On November 18, 2019 KIYATEC, Inc. and CarThera reported that they have entered into a clinical collaboration for the purpose of advancing innovation and improving treatments for patients diagnosed with glioblastoma, a highly aggressive form of brain cancer that afflicts more than 130,000 patients worldwide per year and is characterized by historically poor clinical outcomes (Press release, KIYATEC, NOV 18, 2019, View Source [SID1234551434]). The collaboration will focus on accelerating the development and validation of their emerging technologies to improve both the selection and effectiveness of drugs commonly recommended and used to treat the disease.

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"Relevant clinical advances that improve outcomes for patients with glioblastoma have been few and far between over the last two decades," said Frederic Sottilini, CEO of CarThera. "Despite multimodal therapy, median survival remains around 15 months for these patients, virtually all of whom recur. Our goal is to optimize the selection and delivery of drug therapies to extend the lives of patients with glioblastoma."

The two companies were brought together by one of the world’s leading neuro-oncology and glioblastoma experts, John de Groot, M.D., professor and chairman ad interim, The University of Texas MD Anderson Cancer Center, who recognized the synergistic nature of their respective clinical initiatives. CarThera is currently conducting a multi-center clinical study of its novel ultrasound technology, SonoCloud-9, designed to increase the permeability of the blood brain barrier to improve the delivery of chemotherapeutic agents to the brains of patients with recurrent glioblastoma. KIYATEC is conducting a multi-center clinical study of its ex vivo 3D cell culture technology to accurately predict pre-treatment, patient-specific response to recommended standard of care cancer drugs for newly diagnosed and recurrent glioblastoma.

"As someone who cares for patients with glioblastoma, I applaud the efforts of CarThera and KIYATEC to bring evidence-based advances to the clinic for the purpose of improving outcomes for patients with glioblastoma," said Dr. de Groot. "I envision these two technologies as being complementary with the potential to transform the way in which neuro-oncologists manage glioblastoma patients."

Under the terms of the clinical collaboration, KIYATEC will conduct ex vivo drug response profiling on glioblastoma tissue samples from patients enrolled in CarThera’s clinical study. CarThera will benefit from having ex vivo drug response profiling for patients enrolled in its study, while KIYATEC will correlate its patient-specific, pre-treatment drug response predictions with actual clinical outcomes of patients in CarThera’s study. For both companies, this collaboration represents an opportunity to enrich their portfolios of clinical evidence with the goal of helping clinicians improve outcomes for their patients with glioblastoma.

"Both of our companies are dedicated to ensuring that glioblastoma patients receive the most appropriate drug therapy at the right time, and that the efficacy of that therapy is maximized to its fullest therapeutic potential," said Matthew Gevaert, CEO and co-founder of KIYATEC. "We believe that this clinical collaboration has the potential to help us accelerate and deliver on the long-awaited promise of personalized medicine for these deserving patients."

Both companies will be sending delegates to the 24th Annual Meeting of the Society for Neuro-Oncology, November 20-24 in Phoenix, Arizona.

On November 18, 2019 AgilVax Inc., a biopharmaceutical company that discovers and develops targeted antibody-based therapeutics, reported that preclinical data describing M5, the Company’s monoclonal antibody targeting xCT, will be presented by Dr. Salameh at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Tumor Immunology and Immunotherapy Conference being held at the Boston Marriott Copley Place in Boston, MA (Press release, Agilvax, NOV 18, 2019, View Source [SID1234551435]).

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Title:

Development of a monoclonal antibody targeting xCT/SLC7A11 expressed in metastatic cancer cells

Poster Session:

Poster Session B

Session Date:

Tuesday, November 19

Board Number (poster number):

B37

Time:

4:30 p.m. to 7:00 p.m.

Session Location:

Back Bay

"We are pleased with our continued progress on developing multiple solutions to target cancer cells overexpressing xCT and thrilled to have the opportunity to showcase our advancements in a poster presentation at such a prestigious meeting," said Dr. Joseph Patti, President and CEO of AgilVax. Dr. Patti further stated, "xCT overexpression occurs in several cancers leading to metabolic changes that reprograms cells for growth and progression. AgilVax’s antibody-based therapeutics have shown reduction of primary tumor formation and lung metastases illustrating the potential to create durable responses in patients suffering from colorectal and other metastatic cancers.

On November 18, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported financial results for the quarter ended September 30, 2019 (Press release, Ascendis Pharma, NOV 18, 2019, View Source [SID1234551454]).

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"Our achievements this year reflect our ability to bring a product from idea stage all the way through clinic, as we near the finish line for TransCon hGH and approach our planned regulatory filings in the United States (U.S.) and Europe," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "Our recent progress in the TransCon hGH program, including both in Europe and China, also support our strategy to establish global reach. The power of the TransCon technology is enabling us to build a leading fully integrated patient-focused biopharma company, and advance towards our ‘Vision 3×3’ goals."

He continued, "One of our driving values at Ascendis is patient focus. In response to the recent recall of NATPARA in the U.S., we recently expanded our TransCon PTH Phase 2 PaTH Forward Trial with a protocol addendum to help expedite participation of some of those patients affected by the recall. We believe the expanded trial will provide meaningful clinical data to help patients, both naïve to PTH and previously treated with PTH, and further demonstrate the value of our unique approach to product development."

Corporate Highlights & Progress

Completed the last subject visit for the long-term clinical database for TransCon hGH, paving the way for the company’s planned Biologics License Application to the U.S. Food and Drug Administration in the first half of 2020 and the Marketing Authorisation Application to the European Medicines Agency in the second half of 2020. TransCon hGH is a long-acting prodrug of human growth hormone (hGH) in phase 3 development as a once-weekly therapy for pediatric growth hormone deficiency (GHD).
Completed the manufacturing of drug product Process Performance Qualification (PPQ) batches required to support the planned regulatory filings in 2020 for TransCon hGH. The company is now finalizing the associated analytics and preparing qualification reports.
Advanced the TransCon hGH program in Greater China with VISEN Pharmaceuticals, who initiated a phase 3 trial for TransCon hGH in pediatric GHD.
Received Orphan Designation from the European Commission for TransCon hGH, which is provided to therapies aimed at treating, preventing or diagnosing a disease that is life-threatening or chronically debilitating, affects no more than five in 10,000 persons in the European Union and which may provide significant additional benefit over existing therapies.
Announced a protocol addendum in the U.S. designed to expedite enrollment of subjects previously treated with NATPARA in the TransCon PTH PaTH Forward Trial, a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism (HP). TransCon PTH is an investigational long-acting prodrug of PTH in development as a potential once-daily replacement therapy for HP, designed to provide physiologic levels of PTH for 24 hours a day, seven days a week. Under the addendum, patients previously treated with NATPARA in the U.S. will now have an expedited pathway to enroll in PaTH Forward. As a result, the company expects to exceed targeted enrollment of 40 subjects, and plans to report top-line data from the expanded trial in first quarter of 2020. The goal of PaTH Forward is to evaluate TransCon PTH control of serum and urinary calcium, and identify a titration regimen for complete withdrawal of standard of care (i.e., active vitamin D and calcium supplements).
Initiated the ACcomplisH Trial, a global, phase 2, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of TransCon CNP, a long-acting prodrug of C-type natriuretic peptide (CNP), at escalating doses in children with achondroplasia (ACH). TransCon CNP is designed to provide continuous exposure to CNP at therapeutic levels with once-weekly dosing.
Presented preclinical data for TransCon TLR7/8 Agonist, a product candidate in development for oncology, at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. TransCon TLR7/8 Agonist is prodrug of resiquimod, a small molecule with immune-activating and anti-tumor properties that is transiently conjugated to a hydrogel carrier via a TransCon linker. Administered as an intratumoral injection, TransCon TLR7/8 Agonist delivered sustained local release of resiquimod over weeks directly to the tumor site and demonstrated potent anti-tumor activity as a monotherapy, as well as in combination with interleukin-2 (IL-2).
Ended the third quarter of 2019 with cash and cash equivalents of €658.7 million.
Third Quarter 2019 Financial Results

For the third quarter, Ascendis Pharma reported a net loss of €25.1 million, or €0.53 per share (basic and diluted) compared to a net loss of €34.0 million, or €0.81 per share (basic and diluted) for the same period in 2018.

Revenue for the third quarter was €2.2 million compared to €20 thousand in the same quarter of 2018. The increase relates to our November 2018 strategic investment in VISEN Pharmaceuticals.

Research and development (R&D) costs for the third quarter were €46.3 million compared to €31.5 million during the same period in 2018. Higher R&D costs in 2019 reflect an increase in personnel-related costs to support development and manufacturing of TransCon hGH, TransCon PTH and TransCon CNP, increasing clinical trial costs for the PaTH Forward Trial and the ACcomplish Trial, as well as increased costs for other research programs, including oncology.

General and administrative expenses for the third quarter were €10.0 million compared to €6.8 million during the same period in 2018. The increase is primarily due to higher personnel-related costs and other increasing costs of expanding the company and preparing to become a commercial organization.

As of September 30, 2019, Ascendis Pharma had cash and cash equivalents of €658.7 million compared to €690.4 million as of June 30, 2019. As of September 30, 2019, Ascendis Pharma had 47,739,647 ordinary shares outstanding.

Conference Call and Webcast information

Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. ET to discuss its third quarter 2019 financial results. Details include:

Date Monday, November 18, 2019
Time 4:30 p.m. ET
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 5897398
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

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.