On April 14, 2020 Cyclica reported a multi-year and multi-project collaboration with the Genome Institute of Singapore (GIS), a research institute under the Agency for Science, Technology and Research (A*STAR) (Press release, Cyclica, APR 14, 2020, View Source [SID1234556316]). Cyclica and GIS will carry out research efforts spanning from polypharmacology profiling to novel compound design for diverse drug discovery programs in oncology and related diseases . The collaboration will leverage GIS’ deep expertise in functional genomics, drug target discovery, and data analytics, and Cyclica’s AI-augmented and proprietary, Ligand Design and Ligand Express platform.

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The world-class team of scientists at GIS will conduct new compound design and off-target profiling to discover hits and subsequently develop the lead compounds. GIS will perform functional analyses and testing of compounds derived from Cyclica’s drug discovery platform against gene targets of interest to GIS. This cross-border collaboration provides a unique opportunity to tailor drug identification and development efforts in a holistic way that will enable the advancement of precision medicine. By empowering researchers and healthcare institutes who are at the forefront of innovation, Cyclica and GIS will pave the way to decentralize the drug discovery process and develop the next generation of improved treatments for patients based on the individual’s disease features.

Dr. Tam Wai Leong, Group Leader of Precision Oncology at GIS, said, "Applying AI-augmented approaches towards drug design is innovative and forward-looking. It has the potential to rapidly grow the arsenal of new drugs in our fight against diseases like cancer, especially in an era of genomic medicine where physicians and scientists can better define the underlying genetic and molecular drivers of cancers."

Professor Liu Jianjun, Deputy Executive Director at GIS, added, "Our ability to harness advanced genomic technologies has enhanced our discovery of genetic contributions to a spectrum of diseases, including cancer. Many of these important cancer drivers currently do not have drugs that target them. We believe that machine learning and deep learning models will shorten the time and cost for the development of new therapeutics, and are pleased to collaborate with Cyclica to further our efforts in developing therapeutics that can have a positive impact on patients."

"The calibre of genomic research at GIS is world-class. We are thrilled to have the opportunity to work with many leading scientists at GIS to innovate novel therapeutics, based on genomic discoveries, for a wide range of diseases. This opportunity to make a meaningful contribution and impact to patients are common values we share with our partners at GIS," said Dr. Verner De Biasi, VP, Global Head of Strategic Partnerships at Cyclica.

On April 14, 2020 Grid Therapeutics, LLC, a biotechnology company developing a first-in-class, novel human-derived targeted immunotherapy for cancer, reported that the U.S. Food and Drug Administration approved its investigational new drug (IND) application for GT103, Grid’s lead therapeutic candidate for the treatment of solid tumors (Press release, Grid Therapeutics, APR 14, 2020, View Source [SID1234556315]).

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Under this IND, the Company is now poised to initiate a Phase 1 clinical trial in patients with refractory non-small cell lung cancer. Expected to begin in the second quarter of 2020, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of GT103. The study shall begin at Duke University Health System, where startup activities are currently underway. Additional sites will be added once the initial site is up and recruiting patients.

"The FDA’s IND clearance for GT103 marks a critical milestone for Grid Therapeutics as we evaluate this first in class therapeutic in the clinic," said Dr. Edward Patz, Jr., CEO of Grid. "We believe GT103 has the potential to improve clinical responses in lung cancer patients, including those who are refractory to currently approved immunotherapies. As the only company developing human-derived antibodies from single B cells against novel targets, we hold a differentiated and important position in the immuno-oncology space."

On April 14, 2020 Orion reported that Interim Report for January-March 2020 on Tuesday 28 April 2020 (Press release, Orion Biotechnology, APR 14, 2020, View Source [SID1234556313]).

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Orion will publish Interim Report for January-March 2020 on Tuesday, 28 April 2020 approximately at 12.00 noon EEST. The report and related presentation material will be available on the company’s website at www.orion.fi/en/investors after publishing.

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Tuesday, 28 April 2020 at 13.30 EEST. Due to COVID-19 pandemic the event will be exceptionally held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

On April 14, 2020 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported a preliminary insight into progress of its Phase I/IIa trial of BI-1206 in combination with rituximab for treatment of Non-Hodgkin Lymphoma (NHL) (Press release, BioInvent, APR 14, 2020, View Source [SID1234556312]).

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In the Phase I part of the trial, three separate responses have been observed across different subtypes of NHL at doses of BI-1206 below what is believed to be optimal. In particular, a patient in the 70mg cohort has achieved a complete response. The patient is reported to be in "a very good general condition and without any signs of toxicity". In the 30mg cohort, one patient with FL remained on treatment for the full maintenance period of one year, and one patient with MCL showed complete depletion of circulating MCL cells. The dose escalation process continues as planned.

The Phase I/IIa study is a dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL. It consists of two main parts: Phase l, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase II dose (RP2D); and Phase IIa, an expansion cohort at the RP2D, enriched with patients with MCL.

Martin Welschof, CEO of BioInvent, says: "Although it is early days and this Phase I part of the trial is designed to evaluate safety and tolerability, we are very pleased to observe initial signs of efficacy. We are particularly impressed by the complete response of one NHL patient, and the complete depletion of circulating mantle cell lymphoma cells in another patient already before reaching the optimal dose. Early results from the Phase I part of the trial are on track for H2 2020. Meanwhile, we are closely monitoring the spread of COVID-19 and for now, our ongoing clinical trials and planned initiations remain on track. There may be potential changes depending on how the spread develops. We will provide updates as necessary."

On April 14, 2020, Brickell Biotech, Inc. a Delaware corporation (the "Company"),reported that it has entered into an At Market Issuance Sales Agreement (the "Agreement") with Oppenheimer & Co. Inc. as the Company’s sales agent (the "Agent") (Filing, 8-K, Vical, APR 14, 2020, View Source [SID1234556311]). Pursuant to the terms of the Agreement, the Company may sell from time to time through the Agent shares of the Company’s common stock having an aggregate offering price of up to $8,000,000 (the "Shares"). Any Shares will be issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-236353).

Sales of the Shares, if any, will be made by means of ordinary brokers’ transactions on the Nasdaq Capital Market at market prices or as otherwise agreed by the Company and the Agent. Under the terms of the Agreement, the Company may also sell the Shares from time to time to the Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the Shares to the Agent as principal would be pursuant to the terms of a separate placement notice between the Company and the Agent.

The foregoing description of the Agreement in this report does not purport to be complete and is qualified by reference to the full text of the Agreement, which is filed as Exhibit 1.1 hereto.

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