Uncategorized – Page 15369 – 1stOncology™: Cancer Intelligence Service

Sitka Biopharma Announces New Investment from Global Health Sciences Fund

On October 25, 2018 Sitka Biopharma reported that Quark Venture Inc. and GF Securities, through their Global Health Sciences Fund (GHS), has invested $1.9M into Sitka – financing that will enable the company to complete critical GLP toxicology studies and GMP manufacture of clinical drug product (Press release, Sitka Biopharma, OCT 25, 2018, View Source [SID1234530250]). This in turn will allow Sitka and partner Cancer Research UK (CRUK) to complete initial Phase 1 clinical trials of STK-01, Sitka’s lead product for the treatment of bladder cancer.

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A spin-off of CDRD and the University of British Columbia (UBC), Sitka Biopharma is a preclinical biotechnology company focused on developing its breakthrough nanoparticle platform technology to increase absorption of drugs in difficult-to-penetrate tissues. While STK-01 is being developed for the treatment of bladder cancer, follow-on indications of the current core formulation include intraperitoneal delivery for ovarian cancer and other indications where localized drug delivery would be advantageous but currently ineffective due to those penetration challenges.

Preclinical studies have established that Sitka’s candidate formulation significantly improved bladder tissue uptake when compared to the commercial docetaxel formulation. Furthermore, the proprietary hyperbranched polyglycerols (HPG)-docetaxel formulation demonstrated superior efficacy over commercial docetaxel – providing a preclinical proof-of-concept.

Dr. Michael Parr, Sitka’s President and Chief Scientific Officer said, "This is an extremely pivotal investment for Sitka as it means we can complete the final IND-enabling studies and take our lead therapeutic for bladder cancer into the clinic via our partnership with CRUK. This investment sets up the company for rapid progression through those initial clinical trials and we can also begin planning to expand STK-01 to additional indications."

Ms. Karimah Es Sabar, Chief Executive Officer of Quark Venture and Director of GHS Fund commented "GHS Fund believes Sitka is poised for an important medical breakthrough in bladder cancer. This initial success will be leveraged for further development of the platform in other indications, including ovarian cancer."

Bladder cancer is the 4th most common cancer in men, and has the highest per patient lifetime cost of all cancers. The challenge in bladder cancer is that because of the nature of the bladder, drugs are not well-absorbed and only stay in the bladder for as long as the patient does not void their bladder – a critical issue addressed by the Sitka technology.

This technology was initially developed through a collaboration between the UBC and CDRD. Additional early funding included grants from the Canadian Institutes of Health Research (CIHR), Genome British Columbia, and the National Research Council of Canada’s IRAP Program. Quark Venture provided the first private financing in March 2016

argenx reports third quarter 2018 financial results and provides business update

On October 25, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported financial results and provided a business update for the third quarter ended September 30, 2018 (Press release, argenx, OCT 25, 2018, View Source [SID1234530147]).

"The proof-of-concept data that we have generated in the last year from our Phase 2 clinical trials in generalized myasthenia gravis (gMG), immune thrombocytopenia (ITP) and pemphigus vulgaris (PV) support efgartigimod’s (ARGX-113) potential in severe autoimmune disease, and we are committed to advancing and expanding this clinical program as quickly as possible. We continue to see potential differentiation of our molecule among the anti-FcRn class of therapies in terms of tolerability, improvement in disease scores, and stage of development. We are now evaluating our lead candidate in four indications, two formulations to accommodate tailored therapy, and in one registration trial with another expected to launch next year," commented Tim Van Hauwermeiren, CEO of argenx. "Our second program, cusatuzumab (ARGX-110), will follow quickly as we enroll newly diagnosed, elderly acute myeloid leukemia (AML) patients in a Phase 2 clinical trial. We plan to show the full Phase 1 data in December during our annual American Society of Hematology (ASH) (Free ASH Whitepaper) workshop, along with the full dataset from the Phase 2 clinical trial of efgartigimod in ITP."

"We believe we have differentiated antibody design capabilities and continue to show this through reproducible value creation with the robust clinical datasets from our wholly-owned programs, successes from our collaborations including the in-licensing by AbbVie of ARGX-115, and the pipeline we grow using novel targets from esteemed academic institutions."

THIRD QUARTER 2018 AND RECENT HIGHLIGHTS:

Pipeline Updates:

Efgartigimod (ARGX-113):

Reported positive topline results from Phase 2 proof-of-concept trial of intravenous (IV) efgartigimod in primary ITP:

Well-tolerated, consistent with efgartigimod clinical trials to-date.

Clinically meaningful platelet count improvements seen across doses and ITP patient classifications, correlating with consistent reduction in Immunoglobulin G levels.

Showed separation from placebo at increasing response thresholds, with response rates of 46% and 58% in primary trial and first dosing of open-label extension study, respectively.

Announced plans to advance IV efgartigimod into Phase 3 development in ITP in second half of 2019 and subcutaneous efgartigimod into Phase 2 trial in ITP in first half of 2019.

Dosed first patient in global Phase 3 registration trial of efgartigimod in patients with gMG.

Phase 3 trial, if results are positive, expected to serve as basis to submit Biologics License Application (BLA) in U.S. and for marketing authorization in Japan, based on feedback from U.S. Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Data from Phase 2 proof-of-concept trial of efgartigimod in PV on track to read out in first half of 2019.

Announced chronic inflammatory demyelinating polyneuropathy (CIDP) as fourth indication for efgartigimod with Phase 2 proof-of-concept trial expected to start in first half of 2019.

Cusatuzumab (ARGX-110):

Enrollment ongoing of initial 21 patients in Phase 2 part of Phase 1/2 proof-of-concept trial of 10 mg/kg cusatuzumab in combination with standard of care azacytidine in newly diagnosed, elderly AML and myelodysplastic syndromes patients who are unfit for chemotherapy.

Corporate Updates:

AbbVie exercised its exclusive option to license ARGX-115, a novel immuno-oncology antibody targeting glycoprotein A repetitions predominant (GARP).

argenx received preclinical milestone in its strategic collaboration with Shire plc. The milestone, for which an undisclosed payment has been received, was triggered by Shire exercising its exclusive option to in-license an antibody discovered and developed using argenx’s proprietary SIMPLE Antibody platform and Fc engineering technologies.

FINANCIAL HIGHLIGHTS (as of September 30, 2018) (compared to financial highlights as of September 30, 2017)

Raised approximately $300.6 million in gross proceeds in U.S. public offering from sale of 3,475,000 American Depositary Shares (ADSs) at a price to the public of $86.50 per ADS; proceeds to be used to advance efgartigimod program in ITP, launch efgartigimod program in CIDP, further scale up manufacturing in advance of potential commercial operations, and expand argenx organization.

Operating income of €24.5 million (September 30, 2017: €30.5 million).

Total comprehensive loss of €36.5 million (September 30, 2017: €16.5 million).

Cash position of €582.3 million (cash, cash-equivalents and current financial assets) allowing argenx to pursue development of its pipeline in severe autoimmune diseases and cancer (September 30, 2017: €161.7 million).

UPCOMING CLINICAL MILESTONES

Present full dataset from Phase 2 proof-of-concept trial of efgartigimod in ITP at workshop around ASH (Free ASH Whitepaper) Annual Meeting (San Diego, December 3, 2018).

Report full data from Phase 1 dose-escalation trial of cusatuzumab in AML at workshop around ASH (Free ASH Whitepaper).

Report full data from Phase 2 proof-of-concept trial of efgartigimod in PV in first half of 2019.

Launch Phase 2 clinical trial in ITP using subcutaneous formulation of efgartigimod in first half of 2019.

Launch Phase 2 clinical trial of efgartigimod in CIDP in first half of 2019.

Q3 2018 FINANCIAL RESULTS:

Nine months ended

September 30,

Adjustments

September 30,

2018

Adoption

2018

2017

(in thousands of €)

IAS 18

IFRS 15 (*)

IFRS 15

IAS 18

Variance

Revenue

17,892

2,031

19,924

28,422

(8,498)

Other operating income

4,594

2,090

2,504

Total operating income

22,487

2,031

24,518

30,512

(5,994)

Research and development expenses

(53,352)

(198)

(53,550)

(36,655)

(16,895)

Selling, general and administrative expenses

(18,245)

(7,339)

(10,906)

Operating loss

(49,111)

1,833

(47,278)

(13,482)

(33,796)

Financial income

1,983

1,895

Exchange gains/(losses)

8,826

(2,476)

11,302

Loss before taxes

(38,301)

1,833

(36,468)

(15,870)

(20,598)

Income tax benefit/(expense)

(597)

629

Loss for the period and total comprehensive loss

(38,269)

1,833

(36,436)

(16,467)

(19,969)

Net increase in cash, cash-equivalents and current financial assets compared to year-end 2017 and 2016

222,506

64,989

Cash, cash-equivalents and current financial assets at the end of the period

582,281

161,717

(*) The company has adopted IFRS 15 on January 1, 2018 using a modified retrospective approach. The impact of adopting IFRS 15 amounts to €1.8 million for the nine months ended September 30, 2018.

Total operating income was €24.5 million for the nine months ended September 30, 2018, compared to €30.5 million for the nine months ended September 30, 2017. The decrease in operating income in 2018 was due to a decrease of €8.5 million in revenue primarily related to the completion of the preclinical activities under the ongoing collaborations with LEO Pharma and AbbVie. The decrease in revenue was partially offset by an increase of €2.5 million in other operating income, mainly driven by an increase in payroll tax rebates for employing certain research and development personnel and higher grant income following the approval of two VLAIO grants in 2018.

Research and development expenses were €53.6 million for the nine months ended September 30, 2018, compared to €36.7 million for the nine months ended September 30, 2017. The increase in research and development expenses in 2018 was principally due to (i) an increase of €11.2 million in costs related to the advancement of the clinical development and manufacturing activities of argenx’s product candidates efgartigimod (notably with the start of a Phase 3 registration trial in efgartigimod), cusatuzumab and ARGX-117 and (ii) an increase of €6.2 million in share-based compensation expenses linked to the grant of stock options to the Company’s research and development employees (including an increase of €1.0 million in social security costs on stock options granted to certain Belgian and non-Belgian resident employees). argenx employed 89 employees and consultants in its research and development functions on September 30, 2018, compared to 71 employees and consultants on September 30, 2017.

Selling, general and administrative expenses were €18.2 million for the nine months ended September 30, 2018, compared to €7.3 million for the nine months ended September 30, 2017. The increase in selling, general and administrative expenses in 2018 is mainly explained by an increase of €9.6 million of personnel expenses resulting primarily from an increase of €7.5 million in share-based compensation expenses linked to the grant of stock options to argenx’s selling, general and administrative employees (including an increase of €1.3 million in social security costs on stock options granted to certain Belgian and non-Belgian resident employees). argenx employed 31 employees and consultants in its selling, general and administration functions on September 30, 2018, compared to 19 employees and consultants on September 30, 2017.

Financial income and exchange gains amounted to €10.8 million for the nine months ended September 30, 2018, compared to financial income and exchange losses of €2.4 million for the nine months ended September 30, 2017, which was primarily attributable to €8.8 million of unrealized exchange rate gains on the Company’s cash, cash equivalents and current financial assets position in USD linked to the favorable fluctuation of the USD exchange rate in the nine months ended September 30, 2018.

argenx generated a loss for the period and total comprehensive loss of €36.5 million for the nine months ended September 30, 2018, compared to a loss for the period and total comprehensive loss of €16.5 million for the nine months ended September 30, 2017.

On September 30, 2018, argenx’s cash, cash equivalents and current financial assets amounted to €582.3 million, compared to €359.8 million on December 31, 2017. The significant increase in its cash balance on September 30, 2018 resulted from the follow-on U.S. public offering of ADSs on the Nasdaq Global Select Market completed in September 2018.

EXPECTED 2019 FINANCIAL CALENDAR:

February 28, 2019: FY 2018 business update and financial results

May 9, 2019: Q1 2019 business update and financial results

August 1, 2019: HY 2019 business update and financial results

October 24, 2019: Q3 2019 business update and financial results

SignPath Pharma Reports Extremely Beneficial Blood Level Results of Its Phase 1b Clinical Trials of Liposomal Curcumin in Advanced Cancer Patients as Published in the Cancer Research Journal “Cancer Chemotherapy and Pharmacology”

On October 24, 2018 SignPath Pharma Inc. reported in the October issue of "Cancer Chemotherapy and Pharmacology"*, a leading cancer journal, the final results of a Phase 1b cancer study of proprietary Liposomal Curcumin (Press release, SignPath Pharma, OCT 24, 2018, View Source [SID1234530192]). The study showed that the Liposomal Curcumin formulation (Lipocurc) can result in blood levels up to 1000 times that achieved with oral curcumin. In addition, no major toxicity was noted at these high blood levels. Specifically no toxicity was found in kidney, lung, liver and heart organs. The study involved 31 heavily pretreated cancer patients. Significant tumor marker responses and transient clinical benefit were also observed.

Curcumin has long been of interest as an anti-inflammatory modulator and as a potential therapeutic agent for cancer, central nervous system and other diseases. Orally administered curcumin has not been able to achieve sufficient blood levels. LipoCurc addresses these limitations and has the potential to be a potent, non-toxic modality for treating these dire conditions.

Although Phase 1b studies are designed to determine safety of a drug and not to measure efficacy, two patients had obvious and important signs of tumor response. One was a 75 year old male with colon cancer, who had previously failed seven multi-drug chemotherapy combinations. On Lipocurc, his CEA, a tumor-marker which is elevated in patients with cancer, fell from above 18,000 to just above 6,000, and he showed clinical improvement. The other was a patient with prostate cancer who had previously failed radiation therapy as well as six chemotherapy combinations. His PSA level fell from 649 to 350 and he also showed clinical improvement.

On the basis of these results, SignPath is planning several phase 2 trials to test the efficacy of Lipocurc against specific cancer types. Trials are planned in patients with glioblastoma, in multiple myeloma, and in mesothelioma. Dr. Peter Sordillo, Chief Medical Officer of SignPath Pharma, states "We are very pleased with the Phase 1b results with LipoCurc and look forward to testing it in Phase 2 clinical trials. We believe LipoCurc has the potential to be a new potent, non-toxic therapeutic strategy for cancer and other diseases."

SignPath Pharma, Inc. is a clinical stage biopharmaceutical company developing two major drug platforms:

LipoCurc for cancer, neurodegenerative diseases and sepsis.
SPP 4040 for prevention of drug-induced cardiac arrhythmias, and prevention of heart damage and congestive heart failure secondary to chemotherapy.

Clinical Trial Expected to Yield Promising Results for Oral Cancer Patients

On October 24, 2018 Privo Technologies reported that it was granted the green light from the FDA and several hospitals this summer to begin patient recruitment for a prospective clinical trial (NCT03502148) targeting early-stage oral cavity squamous cell carcinoma (OCSCC) (Press release, Privo Technologies, OCT 24, 2018, View Source [SID1234530215]). Privo is now actively recruiting stage I and II OCSCC patients for this study.

About PRV111:

Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.
Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.
Privo has developed a nano-engineered product called PRV111 consisting of a topical patch designed to deliver and retain high concentrations of various existing systemic agents within the primary tumor and associated nodal basins.

Dr. Manijeh Goldberg, Privo’s founder, and CEO is very encouraged by the result of Privo’s preclinical studies and expects PRV111 to provide a safer and more effective treatment option to patients suffering from oral cancer.

When placed on the tumor, PRV111 releases and retains cisplatin-loaded particles into the tumor, resulting in a dramatic reduction of tumor size, without the accompanying systemic side effects of intravenous cisplatin (i.e., nephrotoxicity and neurotoxicity). Local and regional effects of PRV111 are expected to improve tumor resectability, decrease the need for post-operative radiation and chemotherapy and improve patient survival. According to the National Cancer Institute, 76% of all newly diagnosed oral cancers are locoregional (29% local and 47% regional), and the 5-year survival is about 65%. Privo aims to improve the survival rates with its PRV111 intensive topical treatment. This organ-sparing therapy can preserve oral cavity form and function while improving locoregional disease control, which is the primary driver of disease-specific and overall survival. In patients with the regional metastatic disease, PRV111 can be combined with the standard of care chemo-radiation regimens to provide improved locoregional control while maintaining a tolerable side effect profile and improving quality of life.

When asked about Privo’s clinical trial (NCT03502148), Dr. Vlad Sandulache, surgical oncologist and the clinical study’s principal investigator stated:

"We have learned much about the genomic, epigenetic and proteomic profile of oral cavity squamous cell carcinoma (OCSCC) over the last decade. Unfortunately, this knowledge has not translated into effective novel therapies or improved survival for our patients. Cisplatin, although an old drug, remains by far the most effective systemic agent available for patients with OCSCC; however systemic toxicity limits utilization and can prevent use in patients with pre-existing renal disease. PRV111 presents a unique opportunity to revolutionize utilization of this proven agent. Not only does locoregional delivery completely eliminate systemic toxicity, but the intra-tumoral cisplatin concentrations generated by PRV111exceed those achievable through intravenous administration by over an order of magnitude. This represents a qualitative leap in potential effectiveness which could overcome traditional mechanisms of cisplatin resistance previously described in OCSCC."

Clinical Trial Info

For information regarding this trial, please visit View Source

Participating hospitals include:

Baylor Clinic, 6620 Main Street, Houston, Texas 77030
Baylor St. Luke’s Medical Center, 6720 Bertner Avenue, Houston, Texas 77030
Baylor College of Medicine, 1 Baylor Plaza, Houston, Texas 77030
Houston Methodist Hospital, 6550 Fannin Street, Suite 1701, Houston, Texas 77030
Ben Taub Hospital, 1504 Ben Taub Loop, Houston, Texas 77030
Harris Health System – Smith Clinic, 2525A Holly Hall Street, Houston, Texas 77054
Memorial Hermann-Texas Medical Center, Houston, Texas 77030
The University of Cincinnati Cancer Institute, Head and Neck Cancer Center, 234 Goodman Street, Cincinnati, Ohio 45219
West Chester Hospital, 7700 University Drive, West Chester, Ohio 45069

GlycoMimetics to Present at Upcoming Investor Conferences

On October 24, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at two upcoming investor conferences, as follows (Press release, GlycoMimetics, OCT 24, 2018, View Source [SID1234530099]):

STIFEL 2018 HEALTHCARE CONFERENCE
When: November 13, 2018 at 10:15 a.m. ET
Where: New York, NY, USA

JEFFERIES 2018 LONDON HEALTHCARE CONFERENCE
When: November 15, 2018 at 8:40 a.m. GMT
Where: London, UK

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

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Category: Uncategorized

Sitka Biopharma Announces New Investment from Global Health Sciences Fund

argenx reports third quarter 2018 financial results and provides business update

SignPath Pharma Reports Extremely Beneficial Blood Level Results of Its Phase 1b Clinical Trials of Liposomal Curcumin in Advanced Cancer Patients as Published in the Cancer Research Journal “Cancer Chemotherapy and Pharmacology”

Clinical Trial Expected to Yield Promising Results for Oral Cancer Patients

GlycoMimetics to Present at Upcoming Investor Conferences