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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.

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.

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.

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]).

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.

Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy

On January 22, 2020 Celularity, Inc. ("Celularity" or the "Company"), a clinical-stage company developing allogeneic cellular therapies from human placentas, reported the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for CYNK-001 in patients with glioblastoma multiforme (GBM) (Press release, Celularity, JAN 22, 2020, View Source [SID1234553420]).

The clinical investigation of CYNK-001 in patients with GBM is expected to be the first clinical trial in the U.S. to investigate intratumoral administration of an allogeneic NK cell therapy. The Company plans to initiate first-in-human clinical testing of CYNK-001 administered either intravenously or intratumorally. This study is expected to evaluate the safety, feasibility, and tolerability of multiple doses of CYNK-001 in subjects with relapsed GBM.

"The FDA clearance of our IND validates the versatility of our allogeneic, off-the-shelf, placental-derived NK cell therapy platform to generate novel clinical candidates against a broad range of devastating cancers. This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme," said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. "We will continue to work diligently to advance our investigational and development programs, and to deliver the next-generation of scalable, high quality immunologic approaches for the treatment of devastating cancers."

Nonclinical safety and efficacy data presented at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting, demonstrated that a single administration of CYNK-001 was well-tolerated and showed enhanced in vivo anti-tumor activity against glioblastoma multiforme (GBM). CYNK-001 is currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and as a potential treatment option for various solid tumors.

About CYNK-001
CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. NK cells derived from the placenta are intrinsically safe and versatile, allowing potential uses across a range of organs and tissues.

OncoSec Secures Phesi ClinSite™ License to Select Clinical Trial Investigator Sites

On January 22, 2020 Phesi, a data-driven provider of premier integrated clinical development analytics products and services, reported that OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS) has purchased a multi-year ClinSite license to enable more accurate and precise planning for Phase 2 and 3 clinical trials of anticancer immunotherapies developed with OncoSec’s plasmid DNA delivery platform (Press release, OncoSec Medical, JAN 22, 2020, View Source [SID1234553419]). ClinSite is a self-service, artificial intelligence (AI)-powered tool that allows biopharmaceutical companies to search for and select top-performing investigator sites for clinical trials in all therapeutic areas.

"As a ClinSite licencee, OncoSec can utilize this novel tool to select the right investigator sites for their immune-oncology clinical trials across a range of tumor types," said Gen Li, PhD, MBA, Phesi founder and president. "Many drug studies fail or are unnecessarily prolonged due to the lack of timely and precise data to inform trial protocols and investigator site selection. With our AI-driven predictive analytics and insights, Phesi’s tools generate accurate, real-time data, allowing companies such as OncoSec to accelerate their trial timelines and enhance their efficiency."

"Access to Phesi’s innovative technology will be a boon to OncoSec’s clinical development programs, particularly our later-stage trials in advanced melanoma, head and neck cancer, and triple-negative breast cancer," noted Kellie Malloy Foerter, chief clinical development officer at OncoSec. "Despite the relatively small patient populations affected by these malignancies, the array of unmet medical needs, combined with the sheer number of ongoing and planned clinical trials in these indications, presents a complex landscape for patients, investigators, and trial sponsors to negotiate. We are therefore excited to deploy ClinSite to optimize our clinical development planning processes, and are eager to see the results as Phesi’s ClinSite reporting capabilities evolve."