On May 17, 2018 BioClin Therapeutics, Inc., a clinical stage drug development company reported that data will be presented from its ongoing Phase 1b/2 study of B-701, a first-in-class anti-fibroblast growth factor receptor 3 (FGFR3) monoclonal antibody, plus docetaxel for metastatic bladder cancer at a poster session at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting being held June 1-5, 2018 in Chicago, IL (Press release, BioClin Therapeutics, MAY 17, 2018, View Source [SID1234526785]).

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The details of the poster presentation are as follows:

[Abstract 4534]
FIERCE-21: Phase 1b/2 study of Docetaxel + B-701, a Selective Inhibitor of FGFR3, in Relapsed or Refractory (R/R) Metastatic Urothelial Carcinoma (mUCC).

Joaquim Bellmunt, M.D., Ph.D., Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster Session Date/Time: Saturday, June 3, 2018, 8:00 – 11:30 a.m., CDT, Hall A

On May 16, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of John Celebi, M.B.A., as President and Chief Executive Officer (Press release, Sensei Biotherapeutics, MAY 16, 2018, View Source [SID1234526734]). He also joins the company’s board of directors. Mr. Celebi brings more than two decades of leadership experience with innovative and growing biotechnology companies, most recently in the field of cancer immunotherapies.

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The appointment of Mr. Celebi as President and Chief Executive Officer occurs at a time when Sensei is emerging with a focused immuno-oncology strategy, promising clinical data from the Phase I trial of its lead drug candidate SNS-301, and the proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies. SNS-301 and the SPIRIT platform originated at Panacea Pharmaceuticals which has become Sensei Biotherapeutics. Sensei’s growing team of 14 employees is focused on its growth strategy in
immuno-oncology, operating out of its new 30,000 square foot laboratory and office space.

"I am delighted to join Sensei at this exciting time when we have the opportunity to apply our SPIRIT platform to develop immuno-oncology therapies with an innovative mechanism for detecting and eliminating cancer. We are encouraged by the clinical data that is emerging for our lead drug candidate, SNS-301, which we are advancing to lead the way in our strategy to build a precision pipeline of immuno-oncology therapies through companion diagnostics," said Mr. Celebi. "Sensei is well positioned to leverage our unique technology to develop novel
therapies with the potential to achieve our mission to have a positive and profound impact for
cancer patients."

"We welcome John’s strong experience and strategic business acumen to help build our vision and future for Sensei," said Hossein Ghanbari, PhD, Chief Scientific Officer and Board Chair of Sensei Biotherapeutics, and the company’s original co-founder and Chief Executive Officer.

"John’s oncology background and accomplished track record in biotech will serve Sensei exceptionally well as we move forward with our innovative immuno-oncology platform and advance new medicines for patients." Mr. Celebi has a distinguished track record for growing innovative entrepreneurial biotechnology companies, including in the field of oncology. Previously, Mr. Celebi served as the Chief Operating Officer of X4 Pharmaceuticals where he established and oversaw the company’s oncology business strategy. He also served as Chief Business Officer of Igenica Biotherapeutics, Inc., an immunotherapy company formed by The Column Group, 5AM Ventures, Orbimed and Third Rock Ventures, where he established key academic and industry relationships, including with MedImmune. He has extensive transactional and alliance management experience. Previously, he served as Vice President of Business Development, New Product Planning and Alliance Management at ArQule, Inc., where he played a central role
in the formation of alliances with Roche, Daiichi-Sankyo, and Kyowa Hakko Kirin. Mr. Celebi was one of the early employees at Tularik, Inc., where he conducted drug discovery and basic research for an anti-viral drug program. Mr. Celebi received an M.B.A. from Carnegie Mellon University and a B.S. in Biophysics from the University of California, San Diego.

On May 17, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a poster presentation of additional prostate cancer data (Abstract #229675) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held in Chicago, June 1-5, 2018 (Press release, Inovio, MAY 17, 2018, View Source [SID1234526752]). Previously reported data from a Phase 1b clinical trial demonstrated that Inovio’s cancer immunotherapy (INO-5150) slowed PSA rise in patients with biochemically recurrent prostate cancer. Additional analyses show clinically meaningful PSA stabilization post-administration of Inovio’s immunotherapy in patients with no documented disease progression during the study. Of note, this effect was also observed in the patients with the fastest PSA doubling at the time of study entry.

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The multi-center Phase 1b study enrolled 62 patients with biochemically relapsed prostate cancer following definitive local therapy. Under the trial design, eligible patients received INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA-5P device. Of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50) exhibited CD38+, Perforin+CD8+ T cell responses. Additional analyses are underway to elucidate the correlation between immunologic efficacy and clinical benefit. For more information, please visit ClinicalTrials.gov (Identifier: NCT02514213).

Dr. J. Joseph Kim, Inovio’s President & CEO, said, "The additional results from our Phase 1b INO-5150 study continue to support our rationale that Inovio’s T cell generating INO-5150 could be an important agent as an immunotherapy as it provides strong and durable immune responses in a particularly difficult-to-treat prostate cancer patient population. We remain diligent on establishing an outside partnership to further advance INO-5150 and I look forward to sharing additional observations from our prostate cancer development program later this year."

INO-5150 was generated using Inovio’s proprietary ASPIRE technology process to enable significant production of engineered PSA and PSMA antigens with genetic sequences differentiated from native human PSA and PSMA sequences. This patented approach is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens. PSMA is also one of 3 antigens comprising INO-5401, which is being tested in two separate Phase 1/2 trials as an immunotherapy to treat glioblastoma and metastatic bladder cancer in combination with Regeneron and Genentech/Roche’s checkpoint inhibitors, respectively.

Independently, as part of the active, ongoing collaboration, two additional posters are being presented at the ASCO (Free ASCO Whitepaper) meeting that provide details on the ongoing trials of AstraZeneca/MedImmune’s MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in abstract #TPS6093 and #5525.

On May 17, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that three posters highlighting clinical data from the ongoing Phase 1b/2 STOMP study will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2018 Annual Meeting taking place June 14-17, 2018 in Stockholm, Sweden (Press release, Karyopharm, MAY 17, 2018, View Source [SID1234526769]). These three poster presentations will feature updated data from the STOMP arms evaluating selinexor, the Company’s lead, novel, oral SINE compound, and dexamethasone in combination with standard approved therapies, Velcade, Pomalyst or Darzalex in patients with heavily pretreated multiple myeloma.

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"Following our positive results for selinexor in the STORM study in patients with penta-refractory multiple myeloma, we are pleased to be presenting updated results of selinexor combinations in earlier lines of myeloma treatment," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "In the previously reported Phase 1b/2 STOMP study results, selinexor has shown robust anti-myeloma activity and a manageable safety profile in patients with relapsed or refractory myeloma after at least one prior therapy. The STOMP results not only provide the underlying clinical rationale for the ongoing pivotal Phase 3 BOSTON study evaluating selinexor in combination with once weekly Velcade, but also provide supportive data for selinexor as a potential new backbone therapy in combination with approved myeloma therapies, often with synergistic activity. We look forward to sharing these updated STOMP results from the Velcade, Pomalyst and Darzalex arms with the medical community at EHA (Free EHA Whitepaper) this year."

Details for the EHA (Free EHA Whitepaper) 2018 presentations are as follows:

Title: Selinexor combined with pomalidomide and low dose dexamethasone (SPd) in a relapsed/refractory multiple myeloma patient population
Presenter:Christine Chen, University of Toronto, Princess Margaret Cancer Center
Final Abstract Code: PF586
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Friday, June 15, 2018; 17:30 – 19:00 CEST
Location: Poster area

Title: Selinexor combined with low dose bortezomib and dexamethasone (SVd) induces a high response rate in patients with relapsed or refractory multiple myeloma (MM)
Lead author: Nizar Bahlis, Southern Alberta Cancer Research Institute
Final Abstract Code: PS1322
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area

Title: A Phase 1b study using the combination of selinexor, daratumumab, and dexamethasone in multiple myeloma patients previously exposed to proteasome inhibitors and immunomodulatory drugs
Lead author:Cristina Gasparetto, Duke University
Final Abstract Code: PS1329
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area

About Selinexor

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 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line 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 plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a 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) and as a potential backbone therapy in combination with approved therapies (STOMP), and 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 one or more 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.

On May 17, 2018 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the selection of four abstracts for oral and poster presentations at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 14-17, 2018 in Stockholm, Sweden (Press release, Verastem, MAY 17, 2018, View Source [SID1234526786]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. An oral presentation by Dr. Matthew Davids, Dana-Farber Cancer Institute, will highlight the latest data from a Phase Ib/II study of duvelisib in combination with FCR (dFCR) as a frontline treatment in younger patients with chronic lymphocytic leukemia (CLL). Three posters will highlight additional duvelisib data, including crossover extension results from the Phase 3 DUO study in patients with relapsed or refractory CLL/small lymphocytic lymphoma (CLL/SLL), and new biomarker analyses on the tumor microenvironment modulation from DUOTM and the Phase 2 DYNAMOTM study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and the dual PI3K-delta and PI3K-gamma activity of duvelisib in the CONTEMPOTM study in patients with untreated follicular lymphoma who are treated with duvelisib in combination with CD20 antibody immunotherapy.

"At EHA (Free EHA Whitepaper) 2018, Dr. Matthew Davids will deliver an oral presentation describing results from the ongoing Phase Ib/II study evaluating duvelisib in combination with FCR (chemo-immunotherapy) in younger CLL patients," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology. "To date, the combination regimen has shown to be effective as an initial therapy with an ORR of 97%, including 28% of evaluable patients achieving a complete response or complete response with incomplete blood count recovery, and 69% achieving a partial response. A high rate of 81% bone marrow MRD negativity was observed in patients with at least one evaluation. Collectively, the data being presented at EHA (Free EHA Whitepaper) this year continue to provide important insights to guide the future clinical development of duvelisib across a wide range of hematologic malignancies, both as a monotherapy and in combination with other agents."

Details for the EHA (Free EHA Whitepaper) 2018 presentation and posters are as follows:

Oral Presentation

Title: A Phase IB/II Study of duvelisib in combination with FCR (DFCR) for Frontline Therapy of Younger CLL Patients
Lead author: Dr. Matthew Davids, Dana-Farber Cancer Institute
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Combination treatment with targeted agents in CLL
Date and Time: Saturday, June 16, 12:15 – 12:30 CEST
Location: Victoria Hall
Final Abstract Code: S807
Poster Presentations

Title:The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in a Phase 3 Crossover Extension Study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF354

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma.
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF646

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study).
Lead author: Dr. David Weaver, Verastem Oncology
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF649

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov