On September 15, 2020 Bayer reported that it has entered into an exclusive global license agreement with Systems Oncology for ERSO, a compound in pre-clinical development for metastatic Estrogen Receptor (ER) positive, breast cancer (Press release, Bayer, SEP 15, 2020, View Source [SID1234565173]). ERSO is a small molecule activator of the Unfolded Protein Response (UPR) in ER-positive breast cancer cells. ERSO’s mechanism of action is a therapeutic approach being investigated in women with metastatic ER-positive breast cancer, an area where new therapies are urgently required.

"Despite the overall progress we see in the treatment of breast cancer, there are limited treatment options for patients whose disease progressed, in particular in the metastatic setting," said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "In line with our Oncology strategy to focus on areas with a high medical need and innovative approaches with the potential to make a meaningful impact, we are excited to partner with Systems Oncology in developing ERSO. ERSO is being investigated as an alternative for women with ER-positive breast cancer and enhances our portfolio, enabling us to deliver new treatment options for patients who are waiting for them."

With over 2 million new cases worldwide in 2018, breast cancer is the most common tumor type in women and the second leading tumor type overall. The prognosis as well as available treatment options depend highly on the subtype and stage of breast cancer. Around 70% of all women with breast cancer have ER-positive disease, with the survival rate for metastatic ER-positive breast cancer being only 20%. Thus, the need for additional treatment options beyond established anti-hormonal treatment approaches remains high. In preclinical studies, ERSO showed activity in ER-positive breast cancer cells as well as activity on ER mutations warranting further investigation. In addition, ERSO is also being studied in other tumor types based on its mechanism.

"Given ERSO’s potential in cancer care, it was important for us to align with a sophisticated group that understands innovation. Bayer is a proven innovator who shares our vision for ERSO, and they have the clinical, scientific, and business leadership to succeed," said Dr. Spyro Mousses, CEO and Co-Founder of Systems Oncology.

"With the experienced team at Bayer leading the development effort, I fully expect that this exciting compound has the potential to create a real paradigm-shift for breast cancer care," said Dr. Joyce O’Shaughnessy, Baylor University Medical Center, Texas Oncology, US Oncology.

"The collaboration with Systems Oncology combines their deep experience in identifying alternative treatment pathways with our global footprint and established profile in order to develop new treatment options that can improve patient outcomes," said Marianne De Backer, PhD, MBA, Member of the Executive Committee and EVP, Head Strategy and Business Development & Licensing, Pharmaceuticals Division of Bayer AG. "It underlines our commitment to explore partnerships on innovative treatment approaches at all levels."

Under the terms of the agreement, Bayer will be responsible for developing and commercializing ERSO globally. Systems Oncology will receive an upfront payment of 25 million US dollars and is eligible to receive payments from Bayer upon achievement of certain development, and commercialization milestones totaling 345 million US dollars, as well as royalties on future global net sales.

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.

About ERSO

Scientists at Systems Oncology entered into a strategic research collaboration with two professors at the University of Illinois, Dr. David Shapiro and Dr. Paul Hergenrother, who respectively conducted pioneering research into the biology and chemistry of anticipatory activation of UPR in breast cancer. The research led to intellectual property (IP) that covered small molecule agents that can activate the UPR. Inspired with a multi-scalar systems understanding of this mechanism, Systems Oncology acquired a license to the IP from the University and invested to drive pre-clinical studies and manufacturing development, eventually establishing the ERSO program as a promising investigational compound.

On September 15, 2020 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to participate in two virtual investor conferences this week (Press release, Veracyte, SEP 15, 2020, View Source [SID1234565171]):

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2020 Cantor Virtual Global Healthcare Conference
Presentation on Wednesday, September 16, 2020, at 1:20 p.m. ET
Lake Street’s Virtual 4th Annual (BIG4) Conference
1×1 meetings throughout the day on Thursday, September 17, 2020
A live audio webcast of the company’s presentation, where applicable, will be available by visiting Veracyte’s website at View Source Replays of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On September 15, 2020 Enzon Pharmaceuticals, Inc. (the "Company" or "Enzon") (OTC:ENZN) reported the record date and expected subscription period for its previously-announced rights offering to raise proceeds of approximately $43 million (Press release, Enzon, SEP 15, 2020, View Source [SID1234565170]). The proceeds from the rights offering will be utilized to position the Company as a public company acquisition vehicle, where it can become an acquisition platform and more fully utilize its net operating loss tax carryforwards and enhance stockholder value.

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The Company filed Amendment Number 1 to its Registration Statement on Form S-1 providing 5:00 p.m., New York City time, on September 23, 2020 as the record date. Subject to the Registration Statement becoming effective on or about September 18, 2020, the Company intends to commence the rights offering on September 23, 2020.

Under the rights offering, holders of Enzon’s common stock will receive one transferable subscription right for each share of common stock owned. For every 1,105 subscription rights held, stockholders will be entitled to purchase one unit at the subscription price of $1,090 per unit. Each unit consists of one share of newly designated Series C preferred stock and 750 shares of Enzon’s common stock, all as described in the Registration Statement.

Although the subscription rights are transferable there can be no guarantee that a market will develop during the subscription period or that stockholders will be able to buy or sell additional subscription rights. Accordingly, unless a stockholder is able to acquire additional subscription rights during the subscription period, a stockholder must own shares of common stock as of the record date, or acquire shares of common stock prior to the record date, in multiples of 1,105 in order to receive subscription rights enabling it to purchase units, as no fractional units, preferred stock or common stock will be issued. In connection with the rights offering, Icahn Capital LP has agreed to purchase all units that remain unsubscribed for at the end of the subscription period.

Upon the sale of all 40,000 units available for purchase in the rights offering, the Company will have 40,000 shares of Series C preferred stock outstanding and an aggregate of 74,214,603 shares of common stock outstanding following the rights offering.

The expected calendar for the rights offering, unless extended or modified by Enzon, is as follows:

•September 23, 2020 at 5:00 PM, New York City Time: Record Date

•September 24, 2020: Estimated Distribution Date; Subscription Period Estimated to Begin

•October 9, 2020 at 5:00 PM, New York City Time: Subscription Period Ends

•October 16, 2020: Estimated Date of Distribution of Preferred and Common Stock

Important Information

For additional information on the Rights Offering, please see the prospectus included in Enzon’s registration statement on Form S-1 and related amendments, which has not yet become effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On September 15, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 22, 2020, at 3:20 p.m. ET/12:20 p.m. PT (Press release, Alpine Immune Sciences, SEP 15, 2020, View Source [SID1234565169]).

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A live webcast of the presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast

On September 15, 2020 Van Andel Institute’s Biorepository reported that has been awarded a $2.7 million, two-year subcontract from the Frederick National Laboratory for Cancer Research currently operated by Leidos Biomedical Research, Inc. on behalf of the National Cancer Institute to serve as the biorepository for the Cancer Moonshot Biobank study, a national initiative to transform cancer treatment and prevention through accelerated research (Press release, Van Andel Institute, SEP 15, 2020, View Source;utm_medium=rss&utm_campaign=cancer-moonshot-biorepository-announcement [SID1234565167]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In this role, VAI will assemble and distribute kits for the collection of tumor tissue, blood and other biospecimens to hospitals and medical centers around the U.S. Once samples are collected from volunteers, they will be shipped to VAI for processing and either stored for later study or sent to other organizations conducting analyses for the Cancer Moonshot. In all, the Biobank project is expected to collect biospecimens from more than 1,000 participants.

"Biospecimens are the bedrock of scientific research — without them, we wouldn’t be able to study cancer or develop new treatments and diagnostics," said Scott Jewell, Ph.D., director of VAI’s Core Technologies and Services, which includes the Institute’s Biorepository. "We are honored to be part of the Cancer Moonshot Biobank study and look forward to doing our part to support research and improve cancer care."

The Cancer Moonshot was launched in 2016 by the Obama Administration. Its strategic aims, determined by a Blue Ribbon Panel of experts, are designed to answer critical scientific and medical questions while ensuring the samples collected represent the diversity of the U.S. population.

VAI’s Biorepository provides services for a number of large-scale national and international projects, including NIH’s Clinical Proteomic Tumor Analysis Consortium and the National Cancer Institute’s Biospecimen Pre-Analytical Variables Program. The Biorepository team also played an integral role in biospecimen collection for the NIH’s Genotype-Tissue Expression project, including developing and shipping the kits used by investigators around the country to collect tissue samples. It currently serves as the biobank for the Multiple Myeloma Research Foundation’s CoMMpass Study, the Tuberous Sclerosis Alliance and the Van Andel Institute–Stand Up To Cancer Epigenetics Dream Team. Since 2012, VAI’s Biorepository has been accredited by the College of American Pathologists (no. 8017856), which provides objective assurance that VAI meets or exceeds the high standards set by CAP.

The project has been funded in whole or in part with federal funds from the National Cancer Institute of the National Institutes of Health under contract no. HHSN261201500003I, Task Order HHSN26100042 through Leidos Biomedical Research, Inc. under subcontract no. 20X062Q. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organizations imply endorsement by the U.S. government.