On November 19, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the third quarter 2019. A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below (Press release, Nordic Nanovector, NOV 19, 2019, View Source;results-for-the-third-quarter-2019-300960626.html [SID1234551505]).

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Eduardo Bravo, CEO, commented: "We are encouraged with the clinical results emerging from the different clinical trials with Betalutin in non-Hodgkin’s lymphoma (NHL). As stated by key opinion leaders in the field during the R&D Day hosted by Nordic Nanovector in September, the emerging profile of Betalutin is unique and very competitive. There are many patients who suffer from these devastating diseases who lack effective, safe and convenient treatment options. We remain fully committed to deliver on our timelines to bring this novel product to the market as quickly as possible."

Highlights Q3 `19

Updated analysis from Phase 1/2a LYMRIT 37-01 trial of Betalutin in relapsed/refractory follicular lymphoma (R/R FL) presented at R&D Day (September)
Median duration of response of 13.6 months for all responders and 32.0 months for complete responders (vs 9.0 and 20.7 months, respectively reported at ASH (Free ASH Whitepaper) 2018
Median follow-up time for responders of 30.0 months (range: 12.0 – 60.7 months)
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced, recurrent and CD20 antibody treatment refractory 3L Follicular Lymphoma (FL) is progressing
87 sites in 24 countries open for enrolment as of November 18th, 2019
Patient enrolment is expected to be completed in the second half of 2020
Phase 1b Archer-1 trial of Betalutin in combination with rituximab (RTX) in patients with R/R 2nd line FL (2L FL) advanced to second cohort
100% Overall Response Rate (3/3 Complete Responses) observed in the first patient cohort
Promising preclinical results with Alpha37 for B-cell tumours presented at EANM conference by partner Orano Med
Alpha37 project received grant funding of EUR 0.6 million from Eurostars
Approximately NOK 243 million (USD 26.4m) (gross) raised 18th October in private placement of new shares providing additional funds to support the continued clinical development of Betalutin (including completion of enrolment of PARADIGME and all ongoing clinical trials), manufacturing and other activities in preparation for the commercialisation of Betalutin
Dr Gabriele Elbl appointed as VP Global Regulatory Affairs to drive the company’s Regulatory Affairs strategy
Financial Highlights Q3 `19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the third quarter amounted to NOK 0.0 (NOK 0.0 million). Revenues for the first nine months 2019 were NOK 0.0 (NOK 0.0 million)
Total operating expenses for the third quarter were NOK 100.2 million (NOK 76.9 million). Total operating expenses for the first nine months of 2019 amounted to NOK 301.1 million (NOK 243.7 million)
Research and development (preclinical, clinical, medical affairs, regulatory and CMC (Chemistry, Manufacturing and Controls) activities expenses accounted for 78 % of total operating expenses for the first nine months of 2019 (73 %)
Comprehensive loss for the third quarter amounted to NOK 93.6 million (loss of NOK 75.4 million). Comprehensive loss for the first nine months was NOK 295.6 million (loss of NOK 249.1 million)
Cash and cash equivalents amounted to NOK 345.9 million at the end of September 2019 (NOK 440.1 million at 31 December 2018), exclusive of new funds raised in October 2019 of NOK 243 million (gross)
Outlook

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

Betalutin, the company’s most advanced radioimmunotherapy candidate, is developing a highly differentiated, competitive, clinical profile. Nordic Nanovector is confident that Betalutin could become an attractive and convenient once-only therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Betalutin is being developed for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway. Patient enrolment is expected to be completed in the second half of 2020. The study’s preliminary data read-out is planned a few months later. A BLA filing to gain marketing approval for Betalutin is expected in the first half of 2021. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin in core markets.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies across NHL and other haematological cancer indications.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

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/2019.

On November 19, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the third quarter 2019 (Press release, BerGenBio, NOV 19, 2019, View Source [SID1234551455]).

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A presentation and live webcast by the Company’s management will take place today at 10.00 am CET in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: ​"During the quarter we have continued working to expand our proof of concept trials in AML and NSCLC. Our goal is to confirm that the addition of our selective AXL inhibitor bemcentinib can substantially improve patient outcomes across both these indications. This will inform clinical strategy and position for late stage clinical development, and we remain committed to progressing bemcentinib through to regulatory approval."

Operational Highlights – Third quarter 2019

Non-Small Cell Lung Cancer (NSCLC)

Cohort A of the Phase II clinical trial (BGBC008) evaluating bemcentinib in combination with KEYTRUDA in patients with NSCLC met its primary endpoint.
Primary endpoint of Overall Response Rate (ORR) was met, with 33% ORR in cAXL positive patients; five times the response rate of cAXL negative patients (7%)
Response rate three times greater than that seen with Keytruda monotherapy reported in earlier clinical trials in similar patients.
Secondary endpoint of median Progression Free Survival (mPFS) reported significant 3-fold improvement in cAXL positive vs negative patients,
Data were presented at the prestigious High Impact Clinical Trial session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (6-10 November 2019) conference in Washington DC.
Proprietary Composite AXL Immune Score (cAXL) suggests patients that express AXL in both their tumor and immune cells report significantly improved clinical benefit from bemcentib combination with Keytruda.
Data from Cohort A of BGBC008 was also presented in an oral presentation at the 2019 World Conference on Lung Cancer (WCLC) and as a poster the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper).
Data suggest bemcentinib has potential to enhance patient responses and overall survival, when treated in combination with a PD-1 inhibitor, particularly in patients with no or limited expression of PD-L1, this is a very significant patient population, and a very encouraging development.
The clinical trial BGBC008 is ongoing in two additional cohorts; B) in Check Point Inhibitor refractory patients and C) in CPI/chemotherapy combination refractory patients. Preliminary data read out is anticipated in the first half of 2020.
Acute Myeloid Leukaemia (AML)

U.S Food and Drug Administration (FDA) has granted bemcentinib Fast Track Designation for the treatment of elderly patients with AML whose disease has relapsed.
The purpose of the Fast Track designation is to get important new drugs to the patients earlier
The Fast Track program is designed to facilitate the development and expedite the regulatory review of new drugs to treat serious conditions without any treatment options.
Phase IIa clinical trial data has shown that bemcentinib in combination with low-intensity chemotherapy (LDAC) in elderly AML patients is well tolerated and efficacious.
Preliminary responses were reported in 43% of evaluated patients, with complete responses in a substantially higher percentage of patients compared to previously observed/historical benchmarks in single-agent cytarabine.
Trial has been expanded to include an additional 28 patients to verify this early proof of concept, preliminary data from this expanded trial will be reported in the first half of 2020.
​Financial highlights

Revenue for the third quarter 2019 and the nine months ended 30 September 2019 respectively amounted to NOK 0 million (NOK 0 million) and NOK 8.7 million (NOK 0 million). The revenue was received in Q1 2019 from ADCT as a clinical milestone payment.
Total operating expenses for the third quarter and the nine months ended 30 September 2019 respectively amounted to NOK 47.5 million (NOK 38.1 million) and NOK 154.0 million (NOK 143.6 million).
Cash and Cash equivalents at end of Q3 2019 NOK 289.5 million (NOK 398.2 in Q3 2018).
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET at:

Arctic Securities
Haakon VIIs gate 5
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET.

On November 19, 2019 The Gray Foundation reported an event in Lower Manhattan raised more than $8.5 million for research on BRCA-related cancers (Press release, The Gray Foundation, NOV 19, 2019, View Source [SID1234551473]).

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Eyewitness News reporter and cancer survivor Stacey Sager proudly took part in the Basser Jean Bash at Cipriani Wall Street.

It raised money for The Basser Center for BRCA at Penn Medicine’s Abramson Cancer Center.

Stacey is on the center’s leadership council.

It is making great progress in the fight against the genetic mutations that cause some breast and ovarian cancers

On November 19, 2019 Lucence, a genomic medicine company that invents blood-based tests for cancer screening and treatment selection, reported the close of USD $20 million in Series A funding (Press release, Lucence, NOV 19, 2019, View Source [SID1234551489]). The round was led by IHH Healthcare, one of the world’s largest integrated private healthcare groups. SGInnovate, together with existing investors Temasek Holdings subsidiary Heliconia Capital, Lim Kaling, Koh Boon Hwee and others, also participated in the round. This funding will enable the company to provide its liquid biopsy technology to more patients across Asia and North America for personalized treatment selection. Lucence will also embark on new prospective clinical studies to evaluate its technology for the early detection of multiple cancers.

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Lucence spun out of Singapore’s Agency for Science, Technology and Research (A*STAR) in 2016. In 2018, the company introduced its flagship next-generation sequencing test, LiquidHALLMARK, the first and only clinical sequencing blood test that detects both cancer-related gene mutations and cancer-causing viruses within a single assay. The test has been used by oncologists in cancer diagnosis, monitoring and treatment selection for over 1,000 patients in Asia to date. LiquidHALLMARK detects clinically relevant mutations across 14 cancer types, including lung, breast, colorectal, pancreatic, nasopharyngeal and liver cancers. The test is based on Lucence’s core molecular watermarking technology, AmpliMARK, for improved accuracy and depth in sequencing results. In 2019, Lucence’s Singapore central laboratory became the first laboratory in Southeast Asia to be CLIA-certified and CAP-accredited in order to bring LiquidHALLMARK to physicians and patients in the United States.

"Our mission is to reduce worldwide suffering through early cancer detection. As a medical oncologist, I have worked in the clinic and the laboratory for over a decade, striving towards a world where cancer can be overcome with early screening. Our research discoveries, such as the identification of the circulating tumor-endothelial cluster, can transform the liquid biopsy field, allowing better non-invasive cancer screening and profiling for patients. This partnership with IHH Healthcare will accelerate our work to achieve early cancer detection and effective cures, and expand access to this much-needed liquid biopsy technology to patients across Asia and the United States," said Dr. Min-Han Tan, MBBS, PhD, founder and CEO of Lucence.

Dr. Kelvin Loh, Chief Executive Officer (Designate) of IHH Healthcare, said, "Liquid biopsy is a game-changer in our endeavor to provide cancer patients with better, value-driven outcomes through precise treatment selections and more affordable care. Our investment in Lucence will provide IHH patients with better access to this advanced technology. IHH looks to drive greater synergies with Lucence and co-develop solutions for patients, as well as explore opportunities to sharpen our precision medicine capabilities with other like-minded partners across our 10-country network."

Lucence will be in attendance at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress this week and will be exhibiting at booth B09.

On November 19, 2019 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) has granted marketing authorization for DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd) as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, NOV 19, 2019, View Source [SID1234551468]). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in October 2019. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are pleased that with this approval, patients in the European Union newly diagnosed with multiple myeloma who are not candidates for transplant will now have two potential options for treatment with DARZALEX containing regimens. We look forward to seeing the combination therapy of DARZALEX with lenalidomide and dexamethasone launched in Europe," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval was based on data from the Phase III MAIA (MMY3008) study of daratumumab in combination with Rd as treatment for patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT. Data from this study was published in The New England Journal of Medicine and was presented as a Late-Breaking Abstract at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.

About the MAIA (MMY3008) study
The Phase III study (NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with multiple myeloma who are not candidates for high dose chemotherapy and ASCT. Patients were randomized to receive either treatment with daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or treatment with lenalidomide and dexamethasone alone. In the daratumumab treatment arm, patients received 16 milligrams per kilogram (mg/kg) weekly for the first 8 weeks (Cycles 1 and 2), every other week for 16 weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide is administered at 25 mg orally on days 1 through 21 of each 28-day cycle, and dexamethasone is administered at 40 mg once a week for both treatment arms. Participants in both treatment arms will continue Rd until disease progression or unacceptable toxicity. The primary endpoint of the study is progression free survival.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 16,830 new patients were expected to be diagnosed with multiple myeloma and approximately 10,480 people were expected to die from the disease in the Western Europe in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy6. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.