On October 1, 2020 Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, and MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, reported the first patient has been dosed in the pivotal Phase 2 study of zandelisib (formerly called ME-401), an oral, once-daily, investigational drugcandidate selective for phosphatidylinositol 3-kinase delta (PI3Kδ) in patients with indolent B-cell nonHodgkin’s lymphoma (iNHL) without Small lymphocytic lymphoma, lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) in Japan.

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This Phase 2, multicenter, open-label, single-arm clinical study is conducted by Kyowa Kirin to evaluate zandelisib as monotherapy for treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies.

Yoshifumi Torii, Ph.D., Vice President, Head of R&D Division of Kyowa Kirin, said "I am pleased that we have initiated the clinical study to seek regulatory approval in Japan. We are committed to delivering zandelisib as a new potential treatment option for Japanese patients and their physicians. And we continue to work closely with MEI Pharma to expand the global development program for zandelisib."

"The initiation of the Japanese Phase 2 pivotal study is an important addition to the zandelisib global development program," stated Richard Ghalie, M.D., senior vice president, clinical development of MEI Pharma. "We are excited to continue working diligently in close partnership with Kyowa Kirin to build on the potential for zandelisib inside and outside the U.S., and to expand development into indications beyond follicular lymphoma."

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Indication iNHL* *SLL, WM and LPL are excluded
Phase Phase 2
Design Multicenter, open-label and single-arm study
Administration group Zandelisib monotherapy
Primary Endpoint Objective response rate (ORR)
Sample size 60
Estimated study completion September 2024
Countries/Regions Japan

About Zandelisib
Zandelisib (formerly called ME-401) is an investigational cancer treatment being developed as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies. In March 2020 the U.S. FDA granted zandelisib Fast Track designation.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Ongoing studies evaluating zandelisib include TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma) a Phase 2 clinical trial evaluating zandelisib as a monotherapy for the treatment of adults with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an antiCD20 antibody. Subject to the results, upon completion TIDAL is intended to be submitted to FDA to support an accelerated approval marketing application under 21 CFR Part 314.500, Subpart H. Ongoing zandelisib studies also include a Japanese Phase 2 pivotal study in patients with iNHL without Small lymphocytic lymphoma, LPL and WM being conducted by Kyowa Kirin. (Press release, Kyowa Hakko Kirin, OCT 1, 2020, View Source [SID1234567893])

On October 1, 2020, Protalix BioTherapeutics, Inc., a Delaware corporation (the "Company"), reported that it entered into an ATM Equity OfferingSM Sales Agreement (the "Sales Agreement") with BofA Securities, Inc., as the Company’s sales agent (the "Agent") (Filing, 8-K, Protalix, OCT 1, 2020, View Source [SID1234567892]). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of the Company’s common stock having an aggregate offering price of up to $30 million (the "Shares"). The Shares will be issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-230604). The Company intends to use the net proceeds from the offering, after deducting the Agent’s commissions and the Company’s offering expenses, for general corporate purposes.

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In accordance with the terms of the Sales Agreement, the Company may offer and sell the Shares at any time and from time to time through the Agent. Sales of the Shares, if any, will be made by means of transactions that are deemed to be "at the market" offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including block trades and sales made in ordinary brokers’ transactions on the NYSE American or otherwise at market prices prevailing at the time of the sale, at prices related to prevailing market prices or at negotiated prices. Under the terms of the Sales Agreement, the Company may also sell Shares to the Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of Shares to the Agent as principal would be pursuant to the terms of a separate terms agreement between the Company and the Agent.

The foregoing description of the Sales Agreement in this report does not purport to be complete and is qualified by reference to the full text of the Sales Agreement, which is filed as Exhibit 1.1 hereto. The legal opinion and consent relating to the Shares are included as Exhibits 5.1 and 23.1, respectively, hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any sale of Shares in any state or other 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 other jurisdiction.

On October 1, 2020 Delcath Systems, Inc. (NASDAQ: DCTH) reported that the Board of Directors appointed Gerard Michel as Chief Executive Officer, effective October 1, 2020 (Press release, Delcath Systems, OCT 1, 2020, View Source [SID1234567891]). Mr. Michel will also serve as a member of the Delcath Systems Board of Directors. In his most recent role, Mr. Michel was the Chief Financial Officer and Vice President of Corporate Development at Vericel Corporation. Mr. Michel was a key member of the executive team that successfully restructured Vericel enabling it to become a commercial leader in the fields of advanced Cell Therapy and specialty Biologics.

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In addition to Mr. Michel’s appointment as CEO, John Purpura, was appointed as Chief Operating Officer. Mr. Purpura’s leadership and operational excellence in areas of regulatory affairs, manufacturing and distribution have been a critical component of preparing Delcath for its planned New Drug Application (NDA) resubmission to the FDA in mid-2021.

"Following an intensive process, the Board determined that Gerard is the right leader for Delcath at this critical juncture," said Dr. Roger Stoll, Chairman, Delcath Systems. "He is uniquely qualified to take on this role given his track record of success and experience across therapeutics classes. Gerard’s extensive experience in strategy, operations, commercialization, business development and capital markets will be a tremendous asset." Dr. Stoll added, "We thank John for successfully guiding Delcath as interim CEO over recent months. On behalf of the Board, I congratulate him on his appointment to COO."

Mr. Michel commented, "I am excited to join the talented Delcath team ahead of a transformational year as we prepare to report phase 3 FOCUS trial data in metastatic ocular melanoma (mOM) in early 2021. I am committed to leading the organization towards its goal of making Melphalan/HDS the first product specifically labeled for metastatic ocular melanoma patients, a population which currently has limited therapeutic options."

Mr. Michel added, "Interventional oncology is a rapidly growing segment of comprehensive oncology care. Within that segment Melphalan/HDS is a clinically differentiated, high-value platform with the potential to address multiple cancer indications of high-unmet medical need. I look forward to building value both through the successful commercialization of Melphalan/HDS in mOM and initiating additional targeted clinical programs to expand the market opportunity of this platform technology."

Mr. Michel joins Delcath Systems with over 30 years of experience in the pharmaceutical and medical technology industries across multiple functional areas. Prior to Delcath, he was Chief Financial Officer of Vericel since June 2014 where he was a key member of the management team which integrated a transformative acquisition and revised the company’s business model from a research focused company to a fully integrated, profitable commercial business. Mr. Michel also served as Chief Financial Officer and Vice President, Corporate Development of Biodel from November 2007 to May 2014, and Chief Financial Officer and Vice President of Corporate Development of NPS Pharmaceuticals Inc. from August 2002 to November 2007. Prior to that, Mr. Michel was a Principal at Booz Allen and held a variety of commercial roles at both Lederle Labs and Wyeth Labs. Mr. Michel holds a M.S in Microbiology from the University of Rochester School of Medicine, an M.B.A. from the Simon School of Business, and a B.S. in both Biology and Geology from the University of Rochester.

Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

The Company also announced the grant of an option award to Mr. Michel, which was approved by the Board on August 31, 2020 as an inducement material to his entering employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). The inducement award was approved subject to his commencement of employment with the Company on October 1, 2020 and consists of an option to purchase up to 498,000 shares of the Company’s common stock. The option will be exercisable at a price of $11.67 per share (the closing price on October 1, 2020) as to the first 396,000 shares to vest, (ii) 1.5 times the closing trading price per share of the Company’s common stock on October 1, 2020 as to the next 51,000 shares to vest and (iii) 2.0 times the closing trading price per share of the Company’s common stock on October 1, 2020 as to the remaining 51,000 shares to vest and will vest ratably over thirty-six months, provided that he remains employed by Delcath on each vesting date.

On October 1, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report third quarter 2020 results on Thursday, October 22, 2020, before the market opens (Press release, Quest Diagnostics, OCT 1, 2020, View Source [SID1234567890]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-337-6568 for domestic callers or 402-220-9660 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 22, 2020 until midnight Eastern Time on November 5, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On October 1, 2020 The Scripps Research Institute reported that The U.S. Food and Drug Administration has granted Fast Track designation to a novel "switchable" CAR-T cell therapy in a move to accelerate the drug development and review process (Press release, The Scripps Research Institute, OCT 1, 2020, View Source [SID1234567889]). The therapy is currently being evaluated as a treatment for B-cell malignancies, a class of blood cancers that includes non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

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FDA’s Fast Track designation, which enables enhanced access to the agency during development, is designed to bring important new drugs to patients that address unmet medical needs in serious or life-threatening conditions.

The CAR-T cell therapy known as "CLBR001 + SWI019," has begun enrolling subjects in a Phase 1 trial assessing the safety and tolerability of the cell therapy. The study is being conducted at multiple sites in the United States.

"This important designation will enable Calibr to interact with the agency on study-related items, such as appropriate data collection and study design to support the approval of this innovative therapy," says Pamela Garzone, PhD, chief medical officer of Calibr, who is leading the clinical study of the therapy and was the primary author of the Fast Track application.

Calibr’s investigational CAR-T cell therapy leverages patients’ own immune cells to treat cancer, putting the cells under control of a novel molecular "switch" that seeks to mitigate potentially life-threatening side effects that have hampered the use of cell therapies to date.

"The versatility and potential for greater safety enabled by this switchable platform can yield significant benefits for patients and we look forward to the opportunity to accelerate its development," says Travis Young, PhD, Calibr’s vice president of biologics and leader of its CAR-T program.

CAR-T, short for chimeric antigen receptor T-cell, is a relatively new form of cancer therapy that has achieved remarkable responses in patients with blood- or bone marrow-based diseases such as leukemias and lymphomas. It works by genetically engineering a patient’s T cells—a cell type which plays a key role in anti-tumor immunity—to seek and destroy cancer within the body. However, some patients who receive T-cell therapies experience an adverse effect called cytokine release syndrome, which occurs when the immune system reacts too strongly.

Calibr’s switchable CAR-T cell platform incorporates an antibody known as "SWI019" that acts as a switch, activating the engineered cells (CLBR001) and directing them to engage the cancer target. This may allow doctors to have more control over the therapy which could provide a significant safety advantage. In preclinical studies, the approach proved highly effective at eliminating tumors while controlling the level of cytokines produced in response to treatment. Further, by switching the CLBR001 cells "on" and "off" the approach allows the engineered cells to "rest", which in preclinical models afforded greater efficacy.

The current clinical trial is enrolling patients with blood-based cancers that have returned after remission or didn’t respond to initial treatments. However, Calibr’s switchable CAR-T cell platform employs a universal design that can be applied to solid-tumor cancers and other types of blood cancers in the future—providing potential advantages in an area that CAR-T cell therapies have not been as successful in the past.

The switchable CAR-T cell platform was invented at Scripps Research and progressed to the clinical testing stage with support from the Wellcome Trust. Calibr has partnered its platform with biopharmaceutical company AbbVie, which holds certain rights to commercialization. The clinical trial is the third to be run independently by the institute and the fifth originating from Calibr’s research.

Patients interested in enrolling in the clinical trial (NCT04450069) can learn more on the National Institutes of Health (NIH) clinical trials portal.