On November 21, 2019 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, reported its Board of Directors has appointed David W. Mims as interim Chief Executive Officer (Press release, Progenics Pharmaceuticals, NOV 21, 2019, View Source [SID1234551578]). Mr. Mims, a member of Progenics’ Board of Directors, will assume the leadership of the executive team while the Board of Directors conducts a search to identify a permanent Chief Executive Officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"David is a veteran pharmaceutical executive with deep experience leading multiple commercial organizations, including growing Aptalis Pharma to $475 million in annual net sales in the U.S.," said Ann MacDougall, Interim Chair of the Board. "As the new Progenics Board of Directors assesses our corporate strategy and pipeline initiatives, we are pleased to have David providing internal leadership and guidance through this new chapter of the Company."

During his career as a pharmaceutical executive, Mr. Mims has played a significant role in raising over $1 billion in capital and successfully leading multiple commercial organizations, including new product launches. Mr. Mims was also an integral part of multiple transactions, including the sale of Scandipharm to Axcan Pharma, Inc. for ~$100 million, the sale of Axcan Pharma, Inc. to TPG Capital for $1.3 billion, the acquisition of Eurand, Inc. for $583 million and the sale of Aptalis to Forest Laboratories for $2.9 billion. Mr. Mims previously served as President, U.S. Specialty Pharmaceuticals, for Aptalis Pharma Inc., a privately held pharmaceutical company, from May 2011 until May 2014, shortly after it was acquired by Forest Laboratories, Inc. At Aptalis, Mr. Mims managed over 200 employees and grew the business to over $475 million in annual net sales. He previously held the same role at Axcan Intermediate Holdings Inc., the parent company of Axcan Pharma Inc., from February 2008 until May 2014 and as a member on its board from 2000 to 2007. Mr. Mims also served as Executive Vice President and Chief Operating Officer at Axcan after the company acquired Scandipharm, Inc., a privately held pharmaceutical company that Mr. Mims helped found and served as Vice President, Chief Operating Officer and Chief Financial Officer. Mr. Mims currently serves as a member of the American Institute of Certified Public Accountants and Alabama Society of Certified Public Accountants and on the board of directors of Guideway Care, a healthcare company that provides technology-enabled care guidance, and SouthPoint Bank, a community banking institution. Mr. Mims received his B.S. in accounting from Auburn University.

On November 21, 2019 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has priced its offering of $7,000,000,000 aggregate principal amount of senior notes (Press release, Centene , NOV 21, 2019, View Source [SID1234551597]). The $7,000,000,000 of senior notes will include $1,000,000,000 aggregate principal amount of additional 4.750% senior notes due 2025 (the "Additional 2025 Notes") at a premium to yield 3.76%, $2,500,000,000 aggregate principal amount of new 4.250% senior notes due 2027 (the "2027 Notes") at a discount to yield 4.375% and $3,500,000,000 aggregate principal amount of new 4.625% senior notes due 2029 (the "2029 Notes" and, together with the Additional 2025 Notes and the 2027 Notes, the "Notes"). The Additional 2025 Notes will have the same terms as the Company’s existing 4.750% senior notes due 2025 (the "Existing 2025 Notes"), other than the issue date, the issue price, transfer restrictions, certain related registration rights and certain other limited exceptions. The Additional 2025 Notes will initially constitute a separate series of notes from the Existing 2025 Notes, but the Company has agreed to exchange the Additional 2025 Notes for additional Existing 2025 Notes, subject to certain conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Additional 2025 Notes priced at 102.875% of the principal amount thereof, the 2027 Notes priced at 99.160% of the principal amount thereof and the 2029 Notes priced at 100.000% of the principal amount thereof, which together will result in aggregate gross proceeds of $7,007,750,000. The offering is expected to close on or about December 6, 2019, subject to customary closing conditions.

Centene intends to use the net proceeds of the 2027 Notes and the 2029 Notes and a portion of the proceeds of the Additional 2025 Notes to finance the cash consideration payable in connection with Centene’s previously announced acquisition of WellCare Health Plans, Inc. ("WellCare") and to pay related fees and expenses. Centene expects to use the remainder of the net proceeds of the Additional 2025 Notes for general corporate purposes, including the repayment of revolver borrowings. Centene currently expects the acquisition to be completed by the first half of 2020. The acquisition is, however, subject to customary closing conditions, and Centene cannot guarantee that the acquisition will be completed at or about such time, or at all. The closing of this offering is not conditioned on the closing of the acquisition. If the acquisition is not consummated, the Company will be required to redeem the 2027 Notes and the 2029 Notes at a redemption price equal to 100% of the principal amount thereof, plus accrued and unpaid interest, if any, to but excluding the redemption date. The Additional 2025 Notes will not be subject to a special mandatory redemption.

The Notes will be senior unsecured obligations of the Company and will be equal in right of payment with all of the Company’s existing and future senior indebtedness and will be senior in right of payment to all of the Company’s existing and future subordinated debt. The Notes will not be guaranteed by any of its subsidiaries.

The Notes will be offered to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and to non-United States persons outside the United States in compliance with Regulation S under the Securities Act. The Notes have not been registered under the Securities Act and may not be offered or sold in the United States without registration or an applicable exemption from the registration requirements.

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

On November 21, 2019 VBL Therapeutics (Nasdaq: VBLT) reported that data on the new investigator-sponsored Phase 2 study of VB-111 in recurrent glioblastoma (rGBM) will be presented by Timothy Cloughesy, M.D., Director and Professor, UCLA Neuro-Oncology Program at the 2019 Society for Neuro-Oncology (SNO) annual meeting, being held November 20-24, 2019 in Phoenix, Arizona (Press release, VBL Therapeutics, NOV 21, 2019, View Source [SID1234551579]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The randomized, controlled clinical trial will study VB-111 in rGBM patients undergoing a second surgery. VB-111 will be administrated either before (‘neo-adjuvant’) and after the surgery (‘adjuvant’), or just after the surgery, and will be compared to a third cohort that will receive standard of care as control. The trial will be conducted at seven top neuro-oncology US centers: Dana-Farber Cancer Institute, Boston, MA (DFCI; study sponsor); Massachusetts General Hospital (MGH), Boston, MA; University of California, Los Angeles, CA (UCLA); University of California, San Francisco, CA (UCSF); Memorial Sloan Kettering, New York, NY; University of Utah, Salt Lake City, UT; and University of Texas, San Antonio, TX.

The primary endpoint of this new study is an immunological readout, which is to investigate whether administration of VB-111 prior to surgery can result in an increase in tumor infiltrating T lymphocyte (TIL) within the rGBM tumor. Secondary endpoints include progression free survival at 6 months (PFS-6) and overall survival (OS). Planned enrollment is 45 patients, randomized evenly across three groups.

"MRI analysis conducted at UCLA of the VB-111 Phase 2 and GLOBE Phase 3 studies demonstrated objective responses to VB-111 monotherapy. Importantly, VB-111 responders had a survival advantage. These clinically meaningful findings suggest that VB-111 should be furthered explored in rGBM," said Dr. Cloughesy, a co-principal investigator of the study.

"This important investigator-sponsored study will provide further information on the therapeutic potential of VB-111 in rGBM when administered as monotherapy," said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. "The study is intentionally designed as a randomized, controlled, blinded trial to generate results that can be part of a future filing with the regulatory authorities. We thank the key opinion leaders in the glioblastoma field for pursuing the potential of VB-111 for the benefit of patients in this deadly disease."

Presentation details:
Abstract #: ATIM-09
Abstract Title: Clinical trial in progress: A study of neoadjuvant and adjuvant VB-111 for treatment of recurrent GBM
Date: Saturday November 23, 2019
Presentation Time: 5:00 PM – 7:00 PM MST
Location: Ballroom Lawn

On November 21, 2019 Elios Therapeutics, a biopharmaceutical company developing innovative personalized therapeutic cancer vaccines, reported that the Company presented the primary analysis of the prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating its tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine, in patients with Stage III and IV resected melanoma (Press release, Elios Therapeutics, NOV 21, 2019, View Source [SID1234551598]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Therapeutic cancer vaccines are an attractive alternative immunotherapy because of their potential safety, specificity, and long-lasting response due to stimulation of immune memory," said Mark B. Faries, M.D., co-director of the Melanoma Program and head of Surgical Oncology at The Angeles Clinic and Research Institute, an affiliate of Cedars-Sinai. "These results, coupled with a well-tolerated safety profile, support the rationale to further investigate the TLPLDC vaccine in combination with other immunotherapies and standard of care treatments, which may dramatically help to increase patient responses and prevent disease recurrence."

In the study, 144 participants were randomized to receive either the vaccine or placebo to prevent recurrence. The vaccines were initiated within three months of completion of standard of care therapy at 0, 1, 2, 6, 12, and 18 months. The primary endpoint was 24-month disease-free survival (DFS). The pre-specified per treatment (PT) analysis included all patients who completed the primary TLPLDC or placebo vaccine series (PVS) at six months. In the PT analysis, 24-month DFS was significantly improved in the TLPLDC vaccine group compared to placebo [62.9% vs. 34.8%; (HR=0.52, 95% CI: 0.27-0.98, p<0.041), representing a nearly 60% reduction in the relative risk of disease recurrence. There was a non-significant improvement in 24-month DFS between the TLPLDC and placebo arms in the intent-to-treat (ITT) analysis [38.5% versus 27%, (p=0.974)], but a stronger trend in improved 24-month overall survival (OS) in this analysis [86.4% vs. 75.1% (p=0.15)].

Therapy was well-tolerated with 31.7% of placebo patients and 35.9% of TLPLDC patients experiencing a related adverse event, the majority of which were grade 1 or 2. Additionally, an initial assessment of 36-month follow-up data on all patients indicated that the TLPLDC vaccine benefit is not only durable, but continues to increase beyond 24-months. As a result, the study will continue as designed to the 36-month landmark secondary endpoints of DFS and OS, anticipated in June 2020.

The TLPLDC vaccine is a personalized treatment that is created using a patient’s own blood and tumor cells. Samples are collected at resection, frozen, and sent to the lab where they are used to create autologous tumor lysate, which is loaded into yeast cell wall particles (YCWP). This combination is then introduced to the patient’s dendritic cells, leading to the creation of the final TLPLDC vaccine. The time from resection to injection of the vaccine takes approximately three weeks.

"This is a very different and personalized approach that is able to deliver each patient’s unique composite of tumor antigens to the immune system," said John R. Hyngstrom, M.D., surgical oncologist at the Huntsman Cancer Institute and associate professor of surgery at the University of Utah. "Administered in a six-month regimen, the vaccine ignites an innate and adaptive response that trains a patient’s immune system to ‘see’ melanoma cells and any of the specific proteins from their tumor that may be circulating throughout the body and kill them. A vaccine that can provide a protective benefit against melanoma would represent an important new tool for patients and their physicians," he added.

Melanoma is more likely to grow and spread than other types of skin cancer. When diagnosed and treated at an early stage, melanoma has a high cure rate, however patients with later stages of the disease carry a high risk for melanoma recurrence because some melanoma cells can remain in the body, even after surgery. In the U.S, the incidence of melanoma has increased over the past decades, with 91,270 estimated new cases and 9,320 related deaths in 2018.1

"Melanoma is an aggressive type of cancer that can spread to other parts of the body, even after successful treatment, making adjuvant therapy an important part of the treatment plan," said Kyleigh LiPira, M.B.A, chief executive officer of the Melanoma Research Foundation (MRF). "These results represent an important step forward in reducing the risk of disease recurrence, bringing us closer to the goal of helping each person with melanoma to have better outcomes and potentially extend survival."

"We are very pleased with the results of this study," said Buddy Long, chief executive officer of Elios Therapeutics. "We met with the FDA this month regarding Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations and look forward to our scheduled End-of-Phase 2 meeting in January to seek their guidance on the registrational Phase III trial design and optimal regulatory pathway for the TLPLDC vaccine. Our number one priority is to bring this safe and effective treatment to patients with melanoma as soon as possible."

About the Phase IIb TLPLDC Study
This Phase IIb study is a prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with resected Stage III and IV melanoma. The primary endpoint of the trial is two-year disease-free survival (DFS).

In the study, 144 participants were randomized to receive either the vaccine or placebo to prevent recurrence. TLPLDC or placebo vaccines were initiated within three months of completion of standard of care (SoC) therapies and were given at 0, 1, 2, 6, 12, and 18 months. The protocol was amended to allow concurrent checkpoint inhibitor therapy once approved for the adjuvant setting. Study participants were followed for recurrence per SoC. The primary efficacy analysis was performed on the intent-to-treat (ITT) and the per treatment (PT) populations as co-primary analyses given the high early recurrence rate often seen in patients with advanced melanoma. Secondary endpoints include 36-month DFS and overall survival (OS) which will be compared between the vaccinated and control groups.

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is a unique type of immunotherapy, both in how it is made and how it is delivered. The vaccine is personalized, meaning it is made from a patient’s tumor and blood. Every patient’s tumor has a unique antigenic profile unlike any other, and dendritic cells found in the blood are the most potent antigen-presenting cells in the body. Once TLPLDC is administered, it delivers the patient’s complete repertoire of tumor antigens to the immune system, creating a dual innate and adaptive immune response, activating fighter T cells, and triggering the immune system to recognize, and seek out and destroy any cells containing the antigens and specific mutations from their tumor.

Historically, autologous cancer vaccines have been rather onerous to develop, sometimes taking months between the tumor biopsy and administration. Elios has simplified the process so the time from resection to injection is approximately two weeks. This makes the vaccine highly feasible and will ultimately be easy for community and academic oncologists to adopt into their practices.

The TLPLDC vaccine is currently being studied as a monotherapy and in combination with standard-of-care checkpoint inhibitor therapies in a Phase IIb clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

On November 21, 2019 Molecular Templates, Inc. (Nasdaq: MTEM) (the "Company" or "Molecular"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported the pricing of its underwritten public offering of 6,000,000 shares of its common stock at a public offering price of $8.00 per share and 250 shares of its newly designated Series A convertible preferred stock at a public offering price of $8,000 per share (Press release, Molecular Templates, NOV 21, 2019, View Source [SID1234551562]). Each share of Series A convertible preferred stock will be convertible into 1,000 shares of common stock at the holder’s option, subject to beneficial ownership limitations. All of the shares of common stock and Series A convertible preferred stock to be sold in the offering are being sold by Molecular. In addition, Molecular has granted to the underwriters a 30-day option to purchase up to 900,000 additional shares of common stock. The offering is expected to close on or about November 25, 2019, subject to the satisfaction of customary closing conditions. The gross proceeds to Molecular from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Molecular, are expected to be $50.0 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Molecular intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund: its ongoing Phase II clinical studies for MT-3724; its ongoing Phase I clinical study of MT-5111; its share of development expenses in its CD38 collaboration with Takeda; its program PD-L1 (including its anticipated upcoming Phase I clinical study for PD-L1); further preclinical development and drug discovery activities in its other programs and for working capital and general corporate purposes.

Cowen, Barclays and Stifel are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering. Ladenburg Thalmann is acting as co-manager for the offering.

Laidlaw & Company (UK) Ltd. is acting as financial advisor in connection with the offering.

The securities are being offered by Molecular pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the offering was filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926; Barclays Capital Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at (415) 364-2720 or by email at [email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities, 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.