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Targovax announces poster at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 9, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that the poster "A randomised open-label phase I/II study adding ONCOS-102 to pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma – 12-month analysis of biomarkers and clinical outcomes" are now available at the Company’s website (Press release, Targovax, NOV 9, 2020, View Source [SID1234570361]).

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The abstract presents the 12-month analysis of biomarkers and clinical outcome from the phase I/II trial in malignant pleural mesothelioma where ONCOS-102 is added to standard of care chemotherapy (pemetrexed / cisplatin). This analysis supports the data presented in June.

Title (361): A randomised open-label phase I/II study adding ONCOS-102 to pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma – 12-month analysis of biomarkers and clinical outcomes
Presenter:

Prof. Luis Paz-Ares, Principal Investigator of the trial and Chair of the Medical Oncology Department at the Hospital Doce de Octubre, Madrid

Poster session:

Location:

Wednesday 11. November 23:15-23:45 CET (17:15–17:45 EST)

Friday 13. November 22:40-23:10 CET (16:40-17:10 EST)

Virtual Poster Hall

The poster is also available on Targovax’s website.

Ambrx Closes $200 million in Crossover Financing with Leading Healthcare Investors to Advance its Clinical and Preclinical Pipeline of Precision Biologics

On November 9, 2020 Ambrx Inc., a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code reported the successful closing of an oversubscribed US$200 million crossover financing round (Press release, Ambrx, NOV 9, 2020, View Source [SID1234570360]).

New investors include Fidelity Management & Research Company LLC, funds and accounts managed by BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. BofA Securities acted as the sole placement agent for the offering.

"This financing represents our most significant capital raise to date and includes several leading global and US based healthcare funds. Since mid-2018, our new management team, set on a new long term vision, has committed to building company fundamentals and transforming Ambrx from a technology developer to a full-fledged biopharmaceutical company," said Dr. Feng Tian, CEO and Chairman of Ambrx. "The conclusion of this financing and the strong data emerging from our ongoing clinical programs, as well as our deep preclinical pipeline of proprietary drug candidates, positions the company for rapid growth."

Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long acting therapeutic peptides for metabolic and cardiovascular disease.

The company’s innovation engine continues to expand the clinical and preclinical pipeline by discovering new and valuable programs that take full advantage of the Ambrx technologies. These novel programs have the potential to address a wide range of diseases with new or improved mechanisms of action, providing the company with a rich set of programs to develop internally or in partnership with leading pharmaceutical companies.

VBI Vaccines Announces e-Poster Presentation at the Society for Neuro-Oncology (SNO) 2020 Virtual Meeting

On November 9, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that its abstract highlighting data from Part B of the ongoing Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) was accepted for e-poster presentation at the 25th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), taking place November 19-21, 2020 (Press release, VBI Vaccines, NOV 9, 2020, View Source [SID1234570359]).

Poster #: CTIM-07

Title: Identification of a baseline biomarker associated with tumor responses in a Phase 1/2a trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM)

Session: Clinical trials: Immunologic

Presenter: Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Infrastructure at Herbert Irving Comprehensive Cancer Center, and principal investigator of the ongoing Phase 1/2a study

Date: Available November 19-21, 2020

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in 38 patients with recurrent GBM:

● Phase 1 (Part A)

●Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences
●This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg

●Phase 2a (Part B)

●Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase
●This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants
●Enrollment of the 10 patients in the GM-CSF arm and the 10 patients in the AS01B arm are complete

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.

ASLAN PHARMACEUTICALS REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On November 9, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the third quarter ended September 30, 2020 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, NOV 9, 2020, View Source [SID1234570358]).

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "The third quarter saw great progress being made on multiple fronts for ASLAN. We resumed our multiple ascending dose (MAD) study of ASLAN004 following the lifting of COVID-19 restrictions and quickly completed recruitment of the second cohort, which we believe is an indicator of the scale of the unmet need we aim to address in atopic dermatitis. Recruitment of the third cohort is underway from sites in the US, Australia and Singapore, and we expect to announce new, unblinded data in early 2021. The move of our primary listing to the US is now complete and aligned with our plans to initiate a global Phase 2b study in atopic dermatitis in 2021 and new clinical studies of ASLAN003 in autoimmune disease."

Third quarter 2020 and recent business highlights

Clinical development

ASLAN004

Investigational New Drug application submitted to the US Food and Drug Administration became effective and Clinical Trial Notification cleared by the Therapeutics Goods Administration in Australia.
Seven new clinical sites opened in the US and Australia designed to support recruitment of patients into the ongoing MAD study.
Initiated recruitment of patients into third dose cohort in October at sites in the US, Australia and Singapore following successful safety review of second cohort that resumed recruitment in August. ASLAN004 was found to be well tolerated at 400mg and the Data Monitoring Committee (DMC) recommend that the MAD study continue as planned.
ASLAN003

Announced plans to develop ASLAN003, ASLAN’s next generation inhibitor of dihydroorotate dehydrogenase (DHODH), in autoimmune conditions, such as multiple sclerosis, following review of the data generated on ASLAN003 and discussions with experts in the field. ASLAN believes that ASLAN003 has a potential best in class profile as a potent oral DHODH inhibitor targeting autoimmune indications.
Appointed renowned neurologist Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, as a scientific advisor to the Company. ASLAN will work with Professor Giovannoni on the clinical development plan of ASLAN003.
Based on previous observations of anti-viral activity against Dengue and Zika viruses, ASLAN recently determined that ASLAN003 has nanomolar potency against SARS-CoV-2 in Vero E6 cells (EC50 = 1.4 nM) and is assessing the potential of ASLAN003 as a treatment for COVID-19 and other viral infections.
Corporate updates

Appointed Dr Kenneth Kobayashi as Chief Medical Officer. Dr Kobayashi most recently worked at Dermira, where he was responsible for the development of lebrikizumab, and previously held roles at Novartis and LEO Pharma. Dr Kobayashi brings more than 25 years of experience in drug development, clinical practice and regulatory affairs as a Dermatology expert.
Movement of primary listing to the Nasdaq Global Market and delisting from the Taipei Exchange completed in August. ASLAN has retained its listing of American Depositary Shares (ADS) on Nasdaq in the United States.
Anticipated upcoming milestones

Interim, unblinded data on ASLAN004 from the 3 dose cohorts (up to 24 patients) and initiation of the expansion cohort (an additional 18 patients) expected in early 2021.
Completion of MAD clinical study of ASLAN004 in moderate-to-severe atopic dermatitis (AD) patients expected in 1H 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in 2021.
Third quarter 2020 financial highlights

Cash used in operations for the third quarter of 2020 was US$2.6 million compared to US$7.0 million in the same period in 2019.
Research and development expenses were US$2.2 million in the third quarter of 2020 compared to US$4.1 million in the third quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib.
General and administrative expenses were US$1.3 million in the third quarter of 2020 compared to US$1.1 million in the third quarter of 2019.
Net loss for the third quarter of 2020 was US$3.5 million compared to a net loss of US$5.2 million for the third quarter of 2019.
Cash, cash equivalents and short-term investments totaled US$12.1 million as of September 30, 2020 (this includes US$0.9 million of cash received in connection with the ADS scheme that will be paid to our depository agent in 4Q 2020) compared to US$22.2 million as of 31 December 2019. Weighted average ADS outstanding for the third quarter of 2020 was 38.0 million (or equivalent) compared to 32.0 million (or equivalent) for the third quarter of 2019. One ADS is the equivalent of five ordinary shares.

Neurocrine Biosciences to Present at Upcoming Healthcare Conferences

On November 9, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that Neurocrine Biosciences management will present at the following investor conferences (Press release, Neurocrine Biosciences, NOV 9, 2020, View Source [SID1234570357]):

Kevin Gorman, Chief Executive Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the Stifel 2020 Virtual Healthcare Conference at 11:20 a.m. Eastern Time on Monday, November 16, 2020.
Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the Jefferies Virtual London Healthcare Conference at 2:40 p.m. Greenwich Mean Time (9:40 a.m. Eastern Time) on Tuesday, November 17, 2020.
The live presentations will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.