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.

On June 21, 2023 Interius BioTherapeutics, a leading developer of in vivo cell-specific genetic medicine therapeutics, reported the presentation of compelling preclinical data at the Cellicon Valley 2023 Meeting in Philadelphia, PA (Press release, Interius BioTherapeutics, JUN 21, 2023, View Source [SID1234632824]). The data demonstrates the potential of Interius Bio’s lead program (INT2104) to generate biologically active CAR cells directly in vivo for the treatment of B-cell malignancies. The company will also be unveiling non-human primate data from multiple studies at the In Vivo Engineering of Therapeutic Cells Summit in Boston, MA on July 10-12, 2023.

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In mouse models of systemic lymphoma, complete tumor clearance occurs across a wide dose range after a single intravenous infusion of Interius Bio’s targeted cell-specific lentiviral vector. The proprietary vector mediates direct in vivo creation of CAR T and NK cells that specifically kill malignant B cells. In non-human primates treated with a single vector infusion in the absence of conditioning chemotherapy, significant B cell depletion is observed with no toxicity and has been sustained in one animal for over 6 months.

Interius President and CEO Phil Johnson, MD states "The company’s preclinical data address three critical questions: Does it work? Can you make it? Is it safe? We are thrilled that the answer to each of these questions is yes based on extensive animal model work, including dosing of over 20 cynomolgus macaques, with a vector dose equivalent or exceeding the highest proposed human dose. In all models we have observed no signs of cytokine release syndrome (CRS) or neurotoxicity, no clinical symptoms, and no laboratory abnormalities."

"The compelling preclinical findings of specificity, biologic effect, tolerability and pharmacologic profile in multiple animal models following intravenous administration support the advancement of INT2104 to the clinic as a promising treatment option for B-cell malignancies," says Tim Culp, PhD, VP of Research and Development. "We continue to maintain our timeline to IND with initial human data expected in 2024."