On January 29, 2020 Decibel Therapeutics, a development-stage biotechnology company advancing novel therapeutics for hearing loss and balance disorders, reported that industry veteran Laurence Reid, Ph.D., has been appointed as Decibel’s acting chief executive officer, bringing deep experience in biotech company building (Press release, Decibel Therapeutics, JAN 29, 2020, View Source [SID1234554202]). CEO Steven Holtzman is retiring and will become a strategic business advisor to the company.

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"It has been an honor and joy to work over the last four years with the Decibel team to pioneer the field of drug discovery for hearing and balance loss," said Mr. Holtzman. "I have been equally privileged to have known Laurence for some 25 years and can think of no one better suited to lead Decibel forward. I believe our outstanding team is strongly positioned to advance Decibel’s exciting pipeline and discovery programs. I look forward to working with Laurence in an advisory role."

As CEO, Dr. Reid brings deep experience in company building, strategy, and business development. He is an entrepreneur-in-residence at Third Rock Ventures and has held numerous leadership positions in the biotech industry. Most recently, he served as the CEO of Warp Drive Bio, a drug discovery company advancing novel oncology and anti-infective medicines, and where he ultimately negotiated the successful merger of the company with Revolution Medicines in 2018. In his previous role as chief business officer of Alnylam Pharmaceuticals, he led business development, finance, and legal functions.

Dr. Reid is also a veteran of Millennium Pharmaceuticals, having served for a decade in an array of management roles, including as general manager of Millennium UK, with responsibility for the company’s European operations. He received his B.A. from the University of Cambridge and his Ph.D. in biochemistry from the University of London.

"Hearing and balance disorders have an enormous impact on hundreds of millions of people worldwide, yet there are no medications to treat those disorders. That’s astounding," Dr. Reid said. "Decibel’s deep understanding of the biology of the inner ear gives us a unique opportunity to develop life-changing therapeutics for these disorders. I believe that Decibel has built a superb research and drug discovery team, and I am excited to help that team exploit these opportunities in transformative ways."

On January 29, 2020 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that it has entered into a research collaboration on novel cancer antigens for highly specific immunotherapies with the Université de Montréal (UdeM) and IRICoR, a pan-Canadian drug discovery research commercialization center (Press release, MediGene, JAN 29, 2020, View Source [SID1234553710]). UdeM’s research team, led by Drs. Claude Perreault and Pierre Thibault at the Institute for Research in Immunology and Cancer (IRIC), will provide Medigene with tumor-specific antigens (TSAs) which they discovered using their proprietary platform, as novel targets for various cancer indications, particularly for solid tumors.

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Under the terms of the agreement, Medigene will evaluate a number of proprietary TSA targets provided by UdeM through IRICoR, and will receive an option to exercise an exclusive and worldwide license to develop and commercialize T cell receptors (TCRs) against up to 5 of these novel cancer antigens. Upfront and near-term payments by Medigene to UdeM and IRICoR could potentially reach mid to high single-digit millions over the course of the next five years. Additionally, UdeM and IRICoR are eligible to receive development, regulatory and commercial milestone payments, along with tiered royalties, on a per target basis.

Prof. Dolores Schendel, CEO and CSO of Medigene AG: "The goal of immunotherapies is to fight cancer using the immune system. Medigene’s TCR-based therapies aim to modify the patient’s own T cells so they can specifically recognize and eliminate tumor cells. It is essential that the immune system differentiates precisely between cancer cells and healthy tissue. The research work from UdeM on tumor antigens is fascinating and offers a broad and complementary development opportunity for Medigene’s TCR therapies. These TSAs are uniquely found in tumor cells but are not present in healthy tissue, and are therefore particularly interesting as targets for tailor-made immunotherapies. We believe that this cooperation could expand our portfolio with promising, novel targets that are solely expressed in cancer cells."

Dr. Nadine Beauger, Chief Executive Officer of IRICoR: "IRICoR is delighted to be a part of this new partnership. The foundational funding provided by IRICoR to develop this unique proteogenomic approach led to the unprecedented discovery of human TSAs coded by potentially all genomic regions using high-throughput mass spectrometry. These newly-discovered targets open countless avenues for more targeted cancer treatments for the benefit of patients worldwide."

Dr. Steven Klein, Vice-President, Business Development of IRICoR added: "IRICoR has a strong track record of collaborating with international partners such as Medigene and negotiating the necessary agreements to ensure that these relationships are successful in transforming innovative technologies, such as the TSA platform, into new therapies."

Michel Bouvier, Chief Executive Officer and Principal Investigator, IRIC; Professor, Department of Biochemistry and Molecular Medicine, Université de Montréal: "UdeM and its researchers at IRIC are at the forefront of developing novel therapies for cancers with high unmet medical need. The exciting research of Drs. Perreault and Thibault is a concrete example of how world-class fundamental research carried out at IRIC can be translated into potential new therapies through the financial and business support of IRICoR. We look forward to a very fruitful collaboration between UdeM, IRICoR, and Medigene and to seeing these new T cell-based therapies reach patients who are in need of new therapeutic options."

About UdeM/IRICoR TSAs
A key role of T lymphocytes is to act as extrinsic tumor suppressors and thereby mediate "cancer immunosurveillance". Tumor-specific Antigens (TSAs) can be targeted for T-cell based cancer immunotherapy. TSAs are truly cancer-specific and immunogenic because their presence is induced by cancer-specific somatic mutations. In two murine cancer cell lines and seven human primary tumors, Drs. Perreault and Thibault identified a total of 40 TSAs, about 90% of which derived from allegedly noncoding regions and would have been missed by standard exome-based approaches. Moreover, most of these TSAs derived from nonmutated yet aberrantly expressed transcripts (such as endogenous retroelements) that could be shared by multiple tumor types.

Reference:
Laumont et al. "Noncoding regions are the main source of targetable tumor-specific antigens" Science Translational Medicine 05 Dec 2018:Vol. 10, Issue 470, eaau5516

On January 29, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the pricing of an upsized underwritten public offering of 8,350,000 shares of its common stock at a price of $25.00 per share pursuant to a registration statement on Form S-1 filed previously with the U.S. Securities and Exchange Commission (SEC) (Press release, Alector, JAN 29, 2020, View Source [SID1234553676]). The offering was upsized to 8,350,000 shares of Alector’s common stock from the original offering size of 5,095,000 shares of common stock. The gross proceeds to Alector from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $208,750,000. The offering is expected to close on or about February 3, 2020, subject to customary closing conditions. In addition, Alector has granted the underwriters a 30-day option to purchase up to 1,252,500 additional shares of common stock. All of the shares in the proposed offering will be sold by Alector.

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Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with, and declared effective by, the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained from:

Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or by email at [email protected];
Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, or by email at [email protected];
BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email [email protected]; or
Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926.

On January 29, 2020 Geneos Therapeutics reported that its personalized neoantigen-targeting vaccine, GNOS-PV02 (based on its proprietary GT-EPIC platform), will be evaluated in a clinical trial for patients with advanced Hepatocellular Carcinoma (HCC) (Press release, Geneos Therapeutics, JAN 29, 2020, View Source [SID1234553675]). GNOS-PV02 is a tumor-specific DNA plasmid product designed and manufactured for each patient based on the unique tumor variations (neoantigens) identified by sequencing each patient’s tumors. In the trial, GNOS-PV02 will be combined with a DNA plasmid encoded cytokine immunomodulator IL-12 (INO-9012) and standard of care PD-1 checkpoint inhibitor (pembrolizumab).

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This innovative trial is an open-label, non-randomized, exploratory study designed to assess the safety, immunogenicity, and antitumor activity of the combination treatment in advanced HCC patients who have progressed on or are intolerant to first-line treatment with a Tyrosine Kinase Inhibitor (TKI). The primary study goals are to evaluate safety, biomarkers of immune activity, with special emphasis on CD8+ T cell responses, and clinical outcomes.

Geneos has exclusively licensed the DNA Medicines platform, INO-9012 and CELLECTRA device for in vivo delivery of DNA plasmids from Inovio Pharmaceuticals (NASDAQ: INO) for use in the development of personalized cancer treatments. The two DNA based products, GNOS-PV02 and INO-9012, will be administered to cancer patients via intradermal (ID) administration using the CELLECTRA 2000 ID device.

Dr. Niranjan Y. Sardesai, Founder and Chief Executive Officer of Geneos Therapeutics, said "We are excited about this first clinical trial for the Geneos GT-EPIC neoantigen-targeting platform. This trial will seek to demonstrate that Geneos can produce personalized neoantigen-targeting immunotherapies in a clinically meaningful time frame, which drive strong T cell responses (both CD4+ and CD8+) and that these immunotherapies can enhance the efficacy of a PD-1 inhibitor alone. Enabled by our industry leading rapid biopsy to treatment turnaround time and the unique design of this study, the Geneos personalized therapy will be initiated at the same time the patient receives the first dose of the PD-1 inhibitor – we believe this is a critical success factor for neoantigen-based combination trials."

Dr. Mark Yarchoan, Assistant Professor of Oncology at Johns Hopkins and Investigator for the GT-30 advanced HCC study said "Checkpoint inhibitors and other immunotherapies have advanced the cancer treatment field and have had a significant impact on clinical outcomes. However, every patient’s tumor is unique and in order to further improve outcomes, I believe that personalized approaches are critical. I’m excited about this clinical trial utilizing Geneos’ innovative personalized treatment approach in combination with an approved immunotherapy for the treatment of advanced HCC. HCC is one of the fastest growing cancers in the U.S., and a significant unmet need exists to find more efficacious treatments."

HCC accounts for the majority of primary liver cancers. Globally, liver cancers are the fourth most common cause of cancer-related death and rank sixth in terms of annual incidence. The rate of death from liver cancer in the U.S. has increased 43% from 2000 to 2016 and with a 5-year survival rate of 18% for advanced liver cancer, it is the second most deadly tumor behind pancreatic. To date, immunotherapies have shown limited efficacy with two PD-1 inhibitors (pembrolizumab and nivolumab) approved as second line treatments following a tyrosine kinase inhibitor.

On January 29, 2020 DaVita Inc. (NYSE: DVA), reported that it will hold its quarterly conference call to discuss fourth quarter results on Monday, February 10, 2020, at 5:00 p.m. Eastern Time (Press release, DaVita, JAN 29, 2020, View Source [SID1234553674]). The company plans to release its results after market close the same day.

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This call is also being webcast and can be accessed at the DaVita IR web page. You can join this call as follows:

Monday, February 10, 2020
Starting at 5:00 p.m. EST
Dial in number: 877-918-6630
International dial in: 517-308-9042
Webcast: investors.davita.com

When calling in, please provide the operator the password "Earnings" and provide your name and company affiliation. Investors unable to listen to the conference call will be able to access a replay via our website at investors.davita.com. There will be no telephone replay.