On May 30, 2018 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2018 (Press release, Nordic Nanovector, MAY 30, 2018, View Source [SID1234553502]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Tone Kvåle, CFO and Interim CEO, commented: "We have been focusing our efforts, since the beginning of the year, on getting PARADIGME approved and started. While our progress with the start-up of this pivotal study has been encouraging, we saw reason in April to announce adjustments to the timelines for its duration and are now targeting the first data read-out from the study in the first half of 2020.

"We remain convinced of the significant potential of Betalutin based on the promising clinical data generated to-date. We also believe that PARADIGME provides a robust trial design to generate the data needed to support our regulatory and commercialisation strategy for Betalutin to become an important new treatment option for 3L FL patients."

Operational Highlights Q1’18

• Start-up activities ongoing for pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed/refractory follicular lymphoma (3L R/R FL)

o As at May 29th, 23 sites in 8 countries are open for enrolment

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Events after Q1’18

• Luigi Costa stepped down as CEO

o Tone Kvåle appointed as Interim CEO in addition to existing role as CFO

o Search for new CEO underway

• PARADIGME timelines revised with first results targeted for 1H 2020 (previously 2H 2019)

o Start-up activities and site initiations progressing

• Clinical development of Humalutin postponed for the foreseeable future as resources are re-focused on PARADIGME and the Betalutin development programme

Financial Highlights Q1 ‘18

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues in the first quarter 2018 amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the quarter were NOK 82.3 million (NOK 65.8 million).

o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 76.2 % of total operating expenses in the first quarter 2018 (72.2 %).

• Operating loss for the quarter was NOK 82.3 million (loss of NOK 65.7 million).

• Comprehensive loss for the quarter was NOK 90.7 million (loss of NOK 55.8 million).

• Cash and cash equivalents as at 31 March 2018 amounted to NOK 641.5 million, down from NOK 756.6 million at the end of 31 December 2017.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with initial data read-outs from the study targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Presentation and webcast – First quarter 2018 results and webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST on 30 May at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

On May 30, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, will present at the William Blair 38th Annual Growth Stock Conference on Wednesday, June 13, 2018 at 12:40 p.m. Central Time in Chicago, IL (Press release, Veracyte, MAY 30, 2018, View Source [SID1234526955]).

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The live webcast of the presentation and a subsequent replay may be accessed by visiting Veracyte’s website at View Source The replay of the webcast will be available shortly after the conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

On May 30, 2018 Array BioPharma Inc. (Nasdaq:ARRY) reported that its Chief Executive Officer, Ron Squarer, will speak at the Jefferies 2018 Global Healthcare Conference in New York (Press release, Array BioPharma, MAY 30, 2018, View Source [SID1234527438]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event:

Jefferies 2018 Global Healthcare Conference

Presenter:

Ron Squarer, Chief Executive Officer, Array BioPharma

Date:

Wednesday, June 6, 2018

Time:

2 p.m. Eastern Time

Webcast:

View Source

On May 30, 2018 Helix BioPharma Corp. (TSX, FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that the Safety Review Committee ("SRC") reviewed safety data from the third dosing cohort of the Company’s LDOS001 study and recommended that Helix begin enrollment of patients into the fourth dosing cohort (Press release, Helix BioPharma, MAY 30, 2018, http://www.helixbiopharma.com/helix-biopharma-corp-completes-third-dosing-cohort-initiates-enrollment-next-cohort-u-s-combination-treatment-study-lung-cancer-drug-candidate-l-dos47/ [SID1234527251]). LDOS001 is a dose escalation study of L-DOS47 with pemetrexed and carboplatin in recurrent or metastatic non-squamous non-small cell lung cancer. Patients enrolled in the fourth dosing cohort will receive the next L-DOS47 dose level which is 3.0 micrograms of L-DOS47 per kilogram of patient body weight.

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"We are very encouraged that L-DOS47 in combination with chemotherapeutics continues to be safe and well tolerated by patients," said Heman Chao, Helix’s Chief Executive Officer. "We look forward to completing this trial under an FDA approved amendment to accelerate dose escalation for this trial".

The following is an update regarding the LDOS001 trial:

 No dose limiting toxicities reported at doses up to 1.5 µg/kg (cohort 3)

 From imaging data available on the first nine patients, four confirmed partial response have been observed with one patient achieving a tumor volume reduction of 91%
 Eight additional patients to complete the study if no dose limiting toxicity is observed or cohort expansion is required due to safety concern

On May 30, 2018 Symphogen, a private clinical late-stage antibody oncology focused biopharmaceutical company with a novel and differentiated antibody mixture pipeline, reported that it has enrolled the first patients into two separate Phase 1 clinical trials with two new investigational antibody therapies discovered from its immuno-oncology (I-O) activities with Shire targeting LAG3 (Sym022) and TIM3 (Sym023) (Press release, Symphogen, MAY 30, 2018, View Source [SID1234527007]).

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These are the second and third clinical programs to have been initiated under the I-O activities, the first being a Phase 1 trial of Sym021, an anti-PD1 antibody discovered by Symphogen, for solid tumors or lymphomas. All three I-O programs result from Symphogen’s antibody discovery and development activities under a strategic agreement with Shire plc established in 2016.

The Phase 1 clinical trials for each of these investigational therapies are open-label, dose-escalation studies designed to evaluate the preliminary safety and tolerability of the monotherapies in patients with locally advanced/unresectable or metastatic solid tumors or lymphomas that are refractory to available therapy or for which no standard therapy is available (Sym021: NCT03311412; Sym022: NCT03489369; Sym023: NCT03489343). Data is expected to be available in early 2019.

Commenting on the announcement, Chief Executive Officer of Symphogen, Martin Olin, said:
"We are excited about these important additions to our clinical pipeline. Our ability to advance three important immune checkpoint inhibitors into clinical development within a short period of time further validates the quality and the productivity of our antibody platform to rapidly generate unique antibody therapeutics that may enable new and improved treatment options for cancer patients. We now have seven product candidates in clinical development targeting important unmet medical needs demonstrating the potential significant value of our antibody platform. Our agreement with Shire provides the opportunity to bring next generation immunotherapies to patients for the treatment of cancer that could potentially be used in combination."

About the I-O programs
Symphogen’s research and development activities in the I-O area are focused on employing its antibody discovery and screening methodology against a number of targets demonstrated to be involved in cancer development and progression via negative regulation of the immune system, such as immune checkpoints found on immune cells. PD1, LAG3 and TIM3 are immune checkpoints playing important roles in regulating immune responses, including the body’s immune response to tumor cells (NEJM 2015; 2006-17, NEJM 2015; 372, 2509-20 and Nat Rev Drug Discovery 14; 561-584; 2015).

Sym021 is a novel, high affinity, chicken-derived, humanized antibody against PD1 with promising anti-cancer potential demonstrated in mouse tumor models. Sym022 is a novel antibody against LAG3, which shows enhanced anti-cancer activity in combination with anti-PD1 antibody therapy. Sym023 is an anti-TIM3 antibody with a novel mode of action.

Preclinical data for Sym021, Sym022 and Sym023 were presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 (Sym021: Abstract #3822; Sym022: Abstract #5626; Sym023: Abstract #5629).