On July 6, 2020 LabCorp (NYSE: LH) reported that it will release its second quarter of 2020 financial results before the market opens on Tuesday, July 28, 2020, and then will host a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, JUL 6, 2020, View Source [SID1234561701]). The earnings release and accompanying financial information will be posted on the LabCorp Investor Relations website.

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Interested parties can access the conference call by dialing 1-877-898-8036 within the U.S. and Canada, or 1-720-634-2811 internationally, using the passcode 2597361. In addition, a real-time webcast of the conference call will be available on the LabCorp Investor Relations website.

An audio replay of the conference call will be available from 1:00 p.m. EDT on July 28, 2020, until 11:30 a.m. EDT on August 11, 2020, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 2597361. The webcast of the conference call will be archived and accessible through July 14, 2021, on the LabCorp Investor Relations website.

On July 6, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens (Press release, Daiichi Sankyo, JUL 6, 2020, View Source [SID1234561699]). Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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Validation confirms that the application is complete and commences the scientific review process by the EMA’s CHMP. Accelerated assessment is granted by the CHMP to products expected to be of major interest for public health and therapeutic innovation and can significantly reduce the review timelines.

"The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "Trastuzumab deruxtecan is already available for patients in the U.S. and Japan, and we look forward to working with the EMA to bring this important new medicine to patients in the EU as quickly as possible."

The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens. The results of the DESTINY-Breast01 trial are published in The New England Journal of Medicine.

About HER2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including gastric, breast and lung cancers. HER2 overexpression is associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poorer prognosis.[1]

About HER2 Positive Breast Cancer

Approximately one in five breast cancers are HER2 positive.[2],[3] Despite recent improvements and approvals of new medicines, there remain significant clinical needs for patients with HER2 positive metastatic breast cancer.[4],[5] This disease remains incurable with patients eventually progressing after available treatment.5

About Trastuzumab Deruxtecan

Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker.

Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.

Trastuzumab deruxtecan has not been approved in the EU, or countries outside of Japan and the U.S., for any indication. It is an investigational agent globally for various indications.

About the Trastuzumab Deruxtecan Clinical Development Program

A comprehensive development program for trastuzumab deruxtecan is underway globally with six pivotal trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 cancers including breast, gastric, and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

In May 2020, trastuzumab deruxtecan received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab, and Orphan Drug Designation for gastric cancer, including gastroesophageal junction cancer. In March 2018, trastuzumab deruxtecan received a SAKIGAKE designation for potential use in the same HER2positive patient population and a supplemental New Drug Application was submitted to the Japan Ministry of Health, Labour and Welfare (MHLW) for approval in April 2020.

In May 2020, trastuzumab deruxtecan also received Breakthrough Therapy Designation for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.

About the Collaboration between Daiichi Sankyo and AstraZeneca

In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for the manufacturing and supply.

On July 6, 2020 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that the MELANI-01 trial has been placed on clinical hold by the U.S. Food and Drug Administration (FDA) (Press release, Cellectis, JUL 6, 2020, View Source [SID1234561697]).

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This clinical hold which impacts one of the three Cellectis product candidates currently in clinical studies, was initiated following the submission of a safety report regarding one patient enrolled in the MELANI-01 study at dose level two (DL2), with relapsed and refractory multiple myeloma. This patient, who had been treated unsuccessfully, prior to enrollment with numerous lines of prior therapy, including autologous CAR T-cells, experienced a fatal treatment-emergent adverse event of cardiac arrest. Clinical evaluation of the case remains ongoing and additional details as to the immediate and underlying causes of this event are being collected.

Of note, prior to the clinical hold being issued by the FDA, Cellectis had decided to expand enrollment at DL1, which may be the appropriate dose for further evaluation in the expansion portion of the trial and potentially the recommended Phase 2 dose based on an assessment of the preliminary clinical and translational data. The Company had begun executing updates to the clinical protocol to reflect this as well as to monitor and mitigate for additional potential risks given its novel mechanism of action.

"We share the FDA’s commitment to patient safety and are working collaboratively with the agency and the investigators to resolve this clinical hold," said Carrie Brownstein, MD, Chief Medical Officer, Cellectis. "The safety of patients enrolled in our clinical trials is our utmost priority and we at Cellectis remain committed to safely resuming the clinical development of UCART product candidate targeting CS1 for patients with multiple myeloma and unmet medical need."

Cellectis is working closely with the FDA to address the agency’s requests including changes to the MELANI-01 clinical protocol designed to enhance patient safety, and expect to submit requested information including an amended protocol in due course.

Patient enrollment is ongoing in our two other proprietary Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in relapsed and refractory acute myeloid leukemia and BALLI-01 evaluating UCART22 in relapsed and refractory B-cell acute lymphoblastic leukemia.

About MELANI-01

MELANI-01 is a Phase 1 open-label First-In-Human dose escalation clinical study evaluating UCARTCS1A product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM). UCARTCS1A is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of CS1/SLAMF7-expressing hematologic malignancies. CS1 (SLAMF7) is highly expressed on MM tumor cells.

About Multiple Myeloma (MM)

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Although MM is a chronic disease and an exact cause has not yet been identified, researchers have made significant progress over the years in managing the disease through better understanding MM’s pathophysiology. The progress in finding a cure needs to be continued as The American Cancer Society estimates that 32,110 new cases of MM will be diagnosed, and 12,960 deaths are expected to occur in 2019 in the U.S. alone.

On July 6, 2020 Ascendis Pharma A/S (Nasdaq:ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that it has commenced an underwritten public offering of $500,000,000 of American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis (Press release, Ascendis Pharma, JUL 6, 2020, View Source [SID1234561695]). All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 of ADSs at the public offering price, less the underwriting 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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J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink are acting as joint book-running managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on May 30, 2018 and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at [email protected].

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 6, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 1,705,500 of the Company’s American Depositary Shares (ADSs), at a purchase price of $2.00 per ADS, in a registered direct offering (Press release, Can-Fite BioPharma, JUL 6, 2020, View Source [SID1234561691]). Can-Fite has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 852,750 ADSs. Each ADS represents thirty (30) ordinary shares, par value NIS 0.25 per share, of Can-Fite. The offering is expected to close on or about July 8, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $2.50 per ADS and will be exercisable at any time upon issuance and will expire four and one-half years from the date of issuance.

The gross proceeds from the offering (without taking into account any proceeds from any future cash exercises of warrants issued in the concurrent private placement), before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are expected to be approximately $3.4 million. Can-Fite intends to use the net proceeds for funding research and development and clinical trials, payment of a consulting fee, and for other working capital and general corporate purposes.

The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by Can-Fite pursuant to a "shelf" registration statement on Form F-3 (File No. 333-220644) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on September 26, 2017 and declared effective by the SEC on October 11, 2017. The offering of the ADSs is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.