On June 26, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported results from a retrospective, observational analysis evaluating the safety and effectiveness of 18F-fluciclovine in the detection of recurrent gliomas in adults, using data from multiple research sites (Press release, Blue Earth Diagnostics, JUN 26, 2019, View Source [SID1234537279]). The primary aim was to determine the Positive Predictive Value (PPV) of 18F-fluciclovine PET to detect glioma in comparison to a histopathological truth standard. Results demonstrated that among the patients with recurrent glioma (n=17), 18F-fluciclovine PET demonstrated a PPV of 88.2%, a detection rate of 100% and sensitivity of 100%. No adverse events related to 18F-fluciclovine were reported in the study. 18F-fluciclovine is a synthetic amino acid labeled with the radioisotope F 18, enabling PET imaging which may help visualize the increased amino acid transport that occurs in malignant brain tumors such as glioma.

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Results of the study were announced in an oral presentation, "Safety and effectiveness of 18F-fluciclovine PET in adults with recurrent glioma: a retrospective observational study," by Tore Bach-Gansmo, MD, PhD, Oslo University Hospital, Oslo, Norway, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, June 22 – 26, 2019 in Anaheim, Ca.

"We are pleased to share results from this retrospective study of 18F-fluciclovine PET imaging of recurrent adult glioma with the nuclear medicine community at SNMMI," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Clinical investigations such as this can help to inform the development of innovative PET imaging agents to address important unmet medical needs."

"Glioma is a serious and potentially life-threatening disease, accounting for 80% of all malignant primary brain tumors," said Peter Gardiner, MB ChB, MRCP, FFPM, CMO of Blue Earth Diagnostics. "The ability to identify the location and extent of a tumor is important in planning appropriate treatment for patients, in both initial diagnosis and subsequent monitoring for recurrence."

In another oral presentation at SNMMI, "Evaluation of glioma tumor volume with 18F-fluciclovine positron emission tomography interpreted in combination with MRI, compared with MRI alone: Results from a prospective phase 3 blinded image evaluation," Matthew Miller, PhD, of Blue Earth Diagnostics, presented results from another of the company’s clinical trials. The study, BED006, was a prospective, blinded image evaluation that examined the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with various types of MRI, for imaging of suspected glioma when interpreted by readers unfamiliar with 18F-fluciclovine PET. Results indicated a Positive Predictive Value (PPV) of more than 90% (n=35) for each of the three blinded readers and consistent image interpretation across these readers. In addition, 18F-fluciclovine PET with MRI (CE-T1W MRI) identified additional regions suspicious for glioma that CE-T1W MRI alone was unable to identify, which subsequent biopsies confirmed as malignant. To date, the safety profile of 18F-fluciclovine PET imaging in patients with glioma appears to be consistent with that summarized in current Axumin U.S. prescribing information.

About the Retrospective Observational Study in Adults with Glioma (BED008)

Study BED008 was a retrospective observational study of 18F-fluciclovine PET that was designed to evaluate the safety and efficacy of 18F-fluciclovine PET in the detection or recurrent gliomas in adults. It analyzed results from three clinical sites (Emory University, Atlanta, Ga., Memorial Sloan Kettering Cancer Center, New York, NY; and under a compassionate use program at Oslo University Hospital, Oslo, Norway). The primary objective of the study was to determine the Positive Predictive Value (PPV) of 18F-fluciclovine PET to detect glioma in comparison to a histopathological truth standard. Secondary objectives included determination of the detection rate, sensitivity, specificity, and negative predictive value (NPV). The study also aimed to evaluate adverse events in any patient who received 18F-fluciclovine.

A total of 82 adult patients received at least one injection of 18F-fluciclovine for the detection or primary or recurrent glioma and had had at least one histopathological report confirming the diagnosis of glioma. Only patients whose 18F-fluciclovine PET scan, MRI and histopathology assessment (positive or negative) occurred within 30 days of one another were included in analyses of diagnostic performance. Eighteen of the 82 scans met these criteria (1 scan in a patient with primary glioma and 17 scans in patients with recurrent disease). Among the 17 patients with recurrent glioma, 18F-fluciclovine showed a PPV of 88.2%, a detection rate of 100% and sensitivity of 100%. In patients with recurrent high-grade glioma (n = 12), the PPV, detection rate and sensitivity were 83.3%, 100% and 100%, respectively. In patients with recurrent low-grade glioma (n = 5) these were 100%, 100% and 100%, respectively. Specificity and NPV could not be calculated as no patients had a negative 18F-fluciclovine PET scan. In total, 3.7% (3/82) patients experienced at least one treatment emergent adverse event during the safety monitoring, none of which were considered related to 18F-fluciclovine.

About Glioma

Glioma, the most commonly occurring type of primary brain tumor, is a serious and life-threatening condition. Cancer of the brain and central nervous system (CNS) is the twelfth most common cause of cancer death worldwide. Glioma accounts for about 25% of all brain tumors, and 80% of all malignant brain tumors. The most aggressive form of glioma, glioblastoma multiforme, is associated with significant morbidity and mortality with relatively low 5-year survival estimates after diagnosis. Current treatment options for patients with glioma include surgery, radiation and chemotherapy. Accurate evaluation of the location and extent of a glioma tumor is essential before or during surgery and radiotherapy and in assessing the continuing status of the disease. The detection and assessment of gliomas typically involves magnetic resonance imaging (MRI), which may be complemented by metabolic imaging using an appropriate amino acid-based PET radiopharmaceutical as recommended in the Response Assessment in Neuro-Oncology (RANO) working group and European Association for Neuro-Oncology (EANO) guidelines.1

On June 26, 2019 Novocure (NASDAQ: NVCR) reported that the German Institute for Quality and Efficiency in Healthcare, or IQWiG, has published its rapid report concluding that, based on a review of Novocure’s EF-14 phase 3 pivotal trial, patients with newly diagnosed glioblastoma (GBM) lived longer when treated with Optune in addition to standard chemotherapy, without affecting quality of life (Press release, NovoCure, JUN 26, 2019, View Source [SID1234537278]). This positive conclusion is an important step in Novocure’s process to secure national reimbursement for Optune in Germany.

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In November 2018, the German Federal Joint Committee, or G-BA, commissioned IQWiG to prepare its report, which IQWiG did in an accelerated procedure, known as a rapid report. IQWiG sent this rapid report to the G-BA in May 2019. G-BA should now continue the process toward a national reimbursement decision for Optune in Germany. According to its published timeline, a directive is expected no later than October 2020. As the review process advances in Germany, Novocure will continue to bill payers for individual cases. Each case is evaluated individually on its merits and under the payer’s specific rules for such cases.

IQWiG’s evaluation was based on the EF-14 phase 3 pivotal trial data published in JAMA in December 2017. EF-14 demonstrated that patients with newly diagnosed GBM who added Optune to standard chemotherapy, temozolomide, had a greater opportunity to live longer than those who used chemotherapy alone. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone. Two and five-year survival rates were better with Optune with 13 percent of patients treated with Optune plus chemotherapy alive at five years versus 5 percent of patients treated with chemotherapy alone. Patients treated with Optune were also able to maintain their mental, emotional and physical well-being longer than those on chemotherapy alone.

On June 26, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported the completion of target enrollment of 198 participants for its pivotal Phase 3 registration trial ("REVEAL 1") of VGX-3100, a novel DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus (HPV) (Press release, Inovio, JUN 26, 2019, View Source [SID1234537277]). Left untreated, cervical dysplasia can progress to cervical cancer. If approved, VGX-3100 would be the first immunotherapy and non-surgical alternative for women with late-stage cervical dysplasia.

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Dr. J. Joseph Kim, Inovio’s President & CEO, said, "This establishes an important milestone for the company as it brings Inovio another step closer to providing an innovative treatment alternative to the women suffering with cervical dysplasia for whom surgery is the only option today. Both the U.S. and Europe represent large markets in need of a non-invasive treatment option for women, and we’re now focused on enrolling the confirmatory study (REVEAL 2) to generate a U.S. FDA submission in 2021."

Inovio’s Phase 3 program is assessing the efficacy of VGX-3100 to regress cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and to eliminate the HPV infection that causes these lesions. The REVEAL studies are prospective, randomized (2:1), double-blind, placebo-controlled trials evaluating adult women with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3. REVEAL 1 is designed to provide a one-year safety data for a minimum of 198 patients on VGX-3100. A confirmatory Phase 3 trial (REVEAL 2) is currently enrolling and is designed to provide a one-month safety data for a minimum of 198 patients.

The primary endpoint of the Phase 3 study is regression of cervical HSIL and virologic clearance of HPV 16 and/or HPV 18 in the cervix. The studies will evaluate cervical tissue changes at approximately 9 months after beginning a three dose regimen of VGX-3100 administered at months 0, 1, and 3. Secondary endpoints include safety; tolerability; regression of CIN 2/3 to CIN 1 or normal; virologic clearance of HPV; efficacy measured by non-progression to cancer; and clearance of HPV from non-cervical anatomic locations.

Dr. Prakash Bhuyan, MD PhD, Clinical Development lead for VGX-3100, said, "The completion of REVEAL 1 enrollment is a testament to the dedication of our outstanding investigators and their teams, who span 19 countries – a true global effort – to develop a non-surgical treatment for cervical high-grade dysplasia."

As previously announced in March of 2019, Inovio has also begun recruitment for the confirmatory Phase 3 trial REVEAL 2 in March 2019. Following the completion of enrollment announcement for REVEAL 1, REVEAL 2 will now be enrolling from all sites both within the U.S. and globally, including sites that were utilized in REVEAL 1.

Inovio previously reported that VGX-3100 eliminated high grade dysplasia in almost 50% of women in its Phase 2b randomized, placebo-controlled trial. In 80% of the women whose high grade dysplasia was eliminated, the HPV infection was also cleared by VGX-3100. Further data analysis revealed that the combination of HPV detection and cervical cytology (Pap smear) following dosing was predictive early during the treatment period for both elimination of the high grade dysplasia and clearance of HPV.

In addition, Inovio continues to pursue development of pre-treatment biomarker tests in collaboration with QIAGEN that may provide the ability to predict clinical response to VGX-3100, ultimately aiding in patient selection and physician guidance of patient care. These pre-treatment biomarkers could identify patients most likely to respond to treatment with VGX-3100, increasing absolute efficacy of the product.

About VGX-3100

VGX-3100 is a DNA-based immunotherapy under investigation for the treatment of HPV 16 and HPV 18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva and anus (Phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV 16 and HPV 18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically documented HPV 16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV 16 and HPV 18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.

On June 26, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is reported the acceptance of two oral presentations and five poster presentations at the International Society of Pediatric Oncology (SIOP) Annual Congress held October 23 through October 26, 2019 in Lyon, France (Press release, Y-mAbs Therapeutics, JUN 26, 2019, View Source [SID1234537276]). The abstracts for oral presentations are publicly available online at View Source

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The abstracts include the following presentation of omburtamab, one of the Company’s lead product candidates, which is currently being evaluated for the treatment of patients with CNS/Leptomeningeal metastasis from neuroblastoma, diffuse intrinsic pontine glioma ("DIPG"), and desmoplastic small round cell tumors ("DSRCT"):

"A curative approach to central nervous system metastatis of neuroblastoma," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (oral presentation)
The abstracts also include the following presentations of naxitamab, the Company’s second lead product candidate, which is currently being evaluated for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, osteosarcoma and other GD2-positive tumors:

"Naxitamab-based chemoimmunotherapy for resistant high-risk neuroblastoma: Preliminary results of "HITS" pilot/phase II study," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (oral presentation)
"Preliminary tolerability assessment of naxitamab (humanized anti-GD-2 monoclonal antibody) therapy in a phase 2 osteosarcoma trial," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for consolidating ≥2nd complete remission of high-risk neuroblastoma," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for neuroblastoma: Outpatient treatent low immunogenicity, and major responses in a Phase II trial," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for relapsed neuroblastoma resistant to salvage therapy: A Phase II trial," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for high-risk neuroblastoma: Efficacy against histologically-evident primary refractory metastases in bone marrow," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)

On June 26, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported the pricing of an underwritten public offering of 4,750,000 shares of its common stock, offered at a price of $26.00 per share (Press release, Odonate Therapeutics, JUN 26, 2019, View Source [SID1234537275]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional 712,500 shares of its common stock on the same terms and conditions. All shares of common stock sold in the offering are being sold by Odonate. The offering is expected to close on or about June 28, 2019, subject to customary closing conditions.

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The gross proceeds from the proposed underwritten public offering are expected to be $123.5 million before deducting customary underwriting discounts and offering expenses. Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development and regulatory activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies and Cowen are acting as joint book-running managers. LifeSci Capital is acting as lead manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-229785), which became effective on February 28, 2019. A final prospectus supplement relating to and describing the terms of the offering will be filed with the Securities and Exchange Commission (SEC). The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering can be made only by means of a prospectus supplement and an accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]) or Cowen and Company, LLC (c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; telephone: 631-274-2806; email: [email protected]).