Year: 2015

Loxo Oncology Announces Broad Pipeline Update at AACR-NCI-EORTC, Including New LOXO-101 Phase 1 Data

On October 26, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that it will present clinical and preclinical data from its pipeline of targeted, investigational oncology medicines at the 27th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place in Boston on November 5-9, 2015 (Press release, Loxo Oncology, OCT 26, 2015, View Source [SID:1234507794]). New results from the Phase 1 study of Loxo Oncology’s tropomyosin receptor kinase (TRK) inhibitor, LOXO-101, will be reported in a late-breaking oral presentation. This presentation was selected for inclusion in the press program, and as a result, only the abstract title will appear in the October 26, 2015 online data release. The study data will remain embargoed until November 8, 2015 at 10:30 a.m. Eastern Time.

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Loxo Oncology will also present two preclinical posters containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs. The posters will include in vitro and in vivo data on chemistry series showing potential best-in-class selectivity and target coverage profiles for these exciting emerging targets. Like TRK, RET and FGFR are known to participate in gene fusion events, and thus, activate cancers as single-gene alterations. In addition, RET and FGFR are also known to harbor activating gene mutations which are also likely to confer drug sensitivity. Loxo Oncology plans to use genetically driven patient enrollment strategies to demonstrate proof of efficacy early in clinical development for the RET and FGFR programs.

Loxo Oncology recently announced enrollment of the first patient in its Phase 2 basket trial of LOXO-101. A basket trial is a new clinical trial design that enrolls patients based on a common, defining genetic feature of their cancer rather than based on an anatomic definition. General information about basket trial designs will be discussed in a plenary presentation on November 8, 2015 at 8:50 a.m. Eastern Time in the Veterans Memorial Auditorium by David Hyman, M.D. of Memorial Sloan Kettering Cancer Center, LOXO-101 global principal investigator.

The details of the LOXO-101 oral presentation is as follows:

Press Program Date & Time: November 8, 2015, 10:30 a.m. Eastern Time
Oral Presentation Date & Time: November 8, 2015, 3:45 p.m. to 4:25 p.m. Eastern Time
Title: Clinical Safety and Activity from a Phase 1 Study of LOXO-101, a Selective TRKA/B/C Inhibitor, in Solid Tumor Patients with NTRK Gene Fusions
Session: Spotlight on Proffered Papers Session 3
Presenter: David Hong, M.D., deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Location: Veteran’s Memorial Auditorium

The details of the Loxo Oncology poster presentations are as follows:

Poster Session Data & Time: November 7, 2015, 12:30 p.m. to 3:30 p.m. Eastern Time
Title: Identification and Characterization of Highly Potent and Selective Kinase Inhibitors for the Treatment of RET-Driven Cancers
Session: Poster Session B, Therapeutic Agents: Small Molecule Kinase Inhibitors
Abstract Number: B192
Location: Exhibit Hall C-D

Poster Session Date & Time: November 8, 2015, 12:30 p.m. to 3:30 p.m. Eastern Time
Title: Identification of First-in-Class, Highly Potent FGFR Kinase Inhibitors that Spare FGFR1
Session: Poster Session C, Therapeutic Agents: Small Molecule Kinase Inhibitors
Abstract Number: C196
Location: Exhibit Hall C-D

Conference Call and Webcast Information

Loxo Oncology will host a conference call, live webcast with slides and Q&A on Monday, November 9, 2015 at 8:00 a.m. Eastern Time to discuss the LOXO-101 data and pipeline program updates. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 66690460. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

Data to be Presented on CYC065, Cyclacel’s CDK2/9 Inhibitor, at AACR-NCI-EORTC International Conference

On October 26, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), reported an upcoming presentation of preclinical data from a study with the Company’s second generation cyclin dependent kinase (CDK) 2/9 inhibitor, CYC065, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), November 5-9, 2015, in Boston (Press release, Cyclacel, OCT 26, 2015, View Source [SID:1234507793]).

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The study evaluated the molecular rationale and dosing schedule of CYC065 for targeting tumors that are either dependent on sustained expression of CDK9 transcription targets, including Mcl-1 and MYC, or on activation of CDK2 by overexpression of cyclin E.

Details of the presentation are as follows:

Abstract Number: B182
Presentation Title: Molecular Basis for Clinical Development of the Novel CDK2/9 Inhibitor CYC065 in Oncology
Presentation Time: Saturday, November 7, 2015, 12:30 PM – 3:30 PM
Location: Exhibit Hall C-D
Poster Board Number: Poster Session B
Authors: Craig MacKay, Sheelagh Frame, Chiara Saladino, Elizabeth Pohler, Daniella Zheleva, David Blake. Cyclacel Ltd, Dundee, United Kingdom

The abstract can be accessed through the conference website, View Source

BIND Therapeutics’ Presentations at Upcoming AACR-NCI-EORTC Conference Reinforce Potential of Accurin Platform to Develop Best-in-Class Therapeutics

On October 26, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins, reported that four abstracts have been accepted for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held in Boston, November 5-9, 2015 (Press release, BIND Therapeutics, OCT 26, 2015, View Source [SID:1234507792]). The abstracts were published today on the AACR (Free AACR Whitepaper) website at www.AACR.org.

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"These posters highlight compelling data across multiple payloads and therapeutic pathways that reinforce what we believe is a powerful platform with the potential to create best-in-class therapeutics," said Andrew Hirsch, president and chief executive officer at BIND. "These data add to a growing body of evidence that further validate the ability of our Accurins to control the biodistribution of therapeutic payloads to target diseased cells while limiting exposure to healthy tissues and minimizing on-target but off-tissue toxicities. We are committed to creating innovative medicines, both through internal discovery and collaborations with leading biopharmaceutical companies, that fully leverage the benefits of our proprietary nanomedicine platform."

The posters will include preclinical and clinical pharmacokinetic data from BIND’s clinical stage Accurin compound, BIND-014, data from BIND’s preclinical stage Accurin, BIND-510, and new data from a previously unannounced feasibility study with Merck, demonstrating the potential value of an Accurin formulation of Merck’s proprietary AKT inhibitor, MK-2206.

Poster presentations at AACR (Free AACR Whitepaper) include the following:

BIND-014

1. Poster title: Cardiovascular safety profile of BIND-014 (docetaxel nanoparticles for injectable suspension) evaluated in phase 1 and 2 studies (Abstract/poster board #A161)

Date/time: November 6, 2015; 12:15 – 3:15 pm ET
Poster session category: Therapeutic Agents: Other
Location: Poster Session A; Exhibit hall C-D
2. Poster title: Evaluation of total and encapsulated drug pharmacokinetics for BIND-014 (docetaxel nanoparticles for injectable suspension) in a phase 1 study (Abstract/poster board #B144)

Date/time: November 7, 2015; 12:30 – 3:30 pm ET
Poster session category: Pharmacokinetics and Pharmacodynamics
Location: Poster Session B; Exhibit hall C-D
BIND-510

1. Poster Title: BIND-510 improves the pharmacokinetics, tolerability, tumor accumulation and tumor growth inhibition in preclinical models of cancer compared to vincristine sulfate (Abstract/poster board #C184)

Date/time: November 8, 2015; 12:30 – 3:15 pm ET
Poster session category: Therapeutic Agents: Other
Location: Poster Session C; Exhibit Hall C-D
MK-2206 Accurin

1. Poster Title: Accurins improve the pharmacokinetics, pharmacodynamics, tolerability and anti-tumor activity of the AKT inhibitor MK-2206 (Abstract/poster board #C197)

Collaborator: Merck
Date/time: November 8, 2015; 12:30 – 3:30 pm ET
Poster session category: Therapeutic Agents: Small Molecule Kinase Inhibitors
Location: Poster Session C

Agios to Present Clinical Data from Ongoing AG-120 Phase 1 Trial in Advanced Solid Tumors at AACR-NCI-EORTC

On October 26, 2015 Agios Pharmaceuticals (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported that the first results from the Phase 1 study of AG-120 in patients with IDH1-mutant positive advanced solid tumors will be presented in an oral presentation and featured in the press program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place November 5-9, 2015, in Boston (Press release, Agios Pharmaceuticals, OCT 26, 2015, View Source;p=RssLanding&cat=news&id=2102387 [SID:1234507791]).

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"We look forward to sharing the first clinical data for AG-120 in patients with advanced solid tumors as we continue to understand the potential of this investigational medicine," said Chris Bowden M.D., chief medical officer at Agios. "This is an important step toward our long-term vision of making a difference for people with a broad range of hematologic and solid tumor cancers that harbor IDH mutations."

Title: The First Reported Results of AG-120, a First-in-class, Potent Inhibitor of the IDH1 Mutant Protein, in a Phase 1 Study of Patients with Advanced IDH1-Mutant Solid Tumors, Including Gliomas

Plenary Session Date & Time: Sunday, November 8, 2015, at 8:00 a.m. ET

Session: Advances in Targeted Therapy

Press Program Date & Time: Sunday, November 8, 2015, at 10:30 a.m. ET

Presenter: Howard A. Burris, III, M.D., Sarah Cannon Cancer Center, Nashville, Tennessee

Location: Hynes Convention Center

Investor Lunch and Webcast Information

Agios will host an investor lunch on Sunday, November 8, 2015 in Boston to review data presented at the conference, additional event details to come. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for approximately 30 days following the presentation.

Spectrum Pharmaceuticals Initiates Apaziquone Pivotal Trial for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) Following SPA Agreement

On October 26, 2015 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, reported the Company has initiated the planned Phase 3 clinical study for apaziquone, its novel, potent pro-drug, and the first patient was dosed on Friday, October 23, 2015 (Press release, Spectrum Pharmaceuticals, OCT 26, 2015, View Source [SID:1234507790]). Apaziquone is an alkylating agent being investigated as intravesical treatment to address the unmet medical need for patients with non-muscle invasive bladder cancer (NMIBC), administered as one or two instillations immediately following transurethral resection of bladder tumors (TURBT).

“Apaziquone has the potential to usher in an importantly needed paradigm shift in the treatment of NMIBC, as the first new drug in its indication in over 40 years,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “This Phase 3 study has been specifically designed to address important lessons learned from the previous apaziquone Phase 3 studies, as well as recommendations from the FDA that improve chances of a successful study outcome. Pooled data from the previously completed Phase 3 studies that enrolled over 1,600 patients, showed a statistically significant reduction in the 2-year Recurrence rate and strong safety data. These existing Phase 3 data form the basis of the NDA that we plan to submit to FDA before the end of the year. Because of the high frequency of recurrences, the overall cost for the treatment of bladder cancer in the U.S. is a staggering $3.4 billion annually, most of which is related to direct treatment of the disease. We are hopeful that we can get this drug to the market as soon as possible to meet the significant unmet medical need.”

“I am impressed with the data and the activity of apaziquone in NMIBC that I have seen so far in clinical trials,” said Lawrence Karsh, MD, FACS, Director of Research at The Urology Center of Colorado. “In bladder cancer patients, there is, unfortunately, a high rate of recurrence that necessitates frequent surgeries. Due to the high rate of recurrence, there is significant patient morbidity and the disease is expensive to treat. There is a strong scientific rationale for the use of a chemotherapeutic agent post-TURBT, and NCCN guidelines recommend the post-TURBT instillation of a chemotherapeutic agent. However, no drug has been specifically approved for post-TURBT instillation in the US for this group of patients. The addition of a new effective therapy for this recurring disease would help to address the high unmet medical need, offer patients an important new treatment option, and potentially reduce the healthcare costs associated with the treatment of NMIBC.”

In accordance with the SPA agreement, this Phase 3 trial will be a randomized, double-blind, placebo-controlled, multicenter trial that will enroll patients with Ta, G1-G2 NMIBC. Patients will be randomized to receive either one instillation of apaziquone, two instillations of apaziquone, or placebo with a primary endpoint of Time to Recurrence. Since apaziquone is known to be inactivated in presence of blood, the new protocol requires the dosing of apaziquone in a 30-90 minute window post-TURBT. Patients randomized to receive two instillations of apaziquone, will receive the second dose approximately two weeks after surgery, further minimizing the potential for drug inactivation due to bleeding. In addition, the protocol recommends that patients with significant post-operative bleeding not receive apaziquone.

Apaziquone is an anticancer pro-drug that is activated by bio-reductive enzymes that are over-expressed in bladder cancer cells, rendering it into a highly cytotoxic alkylating agent. Spectrum has conducted two multi-center, international, randomized Phase 3 trials of a single intravesical instillation of apaziquone (4 mg) into the bladder in the immediate post-operative period after surgical resection of low-grade NMIBC. Pooled data from the two studies (n=1,615) showed a statistically significant treatment effect for the primary study endpoint, i.e., a reduction in the 2-Year Recurrence Rate, in favor of apaziquone (p-value = 0.0218), and in a key secondary endpoint, Time to Recurrence (p-value = 0.0096).

About Bladder Cancer

According to the National Cancer Institute, bladder cancer is the fifth most common malignancy in the US with 74,000 new cases of bladder cancer expected in 2015, and currently over 500,000 patients living with the disease. Due to the high recurrence rate, intensive surveillance strategies, and expensive annual treatment costs, bladder cancer has the highest per patient costs with an overall cost estimated at around $3.4 billion. Non-muscle invasive bladder cancer is a form of bladder cancer that is localized in the surface layers of the bladder, and has not invaded or spread to the deeper muscle layer. Approximately 70% of all patients newly diagnosed with bladder cancer have NMIBC. Urologists treat the disease predominantly by TURBT. In the U.S., there are approximately 300,000 TURBT procedures every year to treat bladder cancer. Because of the high recurrence rate, both professional urology associations and NCCN Guidelines recommend the instillation of a cytotoxic agent following TURBT for NMIBC, although in the U.S., there are no FDA-approved agents for this indication.

About Special Protocol Assessments

A Special Protocol Assessment is a written agreement between a Sponsor and the U.S. Food and Drug Administration on the design, execution and analysis for a clinical trial that may form the basis of a new drug application, or NDA. Final marketing approval depends upon the efficacy results, safety profile and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical program.