Next Generation Chemotherapy

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

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Panbela Announces Closing of Approximately $8.5 Million Public Offering

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.

Monopar to Participate in the Radiopharma Forum by the Lake 2023

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.

Interius BioTherapeutics Highlights Strong Preclinical Data Supporting In Vivo Chimeric Antigen Receptor (CAR) Vector Evaluation in Clinic

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."

Exact Sciences Advances Innovative Cancer Technologies and Approaches Through Visionary Collaborations

On June 21, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported separate collaborations with two renowned healthcare organizations at the forefront of cancer research (Press release, Exact Sciences, JUN 21, 2023, View Source [SID1234632822]). The agreements aim to improve patient care by increasing access to genomic information. Combining cutting-edge technologies with expertise from thought leaders at Broad Institute of MIT and Harvard and Baylor Scott & White, Exact Sciences will provide smarter answers before diagnosis and throughout cancer treatment.

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"These collaborations mark a significant milestone in Exact Sciences’ pursuit to eradicate cancer," said Jorge Garces, Chief Science Officer at Exact Sciences. "Our combined efforts will unlock new insights into the complexities of cancer. We hope to enable preventive measures and treatments that address the unique needs of each patient to maximize their chances of achieving positive outcomes."

Agreements with Broad Institute of MIT and Harvard provide e xclusive license to next-generation technology for ultra-sensitive detection of molecular residual disease and ongoing research

Exact Sciences and Broad Institute have entered into a 5-year sponsored research agreement and an exclusive license agreement to utilize Minor Allele Enriched Sequencing Through Recognition Oligonucleotides (MAESTRO) as its molecular residual disease diagnostic testing platform. MAESTRO is a next-generation circulating tumor DNA technology that can detect thousands of patient-specific mutations using minimal sequencing and advanced bioinformatics, creating a scalable test platform for enhanced detection of molecular residual disease. The Broad Institute is globally recognized for leading innovations in the field of genomics and next-generation sequencing methodology. MAESTRO was developed at the Broad Institute’s Gerstner Center for Cancer Diagnostics which is focused on breakthrough innovations for significant unmet needs in cancer diagnostics.

Collaboration with Baylor Scott & White creates real-world experience and evidence supporting Exact Sciences’ multi-cancer early detection (MCED) approach

Exact Sciences and Baylor Scott & White (BSW) have entered an agreement to establish the Texas Multicancer Early Detection Registry program, including implementation of Exact Sciences’ MCED test within a subset of BSW primary care clinics. As part of the program, Exact Sciences will generate real-world evidence related to MCED testing in a clinical setting and provide comprehensive support to patients, ordering providers, and clinical staff. The program aims to provide about 50,000 testing opportunities over three years, helping optimize the clinical workflows of MCED testing. The collaboration will also generate data to support discussions with regulatory agencies, payers, and guideline bodies.