On March 22, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it filed a Registration Statement on Form F-1 with the U.S. Securities and Exchange Commission (SEC) for a proposed offering of ordinary shares in the form of American Depositary Shares ("ADSs") in the United States (Press release, MorphoSys, MAR 22, 2018, View Source [SID1234556339]). The final number of ADSs to be offered and the price for the offering have not yet been determined.

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MorphoSys’s ordinary shares are listed on the Prime Standard Segment in Frankfurt, Germany. Application has been made to list the ADSs to be offered in the proposed offering on the Nasdaq Global Market in the United States under the ticker symbol "MOR".

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Leerink Partners LLC, are acting as lead book-running managers, and Berenberg Capital Markets, LLC and JMP Securities LLC are acting as co-managers for the proposed ADS offering.

A Registration Statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

The securities referred to in this release are to be offered only by means of a prospectus. A copy of the preliminary prospectus, when available, can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by emailing [email protected].

This announcement does not constitute an offer to sell nor a solicitation of an offer to buy, 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 March 22, 2018 AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, reported that after consulting with the U.S. Food and Drug Administration (FDA), it will not seek accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) based on magnitude of effect across multiple parameters in this single-arm study (Press release, AbbVie, MAR 22, 2018, View Source [SID1234525398]).

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"We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers," said Mike Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer."
Summary of Investigator Assessed Best Overall Response Rate, Independent Review Committee (IRC) Assessed Objective Response Rate, Duration of Response and Overall Survival in Third-Line SCLC Patients with High DLL3 Expression (N = 177)*

*Data represent 74 percent of the TRINITY study population with high DLL3 expression
a Best overall response is defined as a subject with a response of complete response (CR) or partial response (PR) at any time prior to receiving any subsequent anticancer therapy.
b Objective response is defined as a subject with a response of complete response (CR) or partial response (PR) prior to receiving any subsequent anticancer therapy, with confirmation of CR or PR at least 4 weeks (28 days) from the initial determination per RECIST v1.1.
­­c Based on Kaplan-Meier estimate.

In the study, the most common treatment-emergent adverse events were fatigue (38 percent), photosensitivity reaction (36 percent), pleural effusion (32 percent), edema peripheral (31 percent), decreased appetite (30 percent), nausea (26 percent), dyspnea (25 percent), thrombocytopenia (25 percent), constipation (22 percent), vomiting (17 percent), anemia (17 percent), hypoalbuminemia (16 percent), and cough (16 percent). Grade three and higher severe toxicities ≥ 5 percent were thrombocytopenia (11 percent), photosensitivity reaction (7 percent) and pleural effusion (5 percent)
.
About the Phase 2 TRINITY Study
TRINITY is a multicenter, open-label, single-arm, Phase 2 study of Rova-T in DLL3-expressing small cell lung cancer (SCLC) patients with relapsed/refractory (R/R) disease after receiving at least two previous regimens, including at least one platinum-based regimen. The primary objective was to investigate the efficacy of Rova-T as third-line and later treatment for R/R DLL3-expressing SCLC. Secondary objectives included assessment of safety and tolerability, pharmacokinetics, RECIST-assessed progression-free survival, duration of response and clinical benefit rate.

About Rovalpituzumab Tesirine (Rova-T)
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)[1], which is expressed in more than 80 percent of small cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.[2] Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. Rova-T is under investigation as a third-line treatment in SCLC.[2] The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers.[2]
Rova-T is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

On March 22, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, reported a strategic licensing agreement with Crown Bioscience, Inc (Press release, CBT Pharmaceuticals, MAR 22, 2018, View Source [SID1234525458]). The agreement gives CBT exclusive world-wide development and commercialization rights to a novel, recombinant, human monoclonal antibody which targets a differentiated epitope on the cytotoxic T-lymphocyte antigen-4 (CTLA-4) molecule. Binding of this antibody to CTLA-4 blocks the interaction of CTLA-4 with its ligands CD80/CD86 thus allowing the cytotoxic T cells to function actively.

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Under the terms of this global licensing agreement, CBT gains access to a third checkpoint inhibitor to complement the existing immuno-oncology pipeline of PD-1 and PD-L1 inhibitors. CrownBio is eligible to receive potential future development, regulatory and sales-based milestones payments over $47 M, as well as royalties on net sales. Once the recommended Phase 1 monotherapy portion of the Phase 1/2 trial is completed, combination with other complementary therapies in CBT’s immuno-oncology and targeted therapy portfolios will be initiated.

"This acquisition from Crown Bio is another building block in our strategy to develop a portfolio of programs in combination with our pipeline of immuno-oncology and targeted therapies that we believe will lead to a meaningful durable clinical benefit and impact on cancer survival in variety of malignancies and in larger proportion of cancer patients," said Sanjeev Redkar, PhD, Chief Executive Officer and President of CBT. "The CTLA-4 asset fits well with our ongoing clinical studies and we hope to advance an additional three single agent and two combination clinical trials are expected to enter the clinic by the end of 2018." Tillman Pearce, MD, Interim Chief Medical Officer, added "The CTLA-4 asset demonstrated stronger binding and its performance in nonclinical models compares quite favorably to the marketed CTLA-4 which may allow for differentiation in the clinic."

Dr. Jean Pierre Wery, CEO of Crown Bio stated, "Crown Bio enables biopharmaceutical clients and partners the scientific platform to advance drugs to market to improve treatment options to patients. This includes strategic licensing of proprietary antibodies. We are pleased to support CBT’s innovati

Caladrius Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Caladrius Biosciences, 2018, MAR 22, 2018, View Source [SID1234524943]).

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On March 22, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported that Bill Enright, President and Chief Executive Officer, will provide a corporate overview at H.C. Wainwright Global Life Sciences Conference, being held April 8-10 in Monte Carlo, Monaco (Press release, Altimmune, MAR 22, 2018, View Source [SID1234524944]).

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Presentation Details – H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, April 10, 2018
Time: 9:25am Eastern Time/3:25pm Central European Time
Location: LeMeridien Beach Plaza Hotel, Monte Carlo, Salon Atlantique-Meridional
Webcast: View Source