Personalis, Inc. to Present at Precision Medicine World Conference 2020

On January 22, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will participate in the Precision Medicine World Conference (PMWC) 2020 in Santa Clara, CA January 22-24 (Press release, Personalis, JAN 22, 2020, View Source [SID1234553421]).

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The presentation titled "Enabling Advanced Composite Biomarkers for Precision Oncology and Cancer Diagnostics," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Richard Chen, MS, MD, Chief Scientific Officer, will present for Personalis. Dr. Chen will provide an overview of how the platform can be used to explore critical immunotherapy-related resistance mechanisms and novel composite biomarkers of response utilizing analytics, including human leukocyte antigen (HLA) typing and HLA loss of heterozygosity (LOH), neoantigen prediction and load, immune repertoire characterization, oncoviral detection, as well as the evaluation of tumor mutational burden (TMB) and microsatellite instability (MSI) status.

ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a single tumor specimen.

Personalis will also be exhibiting during the conference (Exhibit #D2820). Representatives will be available to answer questions about the company’s cancer immunogenomics capabilities.

Genialis, Oncologie Form Partnership on Gastric Cancer Biomarker Prediction

On January 22, 2020 Genialis and Oncologie reported that they have formed a partnership to evaluate and predict biomarkers for gastric cancer (Press release, Oncologie, JAN 22, 2020, View Source [SID1234553407]).

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They initially will concentrate on modeling gene expression signatures that might predict potential treatments for the condition. Houston-based Genialis already has begun applying its Expressions software to the clinical and translational expertise of Oncologie in an effort to improve methodologies for patient stratification, according to the companies.

"One of the most encouraging trends in drug development is innovation around integrating and interrogating diverse datasets," Genialis CEO Rafael Rosengarten said in a statement. "Our work in data science requires a great deal of artistry in addition to technology and benefits from hand-in-hand collaboration with biology domain experts, which makes this opportunity with Oncologie so special.

Boston-based Oncologie said that it eventually wants to take its methodologies to expand into other tumor microenvironment phenotypes.

"To be able to better understand the patient’s tumor microenvironment phenotype and how it is related to patient benefit represents a key objective for the future success of our company," Oncologie CEO Laura Benjamin said in a statement.

Zymeworks Announces Pricing of $279.0 Million Public Offering

On January 22, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics ("Zymeworks" or the "Company"), reported the pricing of its previously-announced underwritten public offering (the "Offering") of 4,924,729 common shares and, in lieu of common shares to a certain investor, pre-funded warrants to purchase up to 1,075,271 common shares (Press release, Zymeworks, JAN 22, 2020, View Source [SID1234553422]). The common shares are being offered at a price to the public of US$46.50 per common share and the pre-funded warrants are being offered at a price of US$46.4999 per pre-funded warrant, for aggregate gross proceeds to the Company of approximately US$279.0 million, before deducting the underwriting discounts and commissions and estimated Offering expenses. In addition, the Company has also granted the underwriters of the Offering a 30-day over-allotment option to purchase up to an additional 900,000 common shares on the same terms and conditions.

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The Company intends to use the net proceeds of the Offering (i) to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, biliary tract, breast and other underserved cancers; (ii) to accelerate and expand the clinical development of ZW49; (iii) to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and (iv) for general corporate purposes.

J.P. Morgan Securities LLC and Citigroup Global Markets Canada Inc. are acting as active bookrunners for the Offering. Stifel, Nicolaus & Company, Incorporated and Wells Fargo Securities Canada, Ltd. are acting as bookrunners, and Raymond James Ltd. is acting as lead manager.

The securities described above are being offered in Canada pursuant to Zymeworks’ final prospectus supplement, dated January 22, 2020 (the "Canadian Supplement"), to its Canadian final base shelf prospectus, dated November 18, 2019 (the "Base Prospectus"), and in the United States pursuant to Zymeworks’ final prospectus supplement, dated January 22, 2020 (the "U.S. Supplement", together with the Canadian Supplement, the "Supplements"), to its U.S. automatic shelf registration statement on Form S-3ASR, including a prospectus dated November 5, 2019 (the "Registration Statement"). The Supplements will be filed in Canada and the United States on January 23, 2020.

The Offering is expected to close on or about January 27, 2020, subject to the satisfaction of customary closing conditions, including the listing of the common shares to be issued and that are issuable under the Offering on the NYSE and any required approvals of such exchange.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement can be found on SEDAR at www.sedar.com and www.sec.gov, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; Citigroup Global Markets Canada Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected]; or Wells Fargo Securities Canada, Ltd., Attention: Equity Syndicate Department, 30 Hudson Yards, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at [email protected]. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

This news 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 province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

GW Cancer Center Expands Clinical Trial Offerings for Patients with High Risk Cutaneous Squamous Cell Carcinoma

On January 22, 2020 The Cutaneous Oncology Program at the George Washington University (GW) Cancer Center reported that it was selected as the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma (Press release, The George Washington University, JAN 22, 2020, View Source [SID1234553408]). This designation highlights the GW Cancer Center’s growing regional and global reputation for treating patients with advanced squamous cell carcinoma, the second most common form of skin cancer behind basal cell carcinoma. The study, sponsored by Regeneron, will examine outcomes for patients treated with Libtayo (cemiplimab) — an immunotherapy treatment — prior to surgery and radiation therapy.

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In June 2019, the GW Cancer Center was selected as the first global site for a related clinical trial on the effectiveness of Libtayo given after primary surgery and radiation therapy. This new study will focus on the impact of Libtayo on tumors prior to surgery, with the goal to help shrink the tumor and potentially prevent the cancer from returning or metastasizing. Preliminary results from a similar trial at MD Anderson Cancer Center showed promising responses to pre-surgical checkpoint inhibitors in patients with advanced cutaneous squamous cell carcinoma of the head and neck.

"By being selected as the first global site for not one, but two clinical trials in 2019, we are continuing to grow our reputation as one of the most innovative programs for patients with advanced cutaneous squamous cell carcinoma," said Vishal A. Patel, MD, FAAD, FACMS, director of the Cutaneous Oncology Program at the GW Cancer Center and principal investigator of the study. "Our growth means even more patients in our region will have access to the latest potentially promising treatments and therapies."

The phase II trial is intended to investigate the safety and effectiveness of Libtayo in helping reduce the size of tumors and prevent recurrence in high risk cutaneous squamous cell carcinoma, particularly when given early. The study, currently only available at the GW Cancer Center, is estimated to enroll over 75 participants.

"This clinical trial fits clearly within our mission to drive transformational research and personalized therapy," said Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences. "Our role as an academic cancer center means we are uniquely positioned to get the latest therapies from bench to bedside, and expanding our clinical trial offerings highlights our commitment to advancing both cancer research and patient care."

Libtayo was approved by the U.S. Food and Drug Administration in September 2018 as cemiplimab-rwlc to treat patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The immunotherapy treatment is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and was the first treatment approved and available in advanced cutaneous squamous cell carcinoma in the U.S. Current treatment options for the disease include surgery, such as Mohs micrographic surgery, radiation therapy, and systemic chemotherapy for metastatic disease. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

"Clinical investigations like this one are critical to expanding the treatment options available to patients," said Mitchell Smith, MD, PhD, associate center director for clinical investigations at the GW Cancer Center. "By examining neoadjuvant applications of immunotherapy drugs like Libtayo, the hope is that patients will be able to be treated with less invasive surgeries or avoid surgery altogether."

The Cutaneous Oncology Program at the GW Cancer Center brings together dermatologists; dermatologic surgeons; medical, surgical, and radiation oncologists; and dermato-pathologists to provide comprehensive and personalized skin cancer care to patients. The program also houses the Supportive Oncodermatology and Cutaneous T-Cell Lymphoma multidisciplinary clinics.
The potential use of Libtayo in neoadjuvant cutaneous squamous cell carcinoma is investigational, and its safety and efficacy have not been evaluated by any regulatory authority for this use.

Blueprint Medicines Announces Pricing of Public Offering of Shares of Common Stock

On January 22, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the pricing of an underwritten public offering of 4,710,144 shares of its common stock at a public offering price of $69.00 per share, before underwriting discounts and commissions (Press release, Blueprint Medicines, JAN 22, 2020, View Source [SID1234553423]). In addition, Blueprint Medicines has granted the underwriters a 30-day option to purchase up to an additional 706,521 shares of its common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock were offered by Blueprint Medicines.

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Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Canaccord Genuity LLC, JMP Securities LLC, and Raymond James & Associates, Inc. are acting as co-lead managers for the offering. The offering is expected to close on or about January 27, 2020, subject to the satisfaction of customary closing conditions.

A registration statement on Form S-3 (File No. 333-216573) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 will be made only by means of a prospectus. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926.