Five Prime Therapeutics Presents Updated Data From the Phase 1a/1b Trial of FPA150 at the European Society for Medical Oncology 2019 Congress

On September 30, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, reported updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain (Press release, Five Prime Therapeutics, SEP 30, 2019, View Source [SID1234539934]). The poster can be found on the Scientific Publications Page of the Five Prime Therapeutics website.

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 FPA150 data presented at ESMO (Free ESMO Whitepaper) included preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda (pembrolizumab, a PD1 antibody) combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer.

"B7-H4 is a novel T cell immune checkpoint and the early results from the phase 1b monotherapy portion of our FPA150 study provide the first clinical demonstration of B7-H4 as a potential therapeutic target," said Helen Collins, Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "Based on the study results to-date, we continue to believe that the most promising opportunity for FPA150 is in combination with other therapeutic agents."

Key highlights from the presentation include:

Phase 1 FPA150 Monotherapy:

Two patients with B7-H4 positive ovarian cancer experienced a confirmed partial response (one in the dose escalation and one at the recommended dose of 20mg/kg)

10 patients with stable disease remain on therapy as of August 9, 2019

Increased tumor infiltration of T cells and NK cells observed in patients with a partial response or stable disease

Recommended dose of 20 mg/kg was well tolerated in all patients

Phase 1 Safety Lead-in Combination of FPA150 + Pembrolizumab :

Combination was well tolerated in the first four patients treated with FPA150 (20 mg/kg) and pembrolizumab (200 mg)

Expansion initiated in August 2019 in a cohort of ovarian cancer patients with B7-H4 overexpression

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 overexpression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as promoting enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4.

UroGen To Present at October 2019 Investor Conference

On September 30, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported that it will present at the following conference in October (Press release, UroGen Pharma, SEP 30, 2019, View Source [SID1234539952]):

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!

2019 Cantor Global Healthcare Conference

Wednesday, October 2nd
8:20AM Eastern Time
New York, NY
A live audio webcast of the event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of the webcast will be available on the website for approximately two weeks.

Entry into a Material Definitive Agreement.

On September 30, 2019, Thermo Fisher Scientific Inc. (the "Company") reported that issued €800,000,000 aggregate principal amount of 0.125% Senior Notes due 2025 (the "2025 Notes"), €800,000,000 aggregate principal amount of 0.500% Senior Notes due 2028 (the "2028 Notes"), €900,000,000 aggregate principal amount of 0.875% Senior Notes due 2031 (the "2031 Notes"), €900,000,000 aggregate principal amount of 1.500% Senior Notes due 2039 (the "2039 Notes") and €1,000,000,000 aggregate principal amount of 1.875% Senior Notes due 2049 (the "2049 Notes", and, together with the 2025 Notes, 2028 Notes, 2031 Notes and 2039 Notes, the "Notes"), in a public offering (the "Euro Offering") pursuant to a registration statement on Form S-3 (File No. 333-229951), and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, Thermo Fisher Scientific, SEP 30, 2019, View Source [SID1234551118]).

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!

On October 8, 2019, the Company plans to issue $900,000,000 aggregate principal amount of 2.600% Senior Notes due 2029 (the "USD Offering").

The Notes are subject to a Paying Agency Agreement (the "Paying Agency Agreement"), dated as of September 30, 2019, between the Company and The Bank of New York Mellon, London Branch, as paying agent. The Notes were issued under an indenture, dated as of November 20, 2009 (the "Base Indenture"), and the Eighteenth Supplemental Indenture, dated as of September 30, 2019 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The sale of the Notes was made pursuant to the terms of an Underwriting Agreement, dated September 24, 2019 (the "Underwriting Agreement"), among the Company, as issuer, and Merrill Lynch International, Goldman Sachs & Co. LLC, Citigroup Global Markets Limited and J.P. Morgan Securities plc as lead managers of the several underwriters named in Schedule A to the Underwriting Agreement. The Underwriting Agreement was separately filed with the SEC on September 25, 2019 as Exhibit 1.1 to the Company’s Current Report on Form 8-K.

The 2025 Notes will mature on March 1, 2025, the 2028 Notes will mature on March 1, 2028, the 2031 Notes will mature on October 1, 2031, the 2039 Notes will mature on October 1, 2039 and the 2049 Notes will mature on October 1, 2049. Interest on the 2025 Notes and the 2028 Notes will be paid annually in arrears on March 1 of each year, beginning on March 1, 2020, and interest on the 2031 Notes, the 2039 Notes and the 2049 Notes will be paid annually in arrears on October 1 of each year, beginning on October 1, 2020.

Prior to February 1, 2025, in the case of the 2025 Notes (one month prior to their maturity), December 1, 2027, in the case of the 2028 Notes (three months prior to their maturity), July 1, 2031, in the case of the 2031 Notes (three months prior to their maturity), April 1, 2039, in the case of the 2039 Notes (six months prior to their maturity), and April 1, 2049, in the case of the 2049 Notes (six months prior to their maturity) (each such date, a "Par Call Date"), the Company may redeem the Notes of any series, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the notes being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such notes to be redeemed matured on their applicable Par Call Date), discounted to the date of redemption on an annual basis (ACTUAL/ACTUAL (ICMA)), using a discount rate equal to the Comparable Bond Rate (as defined in the Indenture) plus 20 basis points, in the case of the 2025 Notes, 20 basis points, in the case of the 2028 Notes, 25 basis points, in the case of the 2031 Notes, 30 basis points, in the case of the 2039 Notes, and 35 basis points, in the case of the 2049 Notes, plus, in each case, accrued and unpaid interest on the Notes being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after the applicable Par Call Date, the Company may redeem some or all of the Notes at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings Limited, the Company will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus any accrued and unpaid interest, if any, to, but excluding, the date of repurchase.

The Notes are general unsecured obligations of the Company. The Notes rank equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company, including any debt securities issued in the USD Offering, and will rank senior in right of payment to

any existing and future indebtedness of the Company that is subordinated to the Notes. The Notes are also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and are structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries.

The Indenture contains limited affirmative and negative covenants of the Company. The negative covenants restrict the ability of the Company and its subsidiaries to incur debt secured by liens on Principal Properties (as defined in the Indenture) or on shares of stock of the Company’s Principal Subsidiaries (as defined in the Indenture) and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of the Company to merge or consolidate or sell all or substantially all of its assets.

Upon the occurrence of an event of default under the Indenture, which includes payment defaults, defaults in the performance of affirmative and negative covenants, bankruptcy and insolvency related defaults and failure to pay certain indebtedness, the obligations of the Company under the Notes may be accelerated, in which case the entire principal amount of the Notes would be immediately due and payable.

The Company expects that the net proceeds will be approximately €4.33 billion from the Euro Offering and $890.68 million from the USD Offering, each after deducting underwriting discounts and estimated offering expenses. The Company intends to use the net proceeds of the offerings (together with cash on hand) to repay commercial paper issued to fund the redemption on September 27, 2019 of $300 million aggregate principal amount of 4.70% Senior Notes due 2020 and $800 million aggregate principal amount of 3.15% Senior Notes due 2023, and to fund the redemption of approximately $4.5 billion aggregate principal amount of outstanding senior notes issued by the Company or its subsidiaries, including all of the outstanding 6.00% Senior Notes due 2020 and 5.00% Senior Notes due 2021 issued by its subsidiary Life Technologies Corporation, of which notice was provided to holders on September 25, 2019, and all of the October 15 Redeemed Notes (as defined below).

Wilmer Cutler Pickering Hale and Dorr LLP, U.S. counsel to the Company, has issued an opinion to the Company, dated September 30, 2019, regarding the Notes. A copy of this opinion is filed as Exhibit 5.1 hereto.

The foregoing description of certain of the terms of the Indenture does not purport to be complete and is qualified in its entirety by reference to the full text of each of the Base Indenture and the Supplemental Indenture, which are filed with this report as Exhibits 4.1 and 4.2 hereto, respectively. Each of the foregoing documents is incorporated herein by reference.

Agenus to Present at the 2019 Cantor Global Healthcare Conference on October 4, 2019

On September 30, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported that Jennifer Buell, PhD, Chief Operating Officer of Agenus, present an update on Agenus’ progress and host one-on-one meetings with investors at the 2019 Cantor Global Healthcare Conference on October 4th, 2019 at the InterContinental New York Barclay Hotel (Press release, Agenus, SEP 30, 2019, View Source [SID1234539919]).

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 presentation will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website www.agenusbio.com or by using the link below. A replay of the webcast will be available on the Agenus website following the conference.

Date: Friday, October 4, 2019

Time: 8:20 A.M. ET

Webcast: View Source

Phase II Study results of trabectedin combined with low-dose radiation therapy for Soft Tissue Sarcoma are presented at ESMO

On September 30, 2019 Sarcoma Research Groups in Spain, France and Italy, in collaboration with PharmaMar (MSE:PHM), reported that have presented the results of the metastatic patient group cohort from the single-arm, phase II multicenter study of trabectedin in combination with low-dose radiation therapy for the treatment of Soft Tissue Sarcoma (STS) (Press release, PharmaMar, SEP 30, 2019, View Source [SID1234539935]). The results were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which is being held from September 27th to October 1st in Barcelona.

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 study, led by Dr. Martín Broto, oncologist at the Virgen del Rocío University Hospital in Seville (Spain), has reached its primary endpoint of Overall Response Rate (ORR), with 55.6% of responses to the treatment.

Trabectedin in combination with a low-dose of radiotherapy has shown relevant activity in a wide range of soft tissue sarcoma types in patients with advanced metastatic disease, giving other therapeutic options for tumor reduction beyond the first line of treatment.

In addition, this combination has shown a significant impact on Progression Free Survival (PFS) and Overall Survival (OS) in patients with advanced disease who have received a median of two previous lines of treatment. The six-month median for PFS was 75%, while the six-month median for OS was reached by 86% of patients.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.