On January 22, 2018 Celgene Corporation (NASDAQ:CELG) and Juno Therapeutics, Inc. (NASDAQ:JUNO) reported the signing of a definitive merger agreement in which Celgene has agreed to acquire Juno. Under the terms of the merger agreement, Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares) (Press release, Celgene, JAN 22, 2018, View Source [SID1234523411]). The transaction was approved by the boards of directors of both companies.

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Juno is a pioneer in the development of CAR (chimeric antigen receptor) T and TCR (T cell receptor) therapeutics with a broad, novel portfolio evaluating multiple targets and cancer indications. Adding to Celgene’s lymphoma program, JCAR017 (lisocabtagene maraleucel; liso-cel) represents a potentially best-in-class CD19-directed CAR T currently in a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). Regulatory approval for JCAR017 in the U.S. is expected in 2019 with potential global peak sales of approximately $3 billion.

"The acquisition of Juno builds on our shared vision to discover and develop transformative medicines for patients with incurable blood cancers," said Mark J. Alles, Celgene’s Chief Executive Officer. "Juno’s advanced cellular immunotherapy portfolio and research capabilities strengthen Celgene’s global leadership in hematology and adds new drivers for growth beyond 2020."

"The people at Juno channel their passion for science and patients towards a common goal of finding cures by creating cell therapies that help people live longer, better lives," said Hans Bishop, Juno’s President and Chief Executive Officer. "Continuing this work will take scientific prowess, manufacturing excellence and global reach. This union will provide all three."

The acquisition will also add a novel scientific platform and scalable manufacturing capabilities which will complement Celgene’s leadership in hematology and oncology. In collaboration with Juno’s team in Seattle, Celgene plans to expand its existing center of excellence for immuno-oncology translational medicine by leveraging Juno’s research and development facility in Seattle, WA as well as Juno’s manufacturing facility in Bothell, WA.

Strategic Rationale for Acquiring Juno

Upon completion of the acquisition of Juno, Celgene will be positioned to become a preeminent cellular immunotherapy company. The strategic advantages of this acquisition will include the opportunity to:

Leverage a novel scientific platform and scalable manufacturing capabilities to position Celgene at the forefront of future advances in the science of cellular immunotherapy
Accelerate Juno’s pipeline development to capture the full potential of cellular immunotherapy
JCAR017, a pivotal stage asset, with an emerging favorable profile in DLBCL, is expected to add approximately $3 billion in peak sales and significantly strengthen Celgene’s lymphoma portfolio
JCARH125 will enhance Celgene’s campaign against BCMA (B-cell maturation antigen), a key target in multiple myeloma
Additional cellular therapy assets in proof-of-concept trials for hematologic malignancies and solid tumors will add to Celgene’s existing pipeline
Accelerate revenue diversification with meaningful growth drivers beyond 2020
Capture 100% of the global economics on all Juno’s cellular immunotherapy assets
Terms of the Agreement

Celgene will acquire all the outstanding shares of common stock of Juno through a tender offer for $87 per share in cash, or an aggregate of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene. The transaction has been approved by the boards of directors of both companies and is subject to customary closing conditions, including the tender of a number of shares of Juno common stock, that when taken together with the shares of Juno common stock already directly and indirectly owned by Celgene, represent at least a majority of outstanding shares of Juno common stock, and expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is anticipated to close in Q1:18.

Celgene expects to fund the transaction through a combination of existing cash and new debt. The resulting capital structure will be consistent with Celgene’s historical financial strategy and strong investment grade profile providing the financial flexibility to pursue Celgene’s strategic priorities and take actions to drive post 2020 growth.

The acquisition is expected to be dilutive to adjusted EPS (earnings per share) in 2018 by approximately $0.50 and is expected to be incrementally additive to net product sales in 2020. There is no change to the previously disclosed 2020 financial targets of total net product sales of $19 billion to $20 billion and adjusted EPS greater than $12.50.

J.P. Morgan Securities LLC is acting as financial advisor to Celgene on the transaction. Morgan Stanley & Co. LLC is acting as financial advisor to Juno. Legal counsel for Celgene is Proskauer Rose LLP and Hogan Lovells, and Juno’s legal counsel is Skadden, Arps, Slate, Meagher and Flom, LLP.

On January 22, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported positive overall survival (OS) results from an ongoing Phase Ib clinical trial of the Company’s second CCR2 inhibitor – CCX872 – in the treatment of locally advanced/metastatic pancreatic cancer (Press release, ChemoCentryx, JAN 22, 2018, View Source [SID1234523413]). The study demonstrated OS of 29% at 18 months with CCX872 and FOLFIRINOX combination therapy in all patients treated. The OS rate of 29% in the present study of CCX872 compares favorably with previously published OS rates of 18.6% using FOLFIRINOX alone to treat pancreatic cancer patients with metastatic disease. The findings will be presented during the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018 in San Francisco, CA.

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"The positive findings from our pancreatic cancer trial demonstrate that improved patient survival could result from selectively inhibiting CCR2 with CCX872, thereby blocking the immune-suppressing cells that CCR2 maintains in the tumor environment. This is a new approach aimed at liberating the body’s own potential for a powerful anti-tumor immune response," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "These data support CCX872 as a very promising, novel immunotherapeutic approach to treating this deadly form of cancer. Building on these highly encouraging results, we look forward to the opportunity to advance CCX872 in combination with other therapies."

The ongoing, Phase Ib, multi-center, open-label clinical trial of CCX872 for advanced pancreatic cancer completed enrollment in March 2016. All patients enrolled in the trial had advanced non-resectable pancreatic cancer (76% of patients having metastatic disease), and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of less than or equal to 2. Fifty patients received FOLFIRINOX (fluorouracil [5-FU], leucovorin, irinotecan, oxaliplatin) once every two weeks (maximum 12 cycles) plus daily doses of CCX872 for 12 weeks. Patients showing at least stable disease at the end of the 12-week treatment period were eligible to continue CCX872 treatment until disease progression.

Patients were followed for OS and blood samples were taken at baseline and at intervals throughout the active treatment period for hematologic and flow cytometric analysis of circulating immune cell populations. At 18 months, better OS was associated with lower peripheral blood monocyte counts at baseline. The presentation at ASCO (Free ASCO Whitepaper)-SITC will be the first publication of OS data at 18 months.

Details for the poster presentation are as follows:

Abstract Title: Overall Survival in a Trial of Orally Administered CCR2 Inhibitor CCX872 in Locally Advanced/Metastatic Pancreatic Cancer: Correlation with Blood Monocyte Counts

Abstract Number: 92

Session Information: Poster Session B, Poster F1

Presentation Date & Time: Friday, January 26, 2018, at 11:30 a.m. – 1:00 p.m. and 5:30 p.m. – 6:30 p.m. PT

Location: San Francisco Marriott Marquis, San Francisco, CA

About CCX872

CCR2 bearing cells are thought to have immunosuppressive behavior and effectively help tumors hide from the body’s immune response to tumor cells.

CCR2 is found on subsets of monocytes, macrophages and myeloid derived suppressor cells (MDSCs). CCX872 is an orally administered, potent and selective inhibitor of CCR2. Inhibition of CCR2 has been associated with decreased tumor growth in many preclinical solid tumor models including pancreatic cancer, metastatic melanoma, colorectal cancer, breast cancer and other solid tumors.

About Pancreatic Cancer

It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year. In the United States, the estimated incidence of pancreatic cancer in 2018 is approximately 55,500 people; prevalence is only negligibly higher owing to the poor survival rates on current therapy. Within five years of diagnosis, 93 percent of patients die from their disease. Current standards of care include chemotherapeutic regimens that have significant toxicities and, in a minority of cases, surgical resection.

On January 22, 2018 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics company, reported validation of a cervical cancer biomarker detection test that provides a highly robust and cost-efficient solution for anatomical pathology (Press release, Enzo Biochem, JAN 22, 2018, View Source [SID1234523414]).

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Specifically, Enzo’s validated p16, a marker used extensively as a key diagnostic and prognostic biomarker of several cancers, is the latest addition to the company’s growing immunohistochemistry pipeline, including, among others, Ki-67, Her2 and p53.

Enzo’s validated p16 provides clear detection of tissue abnormalities in the field of cancer diagnostics, including cervical cancer’s progression. It complements the company’s POLYVIEW immunochemistry detection, the recent subject of a favorable article in the prestigious peer-reviewed Annals of Diagnostic Pathology. The article cited POLYVIEW as having no false-positives in tests unlike some of the leading products in the field, which were found to have large percentages of false-positives that could lead to unnecessary, costly and time-consuming interventions.

With current mounting cost and reimbursement pressures, Enzo’s new p16 test provides a highly cost-effective alternative. Other p16 tests on the market have of late become unaffordable as a result of increasing reagent costs outweighing average reimbursements. When p16 is used in combination with Enzo’s POLYVIEW detection system’s reduction of false-positives, the economics are substantially enhanced. This and other similar compounds comprise a $200 million market.

In an era of high product costs and shrinking reimbursements, Enzo has positioned itself as a growing provider of high quality, cost-effective tests that provide value in bolstering diagnostics profit margins.

"We launched our immunohistochemistry tests in response to market leaders raising prices," said Elazar Rabbani, Ph.D., Enzo CEO and Chairman. "By developing our own p16, Ki-67, and p53 tests, among others, and the fact that we have a truly unique integrated capability to develop, evaluate and manufacture these and other diagnostics, we believe we can alleviate pressure on clinical labs by providing low cost, clinically relevant products and services, which is what we are engaged in doing."

The expanded Anatomical Pathology global program at Enzo offers cost-effective clinically relevant solutions, enhances Enzo’s ongoing collaborations with clinical partners, and expands the company’s clinical and reference services nationwide. This complements Enzo’s long standing position within the women’s health field with a focus on cervical cancer testing dating back to the launch of the first in situ HPV cervical cancer detection system in the early 1980’s. In addition to these products, Enzo’s portfolio includes a line of assays for identification of women’s health infectious diseases as well as for the quantification of viral load in serum or plasma specimens.

On January 22, 2018 Redx Pharma Plc (LON:REDX) reported that it has appointed a chief medical officer ahead of the imminent launch of phase I clinical trials of its lead drug (Press release, Redx Pharma, JAN 22, 2018, View Source [SID1234524742]).

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Dr Andrew Saunders has 25 years in the cancer field and was recruited from Lytix Biopharma, a Norwegian immuno-oncology firm, where he held the same role.

He will work with the research and development team at Redx, "fronting" the clinical development of RXC004.

This is a potentially potent small molecule drug called a porcupine inhibitor that targets Wnt pathway.

Chairman Iain Ross said he was "very pleased" to announce Saunders’ appointment.

"He brings to the company a wealth of relevant experience and expertise in the clinical development of oncology drugs," Ross explained.

"This will be invaluable as the company transforms into a clinical stage company with the anticipated commencement of the first phase I study on lead compound RXC004 in the coming weeks.

"We are very excited by the potential of RXC004 to make a major difference in cancer treatment.

"We intend to progress RXC004 in the clinic both as a monotherapy and in combination with a checkpoint inhibitor. Therefore, we envisage that Andrew’s recent experience in immuno-oncology combination trials will be particularly pertinent to the design and execution of future clinical trials with RXC004."

Porcupine inhibitors such as RXC004 are a new and potentially breakthrough method of fighting the killer disease.

They work by targeting cancer stems cells that can often lie dormant after traditional treatment and are associated with a recurrence of the illness. Kill the stem cells and you have a chance of eradicating the disease completely.

Clinical trials of the new Redx drug commence in the "coming weeks".

On January 22, 2018 Celgene reported Acquisition of Juno Therapeutics (Press release, Juno, JAN 22, 2018, View Source [SID1234524085]).

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