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BioInvent Reports Promising Progress in Phase I/lla Trial of Lead Program BI-1206 in Combination with Rituximab

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."

Entry into a Material Definitive Agreement

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.

Syndax Pharmaceuticals Announces Three Presentations at the 2020 American Association for Cancer Research Virtual Annual Meeting

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]).

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.

Ribon Therapeutics to Present New Preclinical Data at the Upcoming AACR Virtual Annual Meetings

On April 14, 2020 Ribon Therapeutics, a clinical stage oncology company developing first-in-class therapeutics targeting stress response pathways, reported the presentation of new data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place from April 27-28, 2020 (Press release, Ribon Therapeutics, APR 14, 2020, View Source [SID1234556309]).

This meeting will feature a selection of high-impact proffered paper presentations, including:

Session: Advances in Cancer Drug Design and Discovery
Abstract ID: 3974
Title: A Potent and Selective PARP14 Inhibitor Decreases Pro-tumor Macrophage Function and Elicits Inflammatory Responses in Tumor Explants
Presenter: Laurie Schenkel, Ph.D.
Date/Time: April 27, 2020, 12:20 p.m. – 12:30 p.m.
Session: New Drugs on the Horizon – Part 2
Abstract ID: DDT02
Title: RBN-2397: A First-in-Class PARP7 Inhibitor Targeting a Newly Discovered Cancer Vulnerability in Stress-Signaling Pathways
Presenter: Melissa Vasbinder, Ph.D.
Date/Time: April 28, 2020, 10:50 a.m. – 11:10 a.m.
AACR Virtual Meeting I the first of two virtual meetings; the second, AACR (Free AACR Whitepaper) Virtual Meeting II, is taking place on June 22-24, 2020.

Propanc Biopharma Receives First Allowance for Key Patent Family from Australian Patent Office

On April 14, 2020 Propanc Biopharma, Inc. (OTC:PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the first allowance for an important patent family was received from the Australian Patent Office (Press release, Propanc, APR 14, 2020, View Source [SID1234556308]). The allowed claims capture different dosage regimens, including those to be the focus of ongoing research, as the Company’s lead product candidate, PRP, advances towards clinical trials for the treatment of patients with advanced solid tumors.

The key patent application, citing proenzyme compositions, is one of four patent families, consisting of 65 patents either in force or pending, and is the first to be allowed covering high doses of two proenzymes trypsinogen and chymotrypsinogen for the treatment of cancer. As a result, examination of patent applications in a number of other jurisdictions can be expedited where the Australian claims will be utilized for supplementary examination.

"The approval of this key patent application in Australia is a significant step forward for our intellectual property portfolio and is especially important as we prepare for entering the clinic in Australia," said James Nathanielsz, Propanc’s Chief Executive Officer.

Dr Julian Kenyon, Propanc’s Chief Scientific Officer said, "The aim of our first clinical trial will be to identify the maximum tolerated dose patients with advanced solid tumors, knowing that we continue to expand our intellectual property portfolio as a world first in the cancer field using a novel proenzyme treatment approach, helps build confidence that we are on track with our research."