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Invitae Announces Proposed Public Offering of Common Stock

On April 1, 2020 Invitae Corporation (NYSE: NVTA) reported that it has commenced an underwritten public offering of $125.0 million of shares of its common stock, before deducting underwriting discounts and commissions and other offering expenses (Press release, Invitae, APR 1, 2020, View Source [SID1234561377]). All of the shares are being offered by Invitae. In addition, Invitae expects to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as the book-running managers for the offering.

An automatic shelf registration statement relating to the shares was filed with the Securities and Exchange Commission and became effective on March 4, 2019. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; or from 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.

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.

Phase I/II Clinical Study of ONC201 Begins in Japan

On April 1, 2020 Oncoceutics, Inc., reported that it was informed by its Japanese licensee, Ohara Pharmaceutical Co., Ltd., of the initiation of a Phase I/II clinical study of OP-10 (the Japanese name for ONC201) in Japan and the administration of the drug to the first patient (Press release, Oncoceutics, APR 1, 2020, View Source [SID1234558313]).

ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patients with high-grade glioma. In February 2019, Oncoceutics outlicensed rights to ONC201 for Japan to Ohara. Under this strategic partnership, Ohara is responsible for conducting clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.

"We are excited to continue to work with the dedicated team of experts at Ohara as we expand the development of ONC201 to important markets outside the U.S.," said Lee Schalop, MD, Chief Operating Officer of Oncoceutics. "This clinical trial provides Japanese patients with high-grade glioma immediate access to ONC201, and data from this study will be an important part of working toward a Japanese market approval for ONC201."

Iovance Biotherapeutics Announces H. Lee Moffitt Cancer Center to Present Lung Cancer Clinical Data at American Association for Cancer Research (AACR) Virtual Annual Meeting 2020

On April 13, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that H. Lee Moffitt Cancer Center ("Moffitt") plans to present clinical results from a Phase 1 trial using Moffitt’s tumor infiltrating lymphocytes (TIL) in patients with non-small cell lung cancer (NSCLC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020 (Press release, Iovance Biotherapeutics, APR 13, 2020, View Source [SID1234556314]). The Phase 1 study is being conducted at Moffitt with support from Iovance Biotherapeutics, a Stand Up To Cancer Catalyst grant, and other partners.

Maria Fardis, Ph.D., MBA, President and Chief Executive Officer of Iovance, stated, "We are very pleased that Moffitt will present clinical data demonstrating the potential for tumor infiltrating lymphocytes, or TIL, in such an unmet medical need indication, non-small cell lung cancer. This data is the basis of our strategy to investigate Iovance TIL in two cohorts of non-small cell lung cancer patients in our IOV-COM-202 ‘basket’ study. We continue to be excited about the broader potential of Iovance TIL in additional tumor types."

Abstract Title: Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in non-small cell lung cancer (NSCLC): a phase I trial.
Authors: Ben Creelan, et al.
Session: VCTPL05 – Adoptive Cell Transfer Therapy
Date and Time: April 28, 2020, 12:45 PM – 12:55 PM
Abstract Number: 20-LB-10617-AACR
Location: AACR (Free AACR Whitepaper) Virtual Annual Meeting I at www.aacr.org
The AACR (Free AACR Whitepaper) Virtual Annual Meeting I will include more than 30 oral presentations in several clinical trial plenary sessions along with commentaries from expert discussants, as well as clinical trial poster sessions consisting of short videos providing the authors’ perspectives. This Virtual Meeting will be available free to everyone, although attendees will be asked to register to participate. For more information please visit the AACR (Free AACR Whitepaper) Virtual Annual Meeting I page at www.aacr.org.

Affimed Announces FDA Granted Orphan Drug Designation for Lead Innate Cell Engager AFM13 for the Treatment of T-cell Lymphoma

On April 1, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma (Press release, Affimed, APR 1, 2020, View Source [SID1234556107]). The granted designation includes peripheral T cell lymphoma (pTCL), a subtype of T-cell lymphoma. AFM13 is being investigated as a monotherapy for the treatment of relapsed or refractory CD30-positive pTCL in a Phase 2 registration-directed study.

The FDA may grant orphan designation to drugs and biologics intended to treat a rare disease or condition affecting fewer than 200,000 persons in the U.S. The designation qualifies a company for certain benefits, including financial incentives to support clinical development and the potential for seven years of market exclusivity in the U.S. upon regulatory approval.

About AFM13
AFM13 is a first-in-class tetravalent, bispecific innate cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in peripheral T cell lymphoma (pTCL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy as a monotherapy in CD30-positive non-Hodgkin lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD-1 antibody Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition. AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration for HL.

Legend Biotech Raises $150.5 Million in Series A Preferred Financing To Advance its Oncology Pipeline and Platform

On April 1, 2020 Legend Biotech Corporation (Legend), a global, clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it has raised $150.5 million in Series A financing (Press release, Legend Biotech, APR 1, 2020, View Source [SID1234556095]). Proceeds from the financing will be used to advance the research and development and commercialization of Legend’s pipeline programs and expansion of manufacturing facilities, enhancement of its research and development platform, as well as general corporate expenses.

New investors included Hudson Bay Capital Management LP, Johnson & Johnson Innovation-JJDC, Inc., Lilly Asia Ventures, Vivo Capital, RA Capital Management and other large, reputable institutional investor.

Morgan Stanley Asia Limited and Jefferies Hong Kong Limited advised Legend in this transaction.