On October 29, 2015 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for third-quarter 2015 and provided an update on the Company’s development programs (Press release, TESARO, OCT 29, 2015, View Source [SID:1234507845]).

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"The FDA approval of TESARO’s first product, VARUBI, offers a new treatment option for patients with cancer who are affected by nausea and vomiting caused by chemotherapy and represents a significant milestone for TESARO," said Lonnie Moulder, CEO of TESARO. "Our field organization is fully in place, and we look forward to providing VARUBI to patients in mid-November. In addition to VARUBI, we are building a franchise around niraparib in ovarian cancer, and we are enthusiastic about the potential to expand our development program for this molecule to include several new tumor types. The Phase 3 NOVA trial of niraparib was initiated more than two years ago, and patient enrollment completed seven months ago. Based upon a recently completed HRD assessment of tumor samples and a greater than anticipated duration of treatment, we now look forward to top-line data from NOVA in the second quarter of 2016. We are very optimistic about the potential of niraparib for patients with ovarian, breast and other cancers."

Recent Business Highlights

On September 1, 2015, the U.S. Food and Drug Administration (FDA) approved VARUBI (oral rolapitant), in combination with other antiemetic agents in adults, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

The National Comprehensive Cancer Network (NCCN) added VARUBI to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Antiemesis Version 2.2015 as a recommended option, in combination with other antiemetic agents, for patients receiving both high emetic risk intravenous chemotherapy (HEC) and moderate emetic risk intravenous chemotherapy (MEC). Category 1, the highest level category of evidence and consensus, was granted to rolapitant for both HEC and MEC chemotherapy.

The TESARO field organization is now over 120 associates strong and includes sales management, area managers, corporate account directors, medical science liaisons, and clinical nurse educators. Preparation is ongoing to support the successful U.S. commercial launch of VARUBI in mid-November.

The planned intravenous (IV) rolapitant clinical program is now complete, and following a pre-NDA meeting with the U.S. FDA, a New Drug Application (NDA) will be submitted.

An assessment of the patient tumor samples collected from patients enrolled in the Phase 3 NOVA trial of niraparib was recently completed using the myChoice HRD test in preparation for progression-free survival (PFS) endpoint analysis. As anticipated, results from this testing determined that approximately 50% of patients enrolled in the non-gBRCA cohort have HRD-positive tumors.

Based on the observed event rate, new estimates for the NOVA timing of PFS events indicate that top-line PFS results for NOVA are now expected to be available in Q2 2016.

Enrollment of the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy is now more than 50 percent complete.

Antibody drug candidates targeting PD-1, TIM-3, and LAG-3 continue to advance, and Investigational New Drug (IND) application preparations are underway for TSR-042 and TSR-022, our anti-PD-1 and anti-TIM-3 antibody candidates.
The Phase 1/2 clinical trial of TSR-011 has been discontinued, and resources are being reprioritized to support development programs for niraparib and our immuno-oncology candidates.

Third Quarter 2015 Financial Results

TESARO reported a net loss of $66.6 million, or ($1.66) per share, for the third quarter of 2015, compared to a net loss of $36.2 million, or ($1.01) per share, for the third quarter of 2014.

Research and development expenses increased to $40.1 million for the third quarter of 2015, compared to $29.9 million for the third quarter of 2014, driven primarily by higher costs related to expanded development activities and increased headcount.
Selling, general, and administrative expenses increased to $22.8 million for the third quarter of 2015, compared to $6.3 million for the third quarter of 2014, primarily due to pre-launch commercial activities in support of VARUBI, increased commercial headcount, and higher professional service fees.

Operating expenses, as described above, include total non-cash, stock-based compensation expense of $8.1 million for the third quarter of 2015, compared to $2.9 million for the third quarter of 2014.

As of September 30, 2015, TESARO had approximately $302.5 million in cash and cash equivalents and approximately 40.0 million outstanding shares of common stock. TESARO expects cash utilization to be in the mid- to high-$50 million range for the fourth quarter of 2015, excluding a $15 million milestone payment that will be due upon the first commercial sale of VARUBI, which is expected to occur in November.

Corporate Objectives

TESARO anticipates achieving the following key objectives:

Launch VARUBI into the U.S. market in mid-November 2015;
Submit the NDA for IV rolapitant in Q1 2016;
Submit the oral rolapitant Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q2 2016;
Report top-line data from the Phase 3 NOVA trial of niraparib in Q2 2016;
Report top-line data from the QUADRA trial of niraparib in Q2 2016;
Submit the niraparib NDA in 2H 2016;
Continue to enroll the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations through 2016;
Initiate enrollment in the niraparib/KEYTRUDA (pembrolizumab) combination trial in Q1 2016;
Initiate enrollment in the Phase 3 clinical trial of niraparib in first line ovarian cancer (PRIMA) in Q1 2016;
Advance the development of TSR-042 (anti-PD-1 antibody) to support submission of an IND application to the U.S. FDA at year-end 2015; and
Advance the IND-enabling studies for TSR-022 (anti-TIM-3 clinical candidate) to support submission of an IND application in Q2 2016.

On October 29, 2015 Seattle Genetics, Inc. (Nasdaq: SGEN) reported financial results for the third quarter and nine months ended September 30, 2015 (Press release, Seattle Genetics, OCT 29, 2015, View Source;p=RssLanding&cat=news&id=2104338 [SID:1234507844]). The company also highlighted ADCETRIS (brentuximab vedotin) commercialization, regulatory and clinical development accomplishments, progress with other proprietary pipeline programs and antibody-drug conjugate (ADC) collaborator updates.

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"We are pleased to have delivered on several key milestones recently, including an expanded label for ADCETRIS based on our phase 3 AETHERA trial, completing enrollment in the ALCANZA phase 3 trial and reaching our target enrollment in the phase 3 ECHELON-1 trial," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We also completed a successful public offering in September that strongly positions us to continue investing in expanding the ADCETRIS opportunity, advancing our product pipeline and conducting innovative research. We are preparing for a strong presence at the upcoming ASH (Free ASH Whitepaper) annual meeting with data from ADCETRIS, SGN-CD33A and other pipeline programs."

Recent ADCETRIS Highlights

Received regular approval from the U.S. Food and Drug Administration (FDA) for ADCETRIS (brentuximab vedotin) for classical Hodgkin lymphoma (HL) patients at high risk of relapse or progression as post-autologous transplant consolidation based on the phase 3 AETHERA clinical trial. The approval represents the third indication for ADCETRIS in the United States. The AETHERA trial also converted the prior accelerated approval of ADCETRIS in relapsed HL to regular approval.

Completed enrollment in the phase 3 ALCANZA clinical trial for patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who have received prior systemic therapy. The randomized trial is evaluating ADCETRIS versus investigator’s choice of methotrexate or bexarotene in 132 patients. Data are anticipated in the second half of 2016.

Completed target patient enrollment in the phase 3 ECHELON-1 clinical trial. ECHELON-1 is a randomized trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced classical HL.
Initiated a randomized phase 2 trial of rituximab (Rituxan) and bendamustine (Treanda) with or without ADCETRIS for relapsed or refractory patients with CD30-expressing diffuse large B-cell lymphoma (DLBCL).

Initiated a phase 1/2 clinical trial of ADCETRIS in combination with nivolumab (Opdivo) for patients with relapsed or refractory HL after failure of frontline treatment. The trial is being conducted under a previously announced clinical trial collaboration agreement with Bristol-Myers Squibb Company.

Recent Pipeline, Collaborator and Other Highlights

Initiated a randomized phase 2 trial of SGN-CD19A (denintuzumab mafodotin) in combination with the second-line salvage regimen of rituximab, ifosfamide, carboplatin and etoposide (RICE) for patients with relapsed or refractory DLBCL.

Submitted an investigational new drug (IND) application to the FDA for SGN-CD19B, a CD19-targeted ADC utilizing the company’s pyrrolobenzodiazepine (PBD) dimer cell-killing agent and proprietary site-specific conjugation technology (EC-mAb). A phase 1 trial is planned in the first half of 2016.

Expanded our 2011 collaboration with AbbVie to provide access to Seattle Genetics’ PBD dimer and EC-mAb technology. Financial terms were not disclosed.

Received a milestone payment under our collaboration with AbbVie, triggered by its initiation of a phase 1 trial for an auristatin-based ADC for solid tumors utilizing Seattle Genetics’ technology.

Added to and promoted several members of the senior management team, including:
Promoting Elaine Waller, PharmD, to Executive Vice President, Regulatory Affairs and Clinical Development Operations. Dr. Waller has been with Seattle Genetics since September 2008. She has led numerous successful regulatory initiatives for the company, including the recent ADCETRIS label expansion.

Promoting Peter Senter, Ph.D., to Vice President, Chemistry and Senior Distinguished Fellow. Dr. Senter joined Seattle Genetics in August 1998. As an early member of the company’s research organization, he has contributed significantly to Seattle Genetics’ leadership position in ADCs and the innovative science behind its pipeline programs.

Hiring Rachel Lenington as Vice President, Program, Portfolio and Alliance Management. Ms. Lenington previously spent five years at the Bill & Melinda Gates Foundation focused on global health strategies, product development and alliances. Before that she spent 10 years at Amgen.

Hiring Matt Skelton as Vice President, Marketing. Mr. Skelton previously spent 16 years at Amgen in a range of sales and marketing roles. Before that, he was at Eli Lilly.

Promoting Phil Tsai, Ph.D., to Vice President, Process Sciences. Dr. Tsai has been at Seattle Genetics since January 2003. During his tenure, he has led the development of many antibody and ADC manufacturing processes at various stages of the product development life cycle.

Anticipated Upcoming Activities

ADCETRIS

Report ADCETRIS data from multiple clinical trials at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2015 Annual Meeting, being held December 5-8, 2015 in Orlando, FL:
ADCETRIS in HL, including five-year survival data from a pivotal trial in relapsed/refractory patients, data from phase 2 trials in the second-line salvage setting and in the frontline setting for patients age 60 or older, and updated efficacy and safety data from the AETHERA phase 3 trial;
ADCETRIS in non-Hodgkin lymphoma, including frontline and relapsed DLBCL and long-term follow up from a phase 1 trial of ADCETRIS in combination with chemotherapy in T-cell lymphomas; and,
Data from numerous investigator-sponsored trials of ADCETRIS in various lymphoma settings and combinations.
Initiate a phase 1/2 trial of ADCETRIS in combination with nivolumab for relapsed non-Hodgkin lymphoma.
Complete enrollment in phase 3 ECHELON-2 trial during 2016.

ADCETRIS is not currently approved for use in frontline HL, second-line HL, CTCL, DLBCL or non-Hodgkin lymphoma other than systemic anaplastic large cell lymphoma.

SGN-CD33A (Vadastuximab Talirine)

Receive feedback from the FDA and European regulators regarding our regulatory strategy for SGN-CD33A in acute myeloid leukemia (AML).

Report data at ASH (Free ASH Whitepaper) from phase 1 trials of SGN-CD33A in AML, including as monotherapy and in combination with hypomethylating agents (HMAs).

Initiate a phase 1/2 trial of SGN-CD33A as pre-conditioning or post-allogeneic transplant maintenance treatment in patients with AML in the first half of 2016.

Initiate a phase 1/2 trial with SGN-CD33A in combination with azacitidine (Vidaza) for patients with previously untreated myelodysplastic syndrome (MDS) in the first half of 2016.

Other Pipeline Programs

Report data from pipeline programs at ASH (Free ASH Whitepaper):
Phase 1 trials of SGN-CD19A in non-Hodgkin lymphoma and acute leukemia; and,
Preclinical studies of two novel ADCs, SGN-CD19B and SGN-CD123A, which are expected to advance into clinical trials in 2016 for non-Hodgkin lymphoma and AML, respectively.

Report interim phase 1 clinical data from SGN-LIV1A, an ADC targeted to LIV-1 in development for metastatic breast cancer, at the San Antonio Breast Cancer Symposium being held December 8-12, 2015 in San Antonio, TX.

Initiate a randomized phase 2 trial of SGN-CD19A in frontline DLBCL in the first half of 2016.

Report phase 1 clinical data from ASG-15ME and ASG-22ME (enfortumab vedotin) in the first half of 2016. These programs are in development for solid tumors, notably bladder cancer, under a collaboration with Astellas.

Initiate a phase 1 trial of SGN-CD19B in non-Hodgkin lymphoma in the first half of 2016.

Third Quarter and Nine Months 2015 Financial Results

Total revenues in the third quarter and nine month periods ended September 30, 2015 increased to $84.1 million and $243.3 million, respectively, from $75.9 million and $212.4 million for the same periods in 2014. Revenues were derived from:

ADCETRIS sales in the third quarter of $59.1 million, an increase from $48.2 million in the third quarter of 2014. For the year-to-date, ADCETRIS sales were $163.0 million, compared to $131.7 million for the year-to-date period in 2014, a 24 percent increase.
Royalty revenues in the third quarter of 2015 were $9.7 million, compared to $8.1 million in the third quarter of 2014. For the year-to-date in 2015, royalty revenues were $28.4 million, compared to $28.2 million for the first nine months of 2014. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. First quarter 2014 royalty revenues included a $5.0 million sales milestone payment from Takeda.

Amounts earned under the company’s ADCETRIS and ADC collaborations totaled $15.3 million in the third quarter and $51.9 million for the first nine months of 2015, compared to $19.5 million and $52.6 million for the same periods in 2014.
Total costs and expenses for the third quarter of 2015 were $110.6 million, compared to $91.5 million for the third quarter of 2014. For the first nine months of 2015, total costs and expenses were $339.1 million, compared to $262.1 million in the first nine months of 2014. The increase in 2015 costs and expenses was primarily driven by investment in Seattle Genetics’ pipeline programs, including a $25.0 million upfront payment made in the second quarter of 2015 as part of our collaboration with Unum Therapeutics.

Non-cash, share-based compensation cost for the first nine months of 2015 was $28.7 million, compared to $29.0 million for the first nine months of 2014.

Net loss for the third quarter of 2015 was $26.4 million, or $0.21 per share, compared to a net loss of $15.6 million, or $0.13 per share, for the third quarter of 2014. For the nine months ended September 30, 2015, net loss was $95.6 million, or $0.76 per share, compared to a net loss of $49.5 million, or $0.40 per share, for the same period in 2014.

As of September 30, 2015, Seattle Genetics had $736.5 million in cash, cash equivalents and investments, compared to $313.4 million as of December 31, 2014. The increase in cash and investments reflects net proceeds of approximately $526.6 million from the company’s public offering of common stock that closed on September 16, 2015.

2015 Financial Outlook

Seattle Genetics anticipates that 2015 revenues from ADCETRIS net product sales in the U.S. and Canada will be higher than previously anticipated, and are now expected to be in the range of $218 million to $223 million.

On October 29, 2015 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the presentation of new non-clinical data for two of the Company’s proprietary compounds at the 2015 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), which will be held November 5-9, 2015, in Boston, MA (Press release, Onconova, OCT 29, 2015, View Source [SID:1234507843]).

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A poster relating to the novel eIF4E targeted mechanism of action for briciclib, currently in a dose-escalating Phase 1 clinical trial in patients with advanced solid tumors refractory to current therapies, will be presented by Onconova’s collaborators from Harvard University. Another poster will highlight the developmental studies aimed at advancing the Company’s novel CDK4/6 inhibitor, ON 123300, towards an Investigational New Drug (IND) Application filing. The presentations are listed below.

Mechanism of action studies for briciclib

Abstract number: B126
Title: Targeted inhibition of eIF4E-mediated translation by the novel small molecule anti-cancer compound, briciclib (ON 013105).
Date: Saturday, 11/7/2015
Time: 12:30 PM — 3:30 PM ET
Location: Session B, Hall C-D

IND-directed studies for next-generation CDK4/6 inhibitor ON 123300

Abstract number: LB-A21
Title: Single-agent activity and favorable pharmaceutical properties of orally bioavailable next-generation CDK4/6 inhibitor, ON 123300.
Date: Friday, 11/6/2015
Time: 12:15 PM — 3:15 PM ET
Location: Session A, Hall C-D

On October 29, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that data from applying the CombiPlex technology platform to drug combinations incorporating molecularly targeted agents (MTAs) will be presented at the 2015 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, MA on November 5-9, 2015 (Press release, Celator Pharmaceuticals, OCT 29, 2015, View Source [SID:1234507842]).

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CombiPlex is well-positioned to address the challenges with the development of combination drug candidates. Nano-scale delivery systems coordinate the pharmacokinetics (PK) of drug combinations after administration so that the optimal ratio of the two drugs is exposed to tumor cells for prolonged times while reducing drug exposure and toxicity to normal tissues.

Celator is applying this technology to create new drug combinations that target pathways associated with tumor cell growth and/or resistance to treatment. Such MTAs are being widely pursued with an increasing focus on combining agents that target multiple cellular pathways in order to improve therapeutic responses.

Celator’s efforts have focused on two combinations: the heat shock protein 90 inhibitor AUY922 combined with docetaxel and the MEK inhibitor selumetinib combined with the Akt inhibitor ipatasertib.

The poster presentation information is listed below:

Presentation Title: Coordinated delivery of anticancer drug combinations incorporating molecularly targeted agents provides markedly increased plasma drug exposure, decreased toxicity and increased efficacy in preclinical tumor models
Date: Saturday, November 7, 2015
Time: 12:30 p.m. to 3:30 p.m.
Session Title: Drug Delivery
Location: Exhibit Hall C-D
Abstract Number: B34

The poster will be available on Celator’s website (www.celatorpharma.com) at the conclusion of the conference.

On October 29, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported the acceptance of four abstracts for poster presentations at the 27th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts (Press release, Ignyta, OCT 29, 2015, View Source [SID:1234507838]). The presentations relate to the company’s three clinical-stage product candidates, entrectinib, RXDX-105 and RXDX-107, and will be made on November 6-8, 2015.

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"We look forward to sharing data for each of these development programs in this prestigious forum, and to discussing the data and our future plans with key scientific and clinical experts."

"We are honored that the Scientific Program Committee has selected our four abstracts for poster presentations, consisting of a clinical presentation relating to our RXDX-105 product candidate for which we will be presenting recent safety, PK and efficacy data, and preclinical presentations relating to each of our product candidates entrectinib, RXDX-105 and RXDX-107," said Pratik Multani, M.D., Chief Medical Officer of Ignyta. "We look forward to sharing data for each of these development programs in this prestigious forum, and to discussing the data and our future plans with key scientific and clinical experts."

Details of the presentations are as follows:

Date/time: Friday, November 6, 2015, 12:15 PM – 3:15 PM, Eastern Time
Title: Potent anti-tumor activity of entrectinib in patient-derived models harboring oncogenic gene rearrangements of NTRKs. (Poster number A173)

Date/time: Friday, November 6, 2015, 12:15 PM – 3:15 PM, Eastern Time
Title: RXDX-105 demonstrates potent RET inhibitory activity with therapeutic potential in multiple preclinical models of RET-rearrangement driven cancer. (Poster number A174)

Date/time: Saturday, November 7, 2015, 12:30 PM – 3:30 PM, Eastern Time
Title: RXDX-107, a dodecanol alkyl ester of bendamustine, demonstrates improved pharmacokinetic properties and significant anti-tumor efficacy in preclinical models of solid tumors. (Poster number B177)

Date/time: Sunday, November 8, 2015, 12:30 PM – 3:30 PM, Eastern Time
Title: A phase 1 study of RXDX-105, an oral RET, BRAF and EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic cancers. (Poster number C188)