On November 1, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that 14 abstracts have been selected for presentation, including three oral presentations, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 annual meeting being held December 9-12, 2017 in Atlanta (Press release, Karyopharm, NOV 1, 2017, View Source [SID1234521436]). Four key abstracts being presented at the meeting will feature clinical data from Karyopharm’s ongoing Phase 1b/2 STOMP study evaluating selinexor, the Company’s lead, novel, oral SINE compound, in combination with backbone therapies for the treatment of patients with heavily pretreated multiple myeloma (MM). The four STOMP presentations will include updated data from the arms evaluating selinexor in combination with Velcade (bortezomib) and low-dose dexamethasone (SVd), selinexor in combination with Pomalyst (pomalidomide) and low-dose dexamethasone (SPd), and selinexor in combination with Revlimid (lenalidomide) and low-dose dexamethasone (SRd), and preliminary data from the arm evaluating selinexor in combination with Darzalex (daratumumab) and low-dose dexamethasone (SDd).

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“Despite several treatment advances for myeloma patients, there is a need for treatments with novel mechanisms, and many patients favor orally administered medicines,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “Previously reported data from the ongoing Phase 1b/2 STOMP study showed promising response rates in patients with heavily pretreated myeloma when oral selinexor is combined with Velcade (“SVd”) or Pomalyst (“SPd”). We are very pleased to provide updated data for selinexor in combination with these agents, new data for selinexor in combination with Revlimid (“SRd”), and early results from the new Darzalex (“SDd”) combination arm at ASH (Free ASH Whitepaper) this year. We believe these data support the potential of selinexor as a backbone therapy with commonly used agents for multiple myeloma. Moreover, we believe the new data continue to support our ongoing Phase 3 BOSTON study of SVd in myeloma.”

Details for the ASH (Free ASH Whitepaper) 2017 presentations are as follows:

Phase 1b/2 STOMP Study Data Presentations

Title: Selinexor in combination with weekly low dose bortezomib and dexamethasone (SVd) induces a high response rate with durable responses in patients with refractory multiple myeloma (MM)

Presenter: Nizar Bahlis, Southern Alberta Cancer Research Institute, Calgary, Alberta

Abstract Number/Publication ID: 3135

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II

Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Selinexor in Combination with Pomalidomide and Low Dose Dexamethasone in a Relapsed / Refractory Multiple Myeloma Patient Population with Prior Proteasome Inhibitor and Lenalidomide Exposure

Presenter:Christine Chen, Princess Margaret Cancer Center, Toronto, Ontario

Abstract Number/Publication ID: 3136

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II

Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase Ib/II Trial of Selinexor Combined with Lenalidomide and Low Dose Dexamethasone in Patients with Relapsed / Refractory Multiple Myeloma

Presenter:Darrell White, Dalhousie University and QEII Health Sciences Center, Halifax; Nova Scotia

Abstract Number/Publication ID: 1861

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I

Date and Time:Saturday, December 9, 2017; 5:30-7:30 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase 1b Study to Assess the Combination of Selinexor and Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma Previously Exposed to Proteasome Inhibitors (PI) and Immunomodulatory Drugs (IMiDs)

Presenter:Cristina Gasparetto, Duke University Cancer Center, Durham, North Carolina

Abstract Number/Publication ID: 3100

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II

Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Investigator-sponsored Study Oral Presentations

Title: Selinexor in Combination with Cladribine, Cytarabine and G-CSF for Relapsed or Refractory AML

Presenter:Geoffrey Uy, Washington University School of Medicine in St. Louis

Abstract Number/Publication ID: 816

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeted and Immune-based Approaches in the Treatment of AML; Monday, December 11, 2017 from 4:30-6:00 PM ET

Date and Time:Monday, December 11, 2017 at 5:45 PM ET

Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 1-2

Investigator-sponsored Study Poster Presentations

Title: Selinexor maintenance is feasible and tolerable after allogeneic stem cell transplant (allo-SCT) for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

Presenter:Hongtao Liu, University of Chicago Medical Center

Abstract Number/Publication ID: 3312

Session: 732. Clinical Allogeneic Transplantation: Results: Poster II

Date and Time:Sunday, December 10, 2017 from 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase I/II study of Selinexor (SEL) with Sorafenib in Patients (pts) with Relapsed and/or Refractory (R/R) FLT3 mutated Acute Myeloid Leukemia (AML)

Presenter: Naval Daver, University of Texas MD Anderson Cancer Center

Abstract Number/Publication ID: 1344

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Date and Time:Saturday, December 9, 2017 from 5:30-7:30 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Phase I/II Study of Liposomal Doxorubicin (DOX) in Combination with Selinexor (SEL) and Dexamethasone (Dex) for Relapsed and Refractory Multiple Myeloma (RRMM)

Presenter:Rachid Baz, H. Lee Moffitt Cancer Center and Research Institute

Abstract Number/Publication ID: 3095

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II

Date and Time:Sunday, December 10, 2017 from 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Preclinical Oral Presentations

Title: Non-cytotoxic Low Doses of Selinexor Promote the Differentiation of AML Cells Harboring Mutant-NPM1 into Monocytes

Presenter: Saunthararajah Yogen, Cleveland Clinic

Abstract Number/Publication ID: 105742

Session: 603. Oncogenes and Tumor Suppressors: Nuclear Export and Metabolic Regulation; Monday, December 11, 2017, 6:15-7:45 PM ET

Date and Time:Monday, December 11, 2017 at 6:30 PM ET

Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Title: PAK4 Inhibition Impacts Growth and Survival, and Increases Sensitivity to DNA-Damaging Agents in Waldenstrom Macroglobulinemia

Presenter:Li Na, Dana Farber Cancer Institute

Abstract Number/Publication ID: 102879

Session: 622. Lymphoma Biology—Non-Genetic Studies: Novel Mechanisms Implicated in Lymphoma Biology; Monday, December 11, 2017, 10:30AM – 12:00 PM ET

Date and Time:Monday, December 11, 2017 at 11:45 AM ET

Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Preclinical Poster Presentations

Title: XPO1 Inhibitor Selinexor Overcomes Ibrutinib Resistance in Mantle Cell Lymphoma (MCL) via Nuclear Retention of IκB

Presenter:Mei Ming, University of Chicago

Abstract Number/Publication ID: 104320

Session: 605. Molecular Pharmacology, Drug Resistance-Lymphoid and Other Diseases

Date and Time:Monday, December 11, 2017; 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: XPO1 Inhibition Synergizes with BCR Inhibition, Blocks Tumor Growth and Prolongs Survival in a Bioluminescent Animal Model of Primary Central Nervous System Lymphoma

Presenter:Marta Crespo, Hall d’Hebron, Barcelona

Abstract Number/Publication ID: 107008

Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents

Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Eltanexor (KPT-8602), a Second-Generation Selective Inhibitor of Nuclear Export (SINE) Compound, in Patients with Refractory Multiple Myeloma

Presenter:Robert Frank Cornell, Vanderbilt University Medical Center

Abstract Number/Publication ID: 107422

Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II

Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET

Location: Georgia World Congress Center, Building A, Level 1, Hall A2

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 2,200 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 a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), 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.

Tetraphase has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Tetraphase, 2017, NOV 1, 2017, View Source [SID1234521473]).

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On November 1, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported that it will report its third quarter financial results after the close of the U.S. financial markets on Wednesday, November 8, 2017 (Press release, Cascadian Therapeutics, NOV 1, 2017, View Source [SID1234521383]). Following the financial results announcement, members of management will host a conference call and live audio webcast to discuss the results and provide a general corporate update. Access to the conference call can be obtained as follows:

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Live access on Wednesday, November 8, 2017

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone: +1 (877) 280-7291 (domestic) or +1 (707) 287-9361 (international)

Live webcast and replay will be available via the “Events & Presentations” page of the “News & Events” section of the Cascadian Therapeutics’ website at www.cascadianrx.com.

On November 1, 2017 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter ended September 30, 2017. Net loss for the third quarter of 2017 was $2.6 million, or $0.40 per share, respectively, compared to a net loss for the same period in 2016 of $3.5 million, or $0.54 per share (Press release, Pain Therapeutics, NOV 1, 2017, View Source [SID1234521444]). Net cash used during the third quarter was $2.2 million. Cash and investments were $11.9 million as of September 30, 2017, with no debt. The Company still expects net cash usage in the calendar year 2017 may be approximately $10 million. Following the resubmission of the REMOXY NDA in Q1 2018, the Company believes net cash usage in 2018 will decrease significantly compared to 2017.

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“The White House recently declared the opioid epidemic a public health emergency,” said Remi Barbier, President & CEO. “We fully support this policy position, and have been a voice in support of such a policy for many years. Nearly 15 years ago, Pain Therapeutics pioneered abuse-deterrent technology for opioid drugs specifically to provide policy makers, regulators, physicians, pharmacists and patients an additional tool to help combat the opioid epidemic. In partnership with all constituents, we look forward to doing our part to address the issues of overdose and death from extended-release opioid drugs.”

Operating Highlights for Q3 2017

In September, the National Institutes of Health (NIH) awarded us a $1.8 million research grant to develop a blood-based diagnostic to detect Alzheimer’s disease.
In September, The National Institute on Drug Abuse (NIDA) awarded us a $2.2 million research grant to further develop FENROCK, an abuse-deterrent transdermal patch that contains the prescription drug fentanyl.
In October, we announced a successful Phase I clinical study for PTI-125, our drug candidate for the treatment of Alzheimer’s disease. As previously announced, our scientists plan to present full results of this study at the 10th Annual International Conference on Clinical Trials on Alzheimer’s Disease, in Boston, MA, on November 1-4th.
In October, we announced the FDA had agreed to a pre-NDA guidance meeting on November 14th to discuss the upcoming resubmission of an NDA for REMOXY ER. We will provide details of this FDA meeting after receipt of final meeting minutes.
Recently, we substantially completed a previously announced human nasal study with REMOXY ER. We plan to announce top-line results of this study by yearend 2017.
Financial Highlights for Q3 2017

At September 30, 2017, cash and investments were $11.9 million, compared to $14.1 million at June 30, 2017. The Company has no debt.
Net cash used during the three months ended September 30, 2017 was $2.2 million.
Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, respectively, from $2.7 million for the same period in 2016, primarily due to decreases in REMOXY related expenses and the receipt of research grant funding from the National Institutes of Health for FENROCK and PTI-125, recorded as a reduction in research and development expenses activities. Research and development expenses included non-cash stock-related compensation of $0.3 million in both three months ended September 30, 2017 and 2016.
General and administrative expenses increased slightly to $1.0 million in the three months ended September 30, 2017 from $0.9 million for the same period in 2016. General and administrative expenses included non-cash stock-related compensation of $0.4 million in the three months ended September 30, 2017 compared to $0.5 million for same period in 2016.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remains a serious, persistent problem. Drug overdose deaths exceeded 64,000 in 2016, according to the CDC. For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

On November 1, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data on its approved and investigational medicines for blood diseases will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from 9 – 12 December, in Atlanta (Press release, Hoffmann-La Roche, NOV 1, 2017, View Source [SID1234521400]). Ten Roche medicines will be featured in over 75 abstracts, including 26 oral presentations, across eight blood diseases.

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“At ASH (Free ASH Whitepaper) this year, we look forward to presenting a wealth of data highlighting potential advances across the spectrum of blood diseases, from rare conditions like haemophilia A to common blood cancers like lymphoma,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Our ongoing development programme in haematology is one of the largest in this area, underscoring our commitment to developing practice-changing medicines and improving outcomes for people with diseases of the blood.”

Among Roche’s clinical data to be featured at ASH (Free ASH Whitepaper) are results from the ongoing trials for the investigational medicine emicizumab. Updated data with an additional six months of follow-up from the phase III HAVEN 1 and HAVEN 2 studies evaluating the safety and efficacy of emicizumab in adults, adolescents and children with haemophilia A with inhibitors will be presented. The HAVEN 2 study will be highlighted as part of ASH (Free ASH Whitepaper)’s official press program on 9 December at 07:30am EST. Additional results from the emicizumab clinical development programme will be presented during the meeting, including preliminary data from the phase III HAVEN 4 study exploring emicizumab prophylaxis administered every four weeks in people with haemophilia A with and without inhibitors, as well as real-world data from a non-interventional study in children under 12 years of age with haemophilia A with inhibitors.

Roche will also be sharing data for medicines in late-stage development for a range of blood cancers. Highlights include results from a randomised phase II study evaluating polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate, in combination with MabThera/Rituxan (rituximab) and bendamustine versus MabThera/Rituxan and bendamustine for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Based on data from this study, polatuzumab vedotin was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and had previously received the PRIME (PRIority MEdicines) designation in Europe.

Additionally, results from studies of Gazyva/Gazyvaro (obinutuzumab), including new data from the
phase III GALLIUM study in previously untreated follicular lymphoma, and data from the phase III PrefMab study evaluating patient preference for the subcutaneous (SC) formulation of MabThera/Rituxan Hycela (rituximab/rituximab and hyaluronidase human) as a treatment for DLBCL and follicular lymphoma will also be shared. Finally, results from multiple studies assessing the safety and efficacy of Venclexta/Venclyxto (venetoclax) across chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) and acute myeloid leukaemia (AML) will be presented. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.

Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH17.