On July 17, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that four abstracts showcasing non-clinical data from rucaparib and lucitanib development programs have been accepted for on-demand viewing and publication at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, June 22 – 24, 2020 (Press release, Clovis Oncology, JUN 17, 2020, View Source [SID1234561173]).

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The accepted abstracts summarize findings from pre-clinical studies evaluating the PK, PD and anti-tumor activity of rucaparib,an oral, small molecule PARP inhibitor in orthotopic and intracranial mouse models, and its synergy with CHK1 inhibition in tumor cell lines. Additional abstracts include findings from a study of the pharmacokinetics of lucitanib, an oral, potent inhibitor of tyrosine kinase activity, in a simulated patient population to inform dosing-regimen selection, and from a pre-clinical study evaluating the anti-tumor efficacy and mechanism of action of lucitanib in combination with a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, in a mouse colon cancer model. Lucitanib and ALKS 4230 are both development-stage compounds.

"Data from our ongoing non-clinical studies underscore our commitment to pursuing innovative research that advances novel therapies for cancer patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, we are pleased to present new, non-clinical data exploring the PK/PD of our PARP inhibitor Rubraca, evaluating the synergies of PARP and CHK1 inhibition in combination, as well as important data for lucitanib to understand optimal dosing and use in combination with other anticancer agents to treat solid tumors."

The following Clovis-sponsored, collaborator-sponsored and investigator-sponsored abstracts will be available as AACR (Free AACR Whitepaper) 2020 Virtual Poster Session presentations. E-posters, and when available, accompanying audio descriptions, will be available for on-demand viewing beginning 9:00 a.m. EDT Monday, June 22, and will remain available for viewing by registered attendees for at least three months after the virtual meeting.

Abstract Number: 3026 / 14 – Evaluation of brain pharmacokinetics (PK) and tumor growth inhibition of PARP inhibitors in mouse xenograft models using semi-mechanistic PK/pharmacodynamic (PD) modeling

Presenting Author: Michelle Liao
Session: Pharmacokinetics / Pharmacodynamics
Abstract Number: 3027 / 15 – Application of machine learning and grid search approaches to minimize lucitanib pharmacokinetic variability following different dosing regimens

Presenting Author: Michelle Liao
Session: Pharmacokinetics / Pharmacodynamics
Abstract Number: 2202 / 7 – The combination of a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, and the angiogenesis inhibitor lucitanib enhances antitumor activity

Presenting Author: Jared E. Lopes
Session: Combination Immunotherapies 2
In addition, the three previous posters will be available on the Clovis Oncology website once they become available on the AACR (Free AACR Whitepaper) virtual meeting website.

Abstract Number: 1375 / 11 – Investigating synergy between CHK1 and PARP inhibitors in BRCA2 mutant and restored cells

Presenting Author: Hannah L. Smith
Session: Mechanisms of DNA Damaging Therapeutics
About Rubraca (rucaparib)

Rubraca 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. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with 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 and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, 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.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. 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.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

On June 17, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23 at 8:30 a.m. ET (Press release, Arvinas, JUN 17, 2020, View Source [SID1234561172]).

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A live audio webcast of the presentation will be available here and on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On June 7, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, reported the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL) (Press release, TG Therapeutics, JUN 17, 2020, View Source [SID1234561170]). The FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory MZL and FL. As a company this is a very exciting moment for us, as it marks our very first NDA submission, and I commend our team for all their efforts to get to this point." Mr. Weiss continued, "Importantly, I also want to thank the patients, their families and the research teams who participated in these trials. This has been an incredibly impactful year for TG thus far, with several important milestones yet to come, including topline data from the ULTIMATE trials of ublitximab in multiple sclerosis, presentation of full data from the UNITY-NHL FL/MZL cohorts and from the UNITY-CLL Phase 3 trial of umbralisib plus ublituximab (U2), and a BLA/NDA submission for U2 in chronic lymphocytic leukemia targeted by the end of the year."

ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS
The UNITY- NHL trial is a multicenter, open-label Phase 2b trial.

The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients (n=69). The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the International Conference on Malignant Lymphoma (ICML).

The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients (n=118). The results met the Company’s prespecified response target of 40-50% ORR.

ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients in the United States1, MZL is the third most common B-cell NHL, accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL)2.

ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. Follicular lymphoma is generally not curable and is a chronic disease. Patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.

On June 17, 2020 Lassen Therapeutics reported it has emerged from stealth and secured $31 million in Series A financing to develop antibodies as potential treatments for fibrosis, rare diseases and oncology (Press release, Lassen Therapeutics, JUN 17, 2020, View Source [SID1234561169]). The Series A financing was led by Frazier Healthcare Partners (Frazier) with participation from Alta Partners and Longwood Fund.

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Founded in 2019, Lassen Therapeutics is developing LASN01, a best-in-class monoclonal antibody targeting IL-11 receptor alpha (IL-11R). IL-11, a member of the IL-6 family of cytokines, is a central mediator of fibrosis and blocking its activity has the potential to be more effective than targeting other factors such as TGF-β and CTGF. IL-11 is also a pivotal effector of tumor microenvironment organization and tumor growth, playing a key role as a mediator between cancer and stromal cells.

Lassen acquired best-in-class human anti-IL-11R monoclonal antibodies from CSL Limited (CSL), a leading global biotechnology company with its R&D facilities headquartered in Melbourne, Australia. Accessing IL-11 research and antibodies from CSL greatly accelerates Lassen’s efforts to bring a novel therapeutic candidate to patients.

Lassen is led by a team of drug developers with deep experience in antibody drug discovery and development. The company was co-founded by industry veterans Mark Barrett, Chief Executive Officer, and David King, Ph.D., who serves as Chief Scientific Officer. The Lassen team has collectively brought more than twenty antibody therapeutics into the clinic with several on the market in the areas of oncology and inflammation – experience it will use to rapidly develop LASN01 and a pipeline of novel antibodies.

"IL-11 is a novel target and blocking the IL-11 pathway represents an exciting therapeutic approach for both fibrosis and oncology," said Mr. Barrett. "Inhibition of this previously unexplored pathway has the potential to make a major impact on the course of a number of fibrotic diseases. Targeting IL-11 may also present a strategy to inhibit tumor proliferation and alter the structure of the tumor microenvironment to allow more effective cancer therapies."

Under the agreement, Dr Andrew Nash, Senior Vice President, Research at CSL will join Lassen’s scientific advisory board. "We are pleased that Lassen will continue the development of CSL’s anti-IL-11R monoclonal antibody program," said Dr. Nash. "We hope it will lead to better treatment options for oncology and fibrosis patients."

Lassen has also announced a partnership with FUJIFILM Diosynth Biotechnologies (FDB) to accelerate its anti-IL-11R program. FDB has extensive industry leadership in cell culture processes including monoclonal antibody development and manufacturing. The LASN01 program is leveraging FDB’s high throughput cell culture platform which is based on advanced, single-use technologies to streamline and accelerate production of high-quality drug substance for clinical trials. "Working with leading companies such as CSL, Ltd and FUJIFILM Diosynth Biotechnologies has enabled us to rapidly advance our development programs and best-in-class novel therapies towards clinical evaluation," said Dr. King.

Lassen was formed as part of Frazier’s company creation efforts. Frazier’s Life Sciences team builds companies developing and commercializing novel therapeutics and has started or seeded more than twenty companies since 2005. Frazier leverages its extensive relationships with pharmaceutical companies and academic institutions to identify and license assets into focused new companies with exceptional management teams.

On June 17, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported priced a $4.5 billion public offering of four series of senior unsecured notes (collectively, the "Notes") (Press release, Merck & Co, JUN 17, 2020, View Source [SID1234561167]). The Notes include:

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$1.0 billion of 0.750% notes due 2026
$1.25 billion of 1.450% notes due 2030
$1.0 billion of 2.350% notes due 2040
$1.25 billion of 2.450% notes due 2050

Merck intends to use the net proceeds from the offering for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities. The offering is expected to close on June 24, 2020, subject to customary closing conditions. BNP Paribas Securities Corp., BofA Securities, Inc., Citigroup Global Markets Inc. and Deutsche Bank Securities Inc. are acting as the active joint book-running managers for the offering.

The offering of the Notes is being made pursuant to an effective shelf registration statement (including a base prospectus) filed with the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus and related prospectus supplement, copies of which may be obtained by calling BNP Paribas Securities Corp. toll-free at 1-800-854-5674, BofA Securities, Inc. collect at 1-800-294-1322, Citigroup Global Markets Inc. toll-free at 1-800-831-9146 or Deutsche Bank Securities Inc. toll-free at 1-800-503-4611. An electronic copy of the registration statement and prospectus supplement, together with the base prospectus, is available on 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 the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.