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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On April 14, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported three presentations at the upcoming 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting being held April 27 – 28, 2020 (Press release, Syndax, APR 14, 2020, View Source [SID1234556310]).

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Special Session Details

Title: A first-in-class Menin-MLL1 antagonist for the treatment of MLL-r and NPM1 mutant leukemias
Presenter: Gerard McGeehan, Ph.D.
Session: New Drugs on the Horizon
Session Date and Time: Mon., April 27, 2020; 4:54 p.m. – 5:14 p.m. ET

The New Drugs on the Horizon session will feature discussions of innovative small molecules and biologics that have recently entered Phase I clinical trials. The session will include a presentation on SNDX-5613, the Company’s oral Menin inhibitor, including a brief update of the ongoing AUGMENT-101 trial.

Oral Presentation Details

Title: A phase 1, open-label, dose escalation trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of SNDX-6352 monotherapy in patients with unresectable, recurrent, locally-advanced, or metastatic solid tumors
First author: Nilo Azad, M.D.
Session: Phase I Clinical Trials
Abstract Number: CT149
Session Date and Time: Mon., April 27, 2020; 9:00 a.m. – 6:00 p.m. ET

Title: A phase 1, open-label, dose escalation trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of SNDX-6352 in combination with durvalumab in patients with unresectable, recurrent, locally-advanced, or metastatic solid tumors
First author: Anthony W. Tolcher, M.D.
Session: Phase I Trials in Progress
Abstract Number: CT242
Session Date and Time: Mon., April 27, 2020; 9:00 a.m. – 6:00 p.m. ET

Session information is available online via the Annual Meeting Itinerary Planner through the AACR (Free AACR Whitepaper) website at www.aacr.org.