On June 8, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals reported presentations at the upcoming Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), to be held in a virtual format from June 11 to 15, 2021 (Press release, Blue Earth Diagnostics, JUN 8, 2021, View Source [SID1234583721]). Results to be presented include an interim analysis of the comparative diagnostic performance of Axumin (fluciclovine F 18) PET in biochemical recurrence of prostate cancer, an evaluation of its impact on patient management in oligometastatic disease, and its performance in patients with recurrent prostate cancer who have suffered multiple treatment failures, among others. Details of the presentations to be given by Blue Earth Diagnostics collaborators are listed below. Additionally, the Company will host a satellite symposium, "The Role of PET in Post-Prostatectomy Radiotherapy," which will review the role of PET in guiding management decisions and influencing treatment outcomes and results of the EMPIRE-1 randomized trial.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All SNMMI presentations are available beginning Friday, June 11, 2021.

Title:

Positivity rates of 18F-fluciclovine PET/CT and 68Ga-PSMA PET/CT: Interim analysis of a secondary endpoint from a randomized trial
in patients with biochemical recurrence post-prostatectomy

Author(s):

Olayinka Abiodun-Ojo, Ashesh Jani, Omotayo Adediran, Akinyemi Akintayo, Bridget Fielder, Subir Goyal, Raghuveer Halkar and David Schuster

Session:

Poster – Physician/Pharm

Abstract:

1130

Title:

Incidence and Impact of Oligometastatic Disease Detected on 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer

Author(s):

Redmond-Craig Anderson, Erik Velez and Hossein Jadvar

Session:

Poster – Physician/Pharm

Abstract:

1332

Title:

Diagnostic Performance of F-18 Fluciclovine PET/CT in Prostate Cancer Patients with rising PSA Level < =0.5 ng/ml after multiple
treatment failures

Author(s):

Ajalaya Teyateeti, Achiraya Teyateeti, Gregory Ravizzini, Guofan Xu, Chad Tang, Shi-Ming Tu, Homer Macapinlac and Yang Lu

Session:

Poster – Physician/Pharm

Abstract:

1361

Title:

Single atypical metastases from Prostate Cancer as detected with Fluciclovine PET/CT: A Pictorial Essay

Author(s):

Amer Alassi, Peter Temsah, Leonard Goldfarb, Razi Muzaffar and Medhat Osman

Session:

Poster – Educational Exhibits

Abstract:

2042

Title:

Blanching defects at the pressure points: a potential pitfall in dynamic Total-Body PET/CT studies

Author(s):

Kristin McBride, Edwin Leung, Heather Hunt, Mike Nguyen, Benjamin Spencer, Simon Cherry, Ramsey Badawi, Lorenzo Nardo and Yasser Abdelhafez

Session:

Oral – Technologist

Abstract:

186

Blue Earth Diagnostics invites participants at the 2021 SNMMI Annual Meeting to attend the presentations above and to visit the Company’s virtual Commercial Exhibit Booth. Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about ongoing clinical trials. The Company is also hosting a Satellite Symposium, "The Role of PET in Post-Prostatectomy Radiotherapy," with invited speaker Dr. Ashesh Jani, MD, MSEE, FASTRO, James C. Kennedy Professor, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Ga. The symposium will be held on Saturday, June 12, 2021, from 11:45 a.m. – 12:45 pm ET. For more information about the meeting, please see the SNMMI online program here. Information on abstract presentations is available here.

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:

View Source

About Axumin (fluciclovine F 18)
Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.

On June 8, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate for the treatment of recurrent glioblastoma (GBM) patients with first tumor recurrence (Press release, VBI Vaccines, JUN 8, 2021, View Source [SID1234583720]). Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need.

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"This Fast Track Designation provides additional medical validation and is a meaningful milestone for our development of VBI-1901 as we work to provide clinical benefit for patients who have few treatment options available today," said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. "Building on the encouraging data seen to-date – including updated tumor responses and improvement in overall survival compared to historical controls as presented at ASCO (Free ASCO Whitepaper) – we look forward to working closely with the FDA as we progress this cancer vaccine immunotherapeutic candidate with the hope of improving outcomes for adults with recurrent GBM."

About Fast Track Designation

The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions, and 2) demonstrate the potential to address unmet medical needs. A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until all sections of the application are completed.

Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM.

ASCO 2021 Poster – Phase 2a Tumor Response Data and Overall Survival (OS) Data Update

The e-poster presentation highlighted patient-specific tumor response data and improvement in overall survival (OS) compared to historical controls across both arms:

Study arm 1 : VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF)
6-month and 12-month OS : 80% (n=8/10) and 60% (n=6/10), respectively
2 partial responses (≥ 50% tumor reduction) and 2 stable disease observations – 40% disease control rate
Study arm 2 : VBI-1901 + GSK’s AS01B adjuvant system1
6-month OS : 89% (n=8/9) – 12-month OS not yet reached
5 stable disease observations – 50% disease control rate
With few options for recurrent GBM patients, historical control data have demonstrated overall survival to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.2

The e-poster can be found on the "Posters" page of the "News & Resources" section of VBI’s website.

To learn more about the ongoing Phase 1/2a study, visit clinicaltrials.gov (Identifier: NCT03382977).

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

On June 8, 2021 Foundation Medicine, Inc. and Natera, Inc. (NASDAQ: NTRA), reported the launch of the research use version of FoundationOneTracker, Foundation Medicine’s personalized circulating tumor DNA (ctDNA) monitoring assay (Press release, Foundation Medicine, JUN 8, 2021, View Source [SID1234583719]). FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in ctDNA monitoring.

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FoundationOne Tracker uses optimized algorithms for identifying tumor-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma for use in both advanced- and early-stage research applications. Additionally, the creation of a robust, fully integrated workflow between Foundation Medicine and Natera is expected to provide rapid inclusion of ctDNA monitoring results into retrospective research studies.

"The addition of FoundationOne Tracker for research use provides our biopharma and academic partners access to Foundation Medicine’s broad, advanced-stage CGP footprint," said Foundation Medicine’s Chief Scientific Officer Priti Hegde. "In partnering with Natera, we have been able to leverage the best of both of our technologies to provide a cost-effective and efficient path to bring more personalized monitoring tools to our partners, and down the line, to physicians and patients, to help inform their treatment strategy."

"This partnership will help accelerate personalized ctDNA monitoring as the new standard of care in oncology," said Solomon Moshkevich, Natera’s general manager of oncology. "With Foundation Medicine’s strong track record of scientific leadership and its broad footprint within biopharma, we expect FoundationOne Tracker to become an important new tool for accelerating and improving drug development in oncology."

On June 8, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported the first Clinical Trial Application (CTA) authorization in the European Union (EU) (Press release, NeoImmuneTech, JUN 8, 2021, View Source [SID1234583718]). This authorization comes from Italy’s Agenzia Italiana Del Farmaco (AIFA) for the company’s ongoing Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol-Myers Squibb Company’s (NYSE: BMY) Opdivo (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy.

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"We are excited to expand our investigation of NT-I7 as a potential therapeutic for cancers and other immune-mediated illnesses into the EU," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "This authorization marks a significant milestone for the development of NT-I7 and provides the opportunity to include additional patients in this study whose treatment outcomes may be improved with the use of NT-I7."

This ongoing Phase 2, randomized, proof-of-principle study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric or gastro-esophageal junction (GEJ) cancer, or esophageal adenocarcinoma, and to assess safety and tolerability of the combination in these patients. AIFA’s CTA authorization is for the phase 2 part of the study, upon successful completion of the dose escalation phase. The results of this study will be used to further clinical development of this combination in selected clinical settings and tumor types. More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On June 8, 2021 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into definitive agreements with several institutional and accredited investors, for the purchase and sale of 5,977,300 shares of its common stock, at a purchase price of $1.10 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Conatus Pharmaceuticals, JUN 8, 2021, View Source [SID1234583717]). Histogen also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 4,781,840 shares of its common stock. The closing of the offering is expected to occur on or about June 9, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.00 per share, will be exercisable immediately upon issuance and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering are expected to be approximately $6.5 million, before deducting placement agent’s fees and other offering expenses. Histogen intends to use the net proceeds from this offering for working capital and general corporate purposes, including expenses related to the clinical development of its pipeline programs, further research and development, capital expenditures and general and administrative expenses.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Histogen pursuant to a "shelf" registration statement on Form S-3 (File No. 333-248074) previously filed with the Securities and Exchange Commission (the "SEC") on August 17, 2020 and declared effective by the SEC on August 26, 2020. The offering of the shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a 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.