On October 19, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) and 18F-fluciclovine at the upcoming American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting, to be held in Chicago, Ill., from October 24 to 27, 2021. Details of selected oral and moderated poster presentations are listed below.

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. Presentations noted by "*" discuss results of investigational studies of an approved product that is not approved by the FDA for the specific use or purpose noted.

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Monday, October 25, 2021

Axumin (fluciclovine F 18) presentations

Category:

Genitourinary Cancer

Title:

Detectability Rates and Impact on Management From High-Sensitivity Total-Body 18F-Fluciclovine PET/CT Scans in Patients With Prostate Cancer Biochemical Recurrence

Presenter:

Soheila Fayeghi Azghadi, MD, Department of Radiation Oncology, Comprehensive Cancer Center, University of California Davis, Sacramento, Calif.

Session Title:

Poster Q&A 05 – Session 05 – Genitourinary Cancer, Hematology Malignancies, and Sarcoma and Cutaneous Tumors

Presentation Time:

1:30 PM CT

Location:

McCormick Place West, Outside Room W375

Presentation No.:

2532

Category:

Genitourinary Cancer

Title:

Randomized Trial of Conventional vs Conventional plus Fluciclovine (18F) PET/CT-Guided Post-Prostatectomy Radiotherapy for Prostate Cancer: Volumetric and Patient-Reported Toxicity Analyses

Presenter:

Vishal Ramesh Dhere, MD, Winship Cancer Institute, Department of Radiation Oncology, Emory University, Atlanta, Ga.

Session Title:

Poster Q&A 05 – Session 05 – Genitourinary Cancer, Hematology Malignancies, and Sarcoma and Cutaneous Tumors

Presentation Time:

1:30 PM CT

Location:

McCormick Place West, Outside Room W375

Presentation No.:

2547

Investigational 18F-fluciclovine presentation

Category:

Central Nervous System

Session Title:

18F-Fluciclovine PET/CT to Distinguish Radiation Necrosis From Tumor Progression in Brain Metastases Treated With Stereotactic Radiosurgery: Results of a Prospective Pilot Study*

Presenter:

Martin C. Tom, MD, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio

Session Title:

51 Oral presentation

Presentation Time:

12:15 PM CT

Location:

McCormick Place West, Room W194 a/b

Presentation No.:

51

Blue Earth Diagnostics invites participants at the 2021 ASTRO Annual Meeting to attend the presentations above and visit the company at Exhibit Booth 665. Blue Earth Diagnostics is hosting an Industry-Expert Theater event, "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 event will be held on Sunday, October 24, 2021, from 12:30 to 1:30 PM CT, in Theater 1, Exhibition Floor. For full session details and scientific presentation listings, please see the ASTRO online program here.

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 Axumin prescribing information is available at View Source

On October 19, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that data evaluating the company’s NAM-enabled NK cell platform will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021) taking place in Washington, DC, and virtually November 10-14, 2021 (Press release, Gamida Cell, OCT 19, 2021, View Source [SID1234591527]).

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Details about the SITC (Free SITC Whitepaper) poster presentations are as follows:

Title: Cytotoxicity of nicotinamide enhanced natural killer cells GDA-201 is based on metabolic modulation as demonstrated by AI assisted analysis of NK cell transcriptome and metabolome
Abstract number: 217
Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. EST
Location: Hall E

Title: Nicotinamide rejuvenates ex-vivo expanded NK cells and enhances their tumor killing capacity
Abstract Number: 162
Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST
Location: Hall E

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On October 19, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALONOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the expansion plans of its ongoing Phase 1/2 study of NOX‑A12 in combination with radiotherapy in patients with brain cancer (glioblastoma, GBM) (Press release, NOXXON, OCT 19, 2021, View Source [SID1234591526]).

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The company plans to expand the ongoing GLORIA study to include additional patients in three new arms in the first-line chemotherapy resistant population (unmethylated MGMT promoter) at the highest 600 mg/week dose of NOX-A12 combined with radiotherapy:

– 6 patients with fully resected tumor will receive radiotherapy and NOX-A12;
– 6 patients with partially resected or unresected tumor will receive bevacizumab in combination with radiotherapy and NOX-A12;
– 6 patients with partially resected or unresected tumor will receive a PD-1 immune checkpoint inhibitor in combination with radiotherapy and NOX-A12.

These expansion arms come in addition to the ongoing Phase 1/2 trial evaluating three ascending doses of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. Positive data from the first two cohorts at 200 and 400 mg/week have already been reported and data from the third cohort at 600 mg/week for which patient recruitment has been completed will be reported in Q1 2022. A protocol amendment to expand the study with the first two arms above has been approved by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte), and another amendment for the third arm is being prepared. Once enrolled in the study, patients will be treated for 6 months.

"The expansion of our Phase 1/2 study of NOX-A12 in brain tumor patients will allow us to explore three further treatment configurations, all of which are supported by the clinical data emerging from the GLORIA trial. We will extend our safety data to the full surgical resection population, as we also plan to include this population of patients in our future pivotal glioblastoma study.

In addition, the extensions will assess the safety and potential synergistic benefit of NOX-A12 with anti-PD-1 and anti-VEGF combinations. Our interest in the anti-PD-1 combination is driven by the observation that NOX-A12 appears to drive infiltration of activated cytotoxic immune cells into the tumor tissue, and thus the combination with anti-PD-1 is expected to unlock a significantly stronger tumor response. We will also test a combination with anti-VEGF therapy which is commonly used in this patient population. We look forward to evaluating all these combinations," commented Aram Mangasarian, CEO of NOXXON.

NOX-A12 targets CXCL12, a crucial signal molecule that is used by malignant cells to form the tumor microenvironment to their favor, and is designed to (i) prevent tumor recurrence after radiotherapy by blocking the influx of tumor repair cells from the bone marrow and (ii) modify the tumor microenvironment in order to enable the action of anti-cancer immune cells, such as killer T-cells.

On October 19, 2021 Targovax ASA, reported that members of its executive management team are invited to present and participate in upcoming conferences (Press release, Targovax, OCT 19, 2021, View Source [SID1234591525]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Økonomisk Ugebrev’s Life Science Investor conference
Date: 20 October 2021
Presenter: Lone Ottesen (CDO)
Time: 14:35 CET

Next Gen Immuno-Oncology Virtual Conference-UK/EU Edition
Date: 26 October 2021
Presenter: Victor Levitsky (CSO)
Time: 17:45 CET

Oncolytic Virotherapy Summit
Date: 28 October 2021
Presenter: Erik Digman Wiklund (CBO)
Time: 09:30 EDT / 15:30 CET

On October 19, 2021 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2021 (Press release, Johnson & Johnson, OCT 19, 2021, View Source [SID1234591524]). "Our third-quarter results demonstrate solid performance across Johnson & Johnson, driven by robust above-market results in Pharmaceuticals, ongoing recovery in Medical Devices, and strong growth in Consumer Health," said Alex Gorsky, Chairman and Chief Executive Officer. "In the face of evolving marketplace dynamics resulting from the effects of COVID-19 and other global trends, we have continued to demonstrate the responsiveness and agility required to meet the needs of our stakeholders, while also successfully investing in a pipeline of innovation and key commercial platforms to drive our future growth. I am incredibly proud of our Company’s transformative growth over the last decade. As I prepare to transition the role of CEO to Joaquin Duato in January, I want to extend my deepest gratitude to our colleagues around the globe who work tirelessly to deliver solutions to address the world’s most urgent and unmet healthcare challenges."

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OVERALL FINANCIAL RESULTS

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Note: values may have been rounded

THIRD QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased 5.7%* primarily driven by over-the-counter (OTC) products. Major contributors to growth were TYLENOL and MOTRIN analgesics, upper respiratory products, and digestive health in OTC, and AVEENO in Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 13.8%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and OPSUMIT (macitentan) an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression. Also contributing to growth was sales of the not-for-profit COVID-19 Vaccine (Ad26.COV2.S) for the treatment of the SARS-CoV-2 virus. This growth was partially offset by declines in U.S. sales of REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and INVOKANA (canagliflozin) for the treatment of adults with type 2 diabetes.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.6%*, driven by electrophysiology products in Interventional Solutions, wound closure products in General Surgery, surgical vision products and contact lenses in Vision, trauma, hips, and knees in Orthopaedics, and energy, endocutters, and biosurgicals in Advanced Surgery. Growth was partially offset by Spine, Sports & Other.

NOTABLE NEW ANNOUCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.

Regulatory
Decisions

INVEGA HAFYERA (paliperidone palmitate) Receives FDA Approval For First and Only Twice-Yearly Treatment for Adults with Schizophrenia

(press release)

XARELTO (rivaroxaban) Plus Aspirin Receives FDA Approval For Expanded Peripheral Artery Disease (PAD) Indication to Include Patients After Lower-Extremity Revascularization (LER)

(press release)

UPTRAVI (selexipag) Receives FDA Approval For Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

(press release)

Regulatory
Submissions

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine 1

(press release)

Janssen Submits Application Seeking U.S. FDA Approval of STELARA (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis 1

(press release)

Other

Alex Gorsky to Transition Role of Chief Executive Officer of Johnson & Johnson to Joaquin Duato, Effective January 3, 2022

(press release)

Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson to Retire, Effective December 31, 2021 1

(press release)

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

(press release)

Johnson & Johnson Issues Statement on Nationwide Opioid Settlement Agreement

(press release)

DePuy Synthes Announces Introduction of the INHANCE Shoulder System, a First-to-Market, Fully Integrated Shoulder Arthroplasty System

(press release)

Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults

(press release)

Janssen Receives Positive CHMP Opinion for BYANNLI (six-monthly paliperidone palmitate) for the Maintenance Treatment of Schizophrenia in Adults

(press release)

Ethicon Announces ECHELON CIRCULAR Powered Stapler Associated with Major Reduction in Serious Complications Following Colorectal Surgery

(press release)

Johnson & Johnson Takes Steps to Equitably Resolve All Current and Future Talc Claims 1

(press release)

Janssen Receives Positive CHMP Opinion for RYBREVANT (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy 1

(press release)

Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee 1

(press release)

1Subsequent to the quarter

FULL-YEAR 2021 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures

Non-GAAP financial measure; excludes the impact of translational currency

Calculated using Euro Average Rate: July 2021 = $1.19 and October = $1.19 (Illustrative purposes only)

Non-GAAP financial measure; excludes intangible amortization expense and special items

Note: % may have been rounded

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.