On October 26, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first clinical site in the United States (in Long Beach, CA) for the pivotal PARADIGME trial has been initiated to enable enrolment of patients (Press release, Nordic Nanovector, OCT 26, 2018, View Source [SID1234553491]).

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PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin (177Lu-satetraxetan-lilotomab) dosing regimens (15 MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20 MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L follicular lymphoma patients who are refractory to anti-CD20 therapy (including rituximab). The trial aims to enrol 130 patients across 80-85 sites in approximately 20 countries.

Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "The enrolment of patients into North American sites is important for the overall clinical development program of Betalutin in NHL. We are pleased to have opened the first US site in the PARADIGME trial and anticipate further clinical sites coming on-board in the coming months."

The objective of PARADIGME is to determine the best dosing regimen for Betalutin as a new treatment option for 3L FL patients. The primary endpoint for the trial is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. The data from this trial are expected to support market authorisation applications for Betalutin as a new treatment option for 3L FL patients.

The initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.

In June, Betalutin received Fast Track designation in the US for the treatment of patients with 3L R/R FL, and on 24 October, the MHRA granted Betalutin a Promising Innovative Medicine Designation in the treatment of advanced relapsed/refractory follicular lymphoma.

About Betalutin

Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20 immunotherapy (including rituximab).

Betalutin is also being investigated in the Phase 1b Archer-1 study in combination with rituximab in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL).

Betalutin has been granted Fast Track designation (in June 2018) in the US for the treatment of patients with R/R FL. Betalutin also received Orphan Drug designations for FL in both the USA and Europe in 2014.

Betalutin is selective for CD37, a novel therapeutic target protein that is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin is internalised, causing DNA damage and cell death.

On October 26, 2018 Helix BioPharma Corp. (TSX, FSE: "HBP"), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the year ended July 31, 2018 (Press release, Helix BioPharma, OCT 26, 2018, View Source content/uploads/2018/10/20181026-HBP-Press-Release-Announces-Fiscal-2018-Results-FINAL.pdf [SID1234530410]).

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FINANCIAL REVIEW
The Company recorded a net loss and total comprehensive loss of $8,625,000 and $10,059,000 (a loss per common
share of $0.09 and $0.11) for the fiscal years ended July 31, 2018 and 2017 respectively.

Research and development
Research and development expenses totalled $6,084,000 and $6,524,000, respectively for the twelve-month periods ended July 31, 2018 and 2017.

L-DOS47 research and development expenses for fiscal 2018 totalled $4,893,000 (2017 – $5,496,000). L-DOS47
research and development expenditures relate primarily to the Company’s LDOS002 European Phase I/II clinical
study in Poland, LDOS001 Phase I clinical study in the U.S., and preliminary expenditures related to the Company’s
LDOS003 Phase II clinical study in

clinical study report. In addition, given the limited cash resources, the LDOS003 clinical trial which was previously
planned to commence enrolment in early 2018 had not moved forward though the Company is still committed to
advance the program. The Company continues to be committed to the LDOS001 study and has re-allocated
resources to improve patient enrollment. An amendment to the LDOS001 study protocol allowed the Company to
advance enrollment from Cohort two at the beginning of the 2018 fiscal year to where it was most recently announced that the Company commenced enrolment in the final two cohorts of the study which is now enrolling patients in Cohort six. In addition, the Company has begun early development of a Phase I/II study, L-DOS47 given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer. An initial draft study protocol was circulated in July 2018 and ongoing development continues.

V-DOS47 research and development expenses for fiscal 2018 totalled $457,000 (2017 – $372,000). The higher
expenditures in the current year mainly reflect the increase in staff and consultants as the Polish subsidiary ramped
up activities in the program. In fiscal 2016 the Company established a wholly-owned subsidiary in Poland and entered
into a grant funding agreement with the Polish National Centre for Research and Development ("PNCRD") for research and development expenditures associated with V-DOS47. The Company’s subsidiary received $475,000
and $335,000 in fiscal 2018 and 2017, respectively, from the PNCRD.

CAR-T research and development expenses for fiscal 2018 and 2017 totalled $318,000 (2017 – $259,000). During
the current fiscal year, the Company announced a collaboration agreement related to novel CAR-T therapeutics and
new antibody-based technologies for cell-based therapies.

Corporate research and development expenses were relatively flat for fiscal 2018 and 2017 and totalled $432,000
(2017 – $474,000). Trademark and patent related expenses for fiscal 2018 and 2017 totalled $440,000 (2017 – $361,000). The Company continues to ensure it works to adequately protect its intellectual property.

Operating, general and administration
Operating, general and administration expenses totalled $2,462,000 and $3,738,000, respectively for the fiscal years
ended July 31, 2018 and 2016. The decrease in operating, general and administration expenses reflects the
Company’s cost cutting initiatives. The Company eliminated the employment/contractual arrangement with its then
CEO, who was also a director of the Company, and also let go if it’s controller as part of a headcount reduction plan.
Aggressive steps were also taken to reduce unnecessary expenditures such as travel and conferences. In addition,
various third-party contracts were also eliminated. During the fiscal year the Company hired Deloitte as strategic
advisor to explore partnering and licensing opportunities. Cost reductions in Canada were offset by operating, general and administrative expenditure increases incurred at the Company’s Polish subsidiary.

LIQUIDITY AND CAPITAL RESOURCES
As at July 31, 2018 the Company had a working capital deficiency of $1,901,000 (2017 – $504,000), shareholders’
deficiency of $1,527,000 (2017 – $17,000) and a deficit of $164,005,000 (2017 – $155,380,000).
The Company’s cash reserves of $366,000, as at July 31, 2018 are insufficient to meet anticipated cash needs for
working capital and capital expenditures through the next twelve months, nor are they sufficient to see the current
research and development initiatives through to completion. Subsequent to the Company’s fiscal year ending July
31, 2018, the Company closed two additional private placements for gross proceeds of $1,274,000. Though the
funds raised have assisted the Company in dealing with the working capital deficiency, additional funds are required
to advance the various clinical and preclinical programs and pay for the Company’s overhead costs. To the extent
that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers
securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its
development needs.

The Company’s consolidated financial statements, management’s discussion and analysis and annual information
form will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website
at www.helixbiopharma.com.

On October 26, 2018 ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for cancer reported that it will present the results of its latest clinical trial in lung cancer patients (Press release, Andarix Pharmaceuticals, OCT 26, 2018, View Source [SID1234530404]). The trial focused on the administration of Tozaride, the company’s lead candidate in neuroendocrine lung cancer patients. The abstract is entitled "Targeted Clinical Study with 188 Re P2045 in lung cancer expressing SSTR and well differentiated Neuroendocrine tumours," and will be presented at the SNMMI Northeast Regional Meeting 2018 in Newport, RI. October 26-27, 2018.

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About Tozaride
Tozaride is a novel, best-in-class cancer therapy based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with enough expression of the peptide’s target Tozaride could provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.

On October 26, 2018 Amgen (NASDAQ:AMGN) reported that it will report its third quarter 2018 financial results on Tuesday, Oct. 30, 2018, after the close of the U.S. financial markets (Press release, Amgen, OCT 26, 2018, View Source;p=RssLanding&cat=news&id=2373775 [SID1234530308]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 26, 2018 Johnson & Johnson (NYSE: JNJ) reported that the United States District Court, District of New Jersey has issued a ruling invalidating all asserted claims of U.S. Patent No. 8,822,438 for ZYTIGA (abiraterone acetate) (Press release, Johnson & Johnson, OCT 26, 2018, View Source [SID1234530301]). The Court held that the patent claims would be infringed if the patent were valid. The patent infringement case was filed against several companies who have submitted Abbreviated New Drug Applications for 250 mg and/or 500 mg tablets.

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Janssen strongly disagrees with the court’s ruling and will continue to defend the patent. We plan to appeal the decision. The Court has ordered that the status quo be maintained through October 30, 2018, and no generic launch shall occur before October 31, 2018 so that Janssen’s preliminary injunction motion to enjoin defendants from launching their generic products pending the appeal process can be decided. Janssen has filed a motion for rehearing with the U.S. Patent & Trademark Office (USPTO) in connection with the prior Inter Partes Review decisions related to the ‘438 patent.

Commercial launch of generic abiraterone acetate prior to the outcome of the appeals would be considered an at-risk launch. In Europe, ZYTIGA is protected by regulatory exclusivity through September 2022.

Janssen will continue to defend intellectual property rights relating to its innovative medicines. The company reaffirms its guidance provided on October 16, 2018 for operational sales growth of 5.5% to 6.0% and its adjusted earnings per share guidance of $8.13 – $8.18 for the full-year 2018.