On November 22, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported a collaboration with Urology Centers of Alabama (UCA) in the Cchek early prostate cancer detection study (Press release, Anixa Biosciences, NOV 22, 2019, View Source [SID1234551607]). UCA will provide patient samples in Anixa’s ongoing study, including support of clinical validation of Anixa’s Cchek Prostate Cancer Confirmation test.

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UCA is one of several sites across the U.S. participating in this study. Dr. Charles Edward Bugg, Jr. will serve as the Principal Investigator at UCA.

Amit Kumar, Ph.D., Chief Executive Officer of Anixa, stated, "We are pleased to have another highly regarded urology practice join our team of collaboration partners. We look forward to UCA’s participation as we continue the clinical validation phase of the Cchek Prostate Cancer Confirmation test in preparation for commercial launch later this year."

About Cchek
Cchek is an early cancer detection technology, that measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method that offers improved affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.

Urology Centers of Alabama
For over 60 years, Urology Centers of Alabama has been committed to providing the highest quality medical services in a compassionate and caring environment. With 24 skilled urologists, two urogynecologists, two radiation oncologist, one medical oncologist, one pathologist, a team of physicians’ assistants and nurse practitioners and over 160 employees, the practice has earned a well deserved reputation for excellence.

On November 22, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) ("Spark") reported that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock (the "Shares") of Spark for USD 114.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the "Offer") (Press release, Hoffmann-La Roche, NOV 22, 2019, View Source [SID1234551605]).

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Pursuant to the Agreement and Plan of Merger, dated as of February 22, 2019, by and among Roche Holdings, Inc., 022019 Merger Subsidiary, Inc., and Spark (as amended, the "Merger Agreement"), the Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on Monday, November 25, 2019, has been extended until 5:00 p.m., New York City time, on Tuesday, December 10, 2019, unless it is extended further under the circumstances set forth in the Merger Agreement. All terms and conditions of the Offer shall remain unchanged during the extended period.

The Offer was extended to provide additional time for the U.S. Federal Trade Commission (the "FTC") and the UK Competition and Markets Authority (the "CMA") to complete their previously disclosed reviews of Roche’s pending acquisition of Spark. The parties remain committed to the transaction and are working cooperatively and expeditiously with the FTC and the CMA.

Citibank, N.A., the depository for the Offer, has advised Roche that, as of 5:00 p.m., New York City time, on November 21, 2019, approximately 5,717,437 Shares of Spark (none of which were tendered by notice of guaranteed delivery) had been validly tendered and received, and not validly withdrawn, pursuant to the Offer, representing approximately 14.8% of Spark’s outstanding Shares. Stockholders who have already tendered their Shares of Spark do not have to re-tender their Shares or take any other action as a result of the extension of the expiration date of the Offer.

Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and received, and not validly withdrawn, a majority of the outstanding Spark Shares.

MacKenzie Partners, Inc. is acting as information agent for the Offer. Requests for documents and questions regarding the Offer may be directed to MacKenzie Partners, Inc. by telephone, toll-free at (800) 322-2885 (please call (212) 929-5500 (collect) if you are located outside the US or Canada) or via email at [email protected].

On November 22, 2019 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported updated Phase 1 data for single agent ZW25 in heavily pretreated patients with HER2‑expressing solid tumors in a mini oral presentation by Dr. Do-Youn Oh, study investigator and Professor at Seoul National University, at the ESMO (Free ESMO Whitepaper) Asia 2019 Congress, taking place November 22 – 24 in Singapore (Press release, Zymeworks, NOV 22, 2019, View Source [SID1234551595]). Zymeworks and its collaborator BeiGene, Ltd. plan to advance ZW25 into potentially registration-enabling global studies in HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA), based on these durable and consistent clinical data.

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"The promising ZW25 data at ESMO (Free ESMO Whitepaper) Asia further build momentum for the expanding footprint of our ZW25 clinical development program with BeiGene," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "Cancer is a global fight, and this strong collaboration helps us to rapidly execute on upcoming late-stage studies for people with HER2-expressing cancers worldwide."

"The encouraging clinical data on ZW25 supports further evaluation of this bispecific antibody in HER2-expressing solid tumors," said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. "We’re enthusiastic about the meaningful progress of ZW25 since we established the collaboration with Zymeworks one year ago and look forward to leveraging our unique strengths and expertise to advance ZW25 clinical development globally."

The updated single agent results of the ongoing Phase 1 trial of ZW25 in patients with HER2‑expressing solid tumors include additional safety and anti-tumor activity data from those presented at the ESMO (Free ESMO Whitepaper) 2019 Congress.

ZW25 Clinical Results Presented Today

Safety, Anti-Tumor Activity, and Biomarker Results of the HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid Tumors (Presentation# 61O, Mini Oral on Friday, November 22 at 3:30 pm SGT)

Data were reported from 69 patients diagnosed with HER2-expressing solid tumors other than breast cancer who received ZW25 at the recommended dose of either 10 mg/kg weekly or 20 mg/kg every other week. Overall, patients received a median of three prior systemic therapies. Those with BTC, GEA, and colorectal cancer (CRC) received a median of 4.5, 3, and 5.5 prior systemic therapies, respectively. Forty-one (59%) patients received prior HER2‑targeted therapies, including 93% of GEA patients. Eleven patients were diagnosed with BTC, 28 with GEA, 14 with CRC, and 16 with other HER2‑expressing cancers, including endometrial, ovarian, pancreatic, and salivary gland.

Fifty-seven of 69 patients were response evaluable at the time of data cut-off. Overall, the disease control rate (DCR) was 70%, comprising 25 (44%) partial responses and 15 (26%) with stable disease, and 18 (32%) patients experienced disease control for greater than six months. In the nine evaluable biliary tract cancer patients, the DCR was 78%, and the objective response rate (ORR) was 67%. In the 13 CRC and 23 GEA patients, ORRs were 46% and 39%, respectively. Notably, confirmed responses were seen across additional tumor types, including a 100% decrease in target lesions in a patient with pancreatic cancer. The overall median progression-free survival was 5.5 months and is still evolving.

Among all patients, ZW25 was well tolerated as an outpatient therapy. The most common treatment-related adverse events (TRAE) were diarrhea (43%), infusion-related reaction (26%), and nausea (13%). All TRAEs were Grade 1 or 2.

About the Phase 1 Clinical Trial

Zymeworks’ Phase 1 study has three parts. From part one of the study (the dose-escalation phase), the recommended single-agent dose was determined to be 20 mg/kg once every two weeks or 10 mg/kg weekly. In the second part of the study (the cohort expansion phase), additional patients are being enrolled to further assess ZW25’s single-agent tolerability and anti-tumor activity against a variety of cancer types in different settings. The third part of the study (the combination phase) is underway and evaluating ZW25 in combination with selected chemotherapy agents in gastroesophageal and breast cancer patients with HER2 high or lower HER2 expression levels. More information about ZW25 clinical trials can be found at clinicaltrials.gov.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.

On November 21, 2019, AbbVie Inc. ("AbbVie") reported that sale of $30 billion aggregate principal amount of its senior unsecured notes, consisting of (i) $750,000,000 aggregate principal amount of senior floating rate notes due May 2021 (the "May 2021 Floating Rate Notes"), (ii) $750,000,000 aggregate principal amount of senior floating rate notes due November 2021 (the "November 2021 Floating Rate Notes"), (iii) $750,000,000 aggregate principal amount of senior floating rate notes due 2022 (the "2022 Floating Rate Notes"), (iv) $1,750,000,000 aggregate principal amount of 2.150% senior notes due 2021 (the "2021 Notes"), (v) $3,000,000,000 aggregate principal amount of 2.300% senior notes due 2022 (the "2022 Notes"), (vi) $3,750,000,000 aggregate principal amount of 2.600% senior notes due 2024 (the "2024 Notes"), (vii) $4,000,000,000 aggregate principal amount of 2.950% senior notes due 2026 (the "2026 Notes"), (viii) $5,500,000,000 aggregate principal amount of 3.200% senior notes due 2029 (the "2029 Notes"), (ix) $4,000,000,000 aggregate principal amount of 4.050% senior notes due 2039 (the "2039 Notes") and (x) $5,750,000,000 aggregate principal amount of 4.250% senior notes due 2049 (the "2049 Notes" and, together with the May 2021 Floating Rate Notes, the November 2021 Floating Rate Notes, the 2022 Floating Rate Notes, the 2021 Notes, the 2022 Notes, the 2024 Notes, the 2026 Notes, the 2029 Notes and the 2039 Notes, the "Notes").

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The offering of the Notes (the "Offering") was made pursuant to a confidential offering memorandum, dated November 12, 2019.

The Notes are governed by an indenture, dated November 8, 2012 (the "Base Indenture"), by and between AbbVie and U.S. Bank National Association, as trustee (the "Trustee"), as supplemented by Supplemental Indenture No. 7, dated November 21, 2019 (the "Supplemental Indenture"), by and between AbbVie and the Trustee. The Notes are unsecured, senior obligations of AbbVie and will rank equally in right of payment with all of AbbVie’s existing and future unsecured, senior indebtedness, liabilities and other obligations.

The May 2021 Floating Rate Notes will bear interest at a floating rate, reset quarterly, equal to the Benchmark (as defined in the Supplemental Indenture), which will initially be three-month London Inter-Bank Offered Rate ("LIBOR") plus 0.350% per annum, and will mature on May 21, 2021. The November 2021 Floating Rate Notes will bear interest at a floating rate, reset quarterly, equal to the Benchmark, which will initially be three-month LIBOR plus 0.460% per annum, and will mature on November 19, 2021. The 2022 Floating Rate Notes will bear interest at a floating rate, reset quarterly, equal to the Benchmark, which will initially be three-month LIBOR plus 0.650% per annum, and will mature on November 21, 2022. The 2021 Notes will bear interest at a rate of 2.150% per annum and will mature on November 19, 2021. The 2022 Notes will bear interest at a rate of 2.300% per annum and will mature on November 21, 2022. The 2024 Notes will bear interest at a rate of 2.600% per annum and will mature on November 21, 2024. The 2026 Notes will bear interest at a rate of 2.950% per annum and will mature on November 21, 2026. The 2029 Notes will bear interest at a rate of 3.200% per annum and will mature on November 21, 2029. The 2039 Notes will bear interest at a rate of 4.050% per annum and will mature on November 21, 2039. The 2049 Notes will bear interest at a rate of 4.250% per annum and will mature on November 21, 2049.

The Offering was conducted in connection with AbbVie’s previously announced acquisition (the "Acquisition") of Allergan plc ("Allergan"). AbbVie expects to use the net proceeds from the Offering to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the Acquisition and to pay related fees and expenses, with any remaining net proceeds being used for general corporate purposes. If (i) the Acquisition has not been consummated on or prior to January 30, 2021 or (ii) prior to such date, AbbVie notifies the Trustee that it will not pursue the consummation of the Acquisition, then AbbVie will be required to redeem all of the Notes then outstanding at a special mandatory redemption price equal to 101% of the aggregate principal amount of the Notes, plus accrued and unpaid interest, if any, to, but not including, the applicable special mandatory redemption date.

Following the closing of the Offering, the commitments under the bridge credit facility entered into by AbbVie, as borrower, on June 25, 2019 were reduced to $2,200,360,000 as a result of AbbVie receiving net cash proceeds from the issuance of the Notes.

The foregoing summary of the Notes does not purport to be complete and is qualified in its entirety by reference to the full text of (i) the Base Indenture attached as Exhibit 4.1 hereto; (ii) the Supplemental Indenture attached as Exhibit 4.2 hereto; and (iii) the forms of the Notes attached as Exhibits 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, 4.11 and 4.12 hereto, the terms of which are in each case incorporated herein by reference.

On November 21, 2019 Biogen Inc. (Nasdaq: BIIB) reported that it will present at the Evercore ISI 2nd Annual HealthCONx Conference (Press release, Biogen, NOV 21, 2019, http://investors.biogen.com/news-releases/news-release-details/biogen-present-evercore-isi-2nd-annual-healthconx-conference [SID1234551616]). The webcast will be live on Tuesday, December 3, at 11:45a.m. ET, with Anirvan Ghosh, Ph.D., Senior Vice President and Head of Research and Early Development at Biogen. To access the live webcast, please visit Biogen’s Investors section at www.investors.biogen.com. An archived version of the webcast will be available following the presentation.

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