1stOncology™: Cancer Intelligence Service – Page 13265 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Cytori Files Pre-submission Request for New Drug Application

On March 7, 2019 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported that it officially filed a formal new drug application pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori (Press release, Cytori Therapeutics, MAR 7, 2019, View Source [SID1234534097]). This submission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval procedure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) confirmed that Doxorubicin Hydrochloride Cytori was eligible for submission of a MAA via the centralized procedure.

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In addition, in late 2018, the EMA CHMP Name Review Group validated Doxorubicin Hydrochloride Cytori as the official invented name to replace ATI-0918. Doxorubicin Hydrochloride Cytori is a liposomal nanoparticle medicinal product being developed for cancer patients that contains the active substance doxorubicin, a widely used chemotherapy drug. Doxorubicin Hydrochloride Cytori is intended for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma.

"Liposomal doxorubicin is a commonly prescribed chemotherapeutic drug for patients with advanced breast and ovarian cancer as well as other indications," said Dr. Marc Hedrick MD, President/CEO of Cytori Therapeutics. "Bringing Doxorubicin Hydrochloride Cytori to market in Europe as an alternative to the branded drug is an important near-term corporate goal."

As a ‘hybrid medicine’, Doxorubicin Hydrochloride Cytori is intended to be similar to a ‘reference medicine’, Adriamycin, already authorized in the EU. Doxorubicin Hydrochloride Cytori is different than Adriamycin in that the active substance is encapsulated in tiny lipid nanospheres called liposomes that are coated in polyethylene glycol or PEG. Cytori believes that it has successfully completed all clinical development work for Doxorubicin Hydrochloride Cytori and is currently manufacturing the drug in its dedicated plant in San Antonio, Texas.

Cytori expects to receive assignment of a rapporteur and co-rapporteur, who will work with the company through the MAA submission and review process, by the end of April 2019. The MAA submission is planned for later in 2019 or early 2020.

Cytori’s MAA will present data from the scientific literature and from non-clinical studies, including comparisons with Janssen’s Caelyx, an authorized medicine containing doxorubicin in pegylated liposomal form. The company will also present the results of a completed clinical study intended to investigate whether Doxorubicin Hydrochloride Cytori is ‘bioequivalent’ to Caelyx, meaning that they both produce the same levels of the active substance in the body.

Janssen’s Caelyx first received a marketing authorization for the EU in 1996, is currently approved for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, and generated over €110M in sales across Europe in 2017. No generic versions of Caelyx are currently approved and available in Europe.

GlycoMimetics to Present at the Cowen and Company 39th Annual Health Care Conference 2019

On March 7, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at the Cowen and Company 39th Annual Health Care Conference in Boston, on Tuesday, March 12, 2019, at 9:20 a.m. ET (Press release, GlycoMimetics, MAR 7, 2019, https://ir.glycomimetics.com/news-releases/news-release-details/glycomimetics-present-cowen-and-company-39th-annual-health-care [SID1234534096]).

To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at www.glycomimetics.com.

SURFACE ONCOLOGY REPORTS FINANCIAL RESULTS AND CORPORATE HIGHLIGHTS FOR FOURTH QUARTER AND FULL YEAR 2018

On March 7, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the fourth quarter and full year 2018, as well as anticipated corporate milestones for 2019 (Press release, Surface Oncology, MAR 7, 2019, View Source [SID1234534095]).

"At Surface we strive to break through and deliver on the promise of next generation immunotherapies to create a meaningful impact on patients’ lives," said Jeff Goater, chief executive officer of Surface Oncology. "2018 was a landmark year for the company as two of our products advanced into phase 1 clinical development and we successfully completed our IPO. With three wholly-owned product candidates either in, or approaching the clinic, and a strong balance sheet, we remain focused on execution across all fronts. Our team of Surfers is ready for, and excited about, the road ahead."

Recent Corporate Highlights:

Continued dose escalation for the phase 1 trial of NZV930 (CD73), with trial sites now recruiting in four countries

Initiation of IND-enabling studies for SRF617 (CD39) and SRF388 (IL-27)

Retention of worldwide rights for SRF388, a first-in-class antibody targeting IL-27

Publication in ImmunoHorizons of research highlighting the role of IL-27 in the upregulation of multiple checkpoint proteins

Deprioritization of SRF231 (CD47) clinical program based upon dose escalation data and competitive landscape

Appointment of F. Stephen Hodi, MD to the Scientific Advisory Board

Promotion of Jessica Fees to senior vice president, finance and business operations

Addition of Surface Oncology to the NASDAQ Biotechnology Index

Selected Anticipated 2019 Corporate Milestones:

Presentation at the Brisbane Immunotherapy Conference, highlighting recent discoveries in tumor microenvironment biology in May 2019

IND filing for SRF617 in Q4 2019

IND filing for SRF388 in Q4 2019

Introduction of new program and clinical candidate in Q4 2019

Inaugural Surface Oncology Investor and Analyst Day in New York City, Q4 2019

Additional findings and learnings related to the deprioritization of SRF231 in H2 2019

Financial Results:

As of December 31, 2018, cash, cash equivalents and marketable securities were $158.8 million, compared to $63.3 million on December 31, 2017. This increase was due to the $108.7 million in net proceeds from Surface’s initial public offering and concurrent private placement completed in April 2018 and receipt of a $45.0 million milestone payment from Novartis related to NZV930, offset by operating costs during the year.

Research and development (R&D) expenses were $10.5 million for the fourth quarter ended December 31, 2018, compared to $16.3 million for the same period in 2017. The decrease was primarily driven by a reduction in costs associated with the SRF231 program, in accordance with the deprioritization of the program in the fourth quarter of 2018. R&D expenses were $52.5 million for the full year 2018, compared to $47.8 million for the same period in 2017. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline as well as increased R&D personnel costs associated with the growth of the company. R&D expenses included $2.5 million in stock-based compensation expenses for the full year 2018.

General and administrative (G&A) expenses were $4.8 million for the fourth quarter ended December 31, 2018, compared to $2.8 million for the same period in 2017. G&A expenses were $16.1 million for the full year 2018, compared to $11.0 million for the same period in 2017. The increase in G&A expenses for both the fourth quarter of 2018 and the full year 2019 was primarily due to increased personnel costs and professional fees associated with the growth of the company and operating as a public company. G&A expenses included $2.7 million in stock-based compensation expenses for the full year 2018.

For the fourth quarter ended December 31, 2018, net loss was $4.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.17. Net loss was $15.8 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $6.16. For the full year ended December 31, 2018, net loss was $6.6 million, or basic and diluted net loss per share attributable to common stockholders of $0.33. Net loss was $45.4 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $18.35.

Financial Outlook:

Based upon its current operating plan, Surface continues to have a projected cash runway through 2021.

Aduro Biotech to Present at Two Upcoming Investor Conferences in March

On March 7, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that Aduro management is scheduled to present at the following investor conferences (Press release, Aduro Biotech, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390489 [SID1234534094]):

39TH Annual Cowen Health Care Conference in Boston, Massachusetts on Wednesday, March 13TH at 8:00 am ET.
29TH Annual Oppenheimer Healthcare Conference in New York, New York on Tuesday, March 19TH at 10:55 am ET.
To access the live webcasts and subsequent archived recordings of these and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcasts will remain available for replay on Aduro’s website for 30 days.

Forbius Announces First Patient Dosed in Phase 2a Squamous Cell Carcinoma of the Head and Neck (SCCHN) Trial of AVID100, a Novel Anti-EGFR ADC

On March 7, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, reported that the first patient has been dosed in a Phase 2a squamous cell carcinoma of the head and neck (SCCHN) clinical trial (Press release, Forbius, MAR 7, 2019, View Source [SID1234534088]).

The majority of SCCHN patients have tumors that overexpress epidermal growth factor receptor (EGFR) and approximately 20% have tumors that highly overexpress EGFR (more than 50% of cells with EGFR 3+ staining by a validated immunohistochemistry assay). No therapy is approved for the treatment of EGFR-overexpressing SCCHN.

The multicenter SCCHN trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with EGFR IHC 3+ tumors and follows the previously announced Phase 2a trial of AVID100 in patients with advanced squamous non-small cell lung cancer.

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development.

A recommended Phase 2 dose (RP2D) of 240 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events in the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in severity.

AVID100-01 is an open label, multicenter, dose-escalation study to evaluate the safety and efficacy of AVID100 in patients with confirmed EGFR-overexpressing tumors.