On January 23, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a company working to improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, reported that its president and chief executive officer, Roger J. Lias, Ph.D., will deliver a corporate presentation at NobleCon14 – Noble Financial Capital Markets’ Fourteenth Annual Investor Conference, being held January 29-30, 2018 at the W Fort Lauderdale Beach Hotel in Fort Lauderdale, Florida (Press release, Peregrine Pharmaceuticals, JAN 23, 2018, View Source [SID1234523566]).

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Details of this presentation are as follows:

NobleCon14
Time/Date: 11:30 a.m. ET on Monday, January 29, 2018
Location: W Fort Lauderdale Beach Hotel
Room: Studio 1
Avid’s presentation at NobleCon14 will be webcast live and available for replay at: View Source

On January 23, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that an overview of the Company’s business strategy and commercial and development-stage programs will be given at the Noble Capital Markets’ Fourteenth Annual Investor Conference being held at the W Hotel, Fort Lauderdale, Florida (Press release, Spectrum Pharmaceuticals, JAN 23, 2018, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-noble-capital [SID1234523570]). The Company presentation is on Tuesday, January 30, 2018, at 1:30 PM EST.

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A high-definition, video webcast of the presentation will be available the following day on the Company’s web site at www.sppirx.com under Investor Relations.

On January 22, 2018 Harbour BioMed reported that it has completed a Series A+ round financing to accelerate its growth, especially the development of multiple clinical programs (Press release, Harbour BioMed, JAN 22, 2018, View Source [SID1234523461]). The A+ round is financed by CDH Investments, a top PE firm in China, with A round investor Advantech Capital participating. Financial details were not disclosed.

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"Within the first year of operation, Harbour BioMed has successfully acquired and integrated the antibody platform company Harbour Antibodies BV, and transformed into a biopharmaceutical company with multifaceted core business. We are building a top-notch antibody discovery and technology team specialized in Immuno-Oncology and Immunology, developing a robust internal pipeline targeting global market, in licensing innovative assets to address high unmet needs for the China market, and forging new partnerships based on internal technology platforms. This progress has been highly recognized by investors and the market," said Dr. Jingsong Wang, CEO of Harbour BioMed. "We are very pleased to collaborate with leading investors such as CDH Investments to accelerate the development of our clinical stage biologic assets, and to strengthen our partnering capabilities."

Dr. Wang noted that in September 2017, Harbour BioMed licensed in two innovative clinical stage biologics, and has assembled an experienced clinical development and regulatory science team. In 2018, Harbour BioMed plans to submit at least two IND targeting multiple indications in areas of high unmet medical needs for Chinese patients.

Harbour BioMed was established in 2016 with $50 million A round financing, and acquired Harbour Antibodies BV and its subsidiaries, one of the few companies that owns technologies for generating fully human monoclonal antibodies, of both conventional as well as heavy chain only form. Current investors of Harbour BioMed include Atlas Venture, Advantech Capital, Legend Capital, CDH Investments and founding team. Harbour BioMed is headquartered with R&D Centers in China. It also has a Business Operation and Innovation Center in Boston, and an Antibody Technology Innovation Center located in Rotterdam, The Netherlands.

On January 22, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today top-line 5-year results from Nymox’s U.S. Study NX03-0040. Study NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S. comprising a highly representative sample of 146 men with the biopsy confirmed diagnosis of T1c prostate cancer, which is the most common type of low grade localized prostate cancer (Press release, Nymox, JAN 22, 2018, View Source [SID1234523418]). After 5 years, the study has now shown that high dose Fexapotide 15mg single dosage treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and that both doses of Fexapotide (15mg and 2.5mg) were consistently effective (p=.0003). There were 4.4% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3% (p=.0061).

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Paul Averback MD, CEO of Nymox, said, "These major new results show the beneficial long-term effect of a single injection of Fexapotide Triflutate. The results are expected to be even better with regimens of additional or multiple treatment administrations if required."

In the studies Fexapotide triflutate was administered by a single painless injection directly into the prostate requiring several minutes or less in an office procedure guided by routine ultrasound. The drug was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040; and repeated biopsies every 18 months, serial PSA measurements and long-term follow-up were performed on all consenting treated patients and controls. After 5 years of study, high dose Fexapotide 15mg single treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and both doses of Fexapotide (15mg and 2.5mg) were consistently effective (p=.0003). There were 4.4% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3% (p=.0061). The new study results also indicated that after 5 years of study, all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 69.8% (p=.0002) in Fexapotide 15mg treated patients compared to the randomized control group.

Dr. Averback added, "Eight years of other related U.S. long-term Phase 3 BPH studies of Fexapotide have shown reduction in new prostate cancer incidence to 1.2%, compared to previous large BPH studies of earlier drugs where the incidence of prostate cancer is in the 10-20% range. There are therefore 2 different long-term Fexapotide programs which have now each independently shown that Fexapotide has a significant and highly beneficial effect for men with prostate cancer."

"These strong results clearly support Management’s ongoing efforts to advance both of the Company’s 2 major projects towards marketing goals. Nymox expects to report further on its U.S. development plans for registration trials for low grade prostate cancer. There is a global unmet medical need for more effective prostate treatments without the undesirable side effects of current treatments," he said.

One of the major problems with the main current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, brachytherapy) is the relatively high incidence of serious sexual problems post-treatment. In 9 studies, Fexapotide treatment has been shown to have a negligible significant adverse effect post-treatment on sexual function or testosterone levels.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of prostate cancers are initially considered low risk.

Fexapotide has shown significant long-term benefit for prostate enlargement (benign prostatic hyperplasia, BPH). The recent results of Phase 3 studies of Fexapotide for BPH were communicated in podium and symposium presentations to the American Urological Association at four sectional Annual Meetings in 2017 in Scottsdale (North Central AUA November 15, 2017), Havana, (New York AUA November 6, 2017), Naples (South Central AUA November 27, 2017), and Savannah (Northeastern AUA October 12, 2017). The Company has filed for approval for Fexapotide in Europe for BPH for prostate enlargement in 2017, and the filing was validated in September 2017.

For more information please contact [email protected] or 800-936-9669.

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 (Press release, Juno, JAN 22, 2018, View Source [SID1234523416]). 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). 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.