1stOncology™: Cancer Intelligence Service – Page 12078 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Nordic Nanovector ASA – Results for the Third Quarter 2019

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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.

Mallinckrodt to Present at Piper Jaffray Annual Healthcare Conference

On November 19, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, will present on Tuesday, Dec. 3, 2019, at the Piper Jaffray Annual Healthcare Conference at the Lotte New York Palace, 455 Madison Ave, New York (Press release, , NOV 19, 2019, View Source [SID1234551504]).

Mark Trudeau, President and Chief Executive Officer, and Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, will represent the company in a fireside chat at 8:30 a.m. Eastern.

Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.

Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results

On November 19, 2019 Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Cellect Biotechnology, NOV 19, 2019, View Source [SID1234551503]).

Recent Highlights

Received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the commencement of a clinical trial to determine the safety and tolerability of the ApoGraft technology for haploidentical bone marrow transplantations. This development represents the Company’s first-ever clinical trial approval in the U.S. using its ApoGraft stem cell selection technology, which is designed to significantly reduce acute graft-versus-host disease (aGVHD) following bone marrow transplantation.
Successfully validated the Company’s technology in collaboration with a regenerative medicine company. The study, when combined with others and internal findings increase the body of evidence supporting the Company’s technology and add further proof to support Cellect ASCs derived stem cells program. Biocompatibility with certain collagen-based matrixes successfully demonstrated that cells grown utilizing the Company’s protocol can be incorporated into matrixes for expansion, transplantation and tissue regeneration.
"Our clinical and regulatory teams remained focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical study of ApoGraft is progressing slowly and we expect to complete the recruitment around the end of the year."

"With our prudent use of cash during the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.

Third Quarter 2019 Financial Results:

Research and development (R&D) expenses for the third quarter of 2019 were $0.71 million compared to $1.18 million in the third quarter of 2018. The Company remains committed to the ongoing clinical trials in Israel as well as pursuing the regulatory approval from the FDA to commence its US-based trial.

General and administrative (G&A) expenses for the third quarter of 2019 were $0.80 million compared to $1.13 million in the third quarter of 2018. The decrease reflects the cost cutting initiatives implemented by the Company during the third quarter of 2019.

Finance income for the third quarter of 2019 were $0.12 million compared to finance income of $0.36 million in the third quarter of 2018. The decrease was primarily due to changes related to fair value of the tradable and non-tradable warrants issued in prior fundraising.

Net loss for the third quarter of 2019 was $1.4 million, or $0.01 per share and $0.12 per ADS, compared to $1.9 million, or $0.014 per share and $0.29 per ADS, in the third quarter of 2018.

Cash and cash equivalents, $6.27 million as of September 30, 2019.
*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 = NIS 3.482).

Strategic Review Progress Update

On May 16, 2019, the Company disclosed that it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than the Company’s in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.

PTC Therapeutics to Present at the Evercore ISI 2nd Annual HealthCONx Conference

On November 19, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will participate in a panel discussion titled, "Gene Therapy with Base Business – Extracting Value," at the 2nd Annual Evercore ISI HealthCONx Conference on Tuesday, December 3rd at 2:45 p.m. ET (Press release, PTC Therapeutics, NOV 19, 2019, https://www.prnewswire.com/news-releases/ptc-therapeutics-to-present-at-the-evercore-isi-2nd-annual-healthconx-conference-300960397.html [SID1234551502]).

The panel discussion will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at www.ptcbio.com and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection. PTC’s current Corporate Presentation is available at the same website location.

Biosight Announces Data to be Presented at ASH 2019 Annual Meeting

On November 19, 2019 Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported that results from an ongoing Phase 2b clinical trial of BST-236 (aspacytarabine) for treatment of acute myeloid leukemia (AML), will be presented during an oral session at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, FL (Press release, BioSight, NOV 19, 2019, View Source [SID1234551501]).

The data, to be presented by Dr. Jessica K. Altman, Northwestern University, Chicago IL, will include integrated results from a Phase 1/2a study and an ongoing Phase 2b study, of BST-236 as a first-line single-agent treatment for AML patients who are unfit to receive standard intensive chemotherapy.

Oral presentation details:

Title: Aspacytarabine (BST-236) Is Safe and Efficacious As a Single-Agent, First-Line Therapy for Patients with Acute Myeloid Leukemia Unfit for Standard Chemotherapy. Integrated Results from a Phase 1/2a and an Ongoing Phase 2b
Presenter: Jessica K. Altman MD
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Treatment Strategies
Session Date: Saturday, December 7, 2019
Session Time: 12:00 PM – 1:30 PM
Presentation Time: 1:00 PM
Room: Orange County Convention Center, Chapin Theater (W320)

About BST-236 (Aspacytarabine)

BST-236 (aspacytarabine) is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 40 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically unfit patients. BST-236 is designed to enable high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, BST-236 may serve as a superior core therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

BST-236 was granted Orphan Drug Designation from the FDA, which entitles Biosight to seven years of market exclusivity upon BST-236 marketing approval for the treatment of AML.

A Phase 2b study is ongoing to confirm the promising results obtained in a Phase 1/2a study of BST-236 as a single-agent first-line AML therapy. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.