poster 602

Authors: Semmrich M, Marchand JB, Holmkvist P, Mårtensson L, Tornberg UC, Fend L, Kovacek M, Teige I, McAllister A, Quéméneur E, Frendéus B

Onconova Welcomes Richard (Ric) Woodman, M.D., As Chief Medical Officer (CMO)

On November 7, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported the appointment of Dr. Richard "Ric" Woodman as Chief Medical Officer and Senior Vice President of Research & Development. Dr. Woodman will report to Dr. Steve Fruchtman, President and former CMO of the Company (Press release, Onconova, NOV 7, 2018, View Source [SID1234530908]).

Ric Woodman, M.D., served most recently as Senior Vice President and Head of U.S. Oncology Clinical Development and Medical Affairs for Novartis. In his role, Ric provided strategic medical and scientific leadership for both marketed and development-stage compounds. Previously, Ric served as Franchise Head for Hematology in Global Medical Affairs at Novartis Oncology with global oversight of non-registration clinical programs and has worked on the development and life-cycle management of several compounds including Tasigna, Glivec, Farydak, Rydapt, Odomzo and Kymriah.

Before joining Novartis Oncology, Dr. Woodman was Senior Medical Director with Johnson & Johnson, leading the Oncology franchise at Ortho Biotech Products, LP. Prior to Ortho Biotech, Ric held academic appointments as Professor in the Departments of Medicine and Oncology at the University of Calgary in Canada where he joined the faculty in 1990.

Dr. Woodman completed his hematology/oncology clinical fellowship and postdoctoral research fellowship at Scripps Clinic and Research Institute in the Department of Experimental Medicine.

In his welcome statement, Dr. Steve Fruchtman said, "The addition of Ric to the Onconova leadership team is an exciting boost to our expertise in drug development in malignant hematology and oncology. Ric has a proven track record and expertise in the approval of novel agents that have changed the standard of care in hematology, including an erythropoietic stimulatory agent to promote red cell production by the marrow, a common issue in patients with MDS, as well as agents for CML that have transformed the life expectancy of these patients and the management of CML from a previously lethal disease to a chronic disorder. As a key part of the team, Ric’s expertise will help optimize the development of Rigosertib for patients with unmet medical needs in MDS and cancer."

"I am excited to join Onconova at this advanced stage of development of Rigosertib and other promising pipeline assets," said Dr. Woodman. "The anticipated completion of the INSPIRE trial in higher-risk MDS and advancing the design of a pivotal combination trial of oral rigosertib and azacitidine towards a Special Protocol Assessment (SPA) are positioning the Company for late stage development, which are areas within my experience and expertise. These trials have set a solid foundation for Rigosertib in patients with MDS. While focused on advancing Rigosertib towards regulatory approval for MDS, Onconova has also created additional opportunities for advancement. I am delighted to join my new colleagues at Onconova, and have the opportunity to work with Steve again in advancing new medicines for patients with unmet medical needs."

Onconova is also pleased to announce the hiring of Matthew Parris to the position of Senior Director, Clinical Operations. Matt joined us after leadership roles in Europe and the U.S. at several Biotechnology companies, including, most recently, Inovio, and at Clinical Research Organizations (CROs), including Orion and Pharm-Olam.
Onconova also welcomes David Evans, who joined recently as Associate Director, Regulatory Affairs, after a decade-long successful career at Celgene.

Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

On November 7, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to selinexor, the Company’s first-in-class, oral SINE compound for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy (Press release, Karyopharm, NOV 7, 2018, View Source [SID1234530907]). Selinexor is currently being studied in the ongoing Phase 2b SADAL study in patients with relapsed or refractory DLBCL who are not eligible for stem cell transplantation for which top-line results will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting.

Karyopharm previously received Fast Track Designation for selinexor as a potential new treatment for patients with penta-refractory multiple myeloma who have received at least three prior lines of therapy. In October 2018, the U.S. FDA accepted Karyopharm’s New Drug Application for selinexor seeking accelerated approval as a new treatment for patients with penta-refractory multiple myeloma. The FDA has assigned a Priority Review and given an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA).

The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

"The receipt of Fast Track designation from the FDA for selinexor in relapsed DLBCL underscores the great unmet medical need for this aggressive form of lymphoma," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "Pending positive results from the Phase 2b SADAL study, we plan to submit a second NDA to the FDA in the first half of 2019, with a request for accelerated approval, for oral selinexor as a potential new treatment for patients with relapsed or refractory DLBCL."

About the Phase 2b SADAL Study

The multicenter, open-label Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study is evaluating oral selinexor in patients with relapsed or refractory DLBCL who have received two to five prior therapies and who are not currently eligible for hematopoietic stem cell transplantation. In this study, approximately 125 patients will receive 60mg oral selinexor twice weekly in 4-week cycles. At least 50% of study participants must have the GCB sub-type. Objective response rate is the primary endpoint of the study, with duration of response a key secondary endpoint.

About Selinexor

Selinexor 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 2,800 patients have been treated with selinexor. In April and September 2018, Karyopharm reported positive data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

CytomX to Present at the Jefferies 2018 London Healthcare Conference

On November 7, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that it will present at the Jefferies 2018 London Healthcare Conference (Press release, CytomX Therapeutics, NOV 7, 2018, View Source [SID1234530905]). Sean McCarthy, D.Phil., president and chief executive officer, will deliver a corporate overview on November 14, 2018, at 1:20 p.m. GMT/ 8:20 a.m. EST

A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website at View Source An archived replay will be available for 90 days following the event.