1stOncology™: Cancer Intelligence Service – Page 14625 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Spectrum Pharmaceuticals Reports Third Quarter 2018 Pipeline Update and Financial Results

On November 8, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended September 30, 2018 (Press release, Spectrum Pharmaceuticals, NOV 8, 2018, View Source [SID1234530968]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"In Q3 at the World Conference on Lung Cancer, MD Anderson presented poziotinib interim data in a heavily pre-treated population with exon 20 mutations, which demonstrated strong anti-tumor activity against this difficult-to-treat mutation," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We also actively expanded the poziotinib clinical program on multiple fronts including the initiation of two first-line cohorts in our pivotal ZENITH20 trial and the opening of study sites in Europe. Closing out the year, we expect to receive a response on the poziotinib BTD request and file a BLA with the FDA for our novel G-CSF, ROLONTIS."

Clinical Program Overview:

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:

Updated interim data from the MD Anderson Phase 2 trial in heavily pre-treated, non-small cell lung cancer (NSCLC) patients with exon 20 mutations were presented at the World Conference on Lung Cancer in September.
In evaluable patients with EGFR exon 20 mutations, the confirmed overall response rate (ORR) was 43% and disease control rate was 90%. Median progression free survival (PFS) was 5.5 months (ITT).
In evaluable patients with HER2 exon 20 mutations, the confirmed overall response rate (ORR) was 42% and disease control rate was 83%. Median progression free survival (PFS) was 5.1 months (ITT).
EGFR-related toxicities (including rash, diarrhea, and paronychia) were manageable and required dose reductions in 60% of patients. Discontinuation due to poor tolerance was rare (approximately 3% of patients).
Spectrum submitted a request for Breakthrough Therapy Designation for poziotinib in previously treated metastatic NSCLC with EGFR exon 20 mutations and expects a response from the FDA by the end of 2018.
Spectrum’s Phase 2 ZENITH20 trial studying poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations is well underway and enrolling in four distinct cohorts.
First-line cohorts in both EGFR and HER2 were initiated in the third quarter of 2018.
Enrollment in the EGFR, previously treated cohort is expected to be completed by the first quarter of 2019.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF:

Spectrum had a positive pre-BLA meeting with the FDA in the third quarter of 2018 and expects to file for a BLA in the fourth quarter of 2018.
Data from the RECOVER Phase 3 study will be presented in a poster session at the San Antonio Breast Cancer Symposium in early December 2018.
Financial Guidance

Spectrum is refining its full year 2018 revenue guidance and is now between $100-$110 million, revised from $95-$115 million. Additionally, Spectrum currently anticipates that its current cash and marketable securities will be sufficient to fund operations into 2020.

Three-Month Period Ended September 30, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $24.6 million in the third quarter of 2018. Product sales in the third quarter included: FOLOTYN (pralatrexate injection) net sales of $11.3 million, EVOMELA (melphalan) for injection net sales of $6.9 million, BELEODAQ (belinostat) for injection net sales of $3.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $1.5 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.1 million, and FUSILEV (levoleucovorin) net sales of $0.6 million.

Spectrum recorded net loss of $68.7 million, or $0.66 loss per basic and diluted share, in the three-month period ended September 30, 2018, compared to net loss of $18.3 million, or $0.22 loss per basic and diluted share, in the comparable period in 2017. Total research and development expenses were $21.1 million in the quarter, as compared to $13.8 million in the same period in 2017. Selling, general and administrative expenses were $19.8 million in the quarter, compared to $18.5 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $17.5 million, or $0.17 loss per basic and diluted share, in the three-month period ended September 30, 2018, compared to non-GAAP net loss of $9.2 million, or $0.11 loss per basic and diluted share, in the comparable period in 2017. Non-GAAP research and development expenses were $20.2 million, as compared to $13.2 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $16.6 million, as compared to $16.1 million in the same period in 2017.

Conference Call

Thursday, November 8, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 3075918

International: (973) 796-5077, Conference ID# 3075918
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

Castle Biosciences to Present at the 2018 Canaccord Genuity Medical Technologies & Diagnostics Forum

On November 8, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported that Derek Maetzold, President and CEO, will present at the Canaccord Genuity Medical Technologies & Diagnostics Forum on Thursday, November 15th, 2018 at 3:00 p.m. in New York City (Press release, Castle Biosciences, NOV 8, 2018, View Source [SID1234530967]).

Caladrius Biosciences Reports 2018 Third Quarter Financial Results

On November 8, 2018 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a late-stage therapeutics development biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune disease, reported its financial results for the three ended September 30, 2018, and provides a business update (Press release, Caladrius Biosciences, NOV 8, 2018, View Source [SID1234530965]).

Highlights of the 2018 third quarter and early fourth quarter include:

Continued enrollment in a Phase 2 (SAKIGAKE designated and eligible for early conditional approval) clinical trial in Japan of CLBS12 for the treatment of no-option critical limb ischemia ("CLI"), including completion of enrollment of the five patient Buerger’s disease cohort;

Continued enrollment in a Phase 2 clinical trial using the CD34 cell therapy CLBS14-CMD for the treatment of coronary microvascular dysfunction ("CMD");

Continued follow-up analysis of The Sanford Project: T-Rex Study Phase 2 clinical trial of CLBS03 in type 1 diabetes after completing enrollment and reporting six-month results on 50% of trial subjects in the first quarter of 2018 that concluded the treatment is well-tolerated and non-futile for therapeutic effect; and

Conducted a Type B meeting with the US Food and Drug Administration ("FDA") under the provisions of the RMAT designation for CLBS14-RfA for the treatment of refractory angina to define remaining steps to registration.

"We are pleased with the advancement of our clinical programs during the third quarter. We maintain our previous guidance regarding development milestones and continue to demonstrate efficient management of cash spend," stated Dr. David J. Mazzo, President and CEO. "The fully-enrolled T-Rex Study of CLBS03 in type 1 diabetes remains on track for top-line data in early 2019. Our programs studying our CD34 cell therapy platform for CMD here in the United States and CLI in Japan continue to enroll with a target for top-line data in the second half of 2019 and early 2020, respectively.

"We are also pleased to announce that we recently completed our Type B meeting with the FDA pertaining to CLBS14-RfA for the treatment of refractory angina. This meeting was conducted to obtain FDA guidance and to define the remaining requirements for registration of this product under the terms of its RMAT designation. We believe that the meeting was both collaborative and positive and our assessment of the conversation is that FDA is demonstrating maximum flexibility afforded under the RMAT designation as we work together to establish the development steps necessary to bring this product to registration. We will be working with FDA to finalize the next development steps and to formalize the minutes of the meeting. We look forward to providing further information once these actions are completed."

Third Quarter Financial Highlights

Research and development expenses for the third quarter of 2018 were $1.7 million, a 47% decrease compared with $3.2 million for the third quarter of 2017. The current quarter expenses were principally comprised of costs in our ischemic repair programs for CLBS12 and CLBS14-CMD, as well as initial planning for our CLBS14-RfA

program. Conversely, the prior year quarter expenses were primarily focused on our T-Rex study for CLBS03, which completed enrollment in December 2017 and is now in the follow-up phase of the study.

General and administrative expenses for the third quarter of 2018 were $2.1 million, a 30% decrease compared with $2.9 million for the third quarter of 2017, due to lower general and administrative headcount and corporate-related activities compared with the prior year period.

The net loss from continuing operations for the third quarter of 2018 was $3.5 million, or $0.36 per share, compared with $3.5 million, or $0.38 per share, for the third quarter of 2017.

Nine Month Financial Highlights

Research and development expenses for the nine months ended September 30, 2018 were $6.1 million, a 46% decrease compared with $11.2 million for the nine months of 2017. The current year expenses were principally comprised of costs in our ischemic repair programs for CLBS12 and CLBS14-CMD as well as initial planning for our CLBS14-RfA program. Conversely, the prior year expenses were primarily focused on our T-Rex study for CLBS03, which completed enrollment in December 2017 and is now in the follow-up phase of the study.

General and administrative expenses for the nine months ended September 30, 2018 were $7.1 million, a 22% decrease compared with $9.1 million for the nine months of 2017. The decrease was due to lower general and administrative headcount and corporate-related activities compared with the prior year period, along with the sale of our counter-flow centrifugation system to Hitachi in the second quarter of 2018, which resulted in a one-time $1.4 million gain included in general and administrative expenses.

The net loss from continuing operations for the nine months ended September 30, 2018 was $12.6 million, or $1.31 per share, compared with $25.8 million, or $1.37 per share, for the nine months of 2017.

Balance Sheet Highlights

As of September 30, 2018, Caladrius had cash, cash equivalents and marketable securities of $46.1 million, compared with $60.1 million as of December 31, 2017. Based on existing programs and projections, the Company continues to remain confident that its cash balances and additional grant funding, along with continued disciplined expense management, will allow it to fund its current business plan beyond 2019.

Conference Call

Caladrius management will host a conference call for the investment community today beginning at 4:30 p.m. Eastern time to review financial results, provide a Company update and answer questions.

Stockholders and other interested parties may participate in the conference call by dialing (866) 595-8403 (domestic), or (706) 758-9979 (international), and providing conference ID: 9490459. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate on the live conference call, a replay will be available through November 15, 2018, and can be accessed by dialing (855) 859-2056 or (404) 537-3406. All listeners should provide the following replay access code: 9490459.

The webcast replay will be archived on the Company’s website for 90 days at www.caladrius.com.

Tarveda Therapeutics to Present at EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium

On November 8, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective medicines to treat a wide range of cancers, reported that the company will present at the European CanCer Organisation (ECCO) EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium occurring November 13-16, 2018 in Dublin, Ireland (Press release, Tarveda Therapeutics, NOV 8, 2018, View Source [SID1234530961]).

Samantha Perino, from Tarveda, will present at the Molecular Targeted Agents – PART II poster session from 10:00-2:00 PM GMT on Friday, November 16. The poster is entitled, "Leveraging the Pentarin Platform to Selectively Deliver PI3K Inhibitors to Solid Tumors Leading to Superior Efficacy in Preclinical Models."

"Our presentation at the Molecular Targets and Cancer Therapeutics Symposium will detail how we are leveraging our HSP90 binding conjugate platform to mask the activity of the conjugated payloads in the circulation while accumulating HSP90 binding conjugates in the tumors. The resulting sustained release of active anti-cancer payloads in the tumor, such as phosphoinositide 3-kinase (PI3K) inhibitors, then drives the efficacy," said Richard Wooster, Ph.D., President of Research and Development and Chief Scientific Officer at Tarveda. "The power of targeting potent therapies to tumors is exemplified by our first HSP90 binding conjugate, PEN-866, which carries the topoisomerase I inhibitor SN-38 as its payload. PEN-866 is currently in a Phase 1/2a trial to assess safety and efficacy across a range of tumor types. The data with a PI3K inhibitor in our presentation demonstrates the potential to significantly enhance kinase inhibitor performance using our HSP90 binding conjugate platform."

About Pentarins

Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

Bio-Thera Solutions Announces Poster Presentation at the 2018 EORTC-NCI-AACR Symposium

On November 8, 2018 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company will present one poster at the 2018 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium taking place November 13 – 16, 2018 in Dublin, Ireland.

The poster, entitled "BAT8001, a potent anti-HER2 antibody-drug conjugate with a novel stable linker for the treatment of HER2-positive gastric cancer," will present preclinical data that highlight advantages of BAT8001 as a potential treatment for breast cancer patients. An abstract of the presentation is currently available on EORTC website.

Presentation details are as follows:

Poster Session: Molecular Targeted Agents – PART I
Session Date and Time: Tuesday, November 13, 2018, 12:00 – 18:30
Location: Poster Area/Exhibition Hall

Poster Board Number: PB-084

Abstract Number 133

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8001 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic breast cancer patients (more information on the trial is available at View Source (CTR20180157)). The BAT8001 clinical study program will be expanded beyond metastatic breast cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.