On June 9, 2020 Thermo Fisher Scientific reported that it has expanded its strategic partnership with Agios Pharmaceuticals by adding the co-development of a second companion diagnostic (CDx) for oncology to their existing agreement (Press release, Thermo Fisher Scientific, JUN 9, 2020, View Source [SID1234560954]). The CDx will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System, and will be used globally to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881). Vorasidenib is an investigational, oral, brain-penetrant inhibitor of IDH1 and IDH2 mutations that is being developed by Agios and is currently under evaluation in the Phase 3 INDIGO study.

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Gliomas represent a broad range of primary brain tumors, ranging from highly aggressive glioblastomas to slow-growing LGG. About 11,000 new LGG patients are diagnosed in the U.S. and Europe each year, and about 80 percent have an IDH1 gene mutation. Patient symptoms range from seizures and neurologic deficits to sensory impairment and changes in behavior, with a five-year survival rate of 33 percent.

"The speed of the Genexus System in combination with the Oncomine Precision Assay has the potential to change the pace in which those diagnosed with LGG can be stratified and directed to a potentially more effective treatment in the future," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "We are committed to collaborating with leading pharmaceutical partners to make precision medicine accessible to more patients everywhere."

Under the terms of the agreement, the companies will collaboratively validate the biomarkers for a test that will be based on Thermo Fisher’s Oncomine Precision Assay and used to identify variant-positive patients. Thermo Fisher will retain the rights to commercialize the test globally and will lead filings to seek clearance from the appropriate regulatory agencies.

The new agreement follows a 2017 partnership between the companies to develop and commercialize a CDx to identify patients with IDH1 mutant cholangiocarcinoma who may be eligible for TIBSOVO (ivosidenib or AG-120) as part of the ClarIDHy Phase 3 clinical study. Data from that clinical trial were presented at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

The Oncomine Precision Assay is a next-generation sequencing (NGS) assay that is used to detect key biomarkers from formalin-fixed paraffin-embedded (FFPE) tissue or liquid biopsy specimen. The assay contains more than 50 cancer-related biomarkers and, when run on the Genexus System, features an automated workflow with a one-day turnaround time and the lowest sample requirements on the market for detection of both DNA and RNA variants. The latest CDx agreement is the first that leverages the Oncomine Precision Assay and the Genexus System, which were introduced to the market in November 2019.

On June 9, 2020 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) ("OV" or the "Company") reported that it will issue 751,879 shares at a price per share of SEK 1.33 to Negma Group LTD (Press release, Oncology Venture, JUN 9, 2020, View Source,LTD%20and%20Park%20Partners%20GB.&text=Negma%20Group%20Ltd.%20has%20today,of%20nominal%20DKK%200.05%20each. [SID1234560938]).

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The share issue is carried out pursuant to the convertible note agreement with Negma Group LTD and Park Partners GB.

Oncology Venture announced on April 3rd, 2020, that it has called upon the first tranche of convertible notes of SEK 10 million in line with the terms from the financing agreement communicated on March 31st, 2020. Negma Group Ltd. has today requested to convert SEK 1,000,000 of the notes into 751,879 shares of nominal DKK 0.05 each.

The conversion price is fixed at SEK 1.33 per share of nominal DKK 0.05 share and has been calculated as 95% of the lowest VWAP share price of the seven consecutive trading days prior the receipt of the conversion request, excluding trading days on which the closing VWAP is lower than 90 % of the average closing VWAP over the pricing period otherwise calculated.

The registered share capital of Oncology Venture will after the conversion be nominal DKK 8,011,647.85 divided into 160,232,957 shares of nominal DKK 0,05 each.

On June 9, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz Pharmaceuticals") reported the pricing of $850 million aggregate principal amount of 2.000% exchangeable senior notes due 2026 in a private offering (the "offering") by Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Jazz Pharmaceuticals, JUN 9, 2020, View Source;301072646.html [SID1234560955]). The Issuer also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes. The sale of the notes is expected to close on June 11, 2020, subject to customary closing conditions.

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The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2020, at a rate of 2.000% per year. The notes will mature on June 15, 2026, unless earlier exchanged, repurchased or redeemed. Prior to March 15, 2026, the notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be exchangeable for cash, ordinary shares ("ordinary shares") of Jazz Pharmaceuticals or a combination thereof, at the Issuer’s election. The initial exchange rate will be 6.4182 ordinary shares per $1,000 principal amount of notes (equivalent to an initial exchange price of approximately $155.81 per ordinary share, which represents approximately a 40.0% premium over the closing price per ordinary share on the Nasdaq Global Select Market on June 8, 2020), subject to adjustment in some events but not for any accrued and unpaid interest. The Issuer’s obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals and will rank pari passu in right of payment with the Issuer’s existing 1.875% exchangeable senior notes due 2021 (the "2021 notes") and 1.500% exchangeable senior notes due 2024.

The Issuer may redeem the notes at its option, prior to June 15, 2026, in whole but not in part, in connection with certain tax-related events. The Issuer also may redeem the notes at its option on or after June 20, 2023 and prior to March 15, 2026, in whole or in part, if the last reported sale price of ordinary shares has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending within the three trading days immediately preceding the date on which the Issuer provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If Jazz Pharmaceuticals undergoes a "fundamental change," subject to certain conditions and limited exceptions, holders of the notes may require the Issuer to repurchase for cash all or part of their notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date of the notes or upon the Issuer’s issuance of a notice of redemption, the Issuer will, in certain circumstances, increase the exchange rate for holders of the notes who elect to exchange their notes in connection with such a corporate event or exchange their notes called for redemption during the related redemption period, as the case may be. Jazz Pharmaceuticals estimates that the net proceeds from the offering will be approximately $833.6 million (or approximately $981.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discount and commissions and estimated offering expenses payable by the Issuer. The Issuer intends to use approximately $332.9 million of the net proceeds from the offering to repurchase for cash up to approximately $332.9 million aggregate principal amount of the 2021 notes through individual privately negotiated transactions concurrently with the offering of notes. The remaining net proceeds will be used for general corporate purposes, which may include additional repurchases of 2021 notes from time to time following the offering. Note repurchases occurring concurrently with the offering of the notes, and the potential related market activities by selling holders of the 2021 notes, could increase (or reduce the size of any decrease in) the market price of the ordinary shares concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes. Note repurchases that may occur from time to time following the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares or the trading price of the notes.

None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act or the securities laws of any other jurisdiction, and, unless so registered may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

On June 9, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the Gladman Sachs 41st Annual Healthcare Conference, being held virtually (Press release, TG Therapeutics, JUN 9, 2020, View Source [SID1234560920]). The fireside chat is scheduled to take place on Thursday, June 11, 2020 at 4:40 PM ET.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On June 9, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that, based upon tumor regression and associated clinical responses observed in the heavily pretreated Cohort 1 of the KEYNOTE-890 study, the Company plans to expand into earlier first-line treatment to investigate the combination of OncoSec’s lead product candidate TAVO (plasmid-based interleukin-12 or pIL-12) and Merck’s KEYTRUDA (pembrolizumab) plus chemotherapy in patients with inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) (Press release, OncoSec Medical, JUN 9, 2020, View Source [SID1234560939]). Cohort 2 will be added as a second arm to the ongoing KEYNOTE-890 study.

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Merck’s Phase 3 KEYNOTE-355 trial evaluating KEYTRUDA in combination with chemotherapy in first-line mTNBC recently reported a statistically significant and clinically meaningful improvement in progression free survival (PFS) with the combination of KEYTRUDA plus chemotherapy versus chemotherapy alone for first-line treatment of patients with PD-L1 positive (CPS ≥10) mTNBC. Safety was consistent with known profiles of each regimen. These findings, as well as the strong signal, even in patients with PD-L1 negative tumors, and excellent safety profile observed in KEYNOTE-890 Cohort 1, served as the basis for OncoSec’s decision to move into first-line mTNBC.

Specifically, Cohort 2 of the KEYNOTE-890 study will evaluate the addition of TAVO in combination with KEYTRUDA and chemotherapy in the first-line setting in approximately 40 patients with mTNBC. The primary endpoint will be overall responder rate (ORR) by blinded independent central review (BICR) based on RECIST v1.1. Should positive results from the KEYNOTE 890 Cohort 2 be observed, the Company plans to expand it and utilize the results from the expansion to seek accelerated approval.

In December 2019, OncoSec presented interim data of 28.6% ORR from Cohort 1 at the San Antonio Breast Cancer Symposium. These data included four confirmed partial responses, as assessed by the investigator, in 14 patients who were refractory to chemotherapy and had progressed after an average of three prior lines of therapy. Three of the four responding patients’ lesions were PD-L1 negative by IHC analysis before treatment (the fourth patient was undetermined). Importantly, TAVO and pembrolizumab were well tolerated.

"TAVO and KEYTRUDA have already demonstrated strong clinical data in heavily pretreated metastatic TNBC patients and we, along with our partners at Merck, recognize a compelling opportunity to improve response rates in a much larger overall patient population by moving into first-line metastatic TNBC where there remains a high unmet medical need," said Daniel J. O’Connor, President and Chief Executive Officer at OncoSec. "We are optimistic about the potential for TAVO to improve progression free survival and overall survival for metastatic TNBC patients. We expect to begin enrollment in KEYNOTE-890 Cohort 2 next quarter and, if successful, intend to expand Cohort 2 into a registration directed study."

For more information about the KEYNOTE-890 study, click here.

About Triple Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor, or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 10-20% of patients with breast cancer are diagnosed with TNBC.