On June 26, 2019 Morphic Holding, Inc. ("Morphic"), a biopharmaceutical company discovering and developing oral small-molecule integrin therapeutics, reported the pricing of its upsized initial public offering of 6,000,000 shares of its common stock at a price to the public of $15.00 per share (Press release, Morphic Therapeutic, JUN 26, 2019, View Source [SID1234537281]). The shares are expected to begin trading on The Nasdaq Global Market on June 27, 2019 under the symbol "MORF." The offering is expected to close on July 1, 2019, subject to customary closing conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Morphic, are expected to be approximately $90.0 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 900,000 shares of common stock.

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Jefferies LLC, Cowen and Company, LLC, BMO Capital Markets Corp. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on June 26, 2019. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected], from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 592-5973 or by email at [email protected]; from BMO Capital Markets Corp. at 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627 or by email to [email protected]; or from Wells Fargo Securities, LLC 375 Park Avenue, New York, New York 10152, Attention: Equity Syndicate Department, or by calling (800) 326-5897, or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 26, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported results from early clinical experience in Germany with positron emission tomography (PET) (PET/CT or PET/MRI) imaging using a radiohybrid Prostate Specific Membrane Antigen-targeted compound (18F-rhPSMA-7) (Press release, Blue Earth Diagnostics, JUN 26, 2019, View Source [SID1234537280]). The presentations were made by the Technical University of Munich (TUM) and Ludwig-Maximilian-University (LMU), Munich. Blue Earth Diagnostics acquired exclusive rights to a broad family of rhPSMA agents in 2018. Presentations included early clinical experience with 18F-rhPSMA-7 PET in the detection of biochemical prostate cancer recurrence in patients after radical prostatectomy, after radiation therapy and in high risk primary prostate cancer patients. Additional presentations described the biodistribution profile of 18F-rh-PSMA-7, the initial clinical proof-of-concept evaluation, chemical labeling and GMP production of the radiohybrid compound, and dosimetry and biodistribution characteristics for 18F-rhPSMA-7 and one of its four isomers, 18F-rhPSMA-7.3. Results were presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), from June 22 – 26, 2019 in Anaheim, Ca.

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NOTE: this early clinical experience with 18F-rhPSMA-7 by TUM in Germany, consistent with the German Medicinal Products Act 13 (2b), reflects use of an investigational agent for which safety and efficacy have not been established by the U.S. Food and Drug Administration.

"We are very pleased that TUM and LMU are able to share their initial clinical experiences with 18F-rhPSMA-7 in multiple presentations to the nuclear medicine community at SNMMI," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Blue Earth Diagnostics’ acquisition of rhPSMA has expanded our technologically advanced PET imaging portfolio, and complements approved, commercially available Axumin (fluciclovine F 18). We believe that both agents may ultimately provide physicians and their patients living with prostate cancer the ability to select the diagnostic agent most appropriate to each specific clinical situation. Based on results from these studies, we are progressing the isomer 18F-rhPSMA-7.3 as a lead imaging candidate for further development."

"Effective staging of primary prostate cancer and determining the extent and location of recurrent disease can inform an appropriate clinical management plan specific for each patient," said Wolfgang Weber, MD, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "This is an important consideration for physicians and their patients, as between 30 – 40% of men with prostate cancer will develop local or distant recurrences after radical prostatectomy or radiation therapy. Our early clinical use of 18F-rhPSMA-7 PET imaging at TUM reflects our experiences in prostate cancer patients with biochemical recurrence after radical prostatectomy, after radiation therapy and in primary disease. These preliminary data are encouraging and support further research with rhPSMA."

"Initial experience with 18F-rhPSMA-7 at TUM has allowed us to investigate the potential diagnostic performance of a new class of PSMA-targeting agents that enable efficient labelling with imaging radioisotopes such as 18F for PET imaging," said Matthias Eiber, MD, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "Based on the half-life of the 18F radioisotope, 18F-labeled PSMA-targeted imaging agents can offer efficient distribution and broad availability, outside of select academic research institutions, as well as rapid production, consistent, centralized manufacturing and high resolution PET scans, all of which are important considerations in detecting and localizing prostate cancer."

Highlights of TUM 18F-rhPSMA-7 PET/CT Clinical Presentations at SNMMI

In an oral presentation, "18F-rhPSMA-7 positron emission tomography (PET) for the detection of biochemical recurrence of prostate cancer following curative-intent radiation therapy," Dr. Harun Ilhan of LMU, Munich, presented results of a retrospective analysis of 78 patients who had biochemical recurrence of prostate cancer after primary radiation therapy. 18F-rhPSMA-7 PET/CT demonstrated a detection rate (DR) of 94% (73/78).
In second oral presentation, "18F-rhPSMA-7 positron emission tomography (PET) for the detection of biochemical recurrence of prostate cancer following radical prostatectomy," Dr. Matthias Eiber of TUM described results from a retrospective analysis of 532 patients with biochemically recurrent prostate cancer after radical prostatectomy in which 18F-rhPSMA-7 PET/CT or PET/MRI demonstrated a DR of 79.5% (423/532) at a median PSA level of 0.97 ng/mL. The DR in patients with a PSA of 0.2-<0.5ng/mL was 63.8% (81/127).
Dr. Markus Kroenke of TUM presented results of a retrospective analysis of 58 patients with high risk primary prostate cancer which indicated that 18F-rhPSMA-7 PET/CT or PET/MRI demonstrated sensitivity of 72% (13/18), specificity of 93% (37/40) and diagnostic accuracy 86% (50/58), when compared to histopathological findings in a poster presentation, "Histologically-confirmed diagnostic efficacy of 18F-rhPSMA-7 positron emission tomography for N-staging of patients with high risk primary prostate cancer."
Dr. Oh of TUM and Seoul National University Boramae Medical Center presented a poster, "Quantitative and qualitative analysis of biodistribution and PET image quality of novel radiohybrid PSMA ligand, 18F-rhPSMA-7, in patients with prostate cancer," which described a study to evaluate the optimum activity and imaging timepoint when using 18F-rhPSMA-7 to image patients with prostate cancer. The analysis showed stable uptake of 18F-rhPSMA-7 across multiple uptake times and administered activities, with an early imaging timepoint of 50 – 70 minutes recommended.
A poster presentation by Dr. Oh, "Preclinical dosimetry and human biodistribution of 18F-rhPSMA-7 and 18F-rhPSMA-7.3," compared preclinical dosimetry and human biodistribution characteristics of 18F-rhPSMA-7.3, one of the four isomers of 18F-rhPSMA-7, with that of the parent racemic compound. Standardized Uptake Value (SUV)mean for renal uptake and bladder retention were 55.2 and 10.2, respectively, for 18F-rhPSMA-7 and 35.5 and 2.0, respectively, for 18F-rhPSMA-7.3. Tumor uptake (SUVmean) from an analysis of 89 prostate cancer lesions was 20.0±20.2 for 18F-rhPSMA-7 and 32.5±42.7 for 18F-rhPSMA-7.3 (p<0.001).
In an oral presentation, "PSMA-targeted 18F-labeled Radiohybrid Inhibitors: Labeling chemistry and automated GMP production of 18F-rhPSMA-7," Daniel Di Carlo of TUM presented results on chemical labeling of radiohybrid radiopharmaceuticals, using 18F-rhPSMA-7 as the example compound. The labeling results were then used to establish rapid, fully automated, large-scale production of the compound in a clinical GMP environment.
Alexander Wurzer of TUM presented in an oral presentation, "PSMA-targeted 18F-labeled Radiohybrid Inhibitors: Concept, preclinical evaluation and first proof of concept study in men," which described preclinical evaluation of 18F-rhPSMA-7 and results of clinical proof-of-concept imaging, in which the compound demonstrated rapid renal clearance, minimal bladder uptake and enabled high-contrast imaging of lymph nodes and bone metastasis in men with metastatic castration-resistant prostate cancer.
Abstracts from the SNMMI Annual Meeting are published in the Journal of Nuclear Medicine: View Source

About rhPSMA

Blue Earth Diagnostics acquired exclusive, worldwide rights to radiohybrid Prostate Specific Membrane Antigen (PSMA)-targeted technology (rhPSMA) from Scintomics in 2018. rhPSMA originated from the Chair of Pharmaceutic Radiochemistry at the Technical University of Munich, Germany, by Alexander Wurzer and Hans Juergen Wester, and has been utilized clinically under German legislation at the Department of Nuclear Medicine for the diagnostic imaging of men with both primary and recurrent prostate cancer. 18F-rhPSMA consists of a prostate-specific membrane antigen (PSMA) receptor ligand, which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. 18F-rhPSMA has not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations about 18F-rhPSMA-7 discuss experiences with an investigational agent for which the safety and efficacy have not been established by the FDA.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at www.axumin.com.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics company focused on the development and commercialization of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics is led by recognized experts in the clinical development and commercialization of innovative nuclear medicine products. The company’s first approved and commercially

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.