On November 18, 2019 LabCorp (NYSE: LH) reported that it plans to offer, subject to market and other conditions, senior notes that are expected to be issued in two tranches (the Notes) (Press release, LabCorp, NOV 18, 2019, View Source [SID1234551420]). The Notes will be senior unsecured obligations and will rank equally with LabCorp’s existing and future senior unsecured debt.

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LabCorp intends to use the net proceeds of the Notes offering for general corporate purposes that may include (1) the purchase, redemption or repayment at maturity of its outstanding 2.625% Senior Notes due Feb. 1, 2020, (2) the purchase of up to $300 million aggregate purchase price of its 4.625% Senior Notes, due Nov. 15, 2020 in a concurrent tender offer, and (3) the repayment of some or all of the amounts outstanding under its term loan credit facilities.

The joint book-running managers for the offering are BofA Securities, US Bancorp and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 filed with the Securities and Exchange Commission. A copy of the prospectus and related prospectus supplement may be obtained without charge from the Securities and Exchange Commission. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from US Bancorp by calling toll-free 1-877-558-2607, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This announcement does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

On November 18, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported that it will participate in fireside chats at the following conferences in November (Press release, UroGen Pharma, NOV 18, 2019, View Source [SID1234551436]):

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Stifel 2019 Healthcare Conference

Tuesday, November 19th
2:25PM Eastern Time
New York, NY
Jefferies 2019 London Healthcare Conference

Wednesday, November 20th
4:00PM Greenwich Mean Time
London, UK
A live audio webcast of each event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the website for approximately two weeks.

On November 18, 2019 Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the closing of a public offering of (i) 10,450,000 Class A Units, each consisting of shares of its common stock and common warrants to purchase its common stock and (ii) 1,550,000 Class B Units consisting of pre-funded warrants and warrants to purchase its common stock, at a price of $0.50 per Class A Unit and $0.4999 per Class B Unit, for total gross proceeds to the Company of approximately $6.0 million, before deducting placement agent fees and other estimated offering expenses (Press release, Lipocine, NOV 18, 2019, View Source [SID1234551421]). The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

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Roth Capital Partners acted as sole agent for the public offering.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-220942) (including a prospectus) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering will be filed with the SEC.

A copy of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained by contacting Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus are also available free of charge on the website of the SEC at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On November 18, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported the dosing of the first patient in its Phase 1/2 clinical trial evaluating SNS-301 in patients with ASPH‑positive head and neck cancer who have previously received immune checkpoint inhibitors (Press release, Sensei Biotherapeutics, NOV 18, 2019, View Source [SID1234551437]). SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β‑hydroxylase (ASPH), and is the company’s first program to enter clinical development from its proprietary drug discovery platform.

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The Phase 1/2 clinical trial is a multicenter, open-label trial designed to evaluate the safety, preliminary efficacy and immunogenicity of SNS-301 in combination with pembrolizumab. The study will include ASPH‑positive patients with locally advanced unresectable or metastatic/recurrent squamous cell head and neck cancer currently receiving pembrolizumab or nivolumab. Sensei expects to enroll approximately 30 patients in this two-stage trial with primary efficacy endpoints including objective response rate, duration of response, and multiple secondary endpoints measuring immune responses.

"We are pleased to advance SNS-301 into a Phase 1/2 clinical trial in head and neck cancer, an indication that continues to have a high unmet medical need. We have previously demonstrated dose-dependent ASPH-specific immunogenicity, encouraging clinical activity and a favorable safety profile in ASPH‑positive patients through proof-of-concept studies with SNS-301," said Ildiko Csiki, M.D., Ph.D., consulting Chief Medical Officer of Sensei Biotherapeutics. "Targeting ASPH represents a novel strategy for treating cancer and we believe that SNS-301 has potentially broad applicability across a wide variety of cancers with its unique mechanism combined with checkpoint inhibition. We look forward to providing preliminary results at a major medical meeting in 2020."

About SNS-301

SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Expression of ASPH is upregulated in more than 20 different types of cancer and is related to cancer cell growth, invasiveness, and is inversely correlated with poor disease prognosis. SNS-301 is designed to overcome self-tolerance and induce robust and durable humoral and cellular immune responses that are specific to ASPH. SNS-301 is delivered through intradermal injection and avoids time consuming and uncomfortable infusions, greatly facilitating ease of use.

On November 18, 2019 MorphoSys AG (Prime Sector Segment, MDAX & TecDAX, NASDAQ: MOR) reported that the ongoing Phase 3 B-MIND study with the drug candidate tafasitamab has successfully passed the pre-planned, event-driven interim futility analysis (Press release, MorphoSys, NOV 18, 2019, View Source [SID1234551422]). The data was evaluated by an independent data control committee (IDMC). This recommended increasing the number of patients from the current 330 to 450. The B-MIND study compares the efficacy of the CD19 antibody tafasitamab in combination with bendamustine versus rituximab in combination with bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL).

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As part of the futility interim analysis, the IDMC examined the data for the likelihood of a positive outcome of the study at the time of graduation. The IDMC evaluated the efficacy data in the entire patient population as well as in the biomarker-positive patient subpopulation. The biomarker, which describes patients with a low number of natural killer cells at baseline, was implemented as a co-primary endpoint in the first quarter of 2019 in a supplement to B-MIND. The IDMC’s recommendation to include more patients in the trials aims to increase the statistical power of the study in both the biomarker-positive patient subpopulation and the entire study population. The data from the analysis was not shared with MorphoSys.

Continuing the B-MIND study protocol, patient recruitment will be performed according to the original inclusion and exclusion criteria. This should further enable the comparison of efficacy in the whole as well as the biomarker-positive patient group. Topline results are expected to be available in the first quarter of 2022.

"We are delighted with the IDMC’s recommendation and see it as an important step in the clinical development of tafasitamab," said Drs. Malte Peters, Chief Development Officer of MorphoSys. "DLBCL is a difficult-to-treat disease with a high unmet medical need, so new treatment options are urgently needed, and we are well on our way to approving our BLA approval application for tafasitamab in combination with lenalidomide, regardless of B-MIND positive clinical trial results L-MIND and Re-MIND by the end of 2019. "

About B-MIND
The pivotal Phase 2/3 B-MIND trial is investigating tafasitamab in combination with the chemotherapeutic agent bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (R / R DLBCL) who are not eligible for high-dose chemotherapy and subsequent chemotherapy Autologous stem cell transplantation compared to the combination of the anti-CD20 antibody rituximab plus bendamustine A low number of natural killer cells in the peripheral blood at baseline was implemented as a biomarker in coordination with the FDA in the first quarter of 2019. A pre-planned, event-driven futility interim analysis in the B-MIND study took place in November 2019 and resulted in an increase in patient count to 450 (out of 330).

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed in several malignant B-cell diseases including DLBCL and CLL. It has been shown that CD19 participates in the B cell receptor (BCR) signaling pathway, which is considered to be important for B cell survival and makes CD19 a potential target in B cell disease.
Tafasitamab (MOR208) is a humanized Fc-modified monoclonal antibody against CD19. The Fc modification of tafasitamab should lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus improving a key mechanism of tumor cell killing. Tafasitamab has been studied in preclinical models to induce direct apoptosis by binding to CD19, which is considered to be a critical component for B cell receptor (BCR) signaling.
In addition to B-MIND, MorphoSys is investigating tafasitamab as a therapeutic option in B-cell malignancies in a series of ongoing combination trials. The open-label Phase 2 combination trial (L-MIND trial) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in Question come. Based on preliminary data from L-MIND, the FDA granted the status of breakthrough therapy for tafasitamab plus lenalidomide in this patient population in October 2017.
Re-MIND, the real world data trial in a control group treated with lenalidomide monotherapy, reached its primary endpoint in October 2019 and demonstrated clinical superiority of the tafasitamab / lenalidomide combination compared to lenalidomide alone. In addition, tafasitamab is currently being studied in patients with relapsed / refractory CLL / SLL following the discontinuation of previous bron-tyrosine kinase inhibitor therapy (eg ibrutinib) in combination with idelalisib or venetoclax.