On June 9, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported upcoming presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 11 – 14, 2022 in Vancouver, British Columbia, Canada (Press release, Blue Earth Diagnostics, JUN 9, 2022, View Source [SID1234615836]).

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Presentations on investigational radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds are being made at the conference. They include additional results from the Company’s Phase 3 SPOTLIGHT study (NCT04186845) evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy, and preclinical evaluation of 177Lu-rhPSMA-10.1, being investigated by Blue Earth Therapeutics as a therapeutic radiopharmaceutical candidate for prostate cancer. Presentations on investigational studies of 18F-fluciclovine include an interim report from an exploratory trial in lobular breast cancer, distinguishing pseudoprogression from tumor recurrence in glioblastoma, and amino acid transport mechanisms and staging in muscle invasive bladder cancer. Details of selected oral and poster presentations by Blue Earth Diagnostics and its collaborators are listed below.

NOTE: Currently, rhPSMA compounds are investigational and have not received regulatory approval.

18F-fluciclovine is an approved molecular imaging radiopharmaceutical for use in 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.

Investigational rhPSMA

Oral presentations

18F-rhPSMA-7.3
Tuesday, June 14, 2022

Title:

Inter- and intra-reader reproducibility of 18F-rhPSMA-7.3 PET image interpretation in patients with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT)
Presenter:

Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. and Invicro, Boston, Mass., on behalf of the SPOTLIGHT study group
Session Title:

SS 33 -PSMA-targeted imaging
Session Time:

10:00 – 11:30 AM PT
Presentation:

10:20 – 10:30 AM PT
Room:

118/119/120
Program ID:

2539

177Lu-rhPSMA-10.1
Monday, June 13, 2022

Title:

Preclinical evaluation of a novel radioligand therapy for patients with prostate cancer: biodistribution and efficacy of 177Lu-rhPSMA-10.1 in comparison with 177Lu-PSMA-I&T
Presenter:

Caroline Foxton, Ph.D., Blue Earth Therapeutics, Oxford, UK
Session Title:

SS 16 Radiotherapy and Radiotheranostics
Session Time:

10:00 – 11:30 AM PT
Presentation:

10:50 AM – 11:00 AM PT
Room:

114/115
Program ID:

2567

Axumin (fluciclovine F 18) and Investigational 18F-fluciclovine
Oral presentation
Sunday, June 12, 2022

Title:

18F-Fluciclovine and 68Ga-PSMA-11 PET/CT for Detection of Invasive Lobular Breast Cancer: Interim Report from an Exploratory Trial*
Presenter:

David M. Schuster, MD, FACR, Winship Cancer Institute of Emory University, Atlanta, Ga.
Session Type:

Oral
Session Title:

SS 09 – Thoracic Malignancies: Breast and Lung
Session Time:

12:30 – 2:00 PM PT
Presentation:

1:10 – 1:20 PM PT
Room:

114/115
Program ID:

2592

Poster Award Candidate Presentation
The poster, 18F-fluciclovine PET and multi-parametric MRI to distinguish pseudoprogression from tumor progression in post-treatment glioblastoma*, has been selected as a Poster Award Candidate by SNMMI and will be presented in an oral presentation on Monday, June 13, 2022 at 3:00 PM PT in the Poster Hall.

All SNMMI poster presentations are available beginning Saturday, June 11, 2022 at 6:00 PM PT in Exhibit Hall A.

Title:

Detection rates from 18F-fluciclovine total-body PET/CT in prostate cancer patients with biochemical recurrence
Presenter:

Yasser Abdelhafez, MD, Research Specialist, University of California Davis, Davis, Calif.
Program ID:

3042

Title:

Fluciclovine-PET assessment of amino-acid transporter kinetics for primary staging of muscle-invasive bladder cancer*
Presenter:

Arda Konik,Ph.D., Instructor in Radiology, Department of Radiology, Dana Farber Cancer Institute, Boston, Mass.
Program ID:

3053
Abstract ID:

634

Title:

18F-fluciclovine PET and multi-parametric MRI to distinguish pseudoprogression from tumor progression in post-treatment glioblastoma*
Presenter:

Ali Nabavizadeh, MD, Assistant Professor of Radiology, University of Pennsylvania Health System, Philadelphia, Pa.
Program ID:

3108
Abstract ID:

809

Title:

Pilot Study of 18F-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Before Radical Cystectomy: Preliminary Results*
Presenter:

Thomas Ng, MD, Ph.D., Instructor, Radiology, Harvard Medical School, Boston, Mass.
Program ID:

3052
Abstract ID:

604
Blue Earth Diagnostics invites participants at the 2022 SNMMI Annual Meeting to attend the presentations above and to visit the Company at Exhibit Booth 1419. The Company is hosting a Satellite Symposium, "18F-rhPSMA-7.3, a Unique Investigational Prostate-specific Membrane Antigen (PSMA)-targeted PET Imaging Agent for Men with Prostate Cancer," with invited speaker Dr. Andrei Purysko, MD, Department of Diagnostic Radiology, Cleveland Clinic, Cleveland, Ohio. Additional speakers include David Gauden, D.Phil., Chief Executive Officer, and Eugene M. Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer, of Blue Earth Diagnostics. The event will be held on Sunday, June 12, 2022, from 11:15 a.m. – 12:15 p.m. PT in Ballroom C (East Building) of the Vancouver Convention Center. For full session details and scientific presentation lists, please see the SNMMI 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.

On June 9, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that they will host a webinar highlighting their RenovoTAMP therapy platform (Press release, Renovorx, JUN 9, 2022, View Source [SID1234615835]). The webinar, "Facing Today’s Challenges in Pancreatic Cancer Treatment: Understanding RenovoRx’s Trans-Arterial Micro-Perfusion Therapy Platform," will be held on Tuesday, June 21st at 8:00 am (ET). To register for this event, click here.
Speakers include Dr. Michael Pishvaian, director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs for the Johns Hopkins Kimmel Cancer Center and an associate professor at the School of Medicine, and Shaun R. Bagai, RenovoRx’s Chief Executive Officer.

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During the presentation, Dr. Pishvaian, who also serves as Study Chair for the Company’s Phase 3 TIGeR-PaC clinical trial, will discuss current available treatment options for pancreatic cancer and why they can fall short of providing an effective solution to fighting this deadly disease. He will also discuss how the TIGeR-PaC study is challenging this treatment paradigm by localizing the delivery of chemotherapy directly to the tumor, and how the RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform re-envisions the treatment of pancreatic and other solid tumors with the goal of improving survival and quality of life for patients undergoing chemotherapy. Dr. Pishvaian will also explain the scientific rationale underlying RenovoTAMP’s development. Mr. Bagai will conclude by talking about the Company’s plan for expanding the utility of its innovative therapy platform and its anticipated milestones for the remainder of the year. The virtual presentation will also include a Q & A session.

A recording of this presentation will be posted to the RenovoRx Website Events page when it becomes available.

On Bayer AG and its wholly owned San Diego-based subsidiary Vividion Therapeutics, Inc. (Vividion) reported that it will highlight how the two companies have fostered innovation and collaboration through Bayer’s "arm’s length" operating model during a presentation at the 2022 BIO International Convention (Press release, Bayer, JUN 9, 2022, View Source [SID1234615834]).

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Bayer has built a strong partnership with Vividion since its acquisition of the biopharmaceutical company in 2021, deploying an innovative business model that allows Vividion to operate largely autonomously and independently to develop and advance its novel pipeline and platform technologies.

"Vividion’s arm’s length but connected relationship with Bayer has given us a unique and highly desirable operating model," said Jeffrey Hatfield, Chief Executive Officer at Vividion. "The independence has allowed us to keep our entrepreneurial culture, fast decision making and focus on breakthrough innovation, while the connection adds significant technical expertise, global reach and the financial stability of a major pharmaceutical company. With all these strengths, we’ve been able to accelerate progress on our pipeline of novel, previously undruggable target programs this past year, and we look forward to the possibility of delivering multiple programs into the clinic starting next year."

"Our partners thrive when empowered, and our objective is for Vividion to continue to advance innovation in an entrepreneurial environment focused on patient benefits and outcomes," said Marianne De Backer, MBA, Ph.D., Member of the Executive Committee of the Pharmaceuticals Division and Head of Strategy, Business Development & Licensing and Open Innovation at Bayer. "We listen to our partners’ needs and are flexible in the way we steer our engagements. As a result, we are pursuing innovative business models with external innovators, recognizing that today’s life sciences environment requires adaptive, agile approaches to deals and decision making."

By addressing key limitations of conventional drug discovery techniques, Vividion’s proprietary chemoproteomic platform technology allows the company to unlock high value, traditionally undruggable target biology with precision therapeutics for cancers and immune disorders. Recently, Benjamin Cravatt, Professor of Chemistry at The Scripps Research Institute and Vividion’s scientific co-founder, received the prestigious Wolf Prize in Chemistry for this technologic breakthrough. As the most advanced platform of its kind in the industry, Vividion adds another drug discovery engine that will fuel its pipeline with first-in-class medicines at an unprecedented speed to Bayer’s portfolio.

Vividion is already advancing multiple novel biology, first-in-class programs towards the clinic and has more than a dozen similar pipeline opportunities emerging in early discovery. Combining Bayer’s distinguished history and accomplishments in small molecule development with Vividion’s industry-leading chemoproteomic platform engine addresses known limits in the field of drug discovery to identify small molecules for disease-relevant protein targets traditionally thought to be undruggable.

With Vividion’s new, state-of-the-art research campus in San Diego, Bayer has expanded its operations into this fast-growing life sciences cluster. The company is now present in four of the largest biotechnology hubs in the United States – Boston, San Francisco, San Diego and Research Triangle Park, NC.

Details of the Bayer and Vividion presentation at the 2022 BIO Convention in San Diego:

"Cultivating innovation post-acquisition: Bayer and Vividion’s arm’s length model" by Marianne De Backer, Ph.D., EVP, Head of Strategy, Business Development & Licensing and Open Innovation at Bayer, and Jeffrey Hatfield, CEO of Vividion Therapeutics

Monday, June 13, 1:00 PM – 2:00 PM (PDT), San Diego Convention Center, Upper Level, Session Room 3

On June 9, 2022 STADA reported that it is offering Hukyndra, the Alvotech-developed high-concentration, citrate-free formulation biosimilar of adalimumab to patients and their caregivers in selected European countries, including France, Germany, Finland, and Sweden (Press release, Stada, JUN 9, 2022, View Source [SID1234615833]). Launches in further European countries are scheduled over the coming months.

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The biosimilar to Humira, with its 100 mg/mL adalimumab in 40 mg/0.4 mL custom-designed pre-filled auto-injector pen as well as 40 mg/0.4 mL and 80 mg/0.8 mL pre-filled syringe presentations, offers a comprehensive range of biosimilar presentations and devices designed with ease of patient use in mind.

Adalimumab marks the first biosimilar to be commercialized by STADA under a development and manufacturing partnership with Alvotech that, in total, spans seven biosimilars and biosimilar candidates across autoimmunity, oncology, and ophthalmology indications1. The partners’ goal is to make available these European-made biosimilars to European patients and caregivers over the coming months and years. The pipeline includes the AVT04 ustekinumab biosimilar candidate, for which Alvotech recently announced clinical study results demonstrating therapeutic equivalence to the reference product Stelara.2

Head of Global Specialty, EVP, Bryan Kim commented: "Our Hukyndra high-concentration alternative to Humira – STADA’s fifth marketed biosimilar after epoetin zeta, pegfilgrastim, teriparatide and bevacizumab – adds to STADA’s growing portfolio of biosimilar and specialty care assets aimed at broadening patient access, adding value and supporting sustainable European healthcare systems."

"Although biosimilar medicines have been marketed in Europe for over 16 years, significant unmet needs exist for patients to access key therapies," Kim continued. "Through the combination of Alvotech’s scientific and manufacturing expertise with STADA’s pan-European commercial excellence, we can deliver a portfolio of high-quality biologic products to patients in Europe, with a goal of expanding access to critical therapies. Positively impacting the lives of European patients with inflammatory disorders with our high-concentration, citrate-free alternative to Humirais fully in line with STADA’s purpose of caring for people’s health as a trusted partner."

Anil Okay, Alvotech’s chief commercial officer, commented: "We are thrilled to take this important step with STADA into multiple European markets. The commercial partnership with STADA allows Alvotech to leverage its strengths as a purpose-built R&D and manufacturing platform, singularly focused on biosimilars, which are of vital importance for healthcare systems globally."

In November 2021, STADA received approval from the European Commission for the Hukyndra high-concentration 100 mg/mL adalimumab biosimilar in the 27 EU member countries plus Norway, Iceland and Liechtenstein3. Developed by Alvotech under the AVT02 name, the biosimilar is authorized for all of the reference product’s indications, treating a range of inflammatory conditions in adults and children, including arthritis, psoriasis, Crohn’s disease and ulcerative colitis. In April 2022, Alvotech and STADA announced that they had paved the way to launching their Hukyndra biosimilar to Humira by resolving all intellectual property disputes in Europe with the manufacturer of the reference product4.

Manufactured entirely in Europe by Alvotech, STADA’s Hukyndra biosimilar offers an alternative to Humira with no clinically meaningful differences in terms of safety, quality and efficacy. Hukyndra is a patient-friendly option because of attributes that correlate with less injection-site pain, including an administered volume that is half of low-concentration adalimumab biosimilars, a citrate-free buffer and a thin 29G needle5.

STADA is supporting Hukyndra launches in individual national markets through tailored educational materials and well as dedicated patient support programs.

About AVT02 (adalimumab)

AVT02 is a monoclonal antibody and a biosimilar to Humira (adalimumab). AVT02 is approved in the EU, the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein (Hukyndra) and Canada (Simlandi). AVT02 dossiers are under review in multiple countries; in the U.S. the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspections.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). AVT04 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not claimed.

On June 9, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported new remission data on four additional patients (Press release, Aptevo Therapeutics, JUN 9, 2022, View Source [SID1234615832]). The new data includes one patient who achieved a complete remission (CR), one patient who achieved a complete remission with incomplete hematologic recovery (CRi) and two patients who achieved bone marrow complete remissions, or morphological leukemia-free state (MLFS), in the Company’s on-going multi-cohort, multi-center Phase 1b expansion trial evaluating APVO436 for the treatment of acute myeloid leukemia (AML). The Company also provided an update on a myelodysplastic syndrome (MDS) patient from the dose escalation part of the trial.

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Cohort 1 currently has the highest enrollment rate in the trial and preliminary data show that a total of four out of 11 response-evaluable patients (36%) reported on to date, have experienced remission while on therapy. Of the three new cohort 1 patients announced today, one is a CR, one is a CRi, and one is a bone marrow complete remission (MLFS). Cohort 1 is a combination arm of the trial that includes relapsed patients and those with primary refractory AML that failed to respond to frontline standard induction chemotherapy. Cohort 1 patients receive standard chemotherapy drug cytarabine or the standard chemotherapy triple drug combination MEC (mitoxantrone, etoposide, cytarabine) plus APVO436.

The fourth new patient reported on today participated in cohort 3, a monotherapy arm of the trial, and achieved a bone marrow complete remission (MLFS).

"We are enthusiastic about sharing this remission data for four new patients, including three cohort 1 participants who are receiving APVO436 in combination with standard of care, after experiencing relapsed/refractory disease, meaning they did not respond or stopped responding to prior therapy, narrowing their options for further treatment," said Dirk Huebner, Chief Medical Officer at Aptevo Therapeutics. "The observed data are very encouraging and show a positive trend in the trial, potentially establishing a path for APVO436 in combination therapy."

The Company also announced today that a patient with high-risk myelodysplastic syndrome (MDS) enrolled in the dose escalation trial remains stable and continues treatment with APVO436 now exceeding 18 months. Prior to joining the trial, this patient received and failed treatment with a hypomethylating agent, a situation that is commonly expected to be a poor prognostic event associated with short survival probability of approximately four to six months.

In this study, a "complete remission (CR)" is defined as a patient with no evidence of leukemia after treatment. This means the bone marrow contains < 5% leukemic blasts and hematologic (blood) recovery that includes normal white blood cell and platelet counts and other markers of healthy blood.

A "CRi" is defined as a complete remission except for residual thrombocytopenia or neutropenia. A "bone marrow complete remission (MLFS)" is defined as bone marrow blasts consistent with complete remission, <5%, but where peripheral blood recovery has not yet been observed.