On March 19, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the quarter and full year ended 31 December 2019 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, MAR 19, 2020, View Source [SID1234555690]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "2019 marked a year of change for ASLAN as we focused our development efforts on the highly promising ASLAN004, a fully human monoclonal antibody that binds to the IL-13 receptor α1 subunit (IL-13Rα1), for the treatment of atopic dermatitis (AD) and asthma. The data we announced last December from our ongoing multiple ascending dose (MAD) study in AD was very encouraging, showing early signs of efficacy and a favourable side effect profile, and we believe that ASLAN004 has the potential to be a best-in-disease treatment for AD. The second dose cohort is recruiting well and we plan to wait until the end of cohort 3 to announce additional data, when the full dataset can be unblinded rather than releasing additional blinded data at the end of cohort 2. Our recent fundraising has positioned us well to complete the study and, at the same time, prepare to initiate a Phase 2b study in early 2021 as the next step in our development plan."

Fourth quarter 2019 and recent business highlights

Clinical development

ASLAN004

Initiated a randomised, double-blind, placebo-controlled MAD study in October to evaluate 3 doses of ASLAN004 (between 200mg and 600mg) in moderate to severe AD patients following the successful completion of the Single Ascending Dose clinical trial in healthy volunteers.

In December, preliminary results from the first patients treated with ASLAN004 showed early signs of efficacy in the low dose cohort. In a review of unclean blinded data, the Eczema Area and Severity Index (EASI) scores of the 3 patients who had completed at least one month of dosing were reduced by 85%, 70% and 59% from baseline and the EASI score continued to fall at 4 weeks with maximal efficacy expected at 6 to 8 weeks.

Following a meeting of the Data Monitoring Committee in late December, the second dose cohort began recruiting patients in Singapore. Recruitment currently appears unaffected by the COVID-19 pandemic and the trial is on track to complete in 2H 2020. Rather than announcing additional blinded data at the end of cohort 2, ASLAN plans to wait until the end of cohort 3, when data from all 3 dose cohorts can be unblinded. ASLAN expects to announce this unblinded, interim data in 3Q 2020, and will then open the expansion cohort at the selected dose.

ASLAN003

Published preclinical data in Haematologica Journal that showed ASLAN003’s potential as a potent human dihydroorotate dehydrogenase (DHODH) inhibitor and novel target for differentiation therapy with a favourable toxicity profile.

AhR antagonist

In September, ASLAN transferred the global rights to all of the assets related to aryl hydrocarbon receptor (AhR) antagonists, originally discovered and developed by ASLAN and its collaborators, to JAGUAHR Therapeutics, a joint venture with Bukwang Pharmaceutical.

JAGUAHR will identify a lead development compound to develop as a new immuno-oncology therapeutic

targeting the AhR pathway and file an Investigational New Drug (IND) application. Bukwang will invest US$5 million in JAGUAHR in two tranches to fund the development of the assets.

Additional Pipeline Programs

Announced topline data from the TreeTopp study of varlitinib in second line biliary tract cancer in October.

Corporate updates

Elected existing board member Andrew Howden as non-executive Chairman of the board and separated the roles of Chairman and Chief Executive Officer to maintain high standards of corporate governance.

Secured a US$3 million loan facility provided by the company’s Chairman, members of the board, and several major investors in October.

Successfully closed US$15 million public offering of 5,893,206 American Depositary Shares at a public offering price of US$2.50 per ADS in December supported by new investors, including the exercise in full of the underwriter’s option to purchase additional ADSs.

Anticipated upcoming milestones for ASLAN004

Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 3Q 2020, and initiation of the expansion cohort (an additional 18 patients).

Completion of MAD clinical trial in moderate-to-severe AD patients in 4Q 2020.

Opening of clinical trial sites in Australia and filing of IND application with the US FDA in the middle of 2020

Initiation of Phase 2b study of ASLAN004 for AD in 1H 2021.

Fourth quarter 2019 financial results

Cash used in operations for the quarter ended 31 December 2019 was US$5.1 million compared to US$9.6 million in the same period in 2018.

Research and development expenses were US$2.7 million, general and administrative expenses were US$3.3 million for the fourth quarter of 2019, compared to US$9.2 million and US$1.9 million respectively in the same period in 2018.

Net loss for the fourth quarter of 2019 was US$29.6 million compared to a net loss of US$11.2 million for the fourth quarter of 2018. This reflects a one-off impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the fourth quarter of 2019 was US$6.5 million compared to a net loss of US$11.2 million for the fourth quarter of 2018.

Full Year 2019 financial highlights

Cash used in operations for year ended 31 December 2019 was US$25.8 million compared to US$39.5 million in the same period in 2018.

Research and development expenses were US$16.6 million, general and administrative expenses were US$8.5 million for the full year 2019, compared to US$31.8 million and US$10.5 million respectively in the same period in 2018.

Net loss for the full year 2019 was US$47.0 million including a one-off impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the full year 2019 was US$23.9 million compared to a net loss of US$42.2 million for the full year 2018.

Cash, cash equivalents and short-term investments totaled US$22.2 million as of 31 December 2019 compared to US$28.9 million as of 31 December 2018.

On March 19, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835), reported that it will publish its Full Year Results for 2019 on Thursday, March 26, 2020 (Press release, Vivoryon Therapeutics, MAR 19, 2020, View Source [SID1234555688]). The company will host a conference call and webcast (in English) open to the public. The Full Year 2019 Results will be available to download on the company website (www.vivoryon.com/investors-news/financial-information/)

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Conference call details

Date: Thursday, March 26, 2020
Time: 3:00 pm CET /10:00 am EDT

Access Code: 68603233#

From Germany: +49 69 201 744 220
From UK: +44 203 009 2470
From USA: +1 877 423 0830

Webcast details

A live webcast and slides will be made available at: (www.vivoryon.com/investors-news/financial-information/)

On March 18, 2020 CERo Therapeutics, Inc., a privately held biopharmaceutical company, reported a research collaboration with Lyell Immunopharma, Inc. to develop next generation cell-based immunotherapies for solid tumors (Press release, Cero Therapeutics, MAR 18, 2020, View Source [SID1234573140]). At the same time, CERo announced the completion of a $40 million Series A private financing.

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Under the terms of the agreement, CERo and Lyell will collaborate to pursue proof-of-concept studies for a new class of cell-based therapeutics directed against solid tumors. CERo’s CER-T technology instructs immune cells to engage novel and complementary tumor cell clearance pathways designed to enable deeper and more sustained responses against broad classes of tumors.

"CERo’s technology combines multiple forms of tumor cell clearance and introduces them into single cells to vastly expand their therapeutic potential," said Daniel Corey, MD, Co-founder and Chief Executive Officer of CERo. "Lyell, with their advanced T-cell capabilities, is an ideal partner for CERo. We believe the two platforms have powerful therapeutic synergies."

"CERo is building an innovative class of therapeutics by leveraging understandings from innate immunology and synthetic biology," said Rick Klausner, MD, Founder and Chief Executive Officer of Lyell Immunopharma, Inc. "We look forward to a productive partnership designed to rapidly identify effective cell-based therapies."

Lyell Immunopharma Inc. is a cell therapy company dedicated to understanding and developing technologies to overcome the fundamental barriers to curative therapies. Lyell is focused on advancing the science of T-cell differentiation, functionality, and target specificity in order to develop curative treatments for human disease.

CERo Private Financing
The Series A private financing, which included ARCH Venture Partners, Milky Way Investments Group Limited, Lyell Immunopharma, Inc., Sequoia Capital China, Altitude Life Science Ventures, and existing CERo shareholders raised $40 million. Proceeds from the financing are being used to expand start-up operations and advance the company’s proprietary CER-T technology platform into the clinic.

"CERo is exploring a fresh avenue of rich scientific investigation to reimagine tumor cell clearance" said Robert Nelsen, Co-founder and Managing Director of ARCH Venture Partners.

On March 18, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and cannabinoid research, reported that the Company has completed the acquisition of leading oncology research and development company Sapphire Biotech, Inc. ("Sapphire") (Press release, Sapphire BioTech, MAR 18, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-acquiree-sapphire-biotech-inc-signs-sponsored-research-agreement-with-arizona-state-university-to-develop-metastatic-cancer-inhibitor [SID1234558650]).

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In January of this year, AXIM announced that the Company signed a binding term sheet to acquire Sapphire. As part of the acquisition, AXIM has acquired 100 percent of the capital stock of Sapphire and will operate Sapphire as a wholly-owned subsidiary. Sapphire will continue to be led by Catalina Valencia, as Chief Executive Officer. Ms. Valencia has stewarded Sapphire in the development of its unique patent-pending pipeline.

"With this acquisition of Sapphire Biotech, AXIM enters into a new phase as we shift our focus to both oncology and cannabinoid research," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "We chose to acquire Sapphire because of the team it brings and because the company has already made large discoveries in the field of oncology, which hold the potential to help so many lives when coupled with its impressive IP portfolio."

Sapphire has licensed a leading compound, called SBI-183, which inhibits and suppresses invasion in vitro and metastasis in vivo. The company recently announced that it now holds exclusive license rights to SBI-183 and intends to study the compound’s ability to treat cancer. In February, Sapphire signed a Sponsored Research Agreement with a leading cancer research organization to conduct preclinical studies to develop a metastatic cancer inhibitor using the licensed SBI-183 compound.

In addition to its upcoming research on cancer-treating compounds, Sapphire is also developing a novel line of diagnostics for early cancer detection, response to treatment and recurrence monitoring. One of Sapphire’s diagnostic tools is currently being evaluated in a clinical trial for its potential to diagnose pancreatic cancer.

AXIM chose to acquire Sapphire because of its focus on cancer therapeutics for inhibiting cancer growth and metastasis, its diagnostics line, and a world-renowned research team. Through this acquisition, AXIM not only gains Sapphire’s already existing patent-pending portfolio of technologies but also now has the ability to develop new in-house proprietary molecules and potential treatments for numerous diseases.

"Sapphire’s researchers are excited to work alongside AXIM to continue developing novel diagnostic tools for early detection and potential treatments for halting cancer metastasis," said Catalina Valencia, Chief Executive Officer of Sapphire Biotech. "By combining our expert research teams, we intend to extend the scope of our research even further."

On March 18, 2020 OncoOne reported the close of a EUR 13 million Series A financing round, marking its industry debut. OncoOne will develop several drug modalities to target oxidized macrophage migration inhibitory factor (oxMIF), an isoform of macrophage migration inhibitory factor (MIF) and an exciting new drug target in solid tumor cancer indications (Press release, OncoOne, MAR 18, 2020, View Source [SID1234555687]). With extensive experience in drug discovery and development, the founders, Randolf Kerschbaumer, PhD, Michael Thiele, PhD and Alexander Schinagl, PhD founded OncoOne to develop multiple proprietary drug modalities targeting oxMIF, with the goal of rapidly entering clinical trials in pancreatic, colorectal, lung and ovarian cancer . Investors participating in the Series A included the Austrian Research Promotion Agency (FFG), the Austria Wirtschaftsservice Gesellschaft (AWS), and two family offices. Further details regarding the funding round have not been disclosed.

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"As a target, oxMIF provides a very unique opportunity because in contrast to many other targets currently investigated in cancer therapy, it is generated by a post-translational mechanism and is characterized by a remarkable tumor specificity. OxMIF can be harnessed to attack specific types of tumors through different drug modalities," said Randolf Kerschbaumer, CEO of OncoOne. "Our Company name represents our united ambition to use our combined drug development expertise to access the varied potential of oxMIF and the initial funding will enable us to explore this potential to provide innovative treatments for cancer indications with poor prognosis."