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 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") and Vical Incorporated (NASDAQ: VICL) reported that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or secondary endpoints in the Phase 3 HELIOS clinical trial (Press release, Astellas Pharma US, JAN 22, 2018, View Source [SID1234523370]). The vaccine was generally well tolerated, with injection-site reactions being the most commonly reported adverse event.

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

"We are disappointed that the results did not demonstrate a significant improvement in overall survival and reduction in CMV end-organ disease," said Bernhardt G. Zeiher, president of Development, Astellas. "We would like to thank the patients and clinicians who participated in this important trial."

The Phase 3 trial was designed to evaluate the efficacy of ASP0113 compared with placebo in CMV-seropositive recipients undergoing an allogeneic stem cell transplant. Efficacy was assessed using a primary composite endpoint of overall mortality and CMV end-organ disease through the first year following the transplant, an endpoint which was not met. Secondary endpoints of time to first protocol-defined CMV viremia and time to first use of adjudicated CMV-specific antiviral therapy also were not met.

"The Phase 3 trial outcome is disappointing," said Vijay Samant, Vical’s Chief Executive Officer. "Astellas and Vical employees, the investigators and study site personnel did an outstanding job conducting this study, but unfortunately, the vaccine was unable to provide protection against all-cause mortality in this very difficult-to-treat patient population."

The Phase 3 trial was a 1:1 randomized, double-blind, placebo-controlled study that enrolled a total of 514 CMV seropositive subjects undergoing hematopoietic stem cell transplantation. Randomization was stratified by donor-recipient relatedness and donor CMV serostatus. Subjects were followed for one year post-transplant. For more information about the ASP0113 clinical trial, please visit www.clinicaltrials.gov.

About Cytomegalovirus
CMV is a herpes virus that is estimated to infect more than half of all adults in the United States by age 50, and is even more widespread in developing countries. A healthy immune system typically protects an infected person against CMV disease, but does not prevent or clear latent infection. Individuals whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include HCT and solid-organ transplant recipients, as well as infants born to mothers who first become infected during pregnancy.

About ASP0113
ASP0113 is an investigational vaccine candidate designed to prevent CMV disease and associated complications in CMV-seropositive HCT recipients. ASP0113 is a bivalent DNA vaccine encoding CMV phosphoprotein 65 and glycoprotein B antigens for induction of both cellular and humoral immune responses, formulated with a proprietary poloxamer-based delivery system. ASP0113 was initially developed by Vical which partnered with Astellas for further development and commercialization. ASP0113 received Orphan Drug Designation in the United States and Europe.

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 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, announced that the European Commission has extended the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy (Press release, Seattle Genetics, JAN 22, 2018, View Source;p=RssLanding&cat=news&id=2327637 [SID1234523420]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma, including CTCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on November 9, 2017.

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"CTCL is a debilitating and disfiguring disease with few effective and durable treatment options," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "The approval of ADCETRIS for use in the European Union in CD30-positive CTCL patients represents a meaningful advance for patients with CTCL. We are pleased that our partner Takeda is able to make this therapeutic option available to patients in Europe. Since ADCETRIS was first approved by the FDA in 2011, Seattle Genetics and Takeda have made significant progress in our goal to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas, and we are working together on our next milestone of securing FDA approval and European Union marketing authorization for ADCETRIS’ use as a treatment for frontline advanced Hodgkin lymphoma."

The marketing authorization for ADCETRIS is valid in 28 countries of the European Union (EU), Norway, Liechtenstein and Iceland. It is based on positive results from a phase 3 trial called ALCANZA that were presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2016, published online in the Lancet in June 2017, and recently updated in a poster presentation at the 59th ASH (Free ASH Whitepaper) annual meeting in December 2017. The trial achieved its primary endpoint with the ADCETRIS treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility. The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm (p-value <0.001). The key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in skin symptom burden as measured by the Skindex-29 questionnaire, were all highly statistically significant in favor of the ADCETRIS arm. The safety profile associated with ADCETRIS from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue and neutropenia.

For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

In November 2017, the U.S. Food and Drug Administration (FDA) approved ADCETRIS for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy based on the results of the phase 3 ALCANZA clinical trial. Together, pcALCL and CD30-expressing MF comprise approximately 70 percent of CTCL diagnoses and the majority of patients who require systemic therapy. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

About CTCL

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. The most common subtypes of CTCL include mycosis fungoides and primary cutaneous anaplastic large cell lymphoma. Progression from limited skin involvement may be accompanied by skin tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. The standard treatment for CTCL patients includes skin-directed therapies, radiation and systemic therapies. Prior to the FDA approval of ADCETRIS, systemic therapies approved for treatment demonstrated 30 to 45 percent objective response rates, with low complete response rates.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including three phase 3 studies: the completed ECHELON-1 trial in frontline classical Hodgkin lymphoma that supported the recent FDA Breakthrough Therapy Designation and submission of the supplemental Biologics License Application (BLA) for use in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for four indications: (1) regular approval for adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, (2) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (3) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (4) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission for four indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.