On August 6, 2020 Notable, which is redefining cancer treatment by taking a functional approach to precision oncology in hematological cancers, reported a new precision oncology study with Washington University School of Medicine in St. Louis, exploring the feasibility of ex vivo drug screening to predict sensitivity and resistance to chemotherapy, and to identify novel synergies across a broad panel of anti-cancer therapies (Press release, Notable Labs, AUG 6, 2020, View Source [SID1234563035]).

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The study will help determine to what extent Notable’s technology platform has the ability to predict clinical responses in patients treated with standard of care therapies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). In addition, the study explores how a patient’s disease changes in response to specific therapies, and whether Notable can potentially combat resistance to therapy by finding new effective combinations on its platform.

The study will be conducted at Washington University School of Medicine’s Siteman Cancer Center. Notable is performing the ex vivo drug sensitivity tests in its laboratory in Foster City, CA.

"This is a very important validation study for Notable," said Hiroomi Tada MD PhD, Chief Medical Officer at Notable. "It will provide a large dataset that will enable us to compare our ex vivo test results with patient outcomes, which we need to understand how well our assays work, and determine whether we need to improve the assays for certain classes of drugs to make the tests better. In addition, the study will provide us with insight into how AML and MDS changes in response to treatment, identify potential new combination therapies, and identify if patients are failing a therapy much earlier, allowing us to intervene sooner as resistance is emerging."

Medical oncologist John Welch, MD, PhD, Associate Professor in the Division of Oncology at Washington University School of Medicine, said, "It can be difficult to predict patients’ responses to chemotherapy, and we look forward to evaluating whether Notable’s platform has the potential to change the way clinicians approach cancer therapy for individual patients. This trial is intended to help determine the platform’s accuracy and its value as a clinical care tool."

This is expected to be a five-year study, though data from the first cohort could be available within 12-18 months.

On August 6, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that on August 5, 2020, the Company completed the submission of its Biologics License Application ("BLA") under the FDA’s Rolling Review process for omburtamab (Press release, Y-mAbs Therapeutics, AUG 6, 2020, View Source [SID1234563033]). Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year.

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"I am excited to see the completion of Y-mAbs’ second BLA submission this year in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapsing with brain metastasis and there is currently no standard therapy available for these patients. We believe this is a key milestone for families facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs. As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningeal metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma." stated Thomas Gad, Founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we look forward to working with the FDA to bring omburtamab to appropriate patients. Omburtamab is also being tested in a Phase 2 study for desmoplastic small round cell tumor and we are currently planning a Phase 2 study for diffuse intrinsic pontine glioma, as we believe omburtamab could potentially be developed for wider compartmental use."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.

On August 6, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has entered into a clinical trial collaboration with AstraZeneca (LSE/STO/NYSE: AZN) to evaluate the combination of patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), and TAGRISSO (osimertinib), an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Daiichi Sankyo, AUG 6, 2020, View Source [SID1234563016]).

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There are no HER3 directed therapies approved for the treatment of NSCLC or any cancer. The frequency of HER3 overexpression in EGFR-mutated NSCLC has been reported to be as high as 75 percent, and there is evidence that HER3 expression may be associated with resistance to TKIs.[1],[2]

"The majority of patients with activating mutations of EGFR, or EGFR-mutated NSCLC, overexpress the HER3 protein in the cancer cells, and there is evidence that HER3 expression is a passenger marker of resistance to TKIs. Clinical and preclinical data, as well as biomarker expression and resistance mechanism research, support the further evaluation of patritumab deruxtecan and TAGRISSO as a treatment combination for patients with EGFR-mutated NSCLC who have progressed after treatment with a TKI, typically TAGRISSO," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "This clinical trial collaboration supports our goal to optimize development of patritumab deruxtecan in patients with EGFR-mutated metastatic NSCLC to further improve current standards of care. Daiichi Sankyo is pleased to begin this focused collaboration with AstraZeneca on this important aspect of patritumab deruxtecan development."

"In this trial, we will explore a new potential way to treat patients with advanced disease by combining TAGRISSO with patritumab deruxtecan, a HER3 directed ADC," said Cristian Massacesi, Senior Vice President, Head of Late Stage Development Oncology R&D, AstraZeneca. "This combination approach represents one of our strategies of addressing tumor resistance. As we work to continue maximizing the benefit TAGRISSO can bring to patients, we look forward to collaborating with Daiichi Sankyo in this new area of study."

About the Study

Under the terms of the agreement, Daiichi Sankyo will sponsor and conduct a multicenter, open-label, two-part phase 1 study evaluating patritumab deruxtecan and TAGRISSO as both a first-line and second-line combination treatment in patients with advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation.

The first part of the study (dose escalation) will assess the safety and tolerability of different dosing combinations of patritumab deruxtecan and TAGRISSO to determine the recommended combination dose. The second part of the study (dose expansion) will include a first-line and second-line cohort that will further evaluate the anti-tumor activity and safety of the combination. Patients enrolled in the first-line cohort will receive patritumab deruxtecan and TAGRISSO combination treatment, and patients in the second-line cohort will be randomized 1:1 to receive treatment with patritumab deruxtecan alone or in combination with TAGRISSO. Up to 258 patients will be enrolled into the study, which will be conducted in North America, Europe, and Asia including Japan.

The primary study objectives for the dose escalation part of the study include the assessment of the safety and tolerability of patritumab deruxtecan and TAGRISSO. The primary objective for the dose expansion part of the study for both cohorts is the assessment of anti-tumor activity as measured by objective response rate (ORR) and as assessed by independent central review.

Unmet Need in Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cancer and is the leading cause of cancer mortality worldwide with an estimated 2.1 million new cases of lung cancer in 2018 and 1.8 million deaths.[3] Non-small cell lung cancer (NSCLC) accounts for 80 to 85 percent of all lung cancers.[4]

Mutations in the epidermal growth factor receptor (EGFR) gene are among the most frequently observed genomic alterations in NSCLC, affecting approximately 14 to 30 percent of patients with NSCLC.[5] For patients with EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offers higher response rates, overall survival and progression-free survival compared to chemotherapy.[6] However, most patients eventually develop resistance to the TKIs, and new treatment approaches including combination strategies designed to overcome TKI resistance are needed.[7]

About HER3

HER3 is a member of the EGFR family of tyrosine kinase receptors, which are associated with normal as well as aberrant cell proliferation and survival.2 HER3 expression has been associated with an increased incidence of metastases and reduced survival in patients with NSCLC with expression frequency reported to be as high as 75 percent.1 A majority of EGFR-mutated NSCLCs show some level of HER3 expression.[8],[9] Currently, no HER3 directed therapies are approved for NSCLC or any cancer.

About Patritumab Deruxtecan (U3-1402)

Patritumab deruxtecan (U3-1402) is one of three lead DXd antibody drug conjugates (ADC) in the oncology pipeline of Daiichi Sankyo.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells that express HER3 as a cell surface antigen.

Patritumab deruxtecan is currently being evaluated in a phase 1 study in previously treated patients with metastatic or unresectable NSCLC. Patritumab deruxtecan is also being evaluated in a phase 1/2 study in patients with HER3 expressing metastatic breast cancer.

Patritumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On August 6, 2020 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company is scheduled to present at the virtual Canaccord 40th Annual Growth Conference on Thursday, August 13, 2020 at 1:00 p.m. ET (Press release, Agios Pharmaceuticals, AUG 6, 2020, View Source [SID1234562986]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

On August 6, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, reported the pricing of the previously announced underwritten registered public offering of 4,000,000 of its common shares at a price to the public of $5.00 per share (Press release, DiaMedica, AUG 6, 2020, View Source [SID1234562985]). DiaMedica has also granted the underwriters a 30-day option to purchase up to an additional 600,000 common shares, at the public offering price, less underwriting discounts and commissions. All of the common shares are being offered by DiaMedica. The offering is expected to close on or about August 10, 2020, subject to the satisfaction of customary closing conditions.

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DiaMedica expects the gross proceeds from the offering to be approximately $20 million, before deducting the underwriting discount and other estimated offering expenses payable by DiaMedica. Net proceeds, after the underwriting discount, but before estimated expenses of the offering payable by DiaMedica, are expected to be approximately $18.8 million. As previously announced, DiaMedica intends to use the net proceeds from the offering to continue its clinical and product development activities, including the addition of a new cohort III to its REDUX study to be comprised of participants with Type II diabetes mellitus with chronic kidney disease, hypertension and albuminuria, and for other working capital and general corporate purposes.

Guggenheim Securities, LLC is acting as lead book-running manager for the offering. Craig-Hallum Capital Group LLC is acting as joint book-running manager and National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NASDAQ: NHLD), is acting as lead manager.

The securities described above are being offered by DiaMedica pursuant to a shelf registration statement on Form S-3 (File No. 333-235775) previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC on August 5, 2020. The final prospectus supplement and the accompanying prospectus relating to this offering will be filed with the SEC and, when available, may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].