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 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 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing dedicated viral vector GMP services for gene therapy, oncolytic products and vaccines for all stages of clinical supply, reported that thay have expanded their strategic manufacturing collaboration (Press release, Advanced BioScience Laboratories, JAN 22, 2018, View Source [SID1234565002]). Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen’s multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen’s pipeline product, JX-970.

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"Based on SillaJen’s established partnership with ABL, we are pleased to further expand our agreement to include another exciting product in our pipeline," stated Georg Roth, Ph.D, Senior Vice President, Technical Operations at SillaJen. "ABL has significant experience in virus manufacturing, and we are glad to be able to utilize their expertise in order to continue to expedite the development of these important oncolytic virus therapies."

"We are excited about the significant potential of SillaJen’s oncolytic immunotherapy products and are pleased to further expand our agreement with an additional product," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Our primary focus is ultimately to safely help patients in need, and so we look forward to applying our twenty-plus years of experience in virus manufacturing to these exciting oncolytic products."

Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

The ongoing Phase 3 study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. To learn more about the trial, please visit: View Source

About JX-970
JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.