On May 21, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS), reported that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program taking place May 29 – 31 (Press release, Clovis Oncology, MAY 21, 2020, View Source [SID1234558386]).

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The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as findings from real-world evidence studies of the epidemiology and current treatment landscape of mCRPC.

"We continue to be encouraged by data demonstrating the potential of Rubraca beyond ovarian cancer and look forward to sharing new findings from some of the studies exploring its broader utility and value," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This year’s virtual ASCO (Free ASCO Whitepaper) scientific program provides a timely opportunity to share key clinical updates with the research and medical community, continuing the important dialogue around the adoption and utilization of PARP inhibitors more broadly, and Rubraca in particular."

The following Clovis-sponsored Rubraca abstract has been selected for poster discussion and is available now in the ASCO (Free ASCO Whitepaper) meeting library.

Abstract Number: 6015, Poster Number: 186 – Characterization of Patients (pts) with Long-term Responses to Rucaparib in Recurrent Ovarian Cancer (OC)

Presenting Author: Elizabeth M. Swisher, MD
Session: Gynecologic Cancer
The poster and a discussant presentation will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT. In addition, the poster will be available at View Source once it becomes available in the ASCO (Free ASCO Whitepaper) meeting library.

The two following Clovis-sponsored abstracts are available now in the ASCO (Free ASCO Whitepaper) meeting library:

Abstract Number: e19319 (online abstract publication) – Real-world Evidence of Treatment Patterns and Pharmacy Costs Among Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States

Authors: Kelvin A. Moses, MD, PhD, et al.
Abstract Number: e13592 (online abstract publication) – Epidemiology and Mortality of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States

Authors: Katrine Wallace, PhD, et al.
Additionally, the following three investigator-sponsored abstracts describing studies of Rubraca have also been selected for presentation as part of the 2020 ASCO (Free ASCO Whitepaper) scientific program and are available now in the ASCO (Free ASCO Whitepaper) meeting library.

Abstract Number: 3513, Poster Number: 243 – Phase 1 Study of Rucaparib and Irinotecan in Advanced Solid Tumors with Homologous Recombination Deficiency (HRD) Mutations

Presenting Author: Mallika S. Dhawan, MD
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
The poster and a discussant presentation will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT.

Abstract Number: 9057, Poster Number: 250 – MiST1: A Phase IIa Trial of Rucaparib in Patients Harboring BAP1/BRCA1 Deficient Relapsed Malignant Mesothelioma

Presenting Author: Dean A. Fennell, FRCP, PhD
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
The poster will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT.

Abstract Number: TPS6102, Poster Number: 273 – NOGGO Ov-42/MAMOC: Rucaparib Maintenance After Bevacizumab Maintenance Following Carboplatin-Based First-Line Chemotherapy in Ovarian Cancer Patients

Presenting Author: Elena I. Braicu, MD, PhD
Session: Gynecologic Cancer
The poster will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca U.S. FDA Approved Indications

Ovarian Cancer

Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Prostate Cancer

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

On May 21, 2020 Boston Scientific Corporation (NYSE: BSX) reported the pricing of concurrent offerings of 25,550,000 shares of its common stock ("Common Stock") at a price to the public of $34.25 per share and 8,750,000 shares of its 5.50% Mandatory Convertible Preferred Stock, Series A ("Mandatory Convertible Preferred Stock") at a price to the public and liquidation preference of $100.00 per share (Press release, Boston Scientific, MAY 21, 2020, View Source [SID1234558385]). The underwriters have separate 30-day options to purchase up to an additional 3,832,500 shares of Common Stock and up to an additional 1,312,500 shares of Mandatory Convertible Preferred Stock. The offerings are expected to close on May 27, 2020, subject to customary closing conditions.

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The net proceeds from the Common Stock offering and the Mandatory Convertible Preferred Stock offering will be approximately $847.3 million and $847.3 million, respectively (or approximately $974.7 million and $974.6 million, respectively, if the underwriters exercise their options in full), in each case after deducting underwriting discounts and commissions and estimated offering expenses.

Boston Scientific intends to use a portion of the combined net proceeds from the offerings of $1,694.6 million (or $1,949.3 million if the underwriters for both offerings exercise their options in full) to repay in full the remaining $750.0 million outstanding under its $1.25 billion term loan credit facility maturing on April 20, 2021 and to pay related fees, expenses and premiums, after which it will be terminated. The remaining proceeds will be used for general corporate purposes, which may include refinancing or repayment of other outstanding indebtedness and funding potential future acquisitions and investments.

Unless earlier converted, each share of Mandatory Convertible Preferred Stock will automatically convert on June 1, 2023 (subject to postponement for certain market disruption events, the "mandatory conversion date") into between 2.3834 and 2.9197 shares of Boston Scientific’s Common Stock, subject to customary anti-dilution adjustments. The number of shares of Common Stock issuable upon conversion will be determined based on the average volume-weighted average price (VWAP) per share of Common Stock over the 20 consecutive trading day period beginning on, and including, the 21st scheduled trading day immediately preceding June 1, 2023.

Dividends on the Mandatory Convertible Preferred Stock will be payable on a cumulative basis when, as and if declared by Boston Scientific’s board of directors, at an annual rate of 5.50% on the liquidation preference of $100.00 per share. If declared, these dividends will be paid in cash, in shares of Common Stock or in a combination of cash and shares of Common Stock, at Boston Scientific’s election, subject to certain limitations, on March 1, June 1, September 1 and December 1 of each year, commencing on September 1, 2020 and continuing to, and including, June 1, 2023. Until Boston Scientific amends or terminates its existing credit agreements that contain a restriction on its ability to pay cash dividends on its capital stock, or such restrictions are no longer effective under the terms of such credit agreements, Boston Scientific will pay the relevant dividend in shares of its common stock.

The closing of each offering is not contingent upon the closing of the other offering.

J.P. Morgan, BofA Securities, Citigroup, Goldman Sachs & Co. LLC, Wells Fargo Securities, Morgan Stanley, Barclays and RBC Capital Markets are acting as joint book-running managers for the offerings.

The offerings are being made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission (the "SEC"). Each offering will be made by means of a prospectus and related preliminary prospectus supplement only. An electronic copy of each preliminary prospectus supplement, together with the accompanying prospectus, is available on the SEC’s website at www.sec.gov. Alternatively, copies of each preliminary prospectus supplement and accompanying prospectus relating to either offering or information concerning this offering may be obtained by contacting the joint book-running managers: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, Email: [email protected]; or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, Email: [email protected].

Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or 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 jurisdiction.

On May 21, 2020 I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, and Genexine Inc. (KOSDAQ: 095700), a clinical-stage biotechnology company focused on developing innovative immunotherapeutics and novel long-acting biologics, reported that the China National Medical Products Administration (NMPA) has cleared the initiation of a Phase 2 clinical trial of TJ107/HyLeukin-7 (Efineptakin alfa), the novel long-acting recombinant human interleukin-7 (rhIL-7), in lymphopenic patients with newly-diagnosed glioblastoma multiforme (GBM) (Press release, I-Mab Biopharma, MAY 21, 2020, View Source [SID1234558384]). In addition, the two companies expanded their collaboration beyond the initial agreement to include development of TJ107/HyLeukin-7 for this indication.

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The affirmation was provided by NMPA in response to a pre-IND request to support the clinical development plans for TJ107/HyLeukin-7 as a potential treatment for GBM. Per the clearance, I-Mab and Genexine are able to initiate a phase 2 clinical study in China without additional IND application submission required.

"There’s a critical need to bring innovative therapies for patients suffering from GBM, an aggressive brain cancer with a particularly grim prognosis. I-Mab and Genexine appreciate the NMPA’s accelerated assessment and giving the greenlight to initiate a Phase 2 clinical trial of TJ107/Hyleukin-7 for GBM," said Dr. Joan Shen, CEO of I-Mab. "I-Mab’s expanded collaboration with Genexine speaks volume of our productive partnership and excellent progress made to date, which bring us a step closer to deliver on our promise to help patients in need."

Under the terms of the expanded collaboration, I-Mab will be mainly responsible for conducting the Phase 2 GBM clinical trial in China, and Genexine will share the development strategies, data and costs for success of this clinical trial. Financial terms are not disclosed.

"Standard of care in treating GBM induces long-lasting lymphopenia in most patients. As a potential treatment for patients suffering from this devastating cancer, TJ107/HyLeukin-7 has demonstrated to effectively induce T cells, especially naïve and memory T cells, and correct lymphopenia in patients with late stage solid tumors," said Dr. Jung Won Woo, Executive Vice President, CDO, Genexine. "We are delighted to deepen our partnership with I-Mab to develop a potential novel therapy."

The restoring ability of T cell deficiency of TJ107/HyLeukin-7 in a Phase 1b study (NCT03478995) by Genexine was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting in 2019. The study was on 21 terminal patients with solid tumor, and showed that TJ107/HyLeukin-7 was well tolerated without dose limiting toxicity and cytokine release syndrome. Dose-dependent increase of absolute lymphocyte counts and T cell subsets (not Treg) were also observed. The findings suggested that TJ107/HyLeukin-7 can be an excellent combination partner for chemo-radiation, cancer vaccines and immune checkpoint inhibitors such as anti-PD-1/PD-L1 antibodies, by increasing T lymphocytes and thereby contributing to enhanced anti-tumor effects.

By leveraging the results of Genexine’s ongoing clinical trials in South Korea, I-Mab is currently conducting a Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and determine recommended Phase 2 dose (RP2D) of TJ107/HyLeukin-7 in Chinese subjects with advanced solid tumors (NCT04001075).

According to the data released by GLOBOCAN 2018 by International Agency for Research on Cancer, WHO, new cases of brain and nervous system cancers reached 76,494 in China, approximately 17% of which was GBM[1]. The annual incidence rate of GBM in China is 5 to 8 per 100,000 person-year.

[1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014[J]. Neuro-oncology, 2017, 19(suppl_5): v1-v88.

About TJ107/HyLeukin-7

TJ107/HyLeukin-7 (Efineptakin alfa) is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize TJ107/ HyLeukin in Greater China. TJ107/HyLeukin-7 may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. TJ107/HyLeukin-7 has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On May 21, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 3:30 p.m. Eastern Time (Press release, Veracyte, MAY 21, 2020, View Source [SID1234558382]).

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The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On May 21, 2020 Incyte (Nasdaq:INCY) reported that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference (held virtually) on Tuesday, June 9, 2020 at 8:00 a.m. ET (Press release, Incyte, MAY 21, 2020, View Source [SID1234558381]).

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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

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.