On June 21, 2023 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, and PETNET Solutions Inc, A Siemens Healthineers Company, reported the commercial availability of POSLUMA (flotufolastat F 18) in the United States (Press release, Blue Earth Diagnostics, JUN 21, 2023, View Source [SID1234632833]). POSLUMA (formerly referred to as to as 18F-rhPSMA-7.3) is an optimized, high-affinity radiohybrid (rh) Prostate-Specific Membrane Antigen (PSMA)-targeted PET imaging agent. It is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA was approved by the U.S. Food and Drug Administration on May 25, 2023.

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POSLUMA is now commercially available through multiple radiopharmacies of PETNET Solutions, the primary manufacturer and commercial distributor for Blue Earth Diagnostics in the United States. By the end of June 2023, commercial production across the country will be underway at the 31 PETNET radiopharmacies Blue Earth Diagnostics included in its New Drug Application for POSLUMA, marking a record number of sites authorized for the manufacturing of a radiopharmaceutical upon its initial FDA approval. Additional PETNET sites are expected to manufacture POSLUMA before the end of the summer.

"We are pleased to make POSLUMA widely available across the United States for use in men with newly diagnosed or suspected recurrence of prostate cancer, and hope that this will make a real difference to physicians and their patients," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics Ltd. "Our product introduction plan for POSLUMA includes practical education programs for physicians and staff at imaging centers to educate them on the appropriate use of POSLUMA, including image acquisition and reader training programs to help ensure the best information is available to inform patient care. In addition, we are actively communicating with Medicare carriers, Medicare Advantage Plans, private insurers and radiology benefit managers to help them understand the utility and value of POSLUMA, so that they will cover these procedures appropriately."

Dr. Gauden continued, "It is an ongoing pleasure to continue working with PETNET Solutions. We have a long-standing, productive relationship based on our seven-year success with Axumin (fluciclovine F 18). Our companies share a passion for PET molecular imaging, and for providing imaging tools to help inform the management of patients across the prostate cancer care continuum."

"As the main manufacturer and distributor of POSLUMA to imaging centers in the United States, PETNET Solutions is proud to continue our longstanding commercial relationship with Blue Earth Diagnostics, which began in 2015 when we became a commercial supplier of Axumin," said Barry Scott, Head of PETNET Solutions Inc. "With our large national network of cyclotron-equipped radiopharmacies, we are well-positioned to provide broad access to POSLUMA, as well as a wide range of other novel PET biomarkers that facilitate precision medicine for healthcare providers across the country."

Blue Earth Diagnostics and PETNET Solutions welcome visitors to the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Chicago, June 24-27, 2023, to visit their exhibit booths. Blue Earth Diagnostics is at Booth 6025 and PETNET Solutions is at Booth 6075.

About POSLUMA (flotufolastat F 18)

POSLUMA (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is an optimized, targeted radiohybrid diagnostic imaging agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Precision PET imaging with POSLUMA can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management. POSLUMA represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease. POSLUMA was approved by the U.S. Food and Drug Administration in May, 2023.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

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 June 21, 2023 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), reported its founding with a $23 million seed financing led by F-Prime Capital with Omega Funds (Press release, ARTBIO, JUN 21, 2023, View Source [SID1234632831]). ARTBIO was founded in 2021 by Roy Larsen, Øyvind Bruland, Radforsk, and F-Prime Capital to create highly targeted cancer therapies by pairing the optimal alpha-emitting isotope Pb212 with ligands against proven tumor-specific targets. ARTBIO is also creating an entirely new approach to ART manufacturing to overcome production and distribution challenges. In early 2022, Emanuele Ostuni, formerly Head of Europe for Cell and Gene Therapy at Novartis Oncology, joined ARTBIO as CEO to start building its world-class team and advance its proprietary technology, while securing additional funding from F-Prime Capital and Omega Funds.

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The financing enables ARTBIO’s ongoing clinical development of its lead program AB001 for the treatment of prostate cancer. The funds will enable the company to advance a differentiated pipeline, further develop its AlphaDirect Pb212 isolation technology, and expand its distributed manufacturing network.

"Our unique approach combines Pb212 best in class properties with rationally designed ligands against tumor-specific targets to unlock the full therapeutic potential of alpha radioligand therapy," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Many cancer patients still have few or no treatment options. We focus on ARTs with Pb212 because they can selectively deliver lethal energy to tumors in an optimal timeframe, resulting in better outcomes for patients and easier management by health care professionals. We are equally focused on building a distributed manufacturing ecosystem to maximize the potential of these therapies through a footprint tailored to the short half-life of Pb212."

A New Approach for Alpha Radioligand Therapy (ART)
ARTBIO’s unique approach is underpinned by a deep understanding of cancer biology and the infrastructure needed to effectively design, manufacture and distribute ARTs.

There are four distinct pillars of development:

The ideal alpha-emitter profile: Pb212 has a short half-life that matches the properties of the small molecule carriers used by ARTBIO, delivering most of its energy into the tumor quickly.
A differentiated pipeline of ARTs: ARTBIO has one asset in clinical development, with additional assets in rapid pre-clinical development, each focusing on addressing unmet medical needs.
Distributed ART manufacturing ecosystem: The company is building an end-to-end distributed manufacturing network for reliable and fast delivery of therapeutic candidates to the bedside.
Proprietary Pb212 isolation technology: ARTBIO’s AlphaDirect technology delivers highly pure Pb212 from widely available raw materials.
An Expert Leadership Team
ARTBIO has assembled a world-class team of talented professionals spanning multiple disciplines and categories.

"ARTBIO’s team is highly skilled and passionate, bringing together a unique combination of expertise in the radioligand space, drug development and oncology," said Ted W. Love, M.D., Chairman of the Board at ARTBIO. "I believe that ARTBIO’s approach represents the future of radioligand therapy that will radically advance cancer care."

The leadership includes:

Management Team

Emanuele Ostuni, Ph.D., Chief Executive Officer; Former Head of Europe for Cell & Gene Therapy for Novartis Oncology
Bharat Lagu, Ph.D., Sr. Vice President and Head of Discovery; Former Head of Drug Discovery at Mitobridge (acquired by Astellas)
Victor Paulus, Ph.D., Sr. Vice President and Head of Regulatory Affairs; Former SVP of Regulatory Affairs at Fusion and Advanced Accelerator Applications.
Vicki Jardine, M.D., Ph.D., Vice President of Clinical Development; Former Senior Clinical Development Leader (Alpha Radioligand Therapies) at Bayer
Gjermund Olsen, Director of Manufacturing; Former Head of Technology Development (Radiotherapies) at Bayer
Scientific Advisory Board

Øyvind Bruland, M.D.; ARTBIO SAB Chairman and Co-founder
Roy Larsen, Ph.D.; ARTBIO Co-founder
Oliver Sartor, M.D.; Director of Radiopharmaceutical Trials, Mayo Clinic
Richard P. Baum, M.D.; President of the International Centers for Precision Oncology (ICPO) Academy and a Consultant at the Advanced Center for Radiomolecular Precision Oncology (RPO) at Curanosticum Wiesbaden-Frankfurt
Dennis Benjamin, Ph.D.; Former Head of R&D at Seagen
Board of Directors

Ted W. Love, M.D.; Chairman of the ARTBIO Board; Chair of Biotechnology Innovation Organization’s (BIO) Board of Directors
Alex Pasteur, Ph.D.; Partner at F-Prime Capital
Otello Stampacchia, Ph.D.; Managing Director and Founder at Omega Funds
Roy Larsen, Ph.D.; ARTBIO Co-Founder, Founder of Sciencons
Anders Tuv, Partner at Radforsk
Susanne Schaffert, Ph.D.; ARTBIO Independent Director; Former President of Novartis Oncology and Advanced Accelerator Applications
Emanuele Ostuni, Ph.D.; Chief Executive Officer of ARTBIO
Martin Taylor, Ph.D.; Senior Associate at F-Prime Capital (Observer)
Francesco Draetta; Partner at Omega Funds (Observer)
"ARTBIO is a global company that was incubated in Europe, where there has been much innovative development in the radioligand therapy space," said Alex Pasteur, Ph.D., Partner at F-Prime Capital. "Roy and Øyvind are serial entrepreneurs responsible for developing the only alpha particle emitting radiopharmaceutical product currently on the market. We look forward to working with this team to support the development of their pipeline and advance their vision of creating alpha radioligand therapies that are accessible, effective, and safe for patients around the world."

On June 21, 2023 Processa pharmaceuticals presented its corporate presentation (Presentation, Processa Pharmaceuticals, JUN 21, 2023, View Source [SID1234632828]).

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On June 21, 2023-Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the closing of its previously announced public offering of (i) 2,270,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) two classes of warrants to purchase up to an aggregate of 4,540,000 shares of its common stock (the "Public Warrants") at a purchase price of $3.75 per share and associated Public Warrants and $3.749 per pre-funded warrant and associated Public Warrants (Press release, Panbela Therapeutics, JUN 21, 2023, View Source;utm_medium=rss&utm_campaign=panbela-announces-closing-of-approximately-8-5-million-public-offering [SID1234632826]). The prefunded warrants have an exercise price of $0.001 per share. The Public Warrants have an exercise price of $3.75 per share, are exercisable upon issuance, and will expire five years following the date of issuance.

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Roth Capital Partners acted as sole placement agent of the offering.

Gross proceeds, before deducting placement agent fees and commissions and offering expenses, were approximately $8.5 million. The Company intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates, working capital, business development and other general corporate purposes, which may include repayment of debt.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-271729), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 15, 2023. The offering was made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On June 21, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported that Chandler Robinson, MD, Monopar’s Chief Executive Officer, will participate in a panel discussion at the "Radiopharma Forum by the Lake" on Monday June 26, 2023, at 6:15pm CT at the Chicago Club (Press release, Monopar Therapeutics, JUN 21, 2023, View Source [SID1234632825]).

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"We are excited to be a part of this event, which is bringing together leaders in the radiopharma space, from drug development companies to investors to isotope manufacturers to CDMO’s. We intend to highlight our lead radiopharma program focused on the novel target uPAR along with a linker that binds to actinium-225 with high affinity which we filed a patent on," said Dr. Robinson.

Due to favorable properties such as its long half-life, high potency, and short distance of activity, actinium-225 (Ac-225) is quickly emerging as a therapeutic isotope of choice. Monopar’s filed patent relates to the novel finding that antibodies conjugated to the linker PCTA can achieve nearly 100% binding to Ac-225. The PCTA-antibody conjugates also appear to bind daughter ions, such as Bi-213, with high affinity. This high affinity binding may decrease the amount of Ac-225 and its daughter ions that permanently detach from the antibody, which could potentially reduce off-target toxicity and increase efficacy by enabling higher effective dosing.