On June 13, 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection (Press release, Genentech, JUN 13, 2018, View Source [SID1234527302]).

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"Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death."

"This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery," said Melissa Aucoin, chief executive officer, National Ovarian Cancer Coalition (NOCC). "Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers."

The approval for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the treatment of women with stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, is based on data from the pivotal Phase III GOG-0218 trial. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.62; 95% CI 0.52 – 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total). Avastin has boxed warnings for GI perforation, surgery and wound healing complications and hemorrhage.

Avastin is now approved for ten distinct uses across six different types of cancer in the United States. This indication represents Avastin’s fourth gynecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.

About the GOG-0218 Study

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone for a total of up to 22 cycles. The primary endpoint of the study was investigator-assessed PFS and secondary endpoints included overall survival (OS). The study was conducted by the Gynecologic Oncology Group (GOG) and initial results were previously published in the New England Journal of Medicine.

Grade 3-4 adverse events occurring more often (≥2%) in the Avastin with chemotherapy followed by Avastin alone arm or the Avastin with chemotherapy arm versus the chemotherapy alone arm were fatigue (9%, 6%, 6%, respectively), high blood pressure (10%, 6%, 2%), decreased platelet count (21%, 20%, 15%) and decreased white blood cell count (51%, 53%, 50%).

1 Relative to the control arm; stratified hazard ratio

2 Two-sided p-value based on re-randomization test

3 Final overall survival analysis

About Ovarian Cancer

Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2018, more than 22,000 women will be diagnosed with ovarian cancer in the U.S. and about 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly and/or frequent urination, are present, they can be associated with other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

On June 13, 2018 Cytokinetics, Inc. (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the JMP Securities Life Sciences Conference on Wednesday, June 20, 2018 at 11:00 AM EDT at the St. Regis Hotel in New York (Press release, Cytokinetics, JUN 13, 2018, View Source [SID1234527303]).

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Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On June 12, 2018 PharmaMar (MSE:PHM) reported that basedmon recent receipt of OS (overall survival) data from lurbinectedin Phase II small-cellmlung cancer studies, including the monotherapy trial presented at ASCO (Free ASCO Whitepaper) on June 3rd that saw an OS of 11.8 months, a protocol amendment was submitted to FDA and other competent authorities to change the primary endpoint of the ATLANTIS Phase III trial from PFS (progression free survival) to OS (Press release, PharmaMar, JUN 12, 2018, View Source [SID1234527288]). The changes will begin when the competent authorities with responsibility for review and approval of the study approve of the changes, which in the US we expect to happen in the next few weeks. The safety of the patients and the integrity of this study are not compromised by these changes. PharmaMar remains blinded to the data, and
continues to expect completion of recruitment in the third quarter of 2018. This means PharmaMar expects the top line data, which is event driven, to readout in the second half of 2019.

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According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we feel that this change in endpoint to OS given what we have seen in the recent data, including those presented at ASCO (Free ASCO Whitepaper), offers us a better chance for success, especially as we know regulators prefer OS data over a surrogate endpoint subject to interpretation in this type of disease setting."

About Zepsyre
Zepsyre (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%i About 18% of all the lung cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded everyyear. This tumor is strongly associated with tobacco smoking, posing an important public health problemii

After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.

On June 12, 2018 Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP) ("Helix" or the "Company"), a clinical stage
immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported its financial results for its fiscal quarter ended April 30, 2018 (Press release, Helix BioPharma, JUN 12, 2018, View Source [SID1234527598]).

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FINANCIAL REVIEW
The Company recorded a net loss and total comprehensive loss of $2,147,000 ($0.02 loss per common share) and $2,913,000 ($0.03 loss per common share) for the three-month periods ended April 30, 2018 and 2017, respectively. For the nine-month periods ended April 30, 2018 and 2017, respectively, the Company recorded a net loss and total comprehensive loss of $7,105,000 ($0.07 loss per common share) and $8,819,000 ($0.10 loss per common share).

Research and development
Research and development costs for the three and nine-month periods ended April 30, 2018 totalled $1,435,000 and $5,095,000,respectively ($1,932,000 and $6,111,000 respectively for the three and nine-month periods ended April 30, 2017).

L-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2018 totalled $1,029,000 and $4,039,000, respectively ($1,208,000 and $4,480,000 respectively for the three and nine-month periods ended April 30, 2017). L-DOS47 research and development expenditures relate primarily to the Company’s LDOS002 European Phase I/II clinical study in Poland, its LDOS001 Phase I clinical study in the U.S., preliminary expenditures related to the Company’s LDOS003 Phase II clinical study in Poland and the Ukraine and various other expenditures in support of the Company’s overall L-DOS47 program.

The Company’s LDOS001 clinical study has been facing patient enrolment challenges and as a result the Company most recently increased start-up activities to add 6 additional clinical study sites, with planned recruitment to begin mid-summer 2018. In addition, an accelerated dosing protocol has been approved to help accelerate the LDOS001 clinical study. On May 30th, 2018, the Company announced the completion of the third cohort and the initiation of enrollment in the fourth cohort of the LDOS001 clinical study. Enrolment in the Company’s LDOS002 clinical study was previously terminated due to lack of efficacy and the Company is currently awaiting the finalized reports. Given the limited cash resources, the Company has slowed down the previously committed LDOS003 clinical trial which the Company previously planned to commence enrolment in early 2018.

V-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2018 totalled $133,000 and $310,000, respectively ($309,000 and $659,000 respectively for the three and nine-month periods ended April 30, 2017). For the three and nine-month periods ended April 30, 2018 the Company’s Polish subsidiary received grant funding of $144,000 and $344,000, respectively ($92,000 and $228,000 respectively for the three and nine-month periods ended April 30, 2017). The higher expenditures in the prior year mainly reflect the increase in staff and consulting agreements as the Polish subsidiary ramped up activities in the V-DOS47 program. The Company’s wholly owned subsidiary in Poland has entered into a grant funding agreement with the Polish National Centre for Research and Development for research and development expenditures associated with VDOS47.

CAR-T research and development expenses for the three and nine-month periods ended April 30, 2018 totalled $192,000 and $317,000 respectively ($259 and $259 respectively for the three and nine-month periods ended April 30, 2017). During the current fiscal year, the Company commenced development of novel CAR-T therapeutics and new antibody-based technologies for cellbased therapies. The Company’s CAR-T expenditures relate primarily to collaborative research activities with ProMab Biotechnologies Inc.

Corporate research and development expenses for the three and nine-month periods ended April 30, 2018 totalled $122,000 and $346,000 respectively ($170,000 and $672,000 respectively for the three and nine-month periods ended April 30, 2017). Corporate research and development expenditures mainly reflect wages and benefits and related expenses associated with corporate head office staff. The reduction mainly reflects lower wages because of cost cutting initiatives to reduce headcount and third-party consulting costs.

Trademark and patent related expenses for the three and nine-month periods ended April 30, 2018 totalled $70,000 and $308,000, respectively ($75,000 and $197,000 respectively for the three and nine-month periods ended April 30, 2017). The Company continues to ensure it adequately protects its intellectual property.
Operating, general and administration Operating, general and administration expenses for the three and nine-month periods ended April 30, 2018 totalled $686,000 and $1,856,000, respectively ($944,000 and $2,826,000 respectively for the three and nine-month periods ended April 30, 2017). The decrease in operating, general and administration expenses reflects the Company’s cost cutting initiatives. The Company
eliminated the employment arrangement with its then CEO, who was also a director of the Company, and let go of its controller as part of a headcount reduction plan. Aggressive steps were also taken to reduce unnecessary expenditures such as travel, conferences, etc.…. In addition, various third-party contracts were also eliminated. During the fiscal quarter, the Company hired Deloitte as strategic advisor to explore partnering and licensing opportunities. Cost reductions taken at the head office were partially offset by operating, general and administrative expenditures being incurred at the Company’s newly formed subsidiary in Poland which mainly reflect salaries and benefits, legal and accounting services and overhead costs associated with the administrative office.

The Company recorded a net loss and total comprehensive loss of $2,147,000 ($0.02 loss per common share) and $2,913,000 ($0.03 loss per common share) for the three-month periods ended April 30, 2018 and 2017, respectively. For the nine-month periods ended April 30, 2018 and 2017, respectively, the Company recorded a net loss and total comprehensive loss of $7,015,000 ($0.07 loss per common share) and $8,819,000 ($0.10 loss per common share).

As at April 30, 2018 the Company had a working capital deficiency of $1,915,000, a shareholders’ deficiency of $1,507,000 and a deficit of $162,395,000. As at July 31, 2017 the Company had a working capital deficiency of $504,000, shareholders’ deficiency of $17,000 and a deficit of $155,380,000.
The Company continues to work with vendors to manage its cash position while ensuring vendors continue providing services while being paid, albeit over a longer period of time than previously agreed terms. The Company has raised approximately $6,913,000 from private placement financings during the current fiscal year. Nevertheless, the Company’s cash reserves of $770,000 as at April 30, 2018 in addition to the subsequent private placement on June 7, 2018 for gross proceeds of approximately $941,000 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 or any planned research and development initiatives through to completion.

Though the funds raised have somewhat assisted the Company in dealing with its working capital deficiency and attempts to make vendors current, additional funds are required to advance the various clinical and preclinical programs, pay for the Company’s overhead costs and its past due vendors. 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.
Additional information can be found about the Company’s liquidity and capital resources in the Company’s Management

Discussion and Analysis.
The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and ninemonth periods ending April 30, 2018 and 2017 and the condensed unaudited interim consolidated statement of cash flows for the nine-month periods ending April 30, 2018 and 2017

On June 12, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of a Phase I trial of SRF373, a fully human antibody targeting CD73. SRF373, also known as NZV930, is the second of Surface’s immunotherapies to advance into the clinic this year (Press release, Surface Oncology, JUN 12, 2018, View Source [SID1234527367]).

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CD73 is an enzyme overexpressed by many tumors that is critical to the production of extracellular adenosine which in turn suppresses immune cell function and the ability of the immune system to recognize and attack tumors. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased activity of immune cells.

The first-in-human study is being led by Novartis, which was granted a worldwide exclusive license to develop and commercialize NZV930 as part of its broad strategic collaboration with Surface. Under the collaboration, Surface is eligible to receive development and sales milestone payments for NZV930, as well as tiered royalties.

The Phase I study will evaluate the safety, tolerability, and preliminary anti-tumor activity of NZV930 as a single agent and in combination with other cancer immunotherapies. The initial dose escalation portion of the trial will include patients with triple negative breast cancer, ovarian cancer, microsatellite stable colon cancer, pancreatic cancer, non-small cell lung cancer, and renal cell carcinoma.

"We are very excited that Novartis has advanced our second product program into clinical development" said Rob Ross, M.D., chief medical officer of Surface Oncology. "We believe the profile of NZV930 is compelling and targeting adenosine reduction could play an important role in the treatment of patients suffering with a variety of types of cancer."

ABOUT SRF373 / NZV930

NZV930 is a fully human monoclonal antibody designed to inhibit CD73, an enzyme critical to the production of adenosine—an immunosuppressive metabolite within the tumor microenvironment. CD73 is overexpressed by many tumors making it a potential target with broad applicability. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased T cell activity. Novartis holds a worldwide exclusive license to develop and commercialize NZV930.